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From the 9/10/2021 release of VAERS data:

Found 686,636 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 353 out of 6,867

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VAERS ID: 1656547 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-02-18
Onset:2021-07-16
   Days after vaccination:148
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Blood test, Chest pain, Chills, Computerised tomogram, Dizziness, Dyspnoea, Electrocardiogram, Full blood count, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: calcium, vitamin D, multi-vitamin
Current Illness: none
Preexisting Conditions: osteoporosis
Allergies: none
Diagnostic Lab Data: CBC and other blood work, Covid test, CAT scan of abdomen, EKG
CDC Split Type:

Write-up: Fever, dizziness, pain in chest, shortness of breath, muscle and joint aches, chills


VAERS ID: 1656580 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-03-26
Onset:2021-07-16
   Days after vaccination:112
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046A21A / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Asthenia, Diarrhoea, Foreign travel, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 51 y/o male, BMI 37.7, PMHx of HTN and hypolipidemia, admitted for diarrhea, fever, and generalized weakness on 7/19/21. Pt just returned from 4 weeks stay from traveling and symptoms began the day after he got back. Pt presented with AKI. Pt treated with IV antibiotics and IV fluids. Pt was discharged to home on 7/21/21.


VAERS ID: 1657045 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-07-12
Onset:2021-07-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Blood test, Chest X-ray, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hospital ER 7/17/2021 - ECG, chest x-ray, blood work, Covid test PCP - heart monitor Cardiologist - echocardiogram, heart monitor
CDC Split Type:

Write-up: Tachycardia, palpitations, chest pain, weakness, shortness of breath Visit to Hospital ER on 7/17 - IV fluids; follow up with PCP - heart monitor, antibiotics; and cardiologist - echocardiogram, heart monitor, beta blocker (propranolol) Improvement but not resolved as of 8/30/21.


VAERS ID: 1658772 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-01-13
Onset:2021-07-16
   Days after vaccination:184
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3302 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Chest X-ray, Dyspnoea, 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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypercholesterolemia, Acid reflux, PMR.
Allergies: PCN
Diagnostic Lab Data: 7/16/21: CXR.
CDC Split Type:

Write-up: Pt came to ER with difficulty breathing, was recently covid positive. Lives in a healthcare facility with other positive patients.


VAERS ID: 1658784 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-30
Onset:2021-07-16
   Days after vaccination:108
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017B21A / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Nasal congestion, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive, Upper respiratory tract infection
SMQs:, 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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None.
Allergies: NKA
Diagnostic Lab Data: 7/16/21: Covid test: positive.
CDC Split Type:

Write-up: Pt came to ER with URI onset 1 week prior. Nasal congestion, rhinorrhea, and sore throat.


VAERS ID: 1661276 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Allergy to vaccine, Arthralgia, Nausea, Neck pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (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: Allergic reaction; Allergy to molds; Complex regional pain syndrome (Nerve reflection dystrophy bilateral hands and arms); Hives; Milk allergy; Weight increased
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101119217

Write-up: This is a spontaneous report from a program from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 16Jul2021 12:00 (Batch/Lot Number: EW0181) (at the age of 62 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included complex regional pain syndrome from 1985 to an unknown date (Nerve reflection dystrophy bilateral hands and arms), milk allergy from an unknown date and unknown if ongoing, weight increased from an unknown date and unknown if ongoing, allergy reactions for decades and knows to what to do, mold allergy for decades, urticaria from an unknown date and unknown if ongoing (Initially she had to delay getting the vaccine because she was having hives). There were no concomitant medications. The patient previously took varicella zoster vaccine for immunization on 2021 (Ten weeks prior she had shingles vaccine). Patient stated that she experienced the same allergic reaction within 3 to 4 hours after both doses of the vaccine, initially sinus pressure, head ache that eventually involved entire head, neck, and shoulders, nausea, and congestion that resulted in a really thick heavy mucus when able to clear my sinuses. Within 4 hours of getting the first dose patient had a headache across her sinuses and over her head around the back. This lasted for 2.5 - 3 days. She had neck and shoulder pain and nausea. Described all of this as a heavy ache. Usually all of her reactions are about that long. That tells her there is a lot of mold in the vaccine (as reported). Patient took pain and other medications. Patient added with both doses she had sinus pressure and thick mucus formation. She hasn''t had this in a long time. She had an onset of sinus pain. She has had a recurring headache since then. Her neighbor flooded the bathroom floor. Patient feels that there was mold between the flooring. She thinks she was currently being exposed to mold. She developed a bad headache in her forehead that went to the back and sides. This lasted for 2.5 days. She still has a headache but cannot rule out if it is related or not. She also had nausea after the second dose. Patient stated the symptoms took 4 days to resolve after the first dose and 3 to 3.5 days to resolve after the second dose. Patient stated this reaction mimics a classic reaction to mold. Patient stated she has had a mold allergy for decades. Patient stated, It has been years since I have been this sick with an allergic reaction. Patient suspects there may either be a mold component to the vaccine or that the vaccine was stored improperly resulting in microbial growth in the vial. Initially patient had to delay getting the vaccine because she was having hives. She received the second dose on 06Aug2021. It was given in her right arm. Lot: EW0181. The outcome of events was recovered.


VAERS ID: 1662218 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-07-02
Onset:2021-07-16
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027B21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood iron normal, Contusion, Platelet count normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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: Citalopram, Levothyroxine, Pantoprazole
Current Illness: ITP
Preexisting Conditions: Gastric Bypass
Allergies: Macrolides
Diagnostic Lab Data: Platelets and iron levels - normal
CDC Split Type:

Write-up: Deep bruising began 2-3 weeks after both COVID shots


VAERS ID: 1665484 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051C21A / 2 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Pruritus, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Intermittent itching palms,bilateral itching palms,intermittent itching knuckles; Pain at the injection site; Achy knee issue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Intermittent itching palms,bilateral itching palms,intermittent itching knuckles), VACCINATION SITE PAIN (Pain at the injection site) and ARTHRALGIA (Achy knee issue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and ARTHRALGIA (Achy knee issue). On 26-Jul-2021, the patient experienced PRURITUS (Intermittent itching palms,bilateral itching palms,intermittent itching knuckles). The patient was treated with PARACETAMOL (OTC VOLTAREN) for Adverse event, at an unspecified dose and frequency. On 20-Jul-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, PRURITUS (Intermittent itching palms,bilateral itching palms,intermittent itching knuckles) and ARTHRALGIA (Achy knee issue) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. The patient did not experience the same issues after receiving the second dose than compared to the first dose. Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: follow up contains added dose details and updated action taken of suspect vaccine and added event of aching in knees, updated outcome of itching both hands, treatment drug added


VAERS ID: 1665520 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: A16-year-old received her first dose of vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A16-year-old received her first dose of vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A16-year-old received her first dose of vaccine). On 16-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A16-year-old received her first dose of vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A16-year-old received her first dose of vaccine) to be not applicable. No concomitant medications were reported. No treatment information was provided.


VAERS ID: 1665574 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination site pain
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: USMODERNATX, INC.MOD20212

Write-up: Arm hurting from first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Arm hurting from first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced VACCINATION SITE PAIN (Arm hurting from first dose). At the time of the report, VACCINATION SITE PAIN (Arm hurting from first dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Medications details were provided. No Treatment Medications details were provided. Pharmacist called regarding a patient who received both doses of Moderna Vaccine but his arm was still hurting from his first dose when getting the second one on the same arm. Pharmacist wanted to know if patient can take painkillers.


VAERS ID: 1666648 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: California  
Vaccinated:2021-06-15
Onset:2021-07-16
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Blood culture negative, CSF glucose decreased, CSF protein normal, CSF red blood cell count positive, CSF white blood cell count negative, Chest pain, Clostridium test negative, Dysphagia, Echocardiogram abnormal, Electrocardiogram abnormal, Enteral nutrition, Enterovirus test negative, Eyelid ptosis, Intensive care, Laboratory test normal, Macule, Muscular weakness, Neck pain, Paralysis, Pericardial effusion, Pericarditis, Respiratory viral panel, SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative, West Nile virus test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Chronic kidney disease (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 7/18 throat COVID-19 PCR neg 7/18 West Nile Virus AB IgG/IgM negative 7/18, 7/20, 7/21 blood cultures negative 7/19, 7/20} respiratory virus panel PCR neg 7/19 Botulism toxin blood: mouse assay negative. MALDI-TOFF assay negative 7/19 Enterovirus RT-PCR blood negative 7/19 CSF: wbc 1, RBC 1, protein 26, gluc 43, meningoencephalitis panel negative 8/5 COVID-19 IgG $g20. COVID-19 IgM (Stanford) neg
CDC Split Type:

Write-up: Progressive neck soreness and inability to extend the neck/support his head, in addition to droopy eyelids and difficulty swallowing. Progressed to upper limb weakness. Patient was initially admitted to the ICU due to concern for possible botulism poisoning given his descending paralysis, and was given Botulism heptavalent antitoxin on 7/19 with minimal improvement. He was also on a course of antibiotics (Unasyn and then Zosyn) from 7/21 to 7/28. He had slow gradual recovery of neck strength, with mild residual ptosis and dysphagia requiring feeding through a nasal tube which persisted for about a month. At time of discharge 8/14, he still had some mild limb weakness. Of note, he also had multiple episodes of intermittent scattered erythematous macules that appeared over his abdomen for a few minutes before completely resolving, which continued throughout admission. On 8/5-8/6, he also had chest pain with an EKG consistent with pericarditis and an echo showing mild pericardial effusion. Although the pericarditis was mild, given the clinical picture of bulbar and descending weakness/paralysis, there was the concern for his symptoms being due to a variant of Guillain Barre syndrome called "phayngeal-cervical-brachial" GBS which apparently can be descending and limited to the upper body, and might match this patient''s findings. This is especially a concern since botulism testing by Public Health was negative. Please contact the family for more details about his vaccine administration, as he is now discharged


VAERS ID: 1666943 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-02-19
Onset:2021-07-16
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 015M20A / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Atypical pneumonia, Blood test, Bronchitis, Chest X-ray normal, Cough, Electrocardiogram normal, Feeling abnormal, Headache, Oropharyngeal pain, Throat irritation
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Estradiol; Norethindrone; Berberine Plus; Citracal plus D3; Rosuvastatin; CoQ10
Current Illness: No
Preexisting Conditions: Pre-diabetes but has never progressed to diabetes
Allergies: Sulfa
Diagnostic Lab Data: Urgent Care went to that first - No tests; just listened to me and said it was Bronchitis - no treatment; they gave me a Perl Cough medicine - cough suppressant - to take and I was taking OTC Coricidin, At Urgent Care - they did an EKG and chest x-ray - but nothing was wrong on the EKG or chest x-ray; but he was being cautious and sent me to ER for my heart; they said it was Bronchitis, Hospital - ER - they drew blood; EKG; listened to me breathe and determined it was bronchitis
CDC Split Type: vsafe

Write-up: I first had a sore throat and I woke up on 7/17/2021 with it. Over the course of the next few days, it progressed to a scratchy throat and a cough and headache. Around the 24th or 25th, I had a COVID test (PCR) at Pharmacy which came back negative. The next week, I went to Urgent Care clinic (the week of the 26th). They wanted to make sure it didn''t have anything to do with my heart. Sent me to Hospital ER - was diagnosed with Bronchitis. And then I still I wasn''t feeling good and I went on August 3rd, to my doctor and he thought I had walking Pneumonia - he put me on a 10 or 12 day pack of Prednisone and after that is finally sort of went away. I still have a residual cough but I don''t feel sick like I did before.


VAERS ID: 1670454 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-02-26
Onset:2021-07-16
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031M20A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erythema of eyelid, Lacrimation increased
SMQs:, Lacrimal disorders (narrow), Periorbital and eyelid disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin; Montelukast; Levothyroxine; Zyrtec; Omega 3; calcium with vitamin D3; Flonase; Epinastine
Current Illness: None
Preexisting Conditions: None
Allergies: Dust; pollen; trees; grass; hay fever
Diagnostic Lab Data: None
CDC Split Type: vsafe

Write-up: It started out with eye lids that were bright hot pink dark red. It continued for 2 weeks. We got rid of that. I used some ointments on it and I used some eye drops. We went through an entire list of eyedrops. My eyes were watering so badly. They prescribed something one day and handed me samples and that continued for a couple of days until we found something that really worked for me. Now I am using Prednisolone eye drop, Epinastine, Refresh Relieva PF. I am going to start a new treatment starting today.


VAERS ID: 1670834 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-01
Onset:2021-07-16
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022B21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Muscle spasms
SMQs:, Dystonia (broad)

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

Write-up: RT foot started cramping and lasted 20 min.


VAERS ID: 1673308 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / UNK LA / -

Administered by: Private       Purchased by: ?
Symptoms: Bradycardia, Heart rate, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery disease; Epilepsy; GERD; Heart failure; Hypothyroidism; Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Heart rate; Result Unstructured Data: Test Result:under 60bpm 47bpm
CDC Split Type: USPFIZER INC202101084049

Write-up: Pericarditis; Bradycardia; This is a spontaneous report from a contactable consumer. This contactable 33-year-old male consumer (patient) received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0187), via an unspecified route of administration, administered in Arm Left on 13Jul2021 10:30 as dose umber unknown, single for COVID-19 immunisation (Age at Vaccination 33 years). Medical history included cardiac failure, epilepsy, hypothyroidism, coronary artery disease, gastroesophageal reflux disease, drug hypersensitivity (Penicillin). The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient been tested for COVID-19 it was unknown. On 16Jul2021 07:00 patient experienced pericarditis, bradycardia, heart rate under 60bpm 47bpm, swelling of heart. The patient underwent lab tests which included heart rate: under 60bpm 47bpm on 16Jul2021. The events did not result into death/ Life threatening/ Caused/prolonged hospitalization/ Disabling/Incapacitating/Congenital anomaly/birth defect. The adverse event result in Emergency room/department or urgent care. No treatment was received as result of events. The outcome of all events was not recovered.


VAERS ID: 1677306 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Balance disorder, Chest discomfort, Dizziness, Dyspnoea, Dysstasia, Heart rate, Heart rate increased, Lethargy, Muscle spasms, Nausea, Somnolence, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (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 (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ISOSORBIDE; OMEPRAZOLE; SERTRALINE; PROPRANOLOL; INSULIN; VITAMIN D3
Current Illness: Blood pressure abnormal; Stomach cancer (~~~); Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: pulse rate; Result Unstructured Data: Test Result:High
CDC Split Type: USPFIZER INC202100911389

Write-up: Dizzy; I didn''t have a balance; Felt lethargic like sleepy and took a short nap that was late in the afternoon.; Felt lethargic like sleepy and took a short nap that was late in the afternoon.; she feel nauseous; she threw up and came back and recline her sofa and lay down and try to get up from the seat; Leg cramps like in the side of my legs from the knees, both knees, Had severe leg cramps, it went up to my shoulders; High pulse rate,Rapid heartbeat; Had severe leg cramps, it went up to my shoulders and I felt like my chest was tight and had very high pulse,rapid heartbeat.; Couldn''t stand up; Problem with breathing; This is a spontaneous report from a contactable consumer (patient). This is the first case out of the 2 cases. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA6780), dose 2 via an unspecified route of administration on 16Jul2021 at 06:00 PM as a single dose for (at the age of-65 year) COVID-19 immunisation. Medical history included ongoing stomach cancer, ongoing Type 2 diabetes, and ongoing BP/blood pressure. Concomitant medication(s) included isosorbide ''3'' mg (Not appropriately clarified hence dose was not captured in tab), omeprazole, 80 mg taken for stomach cancer (take total 80 mg); sertraline taken for blood pressure; propranolol, 40 mg; insulin (43 Units Insulin, the pen) taken for diabetes (at bed time in the night); vitamin d3, 5 Units. The Oncologist put me on (incomprehensive voice) 5 Units, IU of Vitamin ''D3''." Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA6780), dose 1 via an unspecified route of administration on 25Jun2021 (at the age of-65 year) as a single dose for COVID-19 immunisation. She didn''t have any side effect from the first shot. No other vaccine prior to 4 weeks of COVID Vaccine. On 16Jul2021 patient had the shaky experience few minutes ago because like she said after she walks from the pharmacy they kept her for few minutes under the observation and when she got up from the seat she felt dizzy, like she didn''t have a balance, when she came home she felt lethargic like sleepy and took a short nap that was late in the afternoon (probably 5 in the afternoon), then she felt nauseous, she threw up and came back and reclined in sofa and lay down and she tried to get up from the seat and she had leg cramps like in the side of legs from the knees, both knees. She had severe leg cramps, it went up to shoulders and felt like her chest was tight and had very high pulse, rapid heartbeat and her husband was in the bedroom and he came and thought that (incomplete sentence). So she couldn''t stand up and her husband brought the spray Biofreeze (Treatment). She felt dizziness and took up little aspirin (treatment) and now she was having some relief. She still has a little problem with breathing. Patient was advised to reach out to nearest Emergency room in case of any medical emergency. She was am disabled. (Further not clarified if consumer was financially or physically disabled, hence not captured in tab). She is a cancer patient but on ''remission'' so she does not take any treatment anymore and ''radiation therapy''. Now just the doctors, the oncologist was observing her. She had Laboratory test in the three months, couple days ago. She meet her oncologist. It was 15 days ago. Yesterday''s two week back." (Further clarification was unknown). She was just wondering what to do in case she has the leg cramps. The outcome of events was unknown. No follow-up attempts are completed. No further information is expected.


VAERS ID: 1677399 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101040283

Write-up: Insomnia since day 2 after vaccine can only sleep an hour or 2 at a time with sleep meds. Get jolted awake, never experienced anything like this.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 14Jul2021 at 11:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not had any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient previously received cefalexin (KEFLEX) and erythromycin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. On 16Jul2021 at 23:00, since day 2 after the vaccine the patient experienced insomnia can only sleep an hour or 2 at a time with sleep medicines. Get jolted awake, never experienced anything like this. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event and included treatment with Trazodone for sleep but it didn''t help. The clinical outcome of the event insomnia was not resolved at the time of this report.


VAERS ID: 1681718 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Cough, Diarrhoea, Eye pain, Headache, Intraocular pressure test, Neck pain, Pain in extremity, Pyrexia, Sinus congestion, Sunburn, Weight
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: Low grade fever; Result Unstructured Data: Test Result:100.2; Test Name: Weight; Result Unstructured Data: Test Result:maybe 190 or 195 lbs
CDC Split Type: USPFIZER INC202100930460

Write-up: Cough, after first vaccine/ Cough, after first vaccine was reported as worsened; Pain in back of neck, and over to the right shoulder, after first vaccine; Pain in back of neck, and over to the right shoulder, after first vaccine; Sensation in the shoulder blade, extending to middle of the back, feels like a sunburn sensation, after first vaccine; Congestion in sinuses, after first vaccine; Diarrhea, after first vaccine; Bad chills, after first vaccine; Low grade fever, 100.2, after first vaccine; Headache, after first vaccine; Eyes sore with pressure, after first vaccine; Eyes sore with pressure, after first vaccine; Soreness in left arm, after first vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EW0179, Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 16Jul2021 12:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history not reported. No prior vaccinations, no relevant tests, no other products, no prior vaccinations (within 4 weeks) and other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There were no concomitant medications. On 17Jul2021 06:00, the patient experienced bad chills, after first vaccine. On 16Jul2021 22:00, the patient experienced soreness in left arm, after first vaccine. On 17Jul2021 07:00, the patient experienced pain in back of neck and over to the right shoulder, sensation in the shoulder blade, extending to middle of the back, feels like a sunburn sensation, congestion in sinuses and diarrhea after first vaccine. On 17Jul2021 18:00, the patient experienced cough and in Jul2021, after first vaccine was reported as worsened. On 17Jul2021, the patient experienced headache and eyes sore with pressure after first vaccine. On 17Jul2021 06:00, the patient experienced low grade fever, 100.2, after first vaccine. The patient underwent lab tests and procedures which included body temperature: 100.2 on 17Jul2021 and weight: maybe 190 or 195 lbs on. Therapeutic measures were taken as a result of bad chills, soreness in left arm, pain in back of neck, and over to the right shoulder, sensation in the shoulder blade, extending to middle of the back, feels like a sunburn sensation, congestion in sinuses, diarrhea, after first vaccine, cough, cough, after first vaccine was reported as worsened, headache, eyes sore with pressure and low grade fever, 100.2. The outcome of bad chills, diarrhea and headache was recovering. The patient has taken generic Tylenol for some of her symptoms. On 20Jul2021, the outcome of the events soreness in left arm and low grade fever, 100.2 was recovered. The outcome of bad chills, diarrhea and headache was recovering. The outcome of pain in back of neck and over to the right shoulder, sensation in the shoulder blade, extending to middle of the back, feels like a sunburn sensation, congestion in sinuses, cough, after first vaccine was reported as worsened and eyes sore with pressure was not recovered.


VAERS ID: 1682424 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-03-05
Onset:2021-07-16
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Atrioventricular block, Blood test abnormal, Cardiac assistance device user, Coronary arterial stent insertion, Dyspnoea, Electrocardiogram, Impaired work ability, Surgery
SMQs:, Anaphylactic reaction (broad), Conduction defects (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Other ischaemic heart disease (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? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Metformin, Omeprazole
Current Illness: none
Preexisting Conditions: diabetes type 2, asthma
Allergies: none
Diagnostic Lab Data: blood work; EKG
CDC Split Type: vsafe

Write-up: On 7/16/2021, I woke up with heavy breathing, My BP was 190/103. My breathing continued to worsen and my BP did not change. I decided to go to the ER. They took blood work and EKG . The blood work indicated blockage and I was admitted for sugery and they placed 5 stents. I was in the hospital for 4 days and discharged with instructions to follow up with cardiologist, lifestyle changes, new medications. , and I am wearing a life vest. I will be starting therapy soon and I have not been back to work yet.


VAERS ID: 1684876 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: New York  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Chest pain, Electrocardiogram
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: ASTHMA
Allergies: NKDA, NO FOOD ALLERGIES
Diagnostic Lab Data: Chest Xray, EKG
CDC Split Type:

Write-up: Vaccine was administed at pharmacy and within 30 minutes developed chest pain. 45 minutes after receiving vaccine MD called. Advised to go to ER. Pt given Epi, Benadryl and Steroids.


VAERS ID: 1478686 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-16
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052C21A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Blood test, Burning sensation, Chills, Erythema, Headache, Injection site infection, Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm, Vaccination complication
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Headache, chills, feeling like my body was on fire, red swollen spot on arm that is hot to touch. Very sore can hardly move it. Went to emergency room they took blood work to rule out a blood clot. Doctor treating me for an infection at injection site. Or also known as covid arm.


VAERS ID: 1486517 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Seizure; This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE (Seizure) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). On 16-Jul-2021, SEIZURE (Seizure) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1486522 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-07-16
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001659 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Disorientation, Dizziness, Inappropriate schedule of product administration, Loss of consciousness, Nausea, Pyrexia, SARS-CoV-2 test, Syncope, Thirst, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Disorientation; Dizziness; Very thirsty; Nausea; High temperature; Fainting; Unresponsive for about 45 seconds; Blacout; Inappropriate schedule of vaccine administered; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), UNRESPONSIVE TO STIMULI (Unresponsive for about 45 seconds) and LOSS OF CONSCIOUSNESS (Blacout) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003608 and 3001659) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), UNRESPONSIVE TO STIMULI (Unresponsive for about 45 seconds) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Blacout) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced DISORIENTATION (Disorientation), DIZZINESS (Dizziness), THIRST (Very thirsty), NAUSEA (Nausea) and PYREXIA (High temperature). On 16-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 17-Jul-2021, SYNCOPE (Fainting) had resolved. At the time of the report, UNRESPONSIVE TO STIMULI (Unresponsive for about 45 seconds) and LOSS OF CONSCIOUSNESS (Blacout) had resolved and DISORIENTATION (Disorientation), DIZZINESS (Dizziness), THIRST (Very thirsty), NAUSEA (Nausea) and PYREXIA (High temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. Concomitant product use was not provided by the reporter. No treatment information was provided. Post vaccination patient woke up with initial feeling of nausea, dizziness, disorientation, thirst, high temperature, then collapsed/ experienced a black out and was unresponsive for about 45 seconds , did not regain a full comprehension for further 2 minutes. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1487972 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline (50mg)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Red, hot, and itchy swelling around injection site after 7 days; only red and hot rash around injection site; approximately 5 inches wide, 3 inches tall No treatment, just icing and keeping it cool to reduce swelling at first, mostly to reduce heat of the site at the moment


VAERS ID: 1488601 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Mobility decreased, Nausea, Pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Ache; Tiredness; Nausea; Mobility decreased; This regulatory authority case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Mobility decreased), PAIN (Ache), FATIGUE (Tiredness) and NAUSEA (Nausea) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced MOBILITY DECREASED (Mobility decreased) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, MOBILITY DECREASED (Mobility decreased), PAIN (Ache), FATIGUE (Tiredness) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1488603 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-16
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Lymphadenopathy, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Swollen lymph nodes; Tiredness; Muscular pain; Headache; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), LYMPHADENOPATHY (Swollen lymph nodes), FATIGUE (Tiredness), MYALGIA (Muscular pain) and HEADACHE (Headache) 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. In July 2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), MYALGIA (Muscular pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm), LYMPHADENOPATHY (Swollen lymph nodes), FATIGUE (Tiredness), MYALGIA (Muscular pain) and HEADACHE (Headache) had not resolved. No concomitant medication were provided. No treatment information was provided. The patient had started symptoms at the night of vaccination. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1488617 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Sudden hearing loss
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: GBMODERNATX, INC.MOD20212

Write-up: Sudden hearing loss; Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (Sudden hearing loss) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. No Medical History information was reported. On 12-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced SUDDEN HEARING LOSS (Sudden hearing loss) (seriousness criterion medically significant). At the time of the report, SUDDEN HEARING LOSS (Sudden hearing loss) 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. The patient has not tested positive for COVID-19 since having the vaccine. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. No treatment information was provided.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1489955 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-07-16
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Interchange of vaccine products, Pyrexia, SARS-CoV-2 test, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: chills; fever; Interchange product; Blurry vision; This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and VISION BLURRED (Blurry vision) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. The patient''s past medical history included Polycystic ovaries, Lactation decreased and Clinical trial participant. On 06-Apr-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 16-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced VISION BLURRED (Blurry vision) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant) and INTERCHANGE OF VACCINE PRODUCTS (Interchange product). At the time of the report, CHILLS (chills) and PYREXIA (fever) had not resolved, VISION BLURRED (Blurry vision) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange product) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. After the Moderna COVID-19 shot patient was not being able to read properly and struggled to focus that was not happened during the Astra Zeneca vaccine. The concomitant medication was not reported. The treatment information was not reported. Patient had not tested positive for COVID-19. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. his is a case of interchange of vaccine products with no associated AEs. However, this patient is a clinical trial participant, further information is available for further assessment. There is no contact information available. for follow-up.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. his is a case of interchange of vaccine products with no associated AEs. However, this patient is a clinical trial participant, further information is available for further assessment. There is no contact information available. for follow-up.


VAERS ID: 1489961 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Fatigue; Vomiting; Headache; Generalised aching; Feeling sick; This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), VOMITING (Vomiting), HEADACHE (Headache), PAIN (Generalised aching) and MALAISE (Feeling sick) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PAIN (Generalised aching) (seriousness criterion medically significant) and MALAISE (Feeling sick) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue) had not resolved and VOMITING (Vomiting), HEADACHE (Headache), PAIN (Generalised aching) and MALAISE (Feeling sick) 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. Concomitant product was not provided by the reporter. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. Treatment product was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1489963 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Dizziness, Nausea, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Pain in arm; Chills; Nausea; Vomiting; Diarrhea; Dizziness; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills), NAUSEA (Nausea), VOMITING (Vomiting), DIARRHOEA (Diarrhea) and DIZZINESS (Dizziness) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 16-Jul-2021, NAUSEA (Nausea), VOMITING (Vomiting), DIARRHOEA (Diarrhea) and DIZZINESS (Dizziness) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm) had not resolved and CHILLS (Chills) was resolving. Concomitant medication use information was not provided by reporter. Patient was not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Treatment medication use information was not provided by reporter. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Not applicable) was Not applicable. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No follow up is possible.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No follow up is possible.


VAERS ID: 1489964 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-07-16
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, 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: PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: High temperature; Fatigue; This regulatory authority case was reported by a non-health professional and describes the occurrence of PYREXIA (High temperature) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included PARACETAMOL from 16-Jul-2021 to an unknown date for High temperature. On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, PYREXIA (High temperature) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2021, SARS-CoV-2 test: negative Negative. Treatment information was not provided. Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1489981 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Injection site pain, SARS-CoV-2 test
SMQs:, Extravasation events (injections, infusions and implants) (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: VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Pain injection site; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain injection site) and FATIGUE (Tiredness) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included VENLAFAXINE from 01-Nov-2020 to an unknown date for Depression. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, INJECTION SITE PAIN (Pain injection site) was resolving and FATIGUE (Tiredness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, both events seems to be non-serious since they resolved with no medical intervention.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, both events seems to be non-serious since they resolved with no medical intervention.


VAERS ID: 1489987 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site warmth, Nausea, Pain, Pyrexia, Thirst
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cellulitis (When get insect bites); Idiopathic thrombocytopenic purpura; Lactation decreased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Ache; Thirst; Headache; Nausea; Shivers; High temperature; has got redder; hot; Pain injection site; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), THIRST (Thirst), HEADACHE (Headache), NAUSEA (Nausea), CHILLS (Shivers), INJECTION SITE PAIN (Pain injection site) and PYREXIA (High temperature) in a 49-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased since an unknown date and Cellulitis (When get insect bites) since an unknown date. Concurrent medical conditions included Idiopathic thrombocytopenic purpura. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), THIRST (Thirst) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), INJECTION SITE ERYTHEMA (has got redder) and INJECTION SITE WARMTH (hot). On 17-Jul-2021, THIRST (Thirst), NAUSEA (Nausea) and CHILLS (Shivers) had resolved. On 18-Jul-2021, PAIN (Ache) and PYREXIA (High temperature) had resolved. At the time of the report, HEADACHE (Headache) was resolving, INJECTION SITE PAIN (Pain injection site) had not resolved and INJECTION SITE ERYTHEMA (has got redder) and INJECTION SITE WARMTH (hot) outcome was unknown. Concomitant medications were not reported. Treatment medications were not reported. The reporter states that the patient after the first jab had a swollen and red arm was treated with a course of antibiotics. It was stated that the patient has experienced with shivers about 12hrs after second jab, patient had high temp, nausea and thirst, body aches and headache. Aches, headache, sore arm continued to the next day. Jab site, has got redder, hot, hard, slightly swollen. Area of redness increased. Company comments:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No follow up is possible.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No follow up is possible.


VAERS ID: 1489989 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Severe swelling in left armpit; Absolutely in agony when touching collarbone area, Shoulder joint is very badly painful; Armpit pain; This regulatory authority case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Armpit pain) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 28-Dec-2020. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING (Severe swelling in left armpit) and ARTHRALGIA (Absolutely in agony when touching collarbone area, Shoulder joint is very badly painful). At the time of the report, AXILLARY PAIN (Armpit pain) had not resolved and SWELLING (Severe swelling in left armpit) and ARTHRALGIA (Absolutely in agony when touching collarbone area, Shoulder joint is very badly painful) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product and Treatment information were not provided by the reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1492162 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Confusional state, Dry mouth, Fatigue, Headache, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: sore arm from the injection which happened on my first one; shivering; Chills; Headache; High temperature; Tiredness; Ache; Dry mouth; Confusion; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), DRY MOUTH (Dry mouth), CONFUSIONAL STATE (Confusion), PAIN IN EXTREMITY (sore arm from the injection which happened on my first one), CHILLS (shivering), CHILLS (Chills), HEADACHE (Headache), PYREXIA (High temperature) and FATIGUE (Tiredness) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), DRY MOUTH (Dry mouth) (seriousness criterion medically significant), CONFUSIONAL STATE (Confusion) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). 16-Jul-2021, the patient experienced CHILLS (shivering) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm from the injection which happened on my first one) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Ache), DRY MOUTH (Dry mouth), CONFUSIONAL STATE (Confusion), CHILLS (Chills), HEADACHE (Headache), PYREXIA (High temperature) and FATIGUE (Tiredness) had not resolved and PAIN IN EXTREMITY (sore arm from the injection which happened on my first one) and CHILLS (shivering) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Patient reported went to bed with a sore arm from the injection which happened on his first one. Woke up in the morning shivering even though it was a really warm day. The other effects have progressed during the day. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of the events are based on the Regulatory Report received, as per medical judgement the events for this case are non serious. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of the events are based on the Regulatory Report received, as per medical judgement the events for this case are non serious. No further information is expected at this time.


VAERS ID: 1492165 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Ache; Flu; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache) and INFLUENZA (Flu) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. Not known and Not known) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant) and INFLUENZA (Flu) (seriousness criterion medically significant). At the time of the report, PAIN (Ache) and INFLUENZA (Flu) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. No concomitant and treatment medication was provided. No treatment information was provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. No further information is expected at this time; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding this events has been provided at this time. No further information is expected at this time


VAERS ID: 1492168 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, Nausea, Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Vomiting
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (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: AMITRIPTYLIN
Current Illness: Fibromyalgia; Hypermobility syndrome; Immunodeficiency (Has an illness or condition, not listed above which reduces the immune response (e.g. immunodef...)
Preexisting Conditions: Medical History/Concurrent Conditions: Pernicious anemia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Feeling sick; Painful arm; Swollen arm; Nausea; Vomited; This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), PAIN IN EXTREMITY (Painful arm), PERIPHERAL SWELLING (Swollen arm), NAUSEA (Nausea) and VOMITING (Vomited) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The patient''s past medical history included Pernicious anemia. Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above which reduces the immune response (e.g. immunodef...), Hypermobility syndrome and Fibromyalgia. Concomitant products included AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLIN) from 20-Dec-2020 to an unknown date for an unknown indication. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Vomited) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Feeling sick) (seriousness criterion medically significant). At the time of the report, MALAISE (Feeling sick) outcome was unknown and PAIN IN EXTREMITY (Painful arm), PERIPHERAL SWELLING (Swollen arm), NAUSEA (Nausea) and VOMITING (Vomited) 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) (Intramuscular) was unknown. No treatment medications were reported by reporter. The patient also had very sore arm and shoulder. Patient felt sick and vomited, very sore arm and shoulder. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1492174 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Lethargy, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: SERTRALINE
Current Illness: Anxiety
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.MOD20212

Write-up: Lethargy; Pain; Fever; Chills; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), PAIN (Pain), FATIGUE (Tiredness), PYREXIA (Fever) and CHILLS (Chills) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Anxiety since 30-Jan-2020. Concomitant products included SERTRALINE from 30-Jan-2020 to an unknown date for Anxiety. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced LETHARGY (Lethargy) (seriousness criterion medically significant). At the time of the report, LETHARGY (Lethargy) outcome was unknown and PAIN (Pain), FATIGUE (Tiredness), PYREXIA (Fever) and CHILLS (Chills) 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) (Intramuscular) was unknown. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1492175 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Injection site pain, Neck pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)

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

Write-up: Generalized aching; Neck pain; Shoulder pain; Headache; Injection site pain; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Generalized aching), NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain), HEADACHE (Headache) and INJECTION SITE PAIN (Injection site pain) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PAIN (Generalized aching) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant), ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). At the time of the report, PAIN (Generalized aching), NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain), HEADACHE (Headache) and INJECTION SITE PAIN (Injection site pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported. No treatment information was provided. Patient reported no side effects on first dose but this one has left patient with a severe headache unable to lift arm shoulder of site and neck pain. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1492176 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Ear pain, Headache, Hyperaesthesia, Myalgia, Nausea, Neck pain, Pain, Pain of skin, 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), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: skin sensitivity; dizzy; agony; Pain stomach; Dizziness; Earache; Skin pain; Neck pain; Headache; Muscle ache; Nausea; Feverish; Generalized joint pain; This regulatory authority case was reported by a consumer and describes the occurrence of HYPERAESTHESIA (skin sensitivity), DIZZINESS (dizzy), PAIN (agony), ABDOMINAL PAIN UPPER (Pain stomach), DIZZINESS (Dizziness), EAR PAIN (Earache), PAIN OF SKIN (Skin pain) and NECK PAIN (Neck pain) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concomitant products included PROPRANOLOL from 28-Jun-2021 to an unknown date for Anxiety. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain stomach) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), EAR PAIN (Earache) (seriousness criterion medically significant), PAIN OF SKIN (Skin pain) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant), HEADACHE (Headache), MYALGIA (Muscle ache), NAUSEA (Nausea), PYREXIA (Feverish) and ARTHRALGIA (Generalized joint pain). On an unknown date, the patient experienced HYPERAESTHESIA (skin sensitivity) (seriousness criterion medically significant), DIZZINESS (dizzy) (seriousness criterion medically significant) and PAIN (agony) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Fever, at an unspecified dose and frequency. On 16-Jul-2021, HEADACHE (Headache) and PYREXIA (Feverish) had resolved. On 17-Jul-2021, ABDOMINAL PAIN UPPER (Pain stomach), DIZZINESS (Dizziness), EAR PAIN (Earache), PAIN OF SKIN (Skin pain), NECK PAIN (Neck pain), MYALGIA (Muscle ache), NAUSEA (Nausea) and ARTHRALGIA (Generalized joint pain) had resolved. At the time of the report, HYPERAESTHESIA (skin sensitivity), DIZZINESS (dizzy) and PAIN (agony) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The reaction started 18hours after injection with achy legs and feeling dizzy. The headache started 20hours after injection followed by feeling feverish. 24 hours after injection the reaction was extreme the pain (muscle, joint, stomach and skin sensitivity) was so bad moving brought me to tears. My whole body was agony for about 4 hours even with paracetamol. Overnight the symptoms steadily reduced but the following day I still feel tired and aching. I followed the advice to keep well hydrated throughout and took paracetamol every 4 hours throughout this seemed to have little effect on the symptoms. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1492180 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Headache, Muscle spasms, Musculoskeletal stiffness, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Stiffness; Sore back; Muscle ache; Headache; Nausea; Cramps; This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps), MUSCULOSKELETAL STIFFNESS (Stiffness), BACK PAIN (Sore back), MYALGIA (Muscle ache), HEADACHE (Headache) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced MUSCLE SPASMS (Cramps) (seriousness criterion medically significant), BACK PAIN (Sore back) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant). At the time of the report, MUSCLE SPASMS (Cramps), MUSCULOSKELETAL STIFFNESS (Stiffness), BACK PAIN (Sore back), MYALGIA (Muscle ache), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved. 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 had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1492181 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Tonsillar hypertrophy
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Swollen tonsils; This regulatory authority case was reported by a consumer and describes the occurrence of TONSILLAR HYPERTROPHY (Swollen tonsils) in a 23-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced TONSILLAR HYPERTROPHY (Swollen tonsils) (seriousness criterion medically significant). At the time of the report, TONSILLAR HYPERTROPHY (Swollen tonsils) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment for the events were not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Event seriousness were captured as per Regulatory Authority assessment in Source Document.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Event seriousness were captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1492182 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002615 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Peripheral swelling, SARS-CoV-2 test, Tremor, Vaccination site pain
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: cannot move it from 6 hours after vaccination; Headache; Swollen arm; Shaking; This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), TREMOR (Shaking), HEADACHE (Headache) and VACCINATION SITE PAIN (cannot move it from 6 hours after vaccination) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002615) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included CETIRIZINE from 01-Mar-2021 to an unknown date for Multiple allergies. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and TREMOR (Shaking) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE PAIN (cannot move it from 6 hours after vaccination) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE PAIN (cannot move it from 6 hours after vaccination) had not resolved and TREMOR (Shaking) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-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. No treatment medication was provided by the reporter. Arm incredibly swollen and cannot move it from 6 hours after vaccination; 10 hours after developed full body shaking and was incredibly hot, but no fever, developed headache next morning Patient has not tested positive for COVID-19 since having the vaccine. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1492185 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Headache, Nausea, Pain in extremity, Peripheral swelling, Pyrexia, SARS-CoV-2 test, Terminal insomnia, Tremor
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-AMOXICLAV [AMOXICILLIN;CLAVULANATE POTASSIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Infection breast; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Increased; Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Waking up; Shaking; Painful arm; Swollen arm; Aching joints; Shivering; Nauseous; Head throbbing; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of TERMINAL INSOMNIA (Waking up), TREMOR (Shaking), PAIN IN EXTREMITY (Painful arm), PERIPHERAL SWELLING (Swollen arm), ARTHRALGIA (Aching joints), CHILLS (Shivering), NAUSEA (Nauseous), HEADACHE (Head throbbing) and PYREXIA (Fever) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Infection breast on 23-Jun-2021. Concomitant products included AMOXICILLIN, CLAVULANATE POTASSIUM (CO-AMOXICLAV [AMOXICILLIN;CLAVULANATE POTASSIUM]) from 23-Jun-2021 to 14-Jul-2021 for Infection breast. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced TERMINAL INSOMNIA (Waking up) (seriousness criterion medically significant), TREMOR (Shaking) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), NAUSEA (Nauseous) (seriousness criterion medically significant), HEADACHE (Head throbbing) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (ANADIN EXTRA) for Throbbing headache, Fever and Aching joints, at a dose of 4 lots. At the time of the report, TERMINAL INSOMNIA (Waking up), TREMOR (Shaking), ARTHRALGIA (Aching joints) and CHILLS (Shivering) was resolving and PAIN IN EXTREMITY (Painful arm), PERIPHERAL SWELLING (Swollen arm), NAUSEA (Nauseous), HEADACHE (Head throbbing) and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. On 16-Jul-2021, Body temperature: 40.3 (High) Increased. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Other treatment information includes cold water for coping with Throbbing head, Fever and Aching body. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events doesn?t seem to be serious by medical judgement, but they were assessed as serious as per regulatory authority report.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events doesn?t seem to be serious by medical judgement, but they were assessed as serious as per regulatory authority report.


VAERS ID: 1492708 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD974 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Embolism, Gait disturbance, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had no known drug allergies. The patient have no drug abuse or illicit drug usage, No known medical history and patient reports he is healthy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLJNJFOC20210739686

Write-up: DIFFICULTIES IN WALKING; LEGS STARTED TO BE SWOLLEN, MOSTLY IN THE AREA OF CALVES; EMBOLISM; This spontaneous report received from a patient concerned a male of unspecified age. The patient''s height, and weight were not reported. The patient had no known drug allergies, the patient have no drug abuse or illicit drug usage, no known medical history. The patient mentioned he was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD974, and expiry: UNKNWON) dose was not reported, administered for left arm on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUL-2021, the patient experienced pain in the left arm and patient mentioned he applied herbal medicine Amol. On the same day the patient mentioned, his right and left arm were very swollen and he had also a grey-blue mark on the arm and he was seen by the doctor and diagnosed with embolism. He was not prescribed with any medicine. On 17-JUL-2021, the patient experienced difficulties in walking and his legs started to be swollen, mostly in the area of calves. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from embolism, difficulties in walking, and legs started to be swollen, mostly in the area of calves. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210739686-Covid-19 vaccine ad26.cov2.s - Embolism. 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: 1493311 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Muscular weakness, SARS-CoV-2 test, Vaccination site pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENADRYL ALLERGY RELIEF
Current Illness:
Preexisting Conditions: Comments: No medical history was reported. Patient has not had symptoms associated with COVID-19.
Allergies:
Diagnostic Lab Data: Test Date: 20210221; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Localised itching; Shoulder soreness; Weakness of arms; This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness of arms), VACCINATION SITE PRURITUS (Localised itching) and ARTHRALGIA (Shoulder soreness) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was reported. Patient has not had symptoms associated with COVID-19. Concomitant products included ACRIVASTINE (BENADRYL ALLERGY RELIEF) from 06-Jun-2021 to an unknown date for Hay fever. On 16-Jul-2021 at 11:25 AM, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021 at 12:00 PM, the patient experienced MUSCULAR WEAKNESS (Weakness of arms) (seriousness criterion medically significant) and ARTHRALGIA (Shoulder soreness) (seriousness criterion medically significant). On 16-Jul-2021 at 9:30 PM, the patient experienced VACCINATION SITE PRURITUS (Localised itching) (seriousness criterion medically significant). At the time of the report, MUSCULAR WEAKNESS (Weakness of arms), VACCINATION SITE PRURITUS (Localised itching) and ARTHRALGIA (Shoulder soreness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, SARS-CoV-2 test: negative Negative. It was reported that patient developed slight soreness and weakness from around 12:00pm, which gradually increased to become too painful to lift his arm. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Treatment medication were not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1493316 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blindness, Blood pressure measurement, Dizziness, Headache, Hypotension, Liver function test, Nausea, Presyncope
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: FLUOXETINE; IRON; NEXPLANON; PARACETAMOL; PIRITEZE
Current Illness: Allergic reaction to wasp sting; Anaemia; Bee sting hypersensitivity; Birth control; Depression; Hay fever; Pain
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Tingling of extremity
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Blood pressure; Result Unstructured Data: Low; Test Name: Liver function test; Result Unstructured Data: Abnormal, did not affect every day life
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Low blood pressure; nausea; Near fainting; Loss of vision; Frontal headache; Dizziness; This regulatory authority case was reported by a consumer and describes the occurrence of HYPOTENSION (Low blood pressure), NAUSEA (nausea), PRESYNCOPE (Near fainting), BLINDNESS (Loss of vision), HEADACHE (Frontal headache) and DIZZINESS (Dizziness) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Tingling of extremity. Previously administered products included for an unreported indication: PENICILLIN NOS. Concurrent medical conditions included Bee sting hypersensitivity, Allergic reaction to wasp sting, Hay fever, Pain, Birth control, Anaemia and Depression. Concomitant products included IRON from 01-Jan-2016 to an unknown date for Anemia, ETONOGESTREL (NEXPLANON) from 04-Jun-2021 to an unknown date for Birth control, FLUOXETINE from 01-Apr-2018 to an unknown date for Depression, CETIRIZINE HYDROCHLORIDE (PIRITEZE) from 01-Jan-2013 to an unknown date for Hay fever, PARACETAMOL for Pain. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced PRESYNCOPE (Near fainting) (seriousness criterion disability), BLINDNESS (Loss of vision) (seriousness criteria disability and medically significant), HEADACHE (Frontal headache) (seriousness criterion disability) and DIZZINESS (Dizziness) (seriousness criterion disability). On an unknown date, the patient experienced HYPOTENSION (Low blood pressure) (seriousness criterion medically significant) and NAUSEA (nausea) (seriousness criterion disability). At the time of the report, HYPOTENSION (Low blood pressure), PRESYNCOPE (Near fainting), BLINDNESS (Loss of vision), HEADACHE (Frontal headache) and DIZZINESS (Dizziness) had not resolved and NAUSEA (nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Blood pressure measurement: low (Low) Low. On an unknown date, Liver function test: abnormal (abnormal) Abnormal, did not affect every day life. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient experienced episodes of visual loss lasting from 30 seconds to 2 minutes. The patient thought the events of nausea and dizziness could be caused by low blood pressure. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1493319 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: DESOGESTREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: body ache; Swollen lymph nodes; Lymph node pain; Joint ache; Chills; Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jul-2021 and was forwarded to Moderna on 19-Jul-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes), LYMPH NODE PAIN (Lymph node pain), ARTHRALGIA (Joint ache), CHILLS (Chills) and PYREXIA (Fever) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concomitant products included DESOGESTREL from 01-Feb-2021 to an unknown date for Contraception. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced ARTHRALGIA (Joint ache) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant) and LYMPH NODE PAIN (Lymph node pain) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (body ache). On 17-Jul-2021, ARTHRALGIA (Joint ache), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) and LYMPH NODE PAIN (Lymph node pain) had not resolved and PAIN (body ache) outcome was unknown. No treatment information mentioned. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1495629 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 840539006 / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal distension, Agitation, Dyspnoea, Fatigue, Hypersensitivity, Malaise, Mobility decreased, Muscle contractions involuntary, Nausea, Paraesthesia, Presyncope, Vaccination site warmth
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (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 (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NEURONTIN; DEROXAT; VALDOXAN; HALDOL [HALOPERIDOL]; BUSPIRONE; DOLIPRANE
Current Illness: Asperger''s disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Adverse drug reaction (with the Norset neuroleptic)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: might be an allergic reaction linked to the treatment [for Asperger]; feeling of heat and burn on the right arm in the second after the injection; vasovagal malaise and had to stay on the ground for 30 min; conscient but unable to stand up; difficulty breathing; tingling in the whole body,random generalised tingling that came and went; generalised muscular contractions; agitation; belly bloated/still abnormally swollen/still very bloated all the time; did not feel well stayed lying in bed; nauseas; very tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (might be an allergic reaction linked to the treatment [for Asperger]) in a 26-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 840539006) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Adverse drug reaction (with the Norset neuroleptic). Concurrent medical conditions included Asperger''s disorder. Concomitant products included GABAPENTIN (NEURONTIN), PAROXETINE HYDROCHLORIDE (DEROXAT), AGOMELATINE (VALDOXAN), HALOPERIDOL (HALDOL [HALOPERIDOL]) and BUSPIRONE for Asperger''s disorder, PARACETAMOL (DOLIPRANE) for an unknown indication. On 16-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 16-Jul-2021, the patient experienced HYPERSENSITIVITY (might be an allergic reaction linked to the treatment [for Asperger]) (seriousness criterion medically significant), VACCINATION SITE WARMTH (feeling of heat and burn on the right arm in the second after the injection), PRESYNCOPE (vasovagal malaise and had to stay on the ground for 30 min), MOBILITY DECREASED (conscient but unable to stand up), DYSPNOEA (difficulty breathing), PARAESTHESIA (tingling in the whole body, random generalised tingling that came and went, MUSCLE CONTRACTIONS INVOLUNTARY (generalised muscular contractions), AGITATION (agitation), ABDOMINAL DISTENSION (belly bloated/still abnormally swollen/still very bloated all the time), MALAISE (did not feel well stayed lying in bed), NAUSEA (nauseas) and FATIGUE (very tired). The patient was treated with DESLORATADINE (AERIUS [DESLORATADINE]) on 16-Jul-2021 at a dose of 5 milligram once a day. On 19-Jul-2021, MALAISE (did not feel well stayed lying in bed) outcome was unknown. At the time of the report, HYPERSENSITIVITY (might be an allergic reaction linked to the treatment [for Asperger]) outcome was unknown, VACCINATION SITE WARMTH (feeling of heat and burn on the right arm in the second after the injection), PRESYNCOPE (vasovagal malaise and had to stay on the ground for 30 min), MOBILITY DECREASED (conscient but unable to stand up), DYSPNOEA (difficulty breathing), PARAESTHESIA (tingling in the whole body,random generalised tingling that came and went), MUSCLE CONTRACTIONS INVOLUNTARY (generalised muscular contractions), AGITATION (agitation), NAUSEA (nauseas) and FATIGUE (very tired) was resolving and ABDOMINAL DISTENSION (belly bloated/still abnormally swollen/still very bloated all the time) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Second dose was scheduled for 18-Aug-2021. Patient was allergic reaction linked to the treatment mentioned above and was prescribed antihistamine aerius. The reporter mentioned that in the past their son had a sustained reaction with the Norset neuroleptic. The enquirer found out that Norset contained PEG (polyethylene glycol) and that all the treatment that their son was prescribed contained PEG. The enquirer read that an overdose of PEG could cause a metabolic disorder. Lab data was not provided. Treatment product was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up contain no new information; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1495769 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Exposure during pregnancy, Headache, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Exposure during pregnancy; Pain in arm; Headache; Fever chills; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headache), PYREXIA (Fever chills) and EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. The patient''s last menstrual period was on 15-Oct-2020 and the estimated date of delivery was 21-Jul-2021. On 16-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna CoviD-19 Vaccine) beginning around the thirty-ninth week of the pregnancy. On 17-Jul-2021, PYREXIA (Fever chills) had resolved. On 18-Jul-2021, HEADACHE (Headache) had resolved. On 19-Jul-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved. mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication use information was not provided by reporter. mRNA-1273 (Moderna CoviD-19 Vaccine) batch number was unknown. Treatment medication use information was not provided by reporter. This is a case of product exposure during pregnancy for this 37-year-old female. The patient experienced associated adverse events of pain in extremity, headache and pyrexia during the same day of vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events pain in extremity, headache and pyrexia, a causal relationship cannot be excluded. The company causality for the event exposure during pregnancy is not applicable.; Sender''s Comments: This is a case of product exposure during pregnancy for this 37-year-old female. The patient experienced associated adverse events of pain in extremity, headache and pyrexia during the same day of vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events pain in extremity, headache and pyrexia, a causal relationship cannot be excluded. The company causality for the event exposure during pregnancy is not applicable.


VAERS ID: 1496358 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Nausea; Chills; Tiredness; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, FATIGUE (Tiredness) and HEADACHE (Headache) had not resolved and NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. Patient reported that very severe headache, chills, nausea a the eve of having the vaccine. Bad headache and tiredness continued the next day to the extent just need to lie down and close eyes away from the light. Treatment medication use information was not provided by reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness were captured as per Regulatory Authority assessment in Source Document.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness were captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1496373 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

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

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

Write-up: Diarrhea; This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. No Medical History information was reported. On 12-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Diarrhea) had not resolved. No concomitant medication information was mentioned No treatment medication information was mentioned. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time.


VAERS ID: 1496374 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Headache, Heart rate, Myalgia, Nausea, Pharyngeal swelling, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), 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: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Throat swelling
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: heart rate; Result Unstructured Data: Increased; Test Date: 20210711; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Headache; Throat swelling; Muscle ache; Tight chest/chest tightness; Dizziness; nausea; This regulatory authority case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Tight chest/chest tightness), PHARYNGEAL SWELLING (Throat swelling), DIZZINESS (Dizziness), MYALGIA (Muscle ache), HEADACHE (Headache) and NAUSEA (nausea) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002621) for COVID-19 vaccination. The patient''s past medical history included Throat swelling and Lactation decreased. Concomitant products included IBUPROFEN for Period pains. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced CHEST DISCOMFORT (Tight chest/chest tightness) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and NAUSEA (nausea) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced PHARYNGEAL SWELLING (Throat swelling) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 17-Jul-2021, CHEST DISCOMFORT (Tight chest/chest tightness) and DIZZINESS (Dizziness) had resolved. On 18-Jul-2021, MYALGIA (Muscle ache) had resolved. At the time of the report, PHARYNGEAL SWELLING (Throat swelling), HEADACHE (Headache) and NAUSEA (nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jul-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. On 16-Jul-2021, Heart rate: increased (High) Increased. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient''s symptoms began around four hours after receiving the vaccine. The patient was still able to breath and drink, but it was hard to eat due to the swelling. The patient called the doctor on 17 Jul 2021, and was prescribed Telfast 180mg and told to seek medical attention if the swelling got worse. No additional treatment information was provided by the reporter.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1496401 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during breast feeding, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal exposures via breast milk (narrow), Termination of pregnancy and risk of abortion (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: FOLIC ACID; PARACETAMOL
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20200518; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during breast feeding; Miscarriage; Maternal exposure during pregnancy; This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Breast feeding since an unknown date. Concomitant products included FOLIC ACID for Folic acid supplementation, PARACETAMOL for Pain. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 16-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). On 18-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (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). The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. On 16-Jul-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. On 19-Jul-2021, ABORTION SPONTANEOUS (Miscarriage) was resolving. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2020, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. Patient reports that she was 4.5 weeks pregnant when she received the 2nd vaccine and miscarried 2 days later. No treatment information was provided. Company Comment: This is a case of product exposure during pregnancy with associated AE of Spontaneous Abortion for this 39-year-old female. There is very limited information regarding the reported maternal exposure during breast feeding as there is inability to confirm breastfeeding while pregnant. No further information is expected. This case was linked to MOD-2021-263018 (Parent-Child Link). See case MOD-2021-263018 for details regarding the child case.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AE of Spontaneous Abortion for this 39-year-old female. There is very limited information regarding the reported maternal exposure during breast feeding as there is inability to confirm breastfeeding while pregnant. No further information is expected.


VAERS ID: 1497622 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Maternal exposure during breast feeding, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Neonatal exposures via breast milk (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENTOLIN [SALBUTAMOL]
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: 39.5; Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during breast feeding; High temperature; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding), PYREXIA (Fever) and PYREXIA (High temperature) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Breast feeding. Concomitant products included SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for Asthma. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Fever, at an unspecified dose and frequency. On 17-Jul-2021, PYREXIA (Fever) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and PYREXIA (High temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, Body temperature: 39.5 (High) 39.5. On 16-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that patient was not responding to paracetamol.; Sender''s Comments: This is a case of product exposure during breastfeeding with associated AEs of Pyrexia. However events for this case are tagged as serious based on the Regulatory Report given, as per medical judgement the events for this case are non serious. No further information is expected at this time.


VAERS ID: 1499215 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Agitation, Blood glucose decreased, Face injury, Feeling abnormal, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: fainted; Visual impairment; Agitation; Feeling abnormal; Blood glucose decreased; fell forward cutting my chin; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (fainted), VISUAL IMPAIRMENT (Visual impairment), AGITATION (Agitation), FEELING ABNORMAL (Feeling abnormal), BLOOD GLUCOSE DECREASED (Blood glucose decreased) and FACE INJURY (fell forward cutting my chin) in a 23-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002621) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced SYNCOPE (fainted) (seriousness criteria hospitalization and medically significant), VISUAL IMPAIRMENT (Visual impairment) (seriousness criterion hospitalization), AGITATION (Agitation) (seriousness criterion hospitalization), FEELING ABNORMAL (Feeling abnormal) (seriousness criterion hospitalization), BLOOD GLUCOSE DECREASED (Blood glucose decreased) (seriousness criterion hospitalization) and FACE INJURY (fell forward cutting my chin) (seriousness criterion hospitalization). The patient was treated with GLUCOSE (intravenous) for Blood sugar decreased, at an unspecified dose and frequency and Surgery (Stitches) for Face injury. On 16-Jul-2021, SYNCOPE (fainted) and BLOOD GLUCOSE DECREASED (Blood glucose decreased) had resolved. At the time of the report, VISUAL IMPAIRMENT (Visual impairment), AGITATION (Agitation), FEELING ABNORMAL (Feeling abnormal) and FACE INJURY (fell forward cutting my chin) outcome was unknown. No concomitant medications were reported. It was reported that while driving home after vaccination, the patient felt his vision started to go. The patient pulled in and fainted and fell forward cutting his chin open. He felt strange and agitated when he came around. EMS was called and he was administered glucose for low blood sugar and admitted to hospital. The patient had stitches to the chin from the fall. The patient is no diabetic and has no previous history of such episodes. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1499753 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyskinesia, Muscle rigidity, Muscle twitching, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (narrow), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Faint; Jerky arm; Spasms; Rigidity; Pale; This regulatory authority case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Faint) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant), DYSKINESIA (Jerky arm), MUSCLE TWITCHING (Spasms), MUSCLE RIGIDITY (Rigidity) and PALLOR (Pale). On 16-Jul-2021, SYNCOPE (Faint), DYSKINESIA (Jerky arm) and MUSCLE TWITCHING (Spasms) had resolved. At the time of the report, MUSCLE RIGIDITY (Rigidity) had resolved and PALLOR (Pale) outcome was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Patient reported that after vaccination he experienced fallen from chair and his face down. he was rigid and began to twitch and had jerky arm movements. Patient reported that his movements stopped and he wanted to sit up. His twitching movements lasted for 3-5 seconds and afterwards he came round and wanted to sit up. He was kept in lying position, raising his legs until color came back as he was very pale. After few minutes , he sat up, had water and jelly babies. He was observed for 25 minutes and advised not to drive and contact General practitioner or if any further similar events to seek urgent medical treatment. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Further information is not expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Further information is not expected.


VAERS ID: 1499801 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Pain in extremity, Peripheral swelling, Pruritus, SARS-CoV-2 test, Vaccination site pruritus, Vaccination site 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), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Achy; quite achy; became itchy; The injection site started off slightly red and raised (2cm)"; Itchy; Tired all the time; Swelling arm; This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), PERIPHERAL SWELLING (Swelling arm), FATIGUE (Tired all the time) and HEADACHE (Achy) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 16-Jan-2021 to 24-Jan-2021. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm). On 17-Jul-2021, the patient experienced FATIGUE (Tired all the time). On an unknown date, the patient experienced PRURITUS (Itchy) and HEADACHE (Achy). At the time of the report, PRURITUS (Itchy), FATIGUE (Tired all the time) and HEADACHE (Achy) was resolving and PERIPHERAL SWELLING (Swelling arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. It was also reported that injection site was slightly red and raised. Treatment information was not provided.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness were captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1499811 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Menstrual disorder; Fever; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstrual disorder), PYREXIA (Fever) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 20-Jul-2021, the patient experienced MENSTRUAL DISORDER (Menstrual disorder) (seriousness criterion medically significant). On 18-Jul-2021, PYREXIA (Fever) had resolved. On 19-Jul-2021, HEADACHE (Headache) had resolved. At the time of the report, MENSTRUAL DISORDER (Menstrual disorder) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided by the Reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1499820 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-16
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Hyperhidrosis, Hypoaesthesia, Nasopharyngitis, Nausea, Oropharyngeal pain, Pyrexia, Rectal haemorrhage, SARS-CoV-2 test, Vaccination site joint erythema
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: fresh air; cold; Sore throat; Sweating; Fever; Headache; Fatigue; Nausea; Fever chills; Numbness of limbs; Vaccination site joint redness; This regulatory authority case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (fresh air) in a 24-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced VACCINATION SITE JOINT ERYTHEMA (Vaccination site joint redness). On 17-Jul-2021, the patient experienced HYPOAESTHESIA (Numbness of limbs). On 18-Jul-2021, the patient experienced PYREXIA (Fever chills). On 19-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Sweating), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea). On an unknown date, the patient experienced RECTAL HAEMORRHAGE (fresh air) (seriousness criterion medically significant) and NASOPHARYNGITIS (cold). The patient was treated with PARACETAMOL for Adverse event, at a dose of 1 dosage form every four hours. At the time of the report, RECTAL HAEMORRHAGE (fresh air) and NASOPHARYNGITIS (cold) outcome was unknown, OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (Sweating), PYREXIA (Fever), PYREXIA (Fever chills), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved and HYPOAESTHESIA (Numbness of limbs) and VACCINATION SITE JOINT ERYTHEMA (Vaccination site joint redness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant product information was provided. Additional diagnostic tests include lateral flow test every second day and result was negative. Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information can''t be requested.


VAERS ID: 1499832 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001659 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: GBMODERNATX, INC.MOD20212

Write-up: Seizures; Seizures; Migraine; This regulatory authority case was reported by a consumer and describes the occurrence of the first episode of SEIZURE (Seizures), the second episode of SEIZURE (Seizures) and MIGRAINE (Migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3001659) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion hospitalization prolonged). On 19-Jul-2021, the patient experienced the first episode of SEIZURE (Seizures) (seriousness criteria hospitalization prolonged and medically significant). On 20-Jul-2021, the patient experienced the second episode of SEIZURE (Seizures) (seriousness criteria hospitalization prolonged and medically significant). On 16-Jul-2021, MIGRAINE (Migraine) had resolved with sequelae. On 21-Jul-2021, last episode of SEIZURE (Seizures) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. The reporter stated that the patient did not have symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient had not tested positive for COVID-19 since having the vaccine. The reporter stated that on an unknown date, the patient had a COVID-19 virus test and the result was negative. It was reported that the patient had severe migraines and also seizures that lasted 12 minutes. No concomitant medications were reported by the reporter. Very limited information regarding this events has been provided at this time. Further information is not expected. Seizures onset and stop date 20Jul-21Jul is provided however the outcome of the event is still inaccurately reported as Recovering/Resolving.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information is not expected. Seizures onset and stop date 20Jul-21Jul is provided however the outcome of the event is still inaccurately reported as Recovering/Resolving.


VAERS ID: 1504162 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Heart rate, Palpitations, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: frightened; Racing heart; Chest was sore; Feverish; frightened; Heart rate; This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Racing heart), CHEST PAIN (Chest was sore), the second episode of PALPITATIONS (frightened) and PYREXIA (Feverish) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Ehlers-Danlos syndrome (hypermobility type). Concomitant products included DESOGESTREL, ETHINYLESTRADIOL (GEDAREL) for Contraception. On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced CHEST PAIN (Chest was sore) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant), the first episode of PALPITATIONS (frightened) and HEART RATE (Heart rate). On 16-Jul-2021 at 2:00 AM, the patient experienced PALPITATIONS (Racing heart) (seriousness criterion medically significant). On an unknown date, the patient experienced the second episode of PALPITATIONS (frightened) (seriousness criterion medically significant). On 16-Jul-2021, HEART RATE (Heart rate) had resolved. On 16-Jul-2021 at 10:00 AM, PALPITATIONS (Racing heart) had resolved. At the time of the report, CHEST PAIN (Chest was sore) outcome was unknown and last episode of PALPITATIONS (frightened) and PYREXIA (Feverish) had resolved. Treatment information was not provided. On an unknown date, the patient tested negative for COVID-19. On 16 Jul 2021, at 2:00 am, approximately 13 hours after receiving the Moderna COVID-19 vaccine, the patient woke up due to heart racing. She was too frightened to measure but estimated, it was approximately 120 beats per minute (BPM). At that time, she debated on calling the ambulance but due to being a little feverish the she decided to wait until the morning to see if she was still feverish. At 10 am, she reported the heart rate was back to normal but her chest was sore for the rest of the day. The patient reported holding off on exercise for approximately a week post-vaccination. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events were classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical judgement none of the events were serious (not IME listed and resolved). Events seriousness captured as per Regulatory Authority assessment.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events were classified as serious by regulatory authority (seriousness criteria: medically important condition). However, as per medical judgement none of the events were serious (not IME listed and resolved). Events seriousness captured as per Regulatory Authority assessment.


VAERS ID: 1504172 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Hot flush, Hypotension, Loss of consciousness, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

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

Write-up: lost consciousness; tiredness; Low blood pressure; Fainting; Hot flush; This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness), SYNCOPE (Fainting), HOT FLUSH (Hot flush), HYPOTENSION (Low blood pressure) and FATIGUE (tiredness) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Suspected COVID-19 (Unsure when symptoms stopped.) on 26-May-2020. On 16-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced HOT FLUSH (Hot flush) (seriousness criterion medically significant). On 17-Jul-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant) and HYPOTENSION (Low blood pressure) (seriousness criterion medically significant). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness) (seriousness criterion medically significant) and FATIGUE (tiredness) (seriousness criterion medically significant). On 18-Jul-2021, SYNCOPE (Fainting), HOT FLUSH (Hot flush) and HYPOTENSION (Low blood pressure) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (lost consciousness) and FATIGUE (tiredness) 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. No relevant concomitant medications were reported. No treatment information was provided. absolutely fine then the next day upon waking up, patient stood up and began to walk around. Patient began to feel extremely hot and was unable to cook herself down, patient continued trying to get daily tasks done however all of a sudden her vision started to turn black around the edges, her ears popped and she could feel herself swaying and being unable to walk without help. Patient took blood pressure with help of nurse and it was 80/56, not long after than blood pressure was taken, patient had briefly lost consciousness for a couple of minutes. When patient came back, she felt heavy, weak and unable to concentrate. All symptoms alleviated after 2 days. Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1504518 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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: Brain contusion (Brain contusion recovered with complications.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021908062

Write-up: Platelet count decreased; This is a spontaneous report from a non-contactable physician received via COVID-19 regulatory authority. A 40-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection) via intramuscular on the right arm on 15Jul 2021 at 14:00 (Lot number: FC3661, Expiration data: 30Sep 2021) at the age of 40-year-old as single dose for COVID-19 immunization. Medical history included brain contusion recovered with sequela of brain contusion. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination (drug name was not provided ). Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medication was not reported. The clinical course was as follows: on 16Jul 2021 at 07:00 (1 day 7 hours after the vaccination), the patient experienced Platelet count decreased. The reporter classified the event as serious (Hospitalized) and stated the event results in prolonged hospitalization. The outcome of the event was recovered without treatment. No follow-up attempts are possible; No further information is expected.; Sender''s Comments: As per available information , there is reasonable possibility of temporal association between the event platelet count decreased and the suspect drug BNT162B2.


VAERS ID: 1507476 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002915 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP061909

Write-up: Anaphylaxis; This spontaneous case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 24-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002915) for COVID-19 vaccination. No medical history was provided. On 16-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criteria hospitalization and medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related. Concomitant product use was not provided by the reporter. Patient reported that she experienced anaphylaxis discomfort in the pharynx and larynx . After administration of histamine blocker she experienced no improvements. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Sender''s comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1507477 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003654 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Fruit allergy (allergic to kiwi fruit); Period pains
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Blood pressure; Result Unstructured Data: 68/41 mmHg; Blood pressure decreased; Test Date: 20210716; Test Name: Blood pressure; Result Unstructured Data: after adrenaline was injected intramuscularly, blood pressure increased to 103/70 mmHg; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Body temperature before the 1st dose of vaccine: 36.9? Celsius
CDC Split Type: JPTAKEDA2021TJP061914

Write-up: Anaphylaxis; This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 26-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003654) for COVID-19 vaccination. Concurrent medical conditions included Period pains and Fruit allergy (allergic to kiwi fruit). On 16-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criteria hospitalization, medically significant and life threatening). The patient was treated with ADRENALINE [EPINEPHRINE] (intramuscular) on 16-Jul-2021 for Adverse event, at a dose of 0.5 milliliter. On 16-Jul-2021, ANAPHYLACTIC REACTION (Anaphylaxis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 36.9 (normal) Body temperature before the 1st dose of vaccine: 36.9? Celsius. On 16-Jul-2021, Blood pressure measurement: 68/41 (Low) 68/41 mmHg; Blood pressure decreased and 103/70 (Low) after adrenaline was injected intramuscularly, blood pressure increased to 103/70 mmHg. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related. On 16-Jul-2021, at 10:20, the patient received the 1st dose of this vaccine. At 10:25, dyspnea and severe abdominal pain developed. Decreased blood pressure (68/41) was noted. At 10:30, adrenaline 0.5 mL was injected intramuscularly. Blood pressure rose to 103/70. Emergency call was made. No relevant concomitant medications were reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1507479 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactoid reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP061916AA

Write-up: Anaphylactoid symptoms; This case was received via Agency Regulatory Authority (Reference number: 2021TJP061916AA) on 17-Jul-2021 and was forwarded to Moderna on 24-Jul-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTOID REACTION (Anaphylactoid symptoms) in a 56-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was provided. On 16-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTOID REACTION (Anaphylactoid symptoms) (seriousness criterion medically significant). The patient was treated with ADRENALINE [EPINEPHRINE] for Anaphylactic reaction, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTOID REACTION (Anaphylactoid symptoms) was resolving. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTOID REACTION (Anaphylactoid symptoms) to be possibly related. Concomitant product use was not provided by the reporter. At 11:45, respiratory discomfort developed. Anaphylactoid symptoms were observed. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1507480 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002915 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP061917

Write-up: Anaphylaxis; This regulatory authority case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 24-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002915) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related. Concomitant medication were not reported. Patient had discomfort of pharynx and larynx so she took Histamine blocker by mouth but symptoms did not improve. Patient received the vaccine at a workplace vaccination site where medical supplies were limited, and therefore an emergency help was requested just in case. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1507491 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-16
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP062861

Write-up: High fever; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERPYREXIA (High fever) in a 5-decade-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 11-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HYPERPYREXIA (High fever) (seriousness criterion medically significant). At the time of the report, HYPERPYREXIA (High fever) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1510525 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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: AUPFIZER INC202100925502

Write-up: Facial paralysis; Hypoaesthesia; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 587796. A 55-year-old female patient received unknown dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Jul2021, patient experienced facial paralysis and hypoaesthesia. The outcome of both events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1510956 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure abnormal, Blood pressure measurement, Body temperature, Nausea, Stridor, Tachypnoea, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Infective pneumonia (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: Alcohol intolerance; Asthma bronchial
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Blood pressure; Result Unstructured Data: Test Result:could not be tested.; Test Date: 20210716; Test Name: Blood pressure; Result Unstructured Data: Test Result:became normally.; Test Date: 20210716; Test Name: Blood pressure; Result Unstructured Data: Test Result:turned to be abnormal; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination.; Test Name: Low grade fever; Result Unstructured Data: Test Result:37.0-37.5 Centigrade
CDC Split Type: JPPFIZER INC202100909816

Write-up: Nausea/feeling queasy; Vomiting; bilateral stridor; Anaphylaxis; Tachypnoea; Asthma-like wheezing/bilateral wheezing; blood pressure turned to be abnormal; This is a spontaneous report from a contactable physician received from the Agency (A). Regulatory authority report number is v21120274. A 65-year and 09-month-old female patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY5422, Expiration date 31Aug2021) dose 2 via an unspecified route of administration on 16Jul2021 at 09:50 (the day of vaccination), (at the age of 65-year and 09-month-old) as dose 2, single for COVID-19 immunization. Body temperature before vaccination was 36.3 degrees Centigrade. Medical history included asthma bronchial, but the patient had not received any management from primary care doctor and could not drink anything contained alcohol. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY, not provided) dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and after the first dose of vaccine, the patient complained of feeling poorly, feeling queasy and Low-grade fever (about 37.0 centigrades-37.5 centigrades). Both of them were mild symptoms and could be self-controlled so the patient hoped to receive the second dose. On 16Jul2021 at 09:58 (8 minutes after the vaccination), the patient experienced anaphylaxis, tachypnoea, bilateral stridor, nausea and vomiting. The clinical course was as follows: 5 minutes after the COVID-19 vaccine, the patient experienced asthma-like wheezing and vomiting. Blood pressure could not be tested. On 16Jul2021 at 10:00, EPIPEN was administrated via intramuscular injection route. Route keep was performed. Then the blood pressure turned to be abnormal, and the wheezing symptoms disappeared. However, the symptoms of tachypnoea and feeling queasy still continued. The outcome of the events for tachypnoea and nausea was not recovered and other events was recovered on 16Jul2021 (the day of vaccination). The reporting physician classified the event as serious (Medically Significant) and assessed that the event was related to BNT162B2. Other possible cause of the event such as any other diseases was the medical history of asthma bronchial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1511222 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002618 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Computerised tomogram, Contusion, Fall, Heart rate, Loss of consciousness, Mouth haemorrhage, Presyncope, Wound
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: Test Name: Blood pressure; Result Unstructured Data: Blood pressure 94/68 with no abnormalities of pulse or respiratory condition.; Test Name: CT scan; Result Unstructured Data: CT imaging was performed in a department of neurosurgery, which revealed no abnormalities.; Test Name: Pulse; Result Unstructured Data: Pulse abnormal.
CDC Split Type: JPTAKEDA2021TJP062830

Write-up: Loss of consciousness; Fall; Head bruise; Cuts in the posterior region of the right ear; Vagal reflex; Hemorrhage in the left area of the mouth; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 25-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002618) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Jul-2021 at 1:36 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRESYNCOPE (Vagal reflex), MOUTH HAEMORRHAGE (Hemorrhage in the left area of the mouth) and CONTUSION (Head bruise). 16-Jul-2021, the patient experienced WOUND (Cuts in the posterior region of the right ear). On 16-Jul-2021 at 1:37 PM, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant). 16-Jul-2021 at 1:37 PM, the patient experienced FALL (Fall). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), PRESYNCOPE (Vagal reflex), MOUTH HAEMORRHAGE (Hemorrhage in the left area of the mouth), FALL (Fall), CONTUSION (Head bruise) and WOUND (Cuts in the posterior region of the right ear) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 94/68 (Low) Blood pressure 94/68 with no abnormalities of pulse or respiratory condition.. On an unknown date, Computerised tomogram: normal (normal) CT imaging was performed in a department of neurosurgery, which revealed no abnormalities.. On an unknown date, Heart rate: abnormal (abnormal) Pulse abnormal.. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered LOSS OF CONSCIOUSNESS (Loss of consciousness), PRESYNCOPE (Vagal reflex), MOUTH HAEMORRHAGE (Hemorrhage in the left area of the mouth), FALL (Fall), CONTUSION (Head bruise) and WOUND (Cuts in the posterior region of the right ear) to be possibly related. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1512136 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dysgeusia, Influenza like illness, Muscle spasms, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVJNJFOC20210758113

Write-up: INFLUENZA LIKE ILLNESS; CRAMPS; MEDICATION AFTER TASTE; SYNCOPE; DIZZINESS; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, LV-SAM-2021076309] concerned a 38 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 and expiry: UNKNOWN) 0.5 ml, 1 total administered on 16-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-JUL-2021,14:50 the patient experienced syncope, dizziness, cramps, medication after taste. On 17-JUL-2021, the patient experienced influenza like illness. On unspecified date, the patient was hospitalized. Hospitalization detail was not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope, dizziness, cramps, and medication after taste on 16-JUL-2021, and was recovering from influenza like illness. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0- 20210758113-Covid-19 vaccine ad26.cov2.S- Syncope, dizziness, influenza like illness, cramps, medication after taste. 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: 1512145 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood immunoglobulin G, Therapy non-responder
SMQs:, Lack of efficacy/effect (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: 20210716; Test Name: IgG; Result Unstructured Data: less than 0.5 u/ml; Comments: No neutralizing antibodies to the S1 protein of SARS-COV-2 were detected.; Test Date: 20210720; Test Name: IgG; Result Unstructured Data: 26.20 BAU/ml; Comments: Method: Chemiluminescence, Antigen: Protein S (Spike) Trimeric
CDC Split Type: PTJNJFOC20210753515

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 57-year-old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: 21C10 -05,expiry: unknown) dose was not reported, 1 total, administered on left arm on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. It was reported that the patient made 2 serology tests, Immunoglobulin G (IgG) after being vaccinated. The tests were performed in different labs. On 16-JUL-2021, Laboratory data included: quantitative chemiluminescence immunoassay (IGG) (NR: not provided) less than 0.5 u/ml, no neutralizing antibodies to the Spike 1 protein of SARS-COV-2 were detected. On 20-JUL-2021, Laboratory data included: IgG (NR: not provided) 26.20 BAU/ml. Method: Chemiluminescence, Antigen: Protein S (Spike) Trimeric. The confirmed immunological vaccine failure was reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000187176. Initial information was processed along with additional information received on 26-JUL-2021.; Sender''s Comments: V0: 20210753515-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine 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: 1513227 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: AUPFIZER INC202100925498

Write-up: Anaphylactic reaction; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 587738. A 46-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced anaphylactic reaction on 16Jul2021 with outcome of recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1513785 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Movement disorder, Pain in extremity, SARS-CoV-2 test
SMQs:, Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started. Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021906823

Write-up: Unable to lift arm; pain going into shoulder blade; Painful arm; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107160428212910-CSRJN, Safety Report Unique Identifier GB-MHRA-ADR 25660547. A female patient of an unspecified age second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 15Jul2021, as a single dose for COVID-19 immunization. The patient''s medical history included suspected COVID-19 (unsure when symptoms started and unsure when symptoms stopped). The patient''s concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. On an unspecified date, the patient experienced unable to lift arm and pain going into shoulder blade. On 16Jul2021, the patient experienced painful arm. The patient underwent lab tests and procedures which included COVID-19 virus test: Negative on an unspecified date (No - Negative COVID-19 test). Outcome of the event painful arm was recovering and for all other events, it was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1514101 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021904005

Write-up: Headache; Arthralgia; chills; pyrexia; feeling queasy; This is a spontaneous report from a contactable consumer received via a Pfizer colleague. A female patient in her 30s received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Jul2021 (Batch/Lot number was not reported) as dose number unknown, 0.3ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Jul2021, the patient experienced headache, arthralgia, chills, pyrexia, feeling queasy. The outcome of events was unknown. The reporter classified the events as non-serious and Medically Significant (as reported). The reporter stated that the events were related to the BNT162b2.


VAERS ID: 1514105 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-16
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP062788

Write-up: COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 09-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced COVID-19 (COVID-19 infection) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, COVID-19 (COVID-19 infection) had not resolved. The patient was prescribed with antipyretics as treatment medication. No relevant concomitant medications were reported. On 09-Jul-2021, the patient received the 1st dose of this vaccine. On 16-Jul-2021, COVID-19 infection developed. Patient was scheduled to be discharged on 27-Jul-2021. Action taken with mRNA-1273 in response to the event was not applicable. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Further information was declined. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Further information was declined.


VAERS ID: 1514106 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003654 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Respiratory distress
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fruit allergy; Pain menstrual
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Blood pressure; Result Unstructured Data: 64/31 mmHg; Test Date: 20210716; Test Name: Blood pressure; Result Unstructured Data: 113/62 mmHg; Test Name: Body temperature; Result Unstructured Data: 36.9 degrees Celsius (before vaccination)
CDC Split Type: JPTAKEDA2021TJP062958

Write-up: Respiratory symptoms:Respiratory distress; Gastrointestinal symptoms:severe squeezing pain of entire abdomen; Cardiovascular symptoms: decrease in blood pressure; Anaphylaxis; This spontaneous case was reported by a physician and describes the occurrence of RESPIRATORY DISTRESS (Respiratory symptoms:Respiratory distress) and ANAPHYLACTIC REACTION (Anaphylaxis) in a 26-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003654) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fruit allergy and Pain menstrual. On 16-Jul-2021 at 10:20 AM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criteria medically significant and life threatening) and BLOOD PRESSURE DECREASED (Cardiovascular symptoms: decrease in blood pressure). On 16-Jul-2021 at 10:25 AM, the patient experienced RESPIRATORY DISTRESS (Respiratory symptoms:Respiratory distress) (seriousness criterion medically significant) and ABDOMINAL PAIN (Gastrointestinal symptoms:severe squeezing pain of entire abdomen). The patient was treated with ADRENALINE [EPINEPHRINE] (intramuscular) on 16-Jul-2021 for Anaphylaxis, at a dose of 0.5 milliliter. At the time of the report, RESPIRATORY DISTRESS (Respiratory symptoms:Respiratory distress), ANAPHYLACTIC REACTION (Anaphylaxis), ABDOMINAL PAIN (Gastrointestinal symptoms:severe squeezing pain of entire abdomen) and BLOOD PRESSURE DECREASED (Cardiovascular symptoms: decrease in blood pressure) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, Blood pressure measurement: 64/31 (Low) 64/31 mmHg and 113/62 (normal) 113/62 mmHg. On an unknown date, Body temperature: 36.9 degrees celsius (normal) 36.9 degrees Celsius (before vaccination). The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related. No further causality assessments were provided for RESPIRATORY DISTRESS (Respiratory symptoms:Respiratory distress), ABDOMINAL PAIN (Gastrointestinal symptoms:severe squeezing pain of entire abdomen) and BLOOD PRESSURE DECREASED (Cardiovascular symptoms: decrease in blood pressure). Concomitant products were not provided. At the time of vaccination, the patient was on period and had menstrual pain. The patient had severe abdominal pain and respiratory discomfort. Anaphylaxis developed suddenly, and the symptoms were rapidly progressive.Blood pressure decreased to 64/31. Adrenaline 0.5 mL was administered intramuscularly into the femoral region. Blood pressure improved to 113/62, but other symptoms persisted, and therefore, the patient was transported by ambulance. The symptoms began to improve on arrival at hospital. On 16-Jul-2021, at 14:30, the patient returned home. Reporter''s comments: The event was likely to be anaphylaxis associated with the vaccination. A possibility that the patient experienced vasovagal reflex also cannot be ruled out. Sender''s comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1514107 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003657 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Bradycardia, Feeling hot, Shock
SMQs:, Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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: Hyperthyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.1 degrees Celsius
CDC Split Type: JPTAKEDA2021TJP062963

Write-up: Psychogenic shock; Bradycardia; Hot feeling; This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SHOCK (Psychogenic shock) and BRADYCARDIA (Bradycardia) in a 31-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003657) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hyperthyroidism. On 16-Jul-2021 at 4:25 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced SHOCK (Psychogenic shock) (seriousness criterion medically significant), BRADYCARDIA (Bradycardia) (seriousness criterion medically significant) and FEELING HOT (Hot feeling). The patient was treated with ADRENALINE [EPINEPHRINE] (intramuscular) for Shock, at a dose of 0.4 milliliter. On 16-Jul-2021, SHOCK (Psychogenic shock), BRADYCARDIA (Bradycardia) and FEELING HOT (Hot feeling) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 36.1 (normal) 36.1 degrees Celsius. No concomitant medication details was provided. On 16-Jul-2021, at 16:25, the patient received the 1st dose of this vaccine. At 16:35, the patient complained of hot feeling. Bradycardia developed. Symptoms of psychogenic shock were noted. Adrenaline 0.4 mL was administered (intramuscular injection). After the administration, the patient''s condition resolved, and the patient returned home. Reported that hyperthyroidism may be another factor. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there was temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1514108 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002915 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP062966

Write-up: Anaphylaxis; This case was received via Regulatory Authority (Reference number: 2021TJP062966) on 20-Jul-2021 and was forwarded to Moderna on 28-Jul-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 24-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002915) for COVID-19 vaccination. No Medical History information was reported. On 16-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criteria hospitalization and medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related. Concomitant medications were not reported. patient received the 1st dose of vaccine on 16-Jul-2021 . Pharyngeal and laryngeal discomfort developed. This was a symptom of anaphylaxis. There were no skin symptoms or abnormal vital signs. Patient patient took a histamine blocker, there was no improvement. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1514195 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7483 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure measurement, Body temperature, Chills, Fatigue, Headache, Hypertension, Nausea, Pyrexia, SARS-CoV-2 test, Tension headache
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: blood pressure; Result Unstructured Data: Test Result:13.5 - 9.5; Test Date: 20210721; Test Name: blood pressure; Result Unstructured Data: Test Result:11 - 7; Test Date: 20210716; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210720; Test Name: COVID-19 swab test; Result Unstructured Data: Test Result:negative
CDC Split Type: PEPFIZER INC202100924026

Write-up: blood pressure high / blood pressure was in 13.5 - 9.5; oppressive headache; nausea; "headache typical of fever"; joint pain; chills; a lot of tiredness; fever; Initially, this case has been considered invalid due to missing one of the four ICH validity criteria (Unspecified product). As of (20Jul2021): Same contactable consumer (patient) reported that she received the Pfizer vaccine as second dose on 16Jul2021 in the morning, at 08:00; and, she was "terrible", with 39 of fever and pain all weekend, but especially with a "horrible headache" that continued until the time of this report. The patient received paracetamol for the adverse events, but she mentioned that it did not work, "her head was exploding". As of (21Jul2021): New information was received this is a spontaneous report from a same contactable consumer or other non Health Professional (patient). A 58-year-old female received BNT162b2 (COMIRNATY, Solution for injection, Lot number- FA7483) via an unspecified route of administration on 16Jul2021 at 08:00 in left arm as dose 2 single (at the age of 58-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number- FA9093) via an unspecified route of administration in left arm on 25Jun2021 as dose 1 single (at the age of 58-year-old) for COVID-19 immunization and experienced joint pain and tiredness with first dose. On the night of 16Jul2021, at bedtime, the patient started to experience joint pain, chills and a lot of tiredness. At that time, her body temperature was 39 centigrade. The patient took paracetamol for those events. Despite that, she slept very badly that night. On 17Jul2021, the "headache typical of fever" was added. On 18Jul2021, the patient stopped experiencing fever, chills, and joint pain; but the tiredness and headache continued. On 19Jul2021 the (type of) headache changed, it was no longer the headache typical of fever but rather an oppressive type; in addition, she started to experience nausea. On 20Jul2021, the patient attended to the Emergency service. The physician who treated her indicated a COVID-19 swab test, which resulted negative. In addition, the patient was found to have high blood pressure. At that time, blood pressure was at 13.5 - 9.5. The patient confirmed that she had never suffered from hypertension before and that her normal blood pressure was usually 11 - 7. For headache, nausea, and high blood pressure, the physician prescribed the following: diclofenac (presentation: ampoule) + orphenadrine (presentation: ampoule), for 2 days; ibuprofen (presentation: tablet) 3 a day for 4 days; orphenadrine (presentation: tablet) 2 a day for 4 days; dimenhydrinate (presentation: tablet); enalapril 1 a day for 3 days. The physician told the patient that he (physician) had seen patients who experienced similar events after vaccination, so he recommended that she continues with the treatment, takes rest during 1 week and when she has recovered from all adverse events, makes an appointment with a cardiologist to evaluate whether treatment will be necessary to continue keeping blood pressure under control. That day, 20Jul2021, the patient returned to home, continued with the treatment. On 21Jul2021, blood pressure was measured before the patient started to work and it was at 11 ? 7 (units not provided). Furthermore, she had stopped experiencing the headache. The only thing she kept experiencing was tiredness. The patient mentioned that the events experienced after the second dose were not like those she experienced after the first dose. The patient did not know the route of administration or the expiration date because it was not provided in her vaccination card. On the night of 25Jun2021, at bedtime, the patient started to experience joint pain and tiredness after first dose. The patient only took paracetamol for the events, without any other additional action. The patient experienced the events throughout that weekend and by Monday, 28Jun2021, she had recovered from the events. The patient underwent lab tests and procedures which included body temperature: 39 centigrade on 16Jul2021; COVID-19 swab test: negative on 20Jul2021; blood pressure measurement: 13.5 - 9.5 on 20Jul2021 and 11 - 7 on 21Jul2021. The outcome of the event joint pain, chills, fever was recovered on 18Jul2021, event headache typical of fever was recovered on 19Jul2021, events oppressive headache, nausea, blood pressure high / blood pressure was in 13.5 - 9.5 was recovered on 21Jul2021 while event a lot of tiredness was not recovered Follow-up attempts have been completed and no further information is expected.


VAERS ID: 1514980 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: COPFIZER INC2021907696

Write-up: dizziness; hypotension; This is a spontaneous report from a contactable physician received from the Regulatory Authority. A 27-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular administered in left arm on 16Jul2021 13:00 (Batch/Lot Number: EW4109) (at the age of 27-year-old) as dose 2, single for covid-19 immunisation, vaccine was administered at a hospital. The patient denies known allergies, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine; the patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient first dose of bnt162b2 intramuscular, administered in left arm on 25Jun2021 12:00 (Batch/Lot Number: EW4109). The patient experienced dizziness and hypotension, onset date was reported as 16Jul2021 13:00, outcome was reported as recovered, the patient received treatment with Trendelenburg maneuver, the events required Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Case reported as serious due to medically significant. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.


VAERS ID: 1515841 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-07-16
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       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: 202107; Test Name: PCR test; Result Unstructured Data: Test Result:positive for Covid-19; Comments: positive for Covid-19
CDC Split Type: BRPFIZER INC202100933283

Write-up: I had the first symptom of covid-19, which has been confirmed by the PCR test; I had the first symptom of covid-19, which has been confirmed by the PCR test; This is a spontaneous report from a contactable consumer (patient) through internet via Pfizer Medical Information Team. A male patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 14May2021 as a Dose 1, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient took the first dose of Pfizer vaccine on day 14May2021. His second dose was scheduled for 06Aug2021. On 16Jul2021, he had the first symptom of Covid-19, which had been confirmed by the PCR test. On and unknown date in Jun2021, the patient underwent lab test and procedure which included SARS-CoV-2 test: Positive for Covid-19. His quarantine (considering 14 days) ends on 29Jul2021. He wanted to know if he could be able to take the second dose on 06Aug2021 or does he have to wait longer to take the second dose. The outcome of the event was unknown. Batch number has been requested on follow-up activities.


VAERS ID: 1516259 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Hypertension, Malaise
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Feeling sick
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210761383

Write-up: SPEECH LOSS; HYPERTENSION ARTERIAL; FEELING SICK; This spontaneous report received from a pharmacist via a Regulatory Authority [EMEA EVHUMAN NLP, FR-AFSSAPS-PO20213663] concerned a 72 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s past medical history included feeling sick, and concurrent conditions included hypertension arterial. On 16-JUL-2021 the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number 21C13-02 expiry: unknown) 0.5 ml, frequency one total, administered for covid-19 vaccination. No concomitant medications were reported. On 16-JUL-2021, the patient experienced speech loss, hypertension arterial and feeling sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from speech loss, hypertension arterial, and feeling sick on 16-JUL-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210761383-covid-19 vaccine ad26.cov2.s-speech loss. 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). 20210761383-covid-19 vaccine ad26.cov2.s-hypertension arterial. 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: MEDICAL HISTORY 20210761383-covid-19 vaccine ad26.cov2.s-feeling sick. This event(s) is labeled per regulatory authority and is therefore considered potentially related.


VAERS ID: 1516321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100908891

Write-up: swelling; Swollen armpit; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-APPCOVID-20210716213029, Safety Report Unique Identifier is GB-MHRA-ADR 25667071. A 36-year-old (non-pregnant) female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 15Jul2021 as dose number unknown single for COVID-19 immunisation. The patient medical history included suppressed lactation. Unsure if patient has had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. It was reported that on an unspecified date, the patient experienced swelling. on 16Jul2021, patient experienced swollen armpit. Large swelling in armpit on side of injection. Not had a COVID-19 test. The outcome of event for swelling was unknown while outcome of swollen armpit was not recovered. Suspect Reactions please provide details of any relevant investigations or tests conducted: "N/A" No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1516326 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       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: GBPFIZER INC202100908890

Write-up: Headache; This is a spontaneous report from a contactable consumer. This is a report received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-APPCOVID-202107172145357030-VVRU6. Safety Report Unique Identifier GB-MHRA-ADR 25669293. A 35-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine, formulation: solution for injection, Batch/Lot Number: FC9001), via an unspecified route of administration on 16Jul2021, as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccination included that the patient received BNT162b2 (PFIZER-BIONTECH COVID-19 Vaccine, formulation: solution for injection, Batch/Lot Number: unknown), via unspecified route on an unspecified date as a dose 1, single for COVID-19 immunisation. Patient had not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. On 16Jul2021, the patient experienced Very bad constant headache. Not controlled by paracetamol or ibuprofen. Therapeutic measures were taken as a result of headache (headache). The outcome of the event was not recovered. No follow-up attempts are possible, No further information is expected.


VAERS ID: 1516327 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Pain in extremity, SARS-CoV-2 test, Tinnitus
SMQs:, Hearing impairment (narrow), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tinnitus
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100916369

Write-up: Tinnitus; Pain in arm; Headache; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-APPCOVID-202107181312331650-NB9HD, Safety Report Unique GB-MHRA-ADR 25669731. A 34-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (lot number: FC9001) as single dose for COVID-19 immunisation. Medical history included tinnitus. Patient has not had symptoms associated with COVID-19 and not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced tinnitus, pain in arm, and headache on 16Jul2021. Patient experienced tinnitus second time. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 18Jul2021. The patient recovered from tinnitus on 18Jul2021, while outcome of other events was not recovered. Case was reported as serious by health authority (disability). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516328 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Haemorrhage, Menstruation irregular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hay fever; Lactation decreased; Myalgia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100916832

Write-up: bleeding; low back pain; Irregular periods; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-APPCOVID-202107181352456890-AGBED, Safety Report Unique Identifier GB-MHRA-ADR 25669753. A 39-year-old female patient received her second dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine), (Lot Number: FC9001), via an unspecified route of administration on 15Jul2021 as single dose for COVID-19 immunisation. Medical history included suppressed lactation, asthma, seasonal allergy, myalgia. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. Concomitant medication included paracetamol taken for myalgia on 15Jul2021. The patient experienced bleeding (non-serious) on 18Jul2021 with outcome of recovering, low back pain (non-serious) on 16Jul2021 with outcome of recovering , irregular periods (non-serious) on 16Jul2021 with outcome of not recovered. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516599 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstruation irregular, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Unsure when symptoms stopped); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100909233

Write-up: Irregular periods; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA).Regulatory authority report number is GB-MHRA-WEBCOVID-202107160950496770-GNNTE.Safety Report Unique Identifier : GB-MHRA-ADR 25662292. A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 13Jul2021 (Lot Number: FD8813) as first dose, single for COVID-19 immunization. Medical history included lactation decreased and positive covid-19 from 31May2021 (unsure when symptoms stopped). The patient''s concomitant medications were not reported. Patient is not pregnant and not currently breastfeeding. Patient is not enrolled in clinical trial. The patient experienced irregular periods on 16Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included covid-19 virus test: Yes - Positive COVID-19 test on 31May2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516606 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-07-16
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Back pain, Dysmenorrhoea, Pain
SMQs:, Retroperitoneal fibrosis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Anti-body blood test; Result Unstructured Data: Test Result:unknown result
CDC Split Type: GBPFIZER INC202100908745

Write-up: pain; pain in lower back; Dysmenorrhea; This is a spontaneous report from a contactable consumer. This is a report, received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107161019279120-NTDMZ, Safety Report Unique Identifier GB-MHRA-ADR 25662467. A 32-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not known), dose 1 via an unspecified route of administration on 16Jun2021 as dose 1, single for COVID-19 immunisation. Medical history included Lactation decreased, Lactation decreased. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not currently breastfeeding. Reporter stated that, really bad lower back pain on lead up to her period. Then extreme pain in lower back and abdomen stopped her from sleeping as the period started. The pain came in waves like contractions. Had to take pain killers and hot water bottle. This is unlike her usual cycle. On an unspecified date, the patient experienced pain and pain in lower back; dysmenorrhea on 16Jul2021. Therapeutic measures were taken as a result of event an included treatment with pain killers. The patient underwent lab tests and procedures, which included Anti-body blood test: unknown result. Patient has not tested positive for COVID-19 since having the vaccine. Clinical trial participant. The outcome of the event pain was recovering and dysmenorrhea and pain in lower back event was unknown. Study details: Anti-body blood test in Education setting No follow-up attempts are possible; information about lot/batch number cannot be obtained


VAERS ID: 1516620 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Headache, Insomnia, 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: HYDROXOCOBALAMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pernicious anemia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909145

Write-up: Ear pain; Headache; Insomnia; This is a spontaneous report from a contactable consumer received from the s Regulatory Agency (RA). The regulatory authority report number is -MHRA-WEBCOVID-202107161140475690-K0RKC, and Safety Report Unique Identifier is -MHRA-ADR 25662896. A 37-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jul2021 (lot number: FD8813) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased, and pernicious anaemia. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant and not currently breastfeeding. Concomitant medication included hydroxocobalamin taken for pernicious anaemia from 09Jul2021. The patient experienced ear pain on 16Jul2021 with outcome of recovering, headache on 16Jul2021 with outcome of recovering, and insomnia on 16Jul2021 with outcome of not recovered. The events were considered serious as other medically important condition. The patient underwent lab test which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516634 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-16
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202100908729

Write-up: Fainting; This is a spontaneous report from a contactable consumer received from a regulatory authority. An 18-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, singl for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had not symptoms associated with COVID-19, did not have a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced fainting on 16Jul2021. This event was reported as medically significant. The outcome of event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516639 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909316

Write-up: anaphylaxis; light- headed; unconscious/passed out; Unconsciousness; This is a spontaneous report from a contactable pharmacist received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107161336051440-FBOWC, Safety Report Unique Identifier is GB-MHRA-ADR 25663922. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: FC9001), via an unspecified route of administration on 16Jul2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was nervous prior to vaccine. Then started becoming light- headed, passed out 10 mins after the vaccine and was unconscious for 5 mins. Woke up holding throat and clutching chest, crash tralley present and adrenaline given, however not confirmed as true anaphylaxis (no change in resp rate, no rash or urticaria). Transferred to A and E dept where now stable and under investigation. Outcome of the events was not resolved. Also reported unconsciousness on 16Jul2021 with outcome of resolving and duration of 1 day. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This case was reported as serious with seriousness criteria-caused/prolonged hospitalization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516640 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100909050

Write-up: Generalised muscle aches; Headache dull; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107161337440160-KEQG8, Safety Report Unique Identifier GB-MHRA-ADR 25663803. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jul2021 (Lot Number: FE1510) as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Patient is not pregnant nor currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced generalised muscle aches and headache dull on 16Jul2021. The events were considered medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative COVID-19 test on 15Jul2021. The patient has not recovered from the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516665 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100908995

Write-up: Abdominal pain; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. A 36-year-old female patient received the 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number was not reported), via an unspecified route of administration on 15Jul2021, as dose 2 , single for COVID-19 immunization. Medical history includes lactation decreased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant; Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced abdominal pain on16Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant). The outcome of the event abdominal pain recovered on 16Jul2021. No follow up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1516668 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Migraine, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
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 INC202100909392

Write-up: Migraine; Headache; Tiredness; Painful arm; Nausea; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107161649454420-WKZ8C. Safety Report Unique Identifier (GB-MHRA-ADR 25665120). A 25-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 15Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced nausea on 16Jul2021, migraine, headache, tiredness and painful arm on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on an unspecified date. The outcome of the events was not resolved. The events were reported as serious due to medically significant. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1516674 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Feeling hot, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (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 Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100909203

Write-up: agitated; Hot; Fainted; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202107161739129100-3ORW2, Safety Report Unique Identifier is GB-MHRA-ADR 25665462. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FC9001), via an unspecified route of administration on 16Jul2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient felt agitated and hot on unspecified date. The patient fainted on 16Jul2021. The report does not relate to possible blood clots or low platelet counts. The patient had negative COVID-19 virus test on unspecified date. The outcome of fainted was recovered in Jul2021, while for the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516683 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-07-16
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dysmenorrhoea, Dyspnoea, Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100909298

Write-up: weakness; pain; Period pains; almost fainted; inability to breath at all for around a minute; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107161833389950-MVCU7, safety report unique identifier is GB-MHRA-ADR 25666629. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Jun2021 (Lot Number: FC9001) as dose 1, single for COVID-19 immunisation. Medical history included lactation decreased. The patient''s concomitant medications were not reported. The patient experienced weakness, pain on an unspecified date, period pains on 16Jul2021. Therapeutic measures were taken as a result of pain, period pain. Clinical course reported: On day 1 of my menstrual period I experienced severe pain in my lower belly (like never before), and I took 1 pill of Panadol (around 9am). Within next 15 minutes the pain increased up to the point that I almost fainted (I had to lay down on the floor) and I experienced inability to breath at all for around a minute, like if my lungs did not work. Luckily after that the ability to breath started to come back to me slowly and I called 111 for advice (around 9.15am). I experienced considerable weakness during next few hours, but the pain was gone. I took another Panadol pill in the afternoon (around 3pm), as pain was starting to come back. Outcome of events weakness, pain was recovering, outcome of other events was recovered on 16Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Case was reported as serious medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1516689 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Fatigue, Feeling abnormal, Headache, Hypophagia, Nausea, Pain, SARS-CoV-2 test, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908961

Write-up: cannot; drink; sleepiness; vomiting; nausea; Headache; Back ache; Tiredness; Pain; This is a spontaneous report from a contactable consumer or other non-HCP received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107161901300880-WYWKK, Safety Report GB-MHRA-ADR 25666149. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: Unknown), via an unspecified route of administration on 15Jul2021 as second dose, single for COVID-19 immunization. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: Unknown), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. Patient had no symptoms associated with COVID-19. The patient''s medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced cannot, drink, sleepiness, vomiting and nausea. On 16Jul2021, patient experienced headache, back ache, tiredness and pain. Clinical course was severe headache even when laying down, pain all over body and extreme tiredness even sleepiness. Severe nausea and vomiting where you cannot eat or drink. On 16Jul2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative (No-Negative COVID-19 test). The outcome of the events cannot, drink, sleepiness, vomiting and nausea was unknown and for remaining events was not resolved. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


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