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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 311 out of 7,116

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VAERS ID: 1692202 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-07
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: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Covid; Test Result: Positive
CDC Split Type: USPFIZER INC202101122463

Write-up: He received the first dose on 07Aug2021 and today he is supposed to have the second dose. However, after getting the first dose he tested positive for COVID; He received the first dose on 07Aug2021 and today he is supposed to have the second dose. However, after getting the first dose he tested positive for COVID; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration date: Unknown), via an unspecified route of administration on 07Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient reported that he received the first dose on 07Aug2021 and today (date unspecified) he was supposed to have the second dose. On an unspecified date in Aug2021, after getting the first dose, the patient had tested positive for Covid. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on Aug2021. The outcome of the events was unknown. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.


VAERS ID: 1692206 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: New York  
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 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL3183 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Allergy test, Blood cholesterol, Bone pain, Chest pain, Discomfort, Dizziness, Headache, Helicobacter test, Hyperhidrosis, Investigation, Liver function test, Oxygen saturation, Pain, Pain in extremity, Paraesthesia, Peripheral swelling, Pruritus, Pyrexia, Rash macular, Shock, Skin irritation, Swelling, Vaccination site pain, Vaccination site swelling, X-ray
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia (I always had thalassemia, anemia and like may be 19 years ago,); Thalassemia (I always had thalassemia, anemia and like may be 19 years ago,); Tuberculosis (I had tuberculosis, like actual tuberculosis, actual TB.); Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: Allergies test; Result Unstructured Data: Test Result:Unknown; Test Date: 2021; Test Name: cholesterol; Result Unstructured Data: Test Result:Elevated; Comments: I dont have a high cholesterol but it is just little elevated; Test Date: 202107; Test Name: H. pylori in my stomach; Test Result: Negative ; Comments: the lab results in July, for the H. pylori came back negative.; Test Date: 2021; Test Name: Kidney test; Result Unstructured Data: Test Result:everything was fine.; Comments: checked liver kidney and everything was fine.; Test Date: 2021; Test Name: Liver test; Result Unstructured Data: Test Result:everything was fine.; Comments: checked liver kidney and everything was fine.; Test Date: 2021; Test Name: Oximeter; Result Unstructured Data: Test Result:99 or 98; Test Date: 2021; Test Name: X- ray; Result Unstructured Data: Test Result:unknown; Comments: I checked multiple times X-rays and everything is gone
CDC Split Type: USPFIZER INC202101123222

Write-up: bumpiness to the back of the neck on left side; bumps were itchy with a weird tingling sensation; bumps were itchy with a weird tingling sensation/ her whole body was tingling; she had sweating.; There are lot of red circle blotches, some of them are circle, a lot of them are clustered; Fever; Body and my bones were hurting; Pain in my back and in my front under my breast like where my lungs are and my legs, my pelvic bone which is behind my butt, so both sides of my butt, my hips, my hands, I couldn''t grasp;; Pain in my arm/Feel a lot of soreness in my bone; Hand is still sore/ weird pain in leg; The hand is still sore, some turns with pain and is swollen (not clear)./ pain continued along with swelling; feeling a little uncomfortable; chest pain; Injection site has been swollen and hurting; Injection site has been swollen and hurting; lot of irritation in that same area; Lightheadedness; Headache; shocking sensation over her body; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 26Aug2021 13:00 (at the age of 42-years-old) (Batch/Lot Number: FL3183) as dose 2, single for covid-19 immunization. Medical history included thalassemia, anemia which was almost 19 years ago, actual tuberculosis, vitamin D low form an unknown date and unknown if ongoing. The patient''s concomitant medications include multivitamin. Patient previously took first dose of BNT162B2 (at the age of 42-years-old) (lot number: EW0177) on 05Aug2021 for covid-19 immunization and experienced pain in arm. The patient experienced pain in her arm and felt a lot of soreness in her bone. Hand was still sore, weird pain in leg, some turns with pain and is swollen which was not clear, pain continued along with swelling, felt a little uncomfortable on 26Aug2021. Fever, Body and her bones were hurting, and experienced pain in her back and in her front under her breast like where my lungs are and her legs, her pelvic bone which is behind her butt, so both sides of her butt, her hips, her hands, she couldn''t grasp, Lot of body pain, shocking pain from the back of neck on 27Aug2021. There were lot of red circle blotches, some of them were circle, a lot of them were clustered. she had sweating on 28Aug2021. Her bumps were itchy with a weird tingling sensation and her whole body was tingling on 29Aug2021. She experienced shocking sensation over her body, headache, lightheadedness, chest pain, injection site had been swollen and hurting, a lot of irritation in that same area on an unspecified date in Aug2021. She faced bumpiness to the back of the neck on left side on an unknown date. The patient received treatment for the events. The patient underwent lab tests and procedures which included Allergies test (allergy test) with unknown result on an unspecified date in Jun2021, cholesterol (blood cholesterol) was elevated on an unspecified date in 2021, where her blood cholesterol was bit elevated. H. pylori in my stomach (helicobacter test) with negative result on an unspecified date in Jul2021, Kidney test (investigation) where everything was fine on an unspecified date in 2021, liver function test where everything was fine on an unspecified date in 2021, oxygen saturation resulted 99 or 98 on an unspecified date in 2021, x-ray resulted unknown on an unspecified date in 2021 where she checked multiple time X-rays, and everything was gone. The outcome of there were lot of red circle blotches, some of them are circle, a lot of them are clustered was recovering. The outcome of fever was recovered on 27Aug2021. The outcome of pain in her arm and felt a lot of soreness in her bone. Hand was still sore, weird pain in leg, Body and her bones were hurting, pain in her back and in her front under her breast like where my lungs are and her legs, her pelvic bone, which is behind her butt, so both sides of her butt, her hips, her hands, she couldn''t grasp, Lot of body pain, shocking pain from the back of neck, headache was not recovered. The outcome of all the other events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1692210 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-08-25
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 FC3182 / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Discomfort, Fatigue, Haemoptysis, Headache, Lymphadenopathy, Middle insomnia, Pain, Pain in extremity, Pyrexia, Tonsillar erythema, Tonsillar haemorrhage, Tonsillar hypertrophy, Tonsillar inflammation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mononucleosis (problems with her tonsils when she was in her teens and had mono); Tonsillar disorder (problems with her tonsils when she was in her teens and had mono)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Fever; Result Unstructured Data: Test Result:99.6; Comments: low grade fever of 99.6 were tolerable; Test Date: 202108; Test Name: Fever; Result Unstructured Data: Test Result:100.5; Comments: fever was not breaking 100.5
CDC Split Type: USPFIZER INC202101126946

Write-up: swollen lymph nodes; swollen tonsils; body chills; body aches; the tonsil on the opposite side of injection is far more swollen noting it is blackish red; she woke up in the middle of the night; my tonsil is completely swollen and inflamed; a lot of discomfort; bloody tonsils / when she spits, it is bloody / dry blood; bloody tonsils / when she spits, it is bloody / dry blood; headache; sore arm; low grade fever of 99.6/ fever is not breaking 100.5; Fatigue; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Aug2021 (lot FC3182), as the first single dose, in right arm (shoulder), for COVID-19 immunisation. Medical history included problems with her tonsils when she was in her teens and had mono. Concomitant medications were not reported. On an unspecified date in Aug2021, reported as the first two days, she experienced typical side effects mentioning headache, sore arm, low grade fever of 99.6, fatigue and were tolerable. All of a sudden, on 27Aug2021, she had swollen lymph nodes and swollen tonsils. For the following 4 days she had swollen lymph nodes on the opposite side of the vaccine. She also reported bloody tonsils, body chills and body aches. The tonsil on the opposite side of injection was far more swollen noting it was blackish red. When she spitted, it was bloody, it was dry blood. She had to take deeper breaths because of the swollen tonsils. Since an unspecified date in Aug2021 she woke up in the middle of the night where her tonsil was completely swollen and inflamed. It was causing her a lot of discomfort. She has never had problems with her tonsils except when she was in her teens and had mono. Her throat was not sore, just her lymph nodes and tonsils. She was taking Tylenol and Advil around the clock. The fever was not breaking 100.5. The fever was worse now then when she received the vaccine. On 30Aug2021 her tonsils were swollen and getting worse, the lymph nodes on both side of her neck were swollen and specially her left tonsil was just getting bigger. She got the vaccine in her right arm, and that tonsil on her left side was actually bleeding, spitting of blood and everything too. And she still had headache and the fever. She also went to her Doctor. She stated this was way too much of a coincidence and did not know if this was the norm. She stated she did not want to get the vaccine but had to for work because she was a healthcare. The final events outcome was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1692214 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: California  
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 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: USPFIZER INC202101127292

Write-up: Tested positive for Covid 19 on Aug 27, despite being vaccinated; Tested positive for Covid 19 on Aug 27, despite being vaccinated; This is a spontaneous report from a contactable consumer or other non-health care professional. A 72-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration (at the age of 72-years) on Jan2021 as dose 1, single for COVID-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an intramuscular route of administration (at the age of 72-years) on Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The facility where the most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 27Aug2021, the patient experienced tested positive for covid 19 on 27Aug, despite being vaccinated. On unspecified date in Aug2021, experienced tested positive for covid 19 on aug 27, despite being vaccinated (drug ineffective). The treatment was not received for all the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1692220 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-07-09
Onset:2021-08-01
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Condition aggravated, Pain
SMQs:, Retroperitoneal fibrosis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TOPIRAMATE; CLOMID; VITAMIN C [ASCORBIC ACID]; VITAMIN D 2000
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney stones (other medical history migraines, kidney stones); Migraine (other medical history migraines, kidney stones)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101127635

Write-up: same pains flared up; severe pain across back, arms/hands, feet/legs; back pain started; same pains flared up; severe pain across back, arms/hands, feet/legs; This is a spontaneous report from a contactable consumer. This 46-year-old male consumer (patient) reported that: A 46-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: FA6780), via an unspecified route of administration on Jul2021 as DOSE 2, SINGLE for covid-19 immunization. Patient medical history included migraine from an unknown date and unknown if ongoing (other medical history migraines, kidney stones), Kidney stones (nephrolithiasis) from an unknown date and unknown if ongoing (other medical history migraines, kidney stones). Patient concomitant medication(s) included Topiramate (Topiramate) taken for an unspecified indication, start and stop date were not reported; Clomid (Clomifene Citrate) taken for an unspecified indication, start and stop date were not reported; Vitamin C (ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported; calcium carbonate, colecalciferol (VITAMIN D 2000) taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin, morphine and experienced drug hypersensitivity (Known allergies erythromycin and morphine-based medications). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection;Lot number: unknown), via an unspecified route of administration, administered on unspecified date as single dose for COVID-19 immunisation .It was reported that If other vaccine in four weeks was no. Covid prior vaccination was no. Covid tested post vaccination was no. The patient experienced same pains flared up; severe pain across back, arms/hands, feet/legs and back pain started on 15Apr2021. After second dose, same pains flared up. 3 weeks ago, back pain started. Became so bad 1 week ago that I was rushed to the emergency room (Friday). Went home that night after pain medications. Had to go back Sunday morning - no relief. Was in the hospital until Thursday with severe pain across back, arms/hands, feet/legs. The patient was hospitalized for same pains flared up; severe pain across back, arms/hands, feet/legs for 5 days. Therapeutic measures were taken with Pain medications as a result of same pains flared up; severe pain across back, arms/hands, feet/legs and back pain started. The outcome of events was Not recovered. Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected; Sender''s Comments: Linked Report(s) : PFIZER INC-202101119239 same patient/drug, different dose/event


VAERS ID: 1692228 (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 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Extra dose administered, Hyperhidrosis, Illness, Off label use, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (narrow), 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101128674

Write-up: I got the Booster vaccine (Pfizer COVID 19 Vaccine); I got the Booster vaccine (Pfizer COVID 19 Vaccine); I have been sick; I ran out Fever; I ran out Fever and have sweat; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on Aug2021 as dose 3, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose and second dose of bnt162b2 both for COVID-19 immunization. On Aug2021, the patient experienced been sick, ran out fever, had sweat. Outcome of the events was unknown. F/U #1 (PRD/SRD 08Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.


VAERS ID: 1692230 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Tennessee  
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 EW0181 / 1 LA / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Angina pectoris, Blood test, Fear, Pleuritic pain, X-ray
SMQs:, Other ischaemic heart disease (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ROSUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: High cholesterol (Verbatim: High cholesterol)
Allergies:
Diagnostic Lab Data: Test Date: 20210815; Test Name: D-dimer; Test Result: Negative ; Comments: drew blood for D-dimer to check for blood clot; Test Date: 20210815; Test Name: X-ray; Test Result: Negative
CDC Split Type: USPFIZER INC202101131495

Write-up: I was scared that maybe it''s cardiac.; I started feeling ''disc'' pain in my left pleural area around my heart more towards my lung; Now the pain resumed again/I was scared that maybe it''s cardiac.; This is a spontaneous report received from a contactable nurse (patient herself). A 46-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0181, expiry date: unknown, Age at Vaccination: 46 years), via an unspecified route of administration, administered in Arm Left on 06Aug2021 as dose 1, single for COVID-19 immunization. The patient''s medical history included Blood cholesterol increased. Patient did not have diabetes, did not have hypertension. Concomitant medications included Rosuvastatin (20mg) for High cholesterol and Cyclobenzaprine (10mg). It was reported that, she did not have any vaccination 4 weeks prior to COVID 19 Vaccine and not taken any other medications within 4 weeks. On 07Aug2021, it was reported that, the patient started feeling disc pain in her left pleural area around her heart more towards her lung. Patient just could not describe it, but started feeling the pain and so took some pain pills (treatment). Patient slept and woke up and felt like okay it was minimum then it was before. So, didn''t rush to say let me go to hospital or anything. Now, the next day like well it just started just collecting, now patient sleeps and it doesn''t been go away (further clarification unknown). So, ended up in the like ED on 15Aug2021 because was scared that maybe it was cardiac. So, went to the ED, they did x-ray, they drew blood, they did D-dimer all on 15Aug2021 to check for clot, they did a couple of other things and the nurse practitioner came back to tell that they were all negative, they didn''t find any particulate in x-rays, in the blood, they checked for clot, they didn''t find anything. So, she advised to follow-up with primary healthcare doctor and they gave IV Ketorolac (treatment) and immediately and felt a relief. So, came back home. Now, afterwards, though they gave me the prescription for Ketorolac and Cyclobenzaprine which I have been taking. So, I work night shift and the Cyclobenzaprine made very sleepy. So, didn''t take it in one of the night that I don''t, I have to work. Now the pain resumed again on an unspecified date in Aug2021 (further clarification unknown) and yesterday was second shot. So, when patient went to the health department told them that this is the situation so the first one patient got it on my left so said okay this time put it on right and then make sure that it''s not, do not take same side again. So, she put it on my right. So, of course I am having tenderness and the pain at the injection site but I don''t feel the pain that is in my left area I don''t feel like in my right side. So, it was the lady who gave the injection yesterday when told her what patient was going through she is like why didn''t the lady give you as in yeah, she didn''t gave me anything. So, she gave me the brochure with the Pfizer number and said yeah, call this number and let them know whatever happened. I said okay because I didn''t know yeah, so that is what happened and right yeah this morning I was in so much pain. Therapeutic measures were taken as a result of events like some pain pills and IV Ketorolac (10mg). Consumer stated, yes, because she never had any pain in her body until she got it, when asked about causality. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Pleuritic pain and Cardiac pain and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1692236 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Blood test, Cardiac flutter, Electrocardiogram, Heart alternation, Heart rate, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Tachyarrhythmia terms, nonspecific (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety (She has had anxiety in the past related to perimenopause and this felt nothing like anxiety)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Blood work; Result Unstructured Data: Test Result:Normal; Test Date: 202108; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Date: 202108; Test Name: Heart beat; Result Unstructured Data: Test Result:Increased; Comments: Heart beat
CDC Split Type: USPFIZER INC202101133436

Write-up: Fluttering; Increased heart beat; Heart beating out of my chest; Anxiety; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number was not reported), via an unspecified route of administration on 06Aug2021 as dose 1, single for covid-19 immunisation. Medical history included anxiety (She has had anxiety in the past related to perimenopause and this felt nothing like anxiety) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced fluttering, increased heart beat, heart beating out of my chest, anxiety. The patient stated that 2 days after her first dose, she started getting an increased heart beat, it started out with a fluttering and then she could feel her heart beating out of her chest. She was resting on the couch. She said that this lasted continuously for about 2 weeks and then it improved slightly, however, it was still occurring on and off at times and her heart rate was higher than usual at times. She stated that she did see her doctor about this reaction and he told her that he felt like it was anxiety. The patient reported that she has had anxiety in the past related to perimenopause and this felt nothing like anxiety. She stated she know what anxiety feels like, she was not anxious or nervous. She was sitting on the couch resting and then all of the sudden her heart was fluttering and then beating out of her chest and she couldn''t control it. With anxiety she can control it and calm down. This was totally different. She felt like her doctor just wrote her off. It was reported that her doctor performed an EKG and did blood work that was normal. Her doctor told her to proceed with the second dose. The patient stated that, she went back to the pharmacy on Friday 27Aug2021 to get her second dose and the pharmacist told her that based on her reaction to the first dose that she should not receive the second dose as it was not safe. The pharmacist told her that this reaction would happen again with the second dose and probably be more severe, therefore, the pharmacist did not feel safe administering the vaccine to her. The patient wanted to know if what she experienced could potentially happen again with the second dose and if it could be worse. The patient asked if she has any protection from receiving one dose of the Pfizer COVID-19 vaccine -Comirnaty. The AE required a visit to physician office. On an unspecified date in Aug2021, the patient underwent lab tests and procedures which included blood test: normal, electrocardiogram: normal, heart rate: increased (heart beat). Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1692244 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Ohio  
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 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Herpes zoster, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101134587

Write-up: This is a spontaneous report from a contactable consumer (patient). A 73-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: FC3181, Expiry date: not reported), via an unspecified route of administration in right arm on 23Aug2021 09:30 (at age of 73-years-old) as dose 1, single for covid-19 immunisation. Patient''s medical history (including any illness at time of vaccination) was none. There was no family medical history relevant to adverse event. There were no concomitant medications. The patient previously took shingles vaccine (it was stated that the shingles vaccine was a live virus and it gave the caller varicella zoster infection) in 2014. The patient had not received any other vaccine within 4 weeks (patient hasn''t had any vaccines for more than two years). Received the shingles vaccine in 2014, putting out the shingles shot and pulled the shingles vaccine off the market because knew it was bad. The caller stated he had a reaction similar to that one now. Caller cannot provide NDC/lot/expiration. States that was in year 2014. Caller stated the shingles vaccine was a live virus and it gave the caller varicella zoster infection. On 23Aug2021, the patient had a real bad headache. On 24Aug2021, the patient had at the end of the evening, the day after receiving the first dose vaccine, had pens and needles all over body, here, there, and everywhere. On an unspecified date in Aug2021, the patient experienced shingles. Caller stated that the patient received the first dose bnt162b2 covid vaccine a week ago on the day of reporting. Within an hour of receiving the first dose bnt162b2 covid vaccine, the caller had a real bad headache. The headache lasted for half a day. The caller suspected that would have come and little things would go on. At the end of the evening, the day after receiving the first dose vaccine, had pens and needles all over body, here, there, and everywhere. The next day the caller thought he was good to go. The pens and needles all over body had increased every day since. The caller contacted an infectious disease doctor and the doctor was trying some things. The doctor wondered if the first dose bnt162b2 covid vaccine had woke up the shingles virus in the caller''s system. The caller was being treated with Valtrex and that was no good yet. Now, the caller tried an antihistamine, just took the antihistamine on the day of reporting and will see what happens. The caller stated because his issue had increased, he was obviously not a good candidate for another dose bnt162b2 covid vaccine with the reaction the caller was having. The caller stated he did not hear any bad things until he told people what was going on, the problems. Valtrex (lot number: not provided, expiry date: Dec2021): Caller took 500 mg twice a day and did not take the medication until 4 days after had pens and needles all over body. Caller states he received first dose Pfizer Covid 19 Vaccine and had a real bad headache and pens and needles all over body. Caller was taking Valtrex and states the Valtrex is doing no good yet. Valtrex was 500mg and the caller took the medication twice a day. Caller stated did not start taking this medication until 4 days after pens and needles all over body occurred. The caller stated that he needs the medication, caller was trying his best to get over this stuff. The events were assessed as medically significant. Relevant tests done were none. Therapeutic measures were taken as a result of the events. The outcome of the event had a real bad headache was recovered in Aug2021 and outcome of the event at the end of the evening, the day after receiving the first dose vaccine, had pens and needles all over body, here, there, and everywhere was not recovered while outcome of the event shingles was unknown.


VAERS ID: 1692245 (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: Diarrhoea, Dyspnoea, Feeling abnormal, Malaise, Pain
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101134648

Write-up: not feeling good; Diarrhea; Feels sore; shortness of breath; he isn''t feeling well; This is a spontaneous report from a Pfizer sponsored program Support. A contactable male consumer (patient) reported that. A male patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: was not reported) dose 1 via an unspecified route of administration on unspecified date in Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 29Aug2021 the patient experienced shortness of breath, diarrhea and feels sore. On 30Aug2021 the patient experienced not feeling good. On an unspecified date in Aug2021 patient experienced he isn''t feeling well. Consumer was supposed to take his 2nd dose of the Pfizer COVID 19 vaccine today and he is not feeling good. States he is asking for advice on when to take the 2nd dose. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up. Follow-up activities closed. Batch /lot number not available.


VAERS ID: 1692259 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
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 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Balance disorder, Blood glucose, Blood glucose increased, Body temperature increased, Cardiac function test, Computerised tomogram, Dehydration, Diabetic ketoacidosis, Diarrhoea, Feeling abnormal, Feeling cold, Investigation, Lacrimation increased, Loss of consciousness, Pancreatic disorder, Pancreatic enzymes, Pancreatic enzymes increased, Pancreatitis, Pyrexia, Scan brain, Seizure, Skin burning sensation, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Lacrimal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes (not being able to take her diabetes medication during this time)
Preexisting Conditions: Medical History/Concurrent Conditions: Hysterectomy (Had a 22lb ovarian tumor removed and a hysterectomy in Jan2020.); Ovarian cancer (ovarian cancer surgery); Ovarian neoplasm surgery (ovarian cancer surgery at this hospital 1.5 years ago); Tumorectomy
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Blood sugar; Result Unstructured Data: Test Result:High; Test Date: 202108; Test Name: Blood sugar; Result Unstructured Data: Test Result:over 300; Test Date: 202108; Test Name: Temperature; Result Unstructured Data: Test Result:101.8; Test Date: 202108; Test Name: Heart things; Result Unstructured Data: Test Result:Good; Comments: Was told all her scans were good.; Test Date: 202108; Test Name: CAT Scan; Result Unstructured Data: Test Result:Good; Comments: Was told all her scans were good.; Test Date: 202108; Test Name: CT Scan; Result Unstructured Data: Test Result:Good; Comments: Was told all her scans were good.; Test Date: 202108; Test Name: Brain test; Result Unstructured Data: Test Result:unknown results; Test Date: 202108; Test Name: pancreas enzymes; Result Unstructured Data: Test Result:Elevated; Test Date: 20210901; Test Name: pancreas enzymes; Result Unstructured Data: Test Result:Fine; Test Date: 202108; Test Name: Brain Scan; Result Unstructured Data: Test Result:Unknown results; Comments: It was not the stomach flu or pancreatitis
CDC Split Type: USPFIZER INC202101138795

Write-up: severe stomach pain; vomiting; diarrhea; dehydration; pancreas enzymes were elevated; blood sugar was high; pancreatitis; seizure; Eyes water for 18 days like a cold; Passed out four times in one day; Unsteadiness, hard to walk; feeling really weird; Sking was burning; she was freezing; Took her temperature and she was 101.8; get into diabetic ketoacidosis before she could be admitted; Pancreatic levels were up; This is a spontaneous report from a contactable consumer. This 51-year-old female consumer (patient) reported for herself that she received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history includes Diabetes mellitus from Jan2020 and ongoing, ovarian tumour removed in Jan2020, hysterectomy in Jan2020, Ovarian cancer from an unspecified onset and unknown ongoing, Ovarian neoplasm surgery done in unknown date 2020. concomitant medications were not reported. In Aug2021, 06 days after the vaccination, the patient experienced severe stomach pain, vomiting, diarrhoea, and eventually dehydration, Violently ill, Unsteadiness, hard to walk, Dizziness, Elevated pancreatic enzymes, Eyes watered, Blood sugar was over 300. Patient tried Zofran. Took two bottles of Imodium. Drank two bottles of Pepto over the 20 days. She is scared. She was so dehydrated the hospital was preparing her room for her to have a seizure. It was bad. Did brain scans and tests. Would not listen to her that it was not the stomach flu or pancreatitis. Last time her diarrhoea was water and vomit were bile, It was hard for her to walk, she was scared to walk. She was dizzy. Her Eyes water for 18 days like a cold. She Passed out four times in one day. Caller was admitted to this hospital after her COVID-19 Vaccine first dose for pancreatitis. Wants to know where did it come from? She was admitted, given pain meds, fluids, potassium, and insulin. Was also given blood clot medicine. Did scans. Stayed for 1.5 days, almost 2 days. The ER doctor said she could go home, but to come back if it seems worse. Next day she wasn''t feeling well. While driving, she was feeling weird. Skin was burning, but she was freezing. Took her temperature and she was 101.8. She never has a fever. She was miserable. As she was leaving from her CT scan, she passed out. Caller went home. Couple days later, she felt worse. Passed out 4 times at her house. Called the doctor and went to a different hospital on 24Aug2021. She was admitted for the same thing. Pancreatic levels were up. She had no vitamins in her at all. Thought she was going to have a seizure she was so dehydrated. Brain scans were done because she passed out at the doors of the ER. Hospital was afraid why she is passing out. Hospital did all kinds of heart things. She was kept there for two days and started getting better. On pain meds and IVs but doesn''t know what else. Was sent home and got better. She Was supposed to get second COVID-19 Vaccine. Doctors kept advising her to get the second shot. She had three weeks of hell. She can''t be the only person who has experienced this. Maybe there''s something in the vaccine she''s allergic to. She is hurting and scared of what''s coming. It was so violent when it woke her up at 4AM. She was told her pancreas enzymes were elevated and her blood sugar was high. Caller says the doctors "didn''t believe it was from the covid shot". Caller was scheduled to receive her second dose on Friday and waited to receive the second dose on 31Aug2021 at 4:30pm. The patient lab data includes Blood glucose in Aug2021 which showed high value, another reading in same month showed over 300. Body temperature in Aug2021 with a 101.8 centigrade reading, Cardiac function test in Aug2021 Was told all her scans were good, Computerised tomogram in Aug2021 Was told all her scans were good, Brain test in Aug2021 with unspecified results. Pancreatic enzymes with unknown results in Aug2021, Brain Scan in Aug2021 with unknown results. On 01Sep2021 pancreatic enzyme test was found to be fine. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1692295 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Georgia  
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 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GABAPENTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Elevated BP
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101152728

Write-up: This is a spontaneous report received from a contactable consumer(patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, at the left arm, on 21Aug2021 11:00, at dose 1, single for covid-19 immunisation in a pharmacy or drug store. Relevant medical history included blood pressure increased. Concomitant medications in two weeks include gabapentin and unspecified BP medicine. The patient previously took codeine and experienced allergy. The patient did not have other vaccine in four weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. In Aug2021 at 03:00, also reported as 01Aug2021, the patient experienced Diarrhea - loose & watery. Therapeutic measure taken in response to the event included administration of imodium. The outcome of the events was not recovered.


VAERS ID: 1692302 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Virgin Islands  
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 F63180 / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Breast cyst, Chest pain, Fatigue, Feeling abnormal, Feeling cold, Headache, Lymphoma, Malaise, Muscle tightness, Musculoskeletal stiffness, Parosmia, Pleural effusion, Vertigo
SMQs:, Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Malignant lymphomas (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN C [ASCORBIC ACID]; VITAMIN B12 [CYANOCOBALAMIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer (mother had cancer and her son had cancer.); Cancer (but she took Chemo 9-10 years ago because she had cancer); Chemotherapy; Mastectomy bilateral (One was removed 11 years ago and the other one was removed 8 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101154728

Write-up: She has lymphoma in the right side and has had both breast removed; Tightness around neck in back; Fluid inside chest wall; Burning in chest; Feels like she is falling down and has to hold onto things; feels like something cold comes over her; Left arm gets tight and sensation goes to foundation of breast and it gets hard; Tiredness; Slight headache; feels sick; a sensation she feels funny; left breast to her collarbone, there is a big bump that has fluid in it; funny smell like gas all the time; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at the age of 66-years-old via an unspecified route of administration, administered in Arm Left on 27Aug2021 (Batch/Lot Number: F63180) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cancer (she took Chemo 9-10 years ago because she had cancer) from an unknown date, both breasts removed (One was removed 11 years ago and the other one was removed 8 years ago) on an unknown date. Family history included cancer (mother had cancer and her son had cancer). Concomitant medications included VITAMIN C [ASCORBIC ACID], cyanocobalamin (VITAMIN B12); taken for an unspecified indication, start and stop date were not reported; medication for pressure, nerves, water pill. The patient reported that she took the first dose last Friday (27Aug2021). She has been getting some side effects. She has burning in chest on 30Aug2021 and it is not really burning, but she took Chemo 9-10 years ago because she had cancer. She said there is a funny smell like gas all the time on an unspecified date in Aug2021. When she used to take Chemo and radiation, she would also get that feeling in her throat. She also said the fluid from that left arm she got injection in gets tight and then has a sensation that goes to her breast and it gets hard on 29Aug2021. This is on the left side. She has lymphoma in the right side from an unspecified date and has had both breast removed. Where they cut the left breast to her collarbone, there is a big bump that has fluid in it on an unspecified date in Aug2021. It is not blood. She has had a lot of side effects. She originally stated she is falling down all the time, but later clarified that she just feels like she is going to fall on 29Aug2021. She does not actually fall. She has to be holding down when going from one place to another. Regarding feeling of falling, today, she only felt it one time. She went to kitchen and felt it, but it was not much. She has to scramble to hold. She never falls and has her eyes open. She goes to bathroom and does not feel it. She feels like something cold comes over her on 29Aug2021 and it feels like it will start and she sits down. She was not feeling sick but then said she feels sick and has a sensation she feels funny on an unspecified date in Aug2021. She is not actually sick. She was not feeling drowsy, she was just going through feeling like she was falling and feeling tiredness on 29Aug2021. She sees the place on left side of breast foundation has fluid this morning when she woke up because she has no breast on either side. She had them removed when she had cancer. One was removed 11 years ago and the other one was removed 8 years ago. She said it feels hard like a rock. She said the headaches which occurred on 29Aug2021 are better. It was not a heavy headache, just slight from ears to forehead. Now she just has tightness around neck in back on 31Aug2021. She has to go back on 24Sep2021 for second dose. Only thing she worries about is fluid inside chest on 31Aug2021. She doesn''t know if it the fluid inside chest wall is getting worse, she said it is coming back. She is just tired. She is not drowsy, just tired. She confirmed that she has not received any medical treatment for any of the symptoms. The patient did not recover from burning in chest, Left arm gets tight and sensation goes to foundation of breast and it gets hard, Tightness around neck in back, fluid inside chest wall; was recovering from tiredness and headache while the outcome of the other events was unknown.


VAERS ID: 1692306 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-07-24
Onset:2021-08-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal discomfort, Anxiety, Constipation, Cough, Fatigue, Feeling abnormal, Headache, Malaise, Myalgia, Nasal congestion, Nausea, Oropharyngeal pain, Pain, Pain assessment, Pain in extremity, SARS-CoV-2 test, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZADITOR; B COMPLEX [VITAMIN B COMPLEX]; VITAMIN D3; L GLUTAMINE; FLORADIX FLORAVITAL HERBAL IRON EXTRACT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy (Known allergies: Corn and Sesame); Gluten sensitivity (Known allergies: Gluten); Heavy periods; Iron deficiency anemia (Iron deficient anemia)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Pain; Result Unstructured Data: Test Result:7 out of 10; Test Date: 20210818; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC202101161972

Write-up: Body aches; Sore throat; Coughing; Congestion; Nausea; Sick; Swollen, hot, itching, rash at injection site; Swollen, hot, itching, rash at injection site; Swollen, hot, itching, rash at injection site; Swollen, hot, itching, rash at injection site; Arm hurts, still feel pain in my arm 6 weeks after injection; Tired; Headaches; Anxious; Constipation; Brain fog; Some normal, some intense muscle pain in left leg and foot; Upset stomach; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FA7484) via an unspecified route of administration in the right arm on 24Jul2021 at 15:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included iron deficient anemia, heavy periods, allergy to gluten, corn and sesame. 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 medications included ketotifen fumarate (ZADITOR), vitamin b complex (B COMPLEX), colecalciferol (VITAMIN D3), levoglutamide (L GLUTAMINE) and ascorbic acid/ pyridoxine hydrochloride/ thiamine hydrochloride/cyanocobalamin/riboflavin sodium phosphate/ferrous gluconate/matricaria recutita/foeniculum vulgare/rosa canina/spinacia oleracea/hibiscus sabdariffa (FLORADIX FLORAVITAL HERBAL IRON EXTRACT); all for unknown indications and from unknown dates and unknown if ongoing. On 02Aug2021 at 07:00, the patient arm hurted, swollen, hot, itching, rash at injection site. Swelling, rash, itching had gone, but still felt the pain in her arm 6 weeks after injection. It was reported that the patient woke up with a rash at injection site, more swollen and hot than it had been for the last week, also had itching and arm hurted. The patient called her doctor and went to see him. The doctor said that it was not a normal reaction and probably an allergic reaction or infection. The patient took some allergy medicine (unspecified) and the rash went away, but it took a while for the swelling to go down. The patient''s arm was hurt even after 6 weeks. On an unknown date in Aug2021, the patient experienced tired, headaches, brain fog, upset stomach, constipation, some normal, some intense muscle pain in left leg and foot and anxious. It was reported that the pain was 7 out of 10 on some days and sometimes she was anxious like she had to move all the time. On 15Aug2021 (also reported as 15Aug2021-20Aug2021), the patient was sick, sore throat, body aches, coughing, congestion and nausea. It was reported that cough and congestion lasted for weeks. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which was unspecified. Since the vaccination, the patient had been tested for COVID-19. On 18Aug2021, the patient underwent SARS-CoV-2 test via nasal swab and the result was negative. The clinical outcome of the events swollen, hot, itching, rash at injection site; coughing and congestion was resolved on an unknown date in 2021 while that of the event arm hurts, but still feel pain in arm 6 weeks after injection was not resolved. The clinical outcome of the events tired, headaches, brain fog, sick, sore throat, body aches, nausea, upset stomach, constipation, some normal, some intense muscle pain in left leg and foot and anxious was unknown at the time of the report.


VAERS ID: 1693059 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Unknown  
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 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / IM
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 3A9ZG / N/A LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erythema, Inappropriate schedule of product administration, Inflammation, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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? 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:

Write-up: The patient received her COVID vaccine and flu vaccine in the same arm, an inch apart from each other. The patient went to urgent care due to inflammation in her arm and received prescriptions for Norco and Ibuprofen. The redness and swelling did not resolve so she later went to another urgent care where she was given antibiotics and her symptoms resolved days later.


VAERS ID: 1693098 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-08-24
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020F21A / 2 LA / IM

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

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

Write-up: Patient states she is experiencing arm pain from injection site down the length of her arm and into her back.


VAERS ID: 1693167 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-06-01
Onset:2021-08-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Chills, Illness, Influenza like illness, Myalgia, Pain in extremity, Pyrexia, Trigger finger
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Triple positive Breast cancer
Preexisting Conditions:
Allergies: Penicillin, sulfas, amoxicillin
Diagnostic Lab Data: Seeking medical help currently
CDC Split Type:

Write-up: I got very ill with flu-like symptoms after both doses. I had my first dose in May and the 2nd in June 2021. After the 1st dose I was sick for about 8 days. I had a high fever and terrible chills. All my muscles ached. It was extreme. The 4th day I started to feel gradually better. I didn?t feel totally normal for 8-9 days. After the 2nd dose I also had extreme flu-like symptoms but that time they only lasted about 3 days and I felt normal after about 5 days. Fast forward to August. My thumbs no longer work properly. I have trigger thumbs in both hands. It started in the left hand. Then, about 4 weeks later I have the same problem in my right hand. I went to an urgent care center and the doctor determined that I have inflammation in the muscles / area at the base of both thumbs. If I bend my thumbs they bet stick in place and it is extremely painful. Initially I thought that this may have been caused by my herceptin & perjeta infusions- but get this - my husband developed the exact same problems in both of his thumbs! We didn?t change anything about our routines / use of our hands. The only thing we both did recently that was different is get the Moderna vaccine. He got his doses in April & May 2021. He said his thumbs feel better than they did a couple months ago, but he hasn?t regained full usage and is still in pain when he moves them. We are both executives at companies with office jobs. I am reporting this side effect to you in good faith with the hope that you will research it. My husband and I have both been strict vegans for more than 20 years and are healthy food nuts. We take raw vitamin B12, a blood builder, algae oil, and magnesium. We eat mostly organic. While I recently recovered from cancer, I am otherwise in perfect health. My husband and I both look 10 years younger than our ages (he is 46). It is so bizarre that we both experienced the exact same side effect. My husband also had a strong flu-like reaction to the 2nd dose of the vaccine, though his symptoms subsided more quickly than mine. The only theory we have is that we both have very good immune systems and are very healthy people, so perhaps our immune response went into overdrive and attacked healthy parts of our bodies. Neither of us is in the medical profession (I am an accountant - he is a commodities buyer), so we are just guessing. In any case, I hope this information helps the trained scientists to research the potential cause. We try to have a sense of humor about no one on the house being capable of opening jars anymore. I am just thankful that we both have jobs where an inability to use our thumbs is a nuisance but doesn?t prevent us from working.


VAERS ID: 1693234 (history)  
Form: Version 2.0  
Age: 50.0  
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 059E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dry eye, Eye irritation, Eye pain, Eye pruritus, Photophobia, Sleep disorder, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: levothyroxine
Current Illness: none
Preexisting Conditions: hypothyroid, vitiligo, migraines
Allergies: seasonal allergies, allergies to some skin care products, hives due to unknown allergens
Diagnostic Lab Data: Visited ophthalmologist on 8/11/21. Tests did not reveal another cause for the burning, itching, dry sensation, or soreness. Doctor prescribed eye drops.
CDC Split Type:

Write-up: I experienced burning, itchy eyes and blurry vision within just a few minutes of receiving the vaccine. For ~ three weeks after receiving the vaccine I experienced eye soreness which made it difficult to sleep. I continue to experience a burning sensation, eye dryness, and sensitivity to bright light in both eyes to this day (41 days post vaccination).


VAERS ID: 1693367 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-05-17
Onset:2021-08-01
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: 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? 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: Difficulty breathing when exercising at high intensity. I am someone who has worked out 5 days a week with weight training, and cardio. Starting this summer, I have been having trouble getting (what feels like) enough oxygen into my lungs. After this happening for now for over 2 months I am realizing something is materially different with my ability to breath oxygen.


VAERS ID: 1693480 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / SYR

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

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

Write-up: I received my first shot on August 13th, and about 4-5 days later I began experiencing spontaneous pain all over my body. It feels like a needle is stabbing me and it happens randomly without anything triggering it. It can start on my wrist, then start on leg, then on the back of my head, then on my chest, and really just anywhere on my body. It?s not a traveling pain so it doesn?t start on my wrist and travel to my ankle, it?s spontaneous. It doesn?t feel like numbness. The pharmacist advised me to report this since they had not heard anything like it.


VAERS ID: 1693731 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-08-19
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin. Fluoexetine, hydrochlorothiaz, Lisinapril. slow release iron, asprin 81, vitamin d
Current Illness: none
Preexisting Conditions: High blood pressure obesity depression high cloresteral
Allergies: none
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Soreness at injection site, large area of redness and heat at injections site that is still visible today where it was, fever and body aches for 2 days


VAERS ID: 1693754 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053C21A / 3 LA / IM

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

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

Write-up: Patient was inadvertently given a third dose of moderna per his request, pt has memory loss it has been learned.


VAERS ID: 1693834 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Rash, Skin discolouration, Thrombocytopenia
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Hypotonic-hyporesponsive episode (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: After a week of taking my second shot i experienced dark brownish patches that started in my leg, then it started radiating to my arms, thighs and even stomach. It was painful at the beginning but by time it is not anymore. As if i''m experiencing thrombocytopenia, or extra bleeding in my body And it is still there.


VAERS ID: 1693835 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Hypoaesthesia, Paraesthesia, Vitreous floaters
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Retinal disorders (narrow), Hearing impairment (broad), Sexual dysfunction (broad)

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

Write-up: The day after vaccination, I began to feel slight tingles and numbness in the left side of my face. Two days after that, it had intensified and had also spread to my left arm and left leg. The day after that, I became aware of a large floater in my left eye. On occasion, I have also felt milder tingles in the right side of my face. I first visited the ER, and all they could determine was that I hadn''t had a stroke. I later talked to my PCP, who explained that he has seen these kinds of effects with some regularity following COVID vaccination. He believes I have a case of Bell''s palsy, and that my nerves should gradually return to normal without further action. At his suggestion, I''m taking an 81 mg aspirin once a day as a precaution against micro blood clots. I believe my left arm and left leg have returned to normal, though my face is still irregular. Exact symptoms seem to depend on the temperature. The floater in my left eye is still there, and I intend to talk to my eye doctor about it.


VAERS ID: 1694238 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Kansas  
Vaccinated:2021-07-21
Onset:2021-08-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 1 UN / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 2 UN / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Computerised tomogram thorax, Cough, Hypoxia, Organising pneumonia, Paraesthesia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Interstitial lung disease (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Fluticasone, albuterol, hydroxyzine
Current Illness:
Preexisting Conditions:
Allergies: None
Diagnostic Lab Data: CT angio chest on 9/10/21
CDC Split Type:

Write-up: Dry cough developed approximately 1 week after receiving vaccine #1. Two days after receiving vaccine #2 on 8/11/21, patient developed tingling in his legs and weakness. Since the end of August 2021 he has developed worsening cough and wheezing. He was admitted on 9/10/21 for hypoxia and found to have cryptogenic organizing pneumonia.


VAERS ID: 1694569 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-03-11
Onset:2021-08-01
   Days after vaccination:143
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / UNK LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Blood test, COVID-19, Computerised tomogram thorax, Cough, Dyspnoea, Headache, Human rhinovirus test positive, Muscle spasms, Pneumonia, Rhinovirus infection, SARS-CoV-2 test positive, X-ray
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Sentraline 50 mg
Current Illness: N/A
Preexisting Conditions: Since Covid positive, battling double pneumonia
Allergies: Nuts
Diagnostic Lab Data: August 4, xray August 4, blood tests September 1, lung CT September 3, blood tests, xrays September 21-another lung CT scan scheduled
CDC Split Type:

Write-up: Coughing, headache, severe leg cramps, trouble breathing. Double pneumonia, Covid 19, & Rhino virus. X-rays, lung CT scan, blood tests, 3 different antibotics, breathing treatments, cough & cold meds.


VAERS ID: 1694679 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-04-01
Onset:2021-08-01
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / 2 - / SYR

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Atrial fibrillation, Cerebrovascular accident, Electrocardiogram, Electrocardiogram ambulatory, Electroencephalogram, Sleep apnoea syndrome
SMQs:, Supraventricular tachyarrhythmias (narrow), 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), Acute central respiratory depression (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lisinopril 10 mg, Flonase, Prilosec, Phentermine
Current Illness:
Preexisting Conditions: Mild high blood pressure
Allergies:
Diagnostic Lab Data: EKG, EEG, Sleep apnea, something with wires attached to his chest for 5-6 weeks that we sent back yesterday. Cardiologist visit coming up in 2 weeks for results for all the testing done.
CDC Split Type:

Write-up: Stroke on 8-1-2021. Patient never had any prior symptoms leading to this. Patient worked out 5 days/week his entire life. They administered TPA and results look good. Found AFib. Administered blood thinner, Eliquis for the rest of life. We can''t prove this is caused by the vaccine, but enough people that know the patient and his habits believe this to be the cause because he was in such perfect health prior. I am filling this out as I have questions myself as I think it is possible.


VAERS ID: 1694819 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blepharospasm, Dry eye, Dystonia, Eye pain, Eye swelling, Facial paralysis, Headache, Hypoaesthesia, Hypoaesthesia oral, Lacrimation increased, Malaise, Pain, Paraesthesia, Paraesthesia oral, Pyrexia, Sensory disturbance, Visual impairment
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish Oil, Dhea, Ezetimibe,Red Yeast Rice, Synthroid, Zyrtec, Flonase
Current Illness:
Preexisting Conditions: Hypothyroidism Lyme disease
Allergies: Penicillin, seasonal allergies
Diagnostic Lab Data: My doctor has ordered an MRI to rule out stroke. I am in the process of scheduling it.
CDC Split Type:

Write-up: I initially became ill with fever, body aches and general malaise. This lasted two days. On the third day, my right eye felt swollen and dry. It became weepy and then started twitching. The twitching continued and then I developed uncontrolled dystonic muscle firing in my face. It would start on the right and go across to the left side of my face. I had mouth and nose twitching and firing as well. The right side of my face and tongue were numb and tingling. Eventually it progressed to left facial dropping. I have some sharp shooting pains in my head and symptoms similar to those I feel with migraines. I have eye pain, seeing spots in my eye and phantom sensations in my right arm.


VAERS ID: 1694830 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Motor dysfunction, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Pt. states that after receiving the 2nd dose of Moderna 08/2021, started experiencing symptoms mid 08/2021 of intense arm pain and loss of motor skills throughout the hands. Still continuing to experience symptoms.


VAERS ID: 1694852 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-06-12
Onset:2021-08-01
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0151/EW0157 / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Appendicectomy, Appendicitis, Impaired work ability, Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Yes, blood pressure medication, water pill, cholesterol medication, Tylenol, ibuprofen
Current Illness: No
Preexisting Conditions: Hashimoto''s
Allergies: Penicillin, sulfa, Percocet, Prilosec
Diagnostic Lab Data:
CDC Split Type: vsafe

Write-up: After receiving the vaccine, I felt nothing. 2 ? months later, I had appendicitis. On 8/29, I had pain that got worse. I wen to the ER on 8/30 around 2:00. By 6:00am, my appendix was out and all is well. I am able to return to work tomorrow.


VAERS ID: 1694887 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abnormal sensation in eye, Ocular hyperaemia
SMQs:, Anaphylactic reaction (broad), Glaucoma (broad), Corneal 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: Not sure
Current Illness: Unsure
Preexisting Conditions: Unsure
Allergies: Unknown Allergic History
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient reported having redness and hot for both of her eyes. Patient described the adverse effect lasting roughly a week. Nothing was done for treatment.


VAERS ID: 1695276 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-03-09
Onset:2021-08-01
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Deafness neurosensory, Ear discomfort, Magnetic resonance imaging, Nerve compression, Tinnitus
SMQs:, Accidents and injuries (broad), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastatin 10mg daily, Yuvafem 1mcg 2x a week, Pantoprazole 40 mg daily, Prolia 2x year OTC: Sr. multi vitamin, Probiotic 10, Mega Red Krill Oil, Calcium Citrate Magnesium & Zincw/ Vitamin D3 (all daily) 1 Vitamin D/15000I
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: MRI on 9/8/21, determined no growths detected, found small nerves constricting
CDC Split Type:

Write-up: Loss of lower range hearing in left ear, constant white noise and feeling of fullness in ear 8/16/21 primary physician prescribed 10 days of Antibiotic and 6 days of steroids to rule out infection, no improvement, referred to ENT No improvement


VAERS ID: 1695322 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002F21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Peripheral swelling, Pruritus, Rash erythematous, Tenderness, Vaccination site erythema, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL; IBUPROFEN; BABY ASPIRIN
Current Illness:
Preexisting Conditions: Comments: The medical history was not provided by the reporter
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: swelling in the arm; tenderness; Moderna red rash/started experiencing a red rash on my arm; soreness; still experiencing pain at the injection site.; redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch; iitching on hand ,tching on arm,itching on leg,itching on foot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the arm), TENDERNESS (tenderness), PRURITUS (iitching on hand ,tching on arm,itching on leg,itching on foot), RASH ERYTHEMATOUS (Moderna red rash/started experiencing a red rash on my arm) and VACCINATION SITE ERYTHEMA (redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch) in a 69-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. The medical history was not provided by the reporter. Concomitant products included IBUPROFEN for Headache, PARACETAMOL (TYLENOL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced PRURITUS (iitching on hand ,tching on arm,itching on leg,itching on foot) and VACCINATION SITE ERYTHEMA (redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch). On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling in the arm), TENDERNESS (tenderness), RASH ERYTHEMATOUS (Moderna red rash/started experiencing a red rash on my arm), MYALGIA (soreness) and VACCINATION SITE PAIN (still experiencing pain at the injection site.). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itching, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (swelling in the arm), TENDERNESS (tenderness), MYALGIA (soreness) and VACCINATION SITE PAIN (still experiencing pain at the injection site.) had not resolved, PRURITUS (iitching on hand ,tching on arm,itching on leg,itching on foot) and VACCINATION SITE ERYTHEMA (redness at the injection site that was about 2 inch big,redness at the injection site that got bigger about 4 inch) had resolved and RASH ERYTHEMATOUS (Moderna red rash/started experiencing a red rash on my arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment includes ice patch patient states that she was scheduled to receive her second vaccine on 08Sept2021 and does not know if she should based on the symptoms that she experienced with the first. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Event outcome & additional event is added


VAERS ID: 1695326 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Injection site pain, SARS-CoV-2 antibody test, Therapy non-responder
SMQs:, Lack of efficacy/effect (narrow), Extravasation events (injections, infusions and implants) (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Heart disorder
Preexisting Conditions: Comments: Patient had no known allergies.
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: COVID-19 antibody test; Result Unstructured Data: Negative for antibodies; Test Name: Blood test; Result Unstructured Data: Not reported
CDC Split Type: USJNJFOC20210918278

Write-up: INJECTION SITE PAIN FOR 2 WEEKS; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 7 decade old, male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: diabetes, and heart issues, and patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on left arm on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. After receiving the vaccine on MAR-2021, on an unspecified date the patient experienced injection site pain for 2 weeks. Patient went to his physician and had routine blood work due to his history of diabetes and heart issues. On AUG-2021 physician called and told patient that he tested negative for COVID-19 antibody test (confirmed immunological vaccine failure) and needed to get the COVID vaccine. When patient told physician that he had in March, physician told it looked like patient had no vaccine and no protection. Patient was concerned as was going on a cruise soon. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000192884.; Sender''s Comments: V0: 20210918278-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1695373 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Fatigue, Muscular weakness, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: PHENYTOIN; ADVIL 12 HOUR; PANTOPRAZOLE; VITAMIN D 2000; ESCITALOPRAM; LOVASTATIN
Current Illness: Pain; Paralyzed (Left side of their body is paralyzed.); Seizures
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: lack of energy/their strength in the right hand is gone; The weakness in the right hand is moving up their arm to their elbow now; the patient fatigues real easy now; left arm about 2 to 3 inches from the injection site a sore has opened up and clear liquid is coming out; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (lack of energy/their strength in the right hand is gone), MUSCULAR WEAKNESS (The weakness in the right hand is moving up their arm to their elbow now), FATIGUE (the patient fatigues real easy now) and VACCINATION SITE PAIN (left arm about 2 to 3 inches from the injection site a sore has opened up and clear liquid is coming out) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The patient''s past medical history included Stroke. Concurrent medical conditions included Seizures, Pain and Paralyzed (Left side of their body is paralyzed.). Concomitant products included IBUPROFEN (ADVIL 12 HOUR) for Pain, PHENYTOIN for Seizures, PANTOPRAZOLE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ESCITALOPRAM and LOVASTATIN 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 ASTHENIA (lack of energy/their strength in the right hand is gone), MUSCULAR WEAKNESS (The weakness in the right hand is moving up their arm to their elbow now), FATIGUE (the patient fatigues real easy now) and VACCINATION SITE PAIN (left arm about 2 to 3 inches from the injection site a sore has opened up and clear liquid is coming out). At the time of the report, ASTHENIA (lack of energy/their strength in the right hand is gone), MUSCULAR WEAKNESS (The weakness in the right hand is moving up their arm to their elbow now), FATIGUE (the patient fatigues real easy now) and VACCINATION SITE PAIN (left arm about 2 to 3 inches from the injection site a sore has opened up and clear liquid is coming out) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was reported. Reporter did not allow further contact


VAERS ID: 1695583 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Eyelid thickening, Impaired ability to use machinery, Ocular discomfort
SMQs:, Periorbital and eyelid disorders (narrow)

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

Write-up: still unable to wear her contacts; felt like something was in her left eye; bumps under her eyelid like an allergic reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMPAIRED ABILITY TO USE MACHINERY (still unable to wear her contacts), OCULAR DISCOMFORT (felt like something was in her left eye) and EYELID THICKENING (bumps under her eyelid like an allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Contact lens wearer. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced IMPAIRED ABILITY TO USE MACHINERY (still unable to wear her contacts), OCULAR DISCOMFORT (felt like something was in her left eye) and EYELID THICKENING (bumps under her eyelid like an allergic reaction). At the time of the report, IMPAIRED ABILITY TO USE MACHINERY (still unable to wear her contacts) had not resolved and OCULAR DISCOMFORT (felt like something was in her left eye) and EYELID THICKENING (bumps under her eyelid like an allergic reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. On 01-Sep-2021, Patient stated that she got her first Moderna vaccine about 4 weeks ago and was due for the second shot on 02-Sep-2021. After 5-6 hours of vaccine she felt something in her eye and removed her contacts and wore her glasses. Her eye doctor after assessing gave her a lubricant. No relevant concomitant medications were reported.


VAERS ID: 1695647 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: California  
Vaccinated:2021-01-20
Onset:2021-08-01
   Days after vaccination:193
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 029L20A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Inappropriate schedule of product administration, Incorrect dose administered, Infection, Pain in extremity, Pruritus, Vaccination site erythema, Vaccination site induration
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Inappropriate schedule of vaccine administered; She''s worried about that not all the injection went into the muscle; Arm started hurting from the shoulder to the elbow/ it hurt to lay on it; Really itchy/ has a two inches circumference; Headache and stuff; It''s red/it''s very pale/slightly red/has a two inches circumference/feels a flat sort of area under the skin/it''s different.; It''s firm where the injection was/almost hard/it was itchy/a drop of liquid that came out of it, not a lot, just one drop/Currently it''s much flatter; Doctor got worried that she got an infection.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting from the shoulder to the elbow/ it hurt to lay on it), PRURITUS (Really itchy/ has a two inches circumference), INFECTION (Doctor got worried that she got an infection.), HEADACHE (Headache and stuff) and VACCINATION SITE ERYTHEMA (It''s red/it''s very pale/slightly red/has a two inches circumference/feels a flat sort of area under the skin/it''s different.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A, 022M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anaemic and Cancer. Concomitant products included PROGESTERONE, ESTRADIOL (ESTROGEN) and CELECOXIB (CELEBREX) for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INFECTION (Doctor got worried that she got an infection.). In August 2021, the patient experienced PAIN IN EXTREMITY (Arm started hurting from the shoulder to the elbow/ it hurt to lay on it), PRURITUS (Really itchy/ has a two inches circumference), HEADACHE (Headache and stuff), VACCINATION SITE ERYTHEMA (It''s red/it''s very pale/slightly red/has a two inches circumference/feels a flat sort of area under the skin/it''s different.) and VACCINATION SITE INDURATION (It''s firm where the injection was/almost hard/it was itchy/a drop of liquid that came out of it, not a lot, just one drop/Currently it''s much flatter). On 26-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and INCORRECT DOSE ADMINISTERED (She''s worried about that not all the injection went into the muscle). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in August 2021 for Adverse event, at a dose of 1 dosage form. On 26-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and INCORRECT DOSE ADMINISTERED (She''s worried about that not all the injection went into the muscle) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm started hurting from the shoulder to the elbow/ it hurt to lay on it), INFECTION (Doctor got worried that she got an infection.) and HEADACHE (Headache and stuff) outcome was unknown and PRURITUS (Really itchy/ has a two inches circumference), VACCINATION SITE ERYTHEMA (It''s red/it''s very pale/slightly red/has a two inches circumference/feels a flat sort of area under the skin/it''s different.) and VACCINATION SITE INDURATION (It''s firm where the injection was/almost hard/it was itchy/a drop of liquid that came out of it, not a lot, just one drop/Currently it''s much flatter) was resolving. Concomitant medication also include Thyroid medication. Reporter states on 28Aug2021 or 29Aug she took a Benadryl, and itchiness got better and redness reduced. Currently it''s much flatter, it''s very pale, slightly red, feels a flat sort of area under the skin, does not hurt but it''s firm and it''s different. Caller states that she had no changes on her regular medications since the first dose of the vaccine.


VAERS ID: 1695780 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-24
Onset:2021-08-01
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia, Injection site reaction, Mobility decreased, Muscular weakness, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (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: Ibuprofen , vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pain, tingling, numbness, weakness in arm stemming from vaccine location. Arm aches on and off, feels bruised like I just got the shot. Becomes very weak and painful and am unable to lift arm. Eventually it subsides. But returns- comes and goes. Feels bruised afterwards.


VAERS ID: 1696069 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Muscle spasms, Muscular weakness, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Omeprazole and Aviane
Current Illness: N/A
Preexisting Conditions:
Allergies: N/A
Diagnostic Lab Data: I don''t have health insurance. I''m a caregiver for my mom full time so I cannot work.
CDC Split Type:

Write-up: Long term shooting stabbing pain and swelling in right arm, Left hand pain an swelling, tingling, and weakness. Shooting stabbing pain in both legs and cramping in feet. Neck stiffness and pain in upper back. I''m having these symptoms days after my first jab and it''s been over a month and I still can''t bend my right arm nor grip with left fingers without them cramping painfully.


VAERS ID: 1696301 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-14
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Blepharospasm
SMQs:, Dystonia (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: I have had no testing done on this but the vaccine is the only thing that has changed in my body over the past two months
CDC Split Type:

Write-up: I have had both vaccines i had very harsh initial symptoms that went away after a few days however i have developed twitch in my left eye


VAERS ID: 1696344 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-08-20
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / SYR

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

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

Write-up: Patient has chronic itching.


VAERS ID: 1696492 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-07-23
Onset:2021-08-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Arthralgia, Depression, Suicidal ideation
SMQs:, Suicide/self-injury (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (narrow), Arthritis (broad), Hypoglycaemia (broad)

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

Write-up: Patient presented to the ED for right ankle pain and agitation on 8/1/2021. Patient presented to the ED on 8/6/21 with depression with suicidal ideation. Patient was hospitalized on 8/9/2021. These visits are within 6 weeks of receiving COVID vaccination. Patient did receive second dose on 8/13/2021.


VAERS ID: 1696832 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-08-19
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Eye swelling, Injection site pain, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Soreness at injection site. Within first week, swollenness in right eye. Blurring vision in right eye. With two weeks, blurring vision in left eye. Worsening blurring vision in right eye. Worsening vision in both eyes, and getting worse. PCP checked your vision, have appointments with eye doctors.


VAERS ID: 1696960 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-10
Onset:2021-08-01
   Days after vaccination:144
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / 2 AR / SYR

Administered by: Private       Purchased by: ?
Symptoms: Anticoagulant therapy, Carditis, Computerised tomogram abdomen abnormal, Gastrointestinal inflammation
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific inflammation (broad), Ischaemic colitis (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: heart disease
Allergies: none
Diagnostic Lab Data: CT scan- gastrointestinal inflammation
CDC Split Type: vsafe

Write-up: After a hospitalization, with inflammation of the heart for 3 days. I was put on a Heparin drip. I was put on the highest dose of 24 hour Nitrostat. When they did the CT scan, they found GI tract inflammation, this was in the beginning of August. Since August, the inflammation in the GI tract has turned acute. Tomorrow, 09/15/2021 they are doing emergency exploratory surgery and removing a section of the bowel if necessary.


VAERS ID: 1699877 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Condition aggravated, Eczema, Hand dermatitis, Vaccine positive rechallenge
SMQs:, Hypersensitivity (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: Zoloft
Current Illness: None
Preexisting Conditions: Anxiety, eczema
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Moderate flare of eczema to bilateral hands that seem to coincide with both first dose of vaccine, some calming of eczema between doses, and again flare up after second dose. At the same time she was also starting on anxiety medication Zoloft


VAERS ID: 1700271 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-01
Onset:2021-08-01
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002B21A / 1 RA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025B21A / 2 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiac stress test, Computerised tomogram, Deep vein thrombosis, Pulmonary thrombosis, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Gabapentin 300mg and 150 Synthroid.
Current Illness: Neuropathy
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Stress Test 17 August 2021. Blood work 17 August 2021 CT Scans 17 August 2021
CDC Split Type:

Write-up: Blood Clots in both legs, groin and lungs.


VAERS ID: 1700436 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: New York  
Vaccinated:2021-03-08
Onset:2021-08-01
   Days after vaccination:146
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6205 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Alanine aminotransferase, Anion gap decreased, Blood test, Chest pain, Computerised tomogram, Electrocardiogram abnormal, Fibrin D dimer increased, Mean cell haemoglobin, Mean cell haemoglobin concentration, Musculoskeletal chest pain, Pain
SMQs:, Haemorrhage laboratory terms (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: ECG - abnormal T Wave sent to ER Cat scan - not acute that she had for a while, see cardiologist because of abnormal. Bloodwork - Low anion low, SGPT (alt) low - MCHC low. high -MCH, D-dimer - high
CDC Split Type: vsafe

Write-up: Lyme Disease from a tick bite in Aug for 3 weeks, UTI in Jun and July. Mammogram in Sept 2021 - chest pain left side, achy pain, chest wall pain ER - 9/9/2021. Had a scarlet fever as a child.


VAERS ID: 1700456 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-13
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspepsia, Injection site pain, Tinnitus
SMQs:, Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific dysfunction (narrow), Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi-vitamins, D3, DHA
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sore arm at injection site, ringing in the ears, heartburn


VAERS ID: 1700695 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-07-26
Onset:2021-08-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Angiocardiogram, Coronary artery occlusion, Coronary artery thrombosis, Electrocardiogram, Percutaneous coronary intervention, Troponin
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: propranolol 20mg daily as needed (not sure when last taken) escitalopram oxalate 10mg daily calcium carbonate 200mg po as needed (not sure when last taken) Centrum vitamins for men, taken daily
Current Illness: none apparent
Preexisting Conditions: history of depression
Allergies: Cefprozil: rash
Diagnostic Lab Data: ECG, troponin, coronary angiography and percutaneous intervention
CDC Split Type:

Write-up: 1 August, 2021: Acute ST elevation myocardial infarction due to mid- Left Anterior Descending coronary artery thrombotic occlusion


VAERS ID: 1700914 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-20
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Patient did state on vaccine consent form that had, allergic reactions to other medications or vaccines other than the COVID vaccine
Diagnostic Lab Data: I do not have that information
CDC Split Type:

Write-up: Patient fainted and was dizzy within a few minutes of getting the vaccine (Janssen), patient was alert. Made the patient comfortable and helped to keep her cool, with an ice pack, as the pharmacist I spoke with her and did not see any signs of swelling. There was no loss of conscienceness and 911 was called with the ambulance coming to escort the patient. A follow up call was made the following day and the patient was doing fine.


VAERS ID: 1703052 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, Vaccination site lymphadenopathy
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: PVIUS2021001182

Write-up: Painful lump near collarbone/ swollen lymph node; Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Painful lump near collarbone/ swollen lymph node) and PAIN (Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone) 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) (Intramuscular) 1 dosage form. In August 2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Painful lump near collarbone/ swollen lymph node) and PAIN (Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone). The patient was treated with IBUPROFEN from August 2021 to August 2021 for Swollen lymph nodes, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Painful lump near collarbone/ swollen lymph node) and PAIN (Painful lump near collarbone/ whole area surrounding the lump was sore/pain near my collarbone) had not resolved. No concomitant medications were reported by the provider.


VAERS ID: 1703514 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-08-10
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Eye haemorrhage, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retinal 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: She had broken blood vessels in the eyes/she had the same spot in the other ey/had broken blood vessels in one eye.; Felt a little itch but it never itch really bad; It is light red/still see a little light pink again in some spots/It turned pink; Below the injection site of her arm, got on her arm some of the arm they say you get/it was a little sore/wasn''t anything terrible/if she lays on it it is still sore; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (She had broken blood vessels in the eyes/she had the same spot in the other ey/had broken blood vessels in one eye.), VACCINATION SITE PRURITUS (Felt a little itch but it never itch really bad), VACCINATION SITE ERYTHEMA (It is light red/still see a little light pink again in some spots/It turned pink) and VACCINATION SITE PAIN (Below the injection site of her arm, got on her arm some of the arm they say you get/it was a little sore/wasn''t anything terrible/if she lays on it it is still sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-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 EYE HAEMORRHAGE (She had broken blood vessels in the eyes/she had the same spot in the other ey/had broken blood vessels in one eye.), VACCINATION SITE PRURITUS (Felt a little itch but it never itch really bad), VACCINATION SITE ERYTHEMA (It is light red/still see a little light pink again in some spots/It turned pink) and VACCINATION SITE PAIN (Below the injection site of her arm, got on her arm some of the arm they say you get/it was a little sore/wasn''t anything terrible/if she lays on it it is still sore). At the time of the report, EYE HAEMORRHAGE (She had broken blood vessels in the eyes/she had the same spot in the other ey/had broken blood vessels in one eye.), VACCINATION SITE PRURITUS (Felt a little itch but it never itch really bad), VACCINATION SITE ERYTHEMA (It is light red/still see a little light pink again in some spots/It turned pink) and VACCINATION SITE PAIN (Below the injection site of her arm, got on her arm some of the arm they say you get/it was a little sore/wasn''t anything terrible/if she lays on it it is still sore) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Patient did not receive any treatment. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Eye haemorrhage was automatically upgraded as serious as per IME list. However, based on information available and due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious. Further information has been requested. Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Eye haemorrhage was automatically upgraded as serious as per IME list. However, based on information available and due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious. Further information has been requested.


VAERS ID: 1703537 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy, Hepatic enzyme, Hepatic enzyme increased, Liver disorder
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (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: Test Date: 202108; Test Name: Hepatic enzyme; Result Unstructured Data: Elevated; Test Name: Biopsy; Result Unstructured Data: No cancer and hepatic issue
CDC Split Type: USJNJFOC20210920247

Write-up: ELEVATED LIVER ENZYMES; DIAGNOSED WITH LIVER ISSUE; This spontaneous report received from a patient via a company representative concerned a female 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: Unk) dose was not reported, administered on MAR-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 elevated liver enzymes. On AUG-2021, the patient experienced diagnosed with liver issue. Laboratory data included: Hepatic enzyme (NR: not provided) Elevated. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) No cancer and hepatic issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the elevated liver enzymes and diagnosed with liver issue was not reported. This report was non-serious.


VAERS ID: 1703937 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-04-07
Onset:2021-08-01
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / UNK RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Erectile dysfunction, Testicular disorder
SMQs:, Fertility disorders (narrow), Sexual dysfunction (narrow)

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

Write-up: I?m experience erectile dysfunction and swollen testicles. I?ve never experienced these symptoms before. They suddenly appeared some months after taking my vaccine shot. I?ve been healthy otherwise until now.


VAERS ID: 1704004 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-08-26
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK RA / IM

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

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

Write-up: little finger of left hand numb


VAERS ID: 1704051 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Headache, Muscular weakness, Neck pain, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Tendinopathies and ligament 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: At our Thyroid 90 mg.
Current Illness: Back pain, arthritis.
Preexisting Conditions: Back pain.
Allergies: None.
Diagnostic Lab Data: Pending
CDC Split Type:

Write-up: Left arm weakness for over 1 month each shot. Severe neck pain on left side to present day. Headaches till present day. Sharp stabbing pains running up from both ankles to mid calf.


VAERS ID: 1704118 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-12
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

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

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

Write-up: The patient is an 11-year-old female who received the COVID-19 Pfizer vaccine on 8/12/2021. At this time, there are no reported symptoms by the patient or guardian.


VAERS ID: 1704174 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: California  
Vaccinated:2021-05-04
Onset:2021-08-01
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8731 / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Hepatitis A antibody, Hepatitis B antibody, Hepatitis C antibody, Herpes zoster, Varicella virus test positive
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tramadol, gabapentin, amitriptyline.
Current Illness: none
Preexisting Conditions: Sciatica, GERD, anxiety
Allergies: Naproxen causes nightmares Nortriptyline causes nightmares
Diagnostic Lab Data: Tested for MMR immunity, varicella zoster AB, and Hep A,B, C antibody on 5/1/21.
CDC Split Type:

Write-up: Pt developed shingles on 8/1/21. This was treated with oral medication. Symptoms are resolving.


VAERS ID: 1704495 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 1 LA / IM

Administered by: Public       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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shingles type rash on right back/trunk


VAERS ID: 1704562 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-08-08
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Exposure during pregnancy, Ultrasound uterus abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

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

Write-up: Had a pregnancy ultrasound on august 4. Baby measured 5weeks 5days with a heartbeat and normal looking sac. Got the vaccine Sunday, august 8. Went back for another ultrasound on august 18 and the fetus had only progressed 4 days? the same amount of time between first measurement and first vaccine dose. I have had two healthy, full term pregnancies over the last 4 years with zero complications during conception and delivery.


VAERS ID: 1704594 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-03-01
Onset:2021-08-01
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood urine present, Computerised tomogram, Urine analysis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (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: synthroid enalapril fish oil calcium B12
Current Illness: strep throat. Had a negative covid test. Then a positive strep test. Took Doxycycline
Preexisting Conditions: prediabetic hypertension thyroid ablated with iodine
Allergies: penicillin sulfa aspirin inderal
Diagnostic Lab Data: Catscan 9/14/2021 Urinalysis 8/13/2021 Urinalysis 8/27/2021
CDC Split Type:

Write-up: Unknown reason for blood in urine. Had catscan of abdomen. Everything looked normal.


VAERS ID: 1704854 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / -

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

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

Write-up: Tingling and numbness in body that moves around. Has not gone away for multiple weeks.


VAERS ID: 1705477 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: New York  
Vaccinated:2021-01-07
Onset:2021-08-01
   Days after vaccination:206
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3248 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9264 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood thyroid stimulating hormone normal, Thyroid disorder
SMQs:, Hypothyroidism (broad), Hyperthyroidism (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: No medications were being taken at time of vaccination.
Current Illness: None
Preexisting Conditions: PCOS
Allergies: None
Diagnostic Lab Data: Blood work Last TSH before Covid 19 vaccine 7/27/20 : 3.218(normal levels) TSH on 8/9/21 : levels 4.864(abnormal) TSH on 9/15/21 : 5.150(abnormal)
CDC Split Type:

Write-up: Thyroid disorder. Labs showing increased levels on T4 .


VAERS ID: 1705488 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Administered to patient under the age of 18.


VAERS ID: 1705493 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Vaccine administered to patient under the age of 18.


VAERS ID: 1705501 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Administered to patient under the age of 18.


VAERS ID: 1705885 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Administered to patient under the age of 18.


VAERS ID: 1705887 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Administered to patient under the age of 18.


VAERS ID: 1706385 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blister, COVID-19, Drug ineffective, Headache, Nasopharyngitis, Pain, Respiratory distress, Therapeutic product effect incomplete, Viral rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: COVID-19; Test Result: Positive
CDC Split Type: USPFIZER INC202101076904

Write-up: had two doses of the COVID-19 vaccine, completed them in APR/2021; States it is covered with single blisters; developed a new rash over her entire anterior trunk./ viral rash; have symptoms of a severe cold/congested nose, severe headache, extreme muscle/body aching; she began to have symptoms of a severe cold on 8/26/2021 and progressively got worse over the next fewdays/ last week that she had gotten sick and tested positive for COVID; bad headache; Pt states that on day 4 after this injection, her "usual pain came back; usual pain came back/still "hurting"; respiratory distress; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASL2021126859), license party for etanercept (ENBREL). This solicited report (USASL2021126859) was reported to Amgen on 16/AUG/2021 by a consumer from a commercial program and involves a 59 year old female patient who experienced bad headache [PT: headache] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient''s current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on 11/AUG/2021. Approximately 1 days later, on 12/AUG/2021, the patient had a bad headache. Therefore, the patient took Tylenol (paracetamol) to attempt to relieve. The headache lasted for two days. Treatment for the event included Tylenol (paracetamol). The outcome of the event headache was reported as recovered/resolved. The event headache was resolved on 14/AUG/2021. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the event headache. The causal relationship between the event headache and Enbrel and Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined to provide lot number. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen Assessment: The event headache was assessed as related to etanercept by Amgen. The reporter''s assessment of headache with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (23Aug2021): This is a follow-up solicited report form a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021126859), license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 23/AUG/2021: In this follow up report, the patient''s usual pain came back/still hurting [PT: pain], the patient stated that on day four after this injection, her usual pain came back [PT: therapeutic product effect incomplete] while receiving Enbrel with Single Dose Prefilled Autoinjector. On an unknown date in AUG/2021, on day four after this injection, the patient''s usual pain came back that she still hurting. Enbrel injection would due in two days. The outcome of the event pain was reported as not recovered/not resolved. The outcome of the event therapeutic product effect incomplete was reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was continued for the events pain and therapeutic product effect incomplete. The consumer reported that the event therapeutic product effect incomplete was possibly related to Enbrel. The causal relationship between the event pain and Enbrel and Single Dose Prefilled Autoinjector was not provided by the consumer. The causal relationship between the event therapeutic product effect incomplete and Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent to contact. No follow up attempts are possible. No further information is expected. Amgen Causality Assessment: The events headache and drug effect incomplete was assessed as related to etanercept by Amgen. The event pain was assessed as unrelated to etanercept by Amgen. The reporter''s assessment of pain and headache with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (01Sep2021): This is a follow-up solicited report form a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021126859), license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 01/SEP/2021 AND 08/SEP/2021: The case was upgraded to serious 01/SEP/2021. This serious solicited report was reported to Amgen by a consumer from a commercial program and involves a 59 year old female patient who had respiratory distress [PT: respiratory distress], states it is covered with single blisters [PT: blister], developed a new rash over her entire anterior trunk./ viral rash [PT: viral rash], she began to have symptoms of a severe cold on 8/26/2021 and progressively got worse over the next fewdays/ last week that she had gotten sick and tested positive for COVID [PT: sars-cov-2 test positive], have symptoms of a severe cold/congested nose, severe headache, extreme muscle/body aching [PT: nasopharyngitis] while receiving Enbrel with Single Dose Prefilled Autoinjector. The patient''s historical vaccination included COVID-19 vaccine (in APR/2021). On 26/AUG/2021, the patient had gotten sick and was tested positive for COVID-19 on 30/AUG/2021. Patient began to have symptoms of a severe cold on 26/AUG/2021 and progressively got worse over the next few days. On an unknown date in 2021, she had a congested nose, severe headache, extreme muscle/body aching, and some respiratory distress. Patient mentioned she was still feels awful but, her breathing improved and the headache was nearly gone. She had two doses of the COVID-19 vaccine, completed them in APR/2021. Patient was exposed to COVID-19 at work. Patient also mentioned she missed Enbrel doses since 25/AUG/2021. On 05/SEP/2021 three days ago, she developed a new rash over her entire anterior trunk. Patient clarified it was covered with single blisters. She did see her physician and was told that it was not "Shingles", but some other viral rash and patient was given an antiviral to take. On 08/SEP/2021, she reported she was doing somewhat better. The outcome of the events respiratory distress, headache, sars-cov-2 test positive, nasopharyngitis were reported as recovering/resolving. The outcome of the events blister, viral rash was reported as unknown. Action taken with Enbrel was reported as unknown for the event headache. Action taken with Enbrel was temporarily withheld for the events sars-cov-2 test positive, nasopharyngitis and respiratory distress. Action taken with Enbrel was continued for the events pain and therapeutic product effect incomplete. Action taken with Single Dose Prefilled Autoinjector was reported as unknown for the event headache. Action taken with Single Dose Prefilled Autoinjector was continued for the events pain and therapeutic product effect incomplete. Action taken with Single Dose Prefilled Autoinjector was temporarily withheld for the events sars-cov-2 test positive, nasopharyngitis and respiratory distress. The consumer reported that the event therapeutic product effect incomplete was possibly related to Enbrel. The causal relationship between the events headache, pain, sars-cov-2 test positive, blister, viral rash, nasopharyngitis, respiratory distress and Enbrel was not provided by the consumer. The causal relationship between the events headache, pain, therapeutic product effect incomplete, sars-cov-2 test positive, blister, viral rash, nasopharyngitis, respiratory distress and Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected. Amgen comments: This individual case report does not change the safety profile of the product. Amgen Causality Assessment Respiratory distress is serious and unrelated to etanercept. Blisters, viral rash, drug effect incomplete and headache are non-serious and related to etanercept. Pain, sars-cov-2 test positive and cold symptoms are non-serious and unrelated to etanercept. The reporter''s assessment of the events headache, pain, sars-cov-2 test positive, blister, viral rash, nasopharyngitis, respiratory distress with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender''s Comments: Based on temporal association, a causal relationship between the events drug effect incomplete headache Blisters, viral rash, and suspect drug cannot be excluded. Event pain Respiratory distress , and sars-cov-2 test positive and cold symptoms is considered intercurrent medical condition and is not related to etanercept.The contributory role of the COVID-19 Vaccine to the events of sars-cov-2 test positive,Blisters, viral rash, drug effect incomplete , nasopharyngitis and headache is considered possible. Other events were more likely intercurrent conditions The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate..


VAERS ID: 1706501 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Hawaii  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blindness transient, Blood pressure measurement, Fatigue, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal 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: Passed out (The patient got an unspecified vaccine for the STD (sexually transmitted disease) when he was in his teens, and passed out and his blood pressure (BP) went down.); Comments: The patient got an unspecified vaccine for the STD (sexually transmitted disease) when he was in his teens.
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: went down; Comments: The patient''s BP went down and he passed out after her got an unspecified vaccine for the STD (sexually transmitted disease) when he was in his teens.
CDC Split Type: USJNJFOC20210921963

Write-up: BLIND FOR 5 MINUTES/LOST VISION FOR ONE EYE FOR HALF A DAY; THROW UP; WEAK; TIRED; This spontaneous report received from a consumer (patient''s grandmother) concerned a 21-year-old male patient of unspecified race and ethnicity. The patient''s height, and weight were not reported. The patient got an unspecified vaccine for the STD (sexually transmitted disease) when he was in his teens, and passed out and his blood pressure (BP) went down. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, in AUG-2021, soon after vaccination, the patient started to throw up and was blind for 5 minutes. On the same day of vaccination, he lost the vision for one eye for a half of the day. His girlfriend (nurse) stayed with him that night. On the next morning, he was weak and tired but his eye started to get better. It took 2 days for the patient to completely recover. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blind for 5 minutes/lost vision for one eye for half a day, throw up, weak, and tired on an unspecified date in AUG-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210921963-COVID-19 VACCINE AD26.COV2.S-Blind for 5 minutes/lost vision for one eye for half a day. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1706555 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: COVID-19 antibody test; Result Unstructured Data: No antibodies
CDC Split Type: USJNJFOC20210925740

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of an unspecified age, sex, race and ethnic origin. The patient''s height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) dose was not reported, 1 total administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. In AUG-2021, the patient had COVID-19 antibody test which showed no antibodies (confirmed immunological vaccine failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000193282.; Sender''s Comments: V0: 20210925740-Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1706717 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Puerto Rico  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bone pain, Erythema, Induration, Myalgia, Peripheral swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: I had like a ball /my shoulder where I got the shot got swollen again; my arm was a little bit swollen/the arm started to get swollen; the arm started to get swollen and very red; it was hard/had like a ball; pain in his bones; pain in his body/it hurts/my body hurts, too; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my arm was a little bit swollen/the arm started to get swollen), ERYTHEMA (the arm started to get swollen and very red), INDURATION (it was hard/had like a ball), PERIPHERAL SWELLING (my shoulder where I got the shot got swollen again/my left armpit has been swollen) and BONE PAIN (pain in his bones) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced ERYTHEMA (the arm started to get swollen and very red), INDURATION (it was hard/had like a ball), BONE PAIN (pain in his bones) and MYALGIA (pain in his body/it hurts/my body hurts, too). On 16-Aug-2021, the patient experienced PERIPHERAL SWELLING (my arm was a little bit swollen/the arm started to get swollen). On 22-Aug-2021, the patient experienced PERIPHERAL SWELLING (my shoulder where I got the shot got swollen again/my left armpit has been swollen). At the time of the report, PERIPHERAL SWELLING (my arm was a little bit swollen/the arm started to get swollen), ERYTHEMA (the arm started to get swollen and very red), PERIPHERAL SWELLING (my shoulder where I got the shot got swollen again/my left armpit has been swollen), BONE PAIN (pain in his bones) and MYALGIA (pain in his body/it hurts/my body hurts, too) outcome was unknown and INDURATION (it was hard/had like a ball) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported No treatment medications were reported. It was reported that patient''s Second dose of vaccine was scheduled on 13-Sep-2021.


VAERS ID: 1706739 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-14
Onset:2021-08-01
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Headache, Myalgia, Nausea, Pain in extremity, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (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: right arm aching; vertigo; for 3-4 days she had body aches/occasional body aches; headaches on and off; for 3-4 days she had chills; nauseated; dizziness or vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness or vertigo), PAIN IN EXTREMITY (right arm aching), VERTIGO (vertigo), MYALGIA (for 3-4 days she had body aches/occasional body aches) and HEADACHE (headaches on and off) in a 43-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced DIZZINESS (dizziness or vertigo), VERTIGO (vertigo), MYALGIA (for 3-4 days she had body aches/occasional body aches), HEADACHE (headaches on and off), CHILLS (for 3-4 days she had chills) and NAUSEA (nauseated). On 25-Aug-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PAIN IN EXTREMITY (right arm aching). In August 2021, DIZZINESS (dizziness or vertigo) had not resolved, HEADACHE (headaches on and off), CHILLS (for 3-4 days she had chills) and NAUSEA (nauseated) had resolved. At the time of the report, PAIN IN EXTREMITY (right arm aching) and VERTIGO (vertigo) had not resolved and MYALGIA (for 3-4 days she had body aches/occasional body aches) was resolving. She''s a vaccine compromised person, has had vaccine injury. No concomitant medications were provided by reporter. No treatment medications were provided by reporter. Patient received second dose on 13-AUG-2021 and developed nausea, headache on and off, dizzy during first week and 3 to 4 days. By the sixth day she had only dizziness or vertigo and occasional body aches.


VAERS ID: 1706752 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-02
Onset:2021-08-01
   Days after vaccination:152
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012A21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Inappropriate schedule of product administration, Limb discomfort, Nervousness, Off label use, Pain, Pyrexia, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OTEZLA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: Body temperature; Test Result: 100.4 {DF}; Result Unstructured Data: 100.4
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: shaky; my arm is very sore; off label use; Inappropriate schedule of vaccine administered; chills; fever of 100.4 degrees Fahrenheit; extreme pain from mid-elbow to wrist; cannot lift arm beyond 45 degrees; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (cannot lift arm beyond 45 degrees), PAIN (extreme pain from mid-elbow to wrist), NERVOUSNESS (shaky), PAIN IN EXTREMITY (my arm is very sore) and OFF LABEL USE (off label use) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021F21A, 028A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included APREMILAST (OTEZLA) for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced LIMB DISCOMFORT (cannot lift arm beyond 45 degrees). On 29-Aug-2021, the patient experienced PAIN (extreme pain from mid-elbow to wrist). On 30-Aug-2021, the patient experienced PYREXIA (fever of 100.4 degrees Fahrenheit). On an unknown date, the patient experienced NERVOUSNESS (shaky), PAIN IN EXTREMITY (my arm is very sore), OFF LABEL USE (off label use), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and CHILLS (chills). At the time of the report, LIMB DISCOMFORT (cannot lift arm beyond 45 degrees), PAIN (extreme pain from mid-elbow to wrist), NERVOUSNESS (shaky), PAIN IN EXTREMITY (my arm is very sore), CHILLS (chills) and PYREXIA (fever of 100.4 degrees Fahrenheit) outcome was unknown and OFF LABEL USE (off label use) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, Body temperature: 100.4 ?F (abnormal) 100.4. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Significant follow-up received on 30-AUG-2021 : Updated events


VAERS ID: 1706762 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Colorado  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: started to experience itching around 12:00 AM that evening; red rash from the point of injection to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (started to experience itching around 12:00 AM that evening) and RASH ERYTHEMATOUS (red rash from the point of injection to elbow) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Immunocompromised. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 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 PRURITUS (started to experience itching around 12:00 AM that evening) and RASH ERYTHEMATOUS (red rash from the point of injection to elbow). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (started to experience itching around 12:00 AM that evening) and RASH ERYTHEMATOUS (red rash from the point of injection to elbow) outcome was unknown. The patient received her 3rd dose around 4:00 PM, she then started to experience itching around 12:00 AM that evening. The next morning she had a red rash extending from the injection site to her elbow No Concomitant medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up received on 01-SEP-2021 and does not contain any new information On 01-Sep-2021: TCR received on 01-SEP-2021 and does not contain any new information


VAERS ID: 1706773 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-05-05
Onset:2021-08-01
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 001C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram, Neoplasm
SMQs:, Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: CT Scan; Result Unstructured Data: showed it was not a cyst
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: lump where right ear meets his head, about where glasses would sit. Next morning woke up with golf ball sized lump. The lump removed and determined to be a tumor with blood supply and striated nerves.; This spontaneous case was reported by an other health care professional and describes the occurrence of NEOPLASM (lump where right ear meets his head, about where glasses would sit. Next morning woke up with golf ball sized lump. The lump removed and determined to be a tumor with blood supply and striated nerves.) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 001C21A) for COVID-19 vaccination. No Medical History information was reported. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced NEOPLASM (lump where right ear meets his head, about where glasses would sit. Next morning woke up with golf ball sized lump. The lump removed and determined to be a tumor with blood supply and striated nerves.). The patient was treated with Surgery for Neoplasm. At the time of the report, NEOPLASM (lump where right ear meets his head, about where glasses would sit. Next morning woke up with golf ball sized lump. The lump removed and determined to be a tumor with blood supply and striated nerves.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Computerised tomogram: abnormal (abnormal) showed it was not a cyst. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was stated that a few days before 26-Aug-2021 patient noticed a lump. The patient went to an urgent care who said they were not sure what this lump was and to keep an eye on it. patient saw an ENT for this lump. The lump was removed and sent to a pathologist, who forwarded it to a specialist. They have not been able to identify the type of tumor. The patient was a very healthy athlete and has not had any issues like this in the past. He has not taken any medications or treatments. Concomitant medications was not provided by the reporter.


VAERS ID: 1706810 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness; she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness and tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness) and FATIGUE (she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness and tiredness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-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 MYALGIA (she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness) and FATIGUE (she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness and tiredness). At the time of the report, MYALGIA (she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness) and FATIGUE (she had her first vaccine on 1Aug2021 with some very mild side effects of arm soreness and tiredness) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medications was not provided by the reporter Treatment information was not provided This case was linked to MOD-2021-304259 (Patient Link).


VAERS ID: 1706871 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-01-16
Onset:2021-08-01
   Days after vaccination:197
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011J20A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse reaction, Pruritus, Rash, Skin mass, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: trouble with Benadryl and had to go to the Hospital; Hives all over his body except the trunk; lumps all over his body except the trunk; started itching terribly; rash on thighs, legs, and arms/covered with a rash all over his body except the trunk; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ADVERSE REACTION (trouble with Benadryl and had to go to the Hospital) and URTICARIA (Hives all over his body except the trunk) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 013L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ADVERSE REACTION (trouble with Benadryl and had to go to the Hospital) (seriousness criterion hospitalization). On 23-Aug-2021, the patient experienced RASH (rash on thighs, legs, and arms/covered with a rash all over his body except the trunk). On 24-Aug-2021, the patient experienced URTICARIA (Hives all over his body except the trunk) (seriousness criterion medically significant), SKIN MASS (lumps all over his body except the trunk) and PRURITUS (started itching terribly). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 25-Aug-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (trouble with Benadryl and had to go to the Hospital) outcome was unknown and URTICARIA (Hives all over his body except the trunk), SKIN MASS (lumps all over his body except the trunk), PRURITUS (started itching terribly) and RASH (rash on thighs, legs, and arms/covered with a rash all over his body except the trunk) was resolving. Concomitant medications were not reported. The patient did not have any adverse events following the first two doses of the vaccine. On 25-Aug-2021, the doctor started the patient on steroid injections. The patient had trouble with Benadryl and had to go to the hospital and was released (had nothing to do with the vaccine). His reaction was 90% cleared, however, it was reported that he still had some red bumps. The wife of the patient stated that she also received the 3 shots at the same time as her husband and with the same lot number. She denied having had any adverse reactions. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment. For the event adverse reaction: Reporter''s causality assessment considered the event unlikely related to the vaccine. Treatment drug Benadryl is a confounding factor. However, very limited information is available to assess causality. This case refers to a case of third dose of Moderna. Clarification regarding patient?s history of immunodeficiency has been requested.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment. For the event adverse reaction: Reporter''s causality assessment considered the event unlikely related to the vaccine. Treatment drug Benadryl is a confounding factor. However, very limited information is available to assess causality. This case refers to a case of third dose of Moderna. Clarification regarding patient?s history of immunodeficiency has been requested.


VAERS ID: 1706958 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 005621A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Fatigue, Musculoskeletal stiffness, Nausea, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: arm was red; right fingers was swollen; fingers still/stiff back/left fingers were stiff; arm was red and sore/arm was a little sore; nauseas; tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was red), PERIPHERAL SWELLING (right fingers was swollen), PAIN IN EXTREMITY (arm was red and sore/arm was a little sore), NAUSEA (nauseas) and FATIGUE (tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005621A) 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 PAIN IN EXTREMITY (arm was red and sore/arm was a little sore), NAUSEA (nauseas) and FATIGUE (tired). On 23-Aug-2021, the patient experienced ERYTHEMA (arm was red) and PERIPHERAL SWELLING (right fingers was swollen). At the time of the report, ERYTHEMA (arm was red), PERIPHERAL SWELLING (right fingers was swollen), PAIN IN EXTREMITY (arm was red and sore/arm was a little sore), NAUSEA (nauseas) and FATIGUE (tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by reporter. No treatment details were provided by reporter.


VAERS ID: 1706992 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-12
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049C21A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: COVID arm; itchy; very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID arm), PRURITUS (itchy) and MYALGIA (very sore) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. No Medical History information was reported. On 12-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 (COVID arm), PRURITUS (itchy) and MYALGIA (very sore). At the time of the report, VACCINATION COMPLICATION (COVID arm), PRURITUS (itchy) and MYALGIA (very sore) 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. Concomitant product use was not provided by the reporter. Treatment information was not provided. Reported that events lasted about 9 days.


VAERS ID: 1707043 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-08-27
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 058E21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
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.MOD20213

Write-up: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (sore arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered first shot to a 16-year-old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Aug-2021 at 2:30 PM, 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 (sore arm). On 27-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered first shot to a 16-year-old). On 27-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered first shot to a 16-year-old) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) 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 concomitant medications was reported. No treatment drug details was reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received on 08-sep-2021 and contains no new information.


VAERS ID: 1707166 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-02-12
Onset:2021-08-01
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 010M20A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Asthma, Dyspnoea, Electrocardiogram, Oxygen saturation, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN D3; ARMOUR THYROID; SERTRALINE; ATOMOXETINE; OMEPRAZOLE
Current Illness: Asthma; Hashimoto''s disease; Hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: normal; Test Name: Oxygen saturation; Result Unstructured Data: normal
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Report side effects; Breathing problem; Asthma problems; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report side effects), DYSPNEA (Breathing problem), ASTHMA (Asthma problems) and ASTHENIA (Weakness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A, 010M20A and 040A21A) for COVID-19 vaccination. Concurrent medical conditions included Hashimoto''s disease, Hypothyroidism and Asthma. Concomitant products included VITAMIN D3, THYROID (ARMOUR THYROID), SERTRALINE, ATOMOXETINE and OMEPRAZOLE for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced DYSPNEA (Breathing problem), ASTHMA (Asthma problems) and ASTHENIA (Weakness). On an unknown date, the patient experienced VACCINATION COMPLICATION (Report side effects). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Report side effects) outcome was unknown and DYSPNEA (Breathing problem), ASTHMA (Asthma problems) and ASTHENIA (Weakness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Oxygen saturation: 97-98 (normal) normal. Treatment medication include butanol Inhaler. This case was linked to MOD-2021-313599 (Parent-Child Link). This case was linked to MOD-2021-313591 (Patient Link). See case MOD-2021-313599 for details regarding the child case. Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow up received on 08-sep-2021 and contains no new information On 08-Sep-2021: Follow up received on 08-SEP-2021 Reporter information updated, patient demographics updated, medical history updated, lab data updated, concomitant medication updated, treatment medication updated, events updated.


VAERS ID: 1707191 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-25
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erythema, Feeling hot, Mass, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: big lump on the right arm, lump is size of golf ball, getting bigger,; lump is super hot; lump is super itchy; lump is red; This spontaneous case was reported by a nurse and describes the occurrence of MASS (big lump on the right arm, lump is size of golf ball, getting bigger,), FEELING HOT (lump is super hot), PRURITUS (lump is super itchy) and ERYTHEMA (lump is red) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-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 MASS (big lump on the right arm, lump is size of golf ball, getting bigger,), FEELING HOT (lump is super hot), PRURITUS (lump is super itchy) and ERYTHEMA (lump is red). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, MASS (big lump on the right arm, lump is size of golf ball, getting bigger,), FEELING HOT (lump is super hot), PRURITUS (lump is super itchy) and ERYTHEMA (lump is red) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.


VAERS ID: 1707222 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-18
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 3 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Chills, Decreased appetite, Depression, Fatigue, Feeling abnormal, Headache, Illness, Inappropriate schedule of product administration, Insomnia, Irritability, Loss of personal independence in daily activities, Nausea, Pyrexia, SARS-CoV-2 antibody test, Sinusitis, Somnolence, Tremor, Vomiting, Weight
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IMBRUVICA; GAMMA GLOBULIN
Current Illness: Chronic lymphocytic leukemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Antibody Test; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: Weight; Result Unstructured Data: Lost 5 lbs; Test Name: Blood pressure; Result Unstructured Data: Low blood pressure.
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Inappropriate schedule of vaccine administered; Is sick as a dog/very sick; Reoccurring Fever/fevers; Threw up( this was triggered by wine); Headaches; Nausea; chills; Exhausted; Shakes; no appetite; No energy; Sleeping a lot; Depressed; No quality of life can''t do any of her normal activities; irritable/cranky; Sinus infection; can''t sleep well; feels like she has been poisoned; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakes), DECREASED APPETITE (no appetite), ASTHENIA (No energy), SOMNOLENCE (Sleeping a lot) and DEPRESSION (Depressed) in a 69-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. Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included IBRUTINIB (IMBRUVICA) and GAMMA GLOBULIN for an unknown indication. On 18-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 TREMOR (Shakes), DECREASED APPETITE (no appetite), ASTHENIA (No energy), SOMNOLENCE (Sleeping a lot), DEPRESSION (Depressed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (No quality of life can''t do any of her normal activities), IRRITABILITY (irritable/cranky), SINUSITIS (Sinus infection), INSOMNIA (can''t sleep well), FEELING ABNORMAL (feels like she has been poisoned), ILLNESS (Is sick as a dog/very sick), PYREXIA (Reoccurring Fever/fevers), VOMITING (Threw up( this was triggered by wine)), HEADACHE (Headaches), NAUSEA (Nausea), CHILLS (chills) and FATIGUE (Exhausted). On 18-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with AZITHROMYCIN (ZITHROMAX) for Sinus infection, at an unspecified dose and frequency. On 18-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, TREMOR (Shakes), DECREASED APPETITE (no appetite), ASTHENIA (No energy), SOMNOLENCE (Sleeping a lot), DEPRESSION (Depressed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (No quality of life can''t do any of her normal activities), IRRITABILITY (irritable/cranky), SINUSITIS (Sinus infection), INSOMNIA (can''t sleep well), FEELING ABNORMAL (feels like she has been poisoned), ILLNESS (Is sick as a dog/very sick), PYREXIA (Reoccurring Fever/fevers), VOMITING (Threw up( this was triggered by wine)), HEADACHE (Headaches), NAUSEA (Nausea), CHILLS (chills) and FATIGUE (Exhausted) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 99/60 (Low) Low blood pressure.. On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative. On an unknown date, Weight: decreased (abnormal) Lost 5 lbs. It was reported that Hydration treatment given for sinus infection. This case was linked to MOD-2021-308835 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Significant Follow up: new events (difficulty sleeping and irritable) added.


VAERS ID: 1707324 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 (Exposed to COVID on 09 Aug 2021)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Antibody test; Result Unstructured Data: Ab levels were already high; Test Date: 202108; Test Name: Covid-19 virus test; Test Result: Positive ; Result Unstructured Data: Tested positive for COVID; Test Date: 202108; Test Name: Covid-19 virus test; Test Result: Negative ; Result Unstructured Data: She got negative results again
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Got COVID; Got really sick (tested positive for COVID) for 12 days until she got negative results again; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID) and ILLNESS (Got really sick (tested positive for COVID) for 12 days until she got negative results again) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included COVID-19 (Exposed to COVID on 09 Aug 2021) on 09-Aug-2021. On 11-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 COVID-19 (Got COVID) and ILLNESS (Got really sick (tested positive for COVID) for 12 days until she got negative results again). In August 2021, COVID-19 (Got COVID) and ILLNESS (Got really sick (tested positive for COVID) for 12 days until she got negative results again) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Antibody test: high (High) Ab levels were already high. In August 2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID and negative (Negative) She got negative results again. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment information was not provided. Reporter did not allow further contact


VAERS ID: 1707374 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-23
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Dyspnoea, Impaired work ability, Mood altered, Oxygen saturation, Oxygen saturation decreased, Pain in extremity, Pneumonia
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Oxygen saturation; Result Unstructured Data: He has an oximeter and before he was in 91 and this morning he was in 97
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: He was in oximeter: before he was in 91 and this morning he was in 97; diagnosed with pneumonia - his lungs did not sound good; Could not breathe/He was not gasping for air, he noticed he could not breathe well; Started with a cough/dry cough/a horrible cough; Sore arm; He did not go to work; very upset; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (diagnosed with pneumonia - his lungs did not sound good) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included COVID-19 on 05-Jul-2021. 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 IMPAIRED WORK ABILITY (He did not go to work) and MOOD ALTERED (very upset). On 24-Aug-2021, the patient experienced DYSPNOEA (Could not breathe/He was not gasping for air, he noticed he could not breathe well), COUGH (Started with a cough/dry cough/a horrible cough) and PAIN IN EXTREMITY (Sore arm). On 26-Aug-2021, the patient experienced PNEUMONIA (diagnosed with pneumonia - his lungs did not sound good) (seriousness criterion medically significant). On an unknown date, the patient experienced OXYGEN SATURATION DECREASED (He was in oximeter: before he was in 91 and this morning he was in 97). At the time of the report, PNEUMONIA (diagnosed with pneumonia - his lungs did not sound good), DYSPNOEA (Could not breathe/He was not gasping for air, he noticed he could not breathe well), OXYGEN SATURATION DECREASED (He was in oximeter: before he was in 91 and this morning he was in 97), PAIN IN EXTREMITY (Sore arm), IMPAIRED WORK ABILITY (He did not go to work) and MOOD ALTERED (very upset) outcome was unknown and COUGH (Started with a cough/dry cough/a horrible cough) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: decreased to 91 (Low) He has an oximeter and before he was in 91 and this morning he was in 97. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient received first dose of vaccine and was fine that day. The next day patient had sore arm and that night patient woke up saying that he could not breath and he was not gasping the air. Patient was unable to go to work for couple of days. On 26 Aug 2021, patient took urgent care and was diagnosed with pneumonia because his lungs was not good. On the same night patient started coughing and was unable to breath well. Patient reported that it was a dry horrible cough. Patient is better now, but the cough was not recovered. Treatment details included antibiotics, an inhaler and steroids after diagnosing pneumonia. Concomitant medications were not reported. Company Comment: This case concerns a 60-year-old male, with a history of COVID-19, developed a serious unexpected event of pneumonia, and non-serious dyspnoea, cough, oxygen saturation decreased, pain in extremity, impaired work ability, and mood altered. Event latency 2 days after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This case concerns a 60-year-old male, with a history of COVID-19, developed a serious unexpected event of pneumonia, and non-serious dyspnoea, cough, oxygen saturation decreased, pain in extremity, impaired work ability, and mood altered. Event latency 2 days after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1707503 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-15
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Lymphadenopathy, Malaise, Nausea, Pain, Peripheral swelling, Pyrexia, Skin lesion
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

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

Write-up: Became very ill; Nausea; Running a fever; Pain in my joints/ pain in my elbow; Pain in my underarm; Lymph nodes are the size of a golf ball; Extreme swelling in my left arm; Huge big ball of skin coming out; extreme pain; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Became very ill), PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain) and NAUSEA (Nausea) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History was provided. Concomitant products included GABAPENTIN for an unknown indication. On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021, the patient experienced MALAISE (Became very ill), NAUSEA (Nausea) and PYREXIA (Running a fever). In August 2021, the patient experienced PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain), ARTHRALGIA (Pain in my joints/ pain in my elbow), AXILLARY PAIN (Pain in my underarm) and LYMPHADENOPATHY (Lymph nodes are the size of a golf ball). At the time of the report, MALAISE (Became very ill), PERIPHERAL SWELLING (Extreme swelling in my left arm), SKIN LESION (Huge big ball of skin coming out), PAIN (extreme pain), NAUSEA (Nausea), PYREXIA (Running a fever), ARTHRALGIA (Pain in my joints/ pain in my elbow), AXILLARY PAIN (Pain in my underarm) and LYMPHADENOPATHY (Lymph nodes are the size of a golf ball) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were provided. No treatment medications were provided.


VAERS ID: 1707636 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-23
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Computerised tomogram, Diarrhoea, Dizziness, Fall, Feeling abnormal, Feeling hot, Headache, Magnetic resonance imaging, Malaise, Mental impairment, Muscle tightness, Nausea, Ocular discomfort, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Accident (disc herniations and they want to fuse her neck C5-C6 and C2-C3 from the 2004 car rear end accident.); Concussion, unspecified; Cystitis interstitial; Kidney infection NOS; Kidney stones; Traumatic brain injury; Vertebral hernia (disc herniations and they want to fuse her neck C5-C6 and C2-C3 from the 2004 car rear end accident.); Weight loss (States this was the early 2000''s)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: CAT; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: USPFIZER INC202100934871

Write-up: can''t think, digital devices bother my eyes, I cant answer emails; violently dizzy; slept for 2 days after that, not feeling good; head hurts a little, brain is sore, vax fog; brain fog; tension in the jaw; the banner that runs across the bottom on the CNN channel hurts my eyes; painful diarrhea/loose stools; feverish; chills; feels hot; fell into a wall/ get on the floor and crawl; Nauseous; This is a spontaneous report received from contactable consumer (patient), from a Pfizer sponsored program. A 54-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown), via an unspecified route of administration on 23Aug2021 at 11:00 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. Medical history included kidney infection, intervertebral disc protrusion (Caller states she has disc herniations and they want to fuse her neck C5-C6 and C2-C3 from the 2004 car rear end accident), nephrolithiasis, weight decreased, cystitis interstitial, craniocerebral injury, concussion. The patient''s concomitant medications were not reported. Patient stated "I have some possible undiagnosed kidney issues, may have interstitial cystitis and had 3 bouts of kidney stones over the last 2-3 years. We were in the process of trying to diagnose everything when the pandemic hit. My biological dad had kidney cancer I think, but I come from a fractured family and my paternal grandmother is dead now and I have no way of getting that information. I am high risk I feel so I am very careful, I wear a mask, I stay inside most of the time. Now with this delta variant I have to get vaccine. I read that all vaccines are going to expire at the end of July, beginning of August. I just feel bad not getting it now when the people in Africa would kill for it, but I kind of thought I should wait and see since I am high risk". Caller states "I do not want to have a booster and get sick again either. I have been sick for years. I am scared of having side effects. I guess that is better than getting Covid. But I heard of people having nausea and chills, just feeling like they get covid even though it was only for a couple days." Caller states it is not kidney disease, she has undiagnosed kidney issues, she had kidney stones the last 2ish years before the pandemic and her doctor thinks she has some bladder thing and that she is thinking it was not always kidney. States she feels like she has to go all the time and has back pain. Caller states she used pain patches, she was using the new pain patches and she thinks they did something to her kidneys, she is had kidney stones 3 times now since and it was not from Pfizer, she thinks it is through Lifewave or something like that. States it worked and took the pain away but she was having times where she was crying on the floor and could not move and she took the patches away and the pain went away. She would have residual pain and issues from it. States that if she does not have it she can get off the floor and ever since her bladder is not the same. Caller states it said to drink water with it and she does not think she drank enough water. Caller states the pain patch was X39 by Lifewave and it was in Mar2019. Caller provides this happened in 2019 and she had some kidney problems before that but this exacerbated it. Patient stated that she received the injection at around 11 am and felt fine. Patient has 7up and crackers ready because she had read that she might be nauseous or have flu like symptoms. Patient relays that at 8 pm that night she got out of bed to go to the bathroom and she became violently dizzy. Patient stated, "I almost ran into the wall, I was thrown into the wall because I was severely dizzy. Patient had to hold on to the wall to go to the bathroom because she was scared, that was going to fall." Other symptoms mentioned: slept for 2 days after that, not feeling good, bad dizziness that went on and on and on, head hurts a little, brain was sore, vax fog, brain fog, tension in the jaw, CNN channel hurts my eyes, tiny headaches, painful diarrhea for the first day and thinking she was going to thrown up at the same time, loose stools but not really diarrhea for the rest of the time, feverish, chills, face was fine in the morning then from 11 to mid afternoon it feels hot tcan not think, digital devices bother my eyes, she could not answer emails, the banner that runs across the bottom on the hen its fine at night. Patient took a Flexeril because of the jaw tension. Patient have taken Benadryl to try to help with the symptoms as well and it did not help. Patient''s doctors did not know what to do. One doctor prescribed prednisone but patient have not filled it yet because she did not know if she should take it and other doctor wants her to come in so that they can do a neurological exam but she was scared to go in because that will put her at risk and also her car was not working now. Patient was on a form on the internet and all these people are having the same symptoms and its called Vax Fog. On the form there are Neurologist who say that they have seen these patients a lot and that their offices are full of patients with these symptoms after the vaccine. They are saying that for people that had had TBIs or other neurological conditions they should not be taking this vaccine. One girl has MS and she took the vaccine and is now having the same problems. If Patient would have known this Patient would not have taken the vaccine. Patient had 3 TBIs two concussions as a child and 1 in 2018 or 2019. Patient had kidney problems too. No one told that you should not have the vaccine with these issues. Upon follow up it was reported that, patient was violently dizzy, had to get on the floor and crawl. This has continued for two weeks and it was not going away. The dizziness has gotten a little better but she still has the vax fog. Patient was still not feeling well. Patient tried to sign up for VAERS thing but it was difficult because she only has a tablet. Patient called in last weekend on Saturday and it went to India. Patient told them she wanted to talk to an actual Pfizer employee and they told her to call back on Monday. No reference number provided. Patient was worried about kidneys- Patient had no gd idea that if she had a TBI should not get the gd mf vaccine I mf a. Patient was being told by the pharmacist where she got the shot, she wont be able to get the 2 dose. Patient''s brain could be permanently damaged and not only has that happened but still will not be protected from covid because cant take the rest of the shots i would have been better off not getting the vaccine and using the regeneration treatment if i did get covid who the fuck is responsible for this. It was 25 weeks after first Pfizer vaccine and still dealing with disabling Vertigo Saw a neurologist, had MRI, CAT scan, ENT, doctor exam, bloodwork and am still taking meclicine & diazepam just to stop the nausea and vomiting. Neurologist told me that anyone that has any brain problems or autoimmune disease of the brain (have MS), and any brain injury history should not be vaccinated and that he keeps seeing patients with this dizziness problem. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1707733 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Pruritus, Rash, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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 INC202100999256

Write-up: chest pain; rash on his neck and all over the body; itchiness/ rash developing on his skin and is itchy; pain in the injection site (right upper arm); This is a spontaneous report from a contactable Nurse. This Nurse reported for 12-year-old male patient (Reporter''s son). A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in right arm on Aug2021 (at the age of 12-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date, the patient has side effects of chest pain, rash on his neck and all over the body, itchiness/ rash developing on his skin and is itchy, pain in the injection site (right upper arm). The reporter wants to know what to do to alleviate itching and how long will it take to go away. The reporter questioned whether the Pfizer was like neurotoxins, like any of the chemicals that go inside the brain and was asking whether the vaccine was tested on animals, like mice. The clinical outcome for the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1707746 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Rash, Swelling, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101001022

Write-up: My whole body broke out in to a rash; I am breaking out in to hives; My neck is just swelling, like my throat closing up; My neck is just swelling, like my throat closing up; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 03Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced whole body broke out in to a rash, breaking out in to hives causing urticaria, had the neck swelling, like the throat closing up and throat tightness on Aug2021 with outcome of unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1707760 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Cough, Decreased appetite, Gait disturbance, Myalgia, Pyrexia, Sneezing
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: fever of 103; Result Unstructured Data: Test Result:103
CDC Split Type: USPFIZER INC202101008354

Write-up: fever of 103; every muscle and joint in her body is hurting; every muscle and joint in her body is hurting; difficult to walk with the pain; coughing; sneezing; no appetite; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 04Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced fever of 103, every muscle and joint in her body is hurting, difficult to walk with the pain, coughing, sneezing and no appetite. Patient took vaccine yesterday 04Aug2021. Stated everything that she read basically said after the first dose you will get a headache and a sore arm. She was sitting there now with a fever of 103, it had been going up; every muscle and joint in her body is hurting; and it was difficult to walk with the pain; she was coughing and sneezing and has no appetite. She asked should she take the second does? that was three weeks from now and this was just the first dose, asking with these side effects. Call sound was broken but sounds like caller asked if these are side effects? Another voice was heard stating, he already reported and she should go to the emergency room. Patient then stated looks like she should go to the emergency room. The patient underwent lab tests and procedures which included body temperature: 103 on Aug2021. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1707771 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chest pain, Dyspnoea, Heart rate, Heart rate increased, Skin irritation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: beating heart; Result Unstructured Data: Test Result:fast
CDC Split Type: USPFIZER INC202101015554

Write-up: topical irritation; fast beating heart; shortness of breath; Experience brief chest pain like my heart ache, little bit in my upper back and it is not consistent like I am going to watch every minute; Experience brief chest pain like my heart ache, little bit in my upper back and it is not consistent like I am going to watch every minute; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced topical irritation, fast beating heart, shortness of breath, "experience brief chest pain like my heart ache, little bit in my upper back and it is not consistent like i am going to watch every minute" on Aug2021. Reported as, patient received the vaccine counting today 3 days ago on 04Aug Wednesday and don''t know patient have like topical irritation or fast beating heart or shortness of breath anything but have experience like brief chest pain like his heart ache and little bit in his upper back and again it was not like consistent, like patient was going to watch every minute and it''s more sort of, it will go in and out. The patient underwent lab tests and procedures which included heart rate: fast on Aug2021. Outcome of all the events were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


VAERS ID: 1707785 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Redness; Swelling arm (She just had the Pfizer shot and 2 weeks ago her arm is extremely ''swelled'' up and red.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101030555

Write-up: Arm is extremely red; Looks like a birth mark/I looks like a ''bruise'', like birth mark on it.; This is a spontaneous report from contactable consumer. This consumer reported for 20-years-old patient that: A 20-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA6780, Expiry date: Unknown) via an unspecified route of administration in arm right on 01Aug2021 (at the age 20-year-old) at 4 or 5 pm as dose 1, single for COVID-19 immunization. Medical history included patient had Pfizer shot and 2 weeks ago her arm extremely "swelled" up and red (looks like yesterday took shot). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Second shot due ate around 22 or something. Investigation assessment was not reported. On 01Aug2021 patient experienced arm is extremely red; Looks like a birth mark/I looks like a ''bruise'', like birth mark on it. The patient didn''t received treatment for events. The clinical outcome of the event was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1707795 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Anosmia, Cough, Nasopharyngitis, Paranasal sinus discomfort, Productive cough
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Infective pneumonia (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: USPFIZER INC202101039943

Write-up: This is a spontaneous report from a contactable consumer (Patient) or other non HCP from a Pfizer-sponsored program COVAX US support. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 06Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization. On unspecified date in Aug2021, patient experienced Cold, Cough with phlegm, Cough with phlegm, pressure like as sinus on her nose, lost her smell and taste. she was worried because she was around with her mom she is with her mom with lupus (further clarification unknown), so she was worried regarding this experience as well. On paraphrasing the concern: consumer stated, she was not living with her she is just pet sitting (further clarification unknown) for her, she just want to make sure that she gets tested, she means is there any (incomplete sentence). Consumer was informed about the Role of Pfizer Drug Safety Department and Pfizer medical information department. Consumer was provided with the Pfizer Medical Information department number. consumer hung up the call abruptly. Hence further probing could not be done. Limited information available over the call. The outcome for the events was unknown. No follow-up attempts are possible information about lot/batch number cannot be obtained.


VAERS ID: 1707796 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101047980

Write-up: shortly after ward experienced chest pain or tightness in chest; shortly after ward experienced chest pain or tightness in chest; This is a spontaneous report from a Pfizer.A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 11Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and Concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced Chest pain or tightness in chest. It was reported that patient received first dose of vaccine 8/11/21 and shortly after ward experienced Chest pain or tightness in chest and would like to know if this is normal and going to pass. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1524712 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD974 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Negative
CDC Split Type: PTJNJFOC20210801803

Write-up: ZERO IMMUNITY IN ANTIBODIES SEROLOGIC TEST/SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned multiple patients. Initial information processed with additional information received from reporter on 1-AUG-2021. 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: XD974 and expiry: Unknown) dose, frequency of one total, start therapy date were not reported administered for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the reporter stated that most of the people that were vaccinated with the lot (XD974) had the same issue of zero immunity in antibodies serologic test/suspected immunological vaccine failure. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of zero immunity in antibodies serologic test/suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210801488.; Sender''s Comments: V0: 20210801803-COVID-19 VACCINE AD26.COV2.S- Zero immunity in antibodies serologic test/Suspected immunological vaccination failure. This event is considered not related. The event has unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1529946 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-08-01
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

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

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

Write-up: Ache; Nausea; Vomiting; Chills; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003608 and 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included DESOGESTREL, ETHINYLESTRADIOL (GEDAREL) from 01-Mar-2020 to an unknown date for Birth control pill. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-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 PAIN (Ache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 01-Aug-2021, NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) had resolved. At the time of the report, PAIN (Ache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was reported. 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: 1533805 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Fatigue, Feeling abnormal, Injection site pain, Sensory loss, Somnolence
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (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: ASPRIN; ATORVASTATIN; NYSTATIN; OMEPRAZOLE
Current Illness: Non-smoker; Toxemia (suffered chronic fatigue due to colon toxemia from past 20 years.)
Preexisting Conditions: Medical History/Concurrent Conditions: Angina attack; Sickness (around three weeks.); Comments: The patient did not have any history of drug abuse or illicit drug use. Patient does exercise daily. He got their strongest vaccine shot against the flu years ago in 2014 or 2015 and after he had heavy side effects.
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210803458

Write-up: ALMOST IMPOSSIBLE TO FEEL THE SHOT AREA; FEELING THE HEART BEAT IN THE RIGHT ARM AND LEFT LEG; FELT VERY SLEEPY; EXTRA STRONG FATIGUE; PAIN IN THE INJECTION SITE OF THE ARM; HEART TRIBULATIONS OR HEART BEAT; This spontaneous report received from a patient concerned a 66 year old Male. The patient''s weight was 296 pounds, and height was 177.8 centimeters. The patient''s past medical history included angina attack and concurrent conditions included non alcoholic, and colon toxemia (patient suffered chronic fatigue due colon toxemia, for over twenty years) and non smoker and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. Patient does exercise daily. The patient was previously treated with influenza vaccine against the flu in 2014 or 2015 and after he had heavy side effects and he was sick for around three weeks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported), dose was not reported, 1 total, administered on 29-JUL-2021 at 09:26 am to upper left arm for prophylactic vaccination. The batch number was not reported and has been requested. At first patient mentioned that he had a very big size compared to people from Philippines who are very short and small and so because of that nurse filled the entire syringe with the vaccine and injected it in his upper left arm. Then nurse doubled his observation time to a total of one hour and as he had no side effects, so he was released to go. Concomitant medications for many years which included 85 mg acetylsalicylic acid half per day, 1 atorvastatin, and 1 nystatin, plus 1 omeprazole daily around half hour before bedtime. On 01-AUG-2021, the patient experienced heart tribulations or heart beat for about 1 minute at a time around twice a day starting the second day after the vaccine. On 02-AUG-2021, the patient felt the heart beat in the right arm and left leg. So he coughed to keep his heart functioning steadily as he did in his past angina attacks. On 02-AUG-2021, the patient experienced almost impossible to feel the shot area, felt very sleepy, extra strong fatigue, pain in the injection site of the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extra strong fatigue, heart tribulations or heart beat, almost impossible to feel the shot area, feeling the heart beat in the right arm and left leg, felt very sleepy and pain in the injection site of the arm was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0.20210803458-covid-19 vaccine ad26.cov2.s -heart tribulations/heartbeat. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY


VAERS ID: 1537673 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-08-01
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Ischaemic stroke, Polymerase chain reaction, Serology test
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEXAPRO; BIORUTIN; VITAMIN D3; B COMPLEX (B50)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR; Result Unstructured Data: Test Result:negative result; Comments: negative result; Test Name: antigen; Result Unstructured Data: Test Result:negative result; Comments: negative result
CDC Split Type: ARPFIZER INC202101000128

Write-up: ischemic stroke; This is a spontaneous report from received via regulatory authority from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 28Jun2021 (Batch/Lot Number: EW0217) at the age of 45-year-old as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO), bioflavonoids nos, rutoside (BIORUTIN), vitamin d3 and vitamin b complex (B COMPLEX (B50)). The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 07Jun2021 (Batch/Lot Number: EW0191) as single dose for COVID-19 immunization. On 01Aug2021 at 13:00, the patient experienced ischemic stroke and was hospitalized. The event caused hospitalization for 3 days. The patient had a PCR and antigen, both in different dates and both with negative result. Treatment was received. The outcome of event was recovering.


VAERS ID: 1537757 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-08-01
   Days after vaccination:125
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chest pain, Polymerase chain reaction, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: Test Date: 20210720; Test Name: PCR; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab; Test Date: 20210726; Test Name: PCR; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab
CDC Split Type: BEPFIZER INC202100997915

Write-up: Fully vaccinated (29/03/2021 and 19/04/2021) nevertheless Covid positive; Fully vaccinated (29/03/2021 and 19/04/2021) nevertheless Covid positive; pain in chest; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female non pregnant patient received received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EL1484, expiration date was not reported), via intramuscular route of administration in arm right on 19Apr2021 (44-years-old at the time of vaccination) as dose 2, single and first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EL0725, expiration date was not reported), via intramuscular route of administration in arm right on 29Mar2021 (44-years-old at the time of vaccination) as dose 1, single for COVID-19 immunization. . The patient medical history and concomitant medications were not reported. The patient fully vaccinated nevertheless COVID positive (COVID-19), the symptoms were: cough, fever, pain in chest, pain in the muscles and headache on 01Aug2021. The patient took no treatment for events. The patient underwent lab tests and procedures which included polymerase chain reaction: negative on 20Jul2021 Nasal Swab, and polymerase chain reaction: negative on 26Jul2021 Nasal Swab. The outcome of all the event was not recovered.


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