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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 307 out of 7,116

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VAERS ID: 1647085 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blister, Condition aggravated, Pemphigoid
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal); Bullous pemphigoid (The Bullous Pemphigoid is supposed to be gone after 5 years but she still has it. Her last flare was in May2021 or Jun2021.); Kidney stone; Thyroid disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101041186

Write-up: Bullous Pemphigoid; condition aggravated; little blisters all over her body; This is a spontaneous report from a contactable consumer (patient) An 85 years old male patient receivedfirst dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EY0584) on 03Aug2021 at 11:30 at single dose via an unspecified route of administration for COVID-19 immunization. Patients Medical History (included Thyroid disorder, Bullous Pemphigoid and acid reflux. In 2015 patient had kidney stones and she was taking 8 Advils and 1 Hydrocodone every 8 hours at the advice of physician. She had a drug reaction from that and it caused Bullous Pemphigoid which were blisters, a skin problem (as such). She had this for 6 years. The Bullous Pemphigoid was supposed to be gone after 5 years but she still had. (as reported). She stated about every 5 years she gets the pneumonia vaccine and has never had any problems with it. Concomitant medications included SYNTHROID (levothyroxine sodium). Patient informed Her last flare of Bullous Pemphigoid was last May/June this year and after she got the 1st dose of the vaccine, she broke out again in a big flare of Bullous Pemphigoid. d. It was nasty. The doctor gave her cortisone cream and wanted to prescribe a Prednisone Pack for 12 days to take before she gets her second Covid 19 vaccine. She was leery to do this. How can she take a chance in getting the second Covid 19 vaccine. She wants to get the second Covid 19 vaccine but doesn''t want to get another flare. Patient went to her doctor regarding her Bullous Pemphigoid flare. He could see her rash and didn''t know what to do, no one knows what to do. No one was familiar with this skin disease, it''s a very rare autoimmune skin disease. It causes little blisters all over her body. She fortunately had a very mild case so her blisters look like little pimples. She had to put Cortisone, a lot of Cortisone on her legs and thighs and bra line. Patient was also concerning if there is any information on Pfizer Covid vaccine and Prednisone pack interaction and if there is guidance whether she should receive the 2nd dose given that she had a flare with the Bullous Pemphigoid. At the time of the reporting events outcome was unknown. Follow-up attempts are completed. No further information is expected


VAERS ID: 1647104 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH AF7484 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cardiac flutter, Chest pain, Chills, Heart rate, Hypoaesthesia, Palpitations, Piloerection
SMQs:, Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Sexual dysfunction (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Heart rate; Result Unstructured Data: Test Result:heart palpitations/flutter
CDC Split Type: USPFIZER INC202101041535

Write-up: heart palpitations/flutter, sharp chest pains since the date of the injection.; heart palpitations/flutter, sharp chest pains since the date of the injection.; heart palpitations/flutter, sharp chest pains since the date of the injection.; chills and numbness down entire left side of body.; chills and numbness down entire left side of body.; constant goosebumps since the injection date; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient (non-pregnant) received the first dose of BNT162B2 at the age of 43-year-old via an unspecified route of administration, administered in arm left in Aug2021 (Lot Number: AF7484) as single dose for COVID-19 immunisation. Medical history reported as none. No known allergies. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced heart palpitations/flutter, sharp chest pains since the date of the injection in Aug2021, chills and numbness down entire left side of body in Aug2021, constant goosebumps since the injection date in Aug2021. Heart rate in Aug2021 showed heart palpitations/flutter. Seriousness criteria of the events was reported as disabling/incapacitating and life threatening. Events resulted in emergency room/department or urgent care. Treatment received for the events that included anti-imflammatory and aspirin. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1647131 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Anosmia
SMQs:, Taste and smell disorders (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101041893

Write-up: no taste or smell; no taste or smell; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Aug2021 as dose number unknown, single for covid-19 immunisation. No relevant medical history and concomitant medications were reported. On an unspecified date in 2021, the patient experienced no taste or smell. Patient question if it was normal. The outcome of the events no taste or smell was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647137 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (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: Test Date: 202108; Test Name: blood pressure; Result Unstructured Data: Test Result:High; Comments: high blood pressure; Test Date: 202108; Test Name: fever; Result Unstructured Data: Test Result:Positive; Comments: had the fever
CDC Split Type: USPFIZER INC202101042032

Write-up: his blood pressure is high; my son has had a fever; had chills and the shakes and he is cold (chills); had chills and the shakes and he is cold (chills); This is a spontaneous report from a contactable consumer (patient''s mother). A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 11Aug2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fever, chills and the shakes and he is cold (chills), and he has high blood pressure too on Aug2021. Reporter stated she did not know if it''s high because his fever is up or what. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1647145 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101042163

Write-up: This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the second of two reports. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 11Aug2021 (at the age of 61-years-old) at dose, 1 single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient''s husband inquired information regarding treatment for the side effects of Pfizer COVID-19 vaccine. He and the patient received their first dose of the vaccine yesterday (11Aug2021) and within 2 hours, they developed a headache. The patient also developed explosive diarrhea and has no control of it on Aug2021. He asked if IMODIUM can be given or to just let it run its course. The outcome of the event explosive diarrhea was not recovered and unknown for headache. Follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s): US-PFIZER INC-202101041560 same reporter and drug, similar event, different patient.


VAERS ID: 1647158 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Eye disorder, Eye infection, Facial paralysis, Lacrimation increased, Magnetic resonance imaging, Ocular hyperaemia, Oral infection, Speech disorder, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal infections (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (broad), Lacrimal disorders (narrow), Ocular infections (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATORVASTATIN
Current Illness: Blood cholesterol abnormal
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: MRI; Result Unstructured Data: Test Result:did not have a stroke
CDC Split Type: USPFIZER INC202101042614

Write-up: face was paralyzed on the right side; cannot even talk; cannot even see good with her eyes, it was blurry; infection in her eye or red eye since her eye was tearing and tearing; infection in her eye or red eye since her eye was tearing and tearing; infection in her eye or red eye since her eye was tearing and tearing; eye was open and she could not close it normal; noticed like when she goes to the dentist as if she had infection in mouth and trying to clean mouth to wash it, the water was just coming out of her mouth; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 03Aug2021 at 11:45 (Lot Number: FA7485; Expiration Date: Oct2021) as dose 1, single for COVID-19 immunization (reported as to prevent COVID). Medical history included ongoing cholesterol (as reported). Concomitant medication included atorvastatin (manufacturer unknown) taken for cholesterol from 2021 and ongoing. The patient did not have prior vaccinations within 4 weeks from the COVID vaccine. The patient went to 03Aug2021 to get the first dose of the COVID vaccine. On an unknown date in Aug2021 (reported as ''the day before yesterday''), the patient went to the hospital because her face was paralyzed on the right side. They told her in the hospital that it was because of the vaccine and she was told to report it. The patient stated that sometimes she cannot even talk. At first, she thought she had a stoke since her face was going to the left. She was told it was not a stroke. They told her that the vaccine is a virus. She had an MRI in the hospital which showed that she did not have a stroke and she was admitted on Aug2021 (reported that she was ''admitted at midnight or 1 am the day before yesterday'') in the hospital for one night and left in the afternoon of 11Aug2021. The patient started the medication on 11Aug2021 called prednisone 20mg. She was also given valacyclovir to take. She took 3 pills of prednisone on the day of the report, 12Aug2021 and 3 pills the day before, 11Aug2021. She thinks it will take about 5 days to start working. She cannot even see good with her eyes, it was blurry, this started on Aug2021, the 5th day after the vaccine. She thought she had an infection in her eye or red eye since her eye was tearing and tearing. Her eye was open and she could not close it normal. On the day of the report, her eye was better and not tearing too much and thinks the medicine is working since she has less tears that day. About 3 days ago she brushed her teeth at night, she noticed like when she goes to the dentist as if she had infection in mouth and trying to clean mouth to wash it, the water was just coming out of her mouth. She takes a cholesterol medication but did not take it today or the last three days since she does not know if it interferes with the medication she was given. The patient does not know if she should get the second dose that was scheduled for 24Aug2021 at 11:00. The events face was paralyzed on the right side and cannot even talk was not recovered while the outcome of the other events was recovering.


VAERS ID: 1647167 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-07-01
Onset:2021-08-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, SARS-CoV-2 antibody test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Inflammation (Systemic inflammation); Nervous system disorder; Seizure (seizure disorder)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: covid-19 test/other; Test Result: Negative
CDC Split Type: USPFIZER INC202101044149

Write-up: Woke up out of a dead sleep the next day with severe chest pains; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 33-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on Jul2021 (at the age of 33-years-old) as dose number unknown, single for COVID-19 immunisation. The medical history of the patient included systemic inflammation, nervous system disorder and seizure disorder. The patient had no known allergies. The concomitant medications of the patient were not reported. The patient was not pregnant at the time of vaccination. 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 had been tested negative with covid-19. The patient experienced woke up out of a dead sleep the next day with severe chest pains on an unspecified date in Aug2021. The patient reported unlike any chest pain she had experienced and she no stranger to panic attacks or tightness in chest. The event lead to physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on an unspecified date in Aug2021. Therapeutic measures were taken as a result of event that included took Xanax for 2 days with zero relief of persistent chest pains. The outcome of the event was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1647192 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Montana  
Vaccinated:2021-08-12
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Condition aggravated, Feeling hot, Inappropriate schedule of product administration, Musculoskeletal stiffness, Pain in extremity, Pyrexia, Skin burning sensation
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (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: GABAPENTIN; TIZANIDINE
Current Illness: Arthritis (in her right foot)
Preexisting Conditions: Medical History/Concurrent Conditions: Antiphospholipid syndrome (has antibodies for that); Back arthritis (degenerative); Breast cancer; DVT; Fibromyalgia; Osteoarthritis (in her major joints); Pulmonary embolism; Radiation therapy (33 radiation treatments); Shortness of breath; Surgery; Swelling of legs
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101048129

Write-up: she had the 2nd dose of the Pfizer COVID Vaccine yesterday 12Aug2021 and her 1st dose was on 26Jul2021; joint pain/now experiencing joint pain and flare up of the joints; suspected fever; pain in the right arm; flare up of joints; stiffness; felt hot and her skin felt like it was burning; felt hot and her skin felt like it was burning; This is a spontaneous report from a contactable Nurse (patient) via Pfizer sponsored program. A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number) via an unspecified route of administration in Arm Right on 12Aug2021 (at 67 years) as single dose for covid-19 immunisation. The patient was supposed to get the 2nd dose on 16Aug2021, however it was given on12Aug2021.Medical history included ongoing arthritis in her right foot , osteoarthritis in her major joints, degenerative arthritis through her whole spine, breast cancer diagnosed in Oct2013 with lymph node removal (she had surgery and 33 radiation treatments and 5.5 years of Arimidex which is an inhibitor and also took Letrazole for 5.5 years total), fibromyalgia, antiphospholipid syndrome (ATS) diagnosed years ago in 2006 and had antibodies for that , in Oct2019 she was getting short of breath and went to put her jeans on and her right leg was swollen and she went to the emergency room and had multiple blood clots in her lungs and a DVT in her right thigh. The patient''s concomitant medications included gabapentin , tizanidine as muscle relaxer. Previously on 26Jul2021 received the first dose of the vaccine (at the age of 67 years) in the right arm for covid-19 immunisation.Patient clarified that both doses of the COVID Vaccine were administered in her right arm because with her breast cancer history they took several lymph nodes out of her left arm and she can have nothing in her left arm. The patient received the vaccine on 12Aug2021 and 14 hours later (in Aug2021) started having complaints of pain in the right arm, joint pain, flare up of joints, and suspected fever (no temperature to report, skin felt warm and hot per HCP). Joint pain and flare up of the joints were serious as medically significant.The joint pain began in her arm a couple of hours after putting not ice but cool compresses on it and switching from warm to cool compresses. About 1:30am (Aug2021) she woke up with the fever that was not ongoing and subsided.Patient also stated that before she took her medications prescribed by her HCP and was fine and had the COVID Vaccine and 14 hours later she could not stand the pain in her right arm, she took her medications at night that she usually took and those were gabapentin and tizanidine and took two tramadol 100mg but did not want to keep popping the tramadol and limited herself on that due to her age but had to take it at 1:30 am and did not know what was going on. She took paracetamol (TYLENOL) with diphenhydramine hydrochloride (BENADRYL) so she could sleep and woke up with a fever at 1:00 am and her skin was burning (Aug 2021). Stated there was a cold breeze and she took the paracetamol (TYLENOL) at that time and more medication which she usually did not have to do and usually took her medications between 9:00 and 10:00 and that dose covered her throughout the night but last night was terrible and it was an acute flare up. Patient stated the medications she took that she had to take more of were another paracetamol (TYLENOL) extra Strength 500mg and those carry her through the night but last night was horrendous and was still horrendous. Patient clarified the other medications she had to take more of were gabapentin 300 mg, two tramadol, and another tizanidine 4 mg and then took paracetamol (TYLENOL) extra strength 500mg (as reported).The reported events are related to the COVID vaccine because of how suddenly they came on and she usually got up in the middle of the night due to stiffness and felt hot and her skin felt like it was burning (Aug2021). Patient reported the events are medically significant and she had limitations due to mobility.The outcome of Joint pain was not recovered; outcome of the other events was unknown.The lot number for BNT162B2 was not provided and will be requested during follow up; Sender''s Comments: The events of Arthralgia, Pyrexia, Pain in extremity, Condition aggravated, Musculoskeletal stiffness, Feeling hot, Skin burning sensation are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient''s medical history and/or concomitant medications. 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: 1647200 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Kansas  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Covid test; Test Result: Negative ; Test Date: 2021; Test Name: Covid test; Test Result: Negative
CDC Split Type: USPFIZER INC202101048280

Write-up: lost hearing in his right ear; he was a little achy and his arm was sore; his arm was sore; This is a spontaneous report from a contactable consumer. A 30-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm at the age of 30 years old on 11Aug2021 (Batch/Lot Number: FC3181; Expiration Date: 01Oct2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from 1991 and ongoing. There were no concomitant medications. The patient reported getting his first vaccine 11Aug2021 at noon and stated that by 8 o''clock he lost hearing in his right ear. He wanted to know if this is a reported side effect of the vaccine, if it is a known occurrence or a coincidence. He stated that this is not ringing in the ear, if he was to put the phone up to the right ear he would only hear about 50 percent of the sound. He stated it is not ringing and not pressure, it is a loss of everything especially on the right side. He stated he got his shot at noon and by 8 o''clock he noticed a change in his hearing. He stated he was a little achy and his arm was sore, but it has really been his right ear. No treatment was received. The outcome of the event lost hearing in his right ear was not recovered. The outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1647214 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: North Carolina  
Vaccinated:2021-07-28
Onset:2021-08-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Tooth disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101048433

Write-up: currently having dental issues; This is a spontaneous report from a Pfizer sponsored program Support. A contactable consumer reported for a male patient (reporter''s husband) that a male patient of an unspecified age received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration on 28Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced currently having dental issues on Aug2021. received his 1st dose 28Jul and has been having dental issues may need to start antibiotics. The caller wants to know if there are contraindicatios bewteen the vaccine and antibiotics. Will Fax AE for dental issues after the 1st dose. Relayed PMI and transferred to PMI withheld for more information. Support CEP. The outcome of the event was not resolved.


VAERS ID: 1647242 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-10
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Hypersensitivity, Nasal congestion, Rash, Vaccination site erythema
SMQs:, Anaphylactic reaction (broad), Angioedema (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101050229

Write-up: Rash/ like a big, circular, and big rash; allergic reaction; big redness not rash, redness randomly popped up in her body/a red, red round thing underneath her forearm, left and right arm; got the vaccine on her left arm and then she is also having redness up to her second arm; breathing a little bit congested; This is a spontaneous report from a contactable pharmacist. A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180; Expiration/Date: 31Oct2021) DOSE 1 via an unspecified route of administration in the left arm on 10Aug2021 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. In Aug2021, the patient experienced, rash/ big, circular, and big rash; big redness not rash, redness randomly popped up in her body/a red, red round thing underneath her forearm, left and right arm; got the vaccine on her left arm and then she is also having redness up to her second arm; allergic reaction; and breathing a little bit congested. The pharmacist stated, "I am calling because I have your patient that got the vaccine last Tuesday (10Aug2021) and she is having a reaction. Patient got the vaccine on Tuesday and she got the rash. She noticed the rash yesterday. It''s big, circular, and then big rash that appeared on her, big redness not rash I should say but redness that randomly popped up in her body. So she had a red, red round thing underneath her forearm and I guess she got the vaccine on her left and then it also I guess it''s on the left but somehow it also went to the right side. She got the vaccine on her left arm and then she is also having redness up to her second arm and she said prior to that it also shows up in her other parts of the body. It''s the redness that she had been experiencing. She had been taking Benadryl and she was fine and then she went to urgent care too. The urgent care provider told her for the second dose it''s not recommended, for the second dose now that the patient has the reaction. It''s considered an allergic reaction. It''s the rash and she ended up getting redness that randomly popped up in her body. She was confused because according to her some people said to get it but I told her that the standard protocol is if patient is suffering the reaction, then it''s not recommended to get the second dose". For treatment, the pharmacist stated, "She took a Benadryl and it''s already kind of ok right now. All the rashes, it''s still on there. I asked her how is her breathing and she said it''s fine but it''s a little bit congested so I told her to really monitor that one and the urgent care did not give her any EpiPen just the Benadryl". The patient had not recovered from the event, rash. The outcome of the other events was unknown. No further information could be probed as there was no response from the pharmacist and the call was disconnected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events rash, erythema, hypersensitivity, vaccination site erythema 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: 1647245 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Feeling abnormal, Pain, Pyrexia, Suspected COVID-19, Vaccination site swelling, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholesterol; Type 2 diabetes mellitus (Type 2 Diabetes); Vitamin D deficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101050315

Write-up: I have the COVID symptoms; Like I have the COVID; Fever; Breaking fever; Chills; Body Ache; I don''t feel good right now; I feel like I want throw up; My arm is swollen; and my arm is swollen at the site; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 47-year-old female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: Unknown), via an unspecified route on 11Aug2021 (age at vaccination: 47-year-old), as a single dose for covid-19 immunization. Medical history included type 2 Diabetes, vitamin D deficiency and cholesterol. Concomitant medications included Vitamin D because she is vitamin D deficient, she took most of Vitamins, statins for cholesterol and she takes regular medicine/every day. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Aug2021, patient started having fever, breaking fever, started having Chills, body ache. Patient did the Pfizer the first shot experienced covid symptoms because she was having fever, chills; on an unspecified date in Aug2021, her arm was swollen at the site, like she has the covid, she doesn''t feel good right now. She felt like she wants to throw up. Patient will go back in three weeks for the second dose. Therapeutic measures taken as a result of the events included Tylenol for fever. The clinical 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: 1647257 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, Maternal exposure during pregnancy, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101050640

Write-up: my wife puts the vaccine two days ago and she is also pregnant and she feels bad; Vomiting; she feel bad with vaccine; This is a spontaneous report from a contactable consumer (husband) reported for a patient (wife). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date on Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, my wife puts the vaccine two days ago and she is also pregnant and she feels bad, vomiting, she feel bad with vaccine on an unspecified date on Aug2021. Reported as, "Well, my wife she was pregnant and she takes the vaccine two days ago and she feel bad with vaccine, she started vomited, she vomit, she started getting vomiting and I take yesterday to the hospital (Further clarification unknown) and they say that it seems look I mean the laboratory is looking good but she still feel the same thing she started vomiting and then she takes that kind of shower in the head". The mother reported she became pregnant while taking bnt162b2. Outcome of all the events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647293 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2021-08-12
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cold (she had a cold she had just gotten over before receiving the vaccine.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101057353

Write-up: nausea; bronchitis like cough that is bringing up flim; This is a spontaneous report from a contactable Consumer (patient). A 40-year-old female received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 12Aug2021 as DOSE 1, SINGLE for covid-19 immunization. The patient''s medical history included Cold (she had a cold she had just gotten over before receiving the vaccine.) on an unknown date and not ongoing. The concomitant medications were not reported. On Aug2021 patient had experienced nausea and bronchitis like cough that is bringing up flim and also reported that, are these normal side effects following the vaccine. The clinical outcome of the events were unknown . Information on the lot/batch number has been requested


VAERS ID: 1647315 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101058101

Write-up: tingling in the arm that I had the shot in; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (Pfizer BioNTech COVID-19 Vaccine, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm on Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced tingling in the arm that i had the shot in, in Aug2021. Outcome of the event was unknown. PQC Details: Request Name: REQ- Withheld. Product: Pfizer BioNTech COVID-19 Vaccine. Question: Transfer in from DSU Dori: Withheld. Reportum: Withheld. E-transmit, additional information gathered. Did not gather patient''s age. Caller is a consumer asking about how long side effects of the Pfizer-Biontech Covid19 vaccine typically last? She did clarify and stated she received her first dose last Tuesday, and that she''s been experiencing "tingling in the arm that I had the shot in" and that it "started yesterday, and also today". Response: Answered per ''VR-no info'' as there are no reports of "tingling" or "paresthesia" listed in the fact sheet. Explained that frequency data for AEs was gathered in the 7 days after either dose (Tables 1-6). [LAB- Withheld; Revised: 12Aug2021]. Spoke from attached cons doc regarding duration of AEs, "In general, local side effects resolved within 1 to 2 days (systemic side effects) were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter," Referred caller back to HCP for evaluation and treatment if symptoms continue. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647325 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-02-27
Onset:2021-08-01
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM9810 / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, COVID-19, Nasopharyngitis, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]; ATORVASTATIN
Current Illness: Blood pressure high; High cholesterol
Preexisting Conditions: Medical History/Concurrent Conditions: Malignant melanoma ("I have history of malignant melanoma but I have no malignant melanoma that is active now.")
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: Fever/Got the fever; Result Unstructured Data: Test Result:101; Test Date: 20210812; Test Name: Covid-19; Test Result: Positive
CDC Split Type: USPFIZER INC202101058450

Write-up: After getting the two doses of Pfizer vaccine, she tested positive with COVID; Positive with COVID; Sent me for a COVID test which came out positive; After getting the two doses of Pfizer vaccine, she tested positive with COVID; Positive with COVID; Sent me for a COVID test which came out positive; Fever; Got the fever; Feel like I am getting over cold, do not feel badly; This is a spontaneous report from a contactable Nurse (patient) reported herself that an 80-year-old female patient received bnt162b2 (formulation: solution for injection; NDC number; UPC number; Expiry Date: Unknown), dose 1 via intramuscular route administered in right deltoid on 27Feb2021 (Lot Number: EM9810) as dose 1, single and dose 2 via intramuscular route administered in right deltoid on 30Mar2021 (Lot Number: EN6206) as dose 2, single (both doses at the age of 80 years) for covid-19 immunisation. Medical history included ongoing hypertension, ongoing blood cholesterol increased and malignant melanoma from an unknown date, she reported that she had a history of malignant melanoma, but she has no malignant melanoma that is active now. Concomitant medications included bisoprolol fumarate/ hydrochlorothiazide (ZIAC) and atorvastatin taken for blood cholesterol increased, start and stop date were not reported. The patient mentioned that after getting the two doses of Pfizer vaccine, she tested positive with COVID. Now she would like to report that and she would like to know as well on what she needs to do since right now she was positive with COVID. Consumer stated, right, six months later. She had the vaccine in February and March then just last Wednesday the 11Aug2021, the night before she had a fever of 101 on 11Aug2021 and so she went to the doctor next day, they sent her for a COVID test which came out positive on 12Aug2021. They then gave her the monoclonal antibodies (treatment) on the next day, on the 12th and she had no reaction, no serious, any problem at all. She felt like she was getting over cold that were her symptoms but she do not feel badly in Aug2021. She reported that, her concern was 2 things mainly when can she safely be re-tested and know that it''s accurate and how long does she have to, they told her 11 days to quarantine which she is doing now, she was staying in her house, not going anywhere, not doing anything except her housework. And so, she concerned about how long is safe to be anywhere out and do you know anything more about virus ''shedding'' from this? And specially after she have had the monoclonal (incomplete sentence). She was concerned about how much virus shedding information she can get because she does not know how dangerous was, she to other people after quarantine. She reported that, it was just last week that she got the fever that dropped her to the doctor for the test. She will be 81 till January. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that she has been digging answers for her questions yet, but she knows they have got all the information down she hopes she do not need to give it all again. She really needs to know when to be re-tested and how safe it would be. Consumer was informed that Pfizer Medical Information is the right department to answer that question. The patient underwent lab tests which included fever/ got the fever was 101 on 11Aug2021 and covid-19 was positive on 12Aug2021. Therapeutic measures were taken as a result of the events covid-19, pyrexia and nasopharyngitis with Monoclonal Antibody (It is Regen-Cov, that was the ''Casirivimab''). The outcome of the events fever and Cold was unknown at the time of report. Causality: Consumer stated, "It didn''t cause me any discomfort. I didn''t have any problem at all with it, I get no reaction that was painful or discomforting or anything. I really didn''t even get a swollen arm."; Sender''s Comments: Based on the current available information, a possible role of the suspect product BNT162B2 to the development of events vaccination failure and covid19 cannot be totally 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: 1647333 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Diplopia, Electrocardiogram, Eye pain, Eye swelling, Eyelid ptosis, Mydriasis, Ocular discomfort, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; ESTRADIOL; METFORMIN; OZEMPIC; LISINOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Blood work; Result Unstructured Data: Test Result:Normal; Test Date: 20210801; Test Name: CT scan; Result Unstructured Data: Test Result:Normal; Test Date: 20210801; Test Name: EKG; Result Unstructured Data: Test Result:Normal
CDC Split Type: USPFIZER INC202101063142

Write-up: puffiness at bottom of eye; Blurred vision within 45 minutes of taking vaccine; Within 9 hours, right eye lid drooping; pupil dilated; pain with pressure behind & around eye; pain with pressure behind & around eye; blurred and double vision; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (Lot Number: EW0198), via an unspecified route of administration, administered in left arm on 01Aug2021 11:00 (at the age of 53 year old), as dose 1, single for COVID-19 immunisation. Medical history included type 2 diabetes and high blood pressure. Patient had known allergies to sulfur, gold, hydrocodone. Concomitant medication included atorvastatin, estradiol, metformin, semaglutide (OZEMPIC), llisinopril all taken for an unspecified indication. Prior vaccination, the patient was not diagnosed with COVID-19, no other vaccines administered. The patient was not pregnant at the time of vaccination. On 01Aug2021,11:45, patient experienced blurred vision within 45 minutes of taking vaccine. Within 9 hours, her right eye lid was drooping, pupil got dilated, experienced pain with pressure behind & around eye, got blurred and vision was double vision. The events required visit to Emergency room/department or urgent care. The ER/Hospital agreed the symptoms were reaction to the vaccine. The Pain and blurred vision lasted approximately for 3 days. And 15 days later, on 16Aug2021, she had pain in left eye with puffiness at bottom of eye. The patient underwent lab tests and procedures which included, on an unspecified date, CT Scan, blood work and EKG was taken and all found normal. No treatment was given in response to the events. It was unknown whether the patient tested COVID since vaccination. The outcome of the events pain and blurred vision was recovered on 04Aug2021 and of all other events was not recovered.


VAERS ID: 1647342 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-13
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Adrenocortical insufficiency acute, Arthralgia, Dizziness, Extra dose administered, Flank pain, Headache, Insomnia, Myalgia, Nausea, Nightmare, Off label use, Presyncope
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Adrenal crisis (has had adrenal crisis before)
Preexisting Conditions: Medical History/Concurrent Conditions: Addison''s disease (She has a history of underlying Addison Disease.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101064134

Write-up: received her third dose of the Pfizer COVID-19 Vaccine; received her third dose of the Pfizer COVID-19 Vaccine; experienced symptoms she relates to Adrenal Crisis; not be able to go back to sleep.; light headedness/feeling like she is going to pass out; severe muscle and joint pain; severe muscle and joint pain; bilateral flank pain; headache; has had nightly nightmares; Nausea; near syncope; This is a spontaneous report from a contactable other hcp. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), dose 3 via an unspecified route of administration on 13Aug2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunization. Medical history included addison''s disease from an unknown date and unknown if ongoing (she has a history of underlying Addison Disease), ongoing adrenocortical insufficiency acute (has had adrenal crisis before last night). The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on unspecified date (Batch/Lot Number: not reported) as for covid-19 immunization and experienced no symptoms, second dose of bnt162b2 via an unspecified route of administration, on unspecified date (Batch/Lot Number: not reported) as for covid-19 immunization and experienced as she did have a medicine taste in her mouth and then had weakness for about three weeks because of her Addisons, but did not have any pain, no fever, no chills, just weakness. She could tell her body was fighting it. On Aug2021, after receiving that booster she experienced symptoms she relates to Adrenal Crisis including sever light headedness, feeling like she is going to pass out, severe muscle and joint pain, bilateral flank pain, sever headache and has had nightly nightmares after that, which began the night of the injection and are still persisting, she has never had them before, they are pretty life like and medically debilitating because she cannot sleep , she will wake up at 2 am and not be able to go back to sleep. So she has had sever light headedness, feeling like passing out, severe muscle and joint pain, bilateral flank pain, sever headache and nightly nightmares. Do we have anything in our literature about Adrenal Crisis as far as Side effects. She says caller states she has had Addisons and has had adrenal crisis before and then she started getting these symptoms she felt like she was going into adrenal crisis. She did not get care at the emergency department because they were so packed with COVID-19 Patients, so she went home and treated herself, had she not been a medical person and knew who to treat herself, she felt like she would have been in full blown adrenal crisis and could have died. She feels like for future or other Addison Patients or adrenal insufficiency patients this needs to be researched, this is an SAE for her, she knows how to code she has worked in research for 30 years, so this was defiantly SAE. She gave herself a truck load of steroids last night/this morning States she was hypotensive as well which is a sing of adrenal crisis. And nausea, near syncope. The outcome of events received her third dose of the Pfizer COVID-19 Vaccine was unknown. The outcome of all the rest events was not recovered. Information on the lot/batch number has been requested. 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.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event adrenal crisis cannot be totally 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: 1647351 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-07-29
Onset:2021-08-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0164 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Condition aggravated, Feeling abnormal, Herpes zoster, Insomnia, Neuralgia, Pain, Pain in extremity, Rash, Ultrasound scan, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Dementia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NITROFURANTOIN MONO/MAC; MACROBID [NITROFURANTOIN]; CEFDINIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: UTI
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: Ultrasound for blood clot; Result Unstructured Data: Test Result:Negative
CDC Split Type: USPFIZER INC202101065095

Write-up: shingles; pain; UTI infection; joint pain; couldn''t sleep; nerve pain; her leg started hurting after the first dose; Her leg is getting worse; rash came out; miserable; This is a spontaneous report received from contactable consumer (patient). A 62-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0164), via an unspecified route of administration, administrated in Left arm on 29Jul2021 between 4PM - 4:30PM (age at the time of vaccination 62-years-old), as a single dose for COVID-19 immunization. The patient''s medical history included UTI. The patient''s concomitant medications included Nitrofurantoin (Nitrofurantoin Mono/Mac), 100mg 1 capsule twice a day every 12 hours; Macrobid [Nitrofurantoin], for UTI infection; and Cefdinir 300mg from 14Aug2021. On an unspecified date Aug2021, 2 weeks and 10 days later the patient experienced shingles, pain, UTI infection, joint pain, couldn''t sleep, nerve pain, her leg started hurting after the first dose, her leg is getting worse, rash came out, and miserable. On 16Aug2021, the patient underwent lab tests and procedures which included Ultrasound for blood clot: Negative. Patient received treatment as a result of adverse events. Patient visited to emergency room as a result of adverse event. The doctor looked at it, and prescriber her medication, which she took called Valtrex. The reason she went to the doctor is because her stomach was killing her, she thought she was constipated or there was a blockage, she didn''t feel good, the doctor checked her urine saw there was an UTI, because she had high White Blood Cell count, then they gave the Nitrofurantoin Mono/Mac but then her leg started hurting after the 3rd dose of the Nitrofurantoin Mono/Mac, caller clarifies that she took 5 doses in total of the Nitrofurantoin Mono/Mac and then it started hurting with the leg. She went to urgent care on Saturday because she was still having it and they changed her antibiotic. She started the new antibiotic, she knew it was related since the leg pain was already going on when she started it on 14Aug2021, the new one is doing good, it''s called Cefdinir 300mg. Caller wants to know if shingles can be a side effect of the vaccine. Caller wants to know if there is a need to delay in getting the second dose of the Pfizer BioNTech COVID19 vaccine or as scheduled since she got diagnosed with shingles. The outcome of the events shingles was recovered on an unspecified date; pain, UTI infection, joint pain, couldn''t sleep, nerve pain, her leg started hurting after the first dose was not recovered; and Her leg is getting worse, rash came out, miserable was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1647354 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101065377

Write-up: Had pain from the injection; All of a sudden, it has become very severe; This is a spontaneous report from a contactable consumer (parent). A 12-years-old female (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 16Aug2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Aug2021 the patient experienced had pain from the injection all of a sudden, it has become very severe. Consumer stated that the 12 year old twins were given COVID Vaccine today, about five hours ago, about like four and a half hours ago. Well the girls had pain from the injection but it was not that severe, now all of a sudden, it has become very severe. was that normal or was that a cause of a concern. Consumer further stated, "If I need to take my daughter to the hospital, that what I need to know." In response to further probing for safety report reporter stated, "No, it was not the right time and need to find out if my girls were fine." The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101065367 Same reporter/vaccine/event, different patient


VAERS ID: 1647360 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain
SMQs:, 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 INC202101066001

Write-up: his chest hurts; This is a spontaneous report from a contactable consumer (patient''s parent). A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16Aug2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that her son just got the second dose of Covid shot a day before reporting and she called because she was asking him if he had any side effects he really did not have much but he said his chest hurt. The reporter knew there were various reasons and she was at her pediatrician''s office, she was told by them to call safety team to find out if the patient needs to be seen or what reporter need to worry about that. The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1647391 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0170 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: COVID-19; Test Result: Positive
CDC Split Type: USPFIZER INC202101075944

Write-up: received the first dose of the Pfizer Covid-19 vaccine on 02AUG2021 and was diagnosed with Covid-19 on 12AUG2021; fever for the past three days/ran a temperature for 7 days with a cough; ran a temperature for 7 days with a cough; This is a spontaneous report from a contactable consumer (Patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0170), dose 1 via an unspecified route of administration on 02Aug2021 (Age at vaccination: 62 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced received the first dose of the pfizer covid-19 vaccine on 02aug2021 and was diagnosed with covid-19 on 12aug2021 (covid-19), fever for the past three days and ran a temperature for 7 days with a cough in Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 12Aug2021. Reporter received the first dose of the Pfizer Covid-19 vaccine on 02Aug2021 and was diagnosed with Covid-19 on 12Aug2021 (caller stated "we got the vaccine" but did not specify the other person or persons). Reporter stated that she was previously running a fever but has no complaints of fever for the past three days. She was scheduled to get her second dose of the Pfizer Covid-19 vaccine on 25Aug2021. She was asking "should we get our second dose" of the Pfizer Covid-19 vaccine. The outcome of the event received the first dose of the pfizer covid-19 vaccine on 02aug2021 and was diagnosed with covid-19 on 12aug2021 (covid-19), ran a temperature for 7 days with a cough was unknown. The outcome of fever for the past three days was recovered in Aug2021. Follow-up (19Aug2021): This is a follow-up spontaneous report from Pfizer Sponsored Pro-gram. Reporter says she and her husband got their first dose of the Pfizer COVID-19 vaccine on 02Aug2021, then they both tested positive on 12Aug2021 which is merge in above as combine follow up.


VAERS ID: 1647401 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2021-01-27
Onset:2021-08-01
   Days after vaccination:186
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Body mass index, COVID-19, Circumstance or information capable of leading to medication error, Product use issue, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Medication errors (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: 20210801; Test Name: BMI; Result Unstructured Data: Test Result:20; Test Date: 20210801; Test Name: NAAT Covid test; Test Result: Positive
CDC Split Type: USPFIZER INC202101076358

Write-up: she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer. A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6203) via an unspecified route of administration on 23Feb2021 as DOSE 2, SINGLE, and first dose via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Aug2021, the patient tested positive for covid virus, after being fully vaccinated. It was reported that, patient has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. Reporter reclarified later in report that 15% of the breakthrough cases in her county had the same lot number, which was concerning. Reporter stated, she has 37 patients with partial identifiers. She cannot provide some identifying details and that she would need to check with her legal department first. Reporter provided the details she was allowed to identify. Reporter stated she can provide, age, gender, BMI, medical conditions, if reported, and date they tested positive for Covid, and the type of covid test utilized, she cannot provide the zip code. The patient underwent lab tests and procedures which included body mass index: 20 on 01Aug2021 and sars-cov-2 test: positive on 01Aug2021. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1647402 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:2021-02-23
Onset:2021-08-01
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6203 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypothyroidism (Verbatim: Hypothyroidism)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: NAAT Covid test; Result Unstructured Data: Test Result:positive
CDC Split Type: USPFIZER INC202101076359

Write-up: patient tested positive for Covid virus, after being fully vaccinated; patient tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer. This case is for 21st patient of 37 patients. A 68-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EN6203) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unspecified date to ongoing. The patient concomitant medications were not reported. The patient tested positive for Covid virus, after being fully vaccinated on 01Aug2021. The reporter stated they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. Caller stated she has 37 patients with partial identifiers. Caller reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. The patient underwent lab tests and procedures which included NAAT Covid test (sars-cov-2 test): positive on 01Aug2021.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients


VAERS ID: 1647406 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain
SMQs:, 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: Medical History/Concurrent Conditions: Anxiety; Chest pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101076666

Write-up: Irregular pain on the left side of chest; This is a spontaneous report from a contactable consumer via a company representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on Aug2021 as dose number unknown, single for covid-19 immunization. Medical history included chest pain occasionally occur with her anxiety. The patient''s concomitant medications were not reported. Patient experienced irregular pain on the left side of chest in Aug2021. It was reported that the chest pain occasionally occur with her anxiety but the patient had the Covid vaccine over the last weekend and had heard of Cardiomyopathy side effect. The event chest pain has occurred prior to taking provost as a result of anxiety. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647410 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101077781

Write-up: This is a spontaneous report from a contactable consumer (parent) via Pfizer-sponsored program (program name not reported). A 16-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; solution for injection, lot#, expiration date not reported), via an unspecified route of administration, on Aug 2021, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications not reported. On a week before the time of report, patient had the vaccination. About 24 hours later, she experienced a rash in armpit. It turned out as shingles on Aug 2021. The patient visited the doctor on the day before the time of report, because the rash was not getting any better. The outcome of the events: not recovered. The lot number for the vaccine BNT162B2: not provided and will be requested during follow-up.


VAERS ID: 1647418 (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: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain
SMQs:, 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 INC202101085847

Write-up: Got Vaccine on his left side and then feeling sore, like it hurts on his chest; This is a spontaneous report from a contactable consumer. This contactable consumer (Parent) reported for a male patient (reporter''s son) of an unspecified age that he received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3181, NDC Number, UPC Number, Expiry Date: Unknown), via an unspecified route of administration on Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got vaccine on his left side and then feeling sore, like it hurts on his chest on Aug2021. Reporter had a question, about the patient that he got Pfizer Covid vaccine 2 days ago on his left side and then he felt sore like it hurts on his (chest). The reporter wanted to know whether it was normal or not. Reporter stated that not on his hand, it hurts like on his chest. The outcome of event was unknown. 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: 1651226 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nuvaring Lamictal Wellbutrin Xanax Herbs Advil
Current Illness:
Preexisting Conditions: Asthma Arthritis
Allergies: Doxycycline Penicillin Bactrim
Diagnostic Lab Data:
CDC Split Type:

Write-up: Body aches/pains for two and a half days Nausea for one day


VAERS ID: 1651361 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Utah  
Vaccinated:2021-03-11
Onset:2021-08-01
   Days after vaccination:143
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 AR / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cerebrovascular accident, Lymphadenopathy, Magnetic resonance imaging, Positron emission tomogram
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Finastride
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI 08/01/21 PET Scan
CDC Split Type:

Write-up: 2 strokes Enlarged lymph nodes


VAERS ID: 1651538 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (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 says that the day after his vaccination, the area around the injection site was red, itchy and had a "hard lump." this persisted for 4 days, then subsided.


VAERS ID: 1651623 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-07-21
Onset:2021-08-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 RA / SYR

Administered by: Pharmacy       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? 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: experiencing reoccurring rash all over body, specifically hands, arms, legs, feet, & back began a couple of week after receiving 2nd dose


VAERS ID: 1652232 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Bone pain, Chills, Dysstasia, Gait disturbance, Headache, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Osteonecrosis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Hep B series
Other Medications: Vitamin D 5,000iu, Multivitamin, Omega 3 supplement
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Intense fever, chills, headache night one and continued for 48 hours. For 5 additional days my joints and bones hurt so much that I could barely walk or stand. Intermediate nausea for approximately 5 days post vaccine. Joint pain continues currently on a daily basis 5 weeks post vaccine.


VAERS ID: 1653830 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Condition aggravated, Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin 20 mg Levothyroxine 100 mcg Cranberry 650 mg Magnesium 250 mg CoQ10 100 mg Krill Oil 500 mg Ginkgo Biloba 120 mg B-Complex Aller-Flo
Current Illness: None
Preexisting Conditions: Hypothyroidism under control with med. High Cholestrol under control with med.
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: I have tinnitus in both ears that was manageable but a few days after getting vaccination the ringing in my ears was so much louder. It is unbearable now.


VAERS ID: 1653883 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: New York  
Vaccinated:2021-02-01
Onset:2021-08-01
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Asthma, Condition aggravated
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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: Synjardy Crestor Quinapril Amlodipine
Current Illness: None
Preexisting Conditions: Asthma Diabetes Hypertension
Allergies: Tetracycline
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe asthma episode lasting more than one week


VAERS ID: 1653987 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Hot flush, Lymphadenopathy, Migraine, Oropharyngeal pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: Omega 3
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chronic migraines for 6 days my armpit swelled up to the point where I couldn?t move it. Throat was sore for 5 days hot flashes continue to persist a week after getting the shot. Chills and fever for 5 days.


VAERS ID: 1654006 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Condition aggravated, Dizziness, Ear discomfort, Headache, Inflammation, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Hypersensitivity (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: Have STRONG reason to suspect my diagnoses (many inflammatory conditions) are actually misdiagnosed and really have MCAS.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Have very very STRONG reason to believe that I have undiagnosed MCAS and each dose has triggered a flare. 4 hours after first dose - severe nausea, diarrhoea, fainting: episode lasted about 15 to 20 minutes. 24 hours after second dose - headache, chest tightness, dizziness, stuffy ears, inflammation, throat tightness, lasting about one hour or less. Possible mild lingering symptoms.


VAERS ID: 1654013 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-25
Onset:2021-08-01
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

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

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

Write-up: Feeling of pins and needles that started around week 2. Now is 8/29/2021 and hasn''t gone away after about 5 weeks.


VAERS ID: 1654167 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Hawaii  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046B21A / 1 RA / IM

Administered by: Private       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? Yes
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: None
CDC Split Type:

Write-up: Administered to 14 y/o patient. No adverse medical events.


VAERS ID: 1654989 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Limb discomfort, Muscle spasms, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (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: USJNJFOC20210856064

Write-up: FEVER; MUSCLE CRAMPING WORSEN AS THE DAY PROGRESSED; HEAVY LEGS WORSEN AS THE DAY PROGRESSED; This spontaneous report received from a patient concerned an adult male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 16-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient experienced muscle cramping worsen as the day progressed. On AUG-2021, the patient experienced heavy legs worsen as the day progressed. On 16-AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from heavy legs worsen as the day progressed, and muscle cramping worsen as the day progressed. This report was non-serious.


VAERS ID: 1655013 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Dysarthria, Headache, Hypotension, Muscular weakness, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: COVID-19 (If Covid prior vaccination: Yes)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101002770

Write-up: slurred speech; dizziness; headache at the top of the head; weakness on arms; sleepiness; low blood pressure; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old non pregnancy female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration in Arm Right on 04Aug2021 14:15 (age at vaccination 34years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing If Covid prior vaccination: Yes. There were no concomitant medications. The patient has Known allergies reported as unknown. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and Other medications in two weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced slurred speech, dizziness, headache at the top of the head, weakness on arms, sleepiness, low blood pressure on unspecified date in Aug2021. The clinical outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1655021 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 1 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Feeling abnormal, Full blood count, Guillain-Barre syndrome, Hypoaesthesia, Hypoaesthesia oral, Lymphadenopathy, Metabolic function test, Musculoskeletal discomfort, Paraesthesia, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (narrow), Glaucoma (broad), Hypertension (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PROBIOTIC [BIFIDOBACTERIUM LACTIS]; KRILL OIL; VITAMIN D3 K2
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autoimmune disorder (Autoimmune disease but NOT on immunosuppressive); Chronic bronchitis (I have like chronic bronchitis since birth); Ehlers-Danlos syndrome; Food allergy; Heart disorder (I have heart disease starting from my own but I am not on anything.); Lupus syndrome; Milk allergy; Osteoarthritis; Penicillin allergy; RA; Spondylitis; Sulfonamide allergy
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Test Name: CBC; Result Unstructured Data: Test Result:Unspecified; Test Name: Metabolic Panel; Result Unstructured Data: Test Result:Unspecified
CDC Split Type: USPFIZER INC202101048694

Write-up: I have a little bit of blurry vision starting today; Swollen lymph nodes in lower left leg above ankle; Immediate tingling in left hand in arm /tingling in lower extremities; numbness in tip of tongue/it feels like my face today is kind of going numb; Numbness and tingling in lower extremities (parenthesia)/Numbness and tingling; in both my hands, my arms, my leg; Last night I started feel like backstab something, I couldn''t move up to get up to go pee; I am fine this morning; Gullian Barre; left leg near my ankle; I also have high blood pressure; I don''t normally have either; they said it was pretty high; This is kind of not a good sensation. I didn''t have before all this now; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 48-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0185), dose 1 intramuscular, administered in Arm Left (left, upper deltoid) on 11Aug2021 15:30 (03:30 pm) (at the age of 48-years-old) as dose 1, single for covid-19 immunisation. The patient''s medical history included allergy to Penicillins, lupus, rheumatoid arthritis (RA), Ehlers Danlos, osteoarthritis (OA), spondylitis, autoimmune disease but not on immunosuppressive/not on any medicines, chronic bronchitis like since birth, heart disease starting from her own, but she was not on anything. The patient had known allergies to blue cheese and milk. The patient''s concomitant medication included bifidobacterium lactis (PROBIOTIC), krill oil, colecalciferol, menaquinone-7 (VITAMIN D3 K2) and Multivitamin. The patient previously took Sulfa, Doxycycline, Orencia, Humira, Remicade, Enbrel and experienced known allergy. 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 has not been tested for COVID-19. The patient had no prior vaccinations (within 4 weeks). On 11Aug2021 (at 04:30 pm), the patient experienced immediate tingling in left hand in arm she received vaccine in and tingling in lower extremities and numbness in tip of tongue, numbness and tingling in lower extremities (parenthesia), swollen lymph nodes in lower left leg above ankle. The patient went to the emergency room (ER) on 14Aug2021. She was instructed it was safe to go ahead with her second vaccine in 3 weeks but referred to neurology due to the lower extremity numbness and tingling that has not subsided 100 percent and the lymph nodes above her ankle being swollen may be a rare dude affect. of her immune response to the vaccine. The patient stated that, she was calling she did fill out a form online but she had (voice not clear) in the emergency room (ER) and they were not sure exactly where it was but they were trying to get her a neurologist, but, they thought she had paraesthesia and swollen lymph nodes like in her leg in/ lower left leg above ankle after saying it, so they think like Gullian Barre and swollen lymph nodes after her first (Covid-19 Vaccine), the lymph nodes are actually in her leg so they are not like wherever goes down in her ankle. It was not in my neck they were in her leg, her left leg near her ankle. On 11Aug2021, Yes, she had actually numbness and tingling or whatever it was in both her hands now, my arms, my leg, the tip of my tongue and it feels like my face today was kind of going numb but last night she started feel like backstab something, she couldn''t move up to get up to go pee but she was fine this morning. Other than she just feel the same numbness, the numbness and tingling was not going away and it started immediately like about an hour after she got the first dose. It basically started in her left hand in the same arm and it just got kind of weird so she just kind of brushed it off. Yeah, this was kind of not a good sensation. She didn''t have before all this now, she do have an auto immune disease (Medical history) but she was not on any medicines. She was not on so, she mean this was a kind of this took my (voice not clear) and decide to get it, took my husband traveling for the government and she was at rest because she have like chronic bronchitis since birth (Medical history) so you know it was kind of a death for me. This pretty much at right now she mean, she have a little bit of blurry vision starting today (on 16Aug2021), it was new, so, she had an appointment with her doctor, yeah she made an appointment with her doctor for like, see what''s going on. Her second shot scheduled she stated It was supposed to be 01Sep2021, but she was holding off on anything right now, because she doesn''t know what''s going on. She was supposed to go on 01Sep2021. Investigation she stated, yes all she knows that it showed that she also have high blood pressure which she don''t normally have either when she went they said it was pretty high (further not clarified). She done with full blood count/CBC (result unspecified) and whatever that was metabolic panel. As a treatment the patient received Aspirin and Tylenol, they told me she can take, but she has just taken the aspirin right now. The adverse events resulted in visit to emergency room/department or urgent care. The patient received the treatment for the events. The outcome of the event Gullian Barre; left leg near my ankle, I have a little bit of blurry vision starting today, I also have high blood pressure; I don''t normally have either; they said it was pretty high and this was kind of not a good sensation. I didn''t have before all this now was unknown. The outcome of the event Last night I started feel like backstab something, I couldn''t move up to get up to go pee; I am fine this morning was recovered on Aug2021. The outcome of the other events was Recovered/Resolved with Sequel on Aug2021.


VAERS ID: 1655034 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Loss of consciousness, Malaise, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: tested for Covid; Test Result: Positive
CDC Split Type: USPFIZER INC202101057360

Write-up: Not feeling good, feeling awful, after first vaccine; Passed out after first vaccine; Tested positive for Covid virus, after first vaccine; Tested positive for Covid virus, after first vaccine; This is a spontaneous report from a contactable consumer. A 69-year-old male patient (reporter''s Brother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 03Aug2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Aug2021, after first vaccination, patient was not feeling good and was taken to the hospital by ambulance on 06Aug2021. Patient Passed out. And when he was in the emergency room, they tested him for COVID and he tested positive. It was reported that patient had an appointment last Friday (on an unspecified date), to see a primary doctor because he wasn''t feeling good. Event malaise resulted in emergency room and physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test resulted positive on an unspecified date in Aug2021. Reporter wanted to know can the Pfizer shot, give patient COVID, and states that she got the shot the same week as patient and she was reading her information sheet that was provided about the side effects, her brother has all of them, and was feeling awful. Reporter asked, when can patient take another Covid test to see if he was still positive, should he get the second vaccine within the 21 days or wait. Report does not relate to a study or programme. The clinical outcome for events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1655076 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2021-02-24
Onset:2021-08-01
   Days after vaccination:158
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6203 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: NAAT Covid test; Test Result: Positive
CDC Split Type: USPFIZER INC202101076357

Write-up: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Batch/Lot Number: EN5318), via an unspecified route of administration on 26Jan2021 as single dose and received the second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Batch/Lot Number: EN6203), via an unspecified route of administration on 24Feb2021 single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for covid virus, after being fully vaccinated (vaccination failure) on 01Aug2021. The patient underwent lab tests and procedures which included NAAT COVID test which was positive on 01Aug2021. Outcome of the events was unknown. The outcome of the event was unknown.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101075254 same reporter/drug/eevnt, differnt patients


VAERS ID: 1655092 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-09
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest pain, Headache, Hypertension, Pulmonary oedema, Vascular pain
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (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? No
Previous Vaccinations:
Other Medications: TRAZODONE; OMEPRAZOLE; VENLAFAXIN; KLONOPIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: bloodwork; Result Unstructured Data: Test Result:Unknown results; Test Date: 202108; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown results; Test Date: 202108; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown results; Test Date: 202108; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: USPFIZER INC202101083765

Write-up: edema in lungs; veins on fire; high blood pressure; Severe chest pains; headache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Fc3180), via an unspecified route of administration, administered in arm left on 09Aug2021 11:30 (at the age of 37-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient''s medical history was not reported. No known allergies. Concomitant medications the patient received within 2 weeks of vaccination included: Trazadone, omperzole, venlafaxine hydrochloride (VENAFAXCIN) and clonazepam (KLONOPIN). The patient experienced severe chest pains, edema in lungs, veins on fire, high blood pressure, headache in Aug2021. The AEs resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Events Edema lung and Vein pain were reported as serious (Life-threatening). Patient received treatment which included antibiot. The patient underwent Chest X-ray 3 times, lots of blood work in Aug2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1655098 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 20210801; Test Name: covid-19 test; Result Unstructured Data: Test Result:Positive
CDC Split Type: USPFIZER INC202101090338

Write-up: Call received both doses of the Pfizer Covid-19 Vaccine. She tested positive for COVID-19 around 01Aug2021.; Call received both doses of the Pfizer Covid-19 Vaccine. She tested positive for COVID-19 around 01Aug2021.; This is a spontaneous report from a contactable consumer (patient). This female consumer reported for herself. A female patient of unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), unknown dose via an unspecified route of administration on unspecified date at DOSE NUMBER UKNOWN, SINGLE for COVID-19 immunization. She received both doses of COVID-19 Vaccine. No medical history reported. No concomitant medications reported. On 01Aug2021 patient experienced Covid -19. The patient want to know whether she can take booster dose. Believes she is eligible to receive it in Oct2021. The patient underwent SARS-CoV-2 test on 01Aug2021 and found positive. The outcome of event was unknown. Agency: Possible duplicate AE details E-transmitted. Limited details obtained as caller came from Agency. The lot number for [bnt162b2], was not provided and will be requested during follow up.


VAERS ID: 1655119 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Peripheral neuropathy (Verbatim: Now he has a pre-existing condition. Which is Peripheral Neuropathy (Medical Condition))
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101095303

Write-up: pre existing condition; peripheral neuropathy; and it has got a little worse; neuropathy was aggravated; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: not reported), via an unspecified route of administration on 02Aug2021 as dose 1, single for COVID-19 immunization. Medical history included peripheral neuropathy (Now he has a pre-existing condition which is Peripheral Neuropathy (Medical Condition)). Concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced pre-existing condition; peripheral neuropathy; and it has got a little worse; neuropathy was aggravated. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1655394 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Angiogram pulmonary abnormal, Anticoagulant therapy, Aortic thrombosis, Back pain, Computerised tomogram abnormal, Dyspnoea, Fatigue, Fibrin D dimer increased, Malaise
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: DM, HTN, HLD
Allergies: Penicillin
Diagnostic Lab Data: CT PE 8/29/21
CDC Split Type:

Write-up: Fatigue/malaise since 2nd dose of COVID vaccine, developed abdominal pain and SOB, back pain. D-dimer was positive, CT pulmonary angiogram showed aortic clots, admitted for anticoagulation.


VAERS ID: 1655602 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-03-26
Onset:2021-08-01
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6203 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Blood creatinine increased, COVID-19, Chest X-ray abnormal, Chills, Cough, Fatigue, Inflammatory marker increased, Myalgia, Pyrexia, SARS-CoV-2 test positive, Total lung capacity decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: nifedipine XL, omega-3 fish oil, pravastatin, propranolol, sirolimus, azathioprine
Current Illness:
Preexisting Conditions: CKD, Post renal transplant (5/1985, 10/1988, 10/2006), hyperlipidemia,
Allergies: erythrmoycin (Anaphylaxis), MMR vaccine (anaphylaxis), mycophenolate (rash), penicillin (rash), sulfa drugs (rash)
Diagnostic Lab Data: XR Chest 1 View Result Date: 8/2/2021 Narrative: Exam/Procedure: XR CHEST 1 VIEW CLINICAL INDICATION: COVID positive TECHNIQUE: XR CHEST 1 VIEW COMPARISON: CXR August 9, 2011 FINDINGS: Normal cardiomediastinal silhouette. Low lung volumes with hypoventilatory changes. Slight elevation right hemidiaphragm. No focal airspace opacity, pleural effusion, or pneumothorax. No acute osseous finding.
CDC Split Type:

Write-up: Patient vaccinated 3/26/2021, admitted 8/1/2021, tested positive for COVID 8/2/2021. discharged 8/3/2021 to home Date of Vaccination: 3/3/2021 Dose: 1 Vaccine Manufacturer: Pfizer Lot #: ER8732 Clinic Administering Vaccine: Clinic Injection site: L deltoid Date of Vaccination: 3/26/2021 Dose: 2 Vaccine Manufacturer: Pfizer Lot #: EN6203 Clinic Administering Vaccine: Clinic Injection site: L deltoid Description of event/reaction: presented with COVID infection post-vaccination Date of Clinic Visit or Hospitalization: 8/1/2021 Reason for clinic visit or hospitalization: COVID+ (dry cough, fever, weakness) COVID-19 positive test result: Yes, date: 8/2/2021 Chief complaint: COVID + History Of Present Illness Patient is a 37 y.o. male with history of chronic kidney disease status post renal transplant in 5/85, 10/88 and 10/2006. He is currently on Sirolimus and Azathioprine. On Saturday he went to a fair. Saturday evening patient developed mild dry cough, fever and generalized weakness. Today his fever ranged to 102-105F. He took some Tylenol. Then he was tested positive for COVID at urgent treatment center. Family called renal transplant clinic and instructed patient to come to the hospital for evaluation. Patient denies sore throat, dyspnea, diarrhea, loss of taste or smell. He is vaccinated. Currently patient patient''s vital signs are stable. Talked to Dr from Nephrology and recommended no treatment at this time and will need formal renal transplant consult in a.m. And hold am dose of sirolimus and Azathioprine until he is evaluated by renal transplant in am. This encounter used interpreter. Wife is at bedside also. Review of Systems Constitutional: Positive for fatigue and fever. Respiratory: Positive for cough. Neurological: Positive for weakness. All other systems reviewed and are negative. Hospitalization Admit Date/Time: 8/1/2021 8:58 PM Discharge Date: 08/03/21 Referring provider name and address: No referring provider defined for this encounter. Chief Concern, Brief History of Present Illness, and Hospital Course Patient is a 37 y.o. man with a history of ESRD secondary to renal dysplasia s/p LRKT in 10/2006, with prior transplants in 1985, 1988, admitted with Covid-19. Patient presented with high grade fevers 102, some associated dry cough, though no prominent dyspnea, after attending a ceremony. He had received Pfizer vaccine in March 2021 per patient and completed vaccine series. Patient reported fever, chills,and myalgias. He was tested for Covid-19, which returned positive Sunday morning. Family contacted transplant clinic, and they were advised to present to the ED for further evaluation. He reports some associated dry cough, though no prominent dyspnea, and fevers up to 102 at home. Symptoms now improving with scheduled Tylenol. CXR on admission showed low lung volumes without obvious infiltrates. Inflammatory markers were mildly elevated,. He remained stable without fevers and his respiratory status was closely monitored and he required no O2.. Patient will be a candidate for outpatient bamlanivumab and will followed by renl clinic Pt is Chronic kidney disease status post renal transplant in 10/2006 and he was found to have a mildly elevated creatinine at 1.4 which improved to 1.28 with careful hydration. Patient was seen by renal transplant team and recommended reinitiating home sirolimus and Azathioprine. Pt will be followed in transplant clinic On the day of the discharge pt had no fever, chills, nausea, vomiting and cough or sob. He verbalized understanding to f/u in clinic and felt ready to go home


VAERS ID: 1655887 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Chills, Fatigue, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bosulif; Celexa; Multivitamin; Miralax; Compazine;
Current Illness: none
Preexisting Conditions: Chronic Myelocytic Leukemia Generalized Anxiety Disorder Irritable Bowel Syndrome
Allergies: No Known Allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: 12 hours following vaccination patient reported fatigue, chills, sweats,


VAERS ID: 1656169 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 6 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Pain, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (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: Muran, Baclofen, Voltaren, Flonase, HCTZ, Losartan, Antivert, Centrum Silver, Prilosec, Pavastatin, Pravachol, Prednisone
Current Illness: None
Preexisting Conditions: Screening of malignant Neoplasm, colon - Tear of Rt. Supraspinalus - DJD of AC, Impingement Syndrome RT. Shoulder - Autoimmune Liver Disease
Allergies: Latex Natural Rubber and Hydrocodone
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Right arm sore, some body aches


VAERS ID: 1656198 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-07-06
Onset:2021-08-01
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808986 / UNK - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Bell''s palsy


VAERS ID: 1656313 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 2 RA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH WW0198 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Lymphadenopathy, Mammogram, Rash, Urticaria, Vulvovaginal mycotic infection
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unrelated: had a routine mammogram that showed swollen lymph nodes. No further testing at this time.
CDC Split Type:

Write-up: 1st dose: vaginal yeast infection onset 3 days after injection, resistant to over the counter medication, persistent symptoms for 3 weeks. Rash on left arm, 3 days, swollen lymph nodes on mammogram. Second vaccine: large red welt on right arm, spread to rash on right arm, now rash is spreading all over my body.


VAERS ID: 1656422 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: California  
Vaccinated:2021-05-24
Onset:2021-08-01
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Deep vein thrombosis, Infection
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Breakthrough Covid infection, DVT


VAERS ID: 1657041 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-06-24
Onset:2021-08-01
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Headache, Injection site pain
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (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: Atenolol; Pravastatin; Aspirin; Venlafaxine
Current Illness: No
Preexisting Conditions: Cardiomegaly, Takayasu''s Arteritis.
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headache, chest pain, shortness of breath, right arm pain on the same side as the injection.


VAERS ID: 1657438 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Utah  
Vaccinated:2021-07-26
Onset:2021-08-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angina pectoris, Sleep disorder
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zenatane, Vitamin D3, probiotic, turmeric, cinnamon, sudafed, moringa, magnesium, zyrtec, saffron, Vitamin C, cayenne
Current Illness: N/A
Preexisting Conditions: Chronic Sinusitis
Allergies: N/A
Diagnostic Lab Data: None so far.
CDC Split Type:

Write-up: I already reported the rapid heart beating/fluttering (3X) within the first week. But I haven''t had a chance to report the chest/heart pain I had the week after I got the 1st vaccine. I woke up in the middle of the night to severe heart pain in my chest. It was intermittent and finally went away. The next day, it came back briefly for a few seconds, and not as severe. Since then, I haven''t really had many symptoms.


VAERS ID: 1657735 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Oregon  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210855235

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; 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: 1808982) dose was not reported,1 total, administered on APR-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient was sick with covid-19 infection (suspected covid-19 infection) (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint:90000191144 This case, from the same reporter is linked to 20210854979 and 20210855254. Additional information was received from Central Complaint Vigilance on 27-AUG-2021. The following information was updated and incorporated into the case narrative: Updated the batch number & Product Quality number.; Sender''s Comments: V1: This follow up adds Product quality number and batch no. This new information does not change prior causality assessment. 20210855235- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1657736 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Oklahoma  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Dry skin, Fatigue, Headache, Injection site pain, Mental fatigue, Neuropathy peripheral, Pyrexia, Sensory disturbance
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: GABAPENTIN
Current Illness: Fibromyalgia; Neuropathy peripheral; Systemic lupus erythematosus.
Preexisting Conditions: Comments: The patient never had another vaccine in life.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210855258

Write-up: BACK FEELS LIKE SANDPAPER; BACK FEELS LIKE A BAD SUNBURN; MENTALLY TIRED; STOMACH PAIN AND UP THROUGH THE NIGHT WITH IT; DIARRHEA AND UP THROUGH THE NIGHT WITH IT; SHOT HURT LIKE HELL; FEVER ON AND OFF; HEADACHE; PHYSICALLY TIRED; WORSENING NEUROPATHY OF LEFT HAND/FINGERTIPS/LEGS/KNEES/TOPS OF FEET; This spontaneous report received from a patient concerned a 62 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: systemic lupus (SLE), neuropathy on bottoms of feet, and fibromyalgia. The patient never had another vaccine in life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered in left arm on 05-AUG-2021 for prophylactic vaccination. Concomitant medications included gabapentin for neuropathy in feet. After vaccination on an unspecified date in AUG-2021, the patient experienced constant diarrhea and up through the night with it. The patient also experienced bad and ridiculous pain in the legs and knees, which started first in knees and then spread and sometimes felt like legs would buckle due to knees. Further the patient had stomach pain and it was not relieved and up through the night with it. The patient felt like sand paper on her back and also felt like a bad sunburn, the patient lifted her shirt but nothing was visible. Initially the patient had neuropathy only in the bottom of feet but it spread to left hand and fingertips and tops of feet. The patient had severe pain and she was tired of hurting, also she had pain at the shot site and headache. The patient experienced fever on and off and took acetyl salicylic acid (ASA). The patient became mentally and physically tired due to her side effects. The patient visited MD twice for the symptoms but the doctor nothing mentioned about the shot. The patient was previously taken gabapentin (90 capsules per month) and at the time of reporting 270 capsules per month for neuropathy in feet, but it did not help patient. The patient also stated that Nurse practitioner also did not advise about the vaccine and its risks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhea and up through the night with it, back feels like a bad sunburn, worsening neuropathy of left hand/fingertips/legs/knees/tops of feet, stomach pain and up through the night with it, and back feels like sandpaper, and the outcome of shot hurt like hell, fever on and off, headache, mentally tired and physically tired was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210855258-Covid-19 vaccine ad26.cov2.s-WORSENING NEUROPATHY OF LEFT HAND/FINGERTIPS/LEGS/KNEES/TOPS OF FEET. 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: 1657738 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Muscle spasms, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Other ischaemic heart disease (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: Non-smoker
Preexisting Conditions: Comments: The patient was healthy and athlete.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210857424

Write-up: CONSTANT PAIN IN HEART; CRAMPING IN LOWER LEGS; PRICKLY FEELING IN HEART 15 MINUTES AFTER VACCINE ADMINISTRATION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: non smoker, and other pre-existing medical conditions included: The patient was healthy and athlete. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter called in to inquire about an adverse event that the patient was experiencing after receiving the Janssen covid-19 vaccine. On an unspecified date in AUG-2021 (about 3 weeks ago), 15 minutes after vaccine administration, the patient experienced a prickly sensation in her heart. The patient experienced cramping in her lower legs and for the last 3 weeks has had constant pain in her heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cramping in lower legs, and constant pain in heart, and the outcome of prickly feeling in heart 15 minutes after vaccine administration was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210857424-covid-19 vaccine ad26.cov2.s -constant pain in heart. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: 1657742 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Body temperature, Chills, Decreased appetite, Diarrhoea, Fatigue, Headache, Nausea, Pyrexia, SARS-CoV-2 test, Taste disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Non-smoker; Pre-diabetes
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm (5 years ago); Breast cancer (9 years ago); Mastectomy bilateral; Stroke (5 years ago); Comments: The patient had no history of drug abuse or illicit drug use and no known allergies. The patient is on blood thinners, cholesterol, blood pressure medications and on a pill for pre-diabetes and not pregnant at the time of reporting.
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: COVID-19 virus test; Result Unstructured Data: negative; Test Date: 202108; Test Name: COVID-19 virus test; Result Unstructured Data: negative; Test Date: 20210813; Test Name: Body temperature; Result Unstructured Data: not reported
CDC Split Type: USJNJFOC20210858470

Write-up: NAUSEA; VOMITING; EVERYTHING TASTES BAD; LOSS OF APPETITE/CAN''T REALLY EAT; CHILLS; ALL OVER WEAKNESS/FEELING WEAK/LACK OF ENERGY; FEVER; HEADACHES; JOINT PAIN; TIRED; DIARRHEA; This spontaneous report received from a patient concerned a 63 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included: aneurysm, stroke, breast cancer, and double mastectomy, and concurrent conditions included: non alcohol user, non-smoker, and pre-diabetes, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use and no known allergies. The patient is on blood thinners, cholesterol, blood pressure medications and on a pill for pre-diabetes and not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced diarrhea. On AUG-2021, the patient experienced tired. Laboratory data included: COVID-19 virus test (NR: not provided) negative, negative. On 13-AUG-2021, the patient experienced chills. On 13-AUG-2021, the patient experienced joint pain. On 13-AUG-2021, the patient experienced all over weakness/feeling weak/lack of energy. On 13-AUG-2021, the patient experienced fever. On 13-AUG-2021, the patient experienced headaches. Laboratory data included: Body temperature (NR: not provided) not reported. On 14-AUG-2021, the patient experienced everything tastes bad. On 14-AUG-2021, the patient experienced loss of appetite/can''t really eat. On 17-AUG-2021, the patient experienced vomiting. On 17-AUG-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 27-AUG-2021, vomiting, and nausea on 21-AUG-2021, and joint pain, was recovering from all over weakness/feeling weak/lack of energy, and headaches, had not recovered from everything tastes bad, diarrhea, and tired, and the outcome of loss of appetite/can''t really eat was not reported. This report was non-serious.


VAERS ID: 1657744 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Body temperature, Chest discomfort, Chills, Decreased appetite, Discomfort, Feeling abnormal, Gastrointestinal pain, Headache, Illness, Insomnia, Muscle tightness, Muscular weakness, Pain, Pyrexia, Unevaluable event
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 99.5 temperature
CDC Split Type: USJNJFOC20210858507

Write-up: FELT LIKE ALMOST LITERALLY BIT THE BULLET/INABILITY TO GET COMFORTABLE; UNABLE TO SLEEP; CONSTANT URGE TO STRETCH; NO APPETITE; SICK; ACHES; DISCOMFORT; UNCOMFORTABLE ACHY GUT; ENTIRE AREA WAS LIKE BAD MENSTRUAL CRAMPS; TIGHTNESS IN CHEST; MOSTLY BILE; LEGS WERE VERY WEAK; CHILLS; FEVER 99.5 TEMPERATURE; HEADACHE; This spontaneous report received from a patient concerned a 66 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced felt like almost literally bit the bullet/inability to get comfortable. On AUG-2021, the patient experienced unable to sleep. On AUG-2021, the patient experienced constant urge to stretch. On AUG-2021, the patient experienced no appetite. On AUG-2021, the patient experienced sick. On AUG-2021, the patient experienced aches. On AUG-2021, the patient experienced discomfort. On AUG-2021, the patient experienced uncomfortable achy gut. On AUG-2021, the patient experienced entire area was like bad menstrual cramps. On AUG-2021, the patient experienced tightness in chest. On AUG-2021, the patient experienced mostly bile. On AUG-2021, the patient experienced legs were very weak. On AUG-2021, the patient experienced chills. On AUG-2021, the patient experienced fever 99.5 temperature. On AUG-2021, the patient experienced headache. Treatment medications included: acetylsalicylic acid. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like almost literally bit the bullet/inability to get comfortable, unable to sleep, constant urge to stretch, discomfort, uncomfortable achy gut, entire area was like bad menstrual cramps, tightness in chest, fever 99.5 temperature, headache, legs were very weak, chills, aches, sick, no appetite and mostly bile was not reported. This report was non-serious.


VAERS ID: 1657772 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-02-01
Onset:2021-08-01
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: COVID test; Test Result: Positive ; Result Unstructured Data: Diagnosed with the COVID-19 last week
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Diagnosed with COVID-19 after Moderna COVID-19 vaccine (approximatelly five months after vaccination; Diagnosed with COVID-19 after Moderna COVID-19 vaccine and was experiencing respiratory symptoms and chest pressure; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19 after Moderna COVID-19 vaccine and was experiencing respiratory symptoms and chest pressure) and DRUG INEFFECTIVE (Diagnosed with COVID-19 after Moderna COVID-19 vaccine (approximatelly five months after vaccination) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (Diagnosed with COVID-19 after Moderna COVID-19 vaccine and was experiencing respiratory symptoms and chest pressure). On an unknown date, the patient experienced DRUG INEFFECTIVE (Diagnosed with COVID-19 after Moderna COVID-19 vaccine (approximatelly five months after vaccination). At the time of the report, COVID-19 (Diagnosed with COVID-19 after Moderna COVID-19 vaccine and was experiencing respiratory symptoms and chest pressure) and DRUG INEFFECTIVE (Diagnosed with COVID-19 after Moderna COVID-19 vaccine (approximatelly five months after vaccination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 test: positive (Positive) Diagnosed with COVID-19 last week. Patient went to the ER where treated with an experimental IV cocktail and was discharged to rest and quarantine at home. No concomitant medications were reported.


VAERS ID: 1657809 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-01-01
Onset:2021-08-01
   Days after vaccination:212
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: 8 months between the first and second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 months between the first and second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 months between the first and second dose). In August 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 months between the first and second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided.


VAERS ID: 1657915 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-24
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Anaphylactic shock, Anger, Arthralgia, Back pain, Dyspepsia, Near death experience, Pain in extremity, Pulmonary pain, Seizure
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101108934

Write-up: The patient felt like death. The patient literally felt like dying.; Anaphylactic shock; whole body was in the seizure; stomach felt like bonfire; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; legs hurt; angry; This is a spontaneous report from a non-contactable consumer (patient self). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 24Aug2021 (Batch/Lot number was not reported) at the age of unknown as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date at the age of unknown as single dose for COVID-19 immunization. The patient was angry in Aug2021 because the last night (24Aug2021) he/she was in an anaphylactic shock after taking second Pfizer jab. The stomach felt like bonfire on 24Aug2021. The patient felt like death. The patient literally felt like dying. The patient called doctor. And a bunch of other conditions. The vaccine destroyed the whole body. It was not the shock. It was lungs, back, shoulder blade, stomach and legs hurt on 24Aug2021. The whole body was in the seizure on 24Aug2021. Outcome of the events was unknown. No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1658728 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-03-01
Onset:2021-08-01
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6203 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6208 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Induration, Pain in extremity
SMQs:, 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: Lovastatin 40mg Lisinopril 30mg Topriomel 50mg Aspirin 81mg
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient is having pain in the right side back of the head. Patient also has a lump there. Pain started a few weeks ago and is gradually intensifying.


VAERS ID: 1658811 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain
SMQs:, 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: Na
Current Illness: Na
Preexisting Conditions: Na
Allergies: Na
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chest pains every day since first shot


VAERS ID: 1658967 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-02-25
Onset:2021-08-01
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3302 / 2 - / -

Administered by: Work       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue, Intensive care, Mechanical ventilation, Nausea, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

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

Write-up: PUI stated that symptoms started on 07/18/2021 With slight fever loss of taste and smell, sore throat, Cough, fatigue nausea Symptoms resolved by 08/04/2021 PUI Was admitted to hospital from 8/1/2021 to 8/4/2021 PUI was in ICU the entire stay and he was on mechanical ventilation, but he was never intubated. Patient is fully vaccinated and has tested positive.


VAERS ID: 1659018 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-31
Onset:2021-08-01
   Days after vaccination:123
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031B21A / 2 - / -

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive, Sinusitis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: PUI is still hospitalized at Hospital. PUI has a compromised immune system and takes Prednisone for ulcerative colitis. She is long term case taking Prednisone. PUI thought she had a sinus infection and went to her primary care physician and was given rounds of doxycycline and did not improve. PUI began having shortness of breath. PUI went to Family Care where she tested positive for Covid-19 and was given steroids and an inhaler and sent home. PUI did not improve and ended up in the emergency room at Hospital where they tested her and sent her to Hospital another location to receive Monoclonal antibody treatment for five days. PUI was on oxygen until today when she started to improve.


VAERS ID: 1659107 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-07-24
Onset:2021-08-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011D21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020F21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site nodule, Pain in extremity, Wrong product administered
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

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

Write-up: Patient received the Pfizer vaccine series on 2/3/21 and 2/24/21. She asked to receive the Shingles vaccine on 7/24/21 but was administered the Moderna vaccine series on 7/24/21 and 8/28/21. She did not realize until after the series was complete that it was the Moderna vaccine and not the Shingrix. She reports no side effects or adverse events other than a sore arm and a small knot at the injection site that resolved on its own in a few days.


VAERS ID: 1659170 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-01-28
Onset:2021-08-01
   Days after vaccination:185
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3249 / UNK LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6201 / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Asthma, Bronchitis, Chest X-ray normal, Condition aggravated, Cough, Dyspnoea, Environmental exposure, Haemoptysis, Headache, Illness, Loss of personal independence in daily activities, Nasal congestion, SARS-CoV-2 test negative, Sick relative
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Infective pneumonia (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: Prenatal vitamin
Current Illness: None
Preexisting Conditions: Asthma
Allergies: None
Diagnostic Lab Data: Covid19 test (8/6/21), chest xray (8/30/21)
CDC Split Type:

Write-up: At the beginning of August I developed a cough, headache, and a bit of nasal congestion. I was on vacation, and when I returned home I received a covid19 test, on Aug 6th, which was negative. I went into urgent care of Aug 7th due to difficulty breathing with sickness and my asthma. The nurse practioner diagnosed me with bronchitis. I was put on Prednisone for 4 days and issued an inhaler (my inhaler was expired and hadn''t been used for years).I again went in on Aug 13th, and the bronchitis continued. They put me on a decreasing dose of prednisone, an antibiotic, and some coughing medication. I last went in on Aug 30th, where I had a chest xray due to having some blood in my coughed up mucus for a short time after waking up on 8/30/21. Chest xray came back good, and that the bronchitis continues, but no longer hindering everyday activities. I DO NOT BELIEVE THIS IS DUE TO MY VACCINE. We have had unusual drought and fires where I reside that have impacted our air quality not like I''ve ever seen. For about a month before this, we have had off an on issues with air quality. My asthma, and a cold from my 3 year old son, I believe triggered this issue. He had a cough, that was gone after about a week.


VAERS ID: 1659325 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-22
Onset:2021-08-01
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0ZZB21A / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Blood cholesterol increased, Blood pressure increased, Blood test normal, Chest discomfort, Heart rate increased, Joint swelling, Ocular hyperaemia, Palpitations, Scleral discolouration, Tinnitus, Ultrasound scan, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Hypertension (narrow), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Lipodystrophy (broad), Scleral disorders (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Moderna Dose 1-02/18/2021 - VAERS report filed.
Other Medications: no
Current Illness: no
Preexisting Conditions: High Cholesterol
Allergies: z-pack; septra antibiotic
Diagnostic Lab Data: complete labs- noticed my cholesterol went up from 142 to 212 after the vaccine ultrasound- results I will receive 09/01/2021 blood work labs for liver, pancreas results negative
CDC Split Type: vsafe

Write-up: On 08/01/2021, about 10 day after my vaccine, I started to have rapid heart beat, I call this adverse events because this isn''t normal. My eyes turned red. My ears are ringing I bought a blood pressure monitor and I realized my blood pressure was spiking. Every time I try to lay down now, my heart starts beating real fast, every time I lay down. I have to sit up to go to sleep. And my ears are ringing nonstop. My vision has gotten blurry. I have fluid in my ankles and the swelling won''t go down. I have been having heaviness in my chest. All this is still occurring as of now. I am going to different doctors. The are doing different observations because I had never had these conditions prior to the Moderna. I went to a vascular doctor because of the fluid around my legs and they tell me it''s a sign of heart failure when fluid builds up around your legs. I went to my eye doctor, the prescription in my left eye has gone down and she said my eyes are yellow and I should get that checked. I went to my ENT, because I have ringing in my ears. Gastrointestinal doctor- my stomach was hurting and he did an ultrasound on my stomach. All the pain is on my left side under my left breast. On 09/08/2021 I will go to my cardiologist. I have gone from being a healthy person to a person who is at the doctors 2 or 3 day a week after the Moderna Dose 2. I''m just doing a round robin doing test for all these doctors. My heart palpitations doesn''t stop. I have to sit up to sleep.


VAERS ID: 1659497 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-06-25
Onset:2021-08-01
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arrhythmia, Condition aggravated, Dyspnoea, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vit D3 Cal-Mag Multi
Current Illness:
Preexisting Conditions: Had worked very hard to keep heart palpitations to a minimum. When under western medicine doctors had at least 3 drugs and still tons of palpitations, irregular beats, and all forms of arrhythmias including regular gray outs and once or twice blackouts due to lack of oxygen to the brain. So healed self, off all medications had very few irregular beats only if fighting a virus would I have palpitations
Allergies: Foods: preservatives, sulfites, nightshades, Not sure of what all but many things so live a very clean diet and topical products are organic and close to their natural state as possible. If I go to a restaurant usually have a reaction but am not sure what to. So I don''t I just cook good organic basic meals
Diagnostic Lab Data:
CDC Split Type:

Write-up: Significant increase in heart palpitations, arrhythmias, and strong beat. Gray-outs when exerting, like hiking in mountains. Shortness of breath has increased. Started a week or two after the second vaccination


VAERS ID: 1659712 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-04-07
Onset:2021-08-01
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia
SMQs:, Arthritis (broad)

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

Write-up: Pain in left hip


VAERS ID: 1659731 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-14
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK RA / IM

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

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

Write-up: Redness and swelling 7days after vaccination.


VAERS ID: 1659927 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-13
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

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

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

Write-up: I''ve experienced occasional shortness of breath. When this happens, I cough and cannot take a deep breath. I''ve never had asthma or bronchitis, but I''ve seen others with these issues and mine seems to resemble theirs when it occurs.


VAERS ID: 1660330 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-07-29
Onset:2021-08-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 054C21A / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ageusia, Taste disorder
SMQs:, Taste and smell disorders (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: Gabapentin, Zoloft, Famotidine, Zyrtec, Seroquel
Current Illness: None
Preexisting Conditions: Endometriosis, Scoliosis, Asthma, Depression, Anxiety, Chronic Idiopathic Uticaria
Allergies: Cephalosporins, Latex, Avocado, Soy, Kiwi, Eggplant, Cantaloupe, Honeydew, Dates, Figs
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Loss of taste/limited taste spectrum after second injection. Negative tests for Covid prior to vaccine.


VAERS ID: 1660973 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 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: Food allergy (stopped drinking lemonade, patient had food allergies.); Penicillin allergy (The patient had drug allergies.)
Preexisting Conditions: Medical History/Concurrent Conditions: Chickenpox; Prostate cancer; Comments: The patient had one shot of vaccine, had no past history of similar event, had not taken any vaccine since childhood, no adverse event after any previous vaccinations. He had no history of hospitalization in last 30 days with cause, had no family history of any disease (relevant to vaccination) or allergy. The patient had no other suspected causes including co-administered vaccines or risk factors. The patient did not know of pre-existing acute illness 30 days prior to vaccination and also stated that even not known for prostate thing (had history of prostate cancer) was still a problem and haven''t had prostate-specific antigen (PSA).
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: COVID-19 antibody test; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210857423

Write-up: CONFIRM IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 72 year old male. The patient''s weight was 180 pounds, and height was 175.26 centimeters. The patient''s past medical history included prostate cancer and had chickenpox for which the patient''s mom gave him lemon tea and he broke out worse. It was reported that the suspected was lemon. The patient had food and drug allergies mainly of penicillin allergy and lemon (lemonade, lemon tea) allergy for which stopped drinking lemonade. The patient had one shot of vaccine, had no past history of similar event, had not taken any vaccine since childhood, no adverse event after any previous vaccinations. He had no history of hospitalization in last 30 days with cause, had no family history of any disease (relevant to vaccination) or allergy. The patient had no other suspected causes including co-administered vaccines or risk factors. The patient did not know of pre-existing acute illness 30 days prior to vaccination and also stated that even not known for prostate thing (had history of prostate cancer) was still a problem and haven''t had prostate-specific antigen (PSA). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: unknown) dose was not reported, 1 total administered on 26-JUN-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in early AUG-2021, the patient tested negative for COVID-19 antibody test (confirm immunological vaccine failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirm immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number: 90000191365 Additional information was received from patient on 30-AUG-2021. The following information was updated and incorporated into the case: The patient''s height, weight, pre medical history (prostate cancer, chickenpox, penicillin allergy and lemon (lemonade, lemon tea) allergy), PQC number was added.; Sender''s Comments: V2-The following information was updated and incorporated into the case: The patient''s height, weight, pre medical history (prostate cancer, chickenpox, penicillin allergy and lemon (lemonade, lemon tea) allergy), PQC number was added. 20210857423;COVID-19 VACCINE AD26.COV2.S-Confirm immunological vaccine failure This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1660987 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse drug reaction, Blood glucose abnormal, Blood glucose increased, COVID-19, Myocardial infarction, Unevaluable event, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions: Comments: Patient had other medical issues
Allergies:
Diagnostic Lab Data: Test Name: Blood sugar abnormal; Result Unstructured Data: 600
CDC Split Type: USJNJFOC20210860013

Write-up: 2 HEART ATTACKS; BLOOD SUGAR OF 600; WHOLE LOT OF OTHER SHIT; ALMOST DIED; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a consumer via social media (twitter) a company representative concerned a female of unspecified age, unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: diabetes, and other pre-existing medical conditions included: Patient had other medical issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported 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, after taking vaccine, the patient experienced 2 heart attacks, had blood sugar of 600 along with a whole lot of other shit and almost died so the patient was wound up in Intensive care unit. On AUG-2021, the patient experienced covid-19 infection and the suspected clinical vaccination failure and patient was still in Intensive care unit. Laboratory data (dates unspecified) included: Blood sugar abnormal (NR: not provided) 600. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 2 heart attacks, covid-19 infection, blood sugar of 600, suspected clinical vaccination failure, whole lot of other shit and almost died was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint:90000191515.; Sender''s Comments: V0: 20210860013- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20210860013-Covid-19 vaccine ad26.cov2.s-2 heart attacks, covid-19 infection, and blood sugar of 600, whole lot of other shit, almost died. This event(s) is considered unassessable. The event(s) has an 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: 1660996 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: USJNJFOC20210860159

Write-up: BLOOD CLOT; This spontaneous report received from a consumer via a company representative via social media concerned a male of an unspecified age. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, 1 total, start therapy date were not reported 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, the patient experienced blood clot after the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210860159-covid-19 vaccine ad26.cov2.s-Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: 1661001 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Musculoskeletal stiffness
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210860299

Write-up: CANT DO ANY STRENUOUS ACTIVITY WITHOUT GETTING SEVERE CHEST PAIN; NECK STIFFNESS; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 30 year old of unspecified sex. 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 17-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 AUG-2021, the patient experienced cant do any strenuous activity without getting severe chest pain. On AUG-2021, the patient experienced neck stiffness. On AUG-2021, the patient experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cant do any strenuous activity without getting severe chest pain, neck stiffness, and shortness of breath. This report was non-serious.


VAERS ID: 1661002 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Alabama  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Therapy non-responder
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chemotherapy (Patient was on chemotherapy before and after receiving the vaccine.); Endometrial cancer; Food allergy (Garlic causes patient to be ill and nauseated.); Penicillin allergy
Preexisting Conditions: Comments: Patient had no daily medication.
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Blood test; Result Unstructured Data: Negative antibodies
CDC Split Type: USJNJFOC20210860335

Write-up: Confirmed Immunological Vaccine Failure; This spontaneous report received from a patient concerned a 73 year old African American non Hispanic or Latino female. The patient''s weight was 225 pounds, and height was 66 inches. The patient''s concurrent conditions included endometrial cancer, penicillin allergy. The patient had no daily medication. The patient was on chemotherapy before and after receiving the vaccine. The patient stated that garlic caused her to be ill and nauseated. The patient experienced drug allergy when treated with codeine, hydrocodone bitartrate/paracetamol, and oxycodone hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: unknown) dose was not reported, 1 total, administered on 26-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in AUG-2021, the patient tested negative for antibody test (confirmed immunological vaccine failure) which she described as blood test. 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 a product quality complaint: 90000191551.; Sender''s Comments: V0:20210860335 -covid-19 vaccine ad26.cov2.s-confirmed immunological vaccination 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: MEDICAL HISTORY,UNDERLYING DISEASE (CHEMOTHERAPY) SPECIAL SITUATIONS


VAERS ID: 1661013 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling abnormal, Formication, Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (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: USJNJFOC20210860803

Write-up: UNUSUAL FEELING IN SKIN, ALL OVER BODY AND HEAD; FEELING LIKE CRAWLING; ITCH ALL OVER; FEELING LIKE TINGLING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced unusual feeling in skin, all over body and head. On AUG-2021, the patient experienced feeling like crawling. On AUG-2021, the patient experienced itch all over. On AUG-2021, the patient experienced feeling like tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unusual feeling in skin, all over body and head, feeling like tingling, feeling like crawling, and itch all over. This report was non-serious.


VAERS ID: 1661014 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Gait inability, Hypersomnia, Joint swelling, Rash macular
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (narrow), 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: USJNJFOC20210860947

Write-up: COULDN''T WALK ALL DAY LIKE ANKLES BROKE; VERY DIZZY LIKE VERTIGO; FALLING ASLEEP; RED BLOTCHES ALL OVER LEGS BUTT AND BALLS; SWOLLEN ANKLES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient experienced swollen ankles. On AUG-2021, the patient experienced red blotches all over legs butt and balls. On 29-AUG-2021, the patient experienced couldn''t walk all day like ankles broke. On 29-AUG-2021, the patient experienced very dizzy like vertigo. On 29-AUG-2021, the patient experienced falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swollen ankles, red blotches all over legs butt and balls, couldn''t walk all day like ankles broke, very dizzy like vertigo and falling asleep was not reported. This report was non-serious.


VAERS ID: 1661104 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Pennsylvania  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Dyspepsia, Pollakiuria
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101015705

Write-up: I have like heart burn stomach pain; I have like heart burn stomach pain; I have frequent urination; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on 06Aug2021 13:20 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced frequent urination on an unspecified date in Aug2021 and like heart burn stomach pain on 07Aug2021. It was reported that, patient felt fine on the day of vaccination and didn''t have any symptoms, patient got up this morning and had two, patient did not know two things that occurred that did not have yesterday, one was patient had frequent urination had to go every two hours and peed every two hours, with normally patient did not pee like every 4 to 5 hours so, did not know that was reaction to the shot or vaccine and the second one, patient had like heart burn stomach pain and patient had like stomach seen since, woke up this morning it growls all the time like need to fed, like had ache in the wall but patient eat like every 4 hours and did not have that problem yet today after the shot but that just started this morning. Patient thought may be could find out if that was the a reaction to Pfizer COVID shot and wanted to know if it had anything to do with this vaccine. 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: 1661109 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Paraesthesia, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101023497

Write-up: I also has blurred vision; Tingling in my legs, arms and feet and its persistent/They are tingling like pins and needles; This is a spontaneous report from contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA6780, Expiration date: Unknown), via an unspecified route of administration on 05Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Aug2021, the patient experienced I am experiencing today and through the night is tingling in my legs, arms and feet and it''s persistent; I also has blurred vision; they are tingling like pins and needles. Consumer stated he has blurred vision was that something normal or do he need to seek medical attention immediately or what was that. When paraphrased above concern, Consumer stated, they are tingling like pins and needles, do you understand that, exactly yes. Consumer stated, So they are closed today and tomorrow, what do I do, how would I know if need go and seek medical attention immediately or I should wait, if I really go to the hospital for something if I know that emergency. When probed for the concern, caller stated, "I had already called someone (Pfizer Drug Safety) to report an adverse side effect. The clinical outcome of events blurred vision was unknown and outcome of other event Paraesthesia was not recovered.


VAERS ID: 1661117 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: COVID-19 Test; Test Result: Positive
CDC Split Type: USPFIZER INC202101057933

Write-up: received her first dose of the Pfizer Covid-19 Vaccine 2 weeks ago. She tested positive for COVID-19 last week; This is a spontaneous report from a contactable pharmacist. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient is not on any medications or have any medical conditions that the reporter is aware of. The reporter does not know if the patient had any other shots on the day she got the Covid vaccine. The patient experienced received her first dose of the pfizer covid-19 vaccine 2 weeks ago. she tested positive for covid-19 last week on an unknown date in Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date in Aug2021. Outcome of the event was not recovered. Information about lot/batch number has been requested.


VAERS ID: 1661123 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-26
Onset:2021-08-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Pruritus, Rash, Skin burning sensation
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (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 INC202101063917

Write-up: she had rash on the arm where she got the shot and the other arm as well/rash/Week after I got it; I broke out with rash; burning skin feeling; itching; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm on 26Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in 2021 for COVID-19 immunisation. The patient stated that a week after getting the second shot (Aug2021), she had a rash on the arm where she got the shot and the other arm as well. At first it had a burning skin feeling and was itching and was nothing serious. When she took Benadryl, those went away but the rash was still there. She said she never got rashes prior to receiving the vaccine. She asked how long this would last. She wanted to know if anybody have any idea how long will the rash last or what she can do about it. She is taking Benadryl and it is not itching or burning but it was still there. The outcome of the event rash was not recovered while the outcome of the rest of the events was recovered on an unspecified date. The reporter assessed the events as non-serious. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1661126 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101064329

Write-up: complications breathing; rapid heart beating; difficulty breathing; This is a spontaneous report from a contactable consumer (patients mother). A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration, on 01Aug2021 (age at vaccination: 17-years) as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not re-ported. Patient took vaccine around 1 o''clock, and around 9 o''clock that night she had a complications breathing and rapid heart beating so they were thinking about a follow up with the heart specialist on Thursday, on an unspecifed date in Aug2021. So patient mothers question was whether she should take the second vaccine? Because she read about myocarditis and need someone to guide me and tell me if her daughter needs to take a second vaccination having so difficult with the first one. Explained that Pfizer was unable to provide treatment recommendations. Explained that she would be happy to check our information regarding reports of symptoms that her daughter experienced but the question that she was asking if her daughter should get a second dose based on the symptoms experienced would need to be addressed by a treating HCP. Explained one more time that they were unable to provide treatment recommendations. At this point caller stated: so you just don''t know you just gonna do what do what the other people did, you just gonna read. At this point caller asked: are you going to document this? Explained that she will be happy to connect her to our safety group to document her daughter experience. Caller agreed to be transferred to safety, stated that she already reported that to pharmacy. Pharmacy told her to call and report it to Pfizer. Upon a verification caller indicated that her daughter got a vaccine on 01Aug2021, stated her daughter was due for a second dose of the vaccine this weekend stated: I am scared to death to give her a second one. Initially she spoke to safety agent withheld however our call got disconnected. She got back on the line to explain to the caller what happen and offer to connect her to another agent. After explanation caller stated. She had been doing this for over an hour and this was ridiculous that nobody wanted to answer her call be-cause of what happened they don''t want to document it. She was going to stay on this phone all day if I have to. Caller stated: you know what they connect me to people but then you know what happens when I start to talk about my daughter situation they hung up on me. Caller stated next time I am going to have a lawyer to use my phone and he will say what happened because every time I start to talk about my situation, my daughter they hung up on me. Explained to the caller that I will make another attempt to connect her to safety and that I will document her feedback. As caller was transferred to safety caller also mentioned to safety that her daughter had a difficulty breathing. Patients mother wanted to know what does Pfizer recommend for people who experience Microcardia? She had read it can get worse with the second vaccine. She wanted advice. How was Pfizer telling people to get this vaccine when they cannot give advice. The outcome of event was unknown.


VAERS ID: 1661134 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Massachusetts  
Vaccinated:2021-07-01
Onset:2021-08-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWA96 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac flutter, Dyspnoea, Swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101065423

Write-up: Have been having some heart fluttering like on the chest; Got little short of breath; Heart swelling; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified route in Jul2021 (Batch/Lot Number: EWA96) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated, "I am just calling of this number because it says that possible side effects, I have got the shot like 3 weeks ago and I am due for the second shot today (17Aug2021) but last couple of days (Aug2021) I have been having some heart fluttering like on the chest, so I don''t know if I have any heart swelling or what do you call it, you know the heart, something to my heart I am not sure if it is, I have like heart fluttering, it would go away, it come back and go away like I feel like may be got little short of breath, I think that I am not sure about but I am, should I get the second shot that''s what I am asking?". The patient was having heart fluttering last for 3 or 4 days but now it seemed to be going hopefully. The outcome of the event "Have been having some heart fluttering like on the chest" was recovering, of the other events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1661142 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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-19; Result Unstructured Data: Test Result:Positive
CDC Split Type: USPFIZER INC202101067126

Write-up: My daughter received Covid Vaccine last Monday and then she got Covid; now she has Covid; My daughter received Covid Vaccine last Monday and then she got Covid; now she has Covid; This is a spontaneous report from a non-contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration in Aug2021 (Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient''s daughter received Covid vaccine last Monday and then she got covid; now she has Covid in Aug2021. The patient underwent lab tests and procedures which included Covid-19/ SARS-CoV-2 test: positive in Aug2021. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1661146 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, Dizziness, Extra dose administered, Fall, Head injury, Loss of consciousness, Off label use, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101068458

Write-up: Patient took 3rd dose of Pfe/btech Covid 19 vaccine at 5 pm on 16Aug; Patient took 3rd dose of Pfe/btech Covid 19 vaccine at 5 pm on 16Aug; dizzy; burning sensation throughout the body; fell; hit her head; unconscious; fainted; This is a spontaneous report from a non-contactable consumer (patient). An elderly (over 65 years old) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16Aug2021 17:00 (Batch/Lot number was not reported) as dose 3, single for COVID-19 immunisation. Medical history included underlying heart condition. Patient was petit. The patient''s concomitant medications were not reported. The patient previously received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunisation.The patient took 3rd dose of Pfe/btech Covid 19 vaccine at 5 pm on 16Aug2021. At 3 am, she awoke and felt dizzy and burning sensation throughout the body and then proceeded to the bathroom and while en route fell, hit her head and fainted in Aug2021. It''s unclear if fainting occurred after she hit her head or prior to. Patient fell unconscious and did not remember the whole incidence in Aug2021. Patient regained consciousness and was being evaluated by their HCPs. She appeared stable. Event took place after use of product. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1661174 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-01
Onset:2021-08-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Illness, 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-19; Test Result: Positive
CDC Split Type: USPFIZER INC202101075199

Write-up: tested positive for Covid19; tested positive for Covid19; sick; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on an unspecified date in late Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for Covid19 a couple of weeks later, has been sick for about 2 1/2 weeks. Patient would like to know that when he can get second dose. The patient underwent lab tests and procedures which included Covid-19 (sars-cov-2 test): positive on an unspecified date in Aug2021. The outcome of the event was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events Drug Ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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: 1661189 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Dyspepsia, Fatigue, Heart rate, Heart rate increased, Near death experience, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19.
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: Heart rate; Result Unstructured Data: Test Result: 106; Comments: increase in heart rate and that it was 106 bmp at rest.; Test Date: 202103; Test Name: COVID 19; Result Unstructured Data: Test Result: had the COVID 19 virus; Comments: she previously had the COVID 19 virus in March2021.
CDC Split Type: USPFIZER INC202101076016

Write-up: Severe pain in the stomach; Increase in heart rate; her arm "hurt like hell"; Scared to death of COVID; Heartburn; Tired; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 06Aug2021 as dose 1, single for covid-19 immunisation. Medical history included covid-19 virus from Mar2021 to an unknown date. The patient''s concomitant medications were not reported. On unknown date in Aug2021, the patient experienced scared to death of covid; heartburn; tired; her arm "hurt like hell"; On 09Aug2021, increase in heart rate; On 12Aug2021, severe pain in the stomach. The patient underwent lab tests and procedures which included heart rate: 106 on 09Aug2021 increase in heart rate and that it was 106 bmp at rest, sars-cov-2 test: had the covid 19 virus on Mar2021 she previously had the COVID 19 virus in March2021. It was reported that stated that she was looking for some information on the Pfizer COVID 19 vaccination and the symptoms she has experienced since her first dose. She stated that she previously had the COVID 19 virus in Mar2021. She stated that she is healthy and has no underlying conditions. She stated that she waited for 3-4 months after having COVID because she had antibodies. She stated that she''s an elementary school teacher for younger children and she wanted to be fully vaccinated before school started back in September. She stated that she was "scared to death of COVID and did not think she will make it if she gets it again". Once she had her first dose she states that she was fine with the regular side effects and knew what to expect. She mentioned that her arm "hurt like hell" and that she was tied but that wasn''t a problem because she was used to being tired. She got it on the 6th which was a Friday and on the 9th she reported having an increase in heart rate and that it was 106 bmp at rest. She reports that it was the same on the 10th. Elevated heart rate went away and she states that she figured her body was just making antibodies. She then reported on the 12th she began having severe pain in the stomach and it felt like bubbles and somewhat like heartburn. She stated that on the 13th it got worse and then started to level out on the 14th. On the 16th,17th,18th and today the 19th its gradually gotten better but still at a moderate level. She compares it to inflammation of the intestines and/or esophagus and that she was "beside herself". She relays that she spoke with her doctor and they asked if it could possible be something she ate that caused these symptoms. She stated that she had not had any foods that were out of the ordinary for her and had no tried any new foods or experimented with anything she provided an example of, "like, spicy Indian food or anything like that". The clinical outcome of event increase in heart rate was recovered on unknown date in Aug2021; outcome of severe pain in the stomach was recovering; while other events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1661192 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2021-01-26
Onset:2021-08-01
   Days after vaccination:187
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / 1 - / -

Administered by: Public       Purchased by: ?
Symptoms: Body mass index, 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: 20210801; Test Name: BMI; Result Unstructured Data: Test Result:48.5; Test Date: 20210801; Test Name: NAAT Covid test; Test Result: Positive
CDC Split Type: USPFIZER INC202101076360

Write-up: she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 37 patients. This report is for 22nd of 37 patients. This consumer reported for a 38-year-old female patient. A 38-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN5318) via an unspecified route of administration on 26Jan2021 as dose 1, single and she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: N6203) via an unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunization at Public Health Clinic. The patient medical history and concomitant medications were not reported. On 01Aug2021 the patient experienced she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. the lot number provided (medically significant). It was reported that tested positive for COVID virus, after being fully vaccinated. Caller states that COVID positive was defined as having both vaccines and testing positive for COVID longer than two weeks after both doses. On 01Aug2021 the patient underwent lab tests and procedures which included body mass index (48.5) and sars-cov-2 test (positive). Reporter stated that an individual (non-HC) they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The caller at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide to DSU upon transfer. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients


VAERS ID: 1661226 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-21
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Diarrhoea, Disturbance in attention, Dizziness, Malaise, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Noninfectious diarrhoea (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: body temperature; Result Unstructured Data: Test Result:99
CDC Split Type: USPFIZER INC202101091193

Write-up: had aches; chills; low grade fever is the 99''s; had diarrhea all day; light headed; not feeling well; not able to stay focused; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on 24Feb2021 as UNKNOWN, SINGLE for COIVD-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 21Aug2021 the patient experienced had aches, chills, low grade fever is the 99''s, had diarrhea all day, light headed, not feeling well, not able to stay focused. On 22-AUG-2021 outcome of events was recovered. The patient underwent lab tests and procedures which included body temperature: 99 on 21Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1661233 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Allergy test, Feeling abnormal, Myositis, Nerve injury
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nerve damage (She clarified that the multiple surgeries and nerve damage was about 10 years ago.); Surgery (She has had multiple surgeries on her arm She clarified that the multiple surgeries and nerve damage was about 10 years ago.); Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Allergy test; Test Result: Negative ; Comments: Had allergy testing to see if she could get the covid vaccine and everything came back negative.
CDC Split Type: USPFIZER INC202101093447

Write-up: nerves started firing in her arm; nerves started firing in her arm. It feels like sticking her fingers in a socket; arm muscle being inflamed; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on 2021 as dose number unknown, single for covid-19 immunisation. Medical history included surgery, she has had multiple surgeries on her arm She clarified that the multiple surgeries and nerve damage was about 10 years ago, nerve injury. There were no concomitant medications. She has had no reaction in 15 years. She had allergy testing to see if she could get the covid vaccine and everything came back negative. Had allergy testing to see if she could get the covid vaccine and everything came back negative. It was Reported that, the patient experienced nerves started firing in her arm on 20Aug2021 with outcome of recovering, arm muscle being inflamed on 2021 with outcome of unknown, nerves started firing in her arm. it feels like sticking her fingers in a socket on Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included allergy test: negative on 2021 The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1662259 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-05-31
Onset:2021-08-01
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022C21A / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Computerised tomogram normal, Dyspnoea, X-ray normal
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: I was taking Potassium; Alprazolam; Amlodipine; Torsemide; Esomeprazole.
Current Illness: None
Preexisting Conditions: High BP; Potassium deficiency; back pain; Osteoarthritis; depression; anxiety; Acid reflux.
Allergies: I am allergic to Flagyl; Protonic; seafood.
Diagnostic Lab Data: CT Normal, X-ray normal
CDC Split Type: vsafe

Write-up: One day in August I went to the ER for shortness of breath. They gave me an albuterol treatment and an inhaler.


VAERS ID: 1662383 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Burning sensation, Epistaxis, Headache, Respiratory disorder, SARS-CoV-2 test, Von Willebrand's disease
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tramadol, Restoril and Prilosec.
Current Illness: 0
Preexisting Conditions: 0
Allergies: Fish
Diagnostic Lab Data: Had COVID 19 test.
CDC Split Type:

Write-up: Headache, Severe burning in both nostril''s, Severe nose bleeding X 2+ days (have VonWillebrand''s disease. Breathing issues.


VAERS ID: 1662484 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-07-26
Onset:2021-08-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood glucose decreased, COVID-19, Nausea, Productive cough, SARS-CoV-2 test positive
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (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? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ammonium lactate (LAC-HYDRIN) 12 % topical cream aspirin low dose 81 MG chew tablet Blood Glucose Monitoring Suppl (ACCU-CHEK AVIVA PLUS) w/Device KIT BREO ELLIPTA 100-25 MCG/INH AEPB busPIRone (BUSPAR) 5 MG tablet calcium-vitamin D (CALTRA
Current Illness: Patient received vaccine while hospitalized for palpitation.
Preexisting Conditions: Allergic rhinitis Essential hypertension Type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin (HCC) RLS (restless legs syndrome) Obesity Anemia Stasis dermatitis Venous stasis OSA (obstructive sleep apnea) Acute gout, unspecified cause, unspecified site Tremor, essential Stage 3b chronic kidney disease Uncontrolled type 2 diabetes mellitus without complication, with long-term current use of insulin Low back pain, unspecified back pain laterality, unspecified chronicity, with sciatica presence unspecified Poor balance PVC''s (premature ventricular contractions) Pedal edema Uncontrolled type 2 diabetes mellitus with hyperglycemia (HCC) Secondary hyperparathyroidism of renal origin (HCC) COPD (chronic obstructive pulmonary disease) (HCC) Pneumonia Bigeminy Weakness generalized Urinary retention Ventricular bigeminy Palpitations Respiratory distress, acute COVID-19 Hypoglycemia BPH (benign prostatic hyperplasia) Linear atelectasis
Allergies: None known
Diagnostic Lab Data: Patient reported COVID-19 positive test.
CDC Split Type:

Write-up: Patient presented to emergency department due to a low blood sugar reading on 8/16/2021. He was diagnosed with COVID-19 7-10 days prior to presentation. He reported some nausea and productive cough. He was admitted for further management. He was given dexamethasone but did not require antiviral or supplemental oxygen during admission. He was discharged on 8/24/2021.


VAERS ID: 1662712 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-21
Onset:2021-08-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046A21A / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Muscle twitching
SMQs:, Dyskinesia (broad), Dystonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: B Complex, D3/K2, Omega, AREDS
Current Illness: None
Preexisting Conditions: None
Allergies: None that I am aware of.
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Started with twitching feeling in between and behind toes of both feet, particularly the left. Then my third toe began moving side to side. I began occasionally and is now daily, all day and night, clicking at 10-15 minutes apart. Saw big toe move only once. Feel nerve endings firing in right foot but have not seen movement yet. Can feel nerves in both feet all day/night. Even in bed.


VAERS ID: 1662836 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-05-06
Onset:2021-08-01
   Days after vaccination:87
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Chest pain, Cough, Dizziness, Dyspnoea, Headache, Hypoxia, Occupational exposure to SARS-CoV-2, Pleuritic pain, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lasix, prevacid, K-dur, trazadone
Current Illness:
Preexisting Conditions: GERD, diverticulitis of colon, gout, hyperlipidemia, mild obesity
Allergies: None
Diagnostic Lab Data: COVID positive test on 08/01/2021
CDC Split Type:

Write-up: Fully vaccinated patient admitted to hospital for COVID. Patient with positive COVID exposure reported at work on 07/25/21. Fully vaccinated with Jansenn vaccine in May. Patient admitted through ED for shortness of breath and hypoxia at 88%. Admitted for shortness of breath, dizziness, headache, cough, pleuritc chest pain. Recieved Remdesivir, Decadron, Actemra, IV lasix, ATB''s. Sent home on portable O2 and 3L/nasal cannula.


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