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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 310 out of 7,116

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VAERS ID: 1681995 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2021-01-01
Onset:2021-08-01
   Days after vaccination:212
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Drug ineffective, Maternal exposure timing unspecified, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101115088

Write-up: contracted Covid in early Aug2021; contracted Covid in early Aug2021; currently pregnant; This is a spontaneous report from a contactable consumer (patient). A 28-year-old (currently pregnant) female patient received bnt162b2 (BNT162B2), in Jan2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and the medications were not reported. The patient was vaccinated in Jan2021 and contracted Covid in early Aug2021. She was planning on getting her booster vaccine. The patient was pregnant. The outcome was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1682015 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-27
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
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 INC202101125499

Write-up: swollen armpit; Pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer COVAX US Support. A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 27Aug2021 08:00 (Lot number was not reported) (at the age of 35-years-old) as dose 1, single for covid-19 immunisation. Medical history was none and there was no family medical history relevant to event. There were no concomitant medications. The patient did not receive any vaccination 4 weeks prior to COVID 19 Vaccine. In Aug2021, the patient experienced swollen armpit and had pain because of it. At the time of reporting, she was in an emergency room experiencing swollen armpit. The patient took the powdered Aspirin BC and Tylenol PM as treatment for the events. The patient''s second dose was scheduled on 17Sep2021. The outcome of local swelling was not recovered, and outcome of pain was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1682019 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-29
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 2 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthritis, Blood pressure measurement, Blood test, Body temperature, Fatigue, Influenza like illness, Lethargy, Magnetic resonance imaging, Pain, Paraesthesia, Pyrexia, Spinal disorder
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METOPROLOL; HYDROCHLOROTHIAZIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure; Hypertension; Multiple sclerosis
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:Unknown results; Comments: He also said it would be okay.; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210830; Test Name: Temperature; Result Unstructured Data: Test Result:100.5 Fahrenheit; Comments: degrees; Test Name: MRI of my brain; Result Unstructured Data: Test Result:No change; Comments: it said there was no change
CDC Split Type: USPFIZER INC202101127609

Write-up: has a temperature of 100.5 degrees Fahrenheit; spinal issues; Arthritic issues; I do feel very fatigue and achy like I am getting a flu; Tingling on my right lowest foot; being lethargic; I do feel very fatigue and achy like I am getting a flu; Kind of like a flu/I do feel very fatigue and achy like I am getting a flu; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: FC3183), dose 2 via an unspecified route of administration, administered in Arm Right on 29Aug2021 as dose 2, single for covid-19 immunisation. Medical history included, hypertension, blood pressure measurement, multiple sclerosis. Concomitant medication(s) included metoprolol (METOPROLOL) taken for blood pressure measurement; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) .It was Reported that, The patient experienced tingling on my right lowest foot on Aug2021 with outcome of recovered , being lethargic on Aug2021, do feel very fatigue and achy like am getting a flu on Aug2021 with outcome of unknown, kind of like a flu/i do feel very fatigue and achy like am getting a flu, has a temperature of 100.5 degrees Fahrenheit on 30Aug2021 with outcome of unknown , spinal issues , arthritic issues, do feel very fatigue and achy like iam getting a flu on Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: unknown results on He also said it would be okay, blood test: unknown results on ,body temperature: 100.5 Fahrenheit on 30Aug2021 degrees , magnetic resonance imaging: no change on it said there was no change.


VAERS ID: 1682020 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101127669

Write-up: Arm is little sore; This is a spontaneous report from a contactable consumer (Patient''s husband). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FA7485; Expiration Date: Oct2021), via an unspecified route of administration, administered in arm on 05Aug2021 (at the age of 36-years-old) as dose 1, single for covid-19 immunization. Medical history included asthma. The patient had no concomitant medication. The patient after her 1st dose had little sore in the injection area. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1682022 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-25
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWQ175 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Eating disorder, Gingival pain, Gingival swelling, Oral disorder, Oral mucosal eruption, Oral pain, Oropharyngeal discomfort, Pain, Speech disorder, Tooth disorder, Toothache
SMQs:, Angioedema (narrow), Dementia (broad), Oropharyngeal allergic conditions (narrow), Gingival disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101127919

Write-up: sores all in her mouth; there was some patches and streaks/the patches that some are white while some are yellowish which are also present in the back of her throat; there was some patches and streaks/the patches that some are white while some are yellowish which are also present in the back of her throat; gums are swollen; oral lesion through out my mouth; teeth is hurting as well as her gums/pain in my teeth and in my gums; teeth is hurting as well as her gums/pain in my teeth and in my gums; everything hurts; can hardly talk; I cannot even eat/barely eat; her teeth are throbbing; This is a spontaneous report from a contactable nurse (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EWQ175) via an unspecified route of administration on 25Aug2021 (at the age of 64-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Aug2021, the patient experienced teeth was hurting as well as her gums/pain in my teeth and in my gums. On 29Aug2021, she developed sores all in her mouth and there were some patches and streaks. She described the patches that some was white while some were yellowish which was also present in the back of her throat. On Aug2021 she can hardly talk and barely eat/ I cannot even eat and that everything hurts. Her teeth are throbbing and on 28Aug2021 her gums were swollen. She feels her teeth will out since her gums was swollen. She also mentioned that she has developed this oral lesions. Nurse stated, "I had the vaccine on Wednesday, the Pfizer vaccine the first dose and yesterday 3 days after I started feeling pain in my teeth and in my gums and I have oral lesion through out my mouth and my gums were swollen." Nurse stated that she was scheduled for endoscopy and colonoscopy. The outcome of all events was unknown.


VAERS ID: 1682031 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Mobility decreased, Pain, Product administered at inappropriate site
SMQs:, Parkinson-like events (broad), Drug abuse and dependence (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101131311

Write-up: The doctor stated the location of administration was absolutely not in the deltoid/vaccine administered in the top of the shoulder; The caller states she is 9 months pregnant; Lost mobility in the left arm completely for a few days; Unbelievable amount of pain; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 31-years-old female patient received first dose of BNT162B2, Solution for injection, Batch/Lot Number: EW0180, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 06Aug2021 (at the age of 31-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included pregnancy. She stated that she was 9 months pregnant. History: Besides being pregnant, probably not. There were no concomitant medications. Clinical course: She received her first dose Pfizer Covid Vaccine three weeks ago. Vaccine administered in the top of the shoulder: The patient stated the first dose Pfizer Covid Vaccine was incorrectly administered. The person who administered the first dose Pfizer Covid Vaccine, administered the first dose Pfizer Covid Vaccine in the top of the shoulder. This caused lose mobility in the left arm completely for a few days and an unbelievable amount of pain ( on unspecified date in Aug2021). The patient went to the urgent care the next morning because she thought this was not a normal reaction and something went wrong. She told the doctor she was just sitting in the (withheld) chair when the first dose Pfizer Covid Vaccine was administered. The doctor stated the location of administration was absolutely not in the deltoid(Left top of shoulder)(on 06Aug2021), the first dose Pfizer Covid Vaccine was administered in-between the bones and likely hit a nerve or bursa area. Could cause bursitis or whatever. Lost mobility in the left arm completely for a few days/unbelievable amount of pain: She stated that she was still in pain three weeks later and did not have full range of motion in the arm. This was annoying because it was avoidable. The patient was 33 Weeks pregnant at the onset of the event. The outcome of lose mobility in the left arm completely for a few days and an unbelievable amount of pain was not recovered. The outcome of other events was unknown.


VAERS ID: 1682036 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: pulse; Result Unstructured Data: Test Result:High; Test Date: 202108; Test Name: Blood pressure; Result Unstructured Data: Test Result:High
CDC Split Type: USPFIZER INC202101133433

Write-up: high blood pressure; high pulse for a day; This is a spontaneous report received from a contactable consumer (reporter''s wife). A female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 06Aug2021 as dose 1, single for covid-19 immunization. The patient medical history was not reported.. The patient concomitant medications were not reported. The reporter stated that after received her first dose of Pfizer BioNtech covid 19 vaccine on 06Aug2021, she experienced high blood pressure and high pulse for a day. The outcome of events was resolved on Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1682038 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-26
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Constipation
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101133610

Write-up: has had a hard time going to the bathroom. (Asked what that meant: urination or defecation and he said defecation; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. On an unspecified date in Aug 2021, since the vaccination the patient had a hard time going to the bathroom (defecation). He had only gone twice in the last 5 days. The clinical outcome of the event was unknown. Information on lot/ batch number has been requested.


VAERS ID: 1682039 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Circumstance or information capable of leading to medication error, Headache, Inflammation, Nasal discomfort, Pain
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: USPFIZER INC202101133674

Write-up: How important is it to get the vaccine at the 3 week mark? Should take a chance and get it tomorrow or not; Inflammation; pain; Headache; nasal burn; This is a spontaneous report from a contactable Consumer or other non HCP (patient). This 69-year-old female consumer reported that: A 69 years old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Aug2021 as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Active Drug substance names was reported as COVID 19 Vaccine, mRNA. She received the first Pfizer vaccine on 11Aug2021 and was scheduled to get the 2nd one tomorrow afternoon from the day of report. On an unspecified date, the patient experienced and enquired how important was it to get the vaccine at the 3-week mark and Should take a chance and get it tomorrow or not. She wanted to get protection. She felt bad after the first shot because of inflammation. She was holding a lot of fluid and it set up pain. She had headaches after the vaccination. She totally didn''t get rid of the headaches. In August and September, she had headaches and nasal burn on an unspecified date in Aug2021. Initially came on with the shot but continued so was not sure if that was due to the shot or not. She started having problems from not taking the medications she needed to take. Outcome of events were reported as unknown. Information on the lot batch number has been requested.


VAERS ID: 1682047 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-25
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101134226

Write-up: had a fever; body aches/was feeling very achy; Chills; This is a spontaneous report from a contactable consumer. A 47-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 25Aug2021 (age at vaccination was 47-year-old) as dose 2, single for COVID-19 immunisation. The medical history and the concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date (age at vaccination was 47-year-old) as dose 1, single for COVID-19 immunisation. It was reported that, between Thursday and Friday after the vaccine, the patient had a fever chills body aches and um was feeling very achy and it went all the way to Saturday night. At the time of this report event outcome was recovered on 27Aug2021. The lot number for the vaccine was not provided and will be requested during follow up.


VAERS ID: 1682052 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Blood test, Chills, Facial pain, Headache, Neck pain, Rash, SARS-CoV-2 test, Skin discolouration, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: blood work; Result Unstructured Data: Test Result:Unknown result; Test Date: 202108; Test Name: rapid covid test; Test Result: Negative ; Test Date: 202108; Test Name: rapid covid test; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: USPFIZER INC202101137829

Write-up: She got a headache which kept getting worse and worse; chills; shaking; Her neck and back hurt; Her neck and back hurt; Rash; Rash has gotten worse and is spreading and has gotten darker in color; Left side of her daughters face started being painful; This is a spontaneous report from a contactable consumer (mother). A 14-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 16Aug2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter states that her daughter received the vaccine on 16Aug2021 and by in Aug2021 on Friday the patient experienced she got a headache which kept getting worse and worse, chills, shaking, her neck and back hurt. They took patient to the emergency room where they did a rapid COVID test which came back negative. On Monday morning patient was covered with a rash so they took her to her primary care doctor who did blood work and another COVID test. They are currently awaiting the results and state that the rash has gotten worse and was spreading and has gotten darker in color. The reporter states that the doctor says it looks like a COVID rash. The reporter wants to know if the side effects were reported side effects from the vaccine. The reporter states that the left side of her daughter''s (patient) face started being painful and was getting worse as well. Reporter also wants to know if it was contraindicated for her to get the vaccine. The patient underwent lab tests and procedures which included blood test: unknown result, sars-cov-2 test: negative, sars-cov-2 test: unknown result all on Aug2021. The outcome of the events headache, rash, darkened skin, facial pain was not recovered and unknown for events chills, shaking, neck pain and back pain. The lot number for [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1682071 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-24
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Chills, Cough, Diarrhoea, Dry mouth, Dyspepsia, Gastrooesophageal reflux disease, Headache, Myalgia, Oral discomfort, Pain in extremity, Parosmia, Secretion discharge
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (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: OXYCODONE
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 INC202101138679

Write-up: Headache with no fever; Coughing; muscle pains; chest discomfort; mucus; Diarrhea; mouth was like glue; got a weird smell and it was a nauseating smell; burning in her stomach; burning in her stomach,and she had some reflux; burning in her mouth; leg muscle aches; Chills; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3182), via an unspecified route of administration, administered in right deltoid (Right shoulder) on 24Aug2021 (at the age of 65-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient did not had any medical history and family history. The concomitant medication(s) included oxycodone (OXYCODONE) 5 mg taken 4 times daily taken for an unspecified indication started 7 years ago and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: PAG780), via an unspecified route of administration, administered in left shoulder on 03Aug2021 (at the age of 65-years-old) as DOSE 1, SINGLE for covid-19 immunisation and the patient experienced sore arm and hot flashes that lasted a couple of days. The patient did not had any prior vaccination within a four weeks. On 24Aug2021, the patient experienced had some burning in her stomach and she had some reflux anyway and then, some burning in her mouth, and then it was gone. She went home and had some leg muscle aches and chills. She wants to know, her chills lasted for two days. Two days after she got a weird smell and it was a nauseating smell. It could have been the mucus. She clarified as a day later at 2 in the morning Thursday the 26Aug2021. Then everything went away, now yesterday. On 29Aug2021, the patient mouth was like glue. On an unspecified date, the patient reported headache with no fever. All subsided after a few days yesterday the night of the 30Aug2021 and she had a mouth breather and she will take a drink of water and it will be gone. She woke up on Monday night and it was like glue. On 01Sep2021, the patient had diarrhea and on unspecified date, she reported muscle pains, coughing, mucus, chest discomfort, and just sore. Patient reported going for a covid test tomorrow be-cause maybe it was covid. Patient did not any AE(s) require a visit to emergency room and physician office. The outcome of event for burning in her stomach,and she had some reflux, burning in her mouth, Chills, got a weird smell and it was a nauseating smell, was recovered on Aug2021 and, headache was recovered on 30Aug2021 and outcome of rest all events were unknown.


VAERS ID: 1682089 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Poor quality sleep, Rash
SMQs:, Anaphylactic reaction (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101139096

Write-up: Broke out in a rash/all over your arms and legs and torso; woke me up in the middle of night; This is a spontaneous report from a contactable consumer or other non hcp(patient).A female patient of an unspecified age received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number- not reported), via an unspecified route of administration on 04Aug2021 as DOSE 1, SINGLE for covid-19 immunization.The patient''s medical history and concomitant medications were not reported.It was reported that patient received her first dose of the Pfizer COVID vaccine on 04Aug2021 and was wondering if she can skip the second shot and receive the third shot if she qualifies .She was also asking how many weeks was it until she should get the second dose.She also stated, she had a side effect after 2 weeks on Aug2021 after the 1st dose on 04Aug2021. I broke out in a rash while I was sleeping and it woke me up in the middle of the night. I was contributing it to possibly the vaccine. I wanted to ask you if that was typical in side effects all over your arms and legs and torso 2 weeks later on Aug2021 . Should I get the 2nd dose after this adverse effect from the first dose.She also wondering if the second dose will have more severe side effects than the first dose.Patient stated it has been 4 weeks instead of 3 weeks since her first dose and was wondering if that is ok.The oucome of events was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1682102 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Heart murmur; Multiple allergies (Allergies); Seasonal allergy (Known allergies: Seasonal allergies)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101144806

Write-up: Broke into a skin rash over entire body; This is a spontaneous report from a contactable consumer, the patient. A 13-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Aug2021 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, heart murmur and seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included ibuprofen (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Jul2021 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Aug2021, within 18 hours of second vaccination, the patient broke into a skin rash over entire body. The adverse event did not result in doctor or other healthcare professional office/clinic visit/emergency visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with Ibuprofen (MANUFACTURER UNKNOWN) and diphenhydramine hydrochloride (BENADRYL). The clinical outcome of the event broke into a skin rash over entire body was resolved on an unknown date in 2021.


VAERS ID: 1682132 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-01
Onset:2021-08-01
   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 FC3182 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol allergy (Known allergies: Allergic reactions to alcohol); Epstein-Barr viraemia (Epstein Barr Virus (auto-immune) history years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101151637

Write-up: Headache; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on an unknown date in Aug2021 at 15:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included Epstein Barr virus (auto-immune) history years ago and allergic reactions to alcohol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On an unknown date in Aug2021, the patient experienced headache every day since the day after the shot, it had been over 2 weeks at the time of report. The patient never had a history of headaches before. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event headache was unknown at the time of this report.


VAERS ID: 1682160 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-30
Onset:2021-08-01
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy (Known allergies: Peanut butter); Fruit allergy (Known allergies: Peaches)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101154496

Write-up: Very bad rashes on body; Swelling face; Allergy; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy just to peaches and peanut butter. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. On 01Aug2021 the patient experienced allergy, very bad rashes on body and swelling face. The event resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with unspecified antisthaminic. The clinical outcomes of the events allergy, very bad rashes on body and swelling face were unknown at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1682759 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-01
Onset:2021-08-01
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 180503 / 1 LA / SYR

Administered by: School       Purchased by: ?
Symptoms: Ophthalmic vein thrombosis, Ophthalmological examination abnormal, Retinal vein occlusion, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Retinal Center exam, after I developed impaired vision in right eye about a month ago.
CDC Split Type:

Write-up: Retinal Vein Occlusion. Blood clot in eye?


VAERS ID: 1683252 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-27
Onset:2021-08-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache
SMQs:, Anticholinergic syndrome (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: dizziness, fatigue, headache


VAERS ID: 1683590 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: broke out in hives that evening; magnetic at the injection site/stuck at the injection site, not the whole arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in hives that evening) and VACCINATION SITE REACTION (magnetic at the injection site/stuck at the injection site, not the whole arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced URTICARIA (broke out in hives that evening) and VACCINATION SITE REACTION (magnetic at the injection site/stuck at the injection site, not the whole arm). At the time of the report, URTICARIA (broke out in hives that evening) and VACCINATION SITE REACTION (magnetic at the injection site/stuck at the injection site, not the whole arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient was advised not to get the second dose The patient stated that she and her coworker are magnetic at the injection site. Three of them received the Pfizer COVID19 Vaccine , two coworkers also received the Moderna COVID19 Vaccine , and two coworkers received the Johnson & Johnson COVID19 Vaccine. They messed around with their name badges.


VAERS ID: 1683597 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-21
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Musculoskeletal stiffness, Myalgia, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: arm were she got the injection was stiff which goes up to the neck; arm were she got the injection was more painful; joint soreness; fever; chills; muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm were she got the injection was stiff which goes up to the neck), ARTHRALGIA (joint soreness), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle soreness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included COVID-19 in December 2020. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced ARTHRALGIA (joint soreness), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle soreness). On 24-Aug-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (arm were she got the injection was stiff which goes up to the neck) and VACCINATION SITE PAIN (arm were she got the injection was more painful). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm were she got the injection was stiff which goes up to the neck), ARTHRALGIA (joint soreness), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle soreness) and VACCINATION SITE PAIN (arm were she got the injection was more painful) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter.


VAERS ID: 1683623 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-24
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination site erythema, Vaccination site warmth
SMQs:

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

Write-up: the injection site was red and warm to the touch; injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (the injection site was red and warm to the touch) and VACCINATION SITE ERYTHEMA (injection site was red) 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 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE WARMTH (the injection site was red and warm to the touch) and VACCINATION SITE ERYTHEMA (injection site was red). At the time of the report, VACCINATION SITE WARMTH (the injection site was red and warm to the touch) and VACCINATION SITE ERYTHEMA (injection site was red) had not resolved. No concomitant medication was reported. No treatment medication was reported.


VAERS ID: 1683643 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT AVAILABLE / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Fatigue, Peripheral swelling, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: hot to the touch; tiredness, tired; size of a tennis ball; got really red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (size of a tennis ball), ERYTHEMA (got really red), SKIN WARM (hot to the touch) and FATIGUE (tiredness, tired) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not available) for COVID-19 vaccination. The patient''s past medical history included Pneumonia. Concomitant products included DULOXETINE and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PERIPHERAL SWELLING (size of a tennis ball), ERYTHEMA (got really red) and FATIGUE (tiredness, tired). On an unknown date, the patient experienced SKIN WARM (hot to the touch). At the time of the report, PERIPHERAL SWELLING (size of a tennis ball), ERYTHEMA (got really red), SKIN WARM (hot to the touch) and FATIGUE (tiredness, tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient is taking concomitant medications :Blood pressure medication pill ,Thyroid pill patient had COVID in December Treatment information was not provided


VAERS ID: 1683645 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-26
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036B21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Headache, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hashimoto''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: Blood pressure; Result Unstructured Data: A little high; Test Date: 20210827; Test Name: Body temperature; Result Unstructured Data: 101.3F at 4:40am
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Not feeling well; Severe body aches all over; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), MYALGIA (Severe body aches all over) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. Concurrent medical conditions included Hashimoto''s disease. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced MALAISE (Not feeling well), MYALGIA (Severe body aches all over) and HEADACHE (Headache). At the time of the report, MALAISE (Not feeling well), MYALGIA (Severe body aches all over) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, Blood pressure measurement: high (High) A little high. On 27-Aug-2021, Body temperature: 101.3 (High) 101.3F at 4:40am. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided.


VAERS ID: 1683660 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-08-26
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 00521A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Feeling cold, Feeling hot, Headache, Hyperhidrosis, Insomnia, Nausea, Pyrexia, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Hypertension (Hypertension.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: feeling real hot; feel sweaty and that they didn''t sleep; Feeling real cold; they had chills; experiencing severe headache,massive headache; fever; they cant sleep; pain in the arm; their joint hurt; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (they cant sleep), VACCINATION SITE PAIN (pain in the arm), FEELING HOT (feeling real hot), HYPERHIDROSIS (feel sweaty and that they didn''t sleep) and FEELING COLD (Feeling real cold) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00521a and 043l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension (Hypertension). On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced VACCINATION SITE PAIN (pain in the arm), ARTHRALGIA (their joint hurt) and NAUSEA (nausea). On 26-Aug-2021, the patient experienced INSOMNIA (they cant sleep), FEELING HOT (feeling real hot), HYPERHIDROSIS (feel sweaty and that they didn''t sleep), FEELING COLD (Feeling real cold), CHILLS (they had chills), HEADACHE (experiencing severe headache,massive headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 26-Aug-2021, HYPERHIDROSIS (feel sweaty and that they didn''t sleep) had resolved. At the time of the report, INSOMNIA (they cant sleep), VACCINATION SITE PAIN (pain in the arm), FEELING HOT (feeling real hot), FEELING COLD (Feeling real cold), CHILLS (they had chills), PYREXIA (fever), ARTHRALGIA (their joint hurt) and NAUSEA (nausea) outcome was unknown and HEADACHE (experiencing severe headache,massive headache) had not resolved. The patient received 3rd dose of COVID-19 vaccination and experienced events, patient concomitants include high blood pressure medication and vitamins and started taking Tylenol for side effects. This case was linked to MOD-2021-300932 (Patient Link).


VAERS ID: 1683690 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-03-05
Onset:2021-08-01
   Days after vaccination:149
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mesalamine 1.2gm X3 Patoprazole 40 mg X2 (morning and night) Levoceetirizine 5mg Tamsulosin 0.4mg Budesonide 3mg X3 Losartan 200mg
Current Illness: No
Preexisting Conditions: ulcerative colitis
Allergies: None
Diagnostic Lab Data: 08/05/2021 PCR COVID-19 Test
CDC Split Type:

Write-up: Contracted COVID-19


VAERS ID: 1683739 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-01-01
Onset:2021-08-01
   Days after vaccination:212
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody 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: 202108; Test Name: COVID 19 infection; Test Result: Positive
CDC Split Type: USPFIZER INC202101151572

Write-up: Caller is a consumer who received both doses of the Pfizer Biontech COVID19 vaccine on January and got COVID19 infection this August; Caller is a consumer who received both doses of the Pfizer Biontech COVID19 vaccine on January and got COVID19 infection this August; This is a spontaneous report from a Sponsored Program. This 72-year-old male consumer reported for himself. A 72-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date in Jan2021 (72-year-old at the time of vaccination) as dose 1, single, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date in Jan2021 (72-year-old at the time of vaccination) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. On an unspecified date in Aug2021, the patient got COVID19 infection. The patient also stated that he had received a regencov infusion which was an antibody that also boosts immunity. The patient wanted to know if he should receive the booster dose when it comes available in September or if he should wait longer than September. The patient underwent lab tests and procedures which included COVID-19: positive on unspecified date on Aug2021. The outcome of the events were unknown. Information on the lot/batch number has been requested.


VAERS ID: 1683899 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-28
Onset:2021-08-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 2 AR / SYR

Administered by: Other       Purchased by: ?
Symptoms: Angiogram cerebral, Arteriogram carotid, Cerebrovascular accident, Computerised tomogram head, Condition aggravated
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amlodipine 2.5 mg PO daily
Current Illness: none
Preexisting Conditions: essential hypertension. + remote hx of mild CVA circa 2005
Allergies: losartan
Diagnostic Lab Data: CT brain on 8-1-2021. CTA of head and neck on 8-1-2021
CDC Split Type:

Write-up: Acute CVA occurred on 8-1-2021, non-hemorrhagic, involving left occipital lobe and right pons. This is a temporal association to the vaccine; unsure if causually related.


VAERS ID: 1684690 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Dizziness, Heavy menstrual bleeding, Impaired work ability
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular 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: Glucosamine/chondroitin, cranberry supplement, Vitamin D3, Magnesium
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: No lab tests performed.
CDC Split Type:

Write-up: Heavy menstrual cycle which lasted 14 days. After 3 days, I became dizzy and had extremely low energy. I had to take time off work.


VAERS ID: 1684731 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-29
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Inflammation, Joint range of motion decreased, Peripheral swelling, Rotator cuff syndrome, Vaccination complication
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastayin 20mg 1x a day Hydroxide hc1 25 mg 3x a day as needed Omeprazole 40mg 1 x a day Escotalopram Ocalate 20mg 1x a day
Current Illness: No illnesses.
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: They did not do any lab or medical tests
CDC Split Type:

Write-up: It has been 11 days since my first vaccine. I can not move my arm to the side or back. I have been to the urgent care and yesterday followed up. My upper arm is swollen.My. Primary at this appointment told me that due to the shot I now have tendinitis in my shoulder and there is inflammation in my upper arm. They gave me a prescription for stronger ibuprofen and told me that if it wasn?t better in a few days I would have to go to Orthopaedic.


VAERS ID: 1684742 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: New York  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT, HOWEVER, HE THOUGHT HE WAS GETTING HIS FIRST SHOT AND AT THE TIME THERE WAS NO RECORD OF ANY COVID VACCINES GIVEN IN DATABASE OR PHARMACY RECORDS.


VAERS ID: 1685178 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-03-04
Onset:2021-08-01
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6206 / 2 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Herpes zoster, Nervous system disorder, Paraesthesia, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

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

Write-up: I had the typical shingles rash. It lasted for about 2 weeks. The rash portion was on the torso, on the right side of the body. I am still having some of the nerves effects right now. Like tingling and things like that. I did not have fever. My stomach was upset and I had vomiting. On 08/02/2021 I went to the doctor and they diagnosed me with shingles.


VAERS ID: 1685239 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Electrocardiogram, Hypothyroidism, Pain in extremity, Palpitations, Pyrexia, Thyroid hormones test, Weight increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypothyroidism (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair; Acid pills
Current Illness: N/A
Preexisting Conditions: SVT - Supraventricular tachycardia
Allergies: None
Diagnostic Lab Data: EKG; Blood tests; Thyroid elevated to 6.95; I was diagnosed with Hypothyroidism on 09/02/2021.
CDC Split Type: vsafe

Write-up: Slight fever; Arm pain; Heart palpitations; Gained weight; Thyroid elevated.


VAERS ID: 1685388 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-03-07
Onset:2021-08-01
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EFL9264 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cough, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: I was taking Simvastatin; Multivitamin; Claritin; Albuterol inhaler
Current Illness: No
Preexisting Conditions: Asthma
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type: vsafe

Write-up: (Date unknown) 08/2021 serve cough, shortness of breath - lasted 6 weeks.


VAERS ID: 1685424 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-02-01
Onset:2021-08-01
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 UN / UN
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Cough, Endotracheal intubation, Hypoxia, Intensive care, Lung opacity, Positive airway pressure therapy, Pulmonary congestion, SARS-CoV-2 test positive
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 24 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetazolamide, Vitamin C, Vitamin D, Metformin, Metoprolol, Omega 3 fish oil, pioglitazone, rosuvastin, Januvia, Vitamin E, ZInc sulfate
Current Illness: Unknown
Preexisting Conditions: Diabetes, CAD, CABG 20 years ago, hypertension, obesity, dyslipidemia, chronic normocytic anemia
Allergies: None
Diagnostic Lab Data: COVID NAAT & PCR positive, CXR/CT ground glass opacities.
CDC Split Type:

Write-up: Developed cough & chest congestion 8/1/21, progressively worsening. Admitted to hospital 8/17/21, COVID positive. Patient states vaccinated in February. Hypoxemia, continued to worsen. Transfer to ICU 8/27, placed on BIPAP, intubated 8/30/21. Made DNR 9/9/21.


VAERS ID: 1685442 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Lip dry, Oligomenorrhoea
SMQs:, Fertility disorders (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: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Menstrual cycle delayed 7 days. My menstrual cycle is normally on time. My lips have been dry/cracked/peeling since the vaccination.


VAERS ID: 1685647 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Michigan  
Vaccinated:2020-12-29
Onset:2021-08-01
   Days after vaccination:215
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1283 / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Anti-GAD antibody positive, Anti-IA2 antibody positive, Blood glucose increased, Genital infection, Glucose urine present, Glycosylated haemoglobin increased, Type 1 diabetes mellitus, Urinary tract infection
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Blisovi 1/20 FE; Venlafaxine 150 mg; Cetirizine 10 mg; Cyclobenzaprine 5 mg
Current Illness:
Preexisting Conditions: Anxiety; IBS
Allergies: Penicillins
Diagnostic Lab Data: A1c- 6.5%; POCT glucose random- 204 mg/dL; Glucose fasting- 130 mg/dL; Glutamic Acid Decarboxylase- 0.38 nmol/L; Islet antigen 2 antibody- 2.34 nmol/L
CDC Split Type:

Write-up: Type 1 Diabetes- discovered by repeat urogenital infections with glucose in urine. UTIs started in late July 2021 and diagnosis was early August 2021.


VAERS ID: 1685655 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-29
Onset:2021-08-01
   Days after vaccination:3
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: Blood test normal, Cardiac flutter, Cardiac monitoring normal, Chest discomfort, Dyspnoea, Electrocardiogram normal
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (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: OTC Ibuprophen or Tylenol, and OTC Claritin as needed. NOT DAILY
Current Illness: None
Preexisting Conditions: Neck/Back Pain
Allergies: Penicillium
Diagnostic Lab Data: EKG, 24hr Heart Monitor, multiple blood tests and multiple Dr. Consults with no findings or diagnosis. Have Cardiologist appt for Oct 7th.
CDC Split Type:

Write-up: On going chest discomfort, shortness of breath, heart fluttering since the 4th day after 1st dose. When having an episode, while lying down, laying on either side seems to make it worse. After the initial 72hr episode, symptoms subsided for about 10days. Just prior to me scheduling 2nd shot, symptoms returned Friday Aug 27th and have remained. This is as of this report on 9/9/2021. No treatment besides keeping activities light, yard work and occasional walking on days with no issues. Have not worked out or ran since vaccine.


VAERS ID: 1685680 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Dizziness, Heart rate increased, Upper respiratory tract infection, X-ray
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Vestibular disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol, Allegra, Doxycycline, Singulair
Current Illness: n/a
Preexisting Conditions: Total anomalous pulmonary venous return , Asthma
Allergies: Allergic to Sulfa based antibiotics , large amounts of garlic.
Diagnostic Lab Data: ER performed x ray, ekg and blood work and all came back fine. (I had a very severe upper respiratory infection the next week where I could barely breath which is unusual).
CDC Split Type: 053C21A

Write-up: Heart was beating fast and wouldn''t slow down, got dizzy , went to ER at hospital


VAERS ID: 1685697 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-07-03
Onset:2021-08-01
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078C21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Amenorrhoea, Blood urine present
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Fertility disorders (broad)

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

Write-up: I have not had a menstruation since the administration of the vaccine, when I urinate and dry myself I see pink blood. There are days that I stain a little and there are days that I don''t.


VAERS ID: 1685767 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Delaware  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dizziness, Dyspnoea, Influenza, Pain, Palpitations, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
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: Nine
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, flu, vomiting, aches, dizziness, heart racing, weakness of the body, shortness of breath


VAERS ID: 1688832 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-06-01
Onset:2021-08-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Antineutrophil cytoplasmic antibody positive, Blood creatinine increased, Granulomatosis with polyangiitis, Renal disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Interstitial lung disease (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Vasculitis (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: cANCA: 1:640 Pr3: 2,000 creatinine: 3.5
CDC Split Type:

Write-up: Development of Granulomatosis with Polyangiitis, with severe renal involvement.


VAERS ID: 1688851 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-08-19
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Headache, Heavy menstrual bleeding, Hypoaesthesia, Muscle spasms, Paraesthesia, Peripheral coldness, Presyncope, Vaginal haemorrhage
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None at the time
Current Illness: None
Preexisting Conditions: Hypertension, sjogrins disease
Allergies: Hydroxychloroquine, sulfa, phentermine, mangos
Diagnostic Lab Data:
CDC Split Type:

Write-up: Muscle cramps and weakness, cold/numbness/tingling bilateral upper extremities. Abnormal vaginal bleeding, prolonged menstrual cycle. Daily headaches. Near syncope twice.


VAERS ID: 1688870 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-01
Onset:2021-08-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Trigger finger
SMQs:, Tendinopathies and ligament 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Norethindrone 5mg QD Multivitamins Tylenol
Current Illness: none
Preexisting Conditions: Dysmenorrhea Migraine headaches
Allergies: Hydrocodone
Diagnostic Lab Data: none, child is away at college, will be taking her to an urgent care facility this weekend
CDC Split Type:

Write-up: Child developed difficulty using left thumb after vaccine recieved. symptoms similiar to that of trigger finger. uncle and cousin also had similar reaction after recieving their vaccine which self resolved in approx 6 weeks


VAERS ID: 1689303 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-30
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Hypoaesthesia, Muscle tightness, Musculoskeletal stiffness
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Sexual dysfunction (broad)

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

Write-up: Right sided facial numbness: stiff and tight neck, right sided facial numbing. Treat with prednisone.


VAERS ID: 1689306 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-07-23
Onset:2021-08-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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

Write-up: I have been having menstrual cramps ever since my second dose. I did not have a period for the month of August. I am still having painful menstrual cramps almost every day. I did some research and found that other women are having these problem as well.


VAERS ID: 1689409 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-02-26
Onset:2021-08-01
   Days after vaccination:156
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011A21A / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Chest X-ray, Cough, Headache, Pyrexia, Respiratory viral panel, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 26 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hypercholesterolemia
Allergies: NKA
Diagnostic Lab Data: Covid test-positive, CXR, respiratory panel.
CDC Split Type:

Write-up: Pt came to ER c/o fever, cough, headache


VAERS ID: 1689418 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-01-12
Onset:2021-08-01
   Days after vaccination:201
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3302 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Dyspnoea, Oxygen saturation decreased, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: COPD, GERD, Dementia
Allergies: NKA
Diagnostic Lab Data: CXR, covid test
CDC Split Type:

Write-up: Pt came to ER c/o SOB, low oxygen sat.


VAERS ID: 1689706 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-23
Onset:2021-08-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 008D21A / 1 LA / IM

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

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

Write-up: I got sick after getting the injection. Later, after purchasing three small envelopes at the drug store in order to send a key, I got news that the location suffered an armed robbery.


VAERS ID: 1689758 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-11
Onset:2021-08-01
   Days after vaccination:143
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036A21A / 2 RA / SYR

Administered by: School       Purchased by: ?
Symptoms: Condition aggravated, Fibromyalgia, Immune system disorder, Impaired driving ability, Muscle spasms, Muscular weakness, Pruritus, Rash, Sneezing, Urticaria, Walking aid user
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prozac; Gabapentin (Neurontin); Vitamins and Minerals supplements
Current Illness: migraine
Preexisting Conditions: depression; fibromyalgia - until about a year ago and then it was gone
Allergies: Tetracycline; Cipro; I went to allergist - so many allergies that he couldn''t tell me specifically
Diagnostic Lab Data: no
CDC Split Type: vsafe

Write-up: I started having a major allergy attack- I was sneezing constantly. Allergy medicine didn''t help. I was starting to itch. It was itching everywhere, all over my body and I couldn''t scratch enough. Even on my scalp. I realized there was bumps and welts all over my body - a week or so into it. I almost tore my skin up trying to scratch. It was like that until the first Monday of September and I got on a prescription for Prednisone - it was a packet that stepped down the dosage. Slowly and surely the welts started going away. It was 6 days of Prednisone. When I finished day 1 then the next day, I had to start taking the Zyrtec and I am still taking the Zyrtec. I still itch. I don''t itch like I did but it''s more than normal itching. I itch everywhere. At the same time, as the itching started, I kept sneezing - I was thinking it was pollens in the air. It kept getting worse and worse. I took pictures of my body and emailed them to Kaiser for Doctor to look at it. I have a suppressed immune system - on a scale of 1 to 12, I''m at a 3. So when something happens, that immune system goes out of whack. It was trying to kill everything that didn''t belong there. So he had to get the inflammation back in control with the Prednisone. I had the vaccine 6 months ago. I go to physical therapy still - she gives me bunch of things so it goes in stages for like two weeks at a time: First stage, just so I could turn my head or raise my arms. I see her again next week. My muscles aren''t back yet enough. I can''t even drive a car because my muscles are too weak. I still need a walker - my physical therapist said not go out the door without my walker because I could fall anytime. My feet start cramping. I had my feet up and not doing anything. I am having trouble keeping up with the symptoms that I am having. Some days they are there and some days they aren''t. I hadn''t had a Fibro flare-up for over two years; that had been the first time in 40 years that I had not been in pain but now after the vaccines, it has come back - full force.


VAERS ID: 1691300 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 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: IMBRUVICA; ACETAMINOPHEN; CALCIUM CARBONATE; DEXAMETHASONE; DRAMAMINE; IBUPROFEN; LOPERAMIDE; PRILOSEC [OMEPRAZOLE]
Current Illness: CLL
Preexisting Conditions: Medical History/Concurrent Conditions: Pain; Comments: The patient had no known allergies.
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Negative (Lack of covid antibodies)
CDC Split Type: USJNJFOC20210904096

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a 58 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient had pain in his past medical history and concurrent conditions included: Chronic lymphocytic leukaemia (CLL) also had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Imbruvica (ibrutinib) for Chronic lymphocytic leukaemia (CLL), calcium carbonate, dexamethasone, Dramamine (dimenhydrinate), ibuprofen, loperamide, Prilosec (omeprazole), and Acetaminophen (paracetamol) for unknown indication. On AUG-2021, the patient did the Severe acute respiratory syndrome coronavirus 2 (SARS-cov-2) antibody test which showed negative results, hence 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, involving the same patient is linked to 20210856371 and 20210447536. This case is associated with product quality complaint: 90000192062.; Sender''s Comments: V0.20210904096-covid-19 vaccine ad26.cov2.s -confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY, SPECIAL SITUATIONS


VAERS ID: 1691340 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: South Carolina  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia
SMQs:, Guillain-Barre 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210915360

Write-up: FEELING WEAK; This spontaneous report received from a patient concerned a 68 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in AUG-2021, patient felt good but was hospitalized for feeling week. Patient mentioned that hospitalization was after receiving vaccine and it was due to being out in the sun. The number of days hospitalized was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling weak was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210915360-Covid-19 vaccine ad26.cov2.s-Feeling weak. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1691347 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Fatigue, Organic erectile dysfunction, Sexual dysfunction
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Sexual dysfunction (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: USJNJFOC20210915637

Write-up: TIGHTNESS IN CHEST; SHORTNESS OF BREATH; DIZZINESS; SEVERE DECREASE IN SEXUAL PERFORMANCE; LACK OF MORNING ERECTIONS; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced tightness in chest. On AUG-2021, the patient experienced shortness of breath. On AUG-2021, the patient experienced dizziness. On AUG-2021, the patient experienced severe decrease in sexual performance. On AUG-2021, the patient experienced lack of morning erections. On AUG-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, tightness in chest, shortness of breath, dizziness, severe decrease in sexual performance and lack of morning erections was not reported. This report was non-serious.


VAERS ID: 1691468 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-13
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Musculoskeletal stiffness, Pain in extremity, Vaccination site mass, Vaccination site pain
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (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: VITAMINS NOS
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: slightly raised red bump at the injection site; stiffness in the arm; pain in the arm is aching; experiencing pain in the arm at the injection site; previously had a headache which was very aggravating and lasted 6 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (slightly raised red bump at the injection site), MUSCULOSKELETAL STIFFNESS (stiffness in the arm), PAIN IN EXTREMITY (pain in the arm is aching), VACCINATION SITE PAIN (experiencing pain in the arm at the injection site) and HEADACHE (previously had a headache which was very aggravating and lasted 6 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. Concomitant products included VITAMINS NOS for an unknown indication. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE MASS (slightly raised red bump at the injection site), MUSCULOSKELETAL STIFFNESS (stiffness in the arm), PAIN IN EXTREMITY (pain in the arm is aching), VACCINATION SITE PAIN (experiencing pain in the arm at the injection site) and HEADACHE (previously had a headache which was very aggravating and lasted 6 days). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (slightly raised red bump at the injection site), MUSCULOSKELETAL STIFFNESS (stiffness in the arm) and VACCINATION SITE PAIN (experiencing pain in the arm at the injection site) outcome was unknown, PAIN IN EXTREMITY (pain in the arm is aching) had not resolved and HEADACHE (previously had a headache which was very aggravating and lasted 6 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was stated that tylenol for the headache, but she was constantly taking it every day, and the headache kept coming back.


VAERS ID: 1691469 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-01
Onset:2021-08-01
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

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

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

Write-up: This spontaneous case reported by a pharmacist, describes the occurrence of inappropriate schedule of product administration (patient received the first dose and never got the second one/came in March for the first one and for the second one in August) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. March 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. August 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In August 2021, patient experienced inappropriate schedule of product administration (patient received the first dose and never got the second one/came in March for the first one and for the second one in August). In August 2021, inappropriate schedule of product administration (patient received the first dose and never got the second one/came in March for the first one and for the second one in August) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.


VAERS ID: 1691475 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-23
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Sore arm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and NAUSEA (Nausea) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore arm) and NAUSEA (Nausea) was resolving. No Concomitant medications were reported No Treatment information was received This case was linked to MOD-2021-295486 (E2B Linked Report). This case was linked to MOD-2021-011799, MOD-2021-066100 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow-up contains Event outcome updated.; Sender''s Comments: MOD-2021-295486:same reporter, same event and different patient


VAERS ID: 1691477 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Missouri  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, Product storage error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Expired vaccine administered to patient; She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours). On 24-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 24-Aug-2021, PRODUCT STORAGE ERROR (She states that they placed 1 punctured vial of Moderna COVID-19 vaccine, which was first opened yesterday 23AUG2021 around 8-10AM, in the refrigerator for more than 12 hours) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medication was unknown. The treatment information was not provided by the reporter. Dose was administered using the expired punctured vial beyond 12 hours. Injected the expired Moderna COVID-19 vaccine to 7 patients. Number of doses/vials. 7 doses/ 1 vial; Total amount of time the vial was exposed to Refrigerator temperature: Greater than 12 hours in the refrigerator.


VAERS ID: 1691479 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-19
Onset:2021-08-01
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Intentional dose omission, Myalgia, Nasal congestion, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (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), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: SARS-COV-2 antibody test; Test Result: Positive ; Result Unstructured Data: POSITIVE
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: 36 days after first shot and has not received the second shot; Fever 101.5 F; Body ache; Slight cough; Congestion; Positive COVID Test; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 101.5 F), MYALGIA (Body ache), COUGH (Slight cough), NASAL CONGESTION (Congestion) and SARS-COV-2 ANTIBODY TEST POSITIVE (Positive COVID Test) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced PYREXIA (Fever 101.5 F), MYALGIA (Body ache), COUGH (Slight cough), NASAL CONGESTION (Congestion) and SARS-COV-2 ANTIBODY TEST POSITIVE (Positive COVID Test). On 24-Aug-2021, the patient experienced INTENTIONAL DOSE OMISSION (36 days after first shot and has not received the second shot). On 04-Aug-2021, PYREXIA (Fever 101.5 F), MYALGIA (Body ache), COUGH (Slight cough) and NASAL CONGESTION (Congestion) had resolved. At the time of the report, SARS-COV-2 ANTIBODY TEST POSITIVE (Positive COVID Test) outcome was unknown and INTENTIONAL DOSE OMISSION (36 days after first shot and has not received the second shot) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 antibody test: positive (Positive) POSITIVE. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. no concomitant medications were reported. no treatment drugs were reported. Symptoms went away after 4 days. She did a COVID test at a local pharmacy on 01AUG2021 COVID test result came back positive for COVID-19 Disease on 02AUG2021.


VAERS ID: 1691515 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-13
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059E21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Bruxism, Fatigue, Headache, Migraine, Nausea, Non-cardiac chest pain, 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: Medical History/Concurrent Conditions: COVID-19 (Treatment received: Steroids)
Allergies:
Diagnostic Lab Data: Test Date: 20210814; Test Name: 103 degrees F; Result Unstructured Data: High
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: shivering jaw clenched; experienced 2-3 hours of chest pain severe heart burn; felt nauseated sick to stomach; running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever; fatigue; Headache; migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), BRUXISM (shivering jaw clenched), NON-CARDIAC CHEST PAIN (experienced 2-3 hours of chest pain severe heart burn), NAUSEA (felt nauseated sick to stomach) and PYREXIA (running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included COVID-19 (Treatment received: Steroids) in November 2020. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced BRUXISM (shivering jaw clenched), NON-CARDIAC CHEST PAIN (experienced 2-3 hours of chest pain severe heart burn), NAUSEA (felt nauseated sick to stomach) and PYREXIA (running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever). In August 2021, the patient experienced MIGRAINE (migraine), FATIGUE (fatigue) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Adverse event, at a dose of took 4 total that morning; CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) for Adverse event, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 14-Aug-2021, BRUXISM (shivering jaw clenched), NON-CARDIAC CHEST PAIN (experienced 2-3 hours of chest pain severe heart burn) and PYREXIA (running 103 degrees F/ she laid back down at 7 or 8am and was still running a fever) had resolved. On 17-Aug-2021, MIGRAINE (migraine), NAUSEA (felt nauseated sick to stomach) and FATIGUE (fatigue) had resolved. At the time of the report, HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, Body temperature: 103 degrees f (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitants were reported. Patient stated that Tried to have crackers and bread to settle stomach, went to lay back down took more ibuprofen took 4 total that morning. Slept until 10:30-11AM. Could not drink water, nauseated. Patient had COVID-19 last year in November2020 and said that symptoms from 1st dose was similar to COVID-19 she had except for the nausea. Patient was in bed the most of the day. Patient woke up 3pm tried to eat soup broth and experienced 2-3 hours of chest pain ,severe heart burn.


VAERS ID: 1691529 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-08-15
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002F21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Feeling abnormal, Injection site pruritus, Muscle spasms, Muscle twitching, Vaccination site erythema, Vaccination site rash, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Hypersensitivity (narrow)

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

Write-up: A bit pink; Chest tightness; Weird sensation initially on the left arm then it resolved and moved to his right leg; Right leg started twitching; Feels like cramping and constantly present from the knee down to the right calf area.; Itchy (area of the injection); Rash at the area of the injection; Swelling at the area of the injection (left arm); This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest tightness), FEELING ABNORMAL (Weird sensation initially on the left arm then it resolved and moved to his right leg), MUSCLE TWITCHING (Right leg started twitching), MUSCLE SPASMS (Feels like cramping and constantly present from the knee down to the right calf area.) and VACCINATION SITE ERYTHEMA (A bit pink) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthmatic attack. On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Aug-2021, the patient experienced CHEST DISCOMFORT (Chest tightness). In August 2021, the patient experienced FEELING ABNORMAL (Weird sensation initially on the left arm then it resolved and moved to his right leg), MUSCLE TWITCHING (Right leg started twitching), MUSCLE SPASMS (Feels like cramping and constantly present from the knee down to the right calf area.), INJECTION SITE PRURITUS (Itchy (area of the injection)), VACCINATION SITE RASH (Rash at the area of the injection) and VACCINATION SITE SWELLING (Swelling at the area of the injection (left arm)). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (A bit pink). At the time of the report, CHEST DISCOMFORT (Chest tightness), MUSCLE TWITCHING (Right leg started twitching), MUSCLE SPASMS (Feels like cramping and constantly present from the knee down to the right calf area.), VACCINATION SITE ERYTHEMA (A bit pink), INJECTION SITE PRURITUS (Itchy (area of the injection)), VACCINATION SITE RASH (Rash at the area of the injection) and VACCINATION SITE SWELLING (Swelling at the area of the injection (left arm)) had not resolved and FEELING ABNORMAL (Weird sensation initially on the left arm then it resolved and moved to his right leg) was resolving. 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 symptom started, few hours after the vaccination on the same day (15Aug2021).


VAERS ID: 1691558 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-05-15
Onset:2021-08-01
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002C21A / 1 - / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Dizziness, Erythema, Fall, Fatigue, Inappropriate schedule of product administration, Mobility decreased, Muscle tightness, Muscular weakness, Peripheral swelling, Vaccination site pain, Vertigo, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID; GABAPENTIN; TYLENOL
Current Illness: Blood disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Arm discomfort; COVID-19 (Patient was hospitalized.); Tooth extraction NOS (All the bottom teeth were pulled as she has jagged teeth underneath the bridge.)
Allergies:
Diagnostic Lab Data: Test Date: 20210808; Test Name: X-ray; Result Unstructured Data: normal
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Fell out of the sofa onto the floor; Had to crawled because I couldn''t lift myself up, was on the floor from Friday to Sunday; Diarrhea; Weakness; Dizziness, still dizzy; First shot on 15 May2021 and Second shot on 05 Aug2021; Right arm was swollen; Right arm was red; Really tired; It hurt when the needle entered; Vertigo; Weakness in legs; Muscles between the knees and ankles are tight; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizziness, still dizzy), MUSCLE TIGHTNESS (Muscles between the knees and ankles are tight), FALL (Fell out of the sofa onto the floor) and MOBILITY DECREASED (Had to crawled because I couldn''t lift myself up, was on the floor from Friday to Sunday) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included COVID-19 (Patient was hospitalized.) in November 2020, Arm discomfort and Tooth extraction NOS (All the bottom teeth were pulled as she has jagged teeth underneath the bridge.) on 18-May-2021. Concurrent medical conditions included Blood disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot on 15 May2021 and Second shot on 05 Aug2021), PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red) and FATIGUE (Really tired). On 06-Aug-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizziness, still dizzy), FALL (Fell out of the sofa onto the floor), MOBILITY DECREASED (Had to crawled because I couldn''t lift myself up, was on the floor from Friday to Sunday) and DIARRHOEA (Diarrhea). In August 2021, the patient experienced MUSCLE TIGHTNESS (Muscles between the knees and ankles are tight), VERTIGO (Vertigo), MUSCULAR WEAKNESS (Weakness in legs) and VACCINATION SITE PAIN (It hurt when the needle entered). On 05-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot on 15 May2021 and Second shot on 05 Aug2021) had resolved. On 08-Aug-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, ASTHENIA (Weakness) and DIZZINESS (Dizziness, still dizzy) had not resolved, MUSCLE TIGHTNESS (Muscles between the knees and ankles are tight), FALL (Fell out of the sofa onto the floor), MOBILITY DECREASED (Had to crawled because I couldn''t lift myself up, was on the floor from Friday to Sunday), VERTIGO (Vertigo), MUSCULAR WEAKNESS (Weakness in legs), FATIGUE (Really tired) and VACCINATION SITE PAIN (It hurt when the needle entered) outcome was unknown and PERIPHERAL SWELLING (Right arm was swollen) and ERYTHEMA (Right arm was red) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, X-ray: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had spine condition which doesn''t let her to put the hands in front of her body when she felled. Patient reported that the arm redness and swelling lasted until 3-4 days ago before reporting. Patient fell out of sofa on 06 Aug and found by neighbor on 08 Aug and was carried to hospital for 10 hours. Patient had a Brain scan, but the results were unknown. Patient was treated with Pills for diarrhea and blue liquid for diarrhea. Kneecap replacement surgery, shoulder surgery, and a cataracts surgery scheduled before was postponed due to the symptoms experienced after second dose of vaccination. This case was linked to MOD-2021-297455 (Patient Link).


VAERS ID: 1691560 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-23
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040021A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Hypersomnia, Pain
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (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: SINGULAIR; SYMBICORT; BUSPAR; FLUOXETINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Next day, she had really bad body aches.; She also had fatigue next day.; Within couple of hours, she had bad headache around left eye that went down to top of her jaw.; Within couple of hours, she had bad headache around left eye that went down to top of her jaw.; She slept for 23.5 hours; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (She slept for 23.5 hours), PAIN (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.), PAIN (Next day, she had really bad body aches.), FATIGUE (She also had fatigue next day.) and HEADACHE (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040021A) for COVID-19 vaccination. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), BUSPIRONE HYDROCHLORIDE (BUSPAR) and FLUOXETINE for an unknown indication. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced HYPERSOMNIA (She slept for 23.5 hours). On 23-Aug-2021, the patient experienced PAIN (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.) and HEADACHE (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.). On 24-Aug-2021, the patient experienced PAIN (Next day, she had really bad body aches.) and FATIGUE (She also had fatigue next day.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (She slept for 23.5 hours), PAIN (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.), PAIN (Next day, she had really bad body aches.), FATIGUE (She also had fatigue next day.) and HEADACHE (Within couple of hours, she had bad headache around left eye that went down to top of her jaw.) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication included Blood pressure medicine. Patient had body aches. She also had fatigue. She slept for 23.5 hours and at the day of reporting she felt better.


VAERS ID: 1691568 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Kansas  
Vaccinated:2021-02-01
Onset:2021-08-01
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / OT

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

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

Write-up: Inappropriate schedule of vaccine administered; Fatigue; Muscle ache; Nausea; Vomiting; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue), MYALGIA (Muscle ache), NAUSEA (Nausea), VOMITING (Vomiting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced FATIGUE (Fatigue), MYALGIA (Muscle ache), NAUSEA (Nausea) and VOMITING (Vomiting). On 25-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PARACETAMOL (TYLENOL) in August 2021 for Adverse event, at an unspecified dose and frequency. On 25-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, FATIGUE (Fatigue), MYALGIA (Muscle ache), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. Vaccine facility information also included , . This case was linked to MOD-2021-297814 (Patient Link).


VAERS ID: 1691624 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-08-18
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Application site pain, Arthralgia, Chest pain, Chills, Headache, Limb discomfort, Lymphadenopathy, Vaccination site swelling
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: All the neck and arm and chest area hurts; Arm is more swollen, hard and hurts; Headache; Shivering went awat 10 mins later and felt asleep/chills and was Shivering; Swollen Nodule on the Clavicle; On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4; Arm and Shoulder was hurting; Arm is still swollen over there at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (All the neck and arm and chest area hurts), LIMB DISCOMFORT (Arm is more swollen, hard and hurts), APPLICATION SITE PAIN (On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4), LYMPHADENOPATHY (Swollen Nodule on the Clavicle) and ARTHRALGIA (Arm and Shoulder was hurting) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ARTHRALGIA (Arm and Shoulder was hurting) and VACCINATION SITE SWELLING (Arm is still swollen over there at the injection site). On 18-Aug-2021, the patient experienced APPLICATION SITE PAIN (On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4). On 26-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen Nodule on the Clavicle). On an unknown date, the patient experienced CHEST PAIN (All the neck and arm and chest area hurts), LIMB DISCOMFORT (Arm is more swollen, hard and hurts), HEADACHE (Headache) and CHILLS (Shivering went awat 10 mins later and felt asleep/chills and was Shivering). At the time of the report, CHEST PAIN (All the neck and arm and chest area hurts), LIMB DISCOMFORT (Arm is more swollen, hard and hurts), APPLICATION SITE PAIN (On a scale of Pain at the injection site from 1 to 10 it was a 3 to 4), LYMPHADENOPATHY (Swollen Nodule on the Clavicle), ARTHRALGIA (Arm and Shoulder was hurting), HEADACHE (Headache) and CHILLS (Shivering went awat 10 mins later and felt asleep/chills and was Shivering) outcome was unknown and VACCINATION SITE SWELLING (Arm is still swollen over there at the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided.


VAERS ID: 1691633 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Exposure via breast milk, Rash
SMQs:, Anaphylactic reaction (broad), Neonatal exposures via breast milk (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: breastfeed; has broken out in a rash all over his body; This spontaneous case was reported by a non-health professional and describes the occurrence of EXPOSURE VIA BREAST MILK (breastfeed) and RASH (has broken out in a rash all over his body) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) , while the mother received the product for COVID-19 vaccination. No Medical History information was reported. In August 2021, the mother 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. In August 2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (breastfeed) and RASH (has broken out in a rash all over his body). At the time of the report, EXPOSURE VIA BREAST MILK (breastfeed) and RASH (has broken out in a rash all over his body) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Parent received the first dose of the Moderna vaccine two mornings ago and on yesterday morning child has rash to who m she breastfeed and also mentioned that Nothing else has changed in my diet to cause an allergy reaction. No concomitant medications were provided by reporter. No treatment medications were provided by reporter.


VAERS ID: 1691683 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-20
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002F21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Hypersensitivity, Myalgia, Pruritus, Rash, Urticaria, Vaccination site pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: USMODERNATX, INC.MOD20213

Write-up: Whole area on the arm is very itchy; Rash; Arm has been sore for the past couple of days; hives; it was very itchy at the injection site; allergic reaction; very red; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), ERYTHEMA (very red), PRURITUS (Whole area on the arm is very itchy), URTICARIA (hives) and VACCINATION SITE PRURITUS (it was very itchy at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced HYPERSENSITIVITY (allergic reaction), ERYTHEMA (very red), URTICARIA (hives) and VACCINATION SITE PRURITUS (it was very itchy at the injection site). On 28-Aug-2021, the patient experienced PRURITUS (Whole area on the arm is very itchy), RASH (Rash) and MYALGIA (Arm has been sore for the past couple of days). At the time of the report, HYPERSENSITIVITY (allergic reaction) had not resolved and ERYTHEMA (very red), PRURITUS (Whole area on the arm is very itchy), URTICARIA (hives), VACCINATION SITE PRURITUS (it was very itchy at the injection site), RASH (Rash) and MYALGIA (Arm has been sore for the past couple of days) outcome was unknown. 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 treatment medication information was provided. No concomitant medication information was provided. Most recent FOLLOW-UP information incorporated above includes: On 28-Aug-2021: Follow up report contains additional events were added. On 03-Sep-2021: Follow-up document received on 03-SEP-2021. It contains no new information.


VAERS ID: 1691700 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / -

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

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

Write-up: This spontaneous case reported by a consumer, describes the occurrence of rash (around her abdomen), pyrexia (fever) and fatigue in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. August 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. August 2021, patient experienced rash (around her abdomen), pyrexia (fever) and fatigue. At the time of the report, rash (around her abdomen), pyrexia (fever) and fatigue outcome: unknown. Patient given antihistamines. No concomitant medications provided.


VAERS ID: 1691752 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Agitation, Anxiety, Chest pain, Confusional state, Dyspnoea, Emotional disorder, Myalgia, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Chest pain immediately after vaccination; Confused immediately after vaccination; Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination; Very Emotional after vaccination; Anxiety after vaccination; Can not sleep after vaccination; Agitated all the time after vaccination; Body Pain after vaccination; This spontaneous case was reported by a physician and describes the occurrence of CHEST PAIN (Chest pain immediately after vaccination), CONFUSIONAL STATE (Confused immediately after vaccination), DYSPNOEA (Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination), EMOTIONAL DISORDER (Very Emotional after vaccination) and ANXIETY (Anxiety after vaccination) in a 28-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. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced CHEST PAIN (Chest pain immediately after vaccination), CONFUSIONAL STATE (Confused immediately after vaccination), DYSPNOEA (Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination), EMOTIONAL DISORDER (Very Emotional after vaccination), ANXIETY (Anxiety after vaccination), SLEEP DISORDER (Can not sleep after vaccination), AGITATION (Agitated all the time after vaccination) and MYALGIA (Body Pain after vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest pain immediately after vaccination), CONFUSIONAL STATE (Confused immediately after vaccination), DYSPNOEA (Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination), EMOTIONAL DISORDER (Very Emotional after vaccination), ANXIETY (Anxiety after vaccination), SLEEP DISORDER (Can not sleep after vaccination), AGITATION (Agitated all the time after vaccination) and MYALGIA (Body Pain after vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were provided Patients cardio echo and enzymes were normal.


VAERS ID: 1691754 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059E21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypersensitivity, Product dose omission issue, Pyrexia, Rash, SARS-CoV-2 test, Sensitive skin
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MONTELUKAST; PULMICORT FLEXHALER; FLONASE [FLUTICASONE PROPIONATE]
Current Illness: Asthma; Drug allergy (aspirin allergy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: skipped second dose; skin felt sensitive; allergic reaction; rash all over her abdomen and back; kind of like a low grade fever sensitivity feeling; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (skin felt sensitive), HYPERSENSITIVITY (allergic reaction), RASH (rash all over her abdomen and back), PYREXIA (kind of like a low grade fever sensitivity feeling) and PRODUCT DOSE OMISSION ISSUE (skipped second dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Asthma and Drug allergy (aspirin allergy). Concomitant products included MONTELUKAST, BUDESONIDE (PULMICORT FLEXHALER) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced SENSITIVE SKIN (skin felt sensitive), HYPERSENSITIVITY (allergic reaction), RASH (rash all over her abdomen and back) and PYREXIA (kind of like a low grade fever sensitivity feeling). On 28-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (skipped second dose). On 04-Aug-2021, RASH (rash all over her abdomen and back) had resolved. At the time of the report, SENSITIVE SKIN (skin felt sensitive), HYPERSENSITIVITY (allergic reaction) and PYREXIA (kind of like a low grade fever sensitivity feeling) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (skipped second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was diagnosed with COVID-19 infection January 2021 that caused breathing difficulties. Patient is taking Rescue Inhaler No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up information includes no new information.


VAERS ID: 1691768 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: North Carolina  
Vaccinated:2021-08-26
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination site pain
SMQs:

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

Write-up: Pain at the vaccination site/throbbing pain at the site of the injection/bad pain near the shot.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the vaccination site/throbbing pain at the site of the injection/bad pain near the shot.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE PAIN (Pain at the vaccination site/throbbing pain at the site of the injection/bad pain near the shot.). At the time of the report, VACCINATION SITE PAIN (Pain at the vaccination site/throbbing pain at the site of the injection/bad pain near the shot.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided. Patient would call back if he had any symptoms after getting the 2nd shot. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow Up Received on 01sep21 includes Significant Information and Reporter Declined FU


VAERS ID: 1691770 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-01-12
Onset:2021-08-01
   Days after vaccination:201
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012L20A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
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: LEVOTHYROXINE; LOSARTAN; ROSUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder discomfort
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: she got the Delta Variant on 01AUG2021; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (she got the Delta Variant on 01AUG2021) and DRUG INEFFECTIVE (Drug ineffective) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient''s past medical history included Bladder discomfort. Concomitant products included LEVOTHYROXINE, LOSARTAN and ROSUVASTATIN for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced COVID-19 (she got the Delta Variant on 01AUG2021) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 (she got the Delta Variant on 01AUG2021) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient reported that she got the Delta Variant on 01-AUG-2021, after that she got an anti-body infusion.


VAERS ID: 1691785 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088D21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dizziness, Dyspnoea, Fatigue, Influenza like illness, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: left side chest pain like someone was pushing down on chest; shortness of breath/hurts to take a deep breath in; Flu like symptoms; lightheaded; cold tingling sensation along both arms and both legs; very tired; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (left side chest pain like someone was pushing down on chest), DYSPNOEA (shortness of breath/hurts to take a deep breath in), INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (lightheaded) and PARAESTHESIA (cold tingling sensation along both arms and both legs) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PARAESTHESIA (cold tingling sensation along both arms and both legs) and FATIGUE (very tired). August 2021, the patient experienced DIZZINESS (lightheaded). On 30-Aug-2021, the patient experienced CHEST PAIN (left side chest pain like someone was pushing down on chest) and DYSPNOEA (shortness of breath/hurts to take a deep breath in). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Sleeplessness, at a dose of Unknown and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleeplessness, at a dose of Unknown. At the time of the report, CHEST PAIN (left side chest pain like someone was pushing down on chest) and DYSPNOEA (shortness of breath/hurts to take a deep breath in) had not resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms), DIZZINESS (lightheaded), PARAESTHESIA (cold tingling sensation along both arms and both legs) and FATIGUE (very tired) outcome was unknown. No concomitant medication were reported. This case was linked to MOD-2021-301521 (Patient Link).


VAERS ID: 1691810 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bedridden, Body temperature, Illness, Malaise, Pain in extremity, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (she and her husband both had COVID a year ago.)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: fever; Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: fever
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Both arms hurt for almost a week; Didn''t feel good for about 4 days; Both in bed for 2 days/couldn''t get out of bed; Got sick/felt sick for 4 days.; Fever of 102/My fever was 100.7; Vomited; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Both arms hurt for almost a week), MALAISE (Didn''t feel good for about 4 days), BEDRIDDEN (Both in bed for 2 days/couldn''t get out of bed), ILLNESS (Got sick/felt sick for 4 days.) and PYREXIA (Fever of 102/My fever was 100.7) in a 63-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 COVID-19 (she and her husband both had COVID a year ago.) in 2020. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Both arms hurt for almost a week), MALAISE (Didn''t feel good for about 4 days), BEDRIDDEN (Both in bed for 2 days/couldn''t get out of bed), ILLNESS (Got sick/felt sick for 4 days.), PYREXIA (Fever of 102/My fever was 100.7) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) in August 2021 for Fever, at an unspecified dose and frequency. In August 2021, PAIN IN EXTREMITY (Both arms hurt for almost a week), MALAISE (Didn''t feel good for about 4 days) and ILLNESS (Got sick/felt sick for 4 days.) had resolved. At the time of the report, BEDRIDDEN (Both in bed for 2 days/couldn''t get out of bed), PYREXIA (Fever of 102/My fever was 100.7) and VOMITING (Vomited) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 102 (High) fever and 100.7 (High) fever. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Caller stated that the second dose is coming up on this Saturday. This case was linked to MOD-2021-301975 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received on 02-sep-2021 contains significant information( as reported of fever updated)


VAERS ID: 1691820 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Nevada  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bedridden, Body temperature, Chills, Feeling abnormal, Illness, Mobility decreased, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: fever of 100.2
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: both in bed for 2 days; didn''t feel good for about 4 days; couldn''t get out of bed; felt sick for 4 days; fever of 107; chills; both arms hurt for almost a week; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BEDRIDDEN (both in bed for 2 days), FEELING ABNORMAL (didn''t feel good for about 4 days), MOBILITY DECREASED (couldn''t get out of bed), ILLNESS (felt sick for 4 days) and PYREXIA (fever of 107) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced BEDRIDDEN (both in bed for 2 days), FEELING ABNORMAL (didn''t feel good for about 4 days), MOBILITY DECREASED (couldn''t get out of bed), ILLNESS (felt sick for 4 days), PYREXIA (fever of 107), CHILLS (chills) and PAIN IN EXTREMITY (both arms hurt for almost a week). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (both in bed for 2 days), FEELING ABNORMAL (didn''t feel good for about 4 days) and ILLNESS (felt sick for 4 days) had resolved and MOBILITY DECREASED (couldn''t get out of bed), PYREXIA (fever of 107), CHILLS (chills) and PAIN IN EXTREMITY (both arms hurt for almost a week) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) fever of 100.2. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was tested positive for COVID-19 a year ago Concomitant product was not provided by the reporter This case was linked to MOD-2021-301937 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Additional information included lab data and new event.


VAERS ID: 1691822 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: California  
Vaccinated:2021-01-29
Onset:2021-08-01
   Days after vaccination:184
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Depression, Fatigue, Myalgia, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), 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: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Exposure to mold (Exposed to black mold); Solid organ transplant; Type 2 diabetes mellitus (Type 2 diabetes on medication)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Severe depression; Had no appetite; Slept most the day; Felt very fatigued; Mild soreness in the same right arm; This spontaneous case was reported by a pharmacist and describes the occurrence of DEPRESSION (Severe depression), DECREASED APPETITE (Had no appetite), SOMNOLENCE (Slept most the day), FATIGUE (Felt very fatigued) and MYALGIA (Mild soreness in the same right arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The patient''s past medical history included Exposure to mold (Exposed to black mold) and Solid organ transplant. Concurrent medical conditions included Type 2 diabetes mellitus (Type 2 diabetes on medication) and Asthma. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced DEPRESSION (Severe depression), DECREASED APPETITE (Had no appetite), SOMNOLENCE (Slept most the day), FATIGUE (Felt very fatigued) and MYALGIA (Mild soreness in the same right arm). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse drug reaction, at a dose of 1500 mg. At the time of the report, DEPRESSION (Severe depression), DECREASED APPETITE (Had no appetite), SOMNOLENCE (Slept most the day), FATIGUE (Felt very fatigued) and MYALGIA (Mild soreness in the same right arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. This case was linked to MOD-2021-302002, MOD-2021-301965 (Patient Link).


VAERS ID: 1691831 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lethargy, Vaccination site erythema, Vaccination site rash
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

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

Write-up: Stripe of redness/looks like a stripe of redness, like a burn; It is a rash, but not raised; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), VACCINATION SITE ERYTHEMA (Stripe of redness/looks like a stripe of redness, like a burn) and VACCINATION SITE RASH (It is a rash, but not raised) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced LETHARGY (lethargic) and VACCINATION SITE RASH (It is a rash, but not raised). On 29-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Stripe of redness/looks like a stripe of redness, like a burn). At the time of the report, LETHARGY (lethargic), VACCINATION SITE ERYTHEMA (Stripe of redness/looks like a stripe of redness, like a burn) and VACCINATION SITE RASH (It is a rash, but not raised) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was not on any blood thinner. They are on daily medication, one medication they have been on for 20 years, and the other they have been on for 5 years. Patient declined to mention names of the Concomitant medication. Treatment information was not provided. The stripe of redness is about 2 inches by 3 inches, like a burn. It appeared below where the syringe was inserted.


VAERS ID: 1691832 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Anosmia, Illness, Presyncope
SMQs:, Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Felt really sick; About to faint; Lost her taste; Lost her smell; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt really sick), PRESYNCOPE (About to faint), AGEUSIA (Lost her taste) and ANOSMIA (Lost her smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ILLNESS (Felt really sick), PRESYNCOPE (About to faint), AGEUSIA (Lost her taste) and ANOSMIA (Lost her smell). At the time of the report, ILLNESS (Felt really sick), PRESYNCOPE (About to faint), AGEUSIA (Lost her taste) and ANOSMIA (Lost her smell) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. The treatment information was not provided. Reporter did not allow further contact


VAERS ID: 1691862 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nasopharyngitis, Pain in extremity
SMQs:, 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: USMODERNATX, INC.MOD20213

Write-up: Started getting really cold /like I''m catching a bad cold; Arm has been very very sore; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Started getting really cold /like I''m catching a bad cold) and PAIN IN EXTREMITY (Arm has been very very sore) 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. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PAIN IN EXTREMITY (Arm has been very very sore). On an unknown date, the patient experienced NASOPHARYNGITIS (Started getting really cold /like I''m catching a bad cold). At the time of the report, NASOPHARYNGITIS (Started getting really cold /like I''m catching a bad cold) and PAIN IN EXTREMITY (Arm has been very very sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided Treatment information was not reported


VAERS ID: 1691887 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-09
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination site pain, Vaccination site swelling
SMQs:

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

Write-up: Swelling of that portion of it started immediately; Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it''s from the shoulder to the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it''s from the shoulder to the elbow) and VACCINATION SITE SWELLING (Swelling of that portion of it started immediately) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION SITE SWELLING (Swelling of that portion of it started immediately). In August 2021, the patient experienced VACCINATION SITE PAIN (Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it''s from the shoulder to the elbow). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. In August 2021, VACCINATION SITE SWELLING (Swelling of that portion of it started immediately) had resolved. At the time of the report, VACCINATION SITE PAIN (Very very sore arm is not on the outside is on the inside/when has to throw becomes very sore/Pain is more as when someone punches you in the arm, but it''s from the shoulder to the elbow) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. The patient took Tylenol initially for 2 days and then Advil was used when it started hurting again and was put hot prior to work and then iced it. The patient''s pain and swelling went away after vaccination but it started again during training that was probably around 17th or 18th of August and was still painful. Patient had no other symptoms.


VAERS ID: 1691898 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Arkansas  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059E21A / 2 LA / OT

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

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

Write-up: appendicitis/ appendix removed; This spontaneous case was reported by a pharmacist and describes the occurrence of APPENDICITIS (appendicitis/ appendix removed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced APPENDICITIS (appendicitis/ appendix removed) (seriousness criteria hospitalization and medically significant). The patient was treated with Surgery (appendix removed) for Appendicitis. At the time of the report, APPENDICITIS (appendicitis/ appendix removed) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1691901 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-01-01
Onset:2021-08-01
   Days after vaccination:212
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (narrow)

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

Write-up: I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).; I am 7 months pregnant.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).) and MATERNAL EXPOSURE DURING PREGNANCY (I am 7 months pregnant.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).) and MATERNAL EXPOSURE DURING PREGNANCY (I am 7 months pregnant.). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I had the second dose of my Moderna vaccine yesterday (first dose in January 2021).) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (I am 7 months pregnant.) outcome was unknown. Concomitant medications were not provided. Treatment information was not provided.


VAERS ID: 1691919 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-01-06
Onset:2021-08-01
   Days after vaccination:207
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011J20A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Drug ineffective, Fatigue, Malaise, Nasal congestion, Pain in extremity, Pyrexia
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RABEPRAZOLE SODIUM; XYZAL ALLERGY 24HR; MAGNESIUM; AZELASTINE; VITAMIN D3; TYLENOL; IBUPROFEN; TRELEGY
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: congestion; legs were very painful; some fever; got infected with covid-19/ breakthrough case; a little bit of malaise; slight fatigue/ extreme fatigue/ they were very tired; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case), MALAISE (a little bit of malaise), NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful) and FATIGUE (slight fatigue/ extreme fatigue/ they were very tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included RABEPRAZOLE SODIUM, LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL ALLERGY 24HR), MAGNESIUM, AZELASTINE, COLECALCIFEROL (VITAMIN D3), PARACETAMOL (TYLENOL), IBUPROFEN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MALAISE (a little bit of malaise) and FATIGUE (slight fatigue/ extreme fatigue/ they were very tired). In August 2021, the patient experienced DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case). On an unknown date, the patient experienced NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful) and PYREXIA (some fever). At the time of the report, DRUG INEFFECTIVE (got infected with covid-19/ breakthrough case), MALAISE (a little bit of malaise), NASAL CONGESTION (congestion), PAIN IN EXTREMITY (legs were very painful), FATIGUE (slight fatigue/ extreme fatigue/ they were very tired) and PYREXIA (some fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient treatment included Over-the-counter stuff. Patient said that she is in her 70s.


VAERS ID: 1691943 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-02-01
Onset:2021-08-01
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Agitation, Hallucination, Inappropriate schedule of product administration, Lethargy
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Medication errors (narrow), Hypoglycaemia (broad)

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

Write-up: hallucinating thinking that people are in the next room; agitated; she is lethargic; 1st dose in February of 2021 & 2nd dose on 23Aug2021; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of HALLUCINATION (hallucinating thinking that people are in the next room) in an 82-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 COVID-19 in December 2020 and Encephalitis in December 2020. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced HALLUCINATION (hallucinating thinking that people are in the next room) (seriousness criterion medically significant), AGITATION (agitated), LETHARGY (she is lethargic) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in February of 2021 & 2nd dose on 23Aug2021). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in February of 2021 & 2nd dose on 23Aug2021) had resolved. At the time of the report, HALLUCINATION (hallucinating thinking that people are in the next room), AGITATION (agitated) and LETHARGY (she is lethargic) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided She doesn''t have dementia. Company comment- Very limited information regarding these events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-303411 (Patient Link).; Sender''s Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.


VAERS ID: 1691960 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Georgia  
Vaccinated:2021-03-01
Onset:2021-08-01
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Neighbors got COVID-19 last month after being vaccinated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Neighbors got COVID-19 last month after being vaccinated) and DRUG INEFFECTIVE (Drug ineffective) 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. In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced COVID-19 (Neighbors got COVID-19 last month after being vaccinated) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, COVID-19 (Neighbors got COVID-19 last month after being vaccinated) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown. No Concomitant medication was reported. No treatment medications were reported Reporter said they (her neighbors) believe they contracted it from their 4year old grandson who also tested positive for COVID-19. She did not have additional information at the time of the call.


VAERS ID: 1691966 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-20
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088D21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Arthritis, Headache, Lip swelling, Muscle spasms, Nausea, Off label use, Peripheral swelling, Pharyngeal swelling, Swelling of eyelid, Urticaria, Vaccination complication, Vaccination site pain, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Systemic lupus erythematosus (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Hives all over torso/ Hives on hands and legs; Throat was swollen; Bottom lip was swollen; Eye lid swelling; Palms of hands swelled up; The emergency room doctor recommended that she do not take the 2nd dose; Joint pains; Headache; Injection site painful; Nauseous; Left arm was swollen at injection site; her knees were crampy, elbow was cramping; COVID arm; Was hot to touch, very warm; Inflammation in her ankle joints; Immune system ramped up; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over torso/ Hives on hands and legs) and PHARYNGEAL SWELLING (Throat was swollen) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION COMPLICATION (Immune system ramped up), ARTHRITIS (Inflammation in her ankle joints), MUSCLE SPASMS (her knees were crampy, elbow was cramping), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (Was hot to touch, very warm), VACCINATION SITE SWELLING (Left arm was swollen at injection site), VACCINATION SITE PAIN (Injection site painful) and NAUSEA (Nauseous). On 21-Aug-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced URTICARIA (Hives all over torso/ Hives on hands and legs) (seriousness criterion medically significant), PHARYNGEAL SWELLING (Throat was swollen) (seriousness criterion medically significant), LIP SWELLING (Bottom lip was swollen), SWELLING OF EYELID (Eye lid swelling), PERIPHERAL SWELLING (Palms of hands swelled up), OFF LABEL USE (The emergency room doctor recommended that she do not take the 2nd dose ) and ARTHRALGIA (Joint pains). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over torso/ Hives on hands and legs), PHARYNGEAL SWELLING (Throat was swollen), VACCINATION COMPLICATION (Immune system ramped up), LIP SWELLING (Bottom lip was swollen), SWELLING OF EYELID (Eye lid swelling), ARTHRITIS (Inflammation in her ankle joints), PERIPHERAL SWELLING (Palms of hands swelled up), MUSCLE SPASMS (her knees were crampy, elbow was cramping), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (Was hot to touch, very warm), OFF LABEL USE (The emergency room doctor recommended that she do not take the 2nd dose ), VACCINATION SITE SWELLING (Left arm was swollen at injection site), VACCINATION SITE PAIN (Injection site painful), NAUSEA (Nauseous) and ARTHRALGIA (Joint pains) outcome was unknown and HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment medication included steroids. The patient reported that the Emergency Room doctor recommended that she not take the 2nd dose. 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: 1692042 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Breast pain
SMQs:, Lipodystrophy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ARMOUR THYROID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thyroiditis (Verbatim: Thyroid)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101015948

Write-up: Pulsing, small pulsing pain under below my left breast and it comes in and it comes in at intermittent intervals; It is like for a minute or half, sometimes every five seconds; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: unknown, expiry date: 31Oct2021), via an unknown route of administration on 06Aug2021 (at the age of 75-years-old) as single dose for COVID-19 immunization. The patient''s medical history included thyroid from an unknown date to unknown if ongoing. Concomitant medication included thyroid (ARMOUR THYROID) taken for an unknown indication from an unknown date to unknown if ongoing. On an unknown date in Aug2021, the patient experienced pulsing, small pulsing pain under below her left breast and it comes in and it comes in at intermittent intervals; It was like for a minute or half, sometimes every five seconds. Consumer stated, she thought it might be having a reaction, adverse reaction to the shot she got yesterday but she did not know, and wonder if anybody else have had a strange reaction like this. Consumer stated, this was weird, and she have never had anything like this before so that''s why she thought that it must be caused by the vaccine, but she meant that was long time to wait, she might, maybe she should call the pharmacist who could see if they had anybody else that have these types of symptoms. The outcome of the event was not recovered. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.


VAERS ID: 1692046 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Minnesota  
Vaccinated:2021-08-09
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose increased, Blood pressure measurement, Blood test, Blood test abnormal, Condition aggravated
SMQs:, Hyperglycaemia/new onset diabetes mellitus (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: LOSARTAN POTASSIUM; METOPROLOL; ASPIRIN (E.C.)
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal; Diabetic (Verbatim: Diabetic); Leg amputation; Wheelchair user (he is an a wheelchair because he had his leg amputated about 5 months ago)
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:Unknown; Comments: Unknown; Test Date: 202108; Test Name: blood test; Result Unstructured Data: Test Result:increase; Comments: blood levels increased
CDC Split Type: USPFIZER INC202101029169

Write-up: Blood levels increased; blood sugar levels have increased; blood sugar levels have increased; This is a spontaneous report from contactable male consumer (patient) reported for himself. A male patient of unspecified age received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Batch/lot number: Not Provided, Expiry date: Not Provided), via an unspecified route on 09Aug2021 as a single dose for covid-19 immunization. Medical history included patient is diabetic and had his leg amputated in Mar. He was in wheelchair because he had his leg amputated about 5 months ago, before receiving the Covid 19 vaccine. Concomitant medications included blood pressure pills, Losartan Potassium for the heart, Metoprolol and acetylsalicylic acid (ASPIRIN EC). Maybe because last week, since Friday, until yesterday he did not take the Metoprolol. He mentioned that the pharmacy ran out of pills. On an unknown date in Aug2021, after taking first dose patient experienced blood levels increased and blood sugar levels have increased a little bit, yesterday. Patient was asking if this is a side effect with the vaccine. The patient underwent lab test and procedure which included blood pressure measurement: unknown, blood level increased in Aug2021. The clinical outcome of the events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1692047 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Diplopia, Eye irritation, Eye pain, Feeling abnormal, Lacrimation increased, Paraesthesia, Vaccination site pain, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Lacrimal disorders (narrow), Ocular motility 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: CORTISONE; IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Familial mediterranean fever; Inflammation
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101029564

Write-up: This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in Arm Left on 03Aug2021 10:00(age at vaccination: 56 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn''t received other vaccines within 4 weeks prior to vaccination. Medical history included familial Mediterranean fever from an unknown date and unknown if ongoing, inflammation from an unknown date and unknown if ongoing. Concomitant medications included cortisone (CORTISONE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (IBUPROFEN) taken for inflammation, start and stop date were not reported. The patient experienced injection site pain on Aug2021, feeling something like a mild tingling in her left eye about an hour after vaccination on Aug2021, eye was watering, burning, tearing, and she was experiencing pain and double vision on Aug2021, eye was watering, burning, tearing, and she was experiencing pain and double vision on 03Aug2021, blurriness on Aug2021, she has still felt "poking" on Aug2021 with outcome of not recovered. Therapeutic measures were taken as a result of eye was watering, burning, tearing, and she was experiencing pain and double vision, eye was watering, burning, tearing, and she was experiencing pain and double vision, blurriness. The outcome of the events vaccination site pain, lacrimation increased, eye irritation, diplopia, vision blurred, feeling abnormal was recovered, the outcome of the event feeling abnormal, eye pain was not recovered, the outcome of the event paraesthesia was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1692050 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Chills, Dysstasia, Feeling abnormal, Formication, Gait disturbance, Limb discomfort, Pain, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: JANUVIA; ROSUVASTATIN [ROSUVASTATIN CALCIUM]; VALSARTAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101041622

Write-up: chills; pain up his back; hands feel fuzzy; feet started hurting; difficulty walking; crawl; pain; can''t stand; his legs feel frozen; This is a spontaneous report from a contactable consumer (patient). This 69-year-old male patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration in the arm left on 11Aug2021 at age of 69 years old as single dose for COVID-19 immunization. Medical history was unknown. Concomitant medications included sitagliptin phosphate (JANUVIA) for blood sugar, rosuvastatin calcium for cholesterol, valsartan for blood pressure; all ongoing. The patient would normally get the Flu Vaccine. He had had a lot of vaccines. The patient received first dose of the Pfizer BioNTech Covid 19 vaccine yesterday afternoon on 11Aug2021. About 8 hours afterward his feet started hurting on 11Aug2021, had difficulty walking on Aug2021 and had to crawl on Aug2021, chills on 12Aug2021, pain up his back on 12Aug2021 and his hands feel fuzzy on Aug2021. By 2am this morning the pain on Aug2021 was horrible, and he described it as an 8 out of 10. He cannot put weight on his left foot and his wife is looking for crutches for him. He says his feet, ankles and calves feel like they''re in cement boots. He can''t stand, his legs feel frozen on Aug2021 but he can wiggle his toes. He was calling to see if these were side effects of the vaccine and how long they will last. Patient had the first dose yesterday afternoon. He initially stated by midnight he was not feeling terrific. He has been having trouble with his feet hurting. By 2 AM he could not walk. It was like feet were in cement in boots. He could wiggle his toes, but his feet and calves felt like he was walking on rocks or through thorns. He also had chills, he could not get warm. He had pain up his back. His hands felt fuzzy, and still feel fuzzy. The patient had just come back home from an hour in the pool and coming up the stairs. He started the treadmill, but he could not do it all the way because he started to hurt. Trouble with his feet hurting: He stated with his left foot he cannot put any weight on it at all. He had to crawl, he cannot stand. He had the shot yesterday afternoon and it started bothering him before midnight. Clarified it started 11Aug2021. By 2AM the pain was like 8/10.The pain was still there, but now like 6/10 or something. He mentioned he was doing fine until like eight hours later after the shot, but then he started to ache. He further clarified the pain in his right foot was a little better, but the left foot was not better. He had to call his wife on the cell phone while inside the house because he could not get up and get the telephone. That''s how bad it is. Chills started sometime between 2AM and 6 AM. Pain up back initially started around 2 AM, later stated it was at least 6am-7am. He further clarified the start time to be sometime between 2 AM-6 AM. It comes and goes. ''Hands feels fuzzy'' started midnight. He mentioned he was a pianist. When something went on with his hands he can feel it and its pretty apparent. He stated he would have to crawl across the house and get the vaccination card. He further clarified his wife told him it was about noon when he got the vaccine. Now, he was trying to think and put two and two together. He thought it was about two, but was not thinking clearly now. AEs did not require a visit to Emergency Room or Physician Office. Between 2AM-6AM he was considering going to the Emergency Room. The phone was not working. He was lying on the floor, but did not want to wake everyone up. He did not want call for an ambulance to come over, so he just waited to see what happens. He then was sleeping in, well trying to sleep in this morning and found out his cell phone did not work. He could not call anyone. Once his wife got done with the grandkids she provided him with her phone that he was on now. He added, he had to follow-up with the doctor to see if doctor wanted him to come in or to determine if he should give events another day or so to see if get better. Stated that was where he was now. He was due for the second shot , 01Sep2021. He was scared to get the second shot and wondered if he should get the second shot. Outcome of the events feet started hurting, difficulty walking, crawl, pain up his back, pain, can''t stand, his legs feel frozen was unknown, of the event hands feel fuzzy was not recovered, of the event chills was recovering, The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1692051 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-09
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Antibody test, Body temperature, Eye pain, Feeling abnormal, Headache, Hyperaesthesia teeth, Hyperhidrosis, Migraine, Myalgia, Nausea, Pyrexia, Rash, Vision blurred, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OLMESARTAN; HYDROCHLOROTHIAZIDE
Current Illness: Migraine
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; COVID-19 (She had had COVID last June and her husband had also had COVID too)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: She had her antibodies checked last Monday; Result Unstructured Data: Test Result:500+; Test Date: 20210809; Test Name: Body temperature; Result Unstructured Data: Test Result:101; Comments: It was as high as 101 for about three days
CDC Split Type: USPFIZER INC202101043898

Write-up: Terrible migraine; Eye ball pain; Woke up with the sweats; Vomiting; Blurry; Rash; Sensitivity with teeth; Headache; Fever, high as 101 for about three days; Muscle soreness/Muscle pain; Nauseous; Still in a fog.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection), via an unspecified route of administration, administered in the left arm on 09Aug2021 at 11:00 (at the age of 49-years-old) (Lot Number: FA7484) as dose 1, single for COVID-19 immunisation. Medical history included blood pressure high, had COVID on 22Jun2020 to an unknown date, and ongoing migraine. Concomitant medications included olmesartan (strength: 20 mg) taken for hypertension from an unspecified start date and ongoing and hydrochlorothiazide (strength: 12.5 mg) taken for hypertension from an unspecified start date and ongoing. On 09Aug2021, the patient experienced headache, muscle soreness/muscle pain, fever, and sensitivity with teeth (reported event onset time was at 11:00). It was reported that the patient used kinesiology tape regarding her muscle soreness/muscle pain. On 10Aug2021, the patient had a terrible migraine, was having eyeball pain, woke up with the sweats, vomiting, had blurry feeling, and rash. On an unspecified date, the patient experienced nauseous and still in a fog. Events were treated with Tylenol Extra Strength. The patient underwent lab tests and procedures which included antibody test: 500+ on an unspecified date in Aug2021 and body temperature: 101 on 09Aug2021. It was as high as 101 for about three days. The outcome of the events migraine, fever, muscle soreness/muscle pain, sensitivity with teeth, nauseous, blurry, headache, and still in a fog were not recovered/not resolved. Outcome of the event sweating was unknown. The outcome of the event eyeball pain was recovered on 12Aug2021, outcome of the event vomiting was recovered on an unspecified date in Aug2021 and outcome of the event rash was recovered/resolved on 11Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1692052 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Body temperature, Chest pain, Dizziness, Electrocardiogram, Feeling abnormal, Headache, Hypoaesthesia, Muscle spasms, Nausea, Pain, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Bloodwork; Result Unstructured Data: Test Result:Normal; Test Date: 20210805; Test Name: low grade fever; Result Unstructured Data: Test Result:100.4; Test Date: 202108; Test Name: EKG; Result Unstructured Data: Test Result:Normal
CDC Split Type: USPFIZER INC202101050152

Write-up: chest pains, sharp bad chest pains; Leg cramps; low grade fever of 100.4; Headache; Nauseous; Body Aches; numbness in her fingers and toes; Lightheadedness / Dizziness; Arm Pain; she didn''t feel right/her brain was foggy; This is a spontaneous report from a contactable consumer. This 55-year-old Female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,formulation: Solution for injection,), dose 1 via an unspecified route of administration, administered in Arm Left on 04Aug2021 at 18:15 (Batch/Lot Number: EW0179) as DOSE 1, SINGLE for covid-19 immunization (age at vaccination 55-year-old). No relevant Medical history and Family Medical History.There were no concomitant medications. Caller states well she is here so it didnt cause her to go to the hospital, but she did have her first dose of the vaccine and she had some reactions she thought would pass, but it had been over a week, so she went to her PCP and she told them her side effects. Caller states they did blood work and testing and confirmed it was 100% from the vaccine, so her PCP doesnt want her to get the second one. Caller states she is calling to report her reactions. Caller states she has reactions to medications, so she checked with the pharmacy and her doctor and she checked everything in the vaccine, and there was nothing she was allergic too. Caller states sometimes with her, she just has to try a new medication and find out. Caller states she went to get it because she didnt want Covid. Caller states they kept her for 30 minutes and she went to a facility that was like a hospital location. Caller states after the injection, she was dizzy and lightheaded immediately. Caller states the kept her for 30 minutes and had her sit up and then stand up and kept eye on her. Caller states she left and came home and she still had dizziness and she had arm pain which is typical. Caller states over the next couple of days, 2-3 days, she got a headache, body aches, numbness in her fingers and toes and she was nauseous. Caller states she got chest pains, sharp bad chest pains and her leg cramps. Caller states she also had a low-grade fever of 100.4. Caller states the chest pains and leg cramps were a lot and her PCP said she better see her in her office. Caller states headache has improved, it is not all day long, states they are bad when she has them, but they are not all day long now. Caller states leg cramps are ongoing on and off, but they have improved. Caller states chest pain is not as bad, but it is weird, like a tight aching, and sharp pains out of nowhere even when she is sitting. Caller states her doctor said the EKG looks good, so she thinks in time this will pass. Caller states when she went to the doctor she said lets do some blood work and check clotting and do an EKG, and it was all okay. Caller states she told her that this all happened after the vaccine, so she feels it was from the vaccine and she didnt recommend her getting a second one. Caller states the chest pains are on the left where her heart is. Caller states the leg cramps were in both legs, but the left leg was worse. Caller states her doctor told her to try Tylenol, but she has not because she wanted to have some symptoms when she went to her doctor so that she would tell what was going on. The patient not visited emergency room and stated that, she should have went for the chest pain but she has went through a lot and she toughs things out. The patient visited physician office for chest pains. There was no prior Vaccinations (within 4 weeks) and she does not get the flu shots because she was afraid of reactions. The patient experienced lightheadedness / dizziness, arm pain, body aches and numbness in her fingers and toes on 04Aug2021, headache, nauseous and low-grade fever of 100.4 on 05Aug2021, chest pains, sharp bad chest pains and leg cramps on 06Aug2021 and she didn''t feel right/her brain was foggy on an unspecified date in Aug2021. The patient underwent lab tests and procedures which included blood test: normal on an unspecified date in Aug2021, body temperature: 100.4 on 05Aug2021 and electrocardiogram: normal on an unspecified date in Aug2021. Outcome of the events arm pain, body aches, numbness in her fingers and toes, nauseous and low grade fever of 100.4 was recovered on 06Aug2021, recovering from lightheadedness / dizziness, headache, chest pains, sharp bad chest pains and leg cramps and outcome of the other events was unknown. Follow-up attempts are completed. No further information expected.


VAERS ID: 1692075 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-17
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101097862

Write-up: Little rashes, bumps like little bumps all over my arms, my body and they itch; Little rashes, bumps like little bumps all over my arms, my body and they itch; Little rashes, bumps like little bumps all over my arms, my body and they itch; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received bnt162b2 (BNT162B2, solution for injection, (Batch/Lot number: not reported) via an unspecified route of administration on 17Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On an unknown date in Aug2021, the patient experienced little rashes, bumps like little bumps all over my arms, my body and they itch. The patient stated that couple of days after the vaccination started getting in little rashes, bumps like little bumps all over arms, body and they itch and patient was trying to get to know like what can I put on to stop the itching and how long does these usually last. The outcome of the events was reported as unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1692107 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-21
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Angina pectoris, Body temperature, Body temperature decreased, Chest pain, Cough, Heart rate increased, Insomnia, Nasal congestion, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body Temperature; Result Unstructured Data: Test Result:97.5 Fahrenheit; Comments: she is usually 97.5 , running 99.5; Test Date: 202108; Test Name: Body Temperature; Result Unstructured Data: Test Result:99.5 Fahrenheit; Comments: she is usually 97.5 , running 99.5; Test Date: 20210826; Test Name: covid-19 virus test; Result Unstructured Data: Test Result:Negative
CDC Split Type: USPFIZER INC202101109581

Write-up: Bad cough; Chest still hurts; Heart beating fast and kind of hurt; Only got a couple hours of sleep; Heart beating fast and kind of hurt; Stuffy; Low temp; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 30-year-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Aug2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced heart beating fast and kind of hurt leading to angina pectoris, stuffy leading to nasal congestion, low temp leading to body temperature decreased, bad cough, chest still hurts leading to chest pain, heart beating fast and kind of hurt leading to heart rate increased and she only got a couple hours of sleep leading to insomnia on Aug2021. The patient underwent lab tests and procedures which included body temperature at 97.5 Fahrenheit, she is usually 97.5 but running 99.5 , sars-cov-2 test: negative on 26Aug2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1692111 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:2021-08-09
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH GN0191 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ophthalmological examination, Retinal detachment, Vitreous floaters
SMQs:, Accidents and injuries (broad), Retinal 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Broken bones
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: eye exam; Result Unstructured Data: Test Result:two tares and a Detached Retina left eye
CDC Split Type: USPFIZER INC202101109789

Write-up: Detached Retina left eye; experiencing dark floaters; This is a spontaneous serious report from a contactable consumer (patient herself). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jul2021 (Batch/Lot Number: EW0180) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration, administered in Arm Left on 09Aug2021, at noon (Batch/Lot Number: GN0191) as DOSE 2, SINGLE, (age at vaccination was 51 years old) for covid-19 immunisation. Medical history included broken thumb from 07Aug2021 to an unknown date. The patient''s concomitant medications included allergy shot, current frequency every 3 weeks for allergy (last dose was on 29Jul2021, has received on and off for the last decade). Patient reported receiving second dose of Pfizer covid vaccine 09Aug2021 and a couple of days after (unspecified date in Aug2021) she started experiencing dark floaters. She developed a detached retina of the left eye with 2 tears. She had an eye exam on 17Aug2021 and was referred to a specialist. She had surgery that same day due to having the detached retina with 2 tears. The events required a visit to Physician Office. She had no AE(s) following prior vaccination (first dose). Patient stated she has not had any trauma to her eye at all prior to this. She would like to report this experience. Unable to provide outcome of event for dark floaters. She is still is unable to see out of her left eye. Patient adds that she read where others have reported this and ocular issues. Details are unknown to her. One was a science article. She forgot where she read the other one. They were different articles but with the same issues. She is unsure if this has been reported. The patient underwent lab tests and procedures which included eye exam (ophthalmological examination): two tears and a detached retina left eye on 17Aug2021. Treatment for the events was eyesurgery performed on 17Aug2021. The outcome of detached retina left eye was recovered/resolved with Sequel on 17Aug2021 and outcome for experiencing dark floaters in eye was unknown.


VAERS ID: 1692131 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Facial paralysis, Hypoaesthesia, Limb discomfort, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DOXYCYCLINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101110888

Write-up: the left side of my face felt numb like after i''ve been to a dentist but not severe enough I couldnt drink or had droopy features; the left side of my face felt numb like after i''ve been to a dentist but not severe enough I couldnt drink or had droopy features; minutes after shot my left foot fell asleep (Tingley); my left arm and hand fell asleep; This is a spontaneous report from a contactable other HCP (Patient). A 45-year-old male patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 01Aug2021 11:00 (Batch/Lot Number: FA7484) as DOSE 1, SINGLE (at the age of 45-year-old) for COVID-19 immunisation. The patient did not have any medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included doxycycline (received within 2 weeks of vaccination) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated after minutes after shot his left foot fell asleep (Tingley), about 1 hour later my left arm and hand fell asleep. Also stated the left side of his face felt numb like after I''ve been to a dentist but not severe enough I couldn''t drink or had droopy features on 01Aug2021 at 11:30. These symptoms lasted 3 days. Since the vaccination, the patient not tested for COVID-19. No treatment received for the events. The outcome of the events reported as recovered with sequelae on 04Aug2021. No follow-up attempts needed. No further information expected.; Sender''s Comments: A causal association between BNT162B2 and the reported event Facial paralysis cannot be excluded based on a compatible temporal relation. 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: 1692147 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Oligomenorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101116177

Write-up: I had a 15 day heavy menstrual cycle- which is very abnormal for me. Heavy bleeding and very painful.; I had a 15 day heavy menstrual cycle- which is very abnormal for me. Heavy bleeding and very painful.; I had a 15 day heavy menstrual cycle- which is very abnormal for me. Heavy bleeding and very painful.; I had a 15 day heavy menstrual cycle- which is very abnormal for me. Heavy bleeding and very painful.; This is a spontaneous report from a contactable other hcp. A 31-years-old non pregnancy female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0179) dose number unknown via an unspecified route of administration on Aug2021 (age at vaccination 31years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and Other medications in 2 weeks prior to the COVID vaccine. The patient''s concomitant medications were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced I had a 15-day heavy menstrual cycle- which is very abnormal for me. heavy bleeding and very painful on unspecified date in Aug2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1692169 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Peripheral coldness
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), 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: Medical History/Concurrent Conditions: Guillain-Barre syndrome (Maternal aunt had a history of Gillian-Barre)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101117389

Write-up: the patient was presenting with Guillain-Barre syndrome; numbness in her extremities bilaterally, mid-arm that extended distally to her lower extremities, and mid-thigh bilaterally that extended distally.; Difficulty walking/gait changes; Cool extremities; weakness; This is a spontaneous report from a contactable Physician reporting for a patient. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, time the vaccination was given, anatomical location of administration, Batch/lot number, NDC number and Expiry date were unknown), via an unspecified route of administration on 05Aug2021 at the age of 38-years-old as dose 1, single for covid-19 immunisation. Patient''s medical History including any illness at time of vaccination was none. Family medical history relevant to AE(s) included maternal aunt had a history of Gillian-Barre. There were no concomitant medications. Relevant Tests were none. Vaccination facility type was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): this was the patient''s first dose. Additional vaccines administered on same date of the pfizer suspect if applicable, list all vaccines administered on same date with the pfizer vaccine considered as suspect were none. Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine were none. AE(s) following prior vaccinations were none. There was no investigation assessment. The Reporter was calling in regard to Pfizer''s COVID vaccine. The reporter stated that she had a patient, a 38-year-old female, who had numbness in her extremities bilaterally, mid-arm that extended distally to her lower extremities, and mid-thigh bilaterally that extended distally on an unspecified date in Aug2021. She stated that the patient received their first dose on 05Aug2021, and her symptoms started 10 days later. The reporter wanted to gain clarification in regard to the incidences of this type of reaction occurring with the Pfizer COVID-19 vaccine. Her symptoms presented for 3 days and were self-limiting, but because of her weakness and gait changes on an unspecified date in Aug2021, the vaccine facility where she received her first dose had concerns the patient was presenting with Guillain-Barre syndrome on an unspecified date in Aug2021. The reporter explains the patient was never formally assessed when she was symptomatic. The symptoms began 10 days after receiving her first dose and presented for 3 days. The reporter confirmed the patient was not assessed by any provider while she was symptomatic. The reporter confirms the patient had said she had some weakness on an unspecified date in Aug2021, but this cannot be confirmed objectively. Per the patient, the patient had difficulty walking the first day she became symptomatic on an unspecified date in Aug2021, but this was unverified in terms of any cooperation with a medical professional. The reporter confirms the symptoms resolved after 3 days but the diagnosis were unverified. She said the vaccine facility from where she the patient received the vaccine believes it may be GBS. The patient also reported cool extremes of her extremities at the time she was symptomatic on an unspecified date in Aug2021. The Reporter stated that the patient had a physical before her appointment and no new medications were initiated for the patient. The patient did no test after this episode but mentioned her maternal aunt had a history of (name). The reporter states the patient was asymptomatic when they discussed her symptoms today. She is setting the patient up to see neurology for further assessment, however the patient didn''t have any acute symptoms at the time she was assessed today. There were no initial diagnoses other than an exam. Adverse events did not require a visit to Emergency Room or Physician Office. The patient didn''t seek any acute care. HCP wanted to know if there have been reports of numbness after receiving the 1st dose. Physician wanted to know if they should still give the patient a 2nd dose after having a reaction with the 1st dose. The reporter was a healthcare provider and would like to discuss how to treat an adverse event that occurred in one of her patients. Reporter assessed seriousness for numbness in her extremities bilaterally, mid-arm that extended distally to her lower extremities, and mid-thigh bilaterally that extended distally, cool extremities and difficulty walking as medically significant. Causality: Due to the time frame (the patient having symptoms within 10 days of the vaccine), the reporter believes the symptoms are related. Relatedness of drug to reaction(s)/event(s): Reactions assessed: numbness in her extremities bilaterally, mid-arm that extended distally to her lower extremities, and midthigh bilaterally that extended distally and cool extremities. Drug result: Related. The outcome of the events was recovered on an unspecified date in Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender''s Comments: Based on temporal relationship there is reasonable possibility of causal association between the reported events Gullian Barre Syndrome, Hypoaesthesia, gait disturbance, peripheral coldness, asthenia, and the suspect drug BNT162B2. 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: 1692170 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-01
Onset:2021-08-01
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Biopsy, Blood test, Disease recurrence, Eye colour change, Hepatic enzyme, Hepatic enzyme abnormal, Jaundice, Liver disorder, Liver injury, Magnetic resonance imaging, Urinary tract infection, Urine analysis
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Accidents and injuries (narrow), Glaucoma (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Biopsy today or Monday; Result Unstructured Data: Test Result:unknown results; Test Date: 202108; Test Name: Bloodwork; Result Unstructured Data: Test Result:unknown results; Test Date: 202108; Test Name: Liver enzyme abnormal; Result Unstructured Data: Test Result:abnormal; Test Date: 202108; Test Name: MRI; Result Unstructured Data: Test Result:Blockage in the Liver; Test Date: 202108; Test Name: Urine Sample; Result Unstructured Data: Test Result:UTI
CDC Split Type: USPFIZER INC202101117477

Write-up: liver damage; liver damage; Jaundice; Jaundice; Liver Blockage; Eyes are Yellow; UTI; Liver Enzymes are Worse than when she took Tylenol; This is a spontaneous report from a contactable consumer (spouse). A 42-year-old female patient (Reporter''s Wife) received bnt162b2 (COMIRNATY, Covid 19 Vaccine, mRNA), dose 2 via an unspecified route of administration at the end of Apr2021 (Batch/Lot number was not reported) as dose 2, single at the age of 41-year-old for COVID-19 immunisation. No medical history. Concomitant medications were not reported. Historic vaccine was bnt162b2 received via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 1, single at the age of 41-year-old for COVID-19 immunisation. The patient previously took tylenol in 2019 and not ongoing for blood clot and experienced liver damage with jaundice. No additional vaccines administered on same date of the Pfizer suspect. This report is not related to a study or programme. No prior vaccinations (within 4 weeks). Family medical history relevant to AEs: Not that they are aware of. The patient experienced liver damage, liver blockage, jaundice, eyes are yellow, urinary tract infection, liver enzymes were worse than when she took Tylenol in Aug2021. The patient was hospitalized for the events from 26Aug2021 and ongoing. Events resulted in emergency room and physician office visit. 2 years ago the patient had blood clot and had taken Tylenol. She had liver damage with jaundice. She stopped taking Tylenol and so the jaundice went away and she was back to normal. The patient was now in the ER with the same symptoms as when she took Tylenol. Stated that she was back in the hospital because liver damage again. Her husband was trying to figure out why her liver had been damaged, the last thing that she took was only the Pfizer Covid 19 vaccine. Asking if in Pfizer Covid 19 vaccine has an ingredient that Tylenol has. The patient took second shot at the end of April2021. She had a reaction to Tylenol sometime back and it attacked her liver and she was doing okay and then after the second shot her enzymes are worse than when she took the Tylenol. Caller was wondering if she took some type of Tylenol that was in the vaccine or something that triggered her reaction? Caller stated it was a long shot but he wasn''t sure if there was something that is in Tylenol that is in the ingredients of the Covid vaccine? Caller stated the doctors automatically said no but he can''t rule it out until he checks it out. Lab tests on Aug2021: bloodwork, MRI last night, biopsy today or Monday, urine sample found out UTI. Caller stated the MRI showed the blockage in her liver. The patient got her blood results and went to the ER immediately. The patient felt fine and she did the last time. This is the same as when the said to quit taking Tylenol. It was extra strength Tylenol for a blood clot in 2019. UPC, Lot, Expiration: Unknown. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1692187 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Body temperature, Body temperature increased, Decreased appetite, Diabetes mellitus, Illness, Influenza like illness, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210826; Test Name: Temperature; Result Unstructured Data: Test Result:101
CDC Split Type: USPFIZER INC202101119910

Write-up: Temperature just read a 101 today; He is sick right now; He got diabetes; He started feeling like flu not the flu but the flu like symptoms; Feeling weak and vomiting; Feeling weak and vomiting; Totally lost his appetite; This is a spontaneous report from a non-contactable consumer or other non-HCP (reporting for boyfriend). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on an unspecified date in Aug2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient had the shots three weeks ago on an unspecified date in Aug2021. A week ago he started feeling like flu not the flu but the flu like symptoms, reporter had been checking his temperature he was feeling weak and vomiting on an unspecified date in Aug2021, he had all symptoms of flu but no fever but now she was getting worried because now he had totally lost his appetite on an unspecified date in Aug2021 and his temperature just read a 101 today (26Aug2021) and she could not give him to eat or drink anything at all today no matter how hard she tried so, her concern was his second shot is tomorrow is he going to be okay. He got diabetes and she was really worried about him right now. He was sick right now. The outcome of the event he was sick right now was not resolved while that of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1692196 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-27
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Antibody test normal, Arrhythmia, Condition aggravated, Diarrhoea, Extra dose administered, Feeling hot, Heart rate, Off label use
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Noninfectious diarrhoea (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METOPROLOL; XARELTO
Current Illness: Arrhythmia (had no effect on shot one or shot two)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: antibody test; Result Unstructured Data: Test Result:Fine; Comments: doctor said my antibodies are fine.; Test Date: 202108; Test Name: heart rate; Result Unstructured Data: Test Result:jumped up to a very dangerous level; Comments: consistently high, it was still extremely high
CDC Split Type: USPFIZER INC202101121079

Write-up: So I had the booster by Pfizer; So I had the booster by Pfizer; Arrhythmia aggravation; arrhythmia /It is still extremely high; intense heat/got very hot all over; diarrhea; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not reported), via an unspecified route of administration on 27Aug2021 (age at vaccination was 84 years) as DOSE 3, SINGLE for COVID-19 immunisation. The patient''s medical history included arrhythmia (had no effect on shot one or shot two). The patient''s concomitant medications included rivaroxaban (XARELTO) 15 mg for indication blood thinner and metoprolol 25 mg one tablet a day (two medication for her heart and both never affected her heart rate). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not reported), via an unspecified route of administration on unspecified date in Jan2021 as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch/lot number was not reported), via an unspecified route of administration on unspecified date a DOSE 2, SINGLE; both for COVID-19 immunisation. After the first and second shot, she had no stress, no headache, and had no reaction to shot one or shot two. She had no fatigue also after second shot. The patient stated that, in Aug2021 (from the minute she took the shot) her arrhythmia which she had no problem with shot one or shot two her arrhythmia, her heart rate it was jumped up to a very dangerous level and it continued to the day of reporting. In Aug2021, she had no chills, what she had was intense heat, it was sort of like the closest thing she could describe it as, it was like when women have like they have menopause, a woman got very hot all over specially in the top part of the bottom in the top part of the body; burning up, there were no chills, there was just intense heat and she had diarrhea and nothing else. She did absolutely nothing, had no treatment whatsoever there was nothing what she was going to do with heat. She stated burning up was okay and the fact that her heart, she has to go and see her cardiologist and she do not know what they are going to do about her heart to bring it back down to its normal level. She had been checking heart rate in Aug2021 (for the last three days) and it was been consistently high, it was still extremely high, and it has to be gone back to its normal beat. The patient underwent lab test and procedure on unspecified date in 2021 (three week ago) included antibody test and resulted into antibody was fine. The outcome of events was arrhythmia aggravation was not recovered; intense heat/got very hot all over and diarrhea was unknown. The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.


VAERS ID: 1692200 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Nasal congestion, Rhinorrhoea, Sneezing, Suspected COVID-19
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101122254

Write-up: in contact with COVID 19 positive in his school; Very congested; Coughing; Sneezing; Runny nose; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient''s mother) reported for a 13-year-old patient (reporter''s son). A 13-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date Aug2021, after receiving second dose patient experienced that he was very congested, coughing, sneezing and has a runny nose. His mother was not sure if withheld is in contact with COVID 19 positive in his school because there is a lot of COVID 19 positive in his school (further clarification unknown) and stated that I am trying to figure out if this is potential side effects from the vaccine or do I need to go get him tested to see if he was along the way to get actual COVID. Further probing could not be done as the reporter was unwilling to share any further information. Hence limited information available over the call. The clinical outcome of the events was unknown. Information on the lot/batch has been requested.


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