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From the 1/14/2022 release of VAERS data:

Found 1,031,637 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 2013819 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-21
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101860066

Write-up: Apoplectic fit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: AT-BASGAGES-2021-063601 (RA). A 88 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Nov2021 (Lot number: Unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization) with onset 21Nov2021, outcome "not recovered", described as "Apoplectic fit". The patient was hospitalized for cerebrovascular accident (start date: 21Nov2021). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2016103 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain, Computerised tomogram, Dizziness, Eye pain, Fall, Headache, Inappropriate schedule of product administration, Limb discomfort, Nausea, Neck pain, Oropharyngeal discomfort, Pain, Pain in extremity, Panic attack, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:fine; Test Name: Ct scan; Result Unstructured Data: Test Result:fine; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101857433

Write-up: Light-headed; Pain in eyes; Nauseous; Panic attack; Chest pain; Neck pain; Headache; pain; difficulty to use my left arm; fall; throat is getting blocked; pain is mainly on my left side(neck, chest and arm); First dose on 21Sep2021 and second dose on 21Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Regulatory number: GB-RA-WEBCOVID-202112251921061970-B5YUX (MHRA). Other Case identifier(s): GB-RA-ADR 26395012 (RA). A 35 year-old female patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Lot number: FH4751) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient last menstrual period date was 02Dec2021. Patient not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/lot number :FE3380), administration date: 21Sep2021, for COVID-19 immunisation. The following information was reported: PAIN (hospitalization, medically significant) with onset 2021, outcome "recovering", described as "pain"; CHEST PAIN (hospitalization, medically significant) with onset 22Nov2021, outcome "not recovered", described as "Chest pain"; NECK PAIN (hospitalization, medically significant) with onset 22Nov2021, outcome "not recovered", described as "Neck pain"; DIZZINESS (hospitalization, medically significant) with onset 10Dec2021, outcome "not recovered", described as "Light-headed"; PANIC ATTACK (hospitalization, medically significant) with onset 07Dec2021, outcome "not recovered", described as "Panic attack"; EYE PAIN (hospitalization, medically significant) with onset 10Dec2021, outcome "not recovered", described as "Pain in eyes"; LIMB DISCOMFORT (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "difficulty to use my left arm"; FALL (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "fall"; OROPHARYNGEAL DISCOMFORT (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "throat is getting blocked"; PAIN IN EXTREMITY (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "pain is mainly on my left side(neck, chest and arm)"; NAUSEA (hospitalization, medically significant) with onset 10Dec2021, outcome "not recovered", described as "Nauseous"; HEADACHE (hospitalization, medically significant) with onset 22Nov2021, outcome "not recovered", described as "Headache"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Nov2021, outcome "unknown", described as "First dose on 21Sep2021 and second dose on 21Nov2021". The patient underwent the following laboratory tests and procedures: blood test: fine; computerised tomogram: fine; sars-cov-2 test: positive, notes: Yes-Positive COVID-19 test. Since the vaccination, the patient not tested positive for COVID-19. Therapeutic measures were taken as a result of pain, chest pain, neck pain, dizziness, panic attack, eye pain, limb discomfort, fall, oropharyngeal discomfort, pain in extremity, nausea, headache. The patient was prescribed codeine, naproxen and omeprazole. Clinical course: The pain was mainly on my left side (neck, chest and arm). The pain was affecting around her neck. Patient had difficulty to use the left arm. At times feeling lightheaded causing had to fall. Every now and then feel as if the throat was getting blocked. The general physician was not taking the symptoms seriously, he had completely ruled out that the cause could be the vaccine. The report was not related to possible inflammation of the heart myocarditis or pericarditis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016792 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-21
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: PTPFIZER INC202101845831

Write-up: COVID-19; Vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-2099. A 45 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 14Jul2021 (Lot number: FE6029) as dose 2, 0.3 ml single and intramuscular (Batch/Lot number: unknown) as dose 1, 0.3 ml single for covid-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 21Nov2021, outcome "recovered" (07Dec2021), described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 21Nov2021, outcome "recovered" (07Dec2021), described as "Vaccination failure". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: The adverse reaction (ADR) had the approximate duration of unknown. Treatment of adverse reaction with unknown. Investigation results from product quality group includes: The complaint for PFIZERBIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FE6029. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. Reporter Comment: Concomitant Medicine 06-16-2021 "Comirnaty Lot: FA4632 " Other information-Clinic Privacy No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Concomitant Medicine 06-16-2021 "Comirnaty Lot: FA4632 " Other information-Clinic Privacy


VAERS ID: 2016889 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-11-21
   Days after vaccination:154
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7083 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: Iu international unit(s)
CDC Split Type: PTPFIZER INC202101867351

Write-up: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-516 (INFARMED). A 54 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 20Jun2021 (Lot number: FA7083) as dose 1, 0.3 ml single for covid-19 immunization. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 21Nov2021, outcome "unknown" and all described as "COVID-19". This report was considered as non-serious. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) positive, notes: Iu international unit(s). The reporter''s assessment of the causal relationship of the event (Drug ineffective) with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of assessment: Possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-11-21
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4632 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: Iu international unit(s)
CDC Split Type: PTPFIZER INC202101867460

Write-up: Vaccine failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-521 (INFARMED). A 45 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 11Jul2021 (Lot number: FA4632) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 21Nov2021, outcome "unknown", described as "Vaccine failure"; COVID-19 (medically significant) with onset 21Nov2021, outcome "unknown", described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) positive, notes: Iu international unit(s). The reporter''s assessment of the causal relationship of the (Drug ineffective) with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of assessment: Possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016932 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-11-21
   Days after vaccination:112
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Dyslipidaemia (Lipid alteration); Hypertension (No complications); Neoplasm of unspecified nature of digestive system (benign); Overweight; Tobacco abuse; Unspecified functional disorder of stomach
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101847752

Write-up: Vaccination failure; Vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-960 . A 74 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 01Aug2021 (Lot number: FE8235, Expiration Date: 30Nov2021) as dose 2, 0.3 ml single and intramuscular, administration date 04Jul2021 (Lot number: FE6029) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Neoplasm of unspecified nature of digestive system", start date: 2020 (unknown if ongoing), notes: benign; "Tobacco abuse", start date: 2020 (unknown if ongoing); "Overweight", start date: 2016 (unknown if ongoing); "Hypertension", start date: 2019 (unknown if ongoing), notes: No complications; "Dyslipidaemia" (unknown if ongoing) notes: Lipid alteration; "Unspecified functional disorder of stomach", start date: 2021 (unknown if ongoing). The patient''s concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Nov2021, outcome "recovered" (23Nov2021) and all described as "Vaccination failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) positive, notes: Positive Iu international unit(s). On 29Dec2021 the product quality group reported investigation reports. For this lot/s Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion. The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FE8235 and FE6029. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. The reporter''s assessment of the causal relationship of the [Vaccination Failure] with the suspect product was: Source of assessment: Notifier, Method of assessment: Unknown, Result of Assessment: Possible No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other Information - functional disorder of stomach 2021. Neoplasm of unspecified nature of digestive system 2020. Tobacco abuse 2020. Hypertension without complications 2019. Overweight 2016. Lipid alteration.


VAERS ID: 2016933 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-11-21
   Days after vaccination:177
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8142 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: PTPFIZER INC202101875428

Write-up: Covid-19; Vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-961 (INFARMED). A 74-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 28May2021 (Lot number: FA8142) as dose 2, 0.3 ml single and intramuscular, administration date 30Apr2021 (Lot number: EY2172) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 21Nov2021, outcome "recovered" (03Dec2021), described as "Covid-19"; VACCINATION FAILURE (medically significant) with onset 21Nov2021, outcome "recovered" (03Dec2021), described as "Vaccination failure". These events was reported as non-serious. The reporter''s assessment of the causal relationship of the vaccination failure with the suspect product was: Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: possible. Reporter Comment: Other information - Hospital Center PRIVACY No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: Other information - Hospital Center PRIVACY


VAERS ID: 2016934 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-11-21
   Days after vaccination:284
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211121; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Iu international unit(s)
CDC Split Type: PTPFIZER INC202101846921

Write-up: Vaccination failure; Vaccination failure; This is a spontaneous report received from a contactable reporter (Other Health Professional) from the WEB and product quality group. Regulatory number: PT-INFARMED-T202112-962 (INFARMED). A 27-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 10Feb2021 (Lot number: EL0725, Expiration Date: 31Mar2021) as dose 2, 0.3 ml single and intramuscular, administration date 19Jan2021 (Lot number: EL1491, Expiration Date: 30Apr2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 21Nov2021, outcome "recovered" (25Nov2021) and all described as "Vaccination failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) positive, notes: iU international unit(s). Reporter Comment: Other information-no records Investigation result from Product Quality Group. Conclusions: For Lot: EL1491 Conclusion from Puurs division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was reviously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: The complaint for LOE of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EL1491. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. For Lot: EL0725 Conclusion from Puurs division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EL0725. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-no records


VAERS ID: 2020235 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 023F21A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperhidrosis, Presyncope, Vertigo
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker wearer; Depression; Hypertension arterial; Hypertensive heart disease NOS; Thyroidectomy NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: Presyncope, Dizziness, Sweating; Presyncope, Dizziness, Sweating; Presyncope, Dizziness, Sweating; This regulatory authority case was reported by a physician and describes the occurrence of VERTIGO (Presyncope, Dizziness, Sweating), PRESYNCOPE (Presyncope, Dizziness, Sweating) and HYPERHIDROSIS (Presyncope, Dizziness, Sweating) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 023F21A) for COVID-19 vaccination. The patient''s past medical history included Depression, Artificial cardiac pacemaker wearer and Thyroidectomy NOS. Concurrent medical conditions included Hypertension arterial and Hypertensive heart disease NOS. On 21-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 21-Nov-2021, the patient experienced VERTIGO (Presyncope, Dizziness, Sweating) (seriousness criterion medically significant), PRESYNCOPE (Presyncope, Dizziness, Sweating) (seriousness criterion medically significant) and HYPERHIDROSIS (Presyncope, Dizziness, Sweating) (seriousness criterion medically significant). At the time of the report, VERTIGO (Presyncope, Dizziness, Sweating), PRESYNCOPE (Presyncope, Dizziness, Sweating) and HYPERHIDROSIS (Presyncope, Dizziness, Sweating) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The treatment information was unknown This is a regulatory authority case concerning a 65-year-old, female patient with medical history Artificial cardiac pacemaker wearer and Thyroidectomy and concurrent medical conditions of Hypertension arterial and Hypertensive heart disease, who experienced the unexpected serious events of Vertigo, Presyncope, Hyperhidrosis. The events occurred approximately on the same day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The medical history Artificial cardiac pacemaker wearer and Thyroidectomy and concurrent medical conditions of Hypertension arterial and Hypertensive heart disease remains a confounder. The events were reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: Follow-up received on 29-Dec-2021 and contains non-significant information - updated Sender''s Comment; Reporter''s Comments: The report comes from the FARO ACTIVE PHARMACOVIGILANCE study. All the data in our possession has already been entered. CRFV- Based on the information on the data sheet and in the IME list, this report is not to be considered ''serious''.; Sender''s Comments: This is a regulatory authority case concerning a 65-year-old, female patient with medical history Artificial cardiac pacemaker wearer and Thyroidectomy and concurrent medical conditions of Hypertension arterial and Hypertensive heart disease, who experienced the unexpected serious events of Vertigo, Presyncope, Hyperhidrosis. The events occurred approximately on the same day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The medical history Artificial cardiac pacemaker wearer and Thyroidectomy and concurrent medical conditions of Hypertension arterial and Hypertensive heart disease remains a confounder. The events were reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2022420 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004953 / 1 - / OT

Administered by: Unknown       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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20214

Write-up: Dyspnoea; This case was received (Reference number: DE-202100233853) on 29-Dec-2021 and was forwarded to Moderna on 29-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Dyspnoea) in a 54-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004953) for COVID-19 vaccination. No Medical History information was reported. On 21-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization). At the time of the report, DYSPNOEA (Dyspnoea) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. The treatment information was unknown.; Sender''s Comments: This is an RA case concerning a 54-year-old, female patient with no medical history reported, who experienced the events of shortness of breath chest tightness and hypertension which led to hospital admission. The events occurred on the same day the first dose was administered. RA assessed there was a consistent causal association of the events to immunization. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 2023352 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Malaise, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211019; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Unwell; Nausea; Fever; Headache; Shivers; Muscle ache; Tiredness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26412825) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Unwell), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache), CHILLS (Shivers), MYALGIA (Muscle ache) and FATIGUE (Tiredness) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 18-Oct-2021 to 01-Nov-2021. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 04-Mar-2021 to an unknown date for COVID-19 vaccination. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Unwell) (seriousness criterion medically significant). On 22-Nov-2021, NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Shivers) had resolved. On 23-Nov-2021, HEADACHE (Headache), MYALGIA (Muscle ache) and FATIGUE (Tiredness) had resolved. At the time of the report, MALAISE (Unwell) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Vaccine booster at 530pm by 8pm had headache, other symptoms developed throughout the night. Felt extremely unwell for two days and was in bed and was unable to look after family or work. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This regulatory authority case concerns a 36-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) events of Malaise, Nausea, Pyrexia, Headache, Chills, Myalgia and Fatigue after mRNA- 1273 vaccine, booster dose of the vaccination schedule. The patient had received previous dose of COVID-19 Vaccine AstraZeneca. The onset of the events occurred within the first day after the booster dose of mRNA- 1273 vaccine. Nausea, Pyrexia, Headache, Chills, Myalgia and Fatigue are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. The events resolved after 1 to 2 days. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 36-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) events of Malaise, Nausea, Pyrexia, Headache, Chills, Myalgia and Fatigue after mRNA- 1273 vaccine, booster dose of the vaccination schedule. The patient had received previous dose of COVID-19 Vaccine AstraZeneca. The onset of the events occurred within the first day after the booster dose of mRNA- 1273 vaccine. Nausea, Pyrexia, Headache, Chills, Myalgia and Fatigue are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. The events resolved after 1 to 2 days. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2025845 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-11-21
   Days after vaccination:172
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Computerised tomogram, Pneumonia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Bronchial asthma; Non-insulin-dependent diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: Computed tomography; Result Unstructured Data: Test Result:Bi-pulmonary COVID-pneumonia; Test Date: 20211114; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Test Date: 20211121; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Test Date: 20211121; Test Name: Covid-19 rapid antigen test; Result Unstructured Data: Test Result:Positive
CDC Split Type: DEPFIZER INC202101873949

Write-up: COVID-19 PCR test positive; COVID-19 PCR test positive; Pneumonia; bi-pulmonary COVID pneumonia; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: DE-PEI-CADR2021203153 Regulatory Authority. Other Case identifier(s): DE-CADRPEI-2021203153 Regulatory Authority, DE-PEI-202100228008 Regulatory Authority. A 69 year-old female patient received bnt162b2 (COMIRNATY), administration date 02Jun2021 (Batch/Lot number: unknown) as dose 2, 0.3 ml single and administration date 29Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bronchial asthma" (not ongoing); "Non-insulin-dependent" (not ongoing); "Arterial hypertension" (not ongoing). The patient''s concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 21Nov2021, outcome "not recovered" and all described as "COVID-19 PCR test positive"; PNEUMONIA (hospitalization, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Pneumonia"; COVID-19 PNEUMONIA (hospitalization, medically significant) with onset 21Nov2021, outcome "unknown", described as "bi-pulmonary COVID pneumonia". The patient underwent the following laboratory tests and procedures: computerised tomogram: (21Nov2021) bi-pulmonary covid-pneumonia; sars-cov-2 test: (14Nov2021) positive; (21Nov2021) positive; (21Nov2021) positive. Sender comment: Do you or the person concerned have any known allergies? If so, what are they? No. Details of risk factors or previous illnesses: Bronchial asthma, non-insulin-dependent, type 2 diabetes mellitus, arterial hypertension/positive polymerase chain reaction test on 14Nov2021 and 21Nov2021/positive rapid antigen test on 21Nov, hospitalisation due to respiratory insufficiency/computed tomography-graphically confirmed bi-pulmonary COVID- pneumonia/admitted to intensive care unit and nasal high-flow oxygen therapy was required. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026983 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-11-21
   Days after vaccination:110
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Depressive disorder; Skin infection
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: International unit(s)
CDC Split Type: PTPFIZER INC202200002017

Write-up: Vaccination failure; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-1482. A 40 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 03Aug2021 (Lot number: FE8235) as dose 2, 0.3 ml single and intramuscular, administration date 06Jul2021 (Lot number: FE6029) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Skin infection", start date: 2021 (unknown if ongoing); "Depressive disorder" (unknown if ongoing). The patient''s concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Nov2021, outcome "recovered" (30Nov2021) and all described as "Vaccination failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) positive, notes: International unit(s). The reporter assessed casual relationship of the (Vaccination failure) with the suspect product. Source of assessment done by reporter. Method of assessment was unknown, result of assessment was possible. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-"S76 SKIN INFECTION - 2021 P76 DEPRESSIVE DISORDER


VAERS ID: 2029652 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cardiac disorder, Chest pain, Depression, Fatigue, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Arthritis (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood cholesterol abnormal
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882563

Write-up: Shoulder pain; Depression; Tired out; Chest pain; Primary Immunization series: COVID-19 VACCINE ASTRAZENECA, booster: COMIRNATY; Primary Immunization series: COVID-19 VACCINE ASTRAZENECA, booster: COMIRNATY; Booster; patient thought he may be having heart problems; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112291221096920-PENCY (RA). Other Case identifier(s): GB-MHRA-ADR 26408412 (RA). A 50-year-old male patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Lot number: FK9413) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "cholesterol" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), administration date: 19Mar2021, for COVID-19 vaccination; Covid-19 vaccine astrazeneca (DOSE 2), administration date: 22May2021, for COVID-19 vaccination. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 21Nov2021, outcome "unknown" and all described as "Primary Immunization series: COVID-19 VACCINE ASTRAZENECA, booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Booster"; CHEST PAIN (medically significant) with onset 22Nov2021, outcome "recovered with sequelae", described as "Chest pain"; ARTHRALGIA (medically significant) with onset 23Nov2021, outcome "recovering", described as "Shoulder pain"; DEPRESSION (medically significant) with onset 23Nov2021, outcome "recovering", described as "Depression"; FATIGUE (medically significant) with onset 22Nov2021, outcome "recovering", described as "Tired out"; CARDIAC DISORDER (medically significant) with onset 2021, outcome "unknown", described as "patient thought he may be having heart problems". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: No - Negative COVID-19 test. Patient was worried and thought he may be having heart problems. He told his wife in case anything happened to call emergency services. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029759 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Epilepsy, Generalised tonic-clonic seizure, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (Previously epilepsy controlled by medication until booster received); Tonic-clonic seizures (two tonic clonic seizures ever with the last one being two years ago)
Allergies:
Diagnostic Lab Data: Test Date: 20211209; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882697

Write-up: seizures; tonic clonic seizures; tonic clonic seizures; Epilepsy; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112292027578230-3NWFJ (MHRA). Other Case identifier(s): GB-MHRA-ADR 26411566 (MHRA). A 49 year-old male patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Lot number: FL1939) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing), notes: Previously epilepsy controlled by medication until booster received; "Tonic-clonic seizures" (unspecified if ongoing), notes: two tonic clonic seizures ever with the last one being two years ago. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 Immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for Covid-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 21Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 21Nov2021, outcome "unknown", described as "Booster"; EPILEPSY (medically significant) with onset 23Nov2021, outcome "recovered with sequelae", described as "Epilepsy"; SEIZURE (medically significant), outcome "recovered", described as "seizures"; GENERALISED TONIC-CLONIC SEIZURE (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "tonic clonic seizures". The events "epilepsy", "seizures", "tonic clonic seizures" and "tonic clonic seizures" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Dec2021) no - negative, notes: No - Negative COVID-19 test. Clinical course: Two absence seizures followed by two tonic clonic seizures in one day. Previously had only had two tonic clonic seizures ever with the last one being two years ago. Neuro Consultant informed. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029872 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Disease recurrence, Dizziness, Dyspnoea, Fatigue, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, Palpitations, Pericarditis, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Chronic kidney disease (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APIXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac ablation (Underwent last cardiac ablation in Sep2020.); Graves'' disease (Being monitored 3-monthly for return of Graves Disease which was diagnosed in Mar2020); Paroxysmal atrial fibrillation
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885688

Write-up: Fatigue/unusual tiredness; Shortness of breath; Heart palpitations; Racing heart (tachycardia); pericarditis; myocarditis; Atrial fibrillation/cardiac ablation; Atrial fibrillation/cardiac ablation; dose 1 dose 2 covid-19 vaccine manufactuerer unknown and dose 3 BNT162b2; dose 1 dose 2 covid-19 vaccine manufactuerer unknown and dose 3 BNT162b2; Booster; wooziness/woozy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112301139315500-NWTLS (RA). Other Case identifier: GB-MHRA-ADR 26415359 (RA). A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 21Nov2021 (Batch/Lot number: unknown), at 58 year-old, as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Graves'' disease", start date: Mar2020 (unspecified if ongoing), notes: Being monitored 3-monthly for return of Graves Disease which was diagnosed in Mar2020; "Paroxysmal atrial fibrillation" (unspecified if ongoing); "cardiac ablation ", start date: Sep2020 (unspecified if ongoing), notes: Underwent last cardiac ablation in Sep2020. Unsure if patient has had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medication included: APIXABAN taken for atrial fibrillation, start date: Mar2019. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: the patient received dose 1 dose 2 covid-19 vaccine manufactuerer unknown and dose 3 BNT162b2; DIZZINESS (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "wooziness/woozy"; ATRIAL FIBRILLATION (medically significant), DISEASE RECURRENCE (medically significant) all with onset 01Dec2021, outcome "recovered" (01Dec2021) and all described as "Atrial fibrillation/cardiac ablation"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis". The events "wooziness/woozy", "atrial fibrillation/cardiac ablation", "atrial fibrillation/cardiac ablation", "pericarditis" and "myocarditis" were evaluated at the physician office visit. It was reported that arrhythmia nurses suspect booster reaction. The patient had no incidence of Atrial Fibrillation since then except for this post booster vaccine episode exactly 10 days after vaccine. No Afib since this random episode either. Felt woozy 15 minutes after receiving booster which subsided later same day. Wooziness reappeared 5 hours or so prior to onset of this random Afib episode 10 days after booster. This report was related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. It was a diagnosis made by a medical professional and telephone consultation with Arrythmia Nurse. No physical examination. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of atrial fibrillation, disease recurrence included Flecainide 200mg & Apixaban 5mg and cardiac ablation. No relevant tests (chest X-ray, echocardiogram, cardiac MRI, chest computerised tomography (CT)) had been taken. No blood tests, such as for certain proteins (called troponin) that signal heart muscle damage had been taken. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030126 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Dizziness, Insomnia, Limb malformation, Myalgia, Palpitations, Pyrexia, Retching, SARS-CoV-2 test, Vomiting, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Congenital, familial and genetic disorders (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started, Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211025; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fever; Sleep loss; Gagging; Vomiting; Diarrhea NOS; Muscle ache; Wheezy; Dizzy spells; Limb defects; Palpitations; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26421431) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), INSOMNIA (Sleep loss), RETCHING (Gagging), VOMITING (Vomiting), DIARRHOEA (Diarrhea NOS), MYALGIA (Muscle ache), WHEEZING (Wheezy), DIZZINESS (Dizzy spells), LIMB MALFORMATION (Limb defects) and PALPITATIONS (Palpitations) in a 28-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started, Unsure when symptoms stopped). On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), INSOMNIA (Sleep loss) (seriousness criterion medically significant), RETCHING (Gagging) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), DIARRHOEA (Diarrhea NOS) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), WHEEZING (Wheezy) (seriousness criterion medically significant), DIZZINESS (Dizzy spells) (seriousness criterion medically significant), LIMB MALFORMATION (Limb defects) (seriousness criterion medically significant) and PALPITATIONS (Palpitations) (seriousness criterion medically significant). On 21-Nov-2021, DIZZINESS (Dizzy spells) had resolved, PALPITATIONS (Palpitations) was resolving. On 23-Nov-2021, LIMB MALFORMATION (Limb defects) had resolved. On 24-Nov-2021, PYREXIA (Fever) had resolved. On 25-Nov-2021, WHEEZING (Wheezy) had resolved. At the time of the report, INSOMNIA (Sleep loss), RETCHING (Gagging), VOMITING (Vomiting) and DIARRHOEA (Diarrhea NOS) had not resolved and MYALGIA (Muscle ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Oct-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Within 12 hours of vaccination the patient couldn''t move his arm and developed a fever lasting a few days. Since then the patient had not been able to sleep through the night waking up every couple of hours sometimes. The patient''s muscles and bones ached everyday and occasionally got palpitations. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No concomitant product use was provided by the reporter. No treatment medication was provided. This report do not relate to possible inflammation of the heart (myocarditis or pericarditis). Company Comment: This is a regulatory case concerning a 28-year-old, male patient with a history of Suspected COVID-19 (SARS-CoV-2 test positive less than one month before vaccination), who experienced the unexpected serious events of palpitations, dizziness, limb malformation, pyrexia, wheezing, vomiting, diarrhoea, retching, insomnia and myalgia. The patient referred that he couldn''t move his arm and developed a fever lasting a few days approximately 12 hours after the first dose of mRNA-1273 vaccine. Since then, he has had insomnia, myalgia and bone pain daily and occasionally, palpitations. The medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to important medical condition.; Sender''s Comments: This is a regulatory case concerning a 28-year-old, male patient with a history of Suspected COVID-19 (SARS-CoV-2 test positive less than one month before vaccination), who experienced the unexpected serious events of palpitations, dizziness, limb malformation, pyrexia, wheezing, vomiting, diarrhoea, retching, insomnia and myalgia. The patient referred that he couldn''t move his arm and developed a fever lasting a few days approximately 12 hours after the first dose of mRNA-1273 vaccine. Since then, he has had insomnia, myalgia and bone pain daily and occasionally, palpitations. The medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to important medical condition.


VAERS ID: 2030714 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-11-21
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Overweight
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: international unit(s)
CDC Split Type: PTPFIZER INC202200001840

Write-up: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority and product quality group. Regulatory number: PT-INFARMED-T202112-1485 (INFARMED). A 56 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 23Jun2021 (Lot number: FC5435) as dose 2, 0.3 ml single and intramuscular, administration date 26May2021 (Lot number: FA7083) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Overweight", start date: 2018 (unknown if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Nov2021, outcome "recovered" (29Nov2021), described as "Vaccination failure"; COVID-19 (medically significant) with onset 21Nov2021, outcome "recovered" (29Nov2021), described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) positive, notes: international unit(s). Clinical course: The reporter''s assessment of the causal relationship of the event (Vaccination Failure) with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Possible. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information: OVERWEIGHT 2018


VAERS ID: 2030717 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-11-21
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: PTPFIZER INC202200005670

Write-up: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the RA-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-1516. A 52 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15May2021 (Lot number: EX8680) as dose 2, 0.3 ml single and intramuscular, administration date 18Apr2021 (Lot number: EW9127) as dose 1, 0.3 ml single for covid-19 immunization. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Nov2021, outcome "unknown", COVID-19 (medically significant) with onset 21Nov2021, outcome "recovered" (01Dec2021) and all described as "COVID-19". This report was considered as non-serious. The reporter''s assessment of the causal relationship of Drug ineffective with the suspect product was: Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: possible. Reporter Comment: Other information-no records. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-no records


VAERS ID: 2032677 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Dyspnoea at rest, Heart rate, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: heart beat; Result Unstructured Data: Test Result:strong heartbeat/palpitations; Comments: at rest and in his sleep (as measured by the device)
CDC Split Type: CZPFIZER INC202200002370

Write-up: Pain in the left side of chest; Breathlessness/Feeling of insufficient inhaling and exhaling (shortness of breath); Feeling of insufficient inhaling and exhaling (shortness of breath) - at rest; Strong heartbeat /Heart pounding/Palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. The reporter is the patient. Regulatory number: CZ-CZSUKL-21013615 (RA). A 27 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 19Nov2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHEST PAIN (medically significant) with onset 21Nov2021, outcome "recovering", described as "Pain in the left side of chest"; DYSPNOEA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Breathlessness/Feeling of insufficient inhaling and exhaling (shortness of breath)"; DYSPNOEA AT REST (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Feeling of insufficient inhaling and exhaling (shortness of breath) - at rest"; PALPITATIONS (medically significant) with onset 21Nov2021, outcome "recovering", described as "Strong heartbeat /Heart pounding/Palpitations". The patient underwent the following laboratory tests and procedures: heart rate: (21Nov2021) strong heartbeat/palpitations, notes: at rest and in his sleep (as measured by the device). Clinical course: Patient experienced a feeling of insufficient inhaling and exhaling (shortness of breath) - at rest and while walking at work, often before going to bed, it also woke him from sleep; pain in the left side of chest; strong heartbeat/palpitations at rest and in his sleep (as measured by the device) after the vaccination. The reporter did not wish to contact the physician. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1887457 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Nevada  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069F21A / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Muscular weakness, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Rosuvastatin Flovent Restasis Nexium Instaflex Centrum Vitamin D Xyzal
Current Illness:
Preexisting Conditions: Allergy induced asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sore arm and lot of muscle soreness and weakness throughout my body! Also extreme tiredness. This is different than what I experienced after my 2nd shot.


VAERS ID: 1887789 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Female  
Location: Montana  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / SYR

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

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

Write-up: Vomiting.


VAERS ID: 1887867 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032F21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Headache, Injection site erythema, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fever of 102.5 nausea headache redness at injection site


VAERS ID: 1887872 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-03-10
Onset:2021-11-20
   Days after vaccination:255
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Acute kidney injury, Asthenia, Atelectasis, Bacterial test, Blood creatinine increased, Blood gases abnormal, Blood pH increased, Blood potassium decreased, Blood sodium increased, Blood test abnormal, Blood urea increased, Breath sounds abnormal, COVID-19, Chest X-ray abnormal, Cough, Dyspnoea, Hypokalaemia, Hyponatraemia, Hypoxia, Laboratory test, Lung infiltration, Mucosal dryness, Oxygen saturation decreased, PCO2 decreased, Positive airway pressure therapy, SARS-CoV-2 test positive, Urine analysis abnormal, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lactic acidosis (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Hyponatraemia/SIADH (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (narrow), 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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Current Medications 1. amlodipine-benazepril 10 mg-20 mg oral capsule : 1 cap(s) orally once a day 2. apixaban 5 mg oral tablet : 1 tab(s) orally 2 times a day 3. atorvastatin 20 mg oral tablet : 1 tab(s) orally once a day 4. calcium carbon
Current Illness: unknown
Preexisting Conditions: Anxiety, colitis, acute kidney injury, hydrocephalus, hypokalemia,, DVT/ hyperlipidemia/ hypertension/ brain aneurism july 2021, VP shunt
Allergies: none known
Diagnostic Lab Data: This patient is brought to the emergency department with complaint of cough, shortness of breath, and hypoxia. On exam patient has diminished lung sounds and dry mucous membranes. ABG reveals hypoxia with a PaO2 of 70.5 on 100% nonrebreather. Patient''s pH is 7.456, PCO2 is 23.1. IV access established labs are drawn. Patient is given a 1 L fluid bolus. IV access established baseline labs are drawn. Patient is placed on BiPAP for respiratory support secondary to hypoxia. Patient is a DO NOT RESUSCITATE with no intubation. Patient''s Covid swab is positive. Patient''s blood work does reveal a slightly elevated white blood cell count of 14.8, hyponatremia with a sodium of 158 and hypokalemia with potassium of 3.3. Patient has acute renal failure with a BUN of 9 0 and a creatinine of 3.7, in January 2021 patient''s renal function was normal. Urinalysis is 4+ bacteria. Chest x-ray does show streaky infiltrate or atelectasis in the right and left lower lung base as well as the lingula. Patient is started on Rocephin. Case is discussed with on-call hospitalist Dr. who accepts the admission. Patient is given 10 mEq potassium in the emergency department.
CDC Split Type:

Write-up: Patient arrives via EMS with complaint of shortness of breath. Patient is at nursing home and staff noticed her pulse ox was low. Patient is unable to provide history. All history is obtained from nursing home records as well as husband who meets the patient in the emergency department. Husband states the patient has been recently discharged home from the hospital and was placed in rehab for treatment. States he saw her couple days ago and she was eating and was able to carry on a conversation. States he was called today and told she was short of breath. He states she appears more weak and is coughing more than she had been. Patient does have a previous diagnosis of Covid.


VAERS ID: 1887885 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-11-05
Onset:2021-11-20
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Dizziness, Lethargy, Pain, Paraesthesia, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D; Vitamin C; Elderberry; Hctz-Li
Current Illness: N/A
Preexisting Conditions: Controlled HTN
Allergies: N/A
Diagnostic Lab Data: N/A.
CDC Split Type:

Write-up: Fever; chills; whole body achiness; transient tingling down bilateral UE/LE; lethargy; lightheaded.


VAERS ID: 1887946 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027H21B / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Heart rate increased, Hyperhidrosis, Hypoaesthesia oral, Pharyngeal hypoaesthesia
SMQs:, 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), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 1 minute after injection, noted acute diaphoresis, lightheadedness, and throat/tongue numbness. HR at rest increased to 160. Offered water by pharmacy staff, sx resolved after 25 minutes


VAERS ID: 1887959 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Severe headache, vomiting


VAERS ID: 1887960 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Delaware  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 058F21A / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erythema, Lip swelling, Rash macular
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Woke up on the Saturday following a Thursday dose with a swollen bottom lip and red splotches around my neck and collar bone area.


VAERS ID: 1887962 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32030BD / 3 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control, hydrochlorothiazide, sertraline, vitamin D, prenatal vitamins, fish oil.
Current Illness: No illnesses. Just a LOT of stress that manifested in some physical symptoms.
Preexisting Conditions: Anxiety, depression, obesity, knee osteoarthritis, high blood pressure
Allergies: Shrimp.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Woke up at 4 am the day after with severe headache, low-grade fever of 100�, moderate injection site pain. (I am still glad I got the vaccine and would do so again if a 4th is ever needed. I feel icky but I know that means my body is making antibodies to protect me.)


VAERS ID: 1887971 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8030 / 3 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Injection site pain, Injection site swelling, Mobility decreased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: 8am: Bupropion XL 300mg, Vitamin D3 (1,000 iu), Garden of Life Once a Day Female Probiotics, Zyxal (generic) 25mg. 5pm: 2 Tylenol extra strength Arm implant Nexplanon 2 years in.
Current Illness: High Cholesterol
Preexisting Conditions: Asthma
Allergies: Pineapple, fungus/mold, chocolate, shellfish, Aspirin and NSAIDS
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Low fever (101F�), pain in the injection site with swelling and limited mobility. Severe period cramps even though I had a period 2 weeks ago.


VAERS ID: 1887981 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

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

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

Write-up: Headache, severe body aches, fever, chills, nausea


VAERS ID: 1887989 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Nebraska  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 067F21A / 3 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Fever, sore arm, Age 43, Moderna COVID shot, 02/18/2021
Other Medications: Metformin
Current Illness: None
Preexisting Conditions: Diabetes
Allergies: Penicillin Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swollen right arm Arm pain radiating from shoulder to wrist Fever 101.0


VAERS ID: 1887998 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5618 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: No adverse event, Underdose
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: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: 16 year old was given a pediatric dose. Second dose of .1ml was administered per medical authorization, Doctor to complete a full adult dose of Pediatric vaccine. Patient has no adverse effects. Pt mother is present and consented to Medical control authorization of second dose.


VAERS ID: 1888019 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Photosensitivity reaction, Vision blurred
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin 800 mg Synthroid 10 mg
Current Illness: none
Preexisting Conditions: PCOS
Allergies: Allergic to eggs, wheat, yeast, soy, casin, cod, coffee, and corn
Diagnostic Lab Data: None yet. This just started and I don''t have medical insurance so I won''t be running to the doctor unless I have to.
CDC Split Type:

Write-up: Within 30 min. of shot I noticed my eyes were extremely sensitive to sunlight. To the point I had to cover my face and look down at the ground, to get to my car. This has never been an issue for me. Today, 48 hours later, I am seeing zig zag, blurry lines, in my right eye anytime I go in outside, in sunlight. This happened today, while I was driving, within minutes of going outside. Happens only in right eye. I had to immediately go into a store and buy sunglasses, wear them indoors, for 15 minutes before the blurry lines will disappear.


VAERS ID: 1888030 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 3 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Extra dose administered, 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: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Medication error - patient not eligible for booster, but was given booster dose (0.25mL Moderna) after age was missed by forms verification staff. A medication error form was documented with the health department and family was notified of the error. No adverse effect symptoms noted at time of this report.


VAERS ID: 1888039 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Female  
Location: Unknown  
Vaccinated:2020-11-20
Onset:2021-11-20
   Days after vaccination:365
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Chills, Immediate post-injection reaction, Joint swelling, Mobility decreased, Nervousness
SMQs:, Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Patient has leukemia, most recent cycle 2 weeks prior per mother
Current Illness: See above
Preexisting Conditions: See above
Allergies: None
Diagnostic Lab Data: See above
CDC Split Type:

Write-up: Per nurse patient was gripping her right wrist with her left hand when the vaccine was administered into the left arm. Immediately after the vaccine she began complaining of right wrist pain. Mild appreciable swelling noted of right wrist, no color change. Patient continued to complain, normal radial pulses. Ice pack applied to right wrist. Patient was observed for an additional 15 minutes and during that time vitals checked (Temp 37.1, BP 109/74, HR 113). Tylenol was administered by mom after. Patient was interactive with child life during this time but also appeared nervous and shivering in the chair. Child stated that was because she was nervous. No other signs or symptoms. At end of 30 minutes child still with limited ROM of right wrist and hand compared to left. No previous injury per family. Discussed with family that if pain or swelling increases or fails to resolve within 2 hours mom is to seek immediate medical care. Also discussed seeking immediate medical care for appearance of any other symptoms. Patient remained A/O, smiling intermittently when distracted by staff throughout visit.


VAERS ID: 1888043 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Lymphadenopathy, Pain
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Escitalopram 20mg, Vitamin D 5000iu
Current Illness: N/A
Preexisting Conditions: Depression, GAD
Allergies: N/A
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Swollen lymph nodes in left arm pit with pain


VAERS ID: 1888049 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Injection site rash, Pain, Pruritus, Vaccine positive rechallenge
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: Same- covid arm with 1st dose
Other Medications: HRT - bijuva Allegra 1/day
Current Illness: None known
Preexisting Conditions: None
Allergies: Sulfa drugs
Diagnostic Lab Data:
CDC Split Type:

Write-up: Covid arm - rash traveling down from injection down arm. Itchy and painful. Had same reaction after 1st dose, but rash appeared sooner this time.


VAERS ID: 1888058 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8020 / 3 LA / IM
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. 308454 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

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

Write-up: Patient reported feeling dizzy about 10 mins after vaccine administration. She lied down on exam table for about 30 mins and felt better. VS stable. Her spouse came to pick her up.


VAERS ID: 1888073 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939909 / 3 LA / IM

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

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

Write-up: Patient was administered the booster dose before the 6 month time period was up given 23 days early


VAERS ID: 1888094 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Bradycardia, Dizziness, Hyperhidrosis, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft 25mg
Current Illness: None
Preexisting Conditions: No known
Allergies: No known
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was nervous to get vaccine. She tolerated well. She moved locations to a chair and began feeling like she was going to pass out. She was bradycardic, diaphoretic and pale. She did pass out and came to a couple of seconds later. She did not fall. She was placed in a recovery position. Ice pack place on her neck. 11:45 Pulse 44, O2 Sat 99%, Resp 12 . She was on floor for 2nd assessment in recovery position. Color was better. She was talking. Pulse 60, O2 Sat 98%, BP 88/52, Resp 12. Reassessed at 11:56 Pulse 68, O2Sat 100%, BP 95/58, Resp 12. Asked how she feels on a scale of 0-10. 0 is horrible and 10 is feels great. She states she is an 8. Had a sucker and some water. Sat up on Floor. Later sat in a chair. was feeling good. Instructed to seek medical attention if she worsens.


VAERS ID: 1888096 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012F21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Feeling abnormal, Feeling hot, Injection site erythema, Injection site warmth
SMQs:, Dementia (broad), Extravasation events (injections, infusions and implants) (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: atorvastatin 10mg, lovaza 1gm, aspirin adult, multi vitamin, lisinopril hydrochlorothiazide
Current Illness: NA
Preexisting Conditions: HX of obesity, skin rash, pneumonia, mixed hyperlipidemia, hypertension, impaired fasting glucose, hypercalcemia
Allergies: NONE
Diagnostic Lab Data: Pt given 1% hydrocortisone cream and Benadryl 25 mg, Advised pt that drowsiness may occur due to administration of Benadryl. Pt also advised that if sx worsen, return, or she has any difficulty with SOB to go to the ER. Pt verbalized understanding and thanked the office.
CDC Split Type:

Write-up: her arm felt weird and hot and that this did not occur w/ the first 2 vaccines she received, skin above & below injection site was warm to the touch w/ slight erythema present. Pt denied any shortness of breath, palpitations, throat itching/feeling swollen or any tongue complaints. This nurse applied 1% hydrocortisone cream to site and reset the 15 minute timer at 11:05. This nurse checked on patient to reassess after 5 minutes, with the patient in complete eye view the entire time. At this time patient states she is feeling minimally better. Injection site rechecked and erythema not present, with the arm now cool and dry. Benadryl 25mg given PO to patient at 11:12. Pts second timer completed at 11:20. At this time pt is feeling much better.


VAERS ID: 1888097 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5618 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Underdose
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: hydrocortisone 2.5% topical twice daily for 5 days ergocalciferol 1250mcg (50,000) capsule 1 per week for 8 weeks
Current Illness: none/NA
Preexisting Conditions: obesity, contact dermatitis, eczema
Allergies: eggs
Diagnostic Lab Data: none/N.A
CDC Split Type:

Write-up: patient stated he was 11 when he is really 13. RN gave him a pediatric 0.2 mL dose when he should have received a 0.3 mL adult dose instead.


VAERS ID: 1888098 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0809 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Vertigo
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril 10mg once daily. Escitalopram 5 mg once daily.
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: No tests. Called the nurse line and received advice over the phone.
CDC Split Type:

Write-up: Severe vertigo and dizziness the morning after the shot. Could not move my head or get out of bed without the room spinning. Lasted about 30 minutes. Eventually got up very, very slowly and it is getting better as the day goes on.


VAERS ID: 1888100 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Expired product administered, Exposure during pregnancy, No adverse event
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (narrow)

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

Write-up: Patient''s estimated date of delivery is January 2022. Patient received Pfizer vaccine that had been mixed approximately 25.5 hours before administration. No other adverse effects to report. Patient will wait to repeat dose upon delivery.


VAERS ID: 1888112 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1611 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No, none was given to patient
Current Illness: No known illnesses
Preexisting Conditions: No known illnesses
Allergies: No known allergies
Diagnostic Lab Data: None done.
CDC Split Type:

Write-up: Patient fainted then immediately regained consciousness, became pale and was sweating. Called 911. They examined the patient and offered to take him the emergency department. Patient refused. He was slowly improving. He waited a few hours then left the pharmacy on his own.


VAERS ID: 1888116 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 3 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Vitals pre/post BP 120/70 HR 66 RR14 Sat 98% ----- BP 124/74 HR 71 RR14 Sat 98%
CDC Split Type:

Write-up: PT recvd JJ booster vaccine to Left arm. PT began to feel nausea about 5mins post vaccine. PT confirms no previous advised vrs reaction to first dose. PT confirms not eating today. PT given Famotadine 40mg and improved noted in 5mins. Symptoms resolved PT observed a total of 30mins.


VAERS ID: 1888117 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011D21A / 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? 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: Seasonal
Diagnostic Lab Data: None
CDC Split Type:

Write-up: PT and dad approached registration and asked for moderna first shot. PT appeared to be an adult per registration staff but only 16yrs of age. PT given first dose 0.5mls of Moderna to left deltoid. While in observation discovered PT is a minor. Pts parents confirmed pts age as a minor and RN informed parents of error in vaccine given. Vaers report initiated and medical chain of command notified. While waiting further instructions pt observation time increased to 30min and reemphasized what to expect and education. PT without any signs and symptoms if adverse reaction. States she felt fine. Encouraged parents to take PT to ED or urgent care center of choice for additional concerns or monitoring. Pt and mother voiced understanding. Mom asked questions and answers provided. Mom also provided contact number for Director of Clinical solutions and encouraged to reach out. At pts time of discharge from the vax site PT stated they felt fine and both mom and parent reiterated what to do if adverse or signs or symptoms if a reaction occurred. Called mom @130 pm and mom stated the patient was fine and did not feel that emergency medical attention was necessary at the time.


VAERS ID: 1888118 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 3 LA / IM
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 5NF7J / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Dizziness, Erythema, Loss of consciousness, Orthostatic hypotension
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: patient reported this after both vaccines had been administered that this has happened to him 5-6 times prior
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: no
Diagnostic Lab Data: 911 was called and he was transported to the hospital
CDC Split Type:

Write-up: Patient presented today requesting COVID-19 booster dose. The immunization screening questions were reviewed. Booster dose given in accordance with Health Officer guidance at 8:28am. Patient requested flu vaccine. Administered at 8:27am. Shortly after at about 8:29am patient stood up still in nurse vaccine station and stated he felt dizzy, and he needed to lie down. PHN gently helped guide patient to the floor, into the supine position. Patient went unconscious immediately and PHN began to hear a gurgling noise, PHN took off his face mask, checked his airway nothing was found, rolled him onto his right side, PHN helped and lifted his legs. Patient was out for about 15 seconds. PHN then placed him back onto his back and he began to talk. He then went out again and made the gurgling noise, his face turned red. PHN assessed airway, nothing found rolled patient onto his right side. PHN continued to hold his legs up, he was out for approximately 15 seconds again. Patient returned to conscious level and was placed back onto his back, he began talking to the nurses and stated he has a history of vasovagal episodes, patient was encouraged to take a few deep breaths. PHN asked if he had eaten before coming in today, he stated he had not. He was given a cookie and a juice, he had two sips of the juice. The ambulance was called at 8:30am by site lead. PHN notified patient that the ambulance was on the way, vital signs were taken B/P 120/70, P86, O2 Sat 99% RA, he remained lying on the floor until the ambulance arrived at 8:50m. He continued to have trouble with orthostatic hypotension, the ambulance crew took him to the hospital.


VAERS ID: 1888121 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031H21A / 1 LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Heart rate increased, Hypertension, Interchange of vaccine products, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Similar but less dramatic and severe symptoms from my initial Jansen vaccination in April 2021.
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Heart rate, blood pressure, temperature taken.
CDC Split Type:

Write-up: I received my Moderna booster shoot Friday afternoon and woke up a 4 AM on Saturday with a fast heart rate. It was so fast that I thought I could die and I called 911. I was breathing fairly normally and able to walk around and converse. Upon arrival of the paramedics, I had my vitals checked. My pulse rate felt quite a bit lower when checked than when I called 911 but it was still 155 BPM and very steady when breathing in and out and trying to calm down. The paramedics said my blood pressure was high and left it up to me whether I wanted to be admitted. I decided against given that my family had gotten back to me and were on their way. I took my temperature and it was 100.2. I took ibuprofen and my pulse rate and fever slowly went down. I had the Jansen vaccine in early April and experienced similar symptoms, but not as dramatically or serious, so I didn''t report or call 911 then.


VAERS ID: 1888122 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8028 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
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: Patient is 16 years old but received a Pfizer booster dose
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient is 16 years but received Pfizer booster dose


VAERS ID: 1888129 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK127 / 1 RA / IM

Administered by: School       Purchased by: ?
Symptoms: Incorrect dose administered, Muscle rigidity
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Medication errors (narrow)

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

Write-up: Patient became very tense with rigid muscle upon needle insertion. After some vaccine was instilled there was too much resistance to instill further. Very small (difficult to measure <0.1mL) in syringe after needle removed therefore less than full volume administered to patient.


VAERS ID: 1888130 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 2 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Patient received vaccination earlier than recommended date. Patient 1st dose administered 11/07/2021. Parent scheduled child for 11/20/2021 and received second dose. Patient was supposed to receive second dose on 11/28/2021. Father accompanied child. was advised for 15 minute observation. Child feels fine, no signs or symptoms of adverse reaction. All questions and concerns addressed. Fathers telephone number. Parent and child left facility after 30 minute observation (extra 15 minutes as precaution). Thanks.


VAERS ID: 1888141 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013F21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
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: Aspirin
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Patient received the second dose 21 days after the first dose at 9:40 am. A 4-day grace period allowed, however 21 days is fewer than 23 days; therefore required to report as an administration error. Patient informed at 11:40 am (immediately after it was discovered), the dose should be repeated at least 28 days after today''s dose. Patient understood.


VAERS ID: 1888143 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3527 / 1 LA / IM

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

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

Write-up: Patient received vaccine, was leaving pharmacy and fainted near front register. Pt immediately said she was fine. I asked patient if she had eaten or drank anything today and she said yes. I asked them to sit back at the pharmacy but they left.


VAERS ID: 1888146 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1620 / 3 AR / IM

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

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

Write-up: Vaccine administered three weeks too soon


VAERS ID: 1888148 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3527 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: no
Preexisting Conditions: no
Allergies: Not reported
Diagnostic Lab Data:
CDC Split Type:

Write-up: Mother said that patients lips were swelling after coming home approx. 2 hours after shot given


VAERS ID: 1888159 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1620 / 3 AR / IM

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Vaccine administered three weeks too soon. No reactions/complaints noted.


VAERS ID: 1888171 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1855101 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: About 12 hours after injection, sever chills, severe headache, fever of 102.5, body aches and nausea. Left leg pain.


VAERS ID: 1888173 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8030 / 3 LA / IM

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

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

Write-up: Light-headed, dizzy, sweating, vomiting. 911 was called and patient was taken to the hospital.


VAERS ID: 1888176 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Decreased appetite, Fatigue, Feeling cold, Headache, Injection site pain, Mobility decreased, Pain in extremity
SMQs:, Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril with Hydrochorathaside (sp?) Vitamin D3, Elderberry, Vitamin C, vitamin B12, multi vitamin.
Current Illness: None
Preexisting Conditions: High blood pressure, Long Covid side effects including brain fog, fatigue, shortness of breath, headaches ans congestion.
Allergies: No known food allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shot was initially painful. Severely sore arm, can barely lift it. Overall joint pain, fatigue, cold feeling, headache, no fever as of this time, loss of appetite.


VAERS ID: 1888185 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-17
Onset:2021-11-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 065F21A / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Back pain, Intermenstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (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: Zinc, Vitamin C
Current Illness: None
Preexisting Conditions:
Allergies: Codeine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Break Through Menstrual Bleeding - I am post menopausal and have not had a period for approximately 2 years. I also within 8 hours started experiencing a sharp stabbing pain in my left upper back that has not subsided.


VAERS ID: 1888188 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Patient received vaccine. Left counseling to sit in observation room. Patient then fainted for about 20 seconds. After, he felt nauseous and had a headache. Continued to observe patient for 30 minutes after fainting and he did begin to feel better. Patient did start to feel better and Dad decided to take him on home. Patient did state that he had not eaten much today.


VAERS ID: 1888192 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Underdose
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: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: Unknown
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient who is 12 years old and 2 months was given the pfizer dose for <12 year olds (this was her first dose)


VAERS ID: 1888194 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8027 / 3 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dizziness, Dry mouth, Dysphagia, Gait disturbance, Nausea, Sensation of foreign body, Throat tightness, Tunnel vision
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Retinal disorders (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Hypoglycaemia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Naproxen 375 mg 1 tab PO BID Metformin 500mg PO 2 tabs BID Losartan 100mg 1 tab PO qHS Atenolol 50 mg 1 tab PO daily Albuterol inhaler PRN Furosemide 20 mg 1 tab PO daily Amlodipine 20 mg 1 tab PO daily Alvesco 160 mcg 1 puff BID Gabapenti
Current Illness: No known allergies. Patient reports that she "was really sick (i.e. flu symptoms)" after 2nd dose of Moderna., but denies s/sx of anaphylaxis.
Preexisting Conditions: Hypertension, Diabetes, Asthma
Allergies: NKA
Diagnostic Lab Data: Unknown.
CDC Split Type:

Write-up: 10: 30 am: Patient received Pfizer booster, 0.3 ml IM via (L) deltoid. 10:45 am: Pt reported feeling dizzy. Lung sounds clear to auscultation, respiratory rate 20, unlabored, HR 60. Pt reported taking atenolol after breakfast this morning. 10:55 am: Pt reported feeling nauseated with a dry mouth. Pt gaze unfocused, pt reported feeling like she was "staring through a tunnel." Pt tool a sip of water, denied difficulty breathing. Nurse assisted patient to a gurney. 11:00 am: Pt reported that her throat was "tight." Began intermittently coughing. Pt attempted to sip water and complained that it was "hard to swallow, like something was blocking" her throat. Nurse called 911, administered 0.3 epinephrine IM, via (L) anterolateral thigh muscle. 11:10 am: Pt reported that her throat felt less tight, and denied difficulty breathing. Pt reported her vision seemed "better." 11:15 am; Paramedics arrived. Pt with unsteady gait, but ambulated to gurney with assist x 2.


VAERS ID: 1888197 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: No adverse event, Underdose
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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was given 0.2ML Pfizer-Biontech Covid-19 (5-11 Yr) Vaccine Vial (unapproved) instead of Comirnaty Covid-19 Vaccine Vl. Patient came in with 2 other younger siblings. Pharmacist verified with dad that he will be given 3 pediatric doses to the pt.''s. Dad agreed and did not mention that one of them just turned 12. There was no adverse reactions reported during the 15 minutes observation period.


VAERS ID: 1888198 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dexilant
Current Illness: I had Covid 11/15/2021.
Preexisting Conditions: Nothing in my past. I have the same symptoms after the injection as I did when I had covid. Bad leg pains, body aches, fatigue, terrible headaches and nauseous. If I knew this would?ve happened, I never would?ve got the vaccine. We are told it would prevent this issue so why go through it all again if it causes the same symptoms?
Allergies: Penicillin
Diagnostic Lab Data: No need at this time to see a physician
CDC Split Type:

Write-up: Nothing in my past. I have the same symptoms after the injection as I did when I had covid. Bad leg pains, body aches, fatigue, terrible headaches and nauseous. If I knew this would?ve happened, I never would?ve got the vaccine. We are told it would prevent this issue so why go through it all again if it causes the same symptoms?


VAERS ID: 1888202 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Abnormal dreams, Cold sweat, Crying, Hyperhidrosis, Immediate post-injection reaction, Muscle contracture, Pallor, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: none at time of vaccination, prior to month is unknown.
Preexisting Conditions: Unknown
Allergies: None
Diagnostic Lab Data: Unknown
CDC Split Type:

Write-up: The child received vaccine, three seconds later, Site Manager observed the child begin to shake and raise arms in upright and locked position bent at the elbows towards face. At that time RN was called over and began evaluating child. RN also came over and began calming child and evaluating him. The child came to within a couple minutes and began crying and stating he did not know what just happened and stated that he had a weird dream. RN began a set of vitals on child where blood pressure was noted to be 101/88 and pulse 58, respirations 22. Child began to sweat profusely and his skin color became pallor. Child''s skin was also cold and clammy to touch however child was talking and coherent, child answering questions asked of him appropriately. EMS was called to scene and arrived at that point began asking child questions which he was answering appropriately. His skin color and sweating improved before being transported out of facility. Child was taken to Hospital.


VAERS ID: 1888204 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2590 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure decreased, Eye movement disorder, Hyperhidrosis, Loss of consciousness, Panic attack, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Patient had a panic attack after admin of shot. He lost consciousness and had sweating and a drop in BP. He also had rapid eye movements and was unresponsive. 911 was called and paramedics came top assist. He was given fluids and then returned to the pharmacy for observation as he denied a ride to the hospital.


VAERS ID: 1888205 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 065F21A / 3 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Fatigue, flu like symptoms, 35, 4/12/21, moderna second dose
Other Medications: Lexapro, Wellbutrin
Current Illness: None
Preexisting Conditions: Depression, anxiety, cluster headaches
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Swelling of lymph nodes under right arm. About the size of a golf ball just below arm pit.


VAERS ID: 1888211 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211D21A / 1 RA / IM

Administered by: Public       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: The person is 16 years old and a Johnson and Johnson vaccine was given. Johnson and Johnson vaccine is not recommended for persons under 18 years.


VAERS ID: 1888216 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: I woke up Saturday morning with swollen armpit on the same arm of the shot


VAERS ID: 1888230 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 034F21A / 3 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 81 mg aspirin
Current Illness: none
Preexisting Conditions: AFIB
Allergies: penecillin
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Chills, and low grade fever (101)


VAERS ID: 1888240 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1611 / 1 - / IM

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

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

Write-up: Patient received an adult dose of Pfizer instead of the pediatric dose. Managers, Pediatric Doc, Peds Covid physician (Dr. Notified) Had patient stay a full hour to be monitored. Mom is a nurse and she called her peds doc. Had pharmacist also speak with mom. Reassured mom and told her that we would keep her even longer than normal. The patient was playful and not exhibiting any adverse reactions.


VAERS ID: 1888242 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-27
Onset:2021-11-20
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid, Cardiac arrest, Cardiomegaly, Chest X-ray abnormal, Pericardial effusion, Resuscitation, Syncope, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: fish oil
Current Illness: dyslipidemia, obesity
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Lactic acid 5.9, WBC 11.2; portable chest X-ray "Mild cardiomegaly or pericardial effusion"
CDC Split Type:

Write-up: collapse, asystole. Resuscitated successfully.


VAERS ID: 1888243 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8020 / 3 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

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

Write-up: Systemic: Dizziness / Lightheadness-Medium, Additional Details: Lasted about 30 mins. Pt reported feeling better. VS stable. Pt''s spouse came to pick her up.


VAERS ID: 1888249 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-07
Onset:2021-11-20
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Raynaud's phenomenon
SMQs:, Immune-mediated/autoimmune disorders (narrow)

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

Write-up: Raynads Disease


VAERS ID: 1888250 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2590 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Escitalopram 10mg daily
Current Illness: None
Preexisting Conditions: Seasonal allergies/ asthma
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swollen, painful lymph node under left arm


VAERS ID: 1888254 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1611 / UNK - / ID

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

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

Write-up: Patient received an adult dose of Pfizer instead of the pediatric dose. Managers, Pediatric Doc, Peds Covid physician (Doctor Notified) Had patient stay a full hour to be monitored. Mom is a nurse and she called her peds doc. Had pharmacist also speak with mom. Reassured mom and told her that we would keep her even longer than normal. Child was playful and not exhibiting any adverse reactions.


VAERS ID: 1888263 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: New York  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E21A / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Injection site pain, Nausea, Skin warm
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Dull pain at site of injection and fatigue - same day Nausea and fatigue, slight sensation of heat under skin (but no fever) - midday day after injection


VAERS ID: 1888264 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8027 / 3 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, No adverse event
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: UNKNOWN
Current Illness: NONE IDENTIFIED
Preexisting Conditions: NONE IDENTIFIED
Allergies: NO KNOWN ALLERGIES
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: CLIENT RECEIVED 3RD/BOOSTER DOSE AT 5 MONTHS - ONE MONTH EARLIER THAN SUGGESTED BY CURRENT CDC/MANUFACTURER GUIDELINE NO ADVERSE S/S IDENTIFIED AS OF THIS DATE/TIME


VAERS ID: 1888267 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: New York  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1620 / 3 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levoxyl 125 mcg Vitamin D3 125 mcg Vitamin K2 180 mcg Lutein 40mg Lion''s Mane Mushroom Powder Tumeric 1000 mg
Current Illness: None
Preexisting Conditions: Rheumatoid Arthritis Hashimoto''s Thyroiditis
Allergies: Augmentin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: pain went down into my left hand and wrist. The joints are very painful. pain went across my abdoment.


VAERS ID: 1888283 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Unknown  
Location: Washington  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: vaccine administered 2 weeks early
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: vaccine administered 2 weeks early


VAERS ID: 1888290 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8027 / 2 LA / IM

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

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

Write-up: Patient developed a rash on his arms, back, legs and chest. 10 mLs of Syladril was given to help withe the rash. Vitals taken. Obserbeved. The rash resolved and he reported feeling well. He was discharged.


VAERS ID: 1888293 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Electric shock sensation, Headache, Hypotension, Pallor, Vision blurred
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: NKDA
Diagnostic Lab Data: Vitals: BP @ 11:20 86/39 HR 66 @11:41 94/43 HR 85 @12:42 97/50 HR 80
CDC Split Type:

Write-up: Blurry vision, dizzy, pallor, head ache, "Felt like I got tazed" (like electric shock). Hypotension that took about 30 minutes to resolve.


VAERS ID: 1888296 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 058FZ1A / 1 LA / IM
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Fatigue, Flatulence, Headache, Injection site pain, Pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: I didn?t take anything because I read online that you shouldn?t take anything because it may hinder the effectiveness of the Moderna Injection.
Current Illness: Nothing
Preexisting Conditions: Anemic Ulcer
Allergies: Penicillin, Sulfa Antibiotics, Pet Dander & Seasonal Allergies
Diagnostic Lab Data: None as of right now. (Saturday, November 20th, 2021; 4:42PM).
CDC Split Type:

Write-up: *Very sore at injection site and when I move my right arm *Headache *Exhausted/Wore out feeling *Stomach Ache with Gas


VAERS ID: 1888298 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013F21A / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Feeling cold, Head discomfort, Malaise, Pain, SARS-CoV-2 test negative
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Wegovy 1.7
Current Illness: Was sick worse than when I had actual covid for 2 full weeks after my first shot in October 2021. Now feeling again worse than when I had actual covid again. Fever, head pressure, body aches, intense nausea. I still had strong antibody response over a year after having real covid and I got these shots because of the mandates and I can?t afford to lose my job.
Preexisting Conditions: None
Allergies: Allergic to latex
Diagnostic Lab Data: Took covid test after first shot because I was sicker than when I had real covid. It was negative
CDC Split Type:

Write-up: I had real covid in sept 2020 and was pretty sick for 2 weeks. The first shot in October made me sick, worse than covid for another 2 weeks. Then this 2nd shot woke me up at 5am freezing, body aches and intense head pressure. I still had strong antibodies before I ever took these shots but due to mandates and risk of losing my job I decided to get the shot. Worse decision ever. There should be exemptions for people that have antibodies because now I?ve been sick both times with horrible side effects and bottom lines is that I should have never had to take this.


VAERS ID: 1888300 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / SYR
FLUA4: INFLUENZA (SEASONAL) (FLUAD QUADRIVALENT) / SEQIRUS, INC. UJ713AA / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Chills, Dysgeusia, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Taste and smell disorders (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: J&J covid vaccine fever, chills, body aches
Other Medications: Amethia birth control pill
Current Illness: none
Preexisting Conditions: obesity
Allergies: amoxicillin, penicillin, wellbutrin, nickel
Diagnostic Lab Data:
CDC Split Type:

Write-up: pain and swelling under arm that received injection, chills, joint ache, metallic taste in mouth


VAERS ID: 1888301 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2016-09-21
Onset:2021-11-20
   Days after vaccination:1886
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 2 LA / SYR

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

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

Write-up: Pt came in to get their Flu shot but was administered a Covid vaccine. They were given the pediatric strength and dose. They had already been given their 1st dose a week or so ago. I spoke to the patient''s MD and she said that there are no signs/symptoms of any kind and she is not worried about it. SHe told the parents that they would be fine and to let her know if anything else happened or was needed.


VAERS ID: 1888307 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Wrong product administered
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: Pt was accidentally administered a pediatric Covid vaccine instead of the Flu vaccine that they wanted. I have spoken to their MD and she said she had already spoken to them and told then not to worry, that they would be just fine. They were not experiencing any signs/symptoms and she told them they probably wouldn''t and that all would be fine.


VAERS ID: 1888312 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051F21. W OR N / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Headache, Tiredness, 62 Yrs old, Vaccine date 04/09/2021, 5/6/2021, Moderna.
Other Medications: Amlodipine, Motopolol, Benadryl, Cetrizine, Atovastatin, Zyrtec
Current Illness:
Preexisting Conditions: Chronic back pain, Knee pain, Allergies to chemicals
Allergies: Chemical sensitivities
Diagnostic Lab Data:
CDC Split Type:

Write-up: Light Headed, Chills, Tiredness


VAERS ID: 1888318 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822811 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: shortness of breath and chest tightness. Pfizer vaccine.
Other Medications: Benadryl 25mg oral
Current Illness: none
Preexisting Conditions: Obesity Diabetic Thyroid Nodule Hyperlipidemia Vertigo Gerd Pituitary Microadenoma
Allergies: Metformin, Insulin, Amoxicillin, Codeine, Glipizide, Hydrocodone, Nifedipine, Ondansetron, Sitagliptin Phosphate
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approximately 15-20 mins following covid J&J vaccine, patient endorsed symptoms of chest tightness and shortness of breath. Patient said she had similar symptoms with past covid vaccine, which at the time she was given Benadryl. About 4 days following her last covid vaccine, she presented to ED with symptoms of shortness of breath. patient was given 25 mg PO of Benadryl. Following administration, patient reported worsening chest pain. her vital signs were stable 126/85 pulse 104, O2 99. On exam lungs were CTAB, heart sounds were normal regular rhythm no murmurs no gallops. Given worsening symptoms, 911 was called and patient was transported to ED for further work up and management.


VAERS ID: 1888319 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5618 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Blood glucose normal, Blood pressure decreased, Dyskinesia, Enuresis, Gaze palsy, Hyperhidrosis, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Child experienced syncope for 5 seconds and/or seizure. Eyes rolled back, had some jerking movements, became sweaty and wet his pants. Blood pressure dropped to 70s/30s. Blood sugar was 79. Transported to hospital via ambulance.


VAERS ID: 1888320 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069F21A / 3 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Losaartan, HCTZ, Neurontin, prilosec
Current Illness:
Preexisting Conditions: HTN, GERD, anxiety
Allergies: iodine, lemon, ACE drugs
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe nausea, resolved completely


VAERS ID: 1888321 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0809 / 3 LA / IM

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

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

Write-up: PATIENT IS A 16 YEAR OLD FEMALE WHO RECEIVED A COVID PFIZER BOOSTER BY MISTAKE. PT WAS NO AWARE THAT BOOSTER WAS APPROVED ONLY FOR 18 YEARS AND OVER AND FILLED OUT THE FORM WITH THE REST OF HER FAMILY. PARENTS WILL CONTACTED AND THEY WILL CONTACT HER PRIMARY CARE DOCTOR. PATIENT IS DOING WELL WITH NO SIDE EFFECTS


VAERS ID: 1888329 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL0007 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pruritus, 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: HIVES ON FOREHEAD AND BACK OF EAR. ITCHING.


VAERS ID: 1888333 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: New Hampshire  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Private       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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None reported.
Current Illness: None reported.
Preexisting Conditions: None reported.
Allergies: None reported.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: The pfizer vaccine was not diluted prior to administration. 0.2ml of the undiluted vaccine was administered in the left deltoid at 9:12am. This was caught by a coworker in less than an hour and reported to the lead provider. The patient, pfizer manufacturing and poison control were all contacted promptly.


VAERS ID: 1888334 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: New Hampshire  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Private       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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None reported.
Current Illness: None reported.
Preexisting Conditions: None reported.
Allergies: None reported.
Diagnostic Lab Data:
CDC Split Type:

Write-up: The pfizer vaccine was not diluted prior to administration. 0.2ml of the undiluted vaccine was administered in the left deltoid at 9:14am. This was caught by a coworker in less than an hour and reported to the lead provider. The patient, pfizer manufacturing and poison control were all contacted promptly.


VAERS ID: 1888336 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Underdose
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: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: unknown
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient here with parent. patient''s parent provides consent for patient to receive COVID vaccine today. Pt given Pfizer vaccine ped dose 0.2 ml/10mcg , Left deltoid, in error, pt should have rec''d Pfizer 0.3ml/30 mcg instead based on his age of 12 yrs. health officer notified and she recommended that pt be offered full dose of vaccine in 3 wks with parent''s consent. If parent declines additional dose pt should have adequate immune response. Attempted to reach parent x 2, left VM w/ PHN cell phone w/ call back to discuss options.


VAERS ID: 1888339 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 UN / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR - / N/A UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastatiin 20mg, Losartan 100mg
Current Illness: none
Preexisting Conditions: HTN, hyperlipidemia
Allergies: SULFA
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient started with erythematous papular dry rash to face, neck and chest about 12 hours after receiving COVID pfizer booster and HD Flu vaccine. Rash has persisted x 15 days


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