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From the 9/17/2021 release of VAERS data:

Found 711,579 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 288 out of 7,116

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VAERS ID: 1662856 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-02-24
Onset:2021-08-03
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6202 / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Blood test, COVID-19, Confusional state, Lethargy, SARS-CoV-2 test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: bees
Diagnostic Lab Data: COVID-19 test blood work
CDC Split Type: vsafe

Write-up: In August, I started feeling lethargic. I had lose of energy. I was confused at time. My wife noticed it. I went to the doctor. They did a COVID-19 test, which came out positive. They did blood work.


VAERS ID: 1662864 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Montana  
Vaccinated:2021-02-18
Onset:2021-08-03
   Days after vaccination:166
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6201 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (narrow), 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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ? amLODIPine (NORVASC) 5 mg tablet TAKE ONE TABLET BY MOUTH EVERY DAY 90 tablet ? aspirin 81 mg EC tablet Take 81 mg by mouth Daily. ? atorvaSTATin (LIPITOR) 80 MG tablet TAKE ONE TABLET BY MOUTH EVERY DAY 90 tablet ? Blood Glucose Mon
Current Illness: ASHD/CAD Unspec 3/8/2006 anterior MI ? Back pain neck pain w/ lumbar radiculopathy ? Benign hypertension 3/8/2006 ? BPH ? Colon Polyps, adenomatous 5/15/2007 ? Depression 11/29/2007 ? Diabetes (HCC) ? Diabetes Uncompl Type II 5/15/2007 ? Diverticulitis 06/18/2018 muliple found in the sigmoid colon ? Fatigue ? Hypercholesterolemia 1/27/2011 ? Hypogonadism 3/16/2010 ? Myopathy elevated CPK ? Nephrolithiasis ? Obstructive sleep apnea hypopnea, severe ? Pain Back Unspec ? Sessile colonic polyp 06/18/2018 sigmoid, distal transverse, mid ascending colon and cecum (4-7mm size)
Preexisting Conditions: ASHD/CAD Unspec 3/8/2006 anterior MI ? Back pain neck pain w/ lumbar radiculopathy ? Benign hypertension 3/8/2006 ? BPH ? Colon Polyps, adenomatous 5/15/2007 ? Depression 11/29/2007 ? Diabetes (HCC) ? Diabetes Uncompl Type II 5/15/2007 ? Diverticulitis 06/18/2018 muliple found in the sigmoid colon ? Fatigue ? Hypercholesterolemia 1/27/2011 ? Hypogonadism 3/16/2010 ? Myopathy elevated CPK ? Nephrolithiasis ? Obstructive sleep apnea hypopnea, severe ? Pain Back Unspec ? Sessile colonic polyp 06/18/2018 sigmoid, distal transverse, mid ascending colon and cecum (4-7mm size)
Allergies:
Diagnostic Lab Data: SARS-CoV-2 RNA Resp Ql NAA+probe (SARS CoV-2 PCR (COVID-19)) Positive (LOCAL) Ordered Test: SARS-CoV-2 RNA Resp Ql NAA+probe (SARS CoV-2 PCR (In House)) Ordered Test Codes: 94500-6 (LN LOINC)/7459134031 (L LOCAL) Status: Final Accession Number: 2021212002203001 Specimen Source: Nasopharynx Specimen Site: Specimen Collection Date/Time: 2021-07-31 22:36:00.0
CDC Split Type: 1391831

Write-up: Case completed the Pfizer Covid vaccine series on 2/18/21, then was admitted to hospital for treatment of Covid Pneumonia on 8/3/2021.


VAERS ID: 1662975 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-08-03
Onset:2021-08-03
   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 F197485 / 1 UN / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Alcohol use, Computerised tomogram abdomen, Condition aggravated, Full blood count, Metabolic function test, Pancreatitis acute
SMQs:, Acute pancreatitis (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: no reported medications being used at the time of vaccination
Current Illness: Alcohol Dependence, and past medical history of snowmobile accident with subsequent right foot fracture and L1, L4 vertebral fractures
Preexisting Conditions: Alcohol Dependence
Allergies: Sulfa medications
Diagnostic Lab Data: CT of the abdomen and pelvis, CBC, CMP
CDC Split Type:

Write-up: Patient presented to hospital on 8/19/21 with abdominal pain after consuming 10-12 pack of beer over the weekend. He was found to have acute pancreatitis. He had been diagnosed outpatient with pancreatitis prior to hospital admission on 8/16/21.


VAERS ID: 1663213 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-02-04
Onset:2021-08-03
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / 1 UN / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6198 / 2 UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diabetes Mellitus and cardiovascular disease
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient started experiencing COVID-19 symptoms and was admitted into the hospital on 08/05/2021, discharged on 08/08/2021. Patient and close contacts have been fully vaccinated, has pre-existing medical conditions (Cardiovascular, Diabetes Mellitus,)


VAERS ID: 1666346 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-28
Onset:2021-08-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Aspartate aminotransferase normal, Blood cholesterol increased, Blood potassium increased, Blood thyroid stimulating hormone increased, Bradykinesia, Feeling abnormal, Gait disturbance, Inflammation, Kyphosis, Low density lipoprotein increased, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Dyslipidaemia (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Lipodystrophy (broad), Osteoporosis/osteopenia (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: shrimp
Diagnostic Lab Data: Aug 16 lab results-TSH 7.49 results 54 on the Potassium 143 LDL, 217 cholesterol ,33 on the AST Lab result before the vaccine in June were normal for the TSH and the potassium and lower for the rest.
CDC Split Type:

Write-up: inflammation thru out the body, painful joints, swollen face, walking very slow and hunched, elevated TSH level , elevated Potassium level ,elevated other results Was put on thyroid medication and anti inflammatory meds for now. Getting better slowly Fear from the oncoming symptoms after the vaccine. Never felt this bad before


VAERS ID: 1666924 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-03-03
Onset:2021-08-03
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6201 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cough, Fatigue, Malaise, Nasopharyngitis, SARS-CoV-2 test negative, Sinus congestion, Sinus operation
SMQs:, Anaphylactic reaction (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: L-thyroxine, flunisolide nasal solution, trazodone, cetirizine, CapApatite Bone Builder with Magnesium, glucosamine chondroitin, PhytoMulti, Vitamine D, Ortho-Biotic probiotic, metamucil, OmegaGenics EPA-DHA
Current Illness: none
Preexisting Conditions: hemachromatosis, GERD, functional glucose intolerance, osteo arthritis, IBS
Allergies: morphine
Diagnostic Lab Data: quick, home COVID-19 test on August 8, 2021. Negative
CDC Split Type:

Write-up: I took care of my 4- and 2-year old granddaughters who had caught a cold from their mother. I caught the cold too, exhibiting fatigue, head congestion, sinus drainage, and cough. I began to feel better in 2 days, then about 4 days in I felt sick again. August 8 I took a quick, home COVID-19 test that was negative. Thirteen days after becoming ill, I saw Dr. He prescribed Mucinx decongestant and cough suppressant and a Z-pack. I got better, especially in terms of energy level. I still have some congestion, sinus drainage, and cough.


VAERS ID: 1666964 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Computerised tomogram, Fatigue, Feeling abnormal, Influenza like illness, Injection site swelling, Muscular weakness, Nausea, Pain, Pulmonary congestion, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (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), Arthritis (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: 25mg Metoprolol, 20mg Lasix, 20mg prednisone, Combivent 20-100mcg, 25mg Spironolactine, 75 mg/ml injector pen of Praluent.
Current Illness:
Preexisting Conditions: COPD, Congestive Heart Failure, Diabetes II, Coronary Artery Disease
Allergies: Levofloxacin, Sulfa (Sulfinamide Antibiotics)
Diagnostic Lab Data: I?m still waiting for results from the low dose cat scan. No other testing has been done.
CDC Split Type:

Write-up: The first dose on Aug 3 left me with extreme nausea, moderate joint soreness and muscle weakness. I was extremely fatigued that afternoon. I started having chest congestion and sought medical treatment at a Pulmonologist clinic. I was given two injections. One was an antibiotic, I think it was Doxycycline but I?m not sure. I believe the other to be an antibiotic. I was also given a prescription for Doxycycline, 10mg Prednisone and Fluconazole 150mg. I was sent for a low dose cat scan and have yet to receive the results from that. I received the second Moderns vaccination on Aug 31, 2021. Again, the nausea started a few hours after receiving the shot. This time it?s much worse! I haven?t vomited, but my stomach is literally churning. The location of the shot unreasonably swelled up . I?ve been icing that. I don?t have any fever, but I feel terrible. I?m completely exhausted and my have aches and pains throughout my body. It?s flu like without the vomiting.


VAERS ID: 1667890 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Balance disorder, Dizziness, Insomnia, Migraine, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

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

Write-up: Severe debilitating dizziness/ lightheadedness, nausea, migraine, insomnia, loss of balance. Started within 6-8 hours of vaccine. Currently one month later after first dose and no improvement, getting worse.


VAERS ID: 1669645 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Facial pain, Hypoaesthesia, Pain in jaw, Sinus pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Osteonecrosis (broad), Sexual dysfunction (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: Jaw Hurt; Sinus hurt; Face numbness that went away within 24 hours, left side of her face and neck numbed up; Facial pain for a few days; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Face numbness that went away within 24 hours, left side of her face and neck numbed up), FACIAL PAIN (Facial pain for a few days), PAIN IN JAW (Jaw Hurt) and SINUS PAIN (Sinus hurt) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced HYPOAESTHESIA (Face numbness that went away within 24 hours, left side of her face and neck numbed up) and FACIAL PAIN (Facial pain for a few days). On 04-Aug-2021, the patient experienced PAIN IN JAW (Jaw Hurt) and SINUS PAIN (Sinus hurt). On 04-Aug-2021, HYPOAESTHESIA (Face numbness that went away within 24 hours, left side of her face and neck numbed up) and FACIAL PAIN (Facial pain for a few days) had resolved. At the time of the report, PAIN IN JAW (Jaw Hurt) and SINUS PAIN (Sinus hurt) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant product use was provided by the reporter. No Treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow-up received contains updated drug start date, anatomical location and events of pain in jaw, sinus pain updated.


VAERS ID: 1670557 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products
SMQs:, Medication errors (narrow)

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

Write-up: Patient received J&J vaccine 5/11/2021. Per patient report, he spoke to healthcare provider about getting a "booster" of Pfizer. PCP advised that he do so.


VAERS ID: 1672388 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088D21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Insomnia, Micturition urgency, Pollakiuria, Polyuria
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Tubulointerstitial diseases (broad), Hypokalaemia (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: HCTZ; LEVOTHYROXINE
Current Illness: Hypertension (Improvement with weight loss); Hypothyroidism.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Urinating a lot; Constant urge to urinate 3-4 times an hour; Urge to urinate got worst as the day went by; Unable to sleep; This spontaneous case was reported by a consumer and describes the occurrence of POLYURIA (Urinating a lot), POLLAKIURIA (Constant urge to urinate 3-4 times an hour), MICTURITION URGENCY (Urge to urinate got worst as the day went by) and INSOMNIA (Unable to sleep) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (Improvement with weight loss) since 2013 and Hypothyroidism since 2011. Concomitant products included HCTZ for Hypertension, LEVOTHYROXINE for Thyroid disorder. On 02-Aug-2021 at 7:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced POLYURIA (Urinating a lot), POLLAKIURIA (Constant urge to urinate 3-4 times an hour), MICTURITION URGENCY (Urge to urinate got worst as the day went by) and INSOMNIA (Unable to sleep). At the time of the report, POLYURIA (Urinating a lot), POLLAKIURIA (Constant urge to urinate 3-4 times an hour), MICTURITION URGENCY (Urge to urinate got worst as the day went by) and INSOMNIA (Unable to sleep) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient had zero spasms and zero pain while urinating and the urge to urinate went from a rating of 10/10 to 1/10. Patient reported that the patient had stopped taking HCTZ to help with the issue. The patient was going to the bathroom about 12 times in an hour. It was either a normal amount or just a few drops. The patient was unable to sleep on a night as the patient had to go to the bathroom all night. No treatment medication details was reported. Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Follow-up received : updated patient demographics, added patient medical history,concomitant medications, added event of unable to sleep


VAERS ID: 1672521 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 091D21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia, Pain in jaw, Sinus pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Osteonecrosis (broad), Sexual dysfunction (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: Her jaw hurt for 3 days; Her sinuses hurt for 3 days; The left side of her neck numbed up/ the left side of her face numbed up; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (The left side of her neck numbed up/ the left side of her face numbed up), PAIN IN JAW (Her jaw hurt for 3 days) and SINUS PAIN (Her sinuses hurt for 3 days) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced HYPOAESTHESIA (The left side of her neck numbed up/ the left side of her face numbed up). On 04-Aug-2021, the patient experienced PAIN IN JAW (Her jaw hurt for 3 days) and SINUS PAIN (Her sinuses hurt for 3 days). On 04-Aug-2021, HYPOAESTHESIA (The left side of her neck numbed up/ the left side of her face numbed up) had resolved. In August 2021, PAIN IN JAW (Her jaw hurt for 3 days) and SINUS PAIN (Her sinuses hurt for 3 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product use was provided by the reporter. No treatment medications were reported.


VAERS ID: 1673148 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, Vaccination site erythema, Vaccination site mass, Vaccination site swelling
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: USPFIZER INC202101006183

Write-up: Hard knot, swelling, and redness at injection site/ it felt hard in that spot; hard knot, swelling, and redness at injection site; hard knot, swelling, and redness at injection site; hurt a little more, she has more soreness; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself that: A female patient of unspecified age had received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178, Expiration date ??-AUG-2021), via an unspecified route of administration, administered on left arm on 03AUG2021 at single dose for COVID-19 immunisation. Patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0178) via an unspecified route of administration on 13Jul2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. After first dose patient had didn''t have too much of a reaction maybe a little soreness on Jul2021. After 2nd dose on 03Aug2021, patient had experienced did hurt a little more, she has more soreness but throughout the day she noticed a knot, it felt hard in that spot it felt hard in that spot. Yesterday she noticed that in the area it looks like it was getting swollen like a big mosquito bite that spreads when you scratch it. She iced it yesterday and it still is like that today. She didn''t have a reaction the 1st time but she did with the 2nd. Do they put something different in there the 2nd time She was concerned. At the time of reporting, the outcome of the events were not recovered. Description of complaint: Caller reporting AEs following the 1st and 2nd dose of the Pfizer COVID vaccine asked if they put something different in there the 2nd time? She is concerned since she did not have this side effect with the 1st dose. Probed for NDC, lot number and expiry date and caller does not see the NDC or expiry date on the COVID vaccination record card for the 1st dose and doesn''t see an NDC for the 2nd dose. Therapy start date populated as the date for the caller''s first COVID vaccine and the therapy stop date populated as the date for the caller''s second COVID vaccine. Populated 2nd dose lot and expiry date within formal fields since caller''s main concern was after the 2nd dose. Caller confirms that both doses have the same lot number.


VAERS ID: 1673151 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
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: BABY ASPIRIN; AVASTATIN
Current Illness: Cholesterol (Verbatim: Cholesterol)
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke ("Back in Apr2021 I had a stroke." (not clarfied further))
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101006492

Write-up: My arm is still, I mean its still, it is swollen; It is still sore; It is still sore like still red; This is a spontaneous report from a contactable consumer (patient herself). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration administered in Arm Left on 03Aug2021 at 11:30 (age at vaccination was 68 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cholesterol, which was ongoing and stroke in Apr2021. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and atorvastatin calcium (AVASTATIN) taken for blood cholesterol. The patient reported I got my first shot yesterday and yesterday afternoon (03Aug2021), it caused my arm sore and it looks like it''s just sore a little red around it. She stated my arm is still, I mean its still, it is swollen and I put a ice pack on it and it is still sore like still red. So, can you tell me for this what I can do to heal it. The only thing I was trying to find out was just what else I need to do? Do I need to take Ibuprofen or what I need to do? It caused my arm sore and it looks like it'' s just sore a little red around it. No treatment was received by the patient. The outcome of all the events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1673165 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-07-10
Onset:2021-08-03
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ear infection
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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101013977

Write-up: Ear infection; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Jul2021 at 10:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 03Aug2021 the patient experienced an ear infection. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event ear infection was not recovered at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1673186 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Pain in extremity, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunocompromised; Laparoscopically assisted hysterectomy; Precancerous lesion of colon; Surgery (she had surgery on DEC2020 and it took her 3.5 months before making some progress); Vaginal lesion
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101023637

Write-up: Initially she had only hurt in her arm; came down with shaking; she started having all of the pain in her upper stomach and her lower stomach that had escaladed; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 03Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included surgery from Dec2020 to an unknown date she had surgery in DEC2020 that turned into a nightmare and it took her 3.5 months before making some progress, vaginal lesion from an unknown date and unknown if ongoing, precancerous lesion of digestive tract from an unknown date and unknown if ongoing, immunodeficiency from an unknown date and unknown if ongoing, hysterectomy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient previous received flu vaccine for influenza and pneumonia vaccine for pneumonia (STREPTOCOCCUS PNEUMONIAE) on unspecified date for immunisation. On 03Aug2021 the patient experienced initially she had only hurt in her arm, came down with shaking, she started having all of the pain in her upper stomach and her lower stomach that had escaladed. The outcome of the events pain in extremity, tremor, abdominal pain upper was recovered. Information on the lot/batch number has been requested.


VAERS ID: 1673252 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Florida  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse reaction, Coordination abnormal, Dyskinesia, Dysphemia, Fatigue, Feeling abnormal, Head discomfort, Headache, Muscle twitching, Speech disorder, Thinking abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (narrow), Dystonia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101076912

Write-up: have involuntary head movement; have involuntary head movement; hand twitching; loss of coordination; difficulty speaking and understanding; difficulty speaking and understanding; stutter; headaches; brain fog; fatigue; an adverse reaction; This is a spontaneous report from a Pfizer-sponsored program Pfizer.com-General Company Information received via a contactable Nurse (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 03Aug2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On 03Aug2021, within 30 minutes of vaccine administration patient developed an adverse reaction [unspecified] to the vaccine which was documented in hospital record. On 04Aug2021, the next day and following days patient began to have involuntary head movement, hand twitching, loss of coordination, difficulty speaking and understanding with a stutter, headaches, brain fog, and fatigue. Patient was admitted for six days in the hospital. Patient was now home, however, continued to have symptoms. Outcome of the event adverse reaction was unknown and for all other events were not resolved. Information on the lot/batch number has been requested.; Sender''s Comments: Possible contributory role of suspect vaccine BNT162B2 to reported events can not be excluded. information available in this report is limited and does not allow a medically meaningful assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1673311 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-07-31
Onset:2021-08-03
   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 - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Dizziness, Head discomfort, Hyperhidrosis, Hypertension, Loss of consciousness, Pain in extremity, Pallor, Palpitations, Paraesthesia, Photophobia, SARS-CoV-2 test, Visual impairment, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Hypertension (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CORLANOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Ehlers-Danlos syndrome; Postural orthostatic tachycardia syndrome
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: PCR; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101084152

Write-up: Passed out twice; Tingling and pain in feet and hands; Heart flip flops; Weird head pressure; Dizziness; Vision change; Light sensitivity; High blood pressure; Chest pain; Weight loss; Very pale; Sweats; Tingling and pain in feet and hands; This is a spontaneous report from a contactable consumer (patient). A 36-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 31Jul2021 at 17:00 (at the age of 36-years-old) in left arm as a single dose for covid-19 immunization. Medical history included ehlers-danlos syndrome, postural orthostatic tachycardia syndrome and asthma all from an unknown date and unknown if ongoing. The patient past drug history included cipro. 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. Concomitant medication received within 2 weeks of vaccination included ivabradine hydrochloride (CORLANOR) taken for an unspecified indication, start and stop date were not reported. The patient experienced tingling and pain in feet and hands, heart flip flops, weird head pressure and dizziness, vision change, light sensitivity, high blood pressure, chest pain, sweats, weight loss, passed out twice, very pale on 03Aug2021. The events were reported as non-serious. The patient did not require prolonged hospitalisation. Since the vaccination, the patient was tested for covid-19. The patient underwent lab tests and procedures which included sars-cov-2 PCR test (nasal swab): negative on an unspecified date in 2021. The patient did not receive any treatment. The outcome of all the events at the time of last observation was not resolved. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender''s Comments: Based on plausible dose- event relationship post-vaccination and no alternate explanation the causal role of BNT162B2 vaccine cannot be excluded for the reported events The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1674704 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-23
Onset:2021-08-03
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0161 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blister, Chills, Dyspnoea, Eye pain, Fatigue, Gait disturbance, Headache, Herpes zoster, Hyperhidrosis, Nausea, Pain, Photophobia, Rash, Rash pruritic, Sensitive skin, Sensory loss
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (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: Can''t remember - I take a variety of vitamins and supplements for wellness that I change up daily - vitamin B, C, Zinc, probiotic, Magnesium powder, Vitamin C
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: No tests were done. The doctor looked at the rash and confirmed that it was Shingles. Gave me a prescription for the Antiviral medication.
CDC Split Type:

Write-up: I developed Shingles. What started as a tiny itchy rash above my navel, rapidly formed a band of blisters that wrapped around the side of my body to my spine. The headaches pounded, the nausea was abundant and every nerve ending inside and outside my body felt like electric live wires. I was extremely sensitive to light and my eyes hurt. I had the chills, I had the sweats. Walking was difficult, lying down was difficult, and sometimes the pain was so bad, breathing was difficult. After 5 days, the blisters and most of the symptoms were gone, and I was even able to work. The burning pain lasted until week 5. I still get fatigued really quickly, but the rash is better. I''ve lost some feeling and my skin is still sensitive. I caught it just in time to be given a 10 day course of the Antiviral Valacyclovir. I took Tylenol and Advil for the pain, used ice packs and calamine lotion. Took Lysine to help kill the virus. I had Chickenpox as a child.


VAERS ID: 1675597 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test normal, Chest pain, Dizziness, Heavy menstrual bleeding, Menstruation irregular, Pelvic pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Fertility disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Pertussis reaction when a child
Other Medications: Kolonopin - seizures & anxiety
Current Illness: None
Preexisting Conditions: Seizures High anxiety
Allergies: Penicillin . Erithromycin. Veneflaxin.
Diagnostic Lab Data: Bloodwork done in ER. No issues with organs and no anemia. Released to follow up with obgyn even with pains in chest and pelvis
CDC Split Type:

Write-up: 30 min after shot (my period which was almost over) became heavy and I bled for 39 days. I had lightheaded ness for about an hour after the shot, and now that the bleeding stopped I have chest and pelvic pains. Still in the works of going to obgyn to figure out more. Never had period issues prior to shot


VAERS ID: 1675643 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-31
Onset:2021-08-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Echocardiogram, Electrocardiogram, Pericarditis, X-ray
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? 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: Vitamins, Metoprol, Imvexxy
Current Illness: n/a
Preexisting Conditions: High blood pressure, minimal
Allergies: pseudophedrine
Diagnostic Lab Data: EKG and Ultra sound and xrays
CDC Split Type:

Write-up: Severe pain in my chest when laying down. Repeated for about two weeks. Thought I was having a heart attack at first. Pericarditis. Still feel tightness sometimes now.


VAERS ID: 1676784 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-08-01
Onset:2021-08-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Herpes zoster, Hypoaesthesia, Migraine
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Opportunistic infections (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec Flonase Symbicort Junel
Current Illness: None
Preexisting Conditions: Asthma Migraine
Allergies: Penicillins Gluten
Diagnostic Lab Data: Blood work
CDC Split Type:

Write-up: Migraine for 5 days Shingles 5 days after shot Numbness on left side of body starting one week after shot and lasting one and a half weeks.


VAERS ID: 1677340 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: South Dakota  
Vaccinated:2021-08-03
Onset:2021-08-03
   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 EW0191 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Electric shock sensation, Fatigue, Headache, Pain in extremity, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (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: ACETYLCYSTEINE; PREGNENOLONE; VITAMIN D NOS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to plants (known allergies: eyebright); Hypothyroidism; Post-traumatic stress disorder (PTSD)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101015951

Write-up: Electric shock down the arm into the little finger; Painful injection; pain in the arm; pain in the head; Pain in the shoulder blade 2/10; Mild fatigue; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 03Aug2021 at 13:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, post-traumatic stress disorder (PTSD) and allergy to eyebright. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylcysteine (reported as NAC), pregnenolone (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and unspecified thyroid medication; all for unspecified indication from unknown date and unknown if ongoing. The patient previously received cipro (MANUFACTURER UNKNOWN) and metronidazole (MANUFACTURER UNKNOWN); both for unspecified indication from unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 03Aug2021 at 13:00, the patient experienced electric shock down the arm into the little finger and painful injection, within the next hour the patient felt the product moving up into the left side of head and into the left shoulder blade. 48 hours required Tylenol for 8/10 pain. On 08Aug2021, five days later, patient still had pain in the arm head and shoulder blade 2/10, mild fatigue. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with Tylenol for pain (48 hours required Tylenol for 8/10 pain). The clinical outcome of the events electric shock down the arm into the little finger and painful injection, pain in the arm head and shoulder blade, mild fatigue was recovering at the time of this report.


VAERS ID: 1678141 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-07-27
Onset:2021-08-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003C21A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210803; Test Name: SARS CoV-2 test; Test Result: Positive; Result Unstructured Data: Positive
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: tested positive for covid; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for covid) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication details were not provided by the reporter. On 05 Aug 2021, patient received antibodies treatment. He is due for the second dose of the vaccine.


VAERS ID: 1679051 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-03
Onset:2021-08-03
   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 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: 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: Gabapentin 300mg (3 times daily) Hydrocodone 10-325mg (3 times daily) Melatonin Gummy
Current Illness: Auto Immune Issue
Preexisting Conditions: Auto Immune Issue Spinal Issues
Allergies: Sulfa Based Penicillin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Persistent headaches, nausea, fatigue


VAERS ID: 1679259 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-03-04
Onset:2021-08-03
   Days after vaccination:152
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6204 / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Fatigue, Headache, Nasal congestion, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
SMQs:, Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

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

Write-up: I started with horrible headaches, slight sore throat minor congestion, fever, loss of taste and smell. Lots of Fatigue I was contacted by someone from hospital to sign up for an IV infusion I went to Hospital for monoclonal antibody infusion.


VAERS ID: 1679349 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Idaho  
Vaccinated:2021-07-31
Onset:2021-08-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram, Brain natriuretic peptide, Chest X-ray, Dyspnoea, Electrocardiogram, Erythema, Full blood count, Hypertension, Metabolic function test, Pain in extremity, Peripheral swelling, Troponin, Ultrasound scan, Urine analysis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: no medications, dietary supplements or herbal remedies
Current Illness: Hypertension, Hyperlipidemia, Gilberts syndrome, history of colon-polyps
Preexisting Conditions: Hypertension, Hyperlipidemia, Gilberts syndrome, history of colon-polyps
Allergies: Penicillin- reaction 9/2/1965
Diagnostic Lab Data: 8/3/21: EKG, CBC, UA, CMP, troponin, chest x-ray 8/26/21: Chest CTA, CMP, ProBNP, CBC, Venous Duplex U/S,
CDC Split Type:

Write-up: patient was given vaccine at local pharmacy on 7/30/21. On 8/3/21, patient presented to ER for dyspnea. Patient seen by PCP on 8/4/21 for hypertension. Patient called the office 8/25 for Right leg pain that started several weeks ago, patient was advised to go to minor care. Patient seen 8/26/21 at minor care for dyspnea, RT leg red/swollen x 14 days. Chest CTA ordered- showed Scattered bilateral pulmonary emboli. Venous u/s ordered- showed Extensive DVT. Patient started on Eliquis 5mg. Patient was seen by PCP for follow up on 9/2/21. Next follow up appointment scheduled for October.


VAERS ID: 1679373 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017C21A / 1 LA / IM

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

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

Write-up: None, was just underage


VAERS ID: 1681635 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Burning sensation, Chest discomfort, Chills, Dizziness, Dyspnoea, Fatigue, Feeling abnormal, Hypersensitivity, Hypoaesthesia, Muscle spasms, Somnolence, Taste disorder, Thirst, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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: Allergy NOS (mild allergic reaction, an allergic reaction to anesthesia.)
Preexisting Conditions: Medical History/Concurrent Conditions: Anesthesia (An allergic reaction to anesthesia); Injection (With MRI dye Patient had a swollen tongue, face turned red, and throat constriction was at the top of the throat at the back of the mouth.)
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: The patient''s BP was 132, right before the shot.; Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: The patient''s BP was dropped to 120 after 30 minutes.; Test Date: 20210804; Test Name: Body temperature; Result Unstructured Data: The patient''s body temperature was 96.9 Fahrenheit.
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Her breathing was a little bit labored to the point where she had to tell herself to breath in & out; At 3 am she felt very out of breath just walking to the bathroom; Horrible major leg cramps in both legs from her feet to her thighs; Had foggy thinking; Felt spacy; Her throat was tight again but at the back of the mouth / her throat felt tight again but at back of her mouth; Felt a burning up left her arm / felt a burning on the back part of her neck / felt burning in the middle of her back below the shoulder blades; Exhausted/Tired; Chills; Mild allergic reaction; Lightheaded; Weak; Sleepy; Thirsty; A finger in left hand went numb for a few minutes (that happens with that finger every few months even before the shot); Had a weird taste in her mouth; Her chest felt tight in the middle; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Mild allergic reaction), DIZZINESS (Lightheaded), ASTHENIA (Weak), SOMNOLENCE (Sleepy) and THIRST (Thirsty) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Anesthesia (An allergic reaction to anesthesia) and Injection (With MRI dye Patient had a swollen tongue, face turned red, and throat constriction was at the top of the throat at the back of the mouth.). Concurrent medical conditions included Allergy NOS (mild allergic reaction, an allergic reaction to anesthesia.). On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced HYPERSENSITIVITY (Mild allergic reaction), DIZZINESS (Lightheaded), ASTHENIA (Weak), SOMNOLENCE (Sleepy), THIRST (Thirsty), HYPOAESTHESIA (A finger in left hand went numb for a few minutes (that happens with that finger every few months even before the shot)), TASTE DISORDER (Had a weird taste in her mouth), CHEST DISCOMFORT (Her chest felt tight in the middle), FEELING ABNORMAL (Felt spacy), THROAT TIGHTNESS (Her throat was tight again but at the back of the mouth / her throat felt tight again but at back of her mouth), BURNING SENSATION (Felt a burning up left her arm / felt a burning on the back part of her neck / felt burning in the middle of her back below the shoulder blades), FATIGUE (Exhausted/Tired) and CHILLS (Chills). On 04-Aug-2021, the patient experienced MUSCLE SPASMS (Horrible major leg cramps in both legs from her feet to her thighs), FEELING ABNORMAL (Had foggy thinking) and DYSPNOEA (At 3 am she felt very out of breath just walking to the bathroom). On an unknown date, the patient experienced DYSPNOEA (Her breathing was a little bit labored to the point where she had to tell herself to breath in & out). On 03-Aug-2021, BURNING SENSATION (Felt a burning up left her arm / felt a burning on the back part of her neck / felt burning in the middle of her back below the shoulder blades) had resolved. At the time of the report, HYPERSENSITIVITY (Mild allergic reaction), DIZZINESS (Lightheaded), ASTHENIA (Weak), SOMNOLENCE (Sleepy), THIRST (Thirsty), HYPOAESTHESIA (A finger in left hand went numb for a few minutes (that happens with that finger every few months even before the shot)), TASTE DISORDER (Had a weird taste in her mouth), CHEST DISCOMFORT (Her chest felt tight in the middle), MUSCLE SPASMS (Horrible major leg cramps in both legs from her feet to her thighs), FEELING ABNORMAL (Had foggy thinking), DYSPNOEA (Her breathing was a little bit labored to the point where she had to tell herself to breath in & out), DYSPNOEA (At 3 am she felt very out of breath just walking to the bathroom), FEELING ABNORMAL (Felt spacy), FATIGUE (Exhausted/Tired) and CHILLS (Chills) outcome was unknown and THROAT TIGHTNESS (Her throat was tight again but at the back of the mouth / her throat felt tight again but at back of her mouth) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Blood pressure measurement: 132 (High) The patient''s BP was 132, right before the shot. and 120 (normal) The patient''s BP was dropped to 120 after 30 minutes.. On 04-Aug-2021, Body temperature: 96.9 (Low) The patient''s body temperature was 96.9 Fahrenheit.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The consumer stated that a couple minutes after the shot patient throat felt constricted near larynx lower than the back of the mouth with the MRI dye. It gradually subsided after about 30 minutes. It was still there but wasn''t as bad. She felt lightheaded, weak, tired, sleepy, and thirsty. The consumer stated that previously, with MRI dye patient had a swollen tongue, face turned red, and throat constriction was at the top of the throat at the back of the mouth.


VAERS ID: 1681689 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 091D21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac flutter, Chest pain, Heart rate
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (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: 20210803; Test Name: Heart rate; Result Unstructured Data: Increased
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Heart fluttering; Chest pain; This spontaneous case was reported by a pharmacist and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant) and CHEST PAIN (Chest pain). At the time of the report, CARDIAC FLUTTER (Heart fluttering) and CHEST PAIN (Chest pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Heart rate: increased (High) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication details was provided. No treatment medication details was provided. Patient did not confirm whether or not she had a history of myocarditis or pericarditis. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.


VAERS ID: 1682655 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-08-03
Onset:2021-08-03
   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 EW0196 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: Client came to one of our public vaccination clinics. The age written on the administrative form was not the child''s actual birthday(the year was changed to 2008 rather than 2009). This error was not noticed until after the vaccine had been administered. No adverse reactions occurred at the clinic and when the child came back for his second dose, they did not report any adverse reactions to the first dose.


VAERS ID: 1682791 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Dyspnoea, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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:

Write-up: EMERGENCY PHYSICIAN PROVIDER NOTE FINAL IMPRESSION 1. Vaccine reaction, initial encounter ED COURSE AND MEDICAL DECISION MAKING 48-year-old female with a history of diverticulitis persisting despite oral Augmentin who was admitted yesterday for IV antibiotics and received Covid 19 Johnson & Johnson vaccination presents with anxiety and shortness of breath. She is scheduled to start IV ertapenem infusion today. No evidence of anaphylaxis or severe reaction at this time. She was treated with 1 g IV ertapenem as scheduled in the ER and monitored closely without evidence of serious reaction. She was reassured and advised she can follow-up as scheduled in the infusion clinic tomorrow. Return to ED instructions discussed and provided. Pt discharged from ED in stable condition.


VAERS ID: 1684865 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-04-15
Onset:2021-08-03
   Days after vaccination:110
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6199 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Fatigue, Pain, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Taste and smell disorders (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Multiple Sclerosis
Allergies:
Diagnostic Lab Data: 08/08/2021 Antigen+ COVID-19 test, 08/13/2021 PCR+ COVID-19 test
CDC Split Type:

Write-up: Muscle or body aches, New loss of taste or smell, Fatigue or tiredness, breakthrough COVID-19


VAERS ID: 1685220 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-07-23
Onset:2021-08-03
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Menopause, Menstruation irregular
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Estradiol Progestin Metoprolol Hydrochlorothiazide Potassium Chloride Buspar
Current Illness:
Preexisting Conditions: Severe Allergies Chronic generalized anxiety Raynaud?s Syndrome Hypertension
Allergies: Shellfish Aspirin Ibuprofen
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: I am in perimenopause and hadn?t had a period since January 2021. Within a couple of weeks of my first shot, I started my period which was medium flow and lasted 5 days.


VAERS ID: 1685446 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-02-02
Onset:2021-08-03
   Days after vaccination:182
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 1 - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA O28L20A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Rosuvastatin, Chlorthalidon, Tamsulosin Vitamins E, B complex, D, C, Fish Oil
Current Illness: None
Preexisting Conditions: Hyper tension, prostrate
Allergies: Penicillin and related
Diagnostic Lab Data: See 18 above
CDC Split Type:

Write-up: Xray of lungs found pneumonia Prescribed an antibiotic


VAERS ID: 1686720 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA MODERNA 059E21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyskinesia, Hypoaesthesia, Muscle spasms, Pain, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: Hypothyroidism
Allergies: Penicillin
Diagnostic Lab Data: I have not gone to a doctor but will schedule an appointment.
CDC Split Type:

Write-up: My arm began feeling sore a day after I got the vaccine. The pain got progressively worse. Eventually, I was unable to lift my arm without feeling excruciating pain. It nearly brought me to tears. I began having muscle spasms and my arm would exhibit involuntary movements. I sometimes get a shooting pain down my arm, and it falls asleep/goes numb if I don?t move it for an extended period of time. The issue is affecting my ability to do work effectively. It has been over a month, and I have not gone back for the second shot out of fear of losing my arm mobility. I?m able to workout as I did before. However, the arm where I received the shot becomes severely sore afterwards. My arm is always hurting whether I am typing, sitting down, or not even using it.


VAERS ID: 1689328 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-04-01
Onset:2021-08-03
   Days after vaccination:124
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 1 UN / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 2 UN / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19 pneumonia, Deep vein thrombosis, Malaise, Pulmonary thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Infective pneumonia (narrow), 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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: COPD, Diabetes Mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: PUI onset of symptoms was 7/24/21 she had all symptoms and went into the hospital 8/3/21 she had covid pneumonia and has a blood clot in her right leg and several in each lung.


VAERS ID: 1689467 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030B21A / UNK - / -

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

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

Write-up: COVID vaccine was administered afterthe 6 hour administration window from being mixed. Lot # 030B21A Vial Exp-9/30/2021


VAERS ID: 1689478 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030B21A? / UNK - / -

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

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

Write-up: COVID vaccine was administered afterthe 6 hour administration window from being mixed. Lot # 030B21A Vial Exp-9/30/2021


VAERS ID: 1689945 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Computerised tomogram head normal, Dizziness, Fall, Fatigue, Haemorrhage, Head injury, Hypersomnia, Loss of consciousness, Myalgia, Nausea, Night sweats, Reading disorder, Sensory disturbance, Vestibular neuronitis
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), 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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Taken at about 7:00 pm on 8/2/21: Rosuvastatin 10 mg , Ezetimibe 10 mg, Co Q10 Trazadone 50 mg taken approximately 9:30 pm on 8/2/21
Current Illness: none
Preexisting Conditions: osteoporosis, high cholesterol
Allergies: none
Diagnostic Lab Data: CT of head was negative
CDC Split Type:

Write-up: I had received my Pfizer Covid vaccine on 8/2/21, between 10 am - 2:00 pm. Myalgias started around 8 pm. I took Trazadone 50 mg at about 9 pm, at which time I went to bed. ( I had taken Trazadone previously and had not had any adverse reactions.) I woke up in the middle of the night to go to the bathroom, as usual. During the night, I had myalgias and night sweats. At about 7 am, I awoke, had significant myalgias, was a bit dizzy, so I sat up and waited a couple of minutes before getting up. I got up, walked about 10 steps to the bathroom, used the toilet and went to the sink. I felt very dizzy and next thing I knew, I had passed out, hit my head on the tile floor. When I came to, I was extremely dizzy. My husband helped me to bed, I took Tylenol, had ice on my head. I take ASA 81 mg every other day, so my head continued to bleed for 4 hrs. I went to the local Medical Center Emerg department for evaluation and CT. The 1st week after my fall I was very fatigued and slept 10-12 hrs at night with 1-2 naps during the day. (This was a stark contrast to my usual 6-7 hrs/ night, with no naps.) I continued to be dizzy at times, lightheaded and sometimes queezy. I was unable to read much at all, could not tolerate noise or viewing a screen. I started PT on 9/2/21 and the rehab therapist diagnosed me as having a nerve inflammation (neuritis) affecting my vestibular system. I am improving continually.


VAERS ID: 1693435 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206AZ1A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Migraine, Vertigo
SMQs:, Vestibular 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: Elavil, Armour thyroid, Ajovy
Current Illness: No
Preexisting Conditions: Meniere?s, vestibular migraines
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe migraines with vertigo every day. Neurologist prescribed two rounds of steroids. Symptoms relieved during treatment but return immediately afterwards.


VAERS ID: 1694372 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-24
Onset:2021-08-03
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 2 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood electrolytes normal, C-reactive protein normal, Cardiac function test normal, Echocardiogram, Full blood count normal, Liver function test normal, Malaise, Pericardial effusion, Troponin normal
SMQs:, Systemic lupus erythematosus (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lexapro, Ativan, Linzes, Trazadone
Current Illness: Covid 19 started July 2020
Preexisting Conditions: None
Allergies: Pennicillin
Diagnostic Lab Data: Echocardiogram, Normal CBC and Electrolytes and LFT. Normal Troponin, Normal CRP
CDC Split Type:

Write-up: Pericardial effusion, normal troponin, normal cardiac function. Malaise on 8/17/2021


VAERS ID: 1694538 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-09
Onset:2021-08-03
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site swelling, Varicella
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Opportunistic infections (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: SYMBICORD; AFOLIC ACID; MELOXICAM; ESTRADIOL PATCHES; METHOCARBINAL; FISH OILS; VITAMIN D3; TUMERIC; CURAMIN; CBD OIL
Current Illness: KNEE REPLACEMENT
Preexisting Conditions: ARTHRITIS
Allergies: SESAMIE; SOY; PEANUTS; CONTRAST DYE; DERMABOND
Diagnostic Lab Data: NONE
CDC Split Type: vsafe

Write-up: BUMP AT INJECTION SITE, CHICKEN POX


VAERS ID: 1695343 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 09ID21A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chills, Cough, Diarrhoea, Erythema, Fatigue, Headache, Heart rate, Hyperhidrosis, Hypersensitivity, Joint swelling, Oropharyngeal pain, Pain, Pain in extremity, Peripheral swelling, Respiratory rate, Rhinorrhoea, Somnolence, Urticaria, Wheezing
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA D 24 HOUR; ACETAMINOPHEN; ALBUTEROL [SALBUTAMOL]; SYMBICORT; FAMOTIDINE; SINGULAIR
Current Illness: Allergic rhinitis; Allergy to antibiotic (Allergic to Doxycycline causes upset of GI); Allergy to antibiotic (Allergic to Augmentin causes upset of GI); Asthma (persistent asthma); Chronic fatigue syndrome; Drug allergy (Allergic to Naproxen causes upset GI); Drug allergy (Allergic to Flonase causes upset of epistaxis); Drug allergy (Allergic to Bromfed DM causes sedation); GERD; Hay fever; Hypersensitivity; Obesity; Seasonal allergy (she usually has seasonal allergy flare-ups in the fall and the spring.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: Blood pressure; Result Unstructured Data: 116/70 mmHg; Test Date: 20210830; Test Name: Body temperature; Result Unstructured Data: 98 F; Test Date: 20210830; Test Name: Heart rate; Result Unstructured Data: 87 bpm; Test Date: 20210830; Test Name: respiratory rate; Result Unstructured Data: 12 breaths per minute.
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: broke out in a sweat; chills; cough; wheezing; doing nothing but sleeping; had to call out of work because the fatigue was so bad/extreme fatigue; slight sore throat; arm pain in right arm/painful arm; headache; nose has been running really bad; Local Urticaria; Hypersensitivity reaction; Swollen arn; Local erythema; swelling in the right elbow; diarrhea; pain in the right side; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (doing nothing but sleeping), OROPHARYNGEAL PAIN (slight sore throat), PAIN IN EXTREMITY (arm pain in right arm/painful arm), HYPERHIDROSIS (broke out in a sweat) and JOINT SWELLING (swelling in the right elbow) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09ID21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma (persistent asthma), Seasonal allergy (she usually has seasonal allergy flare-ups in the fall and the spring.), Hypersensitivity, Hay fever, Allergy to antibiotic (Allergic to Augmentin causes upset of GI), Drug allergy (Allergic to Bromfed DM causes sedation), Allergy to antibiotic (Allergic to Doxycycline causes upset of GI), Drug allergy (Allergic to Flonase causes upset of epistaxis), Drug allergy (Allergic to Naproxen causes upset GI), Obesity, Chronic fatigue syndrome, Allergic rhinitis and GERD. Concomitant products included FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D 24 HOUR) for Allergy, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for Asthma, FAMOTIDINE for GERD, ACETAMINOPHEN for Pain, ALBUTEROL [SALBUTAMOL] for Shortness of breath, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication. On 03-Aug-2021 at 7:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (slight sore throat), PAIN IN EXTREMITY (arm pain in right arm/painful arm), JOINT SWELLING (swelling in the right elbow), DIARRHOEA (diarrhea), PAIN (pain in the right side), RHINORRHOEA (nose has been running really bad), URTICARIA (Local Urticaria), HYPERSENSITIVITY (Hypersensitivity reaction), PERIPHERAL SWELLING (Swollen arn), ERYTHEMA (Local erythema) and HEADACHE (headache). On 05-Aug-2021, the patient experienced SOMNOLENCE (doing nothing but sleeping). 05-Aug-2021, the patient experienced FATIGUE (had to call out of work because the fatigue was so bad/extreme fatigue). On 08-Aug-2021, the patient experienced COUGH (cough) and WHEEZING (wheezing). On 13-Aug-2021, the patient experienced HYPERHIDROSIS (broke out in a sweat) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 03-Aug-2021 at a dose of 500 mg twice a day and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) (oral) from 17-Aug-2021 to 23-Aug-2021 at an unspecified dose and frequency. On 30-Aug-2002, ERYTHEMA (Local erythema) had resolved. On 30-Aug-2021, URTICARIA (Local Urticaria), HYPERSENSITIVITY (Hypersensitivity reaction) and PERIPHERAL SWELLING (Swollen arn) had resolved. At the time of the report, SOMNOLENCE (doing nothing but sleeping), OROPHARYNGEAL PAIN (slight sore throat), HYPERHIDROSIS (broke out in a sweat), JOINT SWELLING (swelling in the right elbow), DIARRHOEA (diarrhea), PAIN (pain in the right side), RHINORRHOEA (nose has been running really bad), FATIGUE (had to call out of work because the fatigue was so bad/extreme fatigue) and CHILLS (chills) outcome was unknown, PAIN IN EXTREMITY (arm pain in right arm/painful arm), COUGH (cough) and WHEEZING (wheezing) had not resolved and HEADACHE (headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, Blood pressure measurement: 116 (normal) 116/70 mmHg. On 30-Aug-2021, Body temperature: 98 (normal) 98 F. On 30-Aug-2021, Heart rate: 87 (normal) 87 bpm. On 30-Aug-2021, Respiratory rate: 12 (normal) 12 breaths per minute.. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPERSENSITIVITY (Hypersensitivity reaction) to be possibly related. No further causality assessments were provided for SOMNOLENCE (doing nothing but sleeping), OROPHARYNGEAL PAIN (slight sore throat), PAIN IN EXTREMITY (arm pain in right arm/painful arm), HYPERHIDROSIS (broke out in a sweat), JOINT SWELLING (swelling in the right elbow), DIARRHOEA (diarrhea), PAIN (pain in the right side), COUGH (cough), WHEEZING (wheezing), RHINORRHOEA (nose has been running really bad), URTICARIA (Local Urticaria), PERIPHERAL SWELLING (Swollen arn), ERYTHEMA (Local erythema), FATIGUE (had to call out of work because the fatigue was so bad/extreme fatigue), CHILLS (chills) and HEADACHE (headache). The patient reports she began to have a cough and started wheezing, so she had to take her prescribed inhaler to work. Patient used ice as treatment. Patient seek medical care to doctors office. Patient race mentioned as black in source document. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Added new reporter, patient details, current conditions, lab details, concomitant medication, treatment medication, new events and narrative was updated accordingly.


VAERS ID: 1695514 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0165 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Breast swelling, Erythema, Exposure during pregnancy, Skin irritation, Skin warm
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid 50 mcg daily Fish oil 1000 mg daily Aspirin 81 mg daily Honest company once a day prenatal Pepcid 20 mg daily Risaquad 1 cap daily
Current Illness: N/A
Preexisting Conditions: History of Left side breast cancer in 2017 with mastectomy done
Allergies: Compazine Benzoyl Peroxide latex cilantro
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Day after 2nd dose of Pfizer COVID vaccine right breast turned red, warm to touch and swollen. I was checked by OB 3 days after the 2nd dose and she also noted redness and irritation on the breast. She suggested to apply hydrocortisone cream and keep an eye on it. It took almost 2 weeks for all the breast symptoms to go away, Currently 24 weeks pregnant, EDD 1/6/22.


VAERS ID: 1695523 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heart rate increased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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? No
Previous Vaccinations:
Other Medications: Vitamin D, Women''s multi-vitamin
Current Illness:
Preexisting Conditions:
Allergies: amoxicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Heart beating very rapidly on morning after vaccination. Pulse rate according to fitness tracker range from 90 - 110bpm right after waking up (and I was not walking around) lasting approximately 1 hour , dropping to around 85 bpm for about 3 hours afterward. Fever present. pulse returned to normal range around 69-72 bpm after that time.


VAERS ID: 1695645 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011D21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Lymphadenopathy, Vaccination site pain
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Sore arm (left arm) in deltoid and under arm; Sore arm (left arm) in deltoid and under arm; lymph nodes swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm (left arm) in deltoid and under arm), AXILLARY PAIN (Sore arm (left arm) in deltoid and under arm) and LYMPHADENOPATHY (lymph nodes swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced VACCINATION SITE PAIN (Sore arm (left arm) in deltoid and under arm), AXILLARY PAIN (Sore arm (left arm) in deltoid and under arm) and LYMPHADENOPATHY (lymph nodes swollen). At the time of the report, VACCINATION SITE PAIN (Sore arm (left arm) in deltoid and under arm), AXILLARY PAIN (Sore arm (left arm) in deltoid and under arm) and LYMPHADENOPATHY (lymph nodes swollen) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications were reported. On an unknown date the patient had an magnetic resonance imaging (MRI) that found swollen lymph nodes. No treatment information was reported. This case was linked to MOD-2021-306330 (Patient Link).


VAERS ID: 1696585 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Heart rate increased, Stress
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Rapid heart beat, fullness in chest, difficulty taking deep breaths. Lasted for about 6 days. Felt a lot like a stress/ anxiety response, but I was not anxious mentally.


VAERS ID: 1696632 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-02-13
Onset:2021-08-03
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cough, SARS-CoV-2 test negative, Upper respiratory tract irritation
SMQs:, Anaphylactic reaction (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvstatin; Niacin; Vit D; Flonase
Current Illness: none
Preexisting Conditions: mildly high cholesterol
Allergies: none
Diagnostic Lab Data: Negative COVID-19 test done through Walgreen''s on 8/5/2021
CDC Split Type:

Write-up: upper respiratory irritation. diagnosed as viral. symptoms: dry cough. onset: 8/3/20; negative COVID-19 test on 8/5/21; visit to family doc on 8/6/21. prescribed Tesslon Perls and Nasacort. AS of 9/14/21 still have the same symptoms.


VAERS ID: 1696926 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-10
Onset:2021-08-03
   Days after vaccination:146
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026A21A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dry eye, Ocular discomfort, Ocular hyperaemia, Retinogram
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Corneal disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Brimonidine, Myrbetriq, Atorvastatin, Meloxicam, Ambien, B-complex, D3
Current Illness: None
Preexisting Conditions: PreDiabetic, Hyperlipidemia, Joint issues, Drusen macular degeneration
Allergies: Contact dramatist, Neomycin, Nickle, Cobalt, Colophony
Diagnostic Lab Data: 8/17/2021 Photos of optic nerves under dilation
CDC Split Type: vsafe

Write-up: Very red and dry eyes, looking at computer screen discomforting, minor headaches, eyedrops for antihistamine. 08/03/2021 ongoing. Discomfort has improved


VAERS ID: 1697211 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-29
Onset:2021-08-03
   Days after vaccination:127
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ovarian cyst
SMQs:

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

Write-up: Growths in ovaries


VAERS ID: 1697591 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041C21A / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Condition aggravated, Disorientation, Dizziness, Fatigue, Feeling abnormal, Gait disturbance, Headache, Lacrimation increased, Limb discomfort, Pain in extremity, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Lacrimal disorders (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: First Moderna Shot, dizzy, nausea, pain at injection site, shaky. symptoms lasted two weeks!
Other Medications: multivitamin, cranberry, E, cod liver oil, D, Thyroid Blend, calcium, Gingko
Current Illness: none
Preexisting Conditions: shaking in lower extremities occurs if stand more than 15 minutes. Sitting, leaning on something or lying down and it goes away.
Allergies: none
Diagnostic Lab Data: Have appointment for routine bloodwork for chemical imbalances. Physical therapist checked me out and gave me exercises to do. Said my nervous system checked out fine.
CDC Split Type:

Write-up: Difficulty walking, achy legs, very heavy legs, lightheaded, feeling like I have a concussion, headaches front and back of head, disoriented, brain fog, exhausted, shaky, weak, watery eyes


VAERS ID: 1700898 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Cough, Dyspnoea, Pyrexia, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), 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: HAD A MILD ANAPHYLAXIS REACTION TO MMR IN APPROXIMATELY 2006
Other Medications: SYNTHROID, RANEXA, LASIX, FARXIGA,J ANUMET, VITAMIN D, LOSARTAN, HCTZ, BYSTOLIC, ESTRACE, TRAZODONE, ZANAFLEX, POTASSIUM, ASA, ISOSORBIDE, VESCEPA
Current Illness: NO OTHER ILLNESSES AT TIME OF VACCINE
Preexisting Conditions: ADD, CHRONIC SINUSITIS, SEVERE APICAL HYPERTROPHIC CARDIOMYOPATHY, MIGRAINES, DM TYPE 2, HASHIMOTO''S DISEASE, HTN
Allergies: MORPHINE, VICTOZA AND ADHESIVE TAPE
Diagnostic Lab Data: EVER SINCE GETTING THE VACCINE, I HAVE BEEN TESTED ON 4 DIFFERENT OCCASIONS FOR COVID JUST SO I COULD GO BACK TO WORK SINCE THE SYMPTOMS ;CONTINUE.
CDC Split Type:

Write-up: AFTER RECEIVING THE VACCINE, BY 9PM THE JOINT PAIN HAD ALREADY STARTED. THE NEXT DAY I RAN A FEVER OF 102.1 AND CONTINUED UNTIL SATURDAY EVENING OR SUNDAY. I HAVE A COUGH, SHORTNESS OF BREATH, SEVERE JOINT PAIN THAT IS WORSE IN THE JOINT I ALREADY HAD ARTHRITIS IN. THE SYMPTOMS HAVE CONTINUED ON FOR THE LAST 6 WEEKS. THE PERIODIC FEVERS STOPPED ABOUT 3 WEEKS IN BUT THE OTHER SYMTPOMS CONTINUE. IT HAS EFFECTED MY WHOLE LIFE. I HAVE MISSED DAYS AT WORK DUE TO THE SIDE EFFECTS.


VAERS ID: 1704660 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-28
Onset:2021-08-03
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8733 / UNK - / -

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

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

Write-up: Patient fully vaccinated and hospitalized due to covid


VAERS ID: 1704979 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-09
Onset:2021-08-03
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 2 UN / IM

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea, Fatigue, Feeling abnormal, Myalgia, Oropharyngeal pain, Oxygen saturation decreased, Rhinorrhoea, SARS-CoV-2 test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tamoxifen, Metoprolol Benicar
Current Illness: N/A
Preexisting Conditions: ADH Lung Nodule
Allergies: N/A
Diagnostic Lab Data: Covid-19 Positive Blood Work
CDC Split Type: vsafe

Write-up: I started to have muscle aches. I got tested two days later. I had a sore throat, coughing a runny nose and fatigue. My blood oxygen was very low, it was in the low 80s. I felt so bad and I isolated for 10 days. The cough was dry and constant and the only thing that helped was cough syrup. I was prescribed an inhaler, and antibiotics. I still have the cough after six weeks and I still have trouble catching my breath. My worst symptoms lasted for 7 days and I still felt very tired when I returned to work.


VAERS ID: 1705686 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Back pain, Blood pressure increased, Blood test, Faeces discoloured, Fatigue, Gastrointestinal wall thickening, Henoch-Schonlein purpura, Hyperaemia, Intussusception, Joint swelling, Rash, Testicular swelling, Ultrasound abdomen abnormal, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: As above. Abdominal imaging. Blood tests.
CDC Split Type:

Write-up: male who developed acute onset rash (8/3/2021) one day after receiving the first dose of the COVID vaccine (8/2/2021). He subsequently saw his PCP and also had an ED visit for progressive rash. Rash began on his upper thighs and then moved down both legs and arms to hands. This was associated with fatigue, lower back soreness, and subsequently joint and bilateral testicular swelling. After a consult with dermatology, the patient was diagnosed with HSP. On 8/19/2021, he was admitted to the hospital with a 2 day history of abdominal pain in addition to vomiting, and melanotic stool. During his stay, an abdominal ultrasound showed mural thickening and hyperemia, consistent with intussusception. During his inpatient stay, patient received treatment with steroids of 60 mg daily and pain control. He had borderline elevated BPs. His abdominal pain and rash improved during his hospitalization and after discussions with rheumatology, he was discharged home on a 4 week prednisone taper. Since discharge home, patient has done well at home with his rash slowly improving. His abdominal pain has resolved. He is urinating without issues. He has no additional joint or scrotal swelling. We are with holding his second dose of the vaccine.


VAERS ID: 1707067 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Delaware  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026P21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bedridden, Diarrhoea, Feeling of body temperature change, Vomiting
SMQs:, Acute pancreatitis (broad), 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: Comments: No medical history was reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: All day in bed; All night long throwing up and it was coming from the other end too; All night long throwing up and it was coming from the other end too/ Threw up 25 times; Hot and cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), BEDRIDDEN (All day in bed), DIARRHOEA (All night long throwing up and it was coming from the other end too) and VOMITING (All night long throwing up and it was coming from the other end too/ Threw up 25 times) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 026P21A) for COVID-19 vaccination. No medical history was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), DIARRHOEA (All night long throwing up and it was coming from the other end too) and VOMITING (All night long throwing up and it was coming from the other end too/ Threw up 25 times). On 04-Aug-2021, the patient experienced BEDRIDDEN (All day in bed). On 05-Aug-2021, BEDRIDDEN (All day in bed) had resolved. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Hot and cold), DIARRHOEA (All night long throwing up and it was coming from the other end too) and VOMITING (All night long throwing up and it was coming from the other end too/ Threw up 25 times) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications included cancer, heart medicine and 13 medicines every morning. No treatment drug was reported. The patient went home after vaccination and felt hot and cold. After supper time, went to bed but that night was all night long throwing up and it was coming from the other end too. On Thursday patient was also in bed. On 03-Sep-2021, Friday, the patient was feeling a little bit better.


VAERS ID: 1707218 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-07-27
Onset:2021-08-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059E21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Lymphadenopathy, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Swelling in right arm 8 inch by 5 inch patch around bicep; Swelling from armpit to occipital bone with lymph node swelling; Fatigue and headache took three days to go away; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in right arm 8 inch by 5 inch patch around bicep), LYMPHADENOPATHY (Swelling from armpit to occipital bone with lymph node swelling), FATIGUE (Fatigue and headache took three days to go away) and HEADACHE (Headache) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swelling in right arm 8 inch by 5 inch patch around bicep), LYMPHADENOPATHY (Swelling from armpit to occipital bone with lymph node swelling), FATIGUE (Fatigue and headache took three days to go away) and HEADACHE (Headache). In August 2021, FATIGUE (Fatigue and headache took three days to go away) and HEADACHE (Headache) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling in right arm 8 inch by 5 inch patch around bicep) and LYMPHADENOPATHY (Swelling from armpit to occipital bone with lymph node swelling) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medication was not reported. Relevant concomitant medications were not provided by the reporter. This case was linked to MOD-2021-309088 (Patient Link).


VAERS ID: 1707727 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: North Dakota  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chills, Diarrhoea, Dizziness, Dyspnoea, Nausea, Pain, Pyrexia, Vertigo
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: USPFIZER INC202100998714

Write-up: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration on Aug 2, 2021, at 10:00, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. She stated she had every side effect listed and more. She was okay after getting the shot, but at night in bed, (Aug 2021) she experienced chills, fever, aches until midnight. Repeatedly, she tried to get up yesterday (Aug 3, 2021) and she had vertigo, dizziness, nausea and diarrhea. She took Tylenol and left her feel so weak. She experienced shortness of breath and she had chills again yesterday. All day, she wondered if the shortness of breath was related to the vaccine. Therapeutic measures were taken as a result of chills, fever, aches, vertigo, dizziness, nausea and diarrhea. At the time of this report, the outcome of shortness of breath and felt so weak: unknown; other events: recovering. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up. Follow-up attempts completed. No further information expected.


VAERS ID: 1707749 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Kentucky  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Fall, Feeling abnormal
SMQs:, Dementia (broad), Accidents and injuries (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: CARVEDILOL; AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure (I have blood pressure since I was in my 30s); Central nervous system disorder; Sclerosis multiple
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101003327

Write-up: I fell down on the ramp.; I feel this is weird; This is a spontaneous report from a contactable consumer (Retired Nurse) reported for herself. A 59-year-old female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/Lot number: Unknown, Expiry date: unknown), via an unspecified route in the left arm on 02Aug2021 as a single dose for covid-19 immunization. Medical history included blood pressure since she was in her 30s, multiple sclerosis, CNS disease, well-kind of syndrome (not clear) and Mason''s (Not clarified hence not captured in tab) and had it diagnosed in 2008. Concomitant medications included carvedilol 12.5 milligrams once a day and amlodipine 5 milligrams once a day. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Aug2021, patient experienced several incidences and day after day. Her first one was that she was in a blur blur saying she was moving and so coming out on the ramp, she fell down on the ramp. she sits, feeling this rolled down ramp or right into the grass then her husband and her daughter helped get her to sit in a chair and they blame her shoes she has, so they got me another pair of shoes. So, throughout the day she kept noticing she kept trying of fall, her legs like since you know didn''t work or they were, she has this in almost time like she was they see me, her legs were doing the work, but her brain was telling (Unclear and not clarified). Was that make sense and she guess she was falling again like six times more and she kept blame my shoes that she kept after like six times again she told her husband she said she don''t know what is going on but she was trying to fall so much today and reason why she was, we got there and got into my big bath tub and then almost felt again after that and she feel this is weird? She was not dizzy, she doesnt have a headache, anything. She was not off balance, none of those things and she must add and say she do have MS she has multiple sclerosis that was you know, the CNS disease and she do have well kind of syndrome she was dizzy, and she was off balance (Further clarification unknown hence not captured in tab) and all that concept, but she had none of that today she was fine. She talks to the pharmacist that you had her injection and just tell someone about that because its just like hit was the different hell like a quick stand or something. Is that make sense. She didn''t know maybe didn''t get well as much as in it you know its like her inner after she didn''t go handy hand roller, any idea. Patient do have a Mason''s (Not clarified hence not captured in tab) and have had it diagnosed in 2008 and it feels its just the intermediate that I had it then goes away and it comes on and it goes away. She doesnt have it like all the time. After the receiving the shot. She must be bore. Her husband is here. She was sorry her husband had a heart attack last year and everything and this time he was and so he has not, he hasn''t as in she can''t do without that on you it. She thought, you know this year on actually on each you know. So, she will have on her mind because new words every in time on she had broadly bad days and everything and she had loved and far better your idea. Patient did not receive any treatment for the events. No lab tests were performed. The clinical outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1531872 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD985 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
SMQs:, Lack of efficacy/effect (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: Comments: The patient was living in a nursing home and according to the reporter doesn''t remember that he got vaccinated. The patient does not have a dementia diagnose.
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: COVID-19 antibody test; Result Unstructured Data: 14.8 BAU/ml
CDC Split Type: DEJNJFOC20210805815

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a 93 year old male of an unspecified ethnic origin and race. The patient''s height, and weight were not reported. The patient''s concurrent conditions was not reported. The patient was living in a nursing home and does not remember that he got vaccinated. The patient did not diagnosed with dementia. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD985, and expiry: unknown) dose was not reported, 1 total administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the patient had COVID-19 antibody test (NR: not provided). On 03-AUG-2021, results were received of COVID-19 antibody test and found 14.8 BAU/ml (confirmed immunological vaccine failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint 90000188224.; Sender''s Comments: V0: 20210805815-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1533838 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD986 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
SMQs:, Lack of efficacy/effect (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: 20210803; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: <0.5 (negative); Comments: there were no detectable antibodies neutralizing to SARS-COV2 protein S"
CDC Split Type: PTJNJFOC20210806267

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 54 year old male. Initial information was processed along with the additional information received on 05-AUG-2021. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD986, expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-JUN-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, the patient had an antibodies test which showed no detectable antibodies neutralizing to SARS-COV2 protein S (confirmed immunological vaccine failure). Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) <0.5, negative. 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).; Sender''s Comments:Confirmed Immunological 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: 1538791 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-08-03
   Days after vaccination:204
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: ILPFIZER INC202101006178

Write-up: Ineffectiveness of the vaccine; Ineffectiveness of the vaccine; This is a spontaneous report from a consumer (Pfizer colleague). This Pfizer colleague reported similar events about herself and her partner. This is the second of two reports. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 as 1st single dose, and via an unspecified route of administration on 01Feb2021 as 2nd single dose, for COVID-19 immunisation. The patient medical history was not reported and concomitant medications were not reported. The intention was to report on the ineffectiveness of the vaccine. On 03Aug2021, the patient was diagnosed with corona, while the patient''s partner had been previously diagnosed on 28Jul2021. The lot number for the vaccine BNT162b2 was not provided and will be requested during follow up. This is a spontaneous report from a consumer a Pfizer colleague who reported about herself. This Pfizer colleague reported similar events about herself and her partner. This is the second of two reports. Report verbatim: Email subject: Adverse event - self report - ineffectiveness of COVID19 vaccine "I would like to report on ineffectiveness of the vaccine, I am REDACTED and my partner REDACTED We received two vaccine doses: 11Jan 01Feb Yesterday, Tuesday 03Aug, I was diagnosed with corona, my partner was previously diagnosed on 28.07" Information regarding the lot/ batch number will be requested in follow-up activities.; Sender''s Comments: Linked Report(s) : IL-PFIZER INC-202101005550 Same repoter, same product, same event, different patient


VAERS ID: 1539948 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
SMQs:, Lack of efficacy/effect (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: 20210803; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: 47.7 Bau/ml
CDC Split Type: BGJNJFOC20210811677

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. Initial information was processed along with the additional information received on 06-AUG-2021. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) 0.5 ml, 1 administered on 11-APR-2021 10:00 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, 4 months after vaccination the patient had performed a quantitative test for antibodies (SARS-CoV-2 IgG antibody test) and its results were 47.7 Bau/ml, the patient had no antibodies (confirmed immunological vaccine failure) 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 case is associated with Product quality complaint number: 90000182630.; Sender''s Comments: V0: 20210811677 - Covid-19 vaccine ad26.cov2.s - CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1544791 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, Computerised tomogram, Platelet count, Subarachnoid haemorrhage, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ETHINYLESTRADIOL; CHLORMADINONE ACETATE
Current Illness: Non-smoker; Penicillin allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: CT scan; Result Unstructured Data: Frontal/parietal subarachnoid hemorrhage; Test Date: 20210804; Test Name: Platelet count; Result Unstructured Data: 9,000; Test Name: Body mass index; Result Unstructured Data: 23.7
CDC Split Type: BRJNJFOC20210812580

Write-up: Thrombocytopenia; Frontal/parietal subarachnoid hemorrhage; Protocol: VAC31518COV4007: VAC31518COV4007 Program. Manufacturer Receipt Date: 05-AUG-2021. A clinical investigator reported that a female subject of 25 years who experienced grade 4 thrombocytopenia and "frontal/parietal" subarachnoid hemorrhage 11 days after COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number: 201097-07B/ 4381227)S was administered for prevention of symptomatic SARS-CoV-2 virus infection. At time of the report the event of thrombocytopenia and frontal/parietal subarachnoid hemorrhage were not recovered. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable. The subject weight was 66 kilograms, and height was 167 centimeters. No past medical history. Concurrent conditions included penicillin allergy and non-smoker. The subject had a sedentary lifestyle and body mass index of 23.7 kg/m2. The subject did not have a history of cancer, autoimmune disease, clotting disorder, varicose veins, trauma involving leg or pelvis, DVT/PE/VTE, blood transfusions, cardiovascular disorder or organ transplantation. Concomitant medications included chlormadinone acetate for contraception, and ethinyl-estradiol for contraception. The subject was on hormone replacement therapy. The subject initiated treatment with COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number: 201097-07B/ 4381227) 0.25 ml, administered on 23-JUL-2020, for prophylactic vaccination. On 31-JUL-2021, the subject started with headache, vomiting and seizures. The subject was medicated as an outpatient with improvement. On 03-AUG-2021, worsening of headache led to hospital admission. On 04-AUG-2021, the subject presented with seizures and was transferred to ICU. The subject''s "Frontal/parietal subarachnoid hemorrhage" was seen on cranial CT scan. According to attending physician, the subject awoke, responding to simple commands and with myoclonus. The subject''s platelets were 9,000. A hypothesis of venous sinus thrombosis was made and led to administration of immunoglobulin and dexamethasone. The patient had not recovered from thrombocytopenia, and frontal/parietal subarachnoid hemorrhage. Investigator''s causality assessment: The event of thrombocytopenia and frontal/parietal subarachnoid hemorrhage were related to the blinded study vaccine. Company causality assessment: The event of thrombocytopenia and frontal/parietal subarachnoid hemorrhage were related to the blinded study vaccine.; Sender''s Comments: The case concerns a 25-year-old female subject who experienced a grade 4, life-threatening thrombocytopenia and frontal-parietal subarachnoid hemorrhage 11 days after COVID-19 vaccine Ad26.COV2.S was administered for prevention of symptomatic SARS-CoV-2 virus infection. The subject had a BMI of 23.7 kg/m2 and sedentary lifestyle (stays in sitting position for long times). Concurrent conditions included penicillin allergy and non-smoker. Concomitant medications included ethinyl-estradiol and chlormadinone acetate, for contraception. The subject developed headache and vomiting for which she received unspecified medication with improvement of symptoms. Three days later, the symptoms worsened, and she was hospitalized on Day 11 and a day later developed seizures and was transferred to ICU. She was awake, responding to simple commands and with myoclonus and has not yet recovered. With thrombocytopenia (platelet count of 9,000) and a cranial CT finding of frontal-parietal subarachnoid hemorrhage a hypothesis of venous sinus thrombosis was made and had led to treatment with immunoglobulin and dexamethasone. Although the subject''s use of hormonal contraception and sedentary lifestyle may have contributed to the event based on evolving knowledge of Thrombosis with Thrombocytopenia Syndrome (TTS, per definition from Brighton Collaboration-BC) and considering the low platelet count and temporal relationship to vaccination, the events are, at this time, assessed to have a plausible relationship with vaccination. Therefore, the events of thrombocytopenia and frontal-parietal subarachnoid hemorrhage are considered related. Additional information has been requested for further assessment (d-dimer, fibrinogen, antibodies to PF4 (ELISA if available), blood smear, CT angiography).


VAERS ID: 1548810 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-08-03
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 20210803; Test Name: Body temperature; Result Unstructured Data: Test Result:Between 38 and 39 Centigrade; Test Date: 20210803; Test Name: SARS-COV-2 test; Test Result: Positive
CDC Split Type: BEPFIZER INC202101002520

Write-up: Positive Corona test; Positive Corona test; This is a spontaneous report from a contactable consumer (patient). A 44-years old male patient of received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Jan2021 as dose 1, single, and received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EK5788), via an unspecified route of administration on 16Feb2021 13:45 as dose 2, single (At the age of 43-years-old) for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 03Aug2021 20:00, positive corona test. Symptoms in the order of their appearance were sneezing, runny nose, flu like symptoms, fever (between 38 and 39 degrees), loss of smell. The patient underwent lab tests and procedures which included body temperature: between 38 and 39 degrees on an unspecified date, sars-cov-2 test: positive on 03Aug2021. The clinical outcome of events was unknown.


VAERS ID: 1558641 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Liquid product physical issue, Periprosthetic osteolysis, Poor quality product administered, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998284

Write-up: blood clots; there was black particles insitu. Vial was discarded; there was black particles insitu. Vial was discarded; Particle disease; This is a spontaneous report from a contactable Nurse received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108030931330430-YWBT4, Safety Report Unique Identifier .GB-MHRA-ADR 25745369. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: FE3380), via an unspecified route of administration as dose number unknown, single on an unspecified date as for COVID-19 immunization. Patient was not enrolled in clinical trial. The patient medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test. It was reported on an unspecified date, the patient experienced blood clots. On 03Aug2021, particle disease. On an unspecified date, there was black particles insitu. vial was discarded. Nurse A reconstituted Pfizer as per SOP and noted that there was black particles insitu. Vial was discarded. The outcome of events were unknown Reaction: Does your report relate to possible blood clots or low platelet counts? If yes, we will ask you additional questions at the end of this report: "No" No follow-up attempts are possible. No further information is expected.


VAERS ID: 1571105 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Foetal death, Maternal exposure during pregnancy, Pain, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

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

Write-up: spotting; pain; Maternal exposure during pregnancy; fetal death; This spontaneous retrospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FOETAL DEATH (fetal death) and VAGINAL HAEMORRHAGE (spotting) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 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 03-Aug-2021, the patient experienced FOETAL DEATH (fetal death) (seriousness criterion medically significant). On an unknown date, the patient experienced VAGINAL HAEMORRHAGE (spotting) (seriousness criterion medically significant), PAIN (pain) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. Pregnant for 2 months. The patient was treated with Surgery (Procedure to remove fetus) for Foetal death. At the time of the report, FOETAL DEATH (fetal death), VAGINAL HAEMORRHAGE (spotting) and PAIN (pain) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided. The patient had received the first dose of the Moderna vaccine a week before the patient got pregnant. The patient visited the gynecologist three to four times already and blood samples were drawn from the patient. On an unknown date, the heart of the fetus stopped beating. Later, the patient would undergo a procedure for extraction of the dead fetus. Company comment: This is a case of product exposure during pregnancy with an associated adverse events. Based on temporal association a causal relationship cannot be excluded. The patient had received the first dose of the Moderna vaccine a week before the patient got pregnant. Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Live follow up : additional event of pain; Sender''s Comments: This is a case of product exposure during pregnancy with an associated adverse events. Based on temporal association a causal relationship cannot be excluded. The patient had received the first dose of the Moderna vaccine a week before the patient got pregnant.


VAERS ID: 1571385 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Neck 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? 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: Some pain in the neck and stiff feeling in the neck 2 days after vaccine; shivers; High temperature; This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivers) and PYREXIA (High temperature) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced CHILLS (shivers) (seriousness criterion medically significant). 03-Aug-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced NECK PAIN (Some pain in the neck and stiff feeling in the neck 2 days after vaccine). On 04-Aug-2021, PYREXIA (High temperature) had resolved. At the time of the report, CHILLS (shivers) and NECK PAIN (Some pain in the neck and stiff feeling in the neck 2 days after vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Temperature was 38.5C overnight. No concomitant and treatment medication was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1571388 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Chest discomfort, Ear pain, Headache, Pain, Pyrexia, SARS-CoV-2 test, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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: Asthma (asthma as an infant, but had a good treatment and it was put to rest and never returned.); Lactation decreased.
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: tight throat; rough lungs; Asthma; Ear pain; General body pain; Headache; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of ASTHMA (Asthma), THROAT TIGHTNESS (tight throat), EAR PAIN (Ear pain), PAIN (General body pain), HEADACHE (Headache), PYREXIA (Fever) and CHEST DISCOMFORT (rough lungs) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Asthma (asthma as an infant, but had a good treatment and it was put to rest and never returned.) and Lactation decreased. On 02-Aug-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 03-Aug-2021, the patient experienced PAIN (General body pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced ASTHMA (Asthma) (seriousness criterion medically significant) and EAR PAIN (Ear pain) (seriousness criterion medically significant). On an unknown date, the patient experienced THROAT TIGHTNESS (tight throat) (seriousness criterion medically significant) and CHEST DISCOMFORT (rough lungs) (seriousness criterion medically significant). The patient was treated with PREDNISONE (METICORTEN) for Asthma and Throat tightness, at an unspecified dose and frequency. On 03-Aug-2021, PYREXIA (Fever) had resolved. On 05-Aug-2021, PAIN (General body pain) and HEADACHE (Headache) was resolving. At the time of the report, ASTHMA (Asthma) and EAR PAIN (Ear pain) had not resolved, THROAT TIGHTNESS (tight throat) was resolving and CHEST DISCOMFORT (rough lungs) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. No concomitant medications were 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. Seriousness criteria for the events was captured by regulatory authority, however based on medical judgement the case is non serious. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness criteria for the events was captured by regulatory authority, however based on medical judgement the case is non serious. No further information is expected.


VAERS ID: 1571389 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-08-03
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Chills, Dizziness, Dyspnoea, Fatigue, Feeding disorder, Headache, Lymphadenopathy, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (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: MICROGYNON 21
Current Illness: Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Unable to eat; Shortness of breath; Nauseous; Nausea; Light headedness; Swollen lymph nodes; Tiredness; Breathlessness; Tight chest; Fever; Chills; Headache; Muscle ache; This case was received via Reference number: ADR 25757590) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Unable to eat), DYSPNOEA (Shortness of breath), NAUSEA (Nauseous), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Muscle ache), NAUSEA (Nausea), DIZZINESS (Light headedness), CHEST DISCOMFORT (Tight chest), LYMPHADENOPATHY (Swollen lymph nodes), FATIGUE (Tiredness) and DYSPNOEA (Breathlessness) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003607 and 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Penicillin allergy. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (MICROGYNON 21) from 01-Jan-2013 to an unknown date for Contraception. On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), CHEST DISCOMFORT (Tight chest) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and DYSPNOEA (Breathlessness) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), DIZZINESS (Light headedness) (seriousness criterion medically significant) and LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). On an unknown date, the patient experienced FEEDING DISORDER (Unable to eat) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant) and NAUSEA (Nauseous) (seriousness criterion medically significant). On 05-Aug-2021, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle ache), NAUSEA (Nausea), DIZZINESS (Light headedness), FATIGUE (Tiredness) and DYSPNOEA (Breathlessness) had resolved. At the time of the report, FEEDING DISORDER (Unable to eat), DYSPNOEA (Shortness of breath), NAUSEA (Nauseous), HEADACHE (Headache) and CHEST DISCOMFORT (Tight chest) was resolving and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. Paracetamol was taken along with drinking lots of water. Doctor was contacted about the swelling. Patient has not tested positive for COVID-19 since having the vaccine Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.


VAERS ID: 1571392 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-08-03
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Malaise, 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: IBUPROFEN; PARACETAMOL
Current Illness: Shoulder pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210419; 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: Fever; Feeling sick; Chills; This case was received via RA (Reference number: 25747914) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MALAISE (Feeling sick) and CHILLS (Chills) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003651 and 3002332) for COVID-19 vaccination. Concurrent medical conditions included Shoulder pain. Concomitant products included IBUPROFEN from 07-Feb-2021 to an unknown date and PARACETAMOL from 10-Feb-2021 to an unknown date for Shoulder pain. On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), MALAISE (Feeling sick) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 03-Aug-2021, MALAISE (Feeling sick) and CHILLS (Chills) had resolved. At the time of the report, PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No treatment information was 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. 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: 1571549 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210803; Test Name: Blood pressure; Result Unstructured Data: 200/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210823977

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096430] concerned a 61 year old male of unknown race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total dose administered on 03-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021, at 11:45 the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 200/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210823977-covid-19 vaccine ad26.cov2.s-Elevated Blood Pressure. 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: 1573834 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Musculoskeletal chest pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

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

Write-up: chest pain, tenderness, and swelling


VAERS ID: 1575198 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache, Myalgia, Photophobia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; 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: Light headedness; Headache; fever; Light sensitivity to eye; Light-headed; Frontal headache; Muscle ache; Slight fever; This case was received via RA (Reference number: ADR 25755412) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Light-headed), HEADACHE (Frontal headache), MYALGIA (Muscle ache), PYREXIA (Slight fever) and DIZZINESS (Light headedness) in a 35-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 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced HEADACHE (Frontal headache), MYALGIA (Muscle ache) and PYREXIA (Slight fever). On 04-Aug-2021, the patient experienced DIZZINESS (Light-headed) and PHOTOPHOBIA (Light sensitivity to eye). On an unknown date, the patient experienced DIZZINESS (Light headedness), HEADACHE (Headache) and PYREXIA (fever). On 04-Aug-2021, PHOTOPHOBIA (Light sensitivity to eye) had resolved. At the time of the report, DIZZINESS (Light-headed) and HEADACHE (Frontal headache) had not resolved, MYALGIA (Muscle ache) and PYREXIA (Slight fever) was resolving and DIZZINESS (Light headedness), HEADACHE (Headache) and PYREXIA (fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Light headedness continues made hard to walk prolonged periods. Patient was very tired due to affected sleep from fever during the night. Light sensitivity better but really bad this morning. Treatment product was not 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: 1576205 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Aches & pains in legs), HEADACHE (Frontal headache) and PYREXIA (Fever) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (YASMIN) from 17-Sep-2011 to 01-May-2021 for Oral contraceptive. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant), PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant), HEADACHE (Frontal headache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Aches & pains in legs), HEADACHE (Frontal headache) and PYREXIA (Fever) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was 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. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected.


VAERS ID: 1576215 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Maternal exposure during pregnancy, Pain, Pain of skin, Proctalgia, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: Maternal exposure during pregnancy; Ache; Anus pain; Headache dull; Skin pain; This case was received via Regulatory Authority (Reference number: 25749216) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy), PAIN (Ache), PROCTALGIA (Anus pain), HEADACHE (Headache dull) and PAIN OF SKIN (Skin pain) 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 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Aug-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), PROCTALGIA (Anus pain) (seriousness criterion medically significant), HEADACHE (Headache dull) (seriousness criterion medically significant) and PAIN OF SKIN (Skin pain) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved and PAIN (Ache), PROCTALGIA (Anus pain), HEADACHE (Headache dull) and PAIN OF SKIN (Skin pain) 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. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was exposed to the medicine third-trimester (29-40 weeks). Treatment medication was not provided. Company comment: This is a case of product exposure during pregnancy with associated AEs for this 40-year-old female. No further information is expected as there is no contact information for further monitoring of AEs during the pregnancy.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AEs for this 40-year-old female. No further information is expected as there is no contact information for further monitoring of AEs during the pregnancy.


VAERS ID: 1576220 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: pain in and around injection site; Became worst after 24 hours, red and raised; Swelling arm; This case was received via regulatory authority (Reference number: ADR 25749631) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm) in a 34-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 CITALOPRAM for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in and around injection site) and VACCINATION SITE ERYTHEMA (Became worst after 24 hours, red and raised). At the time of the report, PERIPHERAL SWELLING (Swelling arm) had not resolved and VACCINATION SITE PAIN (pain in and around injection site) and VACCINATION SITE ERYTHEMA (Became worst after 24 hours, red and raised) outcome was unknown. Patient took second dose vaccination on Aug 2021. Patient had large swelling and pain in and around injection site. Became worst after 24 hours, red and raised No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1576221 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blister, Gait disturbance, Peripheral swelling, Swelling
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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: MELATONIN
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Swelling; Blisters; difficult to walk; Swelling of feet; This case was received via regulatory authority (Reference number: ADR 25749758) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of feet), SWELLING (Swelling) and BLISTER (Blisters) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included MELATONIN for an unknown indication. On 31-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 03-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swelling of feet) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant) and BLISTER (Blisters) (seriousness criterion medically significant). an unknown date, the patient experienced GAIT DISTURBANCE (difficult to walk). At the time of the report, PERIPHERAL SWELLING (Swelling of feet) had not resolved and SWELLING (Swelling), BLISTER (Blisters) and GAIT DISTURBANCE (difficult to walk) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Reporter stated that the patient experienced flu like side effects on the night of vaccination and also the next day. The swelling in the several areas particularly at 1st metatarsal caused difficulty in walking. 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: 1576224 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Eye pain, Headache, Influenza, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: Flu; Eye pain; Flu symptoms; Stomach upset; Headache; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25749890) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), EYE PAIN (Eye pain), INFLUENZA (Flu symptoms), ABDOMINAL DISCOMFORT (Stomach upset), HEADACHE (Headache) and PYREXIA (Fever) in a 36-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. Concomitant products included IBUPROFEN from 03-Aug-2021 to an unknown date and PARACETAMOL from 03-Aug-2021 to an unknown date for Headache. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced EYE PAIN (Eye pain) (seriousness criterion medically significant), INFLUENZA (Flu symptoms) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (Stomach upset) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA (Flu) (seriousness criterion medically significant). At the time of the report, INFLUENZA (Flu), EYE PAIN (Eye pain), INFLUENZA (Flu symptoms), ABDOMINAL DISCOMFORT (Stomach upset), HEADACHE (Headache) and PYREXIA (Fever) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576241 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Sickness; Chills; Fever; Nausea; 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 ILLNESS (Sickness), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, ILLNESS (Sickness), CHILLS (Chills), PYREXIA (Fever) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient is not enrolled in clinical trial. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded


VAERS ID: 1576244 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity, 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: sore arm; Chills; Muscle pain; Fatigue; Headache; This case was received via Regulatory Authority(Reference number: ADR 25751158) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle pain) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved and HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle pain) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: positive (Positive) positive. 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. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1576254 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005964

Write-up: Heavy periods; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041018327390-2FMVU and Safety Report Unique Identifier GB-MHRA-ADR 25752157. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with covid-19 did not have a covid-19 test. Patient has not tested positive for covid-19 since having the vaccine. Patient is not enrolled in clinical trial. On 03Aug2021 patient experienced heavy periods. The outcome of event was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1576255 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Shivering; Nausea; Vomiting; Headache; Muscle soreness; Tiredness; This case was received via a regulatory authority (Reference number: 25752203) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivering), VOMITING (Vomiting), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle soreness) and NAUSEA (Nausea) in a 33-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and MYALGIA (Muscle soreness) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, CHILLS (Shivering), FATIGUE (Tiredness), HEADACHE (Headache), MYALGIA (Muscle soreness) and NAUSEA (Nausea) had not resolved and VOMITING (Vomiting) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment information was not provided. 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 event, a causal relationship cannot be excluded. These reported event are consistent with the product safety profile; 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. These reported event are consistent with the product safety profile


VAERS ID: 1576262 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness postural, Headache, Migraine, Nausea, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESOGESTREL; MIRTAZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Migraine
Allergies:
Diagnostic Lab Data: Test Date: 20210802; 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: Migraine; Nausea; Headache; Shivers; High temperature; Dizzy on standing; Migraine headache; Ache; This case was received via Regulatory Authority (Reference number: ADR 25752935) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), DIZZINESS POSTURAL (Dizzy on standing), MIGRAINE (Migraine headache), PAIN (Ache), NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Shivers) and PYREXIA (High temperature) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Migraine and Lactation decreased. Concomitant products included MIRTAZAPINE from 04-Jan-2020 to an unknown date for Anxiety, DESOGESTREL for Contraception. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant), MIGRAINE (Migraine headache) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 04-Aug-2021, CHILLS (Shivers) and PYREXIA (High temperature) had resolved. At the time of the report, MIGRAINE (Migraine), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown, DIZZINESS POSTURAL (Dizzy on standing) and MIGRAINE (Migraine headache) was resolving and PAIN (Ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment product was not provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further follow-up 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. No further follow-up information is expected at this time.


VAERS ID: 1576265 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Hallucination, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Hallucinations; feeling schey; Fever; This case was received via a regulatory authority (Reference number: 25753078) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and Suspected COVID-19 (Unsure when symptoms stopped) on 24-Jun-2021. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced HALLUCINATION (Hallucinations) (seriousness criteria disability and medically significant) and DIZZINESS (feeling schey). At the time of the report, HALLUCINATION (Hallucinations) and DIZZINESS (feeling schey) was resolving and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use information was not provided by reporter. No treatment information was provided. Reportedly, after vaccination the patient started feeling achy, shaky and feverish. Later at around 11pm, hallucinations started and carried on for some hours until around 4am next day. Hallucinations manifested in a clawing of skin feeling and seeing things crawling over her skin. Patient is neither pregnant nor is currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine.Patient is not enrolled in clinical trial. Company Comment: Based on the current available information which includes a temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Fever is consistent with the product known safety profile.; Sender''s Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Fever is consistent with the product known safety profile


VAERS ID: 1576268 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-08-03
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 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: 20210803; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101005668

Write-up: This is a spontaneous report from a contactable physician received from the Agency. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ey5456), dose 1 via an unspecified route of administration on 05Jun2021 as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 03Aug2021 Yes - Positive COVID-19 test. On 03Aug2021, the patient experienced covid-19, drug ineffective. The outcome of the events was reported as not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576269 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Heart rate, Myalgia, Palpitations
SMQs:, Rhabdomyolysis/myopathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Heart rate; Result Unstructured Data: High
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: anxiety; palpitations; Muscle ache; Heart pounding; This case was received via Regulatory Authority (Reference number: ADR 25753365) on 05-Aug-2021 and was forwarded to MODERNA on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache), ANXIETY (anxiety), PALPITATIONS (Heart pounding) and PALPITATIONS (palpitations) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant) and PALPITATIONS (Heart pounding) (seriousness criterion medically significant). On an unknown date, the patient experienced ANXIETY (anxiety) (seriousness criterion medically significant) and PALPITATIONS (palpitations) (seriousness criterion medically significant). On 03-Aug-2021, PALPITATIONS (Heart pounding) had resolved. At the time of the report, MYALGIA (Muscle ache) had not resolved and ANXIETY (anxiety) and PALPITATIONS (palpitations) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Heart rate: high (High) High. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Patient reported that she experienced strange feeling in chest, heart palpitations / feeling of anxiety / increased heart rate and breathing. It started 24 hours after the jab and only lasted about 3 hours. Also has really aching muscles and was really tired. Patient has not had symptoms associated with COVID-19. Patient is neither pregnant nor is currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1576273 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Malaise, Myalgia, Poor quality sleep, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (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: LEVOTHYROXINE; MYSIMBA
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Feeling sick; Generalised muscle aches; Headache; Poor sleep; This case was received via Regulatory Agency (Reference number: 25754048) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Poor sleep), MALAISE (Feeling sick), MYALGIA (Generalised muscle aches) and HEADACHE (Headache) in a 28-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE from 01-Apr-2016 to an unknown date for Hypothyroidism, BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE (MYSIMBA) from 20-Jul-2021 to an unknown date for Weight loss. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced POOR QUALITY SLEEP (Poor sleep) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced MALAISE (Feeling sick) (seriousness criterion medically significant), MYALGIA (Generalised muscle aches) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, POOR QUALITY SLEEP (Poor sleep), MALAISE (Feeling sick) and MYALGIA (Generalised muscle aches) had not resolved and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) 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.; 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: 1576278 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-08-03
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Dizziness, Enuresis, Nausea, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201219; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: bending; bed; laid; flat; Dizziness; This case was received via regulatory authority(Reference number: ADR 25754317) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (bending), ENURESIS (bed), NAUSEA (laid), RASH (flat) and DIZZINESS (Dizziness) in a 50-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002621) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 11-Dec-2020 to 24-Dec-2020. On 03-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 03-Aug-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced BACK PAIN (bending) (seriousness criterion medically significant), ENURESIS (bed) (seriousness criterion medically significant), NAUSEA (laid) (seriousness criterion medically significant) and RASH (flat) (seriousness criterion medically significant). At the time of the report, BACK PAIN (bending), ENURESIS (bed), NAUSEA (laid) and RASH (flat) outcome was unknown and DIZZINESS (Dizziness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Dec-2020, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Based on the current available information and temporal association between the use of the product and the 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: 1576284 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Anaemia; 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: Vomiting; Muscle ache; This case was received via Regulatory Authority (Reference number: ADR 25754798) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache) and VOMITING (Vomiting) in a 31-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 Anaemia. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle ache) had not resolved and VOMITING (Vomiting) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported . Treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1576286 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: SERTRALIN [SERTRALINE]
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: chills; Headache; Muscle ache; Fever chills; Feverish; This case was received MHRA (Reference number: ADR 25755001) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Feverish), CHILLS (chills), HEADACHE (Headache), MYALGIA (Muscle ache) and PYREXIA (Fever chills) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 03-Aug-2021. Concomitant products included SERTRALINE (SERTRALIN [SERTRALINE]) for an unknown indication. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant). The patient was treated with PARACETAMOL at an unspecified dose and frequency. At the time of the report, PYREXIA (Feverish), HEADACHE (Headache), MYALGIA (Muscle ache) and PYREXIA (Fever chills) was resolving and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information not provided. Fever was intermittent, with chills and sweats often. Extremely tired. Paracetamol had eased the symptoms. 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: 1576287 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Pain, Pyrexia, Restlessness, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (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: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20201229; 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: Shivers; Restless; Slight temperature; Tired all the time; Ache; This case was received via regulatory authority (Reference number: 25755005) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RESTLESSNESS (Restless), PYREXIA (Slight temperature), FATIGUE (Tired all the time), PAIN (Ache) and CHILLS (Shivers) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced RESTLESSNESS (Restless) (seriousness criterion medically significant), PYREXIA (Slight temperature) (seriousness criterion medically significant), FATIGUE (Tired all the time) (seriousness criterion medically significant) and PAIN (Ache) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant). On 04-Aug-2021, CHILLS (Shivers) had resolved. At the time of the report, RESTLESSNESS (Restless), PYREXIA (Slight temperature) and FATIGUE (Tired all the time) had not resolved and PAIN (Ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Symptoms started approximately 8 hours after vaccine. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Based on current available information and the temporal association between product use and the start date of the events, a causal relationship cannot be excluded. The Company believes that none of the events meets serious criteria.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the events, a causal relationship cannot be excluded. The Company believes that none of the events meets serious criteria.


VAERS ID: 1576288 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Ache; Headache; Fever; High temperature; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 25755030) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), HEADACHE (Headache), PYREXIA (Fever) and PYREXIA (High temperature) in a 34-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-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 03-Aug-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). At the time of the report, PAIN (Ache), HEADACHE (Headache), PYREXIA (Fever) and PYREXIA (High temperature) was resolving. Concomitant medications were not reported. Treatment information was not provided. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. On 03-Aug-2021, the patient had a temperature of above 38 degrees Celsius. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1576293 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Headache, Hyperhidrosis, Injection site pain, Lymphadenopathy, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; VITAMIN D; VITAMIN D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201206; Test Name: COVID-19 virus test; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PYREXIA (Fever chills), HEADACHE (Headache), MYALGIA (Myalgia), NAUSEA (Nausea), FATIGUE (Fatigue), HYPERHIDROSIS (Sweating), INJECTION SITE PAIN (Pain injection site), LYMPHADENOPATHY (Swollen lymph nodes) and DIARRHOEA (Diarrhea) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not Known) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 02-Dec-2020 to 06-Jan-2021. Concomitant products included PARACETAMOL from 03-Aug-2021 to an unknown date for Fever, VITAMIN D from 02-Dec-2020 to an unknown date for Vitamin C supplementation, COLECALCIFEROL (VITAMIN D3) from 02-Dec-2020 to an unknown date for Vitamin D supplementation. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criteria disability and medically significant), PYREXIA (Fever chills) (seriousness criteria disability and medically significant), HEADACHE (Headache) (seriousness criteria disability and medically significant), MYALGIA (Myalgia) (seriousness criteria disability and medically significant), NAUSEA (Nausea) (seriousness criteria disability and medically significant), FATIGUE (Fatigue) (seriousness criteria disability and medically significant), HYPERHIDROSIS (Sweating) (seriousness criteria disability and medically significant), INJECTION SITE PAIN (Pain injection site) (seriousness criteria disability and medically significant) and DIARRHEA (Diarrhea) (seriousness criteria disability and medically significant). On 04-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criteria disability and medically significant). At the time of the report, PYREXIA (Fever), PYREXIA (Fever chills), HEADACHE (Headache), MYALGIA (Myalgia), NAUSEA (Nausea), FATIGUE (Fatigue), HYPERHIDROSIS (Sweating), LYMPHADENOPATHY (Swollen lymph nodes) and DIARRHEA (Diarrhea) had not resolved and INJECTION SITE PAIN (Pain injection site) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2020, SARS-CoV-2 test: yes - positive covid-19 test (abnormal) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment drugs was not 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: 1576302 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Feeling hot, Headache, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Swollen arm; Headache; Fatigue; Feeling hot; Feverish; This case was received via a regulatory authority (Reference number: 25756553) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache), FEELING HOT (Feeling hot), PYREXIA (Feverish) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced FEELING HOT (Feeling hot) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Headache) had not resolved and FEELING HOT (Feeling hot), PYREXIA (Feverish) and FATIGUE (Fatigue) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. 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 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: 1576310 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Decreased appetite, Dizziness, Eye pain, Fatigue, Headache, Injection related reaction, Lacrimation increased, Malaise, Nausea, Ocular hyperaemia, Pruritus, Pyrexia, Rash, Rash papular, Skin burning sensation, Sneezing, Swelling, Vaccination site erythema, Vaccination site mass, Vaccination site movement impairment, Vaccination site warmth, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Lacrimal disorders (narrow), Hypersensitivity (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: EFFEXOR; PROPRANOLOL HYDROCHLORIDE
Current Illness: Blood pressure (Blood pressure issues); Depression; Food allergy; Polycystic ovaries; Short sightedness (shortsighted need glasses); Social anxiety disorder (social anxiety); Thyroid disorder (Not treated yet borderline .)
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever; Lactation decreased; Morbid obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: raised rash; feeling sick/Feeling unwell; watery eyes; fever; shivering; sneezing; wheezing in the chest; cant move arm without pain or grip things; lump on injection site; no appetite; arm red; hot feeling down arm; Joint pain; Injection associated shivering; Eye pain; Itchy; Eyes red; Dizzy; Swelling; Burning skin; Rash; Fatigue; Nauseated; Headache; Fever chills; This case was received via regulatory authority (Reference number: ADR 25756919) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH PAPULAR (raised rash), MALAISE (feeling sick/Feeling unwell), LACRIMATION INCREASED (watery eyes), PYREXIA (fever), CHILLS (shivering), ARTHRALGIA (Joint pain), INJECTION RELATED REACTION (Injection associated shivering), EYE PAIN (Eye pain), PRURITUS (Itchy), OCULAR HYPERAEMIA (Eyes red), DIZZINESS (Dizzy), SWELLING (Swelling), SKIN BURNING SENSATION (Burning skin), RASH (Rash), FATIGUE (Fatigue), NAUSEA (Nauseated), HEADACHE (Headache) and PYREXIA (Fever chills) in a 40-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, Morbid obesity and Hay fever. Concurrent medical conditions included Depression, Social anxiety disorder (social anxiety), Polycystic ovaries, Thyroid disorder (Not treated yet borderline .), Food allergy, Short sightedness (shortsighted need glasses) and Blood pressure (Blood pressure issues). Concomitant products included PROPRANOLOL HYDROCHLORIDE from 11-May-2008 to an unknown date for Anxiety state, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) from 07-Dec-2008 to an unknown date for Depression. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant), INJECTION RELATED REACTION (Injection associated shivering) (seriousness criterion medically significant), EYE PAIN (Eye pain) (seriousness criterion medically significant), PRURITUS (Itchy) (seriousness criterion medically significant), OCULAR HYPERAEMIA (Eyes red) (seriousness criterion medically significant), DIZZINESS (Dizzy) (seriousness criterion medically significant), SWELLING (Swelling) (seriousness criterion medically significant), SKIN BURNING SENSATION (Burning skin) (seriousness criterion medically significant), RASH (Rash) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), NAUSEA (Nauseated) (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 RASH PAPULAR (raised rash) (seriousness criterion medically significant), MALAISE (feeling sick/Feeling unwell) (seriousness criterion medically significant), LACRIMATION INCREASED (watery eyes) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant), SNEEZING (sneezing), WHEEZING (wheezing in the chest), VACCINATION SITE MOVEMENT IMPAIRMENT (cant move arm without pain or grip things), VACCINATION SITE MASS (lump on injection site), DECREASED APPETITE (no appetite), VACCINATION SITE ERYTHEMA (arm red) and VACCINATION SITE WARMTH (hot feeling down arm). On 04-Aug-2021, INJECTION RELATED REACTION (Injection associated shivering) had resolved. At the time of the report, RASH PAPULAR (raised rash), MALAISE (feeling sick/Feeling unwell), LACRIMATION INCREASED (watery eyes), PYREXIA (fever), CHILLS (shivering), ARTHRALGIA (Joint pain), PRURITUS (Itchy), DIZZINESS (Dizzy), SWELLING (Swelling), SKIN BURNING SENSATION (Burning skin), RASH (Rash), FATIGUE (Fatigue), NAUSEA (Nauseated), HEADACHE (Headache) and PYREXIA (Fever chills) had not resolved, EYE PAIN (Eye pain) and OCULAR HYPERAEMIA (Eyes red) was resolving and SNEEZING (sneezing), WHEEZING (wheezing in the chest), VACCINATION SITE MOVEMENT IMPAIRMENT (cant move arm without pain or grip things), VACCINATION SITE MASS (lump on injection site), DECREASED APPETITE (no appetite), VACCINATION SITE ERYTHEMA (arm red) and VACCINATION SITE WARMTH (hot feeling down arm) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that patient injection site swelled, itchy red and had a raised rash. Patient was feeling sick, dizziness, red watery eyes, joint pain, headaches two days since the symptoms appeared and patient was on pain killers and antihistamines which were not helping. Patient injection site is still itchy, can''t move her arm without pain or grip things, lump on injection site, large spread of red rash over arm at least 6 inches on arm, red hot feeling down arm, fever shivering, feeling unwell, no appetite and feeling ill very washed out tired, no energy, Sneezing and wheezing in the chest 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: 1576317 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Body temperature, Ear pain, Eye pain, Headache, Hyperhidrosis, Insomnia, Myalgia, Nausea, Neck pain, Peripheral swelling, Pyrexia, Rash, SARS-CoV-2 test, Skin burning sensation, Uterine pain
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Nausea; Headache; Armpit pain; Sweating; Uterine pain; Earache; Insomnia; Rash NOS; Eyes stinging; Swollen arm; Scapula pain; Neck pain (with radiation); Fever chills; Burning skin; Muscle pain; This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Scapula pain), NECK PAIN (Neck pain (with radiation)), PYREXIA (Fever chills), SKIN BURNING SENSATION (Burning skin), MYALGIA (Muscle pain), NAUSEA (Nausea), HEADACHE (Headache), AXILLARY PAIN (Armpit pain), HYPERHIDROSIS (Sweating), UTERINE PAIN (Uterine pain), EAR PAIN (Earache), INSOMNIA (Insomnia), RASH (Rash NOS), EYE PAIN (Eyes stinging) and PERIPHERAL SWELLING (Swollen arm) 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 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced ARTHRALGIA (Scapula pain) (seriousness criterion medically significant), NECK PAIN (Neck pain (with radiation)) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), SKIN BURNING SENSATION (Burning skin) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), UTERINE PAIN (Uterine pain) (seriousness criterion medically significant), EAR PAIN (Earache) (seriousness criterion medically significant), INSOMNIA (Insomnia) (seriousness criterion medically significant), RASH (Rash NOS) (seriousness criterion medically significant), EYE PAIN (Eyes stinging) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 03-Aug-2021, ARTHRALGIA (Scapula pain), UTERINE PAIN (Uterine pain), EAR PAIN (Earache) and EYE PAIN (Eyes stinging) had resolved. On 04-Aug-2021, PYREXIA (Fever chills), SKIN BURNING SENSATION (Burning skin), MYALGIA (Muscle pain) and NAUSEA (Nausea) had resolved. At the time of the report, NECK PAIN (Neck pain (with radiation)), HEADACHE (Headache), AXILLARY PAIN (Armpit pain), HYPERHIDROSIS (Sweating), RASH (Rash NOS) and PERIPHERAL SWELLING (Swollen arm) had not resolved and INSOMNIA (Insomnia) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. no treatment drug reported no concomitant medication 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. Seriousness of the events was captured as pero Regulatory Authority assessment provided 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. Seriousness of the events was captured as pero Regulatory Authority assessment provided in Source Document.


VAERS ID: 1576326 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Joint pain; Muscle pain; Headache; Tiredness; Fever; Chills; This case was received via United Kingdom MHRA (Reference number: ADR 25758819) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Tiredness) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 04-Aug-2021, CHILLS (Chills) had resolved. On 05-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, ARTHRALGIA (Joint pain), MYALGIA (Muscle pain) and FATIGUE (Tiredness) was resolving and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Concomitant medication of the patient was not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided 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: 1576332 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Dyspepsia, Headache, Heart rate, Heart rate variability test, Hyperhidrosis, Nausea, Poor quality sleep, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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: PARACETAMOL
Current Illness: Chronic fatigue syndrome; Immunodeficiency (which reduces the immune response)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Body temperature; Result Unstructured Data: fluctuation; Test Date: 20210804; Test Name: Heart rate; Result Unstructured Data: 105-115 bpm, elevated by about 35 BPM; Test Date: 20210804; Test Name: Heart rate variability; Result Unstructured Data: Decreased; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority MHRA (Reference number: ADR 25759757) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of POOR QUALITY SLEEP (Poor sleep), HYPERHIDROSIS (Sweating), DYSPEPSIA (Heartburn), CHILLS (Shivering), HEADACHE (Headache) and NAUSEA (Nausea) in a 34-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Chronic fatigue syndrome and Immunodeficiency (which reduces the immune response). Concomitant products included PARACETAMOL from 04-Aug-2021 to an unknown date for Adverse event. On 03-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced POOR QUALITY SLEEP (Poor sleep) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 05-Aug-2021, the patient experienced DYSPEPSIA (Heartburn) (seriousness criterion medically significant). The patient was treated with CALCIUM CARBONATE, MAGNESIUM CARBONATE, SIMETICONE (DEFLATINE) for Heartburn, at an unspecified dose and frequency. On 05-Aug-2021, HYPERHIDROSIS (Sweating), DYSPEPSIA (Heartburn) and CHILLS (Shivering) was resolving, NAUSEA (Nausea) had resolved. At the time of the report, POOR QUALITY SLEEP (Poor sleep) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Body temperature: fluctuation (abnormal) fluctuation. On 04-Aug-2021, Heart rate (70-80): 105-115 (High) 105-115 bpm, elevated by about 35 BPM. On 04-Aug-2021, Heart rate variability test: decreased (Low) Decreased. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient woke up from the sleep due to heartburn which resolved after about 3 hours. Patient burped during the period which provided temporary relief. Patient drank water and felt better temporarily from heartburn. 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. However, underlying medical history of chronic fatigue syndrome and immunodeficiency are confounder.; 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. However, underlying medical history of chronic fatigue syndrome and immunodeficiency are confounder.


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