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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 331 out of 7,116

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VAERS ID: 1646435 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-22
Onset:2021-07-30
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: covid rapid test; Test Result: Negative ; Comments: Rapid test result was actually negative; Test Date: 20210730; Test Name: Nasal swab test; Test Result: Positive ; Comments: because of the symptoms she was experiencing they decided to do the other nasal swab test and sent it off
CDC Split Type: USPFIZER INC202100999505

Write-up: tested positive for covid infection; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 22Jul2021 (Batch/Lot Number: FA7484) as dose 1, single (at the age of 44 years old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first dose of the Pfizer BioNTech Covid-19 Vaccine last 22Jul2021 and tested positive for covid infection last 30Jul2021. She is scheduled to have her second dose on 12Aug2021. The patient asked if she should she get the second vaccine dose on 12Aug021 or does she need to wait. She took the covid test on Friday 30Jul2021 in the ER. She was not admitted into the hospital she was sent back home the same day. The positive result was notified to her on Sunday 01Aug2021. It was 2 tests actually done, they did a rapid and a test that was sent off for which the results would come in 2-3 days. Rapid test result was actually negative, but because of the symptoms she was experiencing they decided to do the other nasal swab test and sent it off. She was at work on Friday and felt like she was hit by a bus or run over. Her muscles were aching, she had a head cold but without the symptoms in the head, the inside of her nostril and the back of the throat was raw and everything even while breathing felt raw. It felt horrible. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1646480 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Headache, Occupational exposure to SARS-CoV-2, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), 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? 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: 20210730; Test Name: tested positive for COVID-19 via PCR testing; Test Result: Positive.
CDC Split Type: USPFIZER INC202101001915

Write-up: This is a spontaneous report from a contactable other hcp (nurse). A 4-decade-old (at late 30s) male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 intramuscular on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient''s wife reported she tested positive for COVID-19 after receiving both doses of the Moderna COVID-19 vaccine. She reports she was indirectly exposed to a patient who had not been vaccinated on Friday and swabbed the same day. The PCR test results came back positive for COVID-19 yesterday, 01Aug2021. Patient who was also fully vaccinated with the Pfizer vaccine, was directly exposed to an unvaccinated patient and also tested positive for COVID-19 via PCR testing (medically significant). The reporting HCP states she tested positive after exposure, but was completely asymptomatic, while the patient experienced a dry cough and a little headache for one day, the patient underwent lab tests and procedures which included sars-cov-2 test positive on 30Jul2021. Declined to provide any identifiers other than initials, age, and gender. No additional information obtained. Safety team follow-up consent provided for reporter. The clinical outcome of event headache and dry cough was recovered on 31Jul2021 and for all other events outcome was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected. Sender''s Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.


VAERS ID: 1646491 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-07-30
Onset:2021-07-30
   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 FA7485 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure measurement, Feeling abnormal, Hypertension, Pain in extremity, Peripheral swelling, Vaccination site swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: Blood pressure; Result Unstructured Data: Test Result:188/122
CDC Split Type: USPFIZER INC202101003310

Write-up: blood pressure was high; at 188/122; one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny; one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny; She took the shot Friday (30Jul2021) and they had taken it in the left shoulder. It was swollen that Friday and Saturday, Sunday, Monday and Tuesday and until today and she was at work.; her left hand, the fingers were swollen; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left (left shoulder) on 30Jul2021 (about 12:15 or 12:30) (Lot Number: FA7485) as DOSE 2, SINGLE for covid-19 immunization. Medical history and family history included high blood pressure. Concomitant medication included losartan taken for high blood pressure from May2021 and from Jun2021. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jul2021 (lot number EW0198) for covid-19 immunization. The patient was calling regarding the Pfizer Covid vaccine. She took the shot Friday (30Jul2021) and they had taken it in the left shoulder. It was swollen that Friday and Saturday, Sunday, Monday and Tuesday and until today and she was at work. In her left hand, the fingers were swollen. She could not lay on her left arm. It was the fingers on the left side and it was on Monday and Tuesday. Today (04Aug2021), one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny. It kind of throbs but was kind of the same. The patient did not receive treatment for these events, she just took her blood pressure medicine. The events did not require visit to emergency room but she was going to go today (04Aug2021), this morning when she got up to take her blood pressure pill, her blood pressure was high. It was basically 188/122. Her hand was still swollen. The patient was advised to contact her primary care provider for any medical advice. Outcome of the event "blood pressure was high; at 188/122" was unknown, while not recovered for other events. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646582 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-07-30
Onset:2021-07-30
   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 ER8737 / 1 - / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Flushing, Hypersensitivity, Malaise, Off label use, Product use issue, Pruritus, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101008328

Write-up: did not feel good; Welts from head to toe/was itchy like a rash/red with welts all over; Diarrhea; allergic reaction; itchy like rash/itching all over; fever; flushed; got another vaccine on the same date as the COVID-19 injection, MENACTRA; got another vaccine on the same date as the COVID-19 injection, MENACTRA; This is a spontaneous report from a contactable nurse (patient''s mother). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the arm (reported as deltoid/arm), in the afternoon of 30Jul2021 (Batch/lot number: ER8737), at age 17 years old, as dose 1, single, for COVID-19 immunisation; and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration, administered in the arm (reported as deltoid/arm), on 30Jul2021 (reported as same date as BNT162B2) (Batch/lot number unknown), as second dose, for meningitis immunisation. Relevant medical history was reported as none. There were no concomitant medications. Historical vaccine included meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) received on an unspecified date, as the first dose, for meningitis immunsiation and the patient did not have any problems after this. The patient had no prior vaccinations within 4 weeks. On 30Jul2021, the patient received BNT162B2. The patient got another vaccine on the same date as the COVID-19 injection, MENACTRA. On 04Aug2021, the started complaining of welts. It was from head to toe. It was itchy like a rash. At first, the reporter thought it was bug bites. He had it all over, it was even behind his ears. It was flushed. Maybe it was from the scratching he''d been doing. He was red with welts all over. The reporter thought the patient had fever, but the patient did not think he had fever and was saying he did not have fever. The patient would not allow the reporter to take his temperature. The patient also had diarrhea. On 05Aug2021, the patient did not feel good and added he was having diarrhea and itching all over. The diarrhea was pretty bad and was worse than the day before. It was reported that welts and diarrhea worsened. The patient''s breathing was fine. The reporter sounded like she stated that "maybe they gave too much" (as reported). The reporter stated that with allergic reaction, she did not think much can be done unless it affects breathing. She then stated, "is there anything that can be done?" The reporter gave the patient some BENADRYL 50 mg. The reporter wanted to know if the patient should get the second shot and if it will be safe. The events did not result to emergency room and physician office visits. The outcome of urticarial rash and diarrhea was not recovered. The outcome of the remaining events was unknown. The reporter assessed the events urticarial rash and diarrhea as serious (medically significant).; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of "Urticarial rash" "Diarrhoea" due to temporal relationship and current known drug safety profile. 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: 1646639 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-15
Onset:2021-07-30
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 2 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Amnesia, Balance disorder, Dizziness, Feeling abnormal, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular 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 INC202101013081

Write-up: Memory loss; Dizziness; Balance off; In a fog; Visual disturbance; This is a spontaneous report from a contactable physician. A 15-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an intramuscular route of administration in the left arm on 15Jul2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known drug allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an intramuscular route of administration in the left arm on 24Jun2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. On 30Jul2021, the patient experienced memory loss, dizziness, balance off, visual disturbance and the patient was in a fog. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events memory loss, dizziness, balance off, visual disturbance, and in a fog were not resolved at the time of this report.


VAERS ID: 1646690 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-07-30
Onset:2021-07-30
   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 FA7485 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Dyspnoea, Lung disorder, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: TOPIRAMATE; METOPROLOL; LISINOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CML (in remission); COPD; Heart disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: BP; Result Unstructured Data: Test Result:198/120; Comments: 196/110 plus still at 110 after 2 hours rushed to hospital
CDC Split Type: USPFIZER INC202101013992

Write-up: my face began to swell; my BP went to 198/120 plus 110/196/110 plus still at 110; I was unable to breath and chocking on my own fluids in my lungs; My lungs were chocking me; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in left arm on 30Jul2021 at 14:15 (Batch/Lot Number: FA7485) as a single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD), chronic myeloid leukaemia (CML) in remission and heart condition. Concomitant medications included topiramate, metoprolol and lisinopril; all taken for an unspecified indication from an unknown date. 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 not been tested for COVID-19. About thirty minutes after the injection at 16:00, the patient face began to swell, and her BP went to 198/120 plus 110. Then 2 hours later she was rushed to hospital and was unable to breath and chocking on her own fluids in her lungs. She arrived at hospital unable to breathe nor catch her breath. Her lungs were chocking her, and her BP was 196/110 plus still at 110. After entering emergency room (ER) they had no clue what to do and treated her as a covid patient. She needed a nebulizer and was told the ER doctor couldn''t give it to her there and no beds were available. The doctor gave her pills without explaining and then kept treating her like she came in for covid. She had the worst reaction of her life and was treated horribly. The doctor did not give her discharge paperwork, nor did hospital follow up. It was not until she went yesterday to her GP and he even said the notes were missing information, also the doctor supposedly sent me with prescriptions which she never got. She encountered, all side effects of the shot. The adverse events resulted in emergency room/department or urgent care. The outcome of the events was recovered with sequel. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on plausible dose-event temporal relationship likely hypersensitivity post-vaccination the causal role of bnt162b2 vaccine cannot be excluded for reported events. Underlying CMLL and chronic onstructive pulmonary disease are significant risk factors. 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: 1646826 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-07-26
Onset:2021-07-30
   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 EW0217 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Autoimmune encephalopathy, Inappropriate schedule of product administration, SARS-CoV-2 test, Status epilepticus
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Noninfectious encephalopathy/delirium (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: COVID-19 Test/Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC202101023460

Write-up: auto-immune encephalopathy; acute respiratory failure; refractory status epilepticus; dose 2: 26Jul2021, dose 1: 05Jun2021; This is a spontaneous report from a contactable nurse. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 26Jul2021 11:15 (lot number: EW0217) at the age of 40 years as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 intramuscular on 05Jun2021 (lot number: EW0191) at the age of 39 years as single dose for covid-19 immunisation. Adverse event concerned for auto-immune encephalopathy, acute respiratory failure, refractory status epilepticus. Adverse event start date was 30Jul2021. AE resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Treatment was received. AE treatment plex for autoimmune encephalitis. Covid tested post vaccination, test type post vaccination=Nasal Swab on 07Aug2021, negative. Outcome of events were not recovered.; Sender''s Comments: Based on the available information in the case, the causal association between the events autoimmune encephalitis, acute respiratory failure, status epilepticus 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: 1646866 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-07-22
Onset:2021-07-30
   Days after vaccination:8
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: COVID-19, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Covid test; Test Result: Positive
CDC Split Type: USPFIZER INC202101027582

Write-up: tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable female consumer (patient) reported for herself that. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 22Jul2021 (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. It was reported that patient received the first dose of vaccine last 22Jul2021 and tested positive for Covid last 30Jul2021. Patient asked when her schedule was to receive the second dose. 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: 1646901 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-02-17
Onset:2021-07-30
   Days after vaccination:163
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Illness, 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Nasal Swab; Test Result: Positive.
CDC Split Type: USPFIZER INC202101028962

Write-up: This is a spontaneous report from a contactable other Healthcare Professional. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular route of administration on 17Feb2021 (at the age of 53-year-old), as dose 2, single in left arm, and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular route of administration on 27Jan2021 (at the age of 53-year-old), as dose 1, single in left arm for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported as unknown if the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported as unknown if the patient had COVID prior vaccination and the patient was tested COVID post vaccination. On 30Jul2021, 5 months and 13 days after second dose of vaccine, the patient was tested positive for COVID and became ill. The patient visited to Doctor or other healthcare professional office/clinic in response to event. It was reported as unknown if the patient received any treatment for event. The patient underwent lab tests and procedures which included SARS-CoV-2 test nasal swab, positive, on 30Jul2021. The clinical outcome of the events was reported as resolving. Based on the available information ,a possible contributory role of suspect product BNT162B2 to the development of the event covid 19 cannot be excluded.


VAERS ID: 1647077 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-07-30
Onset:2021-07-30
   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 FA7484 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ear swelling, Pharyngeal swelling, Pruritus, Rash
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE [LEVOTHYROXINE SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic fatigue syndrome (chronic fatigue immune syndrome CFIDS diagnosed in 1992); Latex allergy; Penicillin allergy (Erythromycin (Erythromycin is used for people that are allergic to penicillin))
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101041040

Write-up: itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm in a pharmacy or drug store facility on 30Jul2021 09:00 (Batch/Lot Number: FA7484) (at the age of 61-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Medical history included chronic fatigue syndrome from 1992 (chronic fatigue immune syndrome CFIDS diagnosed in 1992), latex dermabond allergy, and known allergy to penicillin. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]). The patient previously took erythromycin (Erythromycin is used for people that are allergic to penicillin). On 30Jul2021 09:15 AM, within minutes of 1st vaccine, the patient experienced itched all over, throat and ears swelled up, rash around ribs. The patient took Cetirizine 10 mg (for reactions) it calmed it down. Took another 3 hours later and then another six hours later. Next day itching stopped. Therapeutic measures were taken as a result of the events. On 31Jul2021, the patient recovered from itched all over while outcome of the other events was recovered on unspecified date in Jul2021. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1647099 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-06
Onset:2021-07-30
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Diarrhoea, Drug ineffective, Fatigue, Feeling abnormal, Nasal congestion, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Taste and smell disorders (narrow), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Binax covid test; Result Unstructured Data: Test Result:Positive
CDC Split Type: USPFIZER INC202101041417

Write-up: 1Aug2021 tested postive covid; 1Aug2021 tested postive covid; mild congestion; mild fatigue; moderate brain fog; intermittent loose stools/ diarrhea; severe loss of taste and smell; severe loss of taste and smell; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for himself that a 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0176), dose 1 via an unspecified route of administration on 06May2021 10:15 as dose 1, single for covid-19 immunisation. Medical history included none. There were no concomitant medications. Patient known allergies was none. On 30Jul2021, the patient experienced mild congestion; mild fatigue; moderate brain fog; intermittent loose stools/ diarrhea and severe loss of taste and smell, on1 Aug2021 tested positive covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Aug2021. Patient did not receive treatment for the events. Facility type vaccine was pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received other medications in two weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. COVID test type post vaccination nasal swab. The clinical outcome of all event was recovering. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1647100 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Blood pressure increased, COVID-19, Drug ineffective, Heart rate increased, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy (Known allergies: penicillin)
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: moderate-elevated bp; Result Unstructured Data: Test Result: moderate-elevated; Comments: moderate-elevated; Test Date: 20210730; Test Name: high resting heart rate; Result Unstructured Data: Test Result: high resting; Comments: high resting; Test Date: 20210801; Test Name: COVID; Test Result: Positive; Comments: Nasal Swab, post vaccination.
CDC Split Type: USPFIZER INC202101041456

Write-up: This is a spontaneous report from a contactable consumer (reported himself). A 49-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8735), via an unspecified route of administration on an unknown date 2021 as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8735), via an unspecified route of administration on 25Apr2021 as dose 1, single for covid-19 immunisation. Medical history included Known allergies, penicillin from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 30Jul2021, the patient experienced symptoms included mild/moderate fever, chills, body aches, fatigue, head cold-cough, moderate-elevated bp (blood pressure), high resting heart rate, anxiety, and mild loss of smell and taste. The patient was tested positive covid on 01Aug2021. The events resulted in emergency room/department or urgent care visit. On 30Jul2021, the patient lab test includes moderate-elevated blood pressure, high resting heart rate. On 01Aug2021, the patient lab test included post vaccination the patient was test for covid-19 with COVID test was positive (nasal swab). The patient did not receive any treatment for the events. The outcome of the events COVID-19, moderate-elevated bp, high resting heart rate, and anxiety was resolving. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1647174 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-07-25
Onset:2021-07-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Neoplasm
SMQs:, Non-haematological tumours of unspecified malignancy (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 INC202101046856

Write-up: lump between his neck and his shoulder/got the lumps on Friday/Developed a lump in between my neck and my shoulder; This is a spontaneous report from a contactable consumer (Patient). A 27-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7484), dose 1 via an unspecified route of administration on 25Jul2021 (Age at vaccination: 27 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced "lump between his neck and his shoulder/got the lumps on friday/developed a lump in between his neck and his shoulder" on 30Jul2021. He received his first dose of the Pfizer BioNTech Covid-19 Vaccine three weeks ago. Reporter states that after five days he developed a lump between his neck and his shoulder on the side he got his injection. The lump was still there after two weeks and he was concerned. He was asking that he should consult his doctor about this. He was asking if he should get his second dose of the vaccine after experiencing this side effect from the first dose and he should get his second dose in the opposite arm given his side effects from the first dose. He received response that it sounds like he may be experiencing swollen lymph nodes, which was a commonly reported side effect of the vaccine, but advised caller that Pfizer does not assess or treat patients, and he would need to follow up with his HCP to confirm what he is experiencing.he got in response that Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, was likely to have resulted from a robust vaccine-elicited immune response. The (withheld) provides information regarding Possible Side Effects After Getting a COVID-19 Vaccine. COVID-19 vaccination will help protect you from getting COVID-19. You may have some side effects, which are normal signs that your body is building protection. These side effects may affect your ability to do daily activities, but they should go away in a few days. Some people have no side effects. Side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that your body is building protection and should go away within a few days. Call the vaccination provider or your healthcare provider if you have any side effects that bother you or do not go away. He received Response: Spoke from FAQ-COVID-19 Vaccine-receiving second dose after side effect from first dose. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Caller asking if he should get his second dose in the opposite arm given his side effects from the first dose He received Response: Informed caller that the Pfizer BioNTech Covid-19 Vaccine is an intramuscular injection. Advised caller to speak with vaccination provider at time of second dose in determining whether second dose should be given in the other arm. Informed caller that it is appropriate to receive the dose in the other arm if not contraindicated for any other reason. Consumer was informed that correct option for Medical Information is 3. Further probing could not be done as consumer hung up abruptly. Hence, product details (expiration date, NDC, UPC), purchase details and other details were unknown and limited information was available over the call. Patient did not receive any treatment for the event. The outcome of the event was not recovered. Consumer was provided with the number of Pfizer Medical Information.


VAERS ID: 1647228 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-30
Onset:2021-07-30
   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 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Cerebrovascular accident, Contusion, Deep vein thrombosis, Fibrin D dimer, Heart rate, Hypertension, Hypothyroidism, Ill-defined disorder, Imaging procedure, Paraesthesia oral, Pharyngeal swelling, Rash pruritic, SARS-CoV-2 test, Swollen tongue, Tachycardia, Thrombosis, Transient ischaemic attack
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Hypertension (narrow), Hypothyroidism (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; OMEPRAZOLE; SERTRALINE; CELEBREX; LYRICA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma; Autoimmune disorder (being monitored for autoimmune disease but not diagnosed); COVID-19; Ehlers-Danlos syndrome; Gulf war syndrome; Penicillin allergy (known allergies: Penicillins, doxycycline, clindamycin, cymbalta, higher doses of sertraline,)
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: hypertension; Result Unstructured Data: Test Result:156/100; Test Date: 20210812; Test Name: d-dimer; Result Unstructured Data: Test Result:High; Test Date: 20210812; Test Name: tachycardia; Result Unstructured Data: Test Result:156; Test Date: 20210812; Test Name: multiple imaging; Result Unstructured Data: Test Result:other clots; Test Date: 20210812; Test Name: Oral swab; Test Result: Negative ; Comments: Other Oral swab
CDC Split Type: USPFIZER INC202101048664

Write-up: hospitalized on day 13 with TIA stroke symptoms and high d dimer; sudden hypothyroid; hypertension 156/100; tachycardia 156; 3 doses of IV steroids and multiple imaging for other clots; hospitalized on day 13 with TIA stroke symptoms and high d dimer; developed a DVT 2 days after the vaccine in my left leg; Had an anaphylactic reaction within 30 minutes of the vaccine/severe autoimmune reaction to the vaccine; tongue tingling, swelling; tongue tingling, swelling; moderate throat swelling; itchy rash; Covid toes; sudden bruising; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: Fc3181, expiry date not reported) via an unspecified route of administration, administered in right arm on 30Jul2021 16:45 (at the age of 40 years old), as dose 1, single for covid-19 immunisation. Medical history included gulf war illness, asthma, allergies, Ehler danlos, known allergies to penicillins, and being monitored for autoimmune disease but not diagnosed. The patient had covid prior vaccination (date unspecified). Concomitant medications included cetirizine hydrochloride (ZYRTEC), omeprazole, sertraline, celecoxib (CELEBREX), and pregabalin (LYRICA), all taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient previously took anthrax vaccine as immunization and experienced neurocardiogenic syncope; and patient had known allergies to doxycycline, clindamycin, duloxetine hydrochloride (CYMBALTA), and higher doses of sertraline. The patient was covid tested post vaccination which included oral swab negative on 12Aug2021. Patient had an anaphylactic reaction within 30 minutes of the vaccine (30Jul2021 05:15 PM) with tongue tingling, swelling, moderate throat swelling. These reactions continued for 2 weeks and throat and tongue kept swelling off and on. Patient also developed an itchy rash and covid toes and sudden bruising on 30Jul2021 05:15 PM. Patient was hospitalized with TIA stroke symptoms and high d dimer, sudden hypothyroid, hypertension 156/100 and tachycardia 156, that all began on 12Aug2021 (also reported as on day 13). Patient received 3 doses of IV steroids and multiple imaging for other clots (12Aug2021). Patient believed patient developed a DVT on 01Aug2021, also reported as 2 days after the vaccine, in the left leg but it had seemed to resolve with aspirin so patient did not go to the ER until patient had stroke symptoms on 12Aug2021. Doctors contributed my symptoms to a severe autoimmune reaction to the vaccine (anaphylactic reaction). Adverse events (AEs) resulted in emergency room/department or urgent care, hospitalization for 3 days (12Aug2021 to 15Aug2021), life threatening illness (immediate risk of death from the event), and disability or permanent damage. Therapeutic measures were taken as a result of the events reported which included mag sulfate, high dose solu-medrol, aspirin, and atorvastatin. The event "developed a DVT 2 days after the vaccine in left leg" was recovered on an unspecified date in 2021. The outcome of the other events reported was not recovered.; Sender''s Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events paraesthesia oral ,swollen tongue, pharangeal swelling, ill defined disorder, contusion, transient ischaemic attack, hypothyroidism, hypertension, tachycardia, thrombosis, deep vein thrombosis,and cerebrovascular accident 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: 1647323 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-07-01
Onset:2021-07-30
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blister, Skin exfoliation, Stevens-Johnson syndrome
SMQs:, Severe cutaneous adverse reactions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYMBICORT; TYLENOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Emphysema
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101058346

Write-up: Steven Johnson Syndrome; Blisters on his feet; His hands started peeling; This is a spontaneous report from a contactable consumer (patient''s child). A 62-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on unknown date in Jul2021 at 12:45 (Lot number was not reported) as single dose (at age of 62-year-old) for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), emphysema. Patient had no known allergies. Concomitant medications received within two weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT); paracetamol (TYLENOL). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not have COVID prior vaccination. No COVID tested post vaccination. On 30Jul2021 17:00 patient experienced steven johnson syndrome, blisters on his feet, his hands started peeling. It was reported that patient started out with blisters on his feet and then his hands started peeling. His doctor called it Steven Johnson Syndrome. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient was treated for the events, steroids were prescribed. Patient had not recovered from the events, at the time of the report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1651377 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Back pain, Hypoaesthesia, Muscle spasms, Muscle twitching, Pain in extremity, Paraesthesia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Aspirin, ibuprofen and sulfa
Diagnostic Lab Data: Multiple chiropractor visits for back pain following and neurologist appointment 8/20 with planned EMG tests 9/23
CDC Split Type:

Write-up: Whole body numbness and tingling , muscle twitches, sensation to temperature, severe back spasms and pain in hips and legs


VAERS ID: 1651413 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-24
Onset:2021-07-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Full blood count normal, Metabolic function test, Pain in extremity, Paraesthesia, Rheumatoid factor negative
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), 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: Vitamin C, Labetalol, Bupropion, Quetiapine, Probiotic, Multivitamin
Current Illness:
Preexisting Conditions:
Allergies: Shellfish
Diagnostic Lab Data: Routine labs: CBC, CMP, Lupus, and Rheumatoid Arthritis profiles were all within normal limits and Negative.
CDC Split Type:

Write-up: Received 2nd dose of the vaccine on 7/24/21. On 7/30/21, I developed constant tingling in hands, feet, and legs around 11am. The sensation became more intense by approximately 3pm. I contacted by Primary Care Physician and informed him of my symptoms. He ordered Gabapentin 1-2 capsules twice a day, which I started that evening. That night I developed sharp and intense pains in my feet, legs, and hands. On 8/2/21, I saw my PCP and informed him that the tingling had progressed to extreme pain. He then increased the Gabapentin to three times a day. Within 4-5 days, the pain and tingling started to subside. By 8/9/21, the symptoms had resolved. I discontinued the medication on 8/15/21. Since then, I have only had one episode of sharp pain to my right foot which lasted about 5 minutes and subsided.


VAERS ID: 1654148 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-30
Onset:2021-07-30
   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 EW0181 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Computerised tomogram head, Fatigue, Headache, Laboratory test, Oropharyngeal pain, Pain, Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Bystolic, Atorvastatin, Claritin
Current Illness: None
Preexisting Conditions: None
Allergies: Medicine: Reaction 1. Carvedilol: Headache 2. Spironolactone: Headache 3. Lisinopril: Hives, Angioedema 4. Losartan: Lichen Planus, Chronic Urticaria 5. Metoprolol: not effective, weight gain 6. Amlodipine: not effective 7. Hydrochlorothiazide: Capillaritis 8. Maxzide: Capillaritis 9. Diltiazem: Lichen Planus 10. Hydralazine: Capillaritis, headache 11. Indapamide: Capillaritis, itching 12. Edecrin: GI issues, loss of appetite, nausea 13. Singular: Urticaria 14. Rosuvastatin: fatigue, itching, tingling and numbness in left arm and hand 15. Iodine: hives, itchy rash 16. Flu shot: have not taken over 12-15 years due to become extremely sick for 5-7 days
Diagnostic Lab Data: CT scan Brain: Aug 18 Lab work: Aug 18
CDC Split Type:

Write-up: 30 Jul 2021: 1st dose of Pfizer vaccine I had a minor reaction 15 minute after the administration of the vaccine which included hives, itching, and white tiny bubbly spots (on arms, legs, tummy, and others). Took Benadryl for 3 days, hives and itching were resolved, but the white spots remain. Next 3-4 days included itching, headache, fatigue, sore throat, and body ache All symptoms have subsided except for headache. I?ve had headaches daily since 30 July 2021. Some headaches are mild and some are severe. Some medicines help for 2-6 hours such as Tylenol, Excedrin, Fioricet, and others but the headaches come right back. As of today, I?ve had headaches for 31 days (29 Aug 2021).


VAERS ID: 1655019 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-14
Onset:2021-07-30
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0150 / UNK LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ADDERALL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: COVID-19 Test; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210726; Test Name: COVID-19 Test; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210731; Test Name: COVID-19 Test; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101048591

Write-up: Stroke; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), unknown dose via an unspecified route of administration, administered in Arm Left on 14Apr2021(at the age of 36-years-old), as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered was other. Patient had taken Blood thinners and statin for reported events. Patient visited to emergency room/department or urgent care. On 30Jul2021 at 08:30 AM, the patient experienced stroke. The patient was hospitalized for stroke for 3 days. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab) was negative on 19Jul2021, sars-cov-2 test (Nasal Swab) was negative on 26Jul2021, and sars-cov-2 test (Nasal Swab) was negative on 31Jul2021. The outcome of the event was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1655071 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:2021-02-06
Onset:2021-07-30
   Days after vaccination:174
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / 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: Diabetes; Parkinson''s disease; Rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: NAAT Covid test; Test Result: Positive
CDC Split Type: USPFIZER INC202101076352

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 reporting same event(s) under the same suspect product(s) for 37 patients. This is for 14th (69-year-old-male) of the 37people. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 06Feb2021 (Lot Number: EN5318) as dose 2, single and dose 1 via an unspecified route of administration on 16Jan2021 (Lot Number: EJ1686) as dose 1, single for covid-19 immunisation. Medical history included ongoing diabetes, ongoing Parkinson''s disease, ongoing rheumatoid arthritis. The patient''s concomitant medications were not reported. Caller was an Assistant Director of Health and works at a local health department called because she had some concerns, and the health department was tracking breakthrough cases in her area. Stated 15% of breakthrough cases were from one Pfizer Covid 19 Lot number: EN5318. On 30Jul2021, patient tested positive for covid virus, longer than two weeks after both doses. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Jul2021. Product Complaint description included Caller reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. The clinical outcome of the events was unknown at the time of report.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ AE, different patient


VAERS ID: 1655591 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-02-20
Onset:2021-07-30
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 023M20A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Chest discomfort, Cough, Insomnia, Pyrexia, SARS-CoV-2 test positive, Sinus congestion
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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Advair; Simvastatin; trazodone; Vitamin C; Calcium, B cComplex; Potassium; Turmeric
Current Illness:
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data: COVID-19 rapid test- positive 08/01/2021.
CDC Split Type: vsafe

Write-up: I had a low grade fever, tightness in my chest, very stuffy and clogged head, and very congested. I had a dry cough, the first few nights I had sleeplessness. I was told by nurse to use my nebulizer 2 times a day. At end of virus was when my asthma acted up.


VAERS ID: 1655958 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C1A / 1 LA / IM

Administered by: Other       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: N/A
CDC Split Type:

Write-up: The adverse event, was the Moderna vaccine shot was given to a teenager ( 14 years old) , without it been approve for that age range, but they was no adverse reaction from the vaccine itself.


VAERS ID: 1656133 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-02-23
Onset:2021-07-30
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6198 / 2 - / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tylenol, albuterol, amlodipine, aspirin, Lipitor, Vitamin D3, Plavix, CoQ10, Benadryl, ferrous sulfate, Neurontin, Norco, insulin glargine, metformin, metoprolol, multivitamin, Prilosec, prednisone, probiotic, Ranexa, Januvia, Ambien
Current Illness:
Preexisting Conditions: Aortic stenosis, arthritis, back pain, bronchitis, skin cancer (nose), cataracts, CAD, diabetes mellitus, GERD, heart murmur, high cholesterol, hypertension, history of MI (twice, ''86 and ''03), pancreatitis
Allergies: Cephalexin, ciprofloxacin, tetanus toxoid
Diagnostic Lab Data: SARS-COV-2 (COVID19), POINT OF CARE, ANTIGEN - OFFICE: Positive (7/30/2021) SARS-COV-2 (COVID-19) by NAA, Micro: Detected (8/1/2021)
CDC Split Type:

Write-up: Patient presents to the ED secondary to cough, shortness of breath, generalized malaise and fatigue. Patient was recently diagnosed with COVID - 19. Patient reports a one-week history of worsening symptoms, tested positive 2 days prior to admission. Patient denies any nausea or vomiting. No abdominal pain. No changes in urination or bowel habitus. ID and pulmonology were consulted for COVID pneumonia. Remdesivir and steroids were given. Patient also received antibiotics for bacterial pneumonia. Oxygen supplement via nasal cannula. Symptoms improved and patient felt better, no longer required oxygen supplement. Upon discharge, he had 3 more days of doxycycline for bacterial pneumonia and follow up as outpatient with PCP.


VAERS ID: 1656510 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: New Hampshire  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 1 LA / IM

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

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

Write-up: I have had new onset, severe hyperhidrosis which began within a day of the vaccine AND HAS LASTED FOR FIVE WEEKS, so far.


VAERS ID: 1657013 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   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 FA7485 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event
SMQs:, Medication errors (broad)

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

Write-up: came to the pharmacy on 7/30/2021 requesting his first dose of the Pfizer COVID-19 Vaccination. He filled the consent form completely and stated that this is his first COVID vaccine. The vaccine was administered to him and he was asked to return to the pharmacy 3 weeks later for the 2nd dose. He made no mention of being administered any other COVID vaccine to the pharmacist and did not present any other record to the pharmacy staff. He came back to the pharmacy 3 weeks later on 7/30/21 and when he was asked to present his COVID vaccination record card, the pharmacist noticed 2 cards. One card was the one filled out at our pharmacy for the first Pfizer vaccine and upon inspection, the other card was for a Johnson and Johnson COVID vaccine that he was administered in May 2021. The pharmacist questioned this other card to which replied that his wife was very concerned about COVID and he thought that getting more would be better. He later stated that he didn''t mention getting the Johnson and Johnson vaccine when he got the first Pfizer vaccine. The pharmacist on duty did not administer the 2nd Pfizer vaccine and called Pfizer to get guidance. Pfizer did not have a specific recommendation of whether or not to give the 2nd dose. It was decided not to proceed with the 2nd dose and the patient was made aware. No adverse events have been reported from the patient.


VAERS ID: 1657893 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-08-19
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Drug ineffective, Pain, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Taste and smell disorders (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Neurofibromatosis; Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: Nasal Swab/Binaxnow; Test Result: Negative ; Comments: Hospital test; Test Date: 20210731; Test Name: Nasal Swab/Binaxnow; Test Result: Negative ; Comments: Binaxnow; Test Date: 20210821; Test Name: Nasal Swab/Binaxnow; Test Result: Positive ; Comments: Binaxnow
CDC Split Type: USPFIZER INC202101084410

Write-up: covid test date=21Aug2021, covid test result=Positive/Body aches, lost of smell and taste; covid test date=21Aug2021, covid test result=Positive/Body aches, lost of smell and taste; Body aches; Lost of smell and taste; Lost of smell and taste; This is a spontaneous report from a contactable other health care professional (patient). A 39-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in arm left on 29Jul2021 at 12:30 PM (at the age of 39 years) as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot Number: FC3182) via an unspecified route of administration, administered in arm left on 19Aug2021 at 08:30 AM (at the age of 39 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Vaccine was administered at pharmacy or drug store. No other vaccines were received within four weeks prior to the administration of bnt162b2. Medical history included asthma, neurofibromatosis and penicillin allergy; all from an unknown date and unknown if ongoing. Concomitant medication included montelukast sodium (SINGULAIR) taken within two weeks of vaccination for an unspecified indication, start and stop date were not reported. On 30Jul2021 at 07:30 AM, the patient experienced body aches, lost of smell and taste. The report was non serious (as reported). On 21Jul2021, the patient underwent covid test post vaccination at hospital with covid test type nasal swab: negative, on 31Jul2021, covid test post vaccination as Binaxnow test with covid test type nasal swab: negative, on 21Aug2021, covid test post vaccination as Binaxnow test with covid test type nasal swab: positive. Events were considered as medically significant. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. No treatment was received for the adverse events. Outcome of the events was not recovered.; Sender''s Comments: As there is limited information in the case provided, the causal association between the reported event Covid 19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.


VAERS ID: 1658104 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003C21A / 1 LA / IM

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

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

Write-up: Error: Patient Too Young for Vaccine Administered-


VAERS ID: 1658749 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-16
Onset:2021-07-30
   Days after vaccination:164
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Cycle threshold on 7/31/21 = 14.7
CDC Split Type:

Write-up: hospitalization with COVID-19 reported per vaccine EUA


VAERS ID: 1658936 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-05-03
Onset:2021-07-30
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Fatigue, Headache, Pyrexia, Respiratory tract congestion
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Patient fully vaccinated and hospitalized due to COVID-19. Patient stated her symptoms are a fever, congestion, fatigue, and headaches.


VAERS ID: 1659138 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 - / SYR

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

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

Write-up: Severe headache, not sleeping well and pain in lower extremities and never had these symptoms before


VAERS ID: 1659149 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Blood test normal, Chills, Dizziness, Dyspnoea, Hypertension, Palpitations, Presyncope, Pyrexia, SARS-CoV-2 test negative, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none that day. Usually take a 1 a day vitamin
Current Illness: none
Preexisting Conditions: Crohn''s disease
Allergies: Strawberries
Diagnostic Lab Data: Blood tests ran showing everything looked ok Covid test given to make sure I didn''t have the virus at that moment Elevated blood pressure and pulse were monitored.
CDC Split Type:

Write-up: Hospital listed it as "Adverse reaction to Covid-19 vaccine" Symptoms were: Fever of 104 Uncontrolled chills that shook the ambulance. Heart racing for at least and hour or more. Trouble breathing. Dizziness and almost passed out when I tried to walk to the bathroom High Blood Pressure


VAERS ID: 1659703 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Alaska  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chills, Dizziness, Headache, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Severe body/muscle aches, headache, dizziness, intense chills Onset about 11 hours after injection, lasted about 40 hours


VAERS ID: 1660305 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Fall, Fatigue, Full blood count normal, Headache, Immediate post-injection reaction, Metabolic function test normal, Muscular weakness, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN, OMEPRAZOLE, AMLODIPINE
Current Illness: ALLERGIES, NEG COVID TEST 7/23/21
Preexisting Conditions: HTN, GERD, DIVERTICULOSIS
Allergies: PENICILLIN, LISINOPRIL
Diagnostic Lab Data: CBC and CMP normal on 8/23/21
CDC Split Type:

Write-up: "Reports that immediately after receiving the J&J vaccination on 7/30/21, he felt a fever and diarrhea 1-2 days but then this was followed by persistent lower extremity weakness for approximately one week following, so much so that fell twice with involuntary knee buckling at work the following Monday, Tuesday, Wednesday (August 2,3,4) at truck stop location. Since then these symptoms have resolved after 5+ days but now reporting continuous bilateral frontal headaches lasting one minute and then returning. Also reporting "no energy" and severe fatigue and difficulty getting up in the morning even after 8-10 hours sleep."


VAERS ID: 1661021 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 043B21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Intentional dose omission, Rash, Rash erythematous, Rash pruritic, Vaccination site pain
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: FLECAINIDE; WARFARIN; LIPITOR; AMLODIPINE; BANOPHEN; CEPHALEXIN [CEFALEXIN.]
Current Illness: Allergy to wool; Atrial fibrillation; Cancer; Glaucoma.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: injection site is sore if she pushes on it; I''m not going to get the follow-up shot; itchy pinkish-red rash which started on her legs and went up all over her body,rash started in both my legs,This rash...went to both arms,This rash...went to my mid section,This rash...went to the left, middle & right side of my neck.; itching/intermittently itchy pinkish-red rash which started on her legs and went up all over her body; itching & redness; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itching/intermittently itchy pinkish-red rash which started on her legs and went up all over her body), RASH ERYTHEMATOUS (itching & redness), INTENTIONAL DOSE OMISSION (I''m not going to get the follow-up shot), RASH (itchy pinkish-red rash which started on her legs and went up all over her body,rash started in both my legs,This rash...went to both arms,This rash...went to my mid section,This rash...went to the left, middle & right side of my neck.) and VACCINATION SITE PAIN (injection site is sore if she pushes on it) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. Concurrent medical conditions included Cancer, Allergy to wool, Atrial fibrillation and Glaucoma. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) for Rash, FLECAINIDE, WARFARIN, ATORVASTATIN CALCIUM (LIPITOR), AMLODIPINE and CEPHALEXIN [CEFALEXIN] for an unknown indication. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced RASH PRURITIC (itching/intermittently itchy pinkish-red rash which started on her legs and went up all over her body), RASH ERYTHEMATOUS (itching & redness) and RASH (itchy pinkish-red rash which started on her legs and went up all over her body,rash started in both my legs,This rash...went to both arms,This rash...went to my mid section,This rash...went to the left, middle & right side of my neck.). On 05-Aug-2021, the patient experienced INTENTIONAL DOSE OMISSION (I''m not going to get the follow-up shot). On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site is sore if she pushes on it). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BANOPHEN) for Rash, at an unspecified dose and frequency. On 05-Aug-2021, INTENTIONAL DOSE OMISSION (I''m not going to get the follow-up shot) had resolved. At the time of the report, RASH PRURITIC (itching/intermittently itchy pinkish-red rash which started on her legs and went up all over her body), RASH ERYTHEMATOUS (itching & redness) and RASH (itchy pinkish-red rash which started on her legs and went up all over her body,rash started in both my legs,This rash..went to both arms,This rash..went to my mid section,This rash..went to the left, middle & right side of my neck.) was resolving and VACCINATION SITE PAIN (injection site is sore if she pushes on it) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received had updated medical history, batch number of the suspect, concomitant and treatment details. Additional events of rash erythematous, vaccination site pain and Intentional dose omission were added. On 16-Aug-2021: Follow up information received on contains Significant information i.e concomitant medications addition, treatment information was updated. On 25-Aug-2021: Follow up received contains no new information


VAERS ID: 1661103 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-07-30
   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 EY0584 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Lactation disorder, Menstrual disorder
SMQs:, Functional lactation disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101008324

Write-up: my milk supply started to dry up within 24 hours of vaccine.; my first menstrual cycle since giving birth occurred; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old nonpregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Ey0584) 1 via an unspecified route of administration, administered in Arm Left on 30Jul2021 at 10:00, as DOSE 1, SINGLE for covid-19 immunization. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed for COVID 19. Since the vaccination, has not been tested for COVID-19. The patient did not take any vaccines within 4 weeks prior vaccination On 30Jul2021, at 21:00, the patient experienced my milk supply started to dry up within 24 hours of vaccine (lactation disorder) and Within 72 hours of vaccine, first menstrual cycle since giving birth occurred (menstrual disorder). The patient did not receive any treatment for the adverse events. The clinical outcome of the events was not recovered. 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-202101008335 maternal case/fetal case


VAERS ID: 1662777 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-03
Onset:2021-07-30
   Days after vaccination:149
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Bronchitis, Cough
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril HCTZ20-25, Rosuvastatin 40 MG
Current Illness: None
Preexisting Conditions: High blood pressure, Hart stent
Allergies: N/A
Diagnostic Lab Data: I went to Medical center Urgent care and they diagnosed it as "Bronchitis" that was on Aug. 02, Gave me Azithromycin 250 MG & Tessalon Perles 100 MG. (Did not help) I saw ARNP
CDC Split Type:

Write-up: ?Moderna COVID?19 Vaccine ?I have have a dry cough with clear phlegm. It started shortly after I received the vaccine. I have never had this problem in the past.


VAERS ID: 1662981 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Acoustic stimulation tests, Dizziness, Labyrinthitis, Magnetic resonance imaging, Nausea, Sudden hearing loss, Vertigo
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth Control
Current Illness: Seasonal Allergies
Preexisting Conditions: History of headaches/migraines.
Allergies: None
Diagnostic Lab Data: Hearing tests, MRI
CDC Split Type:

Write-up: Dizziness, nausea, sudden deafness in right ear. Prolonged vertigo symptoms from 7/30/21 to present (9/1/21). Diagnosed with labyrthitis by ENT. Daily lightheadedness/dizziness with no relief.


VAERS ID: 1664486 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 RA / SC

Administered by: Public       Purchased by: ?
Symptoms: Blood pressure decreased, Fatigue, Headache, Vaginal haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Dehydration (broad)

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

Write-up: Serious headache, fatigue 24 hours after vaccine. 4 weeks after the first dose, I experienced a massive bleeding period. My blood pressure dropped to 40/60. I was chilling on the bed under 28C room temperature.


VAERS ID: 1665562 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025C21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Palpitations, Vaccination complication
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

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

Write-up: Worried; Palpitation; Strong side effects; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation), VACCINATION COMPLICATION (Strong side effects) and ANXIETY (Worried) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. Concurrent medical conditions included Hearing impaired. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PALPITATIONS (Palpitation) and VACCINATION COMPLICATION (Strong side effects). On 31-Jul-2021, the patient experienced ANXIETY (Worried). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Palpitation) and VACCINATION COMPLICATION (Strong side effects) was resolving and ANXIETY (Worried) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported.


VAERS ID: 1666449 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-03-20
Onset:2021-07-30
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9269 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Chronic kidney disease, COPD, Crohns disease, hypothryoid
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was diagnosed and hospitalized with COVID-19. Hospitalized 7/30-8/10/2021


VAERS ID: 1666878 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078C21A / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Headache, Heavy menstrual bleeding, Hypoaesthesia, Pain in extremity, Paraesthesia, Sleep disorder, Ultrasound Doppler normal
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish oil, multivitamin, vitamin D3, aspirin
Current Illness: No prior illnesses.
Preexisting Conditions: Environmental allergies, occasional acne. Varicose veins left leg, prior DVT 16 years ago post-surgery. Family history of cerebral hemorrhage in middle-age and ischemic strokes in old age (different people). All my grandparents died of clotting or bleeding issues.
Allergies: Sulfa
Diagnostic Lab Data: On 7/30/21 an ultrasound of my leg showed no evidence of a DVT. I still don''t know why my leg hurts, when it didn''t before the shot, and I was doing no exercises which could have caused this.
CDC Split Type:

Write-up: About three days after I received the shot, I had a deep ache in my left thigh. I had expected possible aches, but I thought it would go away. Over 5 weeks later, I still have it in that spot, where I have never had pain before. It has occasionally woken me up at night, and sometimes I avoid standing due to the pain. Also, on August 21 I started my period and by August 22 my menstrual flow was so heavy I was soaking through a super-sized tampon plus a pad liner every 1-2 hours. This lasted through mid-day on August 23, then it slowed to a normal period for me. I have never had such heavy flow (I normally use one super-sized tampon every 8 hours at the beginning of my period). I have had irregular periods for a while now, since I am in peri-menopause, but usually they are lighter than when I was having periods regularly, and never more heavy. Temporary adverse effects at the beginning (mostly days 1-2 post-vaccination) included prickly random pains in various spots throughout my body, especially my joints, and a numbness/tingling in my face. Also I had a slight intermittent headache, with one that was moderate in my left temple area. These effects went away and were very manageable. But I am concerned about the second vaccine due to my pain which is ongoing in my leg, and my family history of dying from bleeding and clotting, considering that there is a (what appears to be rare) risk of thrombosis with thrombocytopenia with these vaccines and at least one in vitro study showing increased clotting with the S1 spike protein - although COVID-19 caused worse clots in this study


VAERS ID: 1669629 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Body temperature, Chest pain, Chills, Fatigue, Feeling abnormal, Headache, Mobility decreased, Nausea, Night sweats, Pain in extremity, Pyrexia, Rhinorrhoea, Sensitive skin, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Patient had Covid-19 in February with 2 hospitalizations which effected her for 54 days.)
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: measured her temperature with a fever at 100 F
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: arm is a little sensitive under the armpit; vertigo; nausea; headaches; fever; chills; upset stomach; runny nose; felt ran down; her arm was solidly hurting; could not move her arm out in front of her or out to the side; It felt like someone had gut punched me; twinge in my heart; night sweats; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (twinge in my heart), NIGHT SWEATS (night sweats), PAIN IN EXTREMITY (her arm was solidly hurting), MOBILITY DECREASED (could not move her arm out in front of her or out to the side) and FEELING ABNORMAL (It felt like someone had gut punched me) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included COVID-19 (Patient had Covid-19 in February with 2 hospitalizations which effected her for 54 days.). Concomitant products included LORATADINE (CLARITINE) for an unknown indication. On 30-Jul-2021 at 2:24 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced CHEST PAIN (twinge in my heart) and NIGHT SWEATS (night sweats). On 31-Jul-2021, the patient experienced PAIN IN EXTREMITY (her arm was solidly hurting), MOBILITY DECREASED (could not move her arm out in front of her or out to the side), FEELING ABNORMAL (It felt like someone had gut punched me) and FATIGUE (felt ran down). On 01-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), RHINORRHOEA (runny nose), NAUSEA (nausea), HEADACHE (headaches), PYREXIA (fever) and CHILLS (chills). On 02-Aug-2021, the patient experienced SENSITIVE SKIN (arm is a little sensitive under the armpit) and VERTIGO (vertigo). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 30-Jul-2021, CHEST PAIN (twinge in my heart) had resolved. On 01-Aug-2021, PAIN IN EXTREMITY (her arm was solidly hurting) and MOBILITY DECREASED (could not move her arm out in front of her or out to the side) had resolved. At the time of the report, NIGHT SWEATS (night sweats) had not resolved and FEELING ABNORMAL (It felt like someone had gut punched me), ABDOMINAL DISCOMFORT (upset stomach), RHINORRHOEA (runny nose), SENSITIVE SKIN (arm is a little sensitive under the armpit), VERTIGO (vertigo), NAUSEA (nausea), HEADACHE (headaches), PYREXIA (fever), CHILLS (chills) and FATIGUE (felt ran down) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, Body temperature: high (High) measured her temperature with a fever at 100 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that patient took 6 doses of Pepto and it took almost 2 hours to finish an english muffin with butter. It was reported that the patient tried calling her HCP this morning, who claimed they were unable to help, but recommended to "spot treat" for symtpoms as they arose. Besides the Tylenol and Pepto the patient has not taken any other treatments. The patient continues to take her daily multivitamin and Claritin at this time.


VAERS ID: 1669636 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Pennsylvania  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, Product temperature excursion issue
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: 5 doses were administered out of vial that was punctured 15 days ago; Vials are out of range for temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses were administered out of vial that was punctured 15 days ago) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vials are out of range for temperature) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses were administered out of vial that was punctured 15 days ago) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vials are out of range for temperature). On 30-Jul-2021, EXPIRED PRODUCT ADMINISTERED (5 doses were administered out of vial that was punctured 15 days ago) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vials are out of range for temperature) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 5 doses were administered out of vial that was punctured on 16 Aug 2021 and temperature was also recorded out of range. No concomitant medications were reported No treatment medications were reported


VAERS ID: 1669647 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039A21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac discomfort, Dysgeusia, Head discomfort, Hypoaesthesia, Musculoskeletal discomfort, Musculoskeletal stiffness, Neck pain, Ocular discomfort
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Taste and smell disorders (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Biliary stent placement; Infection; Surgery (multiple surgeries)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: metallic taste in mouth; feels like she is having stroke; neck still hurts; side of her face was numb; arm stiff; eyes were stiff; pressure behind head; pressure behind neck; pressure behind eyes; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in mouth), HEAD DISCOMFORT (pressure behind head), MUSCULOSKELETAL DISCOMFORT (pressure behind neck), OCULAR DISCOMFORT (pressure behind eyes) and CARDIAC DISCOMFORT (feels like she is having stroke) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Infection, Surgery (multiple surgeries) and Biliary stent placement. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced HEAD DISCOMFORT (pressure behind head) and MUSCULOSKELETAL DISCOMFORT (pressure behind neck). 30-Jul-2021, the patient experienced OCULAR DISCOMFORT (pressure behind eyes). On an unknown date, the patient experienced DYSGEUSIA (metallic taste in mouth), CARDIAC DISCOMFORT (feels like she is having stroke), NECK PAIN (neck still hurts), HYPOAESTHESIA (side of her face was numb), MUSCULOSKELETAL STIFFNESS (arm stiff) and OCULAR DISCOMFORT (eyes were stiff). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of She took it for 4-5 days and then stopped and PARACETAMOL (TYLENOL) for Adverse event, at a dose of She took it for 4-5 days and then stopped. At the time of the report, DYSGEUSIA (metallic taste in mouth), HEAD DISCOMFORT (pressure behind head), MUSCULOSKELETAL DISCOMFORT (pressure behind neck), OCULAR DISCOMFORT (pressure behind eyes), CARDIAC DISCOMFORT (feels like she is having stroke), NECK PAIN (neck still hurts), HYPOAESTHESIA (side of her face was numb), MUSCULOSKELETAL STIFFNESS (arm stiff) and OCULAR DISCOMFORT (eyes were stiff) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication of the patient was not reported. The pressure behind neck and head started within 10 minutes of getting the vaccine and got worse overnight. The adverse events were fast and differently at each time.


VAERS ID: 1670692 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Hallucination, auditory, Rash, Thirst
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

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

Write-up: 6pm vaccine 2am: woke to Difficulty Breathing, tightness of chest, thirsty, hallucination, rash on arm. about 12hr duration Patient slept most of the day, then began walking bit by bit until symptoms resolved


VAERS ID: 1670775 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-02-19
Onset:2021-07-30
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030M20A / 2 RA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Abortion spontaneous, Laboratory test normal
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Advair, Zyrtec
Current Illness: none
Preexisting Conditions: Asthma
Allergies: Bactrim (sulfa)
Diagnostic Lab Data: Unknown tests - all yielded normal results
CDC Split Type:

Write-up: Pregnancy loss at 16 weeks 3 days.


VAERS ID: 1673127 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 RA / -

Administered by: Work       Purchased by: ?
Symptoms: Overdose, Product preparation error
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100975822

Write-up: vaccine was not diluted; received his first dose of the Pfizer BioNTech Covid 19 vaccine today 30Jul2021 but the vaccine was undiluted; This is a spontaneous report from a contactable nurse. This Nurse reported for a 58-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 58-years-old, via an unspecified route of administration, administered in Deltoid Right on 30Jul2021 (Batch/Lot Number: FA6780; Expiration Date: 26Aug2021) as dose 1, 0.3 ml single (at the age of 58) for COVID-19 immunization. The patient no medical history and no concomitant medications. The patient had no prior vaccination. The administered vaccine was undiluted. Vaccination facility type was workplace clinic. The outcome was unknown. Amendment: This follow up is being submitted in order to update the narrative Follow-up (23Aug2021): New information reported from a contactable nurse includes: medical history and vaccination details. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1673280 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature, Chest pain, Diarrhoea, Dry mouth, Dyspnoea, Fatigue, Feeling abnormal, Headache, Hyperhidrosis, Limb discomfort, Nausea, Pain in extremity, Paraesthesia, Tongue dry
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEXIUM [ESOMEPRAZOLE SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control; GERD; Sulfonamide allergy (Sulfer based medicine)
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Temperature; Result Unstructured Data: Test Result:99
CDC Split Type: USPFIZER INC202101082324

Write-up: chest pain (feeling of heavy gas build up in chest and needle feeling); Arm sensitivity (feeling of arm on clothes felt off); hand tingling within 15 min; Nausea; headache; Tiredness; fog brain; arm pain within 3 hours; intense night sweats; diarrhea; heavy breathing during movement; dry mouth; dry mouth/ tongue; This is a spontaneous report from a non-contactable consumer. A 23-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Fa7485) via an unspecified route of administration, administered in Arm Right on 30Jul2021 at 12:15 as DOSE 1, SINGLE (at the age of 23-year-old) for covid-19 immunisation. The patient''s medical history included drug hypersensitivity (Sulfer based medicine), gastrooesophageal reflux disease, contraception. The patient''s concomitant medication(s) included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for gastrooesophageal reflux disease, contraception. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jul2021 at 12:30, patient experienced arm sensitivity (feeling of arm on clothes felt off) and hand tingling within 15 min (tingling was for 2 minutes), nausea and headache within 1 hour, tiredness, fog brain, and arm pain within 3 hours (arm pain only lasted 8 hours) nausea, intense night sweats, chest pain (feeling of heavy gas build up in chest and needle feeling), diarrhea, heavy breathing during movement, 99 temp, dry mouth/ tongue for 3-4 days (chest pains up to 2 weeks-has never happened before). The patient received the treatment for the events. The outcome of the events was recovered in unspecified date in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1673678 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1816022 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Injection site pain
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: Site: Pain at Injection Site-Mild.


VAERS ID: 1674642 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:1920-07-30
Onset:2021-07-30
   Days after vaccination:36890
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Arthralgia, Chest discomfort, Chills, Fatigue, Headache, Myalgia, Nausea, Pain, Pyrexia, Tenderness
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: sprintec metoprolol escitalopram cetrizine
Current Illness: none
Preexisting Conditions: POTS
Allergies: NSAIDs
Diagnostic Lab Data:
CDC Split Type:

Write-up: within about 2 hours, patient developed headache and mild achiness. Approximately 12 hours later, significant chills, fever 103.5, skin painful to touch, nausea, chest tightness, severe headache, significant muscle and joint pain. Patient took tylenol with no benefit. symptoms persisted approximately 6 hours then improved to fatigue, nausea, mild headache, muscle and joint tenderness that increased again during the night. symptoms persisted in this pattern for approximately 72 hours. fatigue lasted about 5 days.


VAERS ID: 1674778 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation, Blood test, Computerised tomogram head, Condition aggravated, Echocardiogram, Electrocardiogram, Transient ischaemic attack
SMQs:, Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: amlodipine besylate NORVASC 5 MG Take 1 tablet (5 mg total) by mouth daily. apixaban ELIQUIS 5 mg Take 1 tablet (5 mg total) by mouth 2 (two) times daily. aspirin aspirin 81 MG Take 81 mg by mouth daily. Last dose 6/23/19 atorvastatin ca
Current Illness: Recurrence of atrial fibrillation and TIA symptoms
Preexisting Conditions: ? Insomnia ? Cardiac arrhythmia ? Cholelithiasis ? Colon polyp ? Pain of right hip joint 04/19/2018 ? Diabetes mellitus ? Hyperlipidemia ? Hypertension ? Thyroid dysfunction ? Neuropathy ? Palpitations ? Hypercholesterolemia 12/21/2017 ? SVT (supraventricular tachycardia) 12/21/2017 ? GERD with esophagitis 12/21/2017 ? Primary hypothyroidism 12/21/2017 ? Lumbar disc disease 12/21/2017 ? Recurrent UTI 12/21/2017 ? Essential hypertension 12/18/2017 ? Type 2 diabetes mellitus with diabetic neuropathy 12/18/2017 ? Lumbar disc disease 12/18/2017 ? Mitral valve prolapse 12/18/2017
Allergies: Sitagliptan
Diagnostic Lab Data: CT Brain, ECHO, blood work, EKG
CDC Split Type:

Write-up: She developed recurrence of her atrial fib. Required ED visit. Had TIA symptoms. Stroke eval negative. I will resume evaluation as an outpatient. Having to start her on Eliquis.


VAERS ID: 1677081 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial pain, Hypokinesia, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: Environmental allergy (trigger symptoms associated with trigeminal neuralgia); Trigeminal neuralgia (controlled by medication from 10 years).
Preexisting Conditions: Comments: The patient had no other significant history reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210905749

Write-up: FELT PARALYZED FROM THE NECK UP PHYSICALLY (NOT NEUROLOGICALLY); RESUMPTION OF FACIAL PAIN; RESUMPTION OF FACIAL SEIZURES; This spontaneous report received from a patient via a company representative concerned an adult male of unspecified race and ethnic origin. Initial information was processed with additional information received on 03-SEP-2021. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: trigeminal neuralgia, and environmental allergies, and other pre-existing medical conditions included: The patient had no other significant history reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was diagnosed with trigeminal neuralgia, facial pain and facial seizures 10 years ago, which has been well controlled by medication until 30-JUL-2021. The patient previously reported symptoms (facial pain) present only during very bad allergy seasons. On 30-JUL-2021, the patient experienced resumption of facial seizures and resumption of facial pain. On AUG-2021, the patient felt paralyzed from the neck up physically (not neurologically). The patient was assessed by their physician and it was determined that a blood vessel and nerve were touching, causing the facial pain and seizure/paralysis. According to the patient''s physician, severe inflammation triggered by the vaccine was the cause for the return of the patient''s symptoms (facial seizures and facial pain).The patient is receiving ongoing medical care to handle chronic pain symptoms. The patient may require surgical correction for relief. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from resumption of facial seizures, felt paralyzed from the neck up physically (not neurologically), and resumption of facial pain. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210905749-COVID-19 VACCINE AD26.COV2.S-Resumption Of Facial Seizures. 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


VAERS ID: 1677149 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-23
Onset:2021-07-30
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027D21A / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Fatigue, Lethargy, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to chemicals (Sulphur); Fruit allergy (Avocado); Shellfish allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Lethargic; Got COVID; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), COVID-19 (Got COVID), FATIGUE (Tired) and PYREXIA (Fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027D21A and 939902) for COVID-19 vaccination. Concurrent medical conditions included Allergy to chemicals (Sulphur), Shellfish allergy and Fruit allergy (Avocado). On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced LETHARGY (Lethargic), COVID-19 (Got COVID) and PYREXIA (Fever). 30-Jul-2021, the patient experienced FATIGUE (Tired). The patient was treated with VITAMIN C [ASCORBIC ACID] for Adverse event, at an unspecified dose and frequency; VITAMIN D [VITAMIN D NOS] for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 06-Aug-2021, PYREXIA (Fever) had resolved. On 08-Aug-2021, COVID-19 (Got COVID) had resolved. At the time of the report, LETHARGY (Lethargic) and FATIGUE (Tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. Relevant concomitant medications were not reported. Patient went to urgent care on 8-Aug-2021.


VAERS ID: 1677332 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-07-23
Onset:2021-07-30
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Burning sensation, Disturbance in attention, Dizziness, Feeling abnormal, Head discomfort, Musculoskeletal discomfort, SARS-CoV-2 test, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: SARS-CoV-2 test; Test Result: Negative; Comments: Nasal swab.
CDC Split Type: USPFIZER INC202101013941

Write-up: Pressure in the head; Pressure in the head and back of neck.; Dizziness; Intermittent vertigo; Brain fog; Difficulty concentrating; Head feels like it''s burning; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the left arm on 23Jul2021 (at the age of 35-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included prenatal supplement taken for an unknown indication from an unknown date and unknown if ongoing. On 30Jul2021 at 12:00, exactly one week after the vaccination, the patient experienced pressure in the head and back of neck, head feels like it''s like burning, dizziness, intermittent vertigo, brain fog, and difficulty concentrating. It was stated that these symptoms were not reduced for any second of the day or night since 30Jul2021. The symptoms were persisting and there was no relief with pain medications. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included pain medication. Since the vaccination, the patient had been tested for COVID-19. On 04Aug2021, the patient underwent lab test and procedures which included SARS-CoV-2 nasal swab test and the result was found to be negative. The clinical outcome of the events pressure in the head and back of neck, head feels like it''s burning, dizziness, intermittent vertigo, brain fog, and difficulty concentrating were not resolved at the time of reporting.


VAERS ID: 1678250 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: New York  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 005C21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Chest discomfort, Illness, Paraesthesia, Sensory disturbance
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (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: ADVIL [IBUPROFEN]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: he was very anxious, his anxiety level went through the roof; Tightness in his chest; He had pins and needles/He had pins and needles in his hair; it felt like he put charcoal on his skin a few times; he had to call in sick; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (he was very anxious, his anxiety level went through the roof), CHEST DISCOMFORT (Tightness in his chest), PARAESTHESIA (He had pins and needles/He had pins and needles in his hair), SENSORY DISTURBANCE (it felt like he put charcoal on his skin a few times) and ILLNESS (he had to call in sick) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 036A21A) for COVID-19 vaccination. Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced ANXIETY (he was very anxious, his anxiety level went through the roof), CHEST DISCOMFORT (Tightness in his chest), PARAESTHESIA (He had pins and needles/He had pins and needles in his hair), SENSORY DISTURBANCE (it felt like he put charcoal on his skin a few times) and ILLNESS (he had to call in sick). At the time of the report, ANXIETY (he was very anxious, his anxiety level went through the roof), CHEST DISCOMFORT (Tightness in his chest), PARAESTHESIA (He had pins and needles/He had pins and needles in his hair), SENSORY DISTURBANCE (it felt like he put charcoal on his skin a few times) and ILLNESS (he had to call in sick) outcome was unknown. Patient reported that he took multivitamins every third day. This case was linked to MOD-2021-295014 (Patient Link).


VAERS ID: 1679741 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-24
Onset:2021-07-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure increased, Blood test abnormal, Dizziness, Electrocardiogram, Electrocardiogram ambulatory abnormal, Epistaxis, Haemoglobin decreased, Heart rate irregular, Nasal cavity packing, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid .025
Current Illness:
Preexisting Conditions: Hashimoto''s disease
Allergies: none
Diagnostic Lab Data: Jul 30, ER - no tests, nasal packing procedure only Jul 30, ER - blood test 2x, ECG (referred to a cardiologist) Aug 1, ER - blood test, ECG (went to ER as advised by medical hotline due to vaccine reactions) Aug 18 - holter monitor for 48 hours Aug 28 - blood test, ECG (referred to an internist) Sep 8 - appointment with the internist Oct 15 - appointment with an ENT Still waiting for the cardio appointment confirmation
CDC Split Type:

Write-up: Severe nosebleed on 6th day that lasted for 2 hours without slowing-stopped after nasal pack procedure fainted the same morning had to be rushed to ER by paramedics; BP dropped to 88/68; bouts of dizziness from day 2 until now, unusual heartbeat recorded on holter monitor, unusual rise of BP 182/117. Blood test from Aug. 28 showed low haemoglobin.


VAERS ID: 1681549 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027C21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anosmia, COVID-19, Cough, Diarrhoea, Nasal congestion, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Taste and smell disorders (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

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

Write-up: Contracted COVID after vaccination; Lost of smell; Congestions; Cough; Diarrhea; Nausea; vomiting; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Contracted COVID after vaccination), ANOSMIA (Lost of smell), NASAL CONGESTION (Congestions), COUGH (Cough) and DIARRHOEA (Diarrhea) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced ANOSMIA (Lost of smell), NASAL CONGESTION (Congestions), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (vomiting). 30-Jul-2021, the patient experienced COUGH (Cough). On an unknown date, the patient experienced COVID-19 (Contracted COVID after vaccination). At the time of the report, COVID-19 (Contracted COVID after vaccination), ANOSMIA (Lost of smell), NASAL CONGESTION (Congestions), COUGH (Cough), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and VOMITING (vomiting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication information was reported. Patient reported that she self-isolated and treated it like normal cold symptoms Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow-up received and it contains non-significant information.


VAERS ID: 1681749 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ear disorder, Headache, Malaise, Oropharyngeal pain, Pyrexia, Sinus disorder
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101013248

Write-up: She just has a feeling of not feeling too well; fever; sore throat; her ears and face feels like a sinus issue; feeling of ear and face having a "sinus issue"; headache; This is a spontaneous report from a contactable consumer. A 40 years old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: FA7484; Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jul2021 09:30 (at the age of 40 years) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccination 4 weeks prior to COVID-19 vaccination. On 30Jul2021 10:00, the patient experienced headache; 03Aug2021, the patient experienced sore throat, her ears and face feel like a sinus issue (at 07:00), fever (at 14:00), feeling of ear and face having a "sinus issue"; on an unspecified date, the patient experienced she just has a feeling of not feeling too well. The clinical outcome of the events headache, feeling of ear and face having a "sinus issue", her ears and face feels like a sinus issue was not resolved; sore throat was resolving; fever, was resolved on 04Aug2021; She just has a feeling of not feeling too well was unknown. No follow-up attempts are possible. No information is required.


VAERS ID: 1681789 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal discomfort, Blood pressure increased, Blood pressure measurement, Diplopia, Dysphagia, Feeling abnormal, Hypoaesthesia, Palpitations, Paraesthesia, SARS-CoV-2 test, Speech disorder
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Ocular motility disorders (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autoimmune disorder (Autoimmune issues)
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:elevated; Test Date: 20210802; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC202101068450

Write-up: difficulty swallowing; elevated blood pressure; feeling of going to jump out of skin; severe stomach issues; Severe neurological reaction including face; Severe neurological reaction including face, arms; legs tingling and numbness.; Severe neurological reaction including face, arms, legs tingling and numbness.; Heart racing; difficulty speaking; double vision; This is a spontaneous report from a contactable consumer (parents). A 47-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, and patient was 47-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 30Jul2021 at 03:30 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune issues. There were no concomitant medications. No other vaccine received in four weeks; no other medications received in two weeks, no covid prior vaccination, no known allergies were reported. On 30Jul2021 at 08:30 PM, the patient experienced Severe neurological reaction including face, arms, legs tingling and numbness. Heart racing, difficulty speaking and swallowing, double vision, elevated blood pressure, feeling of going to jump out of skin, severe stomach issues. Ae resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021, blood pressure: elevated on 30Jul2021. Therapeutic measures were taken as a result for all reported events with Methyl PrednisoSolone. The outcomes of events were recovering. Information on the lot/batch number has been requested.


VAERS ID: 1681885 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Dizziness, Heart rate, Heart rate increased, Hypersensitivity, Pharyngeal swelling, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s disease; Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: heartbeat; Result Unstructured Data: Test Result:elevated
CDC Split Type: USPFIZER INC202101091264

Write-up: she had a severe allergic reaction, which included swelling of face and throat (could still breathe); she had a severe allergic reaction, which included swelling of face and throat (could still breathe); she had a severe allergic reaction, which included swelling of face and throat (could still breathe); fast heartbeat lasted approximately 3 minutes; dizziness; Weakness; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0217), via an unspecified route of administration, administered in right deltoid on 30Jul2021 as single dose for COVID-19 immunisation. The patient''s medical history included type 1 diabetes on an unspecified date in 1994 and Hashimoto''s disease on an unspecified date in 1997. The patient''s concomitant medications were not reported. The vaccination facility type was pharmacy/drug store. Prior to vaccinations (within 4 weeks), the patient did not received any other vaccinations. The patient reported that she received her first dose of the vaccine 30Jul2021, and had a reaction within 15 minutes. She is concerned about getting the second dose, which is coming up. The patient reported that she had a severe allergic reaction, which included swelling of face and throat (could still breathe), fast heartbeat, dizziness and weakness, all on 30Jul2021. The patient confirmed her reaction was pretty much exactly 15 minutes after she got the injection on 30Jul2021. She stated it was relatively short lived but came on very quickly and all at once. She stated that the swelling of her face and throat lasted probably 6 hours. She could breathe just fine, she just looked in mirror and was like whoa. The fast heartbeat lasted approximately 3 minutes, it was not very long. She stated that the pharmacist did come out and confirmed she had an elevated heartbeat. The dizziness and weakness was worse for the first hour after she had the vaccine. She experienced dizziness the duration of the rest of the day, so she would say probably 12 hours. The patient underwent lab tests and procedures which included heartbeat: elevated on 30Jul2021. The outcome of the events allergic reaction, swelling of face, throat swelling and heartbeats increased was recovered on 30Jul2021; and the outcome of the events dizziness and weakness was recovered on Jul2021.


VAERS ID: 1682755 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Chest discomfort, Flushing, Hypoaesthesia, Nausea
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Sexual dysfunction (broad)

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

Write-up: Patient received first dose of Pfizer COVID vaccine at a local pharmacy (Pharmacy). He did not report symptoms experienced to that pharmacy, although he waited the requested 15 minutes there after vaccination. Several weeks later, he reported post vaccination symptoms during an unrelated visit to the Co. Health Department. He described sensations of chest tightness, facial and chest flushing, mild nausea and numbness in both hands which started ten minutes after vaccine administration. He left the pharmacy without reporting these symptoms and reports they resolved without any intervention or medication, by two hours after receiving the vaccine. During his subsequent visit to the Health Department he asked if he could complete vaccination for COVID.


VAERS ID: 1683231 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-06-09
Onset:2021-07-30
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Bell's palsy, Computerised tomogram, Corneal reflex decreased, Ear pain, Facial paralysis, Headache, Hemiplegia
SMQs:, Taste and smell disorders (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Corneal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Sulfa drugs
Diagnostic Lab Data: CT scan to rule out stroke on 7/31/2021 at Hospital. Diagnosed with Bell?s Palsy and prescribed prednisone and valtrex. Follow up with PCP on 8/3/2021.
CDC Split Type:

Write-up: Complete paralysis of left side of face, severe left side head and ear pain, loss of taste and control of mouth, unable to close eye. First symptom was loss of taste and inability to blink with left eye on the evening of 7/30/2021 and within hours overnight I had full paralysis and drooping on the left side of my face.


VAERS ID: 1684684 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-05-13
Onset:2021-07-30
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 2 RA / -

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

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

Write-up: Extremely heavy periods lasting 3 weeks at a time


VAERS ID: 1684705 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-07-26
Onset:2021-07-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004C21A / 1 LA / SYR

Administered by: Pharmacy       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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Jardiance, testosterone gel, famotidine 40mg ginkgo biloba, turmeric, vitamin B complex, vitamin C, vitamin D3 5,000 unit, vitamin K, Zinc
Current Illness: None
Preexisting Conditions: type 2 diabetic, controlled A1C 6.9
Allergies: None
Diagnostic Lab Data: No test, just a movement discussion with Orthopedic specialist.
CDC Split Type:

Write-up: After the shot, 4 to 5 days later, my body started aching as I noticed when I would wake up in the a.m. I am usually "pain free" and noticed that I was in pain when getting out of bed. My left arm was ok after injection but is now very painful to move "up and down" like a shoulder impingement. I later noticed a problem moving my head(neck) left and right as if I had slept wrong. I am still having that problem. This type of problem I have experience but it usually goes away in a couple of days. This morning I am in whole body pain. Not debilitating but very noticeable. I went to an orthopedic appointment Tuesday(9-7) and informed the doctor of my pains. He prescribed muscle relaxers and told me to return if not better. He did suggest physical therapy but am not doing that at this time. Did not discuss if it could be injection related.


VAERS ID: 1684952 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006A21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Dizziness, Fatigue, Nausea, Neck pain
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (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- lightheadedness- VAERS report submitted polio shot/1954 or 1955/ in Brooklyn, immediately after the shot my arm
Other Medications: amlodipine 5mg od at night benazepril 20 mg 1 tablet containing both medications atenolol 25 mg od at night allergy tablets-Benadryl- od at night
Current Illness: no
Preexisting Conditions: high blood pressure neck and back pain
Allergies: Cipro -12/07/2017 nitrofurantoin 100 mg -07/30/2019
Diagnostic Lab Data: no
CDC Split Type: vsafe

Write-up: Starting at 04:00 PM on the day of the shot. 07/30/2021, I had moderately severe back and neck pain. It was quite severe. I have back pain and neck pain that I manage, but this was quite severe, I would give it a 7.5 on a scale of 1-10. The next day, 07/31/20201 I had the moderate arm pain and the back and neck pain was continuing out on the same pain level. 2 day after,08/01/2021, the side effects were coming on even more, on top of the neck and back pain, I had fatigue, nausea, and lightheadedness. On Tues, 08/03/2021- the dizziness started and I had a strange sensation in my face. I called the doctor''s office on 08/03/2021- Advised me to take Methyl prednls0L0NE. The next day, 08/04/2021, no back pain and I had energy. I had taken 6 tablets the 1st day, Tuesday. On 08/05/2021, no back pain and I had energy, but in the evening I had dizziness. On 08/06/2021, dizziness increased still no back pain, I called the doctor''s office she advised me to increase fluids, start checking BP. My BP is better because it was quite high 154/84 , now 09/07/2021 it''s 118/58. and I still continue to have dizziness. Just moving my head, I feel dizziness.


VAERS ID: 1685118 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 005C21A / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: asthma hx cervical cancer OA HTN CAD
Allergies: PCN theophylline sulfa drugs walnuts
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Pt developed SOB the evening following vaccine dose, worsened significantly the next day. She reports using albuterol rescue inhaler much more frequently following vaccine. This lasted approximately one month.


VAERS ID: 1685292 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-04-08
Onset:2021-07-30
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Acoustic stimulation tests normal, Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: multivitamin
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: August 26, 2021 - hearing test
CDC Split Type:

Write-up: I really don''t know if this is related that''s what I want to find out. I have developed tinnitus about 4 months after last covid vaccine. I had no symptoms before vaccine and I went to Dr on August 26, 2021 who is an ENT doctor and had tests. I have no hearing lost and nothing that should be causing the tinnitus. I read that some are experiencing tinnitus but soon after vaccination but I know with so little research this could be related.


VAERS ID: 1685298 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-07-25
Onset:2021-07-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cheilitis
SMQs:, Hypersensitivity (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: Tacrolimus, esomeprazole, simvastatin, metoprolol
Current Illness: None
Preexisting Conditions: Transplant patient must take anti rejection meds
Allergies: Bananas, avocado
Diagnostic Lab Data:
CDC Split Type:

Write-up: 8-12 days after the first injection I broke out with fever sores on the left upper lip. The same occurred after the 2nd injection and this time it was on the lower lip, right side


VAERS ID: 1685609 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-05-06
Onset:2021-07-30
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, COVID-19, Chest X-ray abnormal, Chest pain, Computerised tomogram thorax abnormal, Cough, Diarrhoea, Dyspnoea, Fibrin D dimer increased, Hypoxia, Inflammatory marker test, Lung opacity, SARS-CoV-2 test positive, Tachycardia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Haemorrhage laboratory terms (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (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? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: unknown
Diagnostic Lab Data: 7/30/2021 CXR - possible infiltrate 7/26/2021 Covid 19 detected per PCR 8/9/2021 CT - ground glass opacities
CDC Split Type:

Write-up: Presented to ED on 7/30/2021 with cough, chest pain, shortness of breath, abdominal pain and diarrhea, hypoxia and tachycardia. -s/p Decadron 10 mg IV in ER, continue Decadron 10 mg x2 doses, then transition to 6 m g x7 pending course, Supportive cares, Antioxidant vitamins, Contact and Droplet precautions, Wean O2 as tolerated, Trend inflammatory markers, D-Dimer elevated to 981, will assess for PE with CT:PE She was discharged to home 8/2/2021. She presented again to the ED on 8/9/2021 with persistent SOB and cough. Patient was given albuterol inhaler, IV fluids, dose of Decadron. She went home with telemedicine/pulse oximetry home monitoring program Submitter does not have access to further detailed medical records or follow up information. If this information is required, please contact Hospital.


VAERS ID: 1685949 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Bronchitis, Chest X-ray abnormal, Cough, Fatigue, Illness, Lung disorder, Mobility decreased, Muscle strain, Nasopharyngitis, Pain, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 07/08/2021, COVID (Pfizer)
Other Medications: Estradiol .5mg 1X day; Zolpidem 10mg 1Xday; Alderol 30mg 1X a day; Fiorcette 2 every 6 hours as needed for migraines; Oxygen hi-flow as needed for Cluster Headaches; Vitamin C, D, E, B
Current Illness: N/A
Preexisting Conditions: Migraine, Cluster Headache
Allergies: Iodine, Fish, Environmental
Diagnostic Lab Data: Chest X-Ray 8/11/2021. per Doctor she said "showed my lungs cloudy but did not see pneumonia".
CDC Split Type: 640170

Write-up: The day of vaccine I was very tired. The next day I felt fine but by dinner time just felt like I was getting a cold. The fever and body aches began. By Monday the 2nd I began to feel as if I had a bad head cold. I had a fever and could barely move. By Thursday the 5th I was very ill and the coughing had begun. I saw the doctor who believed it was merely bronchitis. By Monday the 9th the cough had been so bad, even with medication, I had pulled all muscles in my back and torn something in my stomach. I had called the doctor again on the 11th and my doctor''s associate had then given me a second dose of a different antibiotic. She also ordered a chest X-ray which she said "showed my lungs cloudy but did not see pneumonia". I felt a bit better after 3 days of the new antibiotics. To date I am still coughing but not what I had suffered during the 3 weeks of suffering. Furthermore my left arm is in constant pain and I am unsure if I have pulled a muscle, pinched a nerve or caused damaged to my neck due to the excessive coughing.


VAERS ID: 1685965 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-04-08
Onset:2021-07-30
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Biopsy bladder abnormal, Bladder cancer
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Non-haematological malignant tumours (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: Multiple
Current Illness: Bipolar
Preexisting Conditions: Bipolar
Allergies: None
Diagnostic Lab Data: Biopsy of the bladder - July 2021
CDC Split Type:

Write-up: Diagnosed with bladder cancer 4 months after receiving the Covid-19 vaccine. No previous history of bladder cancer or bladder problems.


VAERS ID: 1688512 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 066D21A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Bedridden, Blood immunoglobulin G, Body temperature, Fatigue, Feeding disorder, Feeling abnormal, Gait inability, Headache, Heart rate irregular, Lymphadenopathy, Malaise, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Cardiac arrhythmia terms, nonspecific (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (COVID infected with follow on pneumonia)
Allergies:
Diagnostic Lab Data: Test Date: 20210316; Test Name: COVID Serum antibody testing igG antibodies; Result Unstructured Data: High; Test Date: 20210316; Test Name: COVID Serum antibody testing igG antibodies; Result Unstructured Data: High; Test Date: 20210723; Test Name: COVID Serum antibody testing igG antibodies; Result Unstructured Data: High; Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: 102.4; Test Date: 20210730; Test Name: irregular heartbeat; Result Unstructured Data: irregular
CDC Split Type: PVIUS2021001205

Write-up: Severe malaise; body aches with main pain in joints sever enough; body aches with main pain in joints sever enough; weakness; barely able to walk; unable to eat; bedridden for day; headache with severely exhaustion; foggy brained; fever 102.4; swollen glands in next armpits and general body swelling; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Severe malaise), PAIN (body aches with main pain in joints sever enough), ARTHRALGIA (body aches with main pain in joints sever enough), ASTHENIA (weakness) and GAIT INABILITY (barely able to walk) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included COVID-19 (COVID infected with follow on pneumonia) from 22-Dec-2020 to 04-Jan-2021. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced MALAISE (Severe malaise), PAIN (body aches with main pain in joints sever enough), PYREXIA (fever 102.4), LYMPHADENOPATHY (swollen glands in next armpits and general body swelling) and HEADACHE (headache). 30-Jul-2021, the patient experienced ARTHRALGIA (body aches with main pain in joints sever enough), ASTHENIA (weakness), GAIT INABILITY (barely able to walk), FEEDING DISORDER (unable to eat), BEDRIDDEN (bedridden for day), FATIGUE (headache with severely exhaustion) and FEELING ABNORMAL (foggy brained). The patient was treated with PARACETAMOL (TYLENOL) for General body pain and Joint pain, at an unspecified dose and frequency and CODEINE for General body pain and Joint pain, at an unspecified dose and frequency. On 30-Jul-2021, MALAISE (Severe malaise), ASTHENIA (weakness), GAIT INABILITY (barely able to walk), FEEDING DISORDER (unable to eat), BEDRIDDEN (bedridden for day) and PYREXIA (fever 102.4) had resolved. On 31-Jul-2021, PAIN (body aches with main pain in joints sever enough) and ARTHRALGIA (body aches with main pain in joints sever enough) had resolved. On 02-Aug-2021, FATIGUE (headache with severely exhaustion), FEELING ABNORMAL (foggy brained) and HEADACHE (headache) had resolved. On 05-Aug-2021, LYMPHADENOPATHY (swollen glands in next armpits and general body swelling) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood immunoglobulin G (Unknown-<1.44): 7.44 (High) High and high (High) High. On 23-Jul-2021, Blood immunoglobulin G (Unknown-<1.44): 3.80 (High) High. On 30-Jul-2021, Body temperature: high (High) 102.4. On 30-Jul-2021, Heart rate irregular: abnormal (abnormal) irregular. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment medication was reported. On 30 Jul 2021 patient had irregular heartbeat.


VAERS ID: 1689116 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-02-22
Onset:2021-07-30
   Days after vaccination:158
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK UN / -

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Dyspnoea, Fatigue, Headache, Rhinorrhoea, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Doctor''s visit on 8/04./2021 that resulted in a positive Covid test on 8/05/2021 and then tested again on 8/12/2021 with a positive test on 8/13/2021
CDC Split Type:

Write-up: I contracted covid and had two positive tests even though I was fully vaccinated. I felt exhausted, slight shortness of breath, runny nose, slight headache and then loss of taste and smell around the 3rd day. I still do not completely have my sense of taste and smell back and it has been over a month since I first contracted Covid.


VAERS ID: 1689423 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Blood test, Headache, Mobility decreased, Musculoskeletal stiffness, Scan
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness:
Preexisting Conditions: asthma, seasonal allergies
Allergies: seasonal allergies
Diagnostic Lab Data: scans and bloodwork have now been ordered
CDC Split Type:

Write-up: Joint issues severe hip pain, can''t roll over, sharp pain, can''t pick anything up, painful to bend over, can''t widen my legs without pain stiff neck can''t lift anything heavier than a couple pounds with my left arm without severe pain pain in rt arm mild headaches tired all the time not sleeping This all began after the vaccine...no issues prior


VAERS ID: 1689443 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030B21A? / UNK - / -

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

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

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


VAERS ID: 1689450 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030B21A / UNK - / IM

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

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

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


VAERS ID: 1689458 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030B21A / UNK - / -

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

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

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


VAERS ID: 1689837 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-04-29
Onset:2021-07-30
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EU0151 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Bell's palsy, Computerised tomogram
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: Lisinopril 5mg daily, Nexium 20 mg daily, store brand daily vitamin
Current Illness: N/a
Preexisting Conditions: High blood pressure
Allergies: NKDA
Diagnostic Lab Data: (2) CT Scans 07/31/21
CDC Split Type:

Write-up: Bells Palsy, right side of face


VAERS ID: 1692029 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Overdose, Product preparation issue, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100975641

Write-up: Caller reported the 3 patients had been administered with undiluted, full vial of the Pfizer BioNTech COVID-19 vaccine each/patient got a full vial of 6 doses undiluted; Caller reported the 3 patients had been administered with undiluted, full vial of the Pfizer BioNTech COVID-19 vaccine each; fever; This is a spontaneous report from a contactable pharmacist. A 20-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: FA7485; Expiration Date: Oct2021; NDC: 592671003), via an unspecified route of administration on 30Jul2021 (at the age of 20-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on unspecified date (at the age of 20-years-old) for covid-19 immunization. The patient had been administered with undiluted, full vial of the Pfizer BioNTech COVID-19 vaccine each. On 30Jul2021, she mentioned that 6 doses of the vaccine, which was in 1 full vial, was administered to each. It was stated that a patient that received a 3 times concentrated dose of the Pfizer COVID-19 vaccine. Stated that upon diluting the 3 doses in the vial the patient received the full vial. She had no idea why in terms she hadn''t done Pfizer before and this was not her home store and she blanked her mind, and she was thinking it was a single dose vial. To be honest she did it and she walked back and then realized. Stated this is not her home store and she doesn''t work at that one, it was for an emergency. She did not have height or weight to provide. Stated it was her 2nd dose of Pfizer COVID-19 vaccine given this morning, 30Jul2021. Somehow, she was walking, and she didn''t know why. States she thought it was single use vial, but it was 6 doses, and it was undiluted. Clarified that the patient got a full vial of 6 doses undiluted. Clarified that she had a total of 3 people all at the same time and received a full vial of 6 doses undiluted. No further details provided on other 2 patients. She couldn''t think right now to continue with the reports and a report on the website and will be doing that. Stated right now she needed more information like what the outlook and recommendations are to contact and monitor and what are the risks in terms of patient safety. She wanted to know the outlook and recommendations in terms of safety, monitoring and contacting the patients for the inadvertent administration. In response, disclaimer was provided.As of 03Aug2021, it was reported that, 0.3mL of undiluted vaccine was administered not the full vial because the dose was correct in the syringe but dilution was not. The vial still had a little liquid left over after pulling the dose, so she thinks she pulled the correct mL in the syringe of 0.3mL, but did not dilute first. The patient reported fever but has since resolved with Tylenol and ibuprofen when the doctor reported back to the pharmacy on Monday, 02Aug2021. The outcome of the event pyrexia was recovered on 02Aug2021 and all other events were unknow. Follow-up (03Aug2021): This is follow-up spontaneous report from a contactable Pharmacist. This Pharmacist reported for a patient in response to HCP letter sent via telephonic follow-up activity which included that: New event and clinical information updated. Follow-up activities closed, No further information expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202100980363 same reporter/product/event, different patient;US-PFIZER INC-202100980364 same reporter/product/event, different patient


VAERS ID: 1692035 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100982523

Write-up: headache; fever; chills; body ache; joint pain; arm pain; The initial case was missing the following minimum criteria: Unspecified product and Unspecified AE. Upon receipt of follow-up information on 30Aug2021, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on the Arm Left on 30Jul2021 15:26 (Batch/Lot Number: EW0196) as dose 2, single for COVID-19 immunization at a pharmacy. There were no concomitant medications. The patient has no medical history. The patient previously received the first dose of bnt162b2 (Lot number: EW0196) on 09Jul2021 12:00, Intramuscular on the Left arm for COVID-19 immunization and experienced headache and arm ache. No other prior vaccinations and relevant tests. On 30Jul2021, the patient experienced headache, fever, chills, body ache, joint pain, and arm pain all considered as important medical event by the reporter. The outcome of the events was recovered on 02Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1693155 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Joint swelling, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Extreme swelling in ankles, feet and lower legs. Overall feeling of tiredness.


VAERS ID: 1693182 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-03-20
Onset:2021-07-30
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Lymphadenopathy, Rash, Skin reaction, Skin warm, Urticaria
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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 150 mg Zoloft, 65 mg of iron supplements, 25 mg of vitamin c.
Current Illness: None.
Preexisting Conditions: None.
Allergies: Allergic to ibuprofen.
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Experienced a red welt-like skin reaction on my upper left thigh and about two weeks later it had begun to spread. The welt did not itch or cause any immediate pain. Over time it became warm to the touch and the lymph node in my groin had swollen.


VAERS ID: 1693424 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-03-01
Onset:2021-07-30
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Amnesia, Computerised tomogram, Electrocardiogram, Laboratory test, Magnetic resonance imaging, SARS-CoV-2 test, Transient global amnesia
SMQs:, Dementia (broad), Noninfectious encephalopathy/delirium (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Finasteride, Metoprolol, Atorvastatin, Levothyroxine, Aspirin, Alopurinol, Plavix,
Current Illness: no
Preexisting Conditions: gout, heart disease, hypertension, hypothyroidism,
Allergies: amoxicillin
Diagnostic Lab Data: COVID test- neg CT- neg MRI- neg labs-neg EKG- normal
CDC Split Type: vsafe

Write-up: On the 30th of July 2021, I didn''t know where I was, I lost my memory, for about 2 hours. I went to the Hospital ER, I was there for 30 hours. Transient global amnesia was the diagnosis I was given at the hospital.


VAERS ID: 1694872 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 RA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Blood test normal, Computerised tomogram normal, Dizziness, Fatigue, Hepatic enzyme, Hepatic pain
SMQs:, Liver related investigations, signs and symptoms (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: lower back pain
Allergies: sensitivity to wheat, very low allergy to pistachios, navy beans, chocolate, alfalfa, egg whites
Diagnostic Lab Data: Bloodwork to test liver enzymes - normal CT scan - all normal
CDC Split Type:

Write-up: Lightheaded/dizzy and very tired after both shots for approximately one hour. In 3 days after first shot (July 27) and 2 days after 2nd shot, I had pain on my right side where my liver is. The pain was mild to very strong. The pain lasted 1 1/2 weeks after my first shot. After my second shot (August 17), the pain started 2 days later and I have had one pain free day since then. My pain has been the same - mild to very strong. The pain was also going around to my back and for a few days down my back to my waistline. For the past three days I have had more pain in my back where the pain would stop when it went around my back. It doesn''t feel like a muscle strain or pull, not a nerve pain, but and organ pain - something inside of me is not happy. I had bloodwork done after my second shot because I had hepatitis A (from shellfish) when I was 21 and my liver enzymes were normal. My doctor ordered a CT scan and it came back normal. If I don''t wear a bra, my pain is much less and I don''t wear tight clothing.


VAERS ID: 1695059 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: New York  
Vaccinated:2021-02-10
Onset:2021-07-30
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/202/21 2nd dose02/10/21 Diagnosed covid positive:07/30/21 Symptom onset: Exposure:community Symptoms:cough, fatigue,muscle aches, loss of smell, sorethroat,chills,runny nose, HA


VAERS ID: 1695745 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-07-16
Onset:2021-07-30
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EA6780 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: Lactose intolerant
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Constant Buzzing in the ears / head No treatment at this time. Planning on seeing my family doctor


VAERS ID: 1700207 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-04-19
Onset:2021-07-30
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8731 / 2 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Angiogram pulmonary abnormal, Deep vein thrombosis, Dyspnoea, Laboratory test abnormal, Myocardial necrosis marker normal, Pain in extremity, Pulmonary embolism, Ultrasound scan abnormal
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Ultrasound of the left leg and CT pulmonary angiogram performed on 11 AUG 2021 which demonstrated left leg DVT and bilateral subsegmental pulmonary embolisms. Labwork done on the same day support this diagnosis. normal cardiac enzymes on lab.
CDC Split Type:

Write-up: The patient developed shortness of breath on 29 MAY 2021, 5 weeks after the 2nd vaccine dose. Two months later, the patient developed left leg pain on 30 JUL 2021 and worsened shortness of breath on 11 AUG 2021, when he was subsequently diagnosed with both a DVT and pulmonary embolism.


VAERS ID: 1700285 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078C21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Decreased appetite, Dizziness, Headache, Injection site reaction, Pain in extremity, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: N/A
Preexisting Conditions: Hashimoto''s Thyroiditis, Anxiety. Major Depressive Disorder, Retinitis Pigmentosa
Allergies: Latex, cats
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Adverse Events: Dizziness, Headache, Feeling of going to pass out around 9:00 PM, lack of appetite, very sore arm and small welps around injection site that spread all over body as weekend advanced Treatment: At home treatment of Tylenol (for head pain), Benadryl (for rash) and warm epsom salt bath (for rash)


VAERS ID: 1700389 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-31
Onset:2021-07-30
   Days after vaccination:121
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 UN / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Antibiotic level, COVID-19, Electrocardiogram, Full blood count, Hepatic enzyme, Metabolic function test, SARS-CoV-2 test positive
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: sucralfate,dicyclomine, prednisone,gabapentin, corisoprodol, buspirone, duloxetine, ursodiol, diclofenac, protonix, eliquis, dilaudid, morphine
Current Illness:
Preexisting Conditions: DM,HTN<, morbid obesity,hyperlipidemia, arthritis, fibromalagia,cervical cancer, endometriosis
Allergies: lidocaine, adhesives,bees, ants, paprika
Diagnostic Lab Data: CBC,CMP, liver enzymes, EKG, antibiotic, COVID 19
CDC Split Type:

Write-up: right upper quadrant pain, tested positive for COVID 19.


VAERS ID: 1700516 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: New York  
Vaccinated:2021-05-21
Onset:2021-07-30
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: NONE


VAERS ID: 1700537 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: New York  
Vaccinated:2021-06-24
Onset:2021-07-30
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21D / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: NONE
CDC Split Type:

Write-up: NONE


VAERS ID: 1700599 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: New York  
Vaccinated:2021-05-17
Onset:2021-07-30
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: NONE
CDC Split Type:

Write-up: NONE


VAERS ID: 1700607 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-13
Onset:2021-07-30
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041C21A / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: NONE
CDC Split Type:

Write-up: NONE


VAERS ID: 1700636 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: New York  
Vaccinated:2021-05-28
Onset:2021-07-30
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808986 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: NONE
CDC Split Type:

Write-up: NONE


VAERS ID: 1700884 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-18
Onset:2021-07-30
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: NONE
CDC Split Type:

Write-up: NONE


VAERS ID: 1700904 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-19
Onset:2021-07-30
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: NONE
CDC Split Type:

Write-up: NONE


VAERS ID: 1703674 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Injection site erythema, Injection site urticaria, Nausea, Palpitations, Pharyngeal swelling, Vaccination site pruritus
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Throat swelling; Heart palpitations; Itching, redness and hive over injection site; Injection Site Hives; Injection site redness; Nausea; fatigue; Armpit pain and local site reaction; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Sep-2021 and was forwarded to Moderna on 05-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Heart palpitations), VACCINATION SITE PRURITUS (Itching, redness and hive over injection site), INJECTION SITE URTICARIA (Injection Site Hives) and INJECTION SITE ERYTHEMA (Injection site redness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced AXILLARY PAIN (Armpit pain and local site reaction). On an unknown date, the patient experienced PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Heart palpitations), VACCINATION SITE PRURITUS (Itching, redness and hive over injection site), INJECTION SITE URTICARIA (Injection Site Hives), INJECTION SITE ERYTHEMA (Injection site redness), NAUSEA (Nausea) and FATIGUE (fatigue). At the time of the report, PHARYNGEAL SWELLING (Throat swelling), PALPITATIONS (Heart palpitations) and NAUSEA (Nausea) outcome was unknown, VACCINATION SITE PRURITUS (Itching, redness and hive over injection site), INJECTION SITE URTICARIA (Injection Site Hives) and INJECTION SITE ERYTHEMA (Injection site redness) had resolved and AXILLARY PAIN (Armpit pain and local site reaction) and FATIGUE (fatigue) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No concomitant medication was reported. No treatment information was provided.


VAERS ID: 1704025 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PH7485 / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (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: 75mcg Levothyroxene
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pharmacist failed to dilute the vaccine prior to administering to my 12 yr old son with Down Syndrome.


VAERS ID: 1704192 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-02-16
Onset:2021-07-30
   Days after vaccination:164
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / 2 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Angiogram pulmonary abnormal, Protein C, Protein S normal, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: CT pulmonary angiogram on July 30, 2021 demonstrated a subsegmental left lower lobe pulmonary embolism with developing lung infarct. Negative COVID-19 test in July 2021. Normal Protein C and S levels in August 2021.
CDC Split Type:

Write-up: Patient developed a pulmonary embolism on 30 July 2021, 5 months following his 2nd dose of COVID-19 vaccine. He did have mild COVID-19 infection on 12 August 2020.


VAERS ID: 1705912 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

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

Write-up: dizziness, vomiting, nauseousness


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