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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)

This is page 550 out of 10,317

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VAERS ID: 1932866 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069F21A / 2 LA / IM

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

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

Write-up: Was administered Moderna vaccine and patient is under 18 years of age.


VAERS ID: 1932979 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32030BD / 2 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Angiogram pulmonary abnormal, COVID-19, Cough, Dyspnoea, Infection, Lung opacity, Pneumonia bacterial, Pulmonary mass, Pyrexia, SARS-CoV-2 test positive, Superinfection
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Metformin and tramadol PRN
Current Illness:
Preexisting Conditions: Diabetes (HCC) and Obesity, Class II, BMI 35-39.9
Allergies:
Diagnostic Lab Data: 11/27/21 COVID19: positive 11/27/21 CTA chest: Extensive bilateral airspace disease and ground-glass opacities within both lungs most consistent with multifocal infection. COVID-19 pneumonia could have this appearance. However, in addition, there is cavitary nodular densities within the right middle lobe which are not common in COVID-19. Other atypical or fungal infection is a possibility. Metastatic disease could have this appearance. Septic emboli thought less likely. Recommend follow-up/further evaluation.
CDC Split Type:

Write-up: Came to ER on 11/27/21. Received 2nd dose of COVID vaccine on 11/17/21. Developed fever on next day Until yesterday. Developed dry cough and shortness of breath for last 3 days, She went to an urgent care, Saturation 86-88% on room air. Transfer to ED for further management. Found to be COVID positive. Was placed on HFNC @4L. Placed on remdesivir and dexamethasone. Also placed on ceftriaxone and doxycycline. Was admitted 11/27/21 for acute hypoxemic respiratory failure secondary to COVID 19 viral and suspected superimposed bacteria pneumonia , also have right middle lobe cavitary lesion . Was on room air on 12/3/21 which patient was discharged


VAERS ID: 1934840 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1855194 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Therapeutic response unexpected
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211145082

Write-up: UNEXPECTED BENEFIT; This spontaneous report received from a patient concerned a 72 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patients received their initial vaccination with covid-19 vaccine ad26.cov2.s (manufacturer not specified) (dose series 1) (suspension for injection, route of admin, batch number, and expiry date were not reported) dose, start therapy date were not reported, administered for prophylactic vaccination. No adverse events were reported (dose series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose series 2) (suspension for injection, route of admin not reported, batch number: 1855194 expiry: 09-APR-2022) dose was not reported, administered on 18-NOV-2021 on left arm at 11:30 am for prophylactic vaccination. No concomitant medications were reported. On 18-NOV-2021, the patient experienced unexpected benefit (dose series 2). He reported that his peripheral neuropathy went away, there was no tingling, sharp pains out of no where, no numbness or cramping in feet. His feet felt great and were still feeling great at the time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected benefit was not reported. This report was non-serious.


VAERS ID: 1934857 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211203745

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, 1 total, administered on MAY-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported. On 18-NOV-2021, the patient got Covid (suspected clinical vaccination failure and suspected covid-19 infection) with minimal symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number:90000205003. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.; Sender''s Comments: V0: 20211203745-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1934930 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Unknown  
Location: South Carolina  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitants and Treatment medications were reported. This case was linked to MOD-2021-399960, MOD-2021-405538, MOD-2021-405545, MOD-2021-405575, MOD-2021-405585, MOD-2021-405622, MOD-2021-405652, MOD-2021-405659, MOD-2021-405696, MOD-2021-405721 (Patient Link).


VAERS ID: 1934936 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Unknown  
Location: South Carolina  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021B21A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021 at 11:31 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Nov-2021 at 11:31 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021 at 11:31 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medication were not reported.


VAERS ID: 1935022 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: New York  
Vaccinated:2021-10-01
Onset:2021-11-18
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: not the full second dose of the Moderna Covid-19 vaccine; greater than 36 days between COVID-19 vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (not the full second dose of the Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between COVID-19 vaccinations) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (not the full second dose of the Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between COVID-19 vaccinations). On 18-Nov-2021, ACCIDENTAL UNDERDOSE (not the full second dose of the Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between COVID-19 vaccinations) had resolved. Concomitant medications were not provided Treatment medications were not provided This case was linked to MOD-2021-406096 (Patient Link). Reporter did not allow further contact


VAERS ID: 1935105 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8027 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Fatigue, Immunisation, Lymphadenopathy, Mental fatigue, 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: LORATADINE; ACETAMINOPHEN
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: other_medical_history : No
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101630701

Write-up: Left axillary lymphadenopathy; fever/rigor; fever/rigor; fatigue; mental fatigue; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 27 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 17:00 (Lot number: FH8027) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LORATADINE; ACETAMINOPHEN, start date: 14Nov2021, stop date: 16Nov2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3246, Location of injection: Left arm), administration date: 18Jan2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL0140, Location of injection: Left arm), administration date: 28Dec2020, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 17:00, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021 20:00, outcome "recovering", described as "Left axillary lymphadenopathy"; PYREXIA (non-serious), CHILLS (non-serious) all with onset 18Nov2021 20:00, outcome "recovering" and all described as "fever/rigor"; FATIGUE (non-serious) with onset 18Nov2021 20:00, outcome "recovering", described as "fatigue"; MENTAL FATIGUE (non-serious) with onset 18Nov2021 20:00, outcome "recovering", described as "mental fatigue". Therapeutic measures were taken as a result of lymphadenopathy, pyrexia, chills, fatigue, mental fatigue. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1935107 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3527 / 3 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101630743

Write-up: Swollen axillary nodes and supraclavicular; Dose Number:3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 12:00 (Lot number: FG3527) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 27Mar2021, when the patient was 36 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EWQ169, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 17Apr2021, when the patient was 36 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 12:00, outcome "unknown", described as "Dose Number:3"; SWELLING (non-serious) with onset 19Nov2021 12:00, outcome "not recovered", described as "Swollen axillary nodes and supraclavicular". Therapeutic measures were not taken as a result of swelling. No follow-up attempts are possible. No further information is expected


VAERS ID: 1935111 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1620 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Condition aggravated, Dizziness, Fatigue, Headache, Immunisation, Lymphadenopathy, Myalgia, Pain, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOVASTATIN; PEPCID [FAMOTIDINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (oesophageal) (Acid reflux)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101638692

Write-up: Injection site pain; tiredness; headache; dizziness; muscle aches and pain; muscle aches and pain; chills for 48 hours; the 3rd injection additionally caused swollen lymph nodes on side of injection site for more than 5 days (left) - still swollen with icing; All symptoms worse with 3rd injection; 3rd injection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 15:30 (Lot number: FJ1620) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing), notes: Acid reflux. Concomitant medication(s) included: FLU, administration date 27Oct2021; LOVASTATIN; PEPCID [FAMOTIDINE]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0175, Location of injection: Arm Left), administration date: 23Apr2021, for Covid-19 immunization, reaction(s): "Injection site pain", "tiredness", "dizziness", "muscle aches", "pain", "chills"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0175, Location of injection: Arm Left), administration date: 23Apr2021, when the patient was 60 years old, for Covid-19 immunization, reaction(s): "headache"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left), administration date: 31Mar2021, for Covid-19 immunization, reaction(s): "Injection site pain", "tiredness", "headache", "dizziness", "muscle aches", "pain", "chills". The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "3rd injection"; VACCINATION SITE PAIN (non-serious) with onset 18Nov2021 15:30, outcome "recovered" (20Nov2021 15:30), described as "Injection site pain"; FATIGUE (non-serious) with onset 18Nov2021 15:30, outcome "recovered" (20Nov2021 15:30), described as "tiredness"; HEADACHE (non-serious) with onset 18Nov2021 15:30, outcome "recovered" (20Nov2021 15:30), described as "headache"; DIZZINESS (non-serious) with onset 18Nov2021 15:30, outcome "recovered" (20Nov2021 15:30), described as "dizziness"; MYALGIA (non-serious), PAIN (non-serious) all with onset 18Nov2021 15:30, outcome "recovered" (20Nov2021 15:30) and all described as "muscle aches and pain"; CHILLS (non-serious) with onset 18Nov2021 15:30, outcome "recovered" (20Nov2021 15:30), described as "chills for 48 hours"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021 15:30, outcome "not recovered", described as "the 3rd injection additionally caused swollen lymph nodes on side of injection site for more than 5 days (left) - still swollen with icing"; CONDITION AGGRAVATED (non-serious) with onset 18Nov2021 15:30, outcome "recovering", described as "All symptoms worse with 3rd injection". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, headache, dizziness, myalgia, pain, chills, condition aggravated. Therapeutic measures were taken as a result of lymphadenopathy. Additional information: the patient was received Tylenol. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1935123 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5618 / 1 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UJ778AA / 1 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Off label use, Papule, Product use issue, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101655117

Write-up: Developed rash on left clavicle, left side of throat; two papules on cheek; itchiness on the clavicle and on her face; Other vaccine same date vaccine date 18Nov2021; Other vaccine same date vaccine date 18Nov2021; This is a spontaneous report received from a contactable reporter (other healthcare professional). A 9-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular, administered in arm left, administration date 18Nov2021 13:15 (Lot number: FK5618) at the age of 9 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA) Sanofi, administered in arm right, administration date 18Nov2021 (Lot number: UJ778aa) as dose 1, single. The patient''s relevant medical history and concomitant medications were not reported. Past drug history included: Cephalexin, reaction(s): "allergies:Cephalexin". The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 18Nov2021, outcome "unknown" and all described as "Other vaccine same date vaccine date 18Nov2021"; RASH (non-serious) with onset 21Nov2021 13:15, outcome "recovering", described as "Developed rash on left clavicle, left side of throat"; PAPULE (non-serious) with onset 21Nov2021 13:15, outcome "recovering", described as "two papules on cheek"; PRURITUS (non-serious) with onset 21Nov2021 13:15, outcome "recovering", described as "itchiness on the clavicle and on her face". Therapeutic measures were taken as a result of rash, papule, pruritus. Treatment included diphenhydramine (Benadryl and hydrocortisone cream. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.


VAERS ID: 1935680 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, Product preparation issue, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received a dose of Pfizer COVID-19 Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1935834 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 RA / IM

Administered by: Private       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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: multivitamins, calcium supplement
Current Illness: none
Preexisting Conditions: ADHD
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: generalized pain for 2 hours that improved over the course of 2 hours. bilateral knee pain persists


VAERS ID: 1935863 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Write-up: Adult received pediatric dose of Pfizer COVID-19 vaccine as a booster dose. Patient will come back in 21 days to received full adult dose.


VAERS ID: 1935930 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Kansas  
Vaccinated:2021-11-13
Onset:2021-11-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (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: developed shingles on 11/18, PCP wanted it entered as potential side effect


VAERS ID: 1936074 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Female  
Location: Alaska  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Dyspnoea, Erythema, Feeling hot, Immediate post-injection reaction, Laboratory test normal, Palpitations, Peripheral swelling, Rash macular
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: All normal per mom. Seen at Clinic on 11/29/21.
CDC Split Type:

Write-up: Immediate severe swelling, redness of entire left forearm-vital signs stable and no other signs of allergy/anaphylaxis. Treated with cool pack and observed for an additional 30 minutes with no other symptoms. Redness resolved in approximately 3 hours post vaccination. 3 days later on 11/21 child developed episodes of being hot, heart racing, shortness of breath, and red/blotchy patches on face. No fever, chills or GI symptoms. It looked almost like "panic attacks or anxiety" per mother''s report. Seen by Pediatrician at Clinic on 11/29 but all tests were normal. Referred to mental health clinician. Episodes have resolved at this time-12/9/21.


VAERS ID: 1936079 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822811 / UNK RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Blood pressure, pulse data 1/1 ? 1/9 BP 156/100, Pulse 80 ? 160/90, 64 ? 158/98, 80 ? 140/80, 75 ? 150/80, 76 ? 140/88, 80 ? 150/86, 68 - 130/180, 70 - 140/90, 64
CDC Split Type:

Write-up: Ringing in ears, bad headaches off and on until 12/5 and ongoing high blood pressure and resting pulse with continued ringing in the ears. Did not realize blood pressure was high until doctors visit 12/1. was prescribed migraine medicine and asked to continue recording blood pressure. Have been prescribed blood pressure meds starting 12/9. Had always previously had low blood pressure and been diagnosed at one point as having syncope due to low BP and normal resting pulse in 55 - 65 range


VAERS ID: 1936099 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received a dose of Pfizer COVID-19Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL , 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1936105 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, Product preparation issue, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received a dose of Pfizer COVID-19 Vaccine formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1936111 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939909 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Joint range of motion decreased, Pain in extremity
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Patient reported extreme left arm pain affecting range of motion starting day after injection. Pain lasted four days after injection. Denies left arm pain or limited range of motion in left arm beginning 11/22/2021.


VAERS ID: 1936361 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Condition aggravated, Crying, Headache, Malaise
SMQs:, Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lamictal and various supplements.
Current Illness: None, other than prior pre-existing health conditions.
Preexisting Conditions: ASD, Asthma, Bi-Pap dependency (Sleep Apnea and hypoventilation), SE (status epilepticus).
Allergies: None Known
Diagnostic Lab Data: None were done yet.
CDC Split Type:

Write-up: . Immediately after receiving the covid vaccine on November18, patient''s stereotypical behavior increased per mother''s report. School noted this as well. 48 hours after the vaccine, while at a restaurant, patient appeared to not feel well and slumped forward, but maintained consciousness. He held his hands to his head and was crying in apparent distress (presumably suffering from a headache). This lasted approximately5-6 minutes and no specific treatment was provided. He appeared ''OK'' later that day. He went to sleep with his Bi-PAP, as was his routine. Sometime after falling asleep at 10pm, his watch alerted his parents. They arrived to the room but did not appreciate convulsive activity. Father states he ''looked like a deer in the headlights'', but was aware and answered his parents questions as per his typical. (The watch has alerted only one other time when patient was exercising). He has had no other suspicious events. However, his anxiety overall is increased.


VAERS ID: 1936483 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Lip swelling, Paraesthesia, Paraesthesia oral, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: peanuts, tree nuts
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Client was at a local clinic on 11/18/2021 to receive Pfizer Covid dose #1. At that time she stated she has a severe allergy to nuts, specially tree nuts, and has an epi pen. After education, the Pfizer Covid vaccine was given, client was instructed to stay for 30 minutes to be monitored for s/s of anaphylaxis. Client stated she stayed in waiting room for 30 minutes without any s/s of anaphylaxis. She left clinic and was driving home when she stated she started to feel a tingling sensation in her lips and nose. When she arrived home, she noticed her lips and nose were swollen. She proceeded to take 50mg of Benadryl by mouth and 1 hour later swelling went away. Denies difficulty in breathing at that time. She denies following up with PCP. Today, Dec. 9th, 2021 client came to clinic for 2nd Pfizer Covid vaccine. She stated she took 50 mg of Benadryl before arriving due to previous injection reaction. Due to the severity of 1st dose we did not vaccinate today. We referred her to follow up with her PCP and immunologist for further evaluation. List of PCP''s provided to her. Client understood and had no further questions.


VAERS ID: 1936568 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-11-13
Onset:2021-11-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: atomoxetine, famotidine
Current Illness: None
Preexisting Conditions: ADHD, anxiety, gastroesophageal reflux
Allergies: benzodiazepines cause anxiety
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Urticaria developed five days after vaccine administration


VAERS ID: 1938326 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211149718

Write-up: HEADACHE; FEVER; This spontaneous report received from a patient via social media (Twitter) through a company representative concerned a patient of unspecified age, sex, race, and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total for prophylactic vaccination (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 in total, administered on 18-NOV-2021 for prophylactic vaccination (dose number in series 2-booster dose).The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 18-NOV-2021, the patient experienced headache and fever which were lasted for two days (both events dose number in series 2). treatment medication included Paracetamol (tylenol helps) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fever on 20-NOV-2021. This report was non-serious.


VAERS ID: 1938338 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Kentucky  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Feeling hot, Influenza like illness, Malaise, Pain in extremity
SMQs:, Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211159512

Write-up: FEELING HOT; FLU LIKE SYMPTOMS; FEELING SICK; ARM SORENESS; NO ENERGY; This spontaneous report received from a patient concerned a 56-year-old female. The patient''s weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 201A21A and expiry: Unknown) dose was not reported, frequency 1 total administered on left arm on 07-Apr-2021 for prophylactic vaccination (Dose number in series 1). On evening of 07-Apr-2021, the patient experienced felt tired, Slight headache. On 08-Apr-2021, the patient experienced very tired, not achy but was just lethargic and did not wanted to do anything. On 08-Apr-2021, later in the day the patient started to feel better. (Dose number in series 1) The patient recovered from felt tired, Slight headache, lethargic on 08-Apr-2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A and expiry: 11-APR-2022) dose was not reported, frequency 1 total administered at left arm on 17-NOV-2021 for prophylactic vaccination.( Dose number in series 2). No concomitant medications were reported. On 18-Nov-2021, early morning the patient experienced no energy. The patient had no headaches this time around, her arm was more sore, compared to the first dose. During evening, the patient felt better ( Dose number in series 2). On 24-Nov-2021, one week after booster dose, the patient stated that she was hit hard with feeling sick. That evening, the patient was hot, with fever, slight headache, no energy, freezing with cold chills, and achy. She felt like she had the flu. ( Dose number in series 2) The patient was planning to get tested for COVID. The patient felt better the following day (25-Nov-2021) with no cold chills, but slight headache and no energy. At the time of reporting the patient felt the same with no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness on 18-NOV-2021, was recovering from feeling hot, flu like symptoms, and feeling sick, and had not recovered from no energy. This report was non-serious. This case, involving the same patient is linked to 20211161728.(Dose number in series 1 case)


VAERS ID: 1938660 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Female  
Location: New York  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5618 / 1 RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101619128

Write-up: Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 15:15 (Lot number: FK5618) at the age of 7 years as dose 1 (tris), single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications.The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Nov2021 16:00, outcome "not recovered", described as "Injection site pain". Therapeutic measures were not taken as a result of vaccination site pain. Additional information: Patient had no allergy. Case is reported as non-serious. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient had not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1938671 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Immunisation, Pain, Product use issue
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101628805

Write-up: Fatigue; Achiness; Booster; other_vaccine_same_date_product=Flu Shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 18Nov2021 (Batch/Lot number: unknown), single. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Mar2021, when the patient was 74 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available to reporter at the time of report completion), administration date: Mar2021, when the patient was 74 years old, for Covid-19 Immunization. The following information was reported IMMUNISATION (non-serious) with onset 18Nov2021, outcome unknown; PRODUCT USE ISSUE (non-serious) with onset 18Nov2021, outcome unknown; FATIGUE (non-serious) with onset 20Nov2021, outcome recovered (Nov2021); PAIN (non-serious) with onset 20Nov2021, outcome recovered (Nov2021). It was unknown if therapeutic measures were taken as a result of fatigue, pain. The lot number for bnt162b2 was not provided and will be requested during follow up. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.


VAERS ID: 1938681 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 3 LA / -

Administered by: Public       Purchased by: ?
Symptoms: Axillary pain, Chest discomfort, Chest pain, Fatigue, Immunisation, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CELEXA; TRULICITY; SYNJARDY; BUPROPION
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD; Anxiety; Depression; Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101630855

Write-up: My arm at injection site is much more sore than previous injections.; armpit is EXTREMELY sore; chest is tight on the same side (left) where the injection was given.; chest does not hurt as much; booster; a little more tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 14:15 (Lot number: FF8841) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Diabetes (unspecified if ongoing); depression (unspecified if ongoing); anxiety (unspecified if ongoing); ADHD (unspecified if ongoing). Concomitant medication(s) included CELEXA; TRULICITY; SYNJARDY; BUPROPION. Past drug history included Codine, Drug Allergy. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Reaction: arm at injection site is much more sore than previous injections), administration date: 22Mar2021, when the patient was 40 years old, for Covid-19 immunization, reaction(s) included arm at injection site is much more sore than previous injections; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN0612, Location of injection Arm Left. The Reaction included arm at injection site is much more sore than previous injections, administration date: 15Apr2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 18Nov2021 14:15, outcome unknown; VACCINATION SITE PAIN (non-serious) with onset 19Nov2021, outcome not recovered; AXILLARY PAIN (non-serious) with onset 19Nov2021, outcome not recovered; CHEST DISCOMFORT (non-serious) with onset 19Nov2021, outcome recovering; FATIGUE (non-serious) with onset 18Nov2021, outcome recovering; CHEST PAIN (non-serious) with onset 19Nov2021, outcome recovering. Therapeutic measures were not taken as a result of vaccination site pain, axillary pain, chest discomfort, fatigue, and chest pain. Patient arm at injection site is much more sore than previous injections. Her armpit is extremely sore and chest is tight on the same side (left) where the injection was given. The same day after receiving the shot, she had no pain. She was a little more tired than usual. The next day, her chest was tight, and armpit hurt real bad. Today is day 3 and still have armpit pain and pain at the injection site, chest does not hurt as much. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Fatigue onset was same day as the vaccination, while other events onset latency was 9 hours 45 minutes. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1938683 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F51611 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Immunisation, 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA; JUNEL FE 1/20; VITAMIN D2
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ovarian cyst; Pulmonary sequestration
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101631081

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 17:30 (Lot number: F51611) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pulmonary sequestration" (unspecified if ongoing); "Ovarian cysts" (unspecified if ongoing). Concomitant medication(s) included: PNEUMOCOCCAL 13 VALENT VACCINE, administration date 29Oct2021; ALLEGRA; JUNEL FE 1/20; VITAMIN D2. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7533, Location of injection: Arm Left, Vaccine Administration Time: 10:15 AM, No Events reported), administration date: 31Mar2021, when the patient was 28 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 12:30 AM), administration date: 22Apr2021, when the patient was 28 years old, for COVID-19 Immunization, reaction(s): "Began to have hives after 2nd dose". The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 17:30, outcome "unknown", described as "Booster"; URTICARIA (non-serious) with onset 18Nov2021 20:00, outcome "not recovered", described as "Hours after 3rd dose, began to see hives again, on arm, face, chest."; PRURITUS (non-serious) with onset 18Nov2021 20:00, outcome "not recovered", described as "A little itchy but not serious". Therapeutic measures were not taken as a result of urticaria, pruritus. Additional information; Addition information: Prior to vaccination, was the patient diagnosed with COVID-19, Since the vaccination, has the patient been tested for COVID-19. Results in death, life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect: was non serious. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1938691 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2593 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Immunisation, Musculoskeletal stiffness, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN D [COLECALCIFEROL]; BIOTIN; VITAMIN C [ASCORBIC ACID]; TURMEE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dermal filler overcorrection (facial filler); Eczema (Eczema-not currently active); Gallbladder removal (gall bladder removal 35 years ago); Ulcer (ulcers 37 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101639559

Write-up: Developed diffuse rash on abdomen of small, pin size red dots within 24 hours of vaccine.; Also developed stiff neck on right side.; Dose number 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 09:15 (Lot number: Ff2593) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing), notes: Eczema-not currently active; "ulcers" (unspecified if ongoing), notes: ulcers 37 years ago; "gall bladder removal" (unspecified if ongoing), notes: gall bladder removal 35 years ago; "facial filler", start date: Jul2020 (unspecified if ongoing), notes: facial filler. Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]; BIOTIN; VITAMIN C [ASCORBIC ACID]; TURMEE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Ew0171, Location of injection: Arm Left, Vaccine Administration Time: 10:30 AM), administration date: 23Apr2021, when the patient was 54 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 2, Batch/Lot No: Ew0183, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 14May2021, when the patient was 54 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 09:15, outcome "unknown", described as "Dose number 3"; RASH ERYTHEMATOUS (non-serious) with onset 18Nov2021 11:30, outcome "recovered" (Nov2021), described as "Developed diffuse rash on abdomen of small, pin size red dots within 24 hours of vaccine."; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 18Nov2021 11:30, outcome "recovered" (Nov2021), described as "Also developed stiff neck on right side.". Therapeutic measures were not taken as a result of rash erythematous, musculoskeletal stiffness. Additional information: Was not itchy or painful. Second day the rash was light pink in color. Third day rash disappeared. Also developed stiff neck on right side. Had vaccine in left arm. Neck stiffness continued for about 32 hoursPrior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1938963 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
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, Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: No adverse reaction. Patient out of age range for vaccine.


VAERS ID: 1939048 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5618 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Underdose
SMQs:, Medication errors (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: Error: Wrong Dose of Vaccine - Too Low-


VAERS ID: 1939049 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8027 / 1 LA / IM

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

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

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


VAERS ID: 1939052 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8030 / 1 LA / IM

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

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

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


VAERS ID: 1939394 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test normal, Nodule, Pain in extremity, Peripheral coldness, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A, NOTE WE ARE 100% NOT ANTI-VACCINE!!!, WE JUST WANT THE PROBLEM(S) IN HER HAND RESOLVED!!! Blood tests already discounted RA and Lymes Disease. WE WILL USE DISCRETION IF SOMEONE IS WILLING TO MORE THOROUGHLY RESEARCH POSSIBLE CONNECTION BETWEEN HER SYMPTOMS AND THE VACCINE! FYI PATIENT HAS HAS A CO-WORKER WITH SIMILAR SYMPTOMS.
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Following the second shot, upper arm remained sore for approx 5 months. Following the third shot (first and only booster) the hand has been swollen, with small nodules in different areas around the palm, and painful. It is also noticeably colder than the other hand.


VAERS ID: 1939423 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Throat tightness, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Cymbalta, Dupixent, gabapentin
Current Illness: none known
Preexisting Conditions: asthma
Allergies: NSAIDs, aspirin, sulfa, oxycodone, linezolid
Diagnostic Lab Data:
CDC Split Type:

Write-up: Two minutes after receiving the PFizer COVID vaccine at the employee vaccination clinic, she experienced chest tightness, throat tightness and shortness of breath / wheezing. She was sent to the Emergency Department where she was given a dose of Benadryl , Epi-pen, Solu-medrol, famotidine, Ativan and Duo-neb. Symptoms improved and patient was sent home with a prescription for albuterol.


VAERS ID: 1939593 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, Product preparation issue, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received a dose of Pfizer COVID-19Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL , 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1939605 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received a dose of Pfizer COVID-19Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL , 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1939628 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received a dose of Pfizer COVID-19Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL , 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1939807 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-11-15
Onset:2021-11-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 320308D / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pain, Rash, 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? 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: unknow.
CDC Split Type:

Write-up: Patient got her second dose vaccine Pfizer on 11-15-2021 and on 12-2-2021 came to the pharmacy to report an adverse reaction that she got 3 days after her second dose. Patient stated that she got hives on her arms, legs, elbows, thighs and joint. she had aches as well. she saw a doctor and gave her a steroid treatment for it. The patient said this rash was related to the vaccine, however, the doctor did not saying anything about this rash was related to the vaccine.


VAERS ID: 1939825 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Cough, Dizziness, Fatigue, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: aspirin (ECOTRIN) 81 MG PO Tablet Delayed Response take 81 mg by mouth once daily. Unknown Unknown time Carboxymeth-Glyc-Polysorb PF (Refresh Optive Advanced PF) 0.5-1-0.5 % OPHTH Solution apply 1 Drop into the eye(s) 4 times daily. For dry
Current Illness: none on file
Preexisting Conditions: none on file
Allergies: Penicillins GI Distress ? Valium [Diazepam] Flushing
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient is a 83y.o. year old female admitted w/ CC as copied from DR. note of 11/17:"This is a 83y.o. female with hx HTN, COPD, presented to the ER with c/o weakness, dizziness, and a mild cough x 2 days. EMS reported patient had a fever of 101. She reports that she''s been feeling weak and fatigued. She lives at an ECF. They provide and give her all her medications. She denies any associated HA, CP, SOB. No reported vomiting or diarrhea. She states she felt so weak that she thought she might fall. Denies any LE edema. No other complaints reported" .Found to be COVID + w/ L basilar airspace dx on CXR Discussed w/ Nursing - per their understanding, pt''s 2L 02 via NC is, indeed, her baseline. Of note, 02 sat after trail of removal of supplemental 02 is 99%! Upon questioning pt further, however, she denies the use of supplemental 02


VAERS ID: 1939837 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-05-07
Onset:2021-11-18
   Days after vaccination:195
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine increased, Blood urea increased, COVID-19, Chest X-ray abnormal, Cognitive disorder, Computerised tomogram head normal, Condition aggravated, Cough, Dyspnoea, Electrocardiogram T wave amplitude increased, Fatigue, Full blood count abnormal, Glomerular filtration rate decreased, Incoherent, Metabolic function test abnormal, Pneumonia, Sinus rhythm, Thrombocytosis, Troponin, Urinary incontinence
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Haematopoietic leukopenia (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACETAMINOPHEN (TYLENOL EXTRA STRENGTH) 500 MG PO TAB take 1,000 mg by mouth every 8 hours as needed. ASPIRIN (ECOTRIN) 81 MG PO TABLET DELAYED RESPONSE take 1 Tablet by mouth once daily. ATORVASTATIN (LIPITOR) 40 MG PO TAB tak
Current Illness: Essential hypertension 9/9/2016 ? GERD (gastroesophageal reflux disease) ? Glaucoma ? Hypertension ? Neuropathy feet ? Renal insufficiency stage 3 ? Type 2 diabetes mellitus (CMS/HCC)
Preexisting Conditions: Essential hypertension 9/9/2016 ? GERD (gastroesophageal reflux disease) ? Glaucoma ? Hypertension ? Neuropathy feet ? Renal insufficiency stage 3 ? Type 2 diabetes mellitus (CMS/HCC)
Allergies: Procardia [Nifedipine] Other Leg swelling
Diagnostic Lab Data: This is a 77y.o. female with hx of +COVID-19, DM2, CKD stage 3, and respiratory failure with hypoxia who presents to hospital by way of EMS, with a chief complaint of SOB. Per EMS, upon their arrival, pt''s pulse ox was low 80s and she was placed on a nonrebreather. Currently pt is on 5L O2 saturating at 98%. She is AOx1, oriented to her name and presence in a hospital, unable to specify hospital name or reason for being here. Pt admits SOB, denies chest pain, abd pain, or HA. Pt''s daughter sitting at bedside notes taking the pt to hospital 10 days ago for cough and fatigue. At that time she was dx''d with covid and sent home to quarantine. Over the next week her cough and fatigue worsened. Her daughter states the pt was found sitting in her own urine for 2 days and not coherent so she decided to call EMS. Per daughter, pt does not drink alcohol, smoke or use tobacco products or recreational drugs, and is not on O2 at home. Baseline is AOx3. Pt is full code. Upon arrival to the ED: o Vitals: T 97.3�F, BP 112/56, HR92, RR 18, SpO2 98% on RA. o EKG demonstrates NSR with increased T wave amplitude in the anterolateral leads o Lab work obtained and remarkable for: ? CBC: thrombocytosis (552) ? BMP: elevated BUN (79), Crt (1.93), decreased GFR (28) ? Trops: 0.04 and 0.03 o Imaging demonstrates: CXR: multifocal pneumonia in the mid-lower portions of both lungs concerning for covid-PNA Head CT: no acute intracranial process o Patient given decadron, azithromycin, rocephin o ID has been consulted
CDC Split Type:

Write-up: This is a 77y.o. female with hx of +COVID-19, DM2, CKD stage 3, and respiratory failure with hypoxia who presents to by way of EMS, with a chief complaint of SOB. Per EMS, upon their arrival, pt''s pulse ox was low 80s and she was placed on a nonrebreather. Currently pt is on 5L O2 saturating at 98%. She is AOx1, oriented to her name and presence in a hospital, unable to specify hospital name or reason for being here. Pt admits SOB, denies chest pain, abd pain, or HA. Pt''s daughter sitting at bedside notes taking the pt to 10 days ago for cough and fatigue. At that time she was dx''d with covid and sent home to quarantine. Over the next week her cough and fatigue worsened. Her daughter states the pt was found sitting in her own urine for 2 days and not coherent so she decided to call EMS. Per daughter, pt does not drink alcohol, smoke or use tobacco products or recreational drugs, and is not on O2 at home. Baseline is AOx3. Pt is full code. Upon arrival to the ED: o Vitals: T 97.3�F, BP 112/56, HR92, RR 18, SpO2 98% on RA. o EKG demonstrates NSR with increased T wave amplitude in the anterolateral leads o Lab work obtained and remarkable for: ? CBC: thrombocytosis (552) ? BMP: elevated BUN (79), Crt (1.93), decreased GFR (28) ? Trops: 0.04 and 0.03 o Imaging demonstrates: CXR: multifocal pneumonia in the mid-lower portions of both lungs concerning for covid-PNA Head CT: no acute intracranial process o Patient given decadron, azithromycin, rocephin o ID has been consulted


VAERS ID: 1939860 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 005C21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Product storage error
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: Moderna was consulted and stated "The vaccine maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration. The dose being administered greater than 12 hours post first vial puncture increases the risk associated with microbial contaminations since the vaccine does not contain a preservative".
CDC Split Type:

Write-up: Booster dose was drawn from a Moderna vial that had been at room temperature for 23 hours.


VAERS ID: 1939876 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-10-27
Onset:2021-11-18
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012F21A / 3 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, COVID-19, COVID-19 pneumonia, Cough, Hypophagia, Nausea, Pyrexia, SARS-CoV-2 test positive, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: albuterol (PROVENTIL, VENTOLIN, PROAIR) HFA 108 (90 Base) MCG/ACT INHAL Aero Soln inhale 2 Puffs into the lungs every 4 hours as needed for FOR SHORTNESS OF BREATH. (disp insurance-pref prod) 11/20/2021 Unknown time apixaban (Eliquis) 5 MG
Current Illness: Atrial fibrillation (CMS/HCC) ? Atrial flutter (CMS/HCC) ? Chronic back pain ? Diarrhea ? Fatigue ? Fibromyalgia ? Gallstones ? High blood pressure ? History of bruising easily ? Hyperlipidemia ? IBS (irritable bowel syndrome) ? Idiopathic thrombocytopenic purpura (CMS/HCC) 3/6/2014 ? Morbid obesity ? Muscle weakness ? Neck pain ? Neuropathy Rt leg and Lt foot, from shingles ? Osteoporosis ? Painful urination ? Raynaud''s disease ? Stroke (CMS/HCC) 2012 ? Tendency toward bleeding easily
Preexisting Conditions: Atrial fibrillation (CMS/HCC) ? Atrial flutter (CMS/HCC) ? Chronic back pain ? Diarrhea ? Fatigue ? Fibromyalgia ? Gallstones ? High blood pressure ? History of bruising easily ? Hyperlipidemia ? IBS (irritable bowel syndrome) ? Idiopathic thrombocytopenic purpura (CMS/HCC) 3/6/2014 ? Morbid obesity ? Muscle weakness ? Neck pain ? Neuropathy Rt leg and Lt foot, from shingles ? Osteoporosis ? Painful urination ? Raynaud''s disease ? Stroke (CMS/HCC) 2012 ? Tendency toward bleeding easily
Allergies: Metformin GI Distress ? Atorvastatin Other Myalgias ? Codeine Other Sensitivity, not an allergy ? Glyburide Other Low blood sugar attacks
Diagnostic Lab Data: Principal Problem: Pneumonia due to COVID-19 virus Assessment & Plan Note: Symptom onset approximately 11/17 Test positive Covid 11/21 Covid vaccinated x3 doses last 10/27 Treated with Rituxan every 6 months for seronegative rheumatoid arthritis Patient admitted for generalized weakness intractable nausea and emesis Monoclonal Antibody (MAB) Emergency Use Authorization for COVID-19 Patient has been identified as a candidate for Monoclonal Antibody therapy under the Emergency use Authorization. This patient is admitted to the hospital for a reason other than COVID-19. Symptom onset is within the past 10 days. Presenting signs and symptoms at the time of the clinical evaluation resulting in the order for MAB therapy include: Any other COVID-19 symptoms (headache, cough, fever, chills, fatigue, body aches, sore throat) Patient has a medical condition(s) or other factors that may place him/her at higher risk for progressing to severe COVID-19 and/or hospitalization.
CDC Split Type:

Write-up: This is a 70y.o.female with a history of hypertension, hyperlipidemia, diabetes, previous stroke, atrial fibrillation who presents secondary to weakness, abdominal pain, nausea, and vomiting. Her symptoms have been progressively worsening over the past couple of days. She also reports a dry cough. She is unable to tolerate oral intake secondary to vomiting. States she is vaccinated for COVID 19 Found to have fever of 100.2 Tachycardic with heart rates in the 100s. COVID 19 positive. Abdominal x-ray, chest x-ray, UA, blood cultures are all pending Started on IV fluids.


VAERS ID: 1940123 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 2 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? 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: None
CDC Split Type:

Write-up: There is no reported adverse event. Patient received the formulation intended for children 5 to 11 years, resulting in underdoses. Patient received 0.2mL instead of 0.3ml.


VAERS ID: 1940136 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-11-09
Onset:2021-11-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011D21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Angioedema, Chest discomfort, Erythema, Full blood count normal, Metabolic function test normal, Oedema peripheral, Pruritus, Serum sickness-like reaction, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: Normal CBC, BMP and Complement levels
CDC Split Type:

Write-up: 9 days after vaccine, hives, erythema, angioedema, peripheral edema, itching, chest tightening. Features of serum sickness


VAERS ID: 1941683 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Computerised tomogram, Fatigue, Pancreatitis acute, Pyrexia
SMQs:, Acute pancreatitis (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Low fat diet; Non-smoker
Preexisting Conditions: Comments: Patient had no known allergies. The patient did not have any drug abuse or illicit drug use. Patient never had pancreatitis previously.
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: CAT scan; Result Unstructured Data: acute pancreatitis
CDC Split Type: USJNJFOC20211201960

Write-up: ACUTE PANCREATITIS; CHILLS; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 54 year old male. The patient''s weight was 240 pounds and height was 69 inches. The patient''s concurrent conditions included: abstains from alcohol and non-smoker. The patient had no known allergies. The patient did not have any drug abuse or illicit drug use. Patient never had pancreatitis previously. On unspecified dates in APR-2021, the patient previously received the series bnt 162 (dose number in series 1, manufacturer: Pfizer) (form of admin, route of admin and batch number: unknown expiry: unknown) dose was not reported, for prophylactic vaccination. On 18-NOV-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported. 12 to 24 hours after vaccination, the patient experienced fever, chills and fatigue (dose number in series 2). On 28-NOV-2021, the patient began experiencing severe epigastric pain around 12pm. That same evening at 7pm, patient went to local hospital emergency room (ER) since the pain was not resolving. The patient was seen and treated for acute pancreatitis (dose number in series 2) with treatment medications which included: pain medications (unable to capture) and an antiemetic (unable to capture). Laboratory data included: CAT (computed tomography) scan abdominal which confirmed acute pancreatitis diagnosis. On 29-NOV-2021 (Monday), the patient was discharged from the ER. On 30-NOV-2021 (Tuesday), the patient followed-up with gastroenterologist who confirmed the diagnosis of acute pancreatitis but unsure of the cause. It was reported, by the patient that he recovered and was on a low fat diet. The patient has a scheduled for an abdominal MRI (Magnetic resonance imaging) for 20-DEC-2021 for further evaluation of the cause. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute pancreatitis and the outcome of fever, chills, and fatigue was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20211201960-covid-19 vaccine ad26.cov2.s-Acute pancreatitis . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1941728 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 067F21A / 1 - / OT

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

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

Write-up: inadvertently administered Moderna COVID-19 first dose in an individual 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered Moderna COVID-19 first dose in an individual 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered Moderna COVID-19 first dose in an individual 17 year old). On 18-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently administered Moderna COVID-19 first dose in an individual 17 year old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. No Treatment medication was provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Follow up information received added 2nd reporter, added dose number and updated event term.


VAERS ID: 1941858 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: New York  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWW0196 / 3 LA / OT

Administered by: Work       Purchased by: ?
Symptoms: Headache, Immunisation, Influenza like illness, Pain, Vaccination site pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101624550

Write-up: Pain at injection site; flu like symptoms; body ache; headache; Dose number= 3; This is a spontaneous report received from a contactable Consumer or other non-HCP. The reporter is the patient. A 48-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Nov2021 10:30 (Lot number: EWW0196) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LIPITOR. Vaccination history included: Bnt162b2 (Previous dose Product= Covid 19, Previous dose brand= Pfizer, Previous dose Lot number= #EL3247, Previous dose administrator route: Intramuscular, Previous dose Dose number= 1, Previous dose vaccine location= left arm), administration date: 24Feb2021, when the patient was 48 years old, for COVID-19 Immunization; Bnt162b2 (Previous dose Product= Covid 19, Previous dose brand= Pfizer, Previous dose Lot number= #EL3247, Previous dose administrator route: Intramuscular, Previous dose Dose number= 2, Previous dose vaccine location= left arm), administration date: 17Mar2021, when the patient was 48 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 10:30, outcome "unknown", described as "Dose number= 3"; VACCINATION SITE PAIN (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Pain at injection site"; INFLUENZA LIKE ILLNESS (non-serious) with onset 19Nov2021, outcome "not recovered", described as "flu like symptoms"; PAIN (non-serious) with onset 19Nov2021, outcome "not recovered", described as "body ache"; HEADACHE (non-serious) with onset 19Nov2021, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of vaccination site pain, influenza like illness, pain, headache. Additional information: No other vaccine administered in four weeks. No known allergies reported for the patient. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1941866 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301458A / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary mass, Immunisation, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALEVE
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: known allergies: No other medical history: No
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101639532

Write-up: Swelling; lump under the left armpit; dose number = 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 19:30 (Lot number: 301458A) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ALEVE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9263, Location of injection: Arm Left, Vaccine Administration Time: 03:00 AM), administration date: 08Feb2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL8982, Location of injection: Arm Left, Vaccine Administration Time: 04:00 AM), administration date: 18Jan2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 19:30, outcome "unknown", described as "dose number = 3"; SWELLING (non-serious) with onset 19Nov2021 14:00, outcome "not recovered", described as "Swelling"; AXILLARY MASS (non-serious) with onset 19Nov2021 14:00, outcome "not recovered", described as "lump under the left armpit". Therapeutic measures were not taken as a result of swelling, axillary mass. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1941892 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32D308N / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angioedema, Asthma, Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? Yes
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: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SYNTHROID; METOPROLOL; HYDROCHLOROTHIAZIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Bone lesion; Cardiac syncope; Ehlers-Danlos syndrome; Hypermobility syndrome; Postural orthostatic tachycardia syndrome; Renal cell carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: Nasal Swab; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101676107

Write-up: multiple Hives over entire body; Shortness of breathe; acute asthma attack(s); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient. A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 17:30 (Lot number: 32D308N) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vascular Ehlers-Danlos disease" (unspecified if ongoing); "hypermobility Ehlers danlos disease" (unspecified if ongoing); "POTS" (unspecified if ongoing); "Cardiac syncopy" (unspecified if ongoing); "Bilat renal cell carcinoma" (unspecified if ongoing); "Lesions to skull bones" (unspecified if ongoing); "allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SYNTHROID; METOPROLOL; HYDROCHLOROTHIAZIDE. The following information was reported: ANGIOEDEMA (medically significant, life threatening) with onset 18Nov2021 03:30, outcome "recovering", described as "multiple Hives over entire body"; DYSPNOEA (life threatening) with onset 18Nov2021 03:30, outcome "recovering", described as "Shortness of breathe"; ASTHMA (life threatening) with onset 18Nov2021 03:30, outcome "recovering", described as "acute asthma attack(s)". The events "multiple hives over entire body", "shortness of breathe" and "acute asthma attack(s)" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of angioedema, dyspnoea, asthma. Clinical Course: The patient did not receive any other vaccine in four weeks. The patient had not Covid prior vaccination. The patient had Covid tested post vaccination. The patient had healthcare providers not to receive the vaccine due to co morbidities but was forced to by employer or lose job. The patient had known allergies. The patient received treatment for adverse event. The physicians appt multiple inhalation thereapies.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Angioedema, Dyspnoea, Asthma and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1941910 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1620 / 3 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysmenorrhoea, Haemorrhage, Immunisation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anterior cruciate ligament tear; Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101678333

Write-up: Along with alot of extra bleeding; my menstrual periods have become more painful and my period was excruciating for a few days; my menstrual periods have become more painful/ booster did the same thing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Nov2021 12:30 (Lot number: FJ1620) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Torn ACL", start date: 2017 (unspecified if ongoing); "Penicillin" (unspecified if ongoing). If other vaccine in four weeks was no and other medications in two weeks was none. If covid prior vaccination was no and if covid tested post vaccination was no.The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0185, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM), administration date: 18May2021, for COVID-19 immunization, reaction(s): "Ever since I received the second shot, my menstrual periods have become more painful."; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0171, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM), administration date: 27Apr2021, for Covid-19 immunization. The following information was reported: HAEMORRHAGE (medically significant) with onset 19Nov2021 12:00, outcome "recovering", described as "Along with alot of extra bleeding"; IMMUNISATION (medically significant) with onset 18Nov2021 12:30, outcome "recovering", described as "my menstrual periods have become more painful/ booster did the same thing"; DYSMENORRHOEA (non-serious) with onset 19Nov2021 12:00, outcome "recovering", described as "my menstrual periods have become more painful and my period was excruciating for a few days". Therapeutic measures were not taken as a result of haemorrhage, immunisation, dysmenorrhoea.


VAERS ID: 1942065 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-11-15
Onset:2021-11-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 065F21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

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

Write-up: I had a miscarriage 3 days after receiving the vaccine


VAERS ID: 1942229 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Burning sensation, Chest discomfort, Chest pain, Chills, Headache, Hypoaesthesia, Malaise, Nausea, Pyrexia, SARS-CoV-2 test negative, Sensitive skin, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Similar reactions, age 63, Moderna May 2021
Other Medications: Synthroid Cymbalta Ambien Symvastatin Otezla Advil
Current Illness:
Preexisting Conditions: Psoriasis - possible fybromyalgia, autoimmune
Allergies:
Diagnostic Lab Data: None I am still not feeling well (1 month past) but was not sure if it''s related to booster shot or if I got sick with a flu. Had a Covid-19 test done 2 weeks ago, which was negative
CDC Split Type:

Write-up: Starting the following day after booster I felt periodic tightening and soreness in my chest, left side. I also had numbness in my feet and fingers (ends turned white periodically) Skin was sensitive to touch - slight burning sensation General malaise, headache, low fever, chills, nausea


VAERS ID: 1942826 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8028 / 1 RA / IM

Administered by: Public       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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received adult Pfizer vaccine, though they are 11 years old. No adverse reaction reported.


VAERS ID: 1942846 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Blepharospasm, Breast pain, Mobility decreased, Pain in extremity
SMQs:, Dystonia (broad), Parkinson-like events (broad), Lipodystrophy (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Severe arm pain day of injection where I was unable to move it for 2 days following, then it would reoccur for the next 2 weeks when shoveling or raking. Also, left eyelid twitch approximately 20x a day, started day after injection and continues to happen over 3 weeks later. And lastly, left breast pain that is sharp that is now, over 3 weeks later now dissipating but still there.


VAERS ID: 1943482 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received a dose of Pfizer COVID-19 Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1944014 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8028 / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Heart rate increased, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (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: Prilosec, lexapro, birth control, vitamin d and b complex
Current Illness: No
Preexisting Conditions: Gerd
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Felt tingly all over in pelvis, arms, face and mouth. Heart rate up a little (100) but felt anxious. It subsided with in a few minutes


VAERS ID: 1944037 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-07-14
Onset:2021-11-18
   Days after vaccination:127
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0163 / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation, Cough, Dizziness, Dyspnoea, Influenza A virus test negative, Influenza B virus test, Palpitations, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (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), 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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: atorvastatin (LIPITOR) 20 MG PO Tab take 1 Tablet by mouth once every night at bedtime. Past Month Unknown time Med Note Wed Dec 1, 2021 1:59 AM) Ran out 1 month insulin aspart (NovoLOG FlexPen) 100 UNIT/ML SQ Solution Pen-injecto
Current Illness: none
Preexisting Conditions: ? Hyperlipidemia ? Hypertension ? New onset type 2 diabetes mellitus 09/2018
Allergies:
Diagnostic Lab Data: Contains abnormal data Covid-19, Flu, RSV by NAA Status: Final result Visible to patient: No (inaccessible) Next appt: None Specimen Information: Nasopharyngeal; Swab 0 Result Notes Ref Range & Units Influenza A Not Detected Not Detected Influenza B Not Detected Not Detected RSV Not Detected Not Detected SARS-CoV-2 (COVID-19) by NAA, Micro Not Detected Detected Abnormal Narrative Methodology: Nucleic Acid Amplification(NAA)/Polymerase Chain Reaction(PCR) The SARS-CoV-2 (COVID-19) test is for in vitro diagnostic use under the FDA Emergency Use Authorization (EUA) for US laboratories certified to perform high complexity testing. This test has not been agency cleared or approved. Specimen Collected: 11/30/21 11:40 PM
CDC Split Type:

Write-up: Patient is a 61y.o. female with T2DM, HTN, HLD who presents to the emergency department for shortness of breath and palpitations. Symptoms of SOB and dry cough for 2 weeks, presented to the ED for palpitations and dizziness. Found to be in atrial fibrillation with rapid ventricular response. No history of atrial fibrillation. No change in weight, fever/chills, diarrhea, chest pain, shortness of breath.


VAERS ID: 1944200 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received a dose of Pfizer COVID-19 Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1944342 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039F21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Heart rate increased, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: None
Preexisting Conditions: None
Allergies: None to knowledge
Diagnostic Lab Data: EKG done on 21 November and 30 November, both were determined normal
CDC Split Type:

Write-up: Fever, Body Aches, Chest Pain, Difficult Breathing - Occurred around 10am and progressively got worse throughout the day. Went to ER on 21 November around 3PM with difficulty breathing and chest pain, and what felt like rapid heart beats.


VAERS ID: 1944429 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 034F21A / 3 LA / IM

Administered by: Private       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? 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: N/A
CDC Split Type:

Write-up: No adverse event. Administered full .5mL dose instead of .25mL booster dose.


VAERS ID: 1958366 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020B21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Needle issue, Underdose
SMQs:, Medication errors (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: No Known
Diagnostic Lab Data:
CDC Split Type:

Write-up: Upon administration of Moderna a booster dosage, Needle point detached from syringe causing patient to not receive dose (complete) of vaccine. Dose was re-administered as advised by CDC recomm. Patient monitored 15 min, and phone follow-up the next day - doing well post vaccine.


VAERS ID: 1946764 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Unknown  
Location: Colorado  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038C21A / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Expired vaccine used; product storage error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (product storage error) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (product storage error). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (product storage error) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.


VAERS ID: 1946890 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Unknown  
Location: Colorado  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038C21A / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Reporter stated that The box of vials was received on 10/14/2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00am to 4:00pm.


VAERS ID: 1946893 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Unknown  
Location: Colorado  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038C21A / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant products were reported. No treatment information was reported by the reporter. Reporter stated that the box of vials was received on 14-Oct-2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00am to 4:00pm. I have attached a spread sheet with the patients that received the vaccine and the dates. Also stated that Sticker included Batch number as 035C21A and Expiry date as 30-Dec-2021 (extended expiration).


VAERS ID: 1946894 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Unknown  
Location: Colorado  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038C21A / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment medications reported. The patient was administered the vaccine beyond the expired date. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use.


VAERS ID: 1946916 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012F21A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOL [OMEPRAZOLE]
Current Illness: Acid reflux (esophageal)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (on late September-early October)
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: the muscle burns, it is aching, muscle aching in the right shoulder, aching in the upper muscle in the right elbow.; since then the injection site hurts; it hurts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (since then the injection site hurts; it hurts) and MYALGIA (the muscle burns, it is aching, muscle aching in the right shoulder, aching in the upper muscle in the right elbow.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination. The patient''s past medical history included COVID-19 (on late September-early October). Concurrent medical conditions included Acid reflux (esophageal). Concomitant products included OMEPRAZOL [OMEPRAZOLE] for Acid reflux (esophageal). On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced VACCINATION SITE PAIN (since then the injection site hurts; it hurts). On an unknown date, the patient experienced MYALGIA (the muscle burns, it is aching, muscle aching in the right shoulder, aching in the upper muscle in the right elbow.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (since then the injection site hurts; it hurts) and MYALGIA (the muscle burns, it is aching, muscle aching in the right shoulder, aching in the upper muscle in the right elbow.) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient thought it was normal for the first day or so, but now it''s been 3 weeks. He has the second dose scheduled for 16-Dec-2021. Patient stated he does a lot of physical work and used to some aches to his age, but this is bothering him the most. Patient took Tylenol because if not the pain wakes him up.


VAERS ID: 1946956 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2021-02-05
Onset:2021-11-18
   Days after vaccination:286
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011M20A / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dry skin, Rash, Rash pruritic, Skin mass, Vaccination site rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMINS NOS; ASPIRINE; TAMSULOSIN
Current Illness: Eye disorder; Weakness
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (was prescribed an inhaler)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: diagnosed with dry skin; spread to legs/After taking my booster shot a few daylight later I developed a rash; broke out in a rash/rash that started on the left arm at the injection site and then eventually spread to the other arm, wrists and leg; bumps on his skin; rash itches like crazy/dry skin causing rash; This spontaneous case was reported by a pharmacist and describes the occurrence of SKIN MASS (bumps on his skin), RASH PRURITIC (rash itches like crazy/dry skin causing rash), DRY SKIN (diagnosed with dry skin), RASH (spread to legs/After taking my booster shot a few daylight later I developed a rash) and VACCINATION SITE RASH (broke out in a rash/rash that started on the left arm at the injection site and then eventually spread to the other arm, wrists and leg) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 011M20A and 025A21A) for COVID-19 vaccination. The patient''s past medical history included COVID-19 (was prescribed an inhaler) on 26-Dec-2020. Concurrent medical conditions included Eye disorder and Weakness. Concomitant products included VITAMINS NOS for Eye disorder, ACETYLSALICYLIC ACID (ASPIRINE) and TAMSULOSIN for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced SKIN MASS (bumps on his skin), RASH PRURITIC (rash itches like crazy/dry skin causing rash), RASH (spread to legs/After taking my booster shot a few daylight later I developed a rash) and VACCINATION SITE RASH (broke out in a rash/rash that started on the left arm at the injection site and then eventually spread to the other arm, wrists and leg). On an unknown date, the patient experienced DRY SKIN (diagnosed with dry skin). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and HALOBETASOL PROPIONATE for Adverse event, at a dose of 0.05% cream. At the time of the report, SKIN MASS (bumps on his skin), RASH PRURITIC (rash itches like crazy/dry skin causing rash), DRY SKIN (diagnosed with dry skin), RASH (spread to legs/After taking my booster shot a few daylight later I developed a rash) and VACCINATION SITE RASH (broke out in a rash/rash that started on the left arm at the injection site and then eventually spread to the other arm, wrists and leg) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient stated he has seen his primary care physician and was prescribed a round of steroids that helped the itchiness but as soon as he stopped the steroid the itchiness came back. He saw a dermatologist and was prescribed halobetasol propionate 0.05% cream on 10-Dec-2021. Patient stated both the dermatologist and primary care physician diagnosed him with dry skin which was causing the rash. This case was linked to MOD-2021-408469 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Dec-2021: Follow up received: updated reporters information


VAERS ID: 1947607 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-02-10
Onset:2021-11-18
   Days after vaccination:281
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9267 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea, Hypoxia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuterol, Atorvastatin, Symbicort, Jardiance, Nexium, Amaryl, Losartan, Fish oil, Januvia, Spiriva, Zanaflex, Desyrel
Current Illness:
Preexisting Conditions: Hyperlipemia Essential hypertension, benign COPD (chronic obstructive pulmonary disease) (*) GERD (gastroesophageal reflux disease) Tobacco use disorder DM (diabetes mellitus) (*) Screening for colorectal cancer Diverticulosis of large intestine without hemorrhage
Allergies: Vicodin
Diagnostic Lab Data: COVID "detected" test on 11/13/21.
CDC Split Type:

Write-up: COVID vaccinated (2 doses) patient admitted through ED with shortness of breath. Provider discharge note below: "70 YO female with COPD presented with dyspnea, admitted with hypoxia due to covid pneumonia. Placed on solumedrol for COPD exacerbation, remdesivir for covid. Improved, not requiring supplemental O2 since yesterday.""


VAERS ID: 1947841 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: COVID - 10/21
Preexisting Conditions: none
Allergies: ibuprofen
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Red, itching bumps all over body - continually having new bumps daily. Was advised to start Zyrtec BID for 6 weeks to help with the itching.


VAERS ID: 1948099 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 018F21A / 3 LA / -

Administered by: Public       Purchased by: ?
Symptoms: Fatigue, Pain, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: I take prescribed medication birth control pill, multivitamin, Zyrtec, Silodosin, Amitriptyline , Simvastatin, glucose medication, and Gabapentin. And I get allergy shots every month.
Current Illness:
Preexisting Conditions: I have had migraines since last November when I had COVID-19, high cholesterol, and I have itching sensitivity.
Allergies:
Diagnostic Lab Data: No.
CDC Split Type: vsafe

Write-up: With the third dose I was really exhausted and had body aches. I just slept a lot and that was it for that dose. With the second dose I had body aches, headaches, exhaustion, I did have some chilis where I was just shivering uncontrollable. . I had abdominal pains, my heart rate had drop, and I had some chest pains. With the first dose I just had soreness in my arm at the injection site and exhaustion.


VAERS ID: 1948257 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Culture, Rash, Staphylococcal infection
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec 5mg, Triamcinolone 0.1% Cream
Current Illness: Eczema
Preexisting Conditions: Eczema
Allergies: Nuts, dogs, cats
Diagnostic Lab Data: Cultures taken 12/4/21
CDC Split Type:

Write-up: Patient developed rash all over body from neck down. Rash got better, then started back up again. Went to Pediatrician on 12/4/21, and got swabs of skin surface. Cultures returned to show Staph infection. Skin has now improved after Antibiotic use.


VAERS ID: 1948356 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Back pain, Computerised tomogram abdomen, Gait inability, Lumbar puncture, Lumbosacral plexopathy, Magnetic resonance imaging spinal, Pain, Ultrasound Doppler, Walking aid user
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: HTN, smoker, prediabetic
Allergies: none
Diagnostic Lab Data: MRI T spine 11/19/21 MRI LS spine 11/19 lumbar puncture 11/19 CT abd and pelvis 11/19 doppler of lower extremity veins 11/19
CDC Split Type:

Write-up: Painful lumbar plexopathy. he was initially unable to walk. after starting prednisone, he was able to walk with a cane. He still has disabling pain, but strength returned to normal or near normal. he still walks slowly with a cane, and pain worsened when prednisone ended. nerve conduction study / EMG has been requested


VAERS ID: 1948867 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anaphylactic reaction, Pharyngeal paraesthesia, Thirst, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: None
Preexisting Conditions: None
Allergies: Bactrum and lavaquin
Diagnostic Lab Data: Currently going to immunologist for further testing
CDC Split Type:

Write-up: 15 minutes after administering drove home began to have access thirst, Broke out in hives down the left side of my face and neck. Began to have anaphylaxis, throat tightening and tingling.


VAERS ID: 1950490 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Alabama  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / UNK - / OT

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

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

Write-up: Received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were mentioned. No treatment details were reported. Patient had no adverse events. Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Added information on occurrence of no adverse events and Reporter''s first name and postal code updated.


VAERS ID: 1951216 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017F21A / 3 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Bone pain, Chills, Cough, Decreased appetite, Dyspnoea, Ear pain, Eye pain, Fatigue, Feeling abnormal, Feeling cold, Gait disturbance, Oropharyngeal pain, Pain in jaw, Pyrexia, Sinus pain, Taste disorder
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Cardiomyopathy (broad), Osteonecrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: flu shot would get me sicker so i stopped taking it and i was fine
Other Medications: none
Current Illness: no
Preexisting Conditions: no
Allergies: when i take flu shots i get sicker so i don''t take it, sulfur, quinine, steroids
Diagnostic Lab Data: no
CDC Split Type: vsafe

Write-up: After I took it at my job, i went back working. around 9pm i felt chills and cold so i went and got a warm blanket from the warmer and got alieve. i finished work and went home and the next day i still had chills. when i would pick something up with my right arm anything i held would drop down. the next day i still had chills with weakness (friday). saturday walking to my car i fell and was having hard time getting up. monday i had severe heavy sinus, eye, jaw, ears, bones, everything up from my upper ear was hurting so bad. i felt sore throat as if i was to have a cough. my job required me to get a covid test from the ER before i would be able to come back to work. ER gave me sudafed and covid test. the next day i was still feeling bad so i got vitamin c because Sudafed wasn''t helping. i did a steam water inhalation, my taste was off, i feel feverish off and on and was so weak i couldn''t walk. I had a virtual doctors appointment because i was still very weak and off from work. now i still don''t have my taste and no appetite and feverish off an on, and still have pain and fatigued with shortness of breath. This has been since November.


VAERS ID: 1951780 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received a dose of Pfizer COVID-19Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL , 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1951907 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-11-11
Onset:2021-11-18
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arrhythmia, Asthenia, Blood test, Computerised tomogram, Decreased appetite, Diarrhoea, Dizziness, Dyspnoea, Electrocardiogram, Hyperhidrosis, Muscle spasms, Myalgia, Nausea, Parosmia, Taste disorder, Tremor, Ultrasound scan, Vertigo, Visual impairment, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Gabapentin Premerin
Current Illness:
Preexisting Conditions: RSD/ CRPS
Allergies: Gluten Sulfa
Diagnostic Lab Data: CT SCAN OF LUNGS EKG LUNG X-RAYS SONOGRAM OF LEGS BLOOD WORK
CDC Split Type:

Write-up: Can?t catch my breath- dizziness- vertigo-shaking-sweating-loss of Appetite-heart arrhythmias- vision issues- foul taste in mouth- foul smelling sweat - nausea - diarrhea- Feeling like I?m going to pass out - muscle aches and spasms Overall weakness


VAERS ID: 1951978 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, Product preparation issue, Product storage error, Underdose
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 received a dose of Pfizer COVID-19 Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1952102 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

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

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

Write-up: Patient gave us a date that did not match the information in the database and MD''s office. He gave a date of 11/15/2016. We called him to confirm. He stated the date he gave us was correct. But when we called MD''s office to compare, they had 12/15/2016, similar what is reported to the immunization database.


VAERS ID: 1952122 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PFIZER 12+ / 3 LA / 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? 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: none
CDC Split Type:

Write-up: Client received his booster vaccine weeks more than 2 weeks early. His booster was due no sooner than 12/7/21.


VAERS ID: 1952155 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8028 / 3 RA / IM

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

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

Write-up: patient received a booster dose though not yet approved for this age group


VAERS ID: 1952168 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8028 / 3 RA / IM

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

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

Write-up: patient received booster dose though not yet approved for his age group


VAERS ID: 1952260 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 067F21A / 3 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Burning sensation, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Estarylla OCP, Ondansetron 8mg prn q 8hr, Rizatriptan 10mg prn max 2/day, albuterol hfa 2 puffs every 6hr prn
Current Illness: None
Preexisting Conditions: Asthma mild intermittent, Migraine without aura
Allergies: Penicillin, Bee Stings
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Same day onset of b/l dorsum rash on hands 3x3cm. Felt like burns. No itch or blisters or bullae. Rash persisted for over 1mth and patient has residural dry plaques but is no longer symptomatic.


VAERS ID: 1954138 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211D21A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
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: USJNJFOC20211233306

Write-up: GIVEN A DOSE OF THE JANSSEN COVID-19 VACCINE THAT WAS EXPOSED TO TEMPERATURES BELOW AND ABOVE THE RECOMMENDED STORAGE TEMPERATURE/TEMPERATURE EXCURSION; INCORRECTLY STORED VACCINE ADMINISTERED; VACCINE STORED OUTSIDE OF THE ACCEPTABLE LIMITS; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 211D21A expiry: 11-APR-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 18-NOV-2021, the patient experienced given a dose of the janssen covid-19 vaccine that was exposed to temperatures below and above the recommended storage temperature/temperature excursion. On 18-NOV-2021, the patient experienced incorrectly stored vaccine administered. On 18-NOV-2021, the patient experienced vaccine stored outside of the acceptable limits. The action taken with covid-19 vaccine was not applicable. The outcome of the incorrectly stored vaccine administered, given a dose of the janssen covid-19 vaccine that was exposed to temperatures below and above the recommended storage temperature/temperature excursion and vaccine stored outside of the acceptable limits was not reported. This report was non-serious.


VAERS ID: 1954160 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-11
Onset:2021-11-18
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myelitis transverse
SMQs:, Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Transverse myelitis; This spontaneous case was reported by a consumer and describes the occurrence of MYELITIS TRANSVERSE (Transverse myelitis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced MYELITIS TRANSVERSE (Transverse myelitis) (seriousness criterion medically significant). At the time of the report, MYELITIS TRANSVERSE (Transverse myelitis) outcome was unknown. It was reported that some test results for a chronic autoimmune disease are still being awaited but this was some kind of transverse myelitis and an autoimmune reaction as id''d by oligoclonal antibodies. Concomitant product use was not provided by reporter. Treatment information was not provided. Company comment: This case concerns a patient of an unknown age and gender with no medical history provided who experienced serious unexpected event of special interest Myelitis transverse. The event occurred seven days after the third dose of mRNA-1273. The rechallenge was not applicable as the event occurred following the third dose of the vaccine. Very limited information regarding clinical course of the event has been provided at this time. It was reported that unspecified test results for chronic autoimmune disease were still being awaited. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-408561 (Patient Link).; Sender''s Comments: This case concerns a patient of an unknown age and gender with no medical history provided who experienced serious unexpected event of special interest Myelitis transverse. The event occurred seven days after the third dose of mRNA-1273. The rechallenge was not applicable as the event occurred following the third dose of the vaccine. Very limited information regarding clinical course of the event has been provided at this time. It was reported that unspecified test results for chronic autoimmune disease were still being awaited. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1954239 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Georgia  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3590 / 3 LA / -
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Off label use, Pain in extremity, Product use issue, Pruritus, Vaccination site mass, Vaccination site warmth
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESTRADIOL; PROGESTERONE; IRON; PRILOSEC [OMEPRAZOLE]; MELATONIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to metals (Fake gold and silver); Edema; Latex allergy (Latex bandaids itch); Obesity; Polycystic ovarian syndrome; Pre-diabetic
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101645492

Write-up: plum sized, hot, hard lump on my left arm where I got the shot; plum sized, hot, hard lump on my left arm where I got the shot; It is sore if I touch it or move a certain way.; I am a little worried that this is infected, because it''s starting to itch a little.; off label use; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 17:30 (Lot number: FE3590) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), administered in arm right, administration date 18Nov2021 (Batch/Lot number: unknown) as 0.5ml for immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "edema in ankles" (unspecified if ongoing); "Known allergy: Latex bandaids itch" (unspecified if ongoing), notes: Latex bandaids itch; "Known allergy: Fake gold and silver" (unspecified if ongoing), notes: Fake gold and silver. Concomitant medication(s) included: ESTRADIOL; PROGESTERONE; IRON; PRILOSEC [OMEPRAZOLE]; MELATONIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Right), administration date: 10Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Right), administration date: 13Mar2021, for COVID-19 immunization. The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE MASS (non-serious) all with onset 22Nov2021, outcome "not recovered" and all described as "plum sized, hot, hard lump on my left arm where I got the shot"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2021, outcome "not recovered", described as "It is sore if I touch it or move a certain way."; PRURITUS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "I am a little worried that this is infected, because it''s starting to itch a little."; OFF LABEL USE (non-serious) with onset 18Nov2021, outcome "unknown", described as "off label use"; PRODUCT USE ISSUE (non-serious) with onset 18Nov2021, outcome "unknown", described as "Product use for unapproved combination". Therapeutic measures were not taken as a result of vaccination site warmth, vaccination site mass, pain in extremity, pruritus. Additional information: With the two previous shots, she did not have these symptoms and was a little worried that this was infected. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccine facility type was Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1954823 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-11-17
Onset:2021-11-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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

Write-up: Constant headaches...


VAERS ID: 1954827 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Unknown  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-11-18
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8020 / 3 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Expired product 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Given past beyond use date, no adverse event associated.


VAERS ID: 1955007 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-11-16
Onset:2021-11-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin Advair Trulicity Tamoxifen Atorvastatin Pioglitazone Benazepril Vitamin D / Glucosamine Fish Oil Baby Aspirin CBD Caps Thorne Zinc
Current Illness: Head Cold / Respitory infection not covid
Preexisting Conditions: Asthma Type 2 Diabetes controlled (ac1 = 6.2) Breast Cancer (2019)
Allergies: None known
Diagnostic Lab Data: Just seeing dr. now
CDC Split Type:

Write-up: Heart Palpitations


VAERS ID: 1955143 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2021-11-09
Onset:2021-11-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 AR / SYR

Administered by: Private       Purchased by: ?
Symptoms: Antinuclear antibody negative, Arthralgia, C-reactive protein increased, Dysphagia, Joint swelling, Oropharyngeal pain, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (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 (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ativan 1 mg oral daily prn anxiety ; protonix 40 mg oral twice daily
Current Illness:
Preexisting Conditions: eosinophilic esophagitis
Allergies: wheat allergy
Diagnostic Lab Data: CRP elevated 14.6. ANA negative.
CDC Split Type:

Write-up: Hives, urticaria, joint swelling, joint pain, throat pain, difficulty swallowing beginning 11/18/21.. Had ED visit for symptoms on 11/19/21- received IV decadron, Benadryl, discharged to home on course of oral prednisone. Returned to ED 11/19/21 with worsening symptoms, admitted to hospital. Treated with IV steroids, Zyrtec, Benadryl. Discharged to home on course of oral prednisone, Benadryl, Zyrtec. Seen by Allergist 12/3/21 for ongoing symptoms. Zyrtec increased from once daily to twice daily. Seen by Medical Clinic 12/16/21 with improved but ongoing symptoms- Pepcid daily added to his regimen.


VAERS ID: 1955242 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: New York  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 067F21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Injection site swelling, Limb injury, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Sexual dysfunction (broad)

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

Write-up: Site: Pain at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: pt is complaining of right arm numbness and not being able to move the arm since getting the first vaccine. symptoms started right after administration of first moderna dose. (numbness in right elbow to fingertips except for pinky, can move it, has motor function, but describes it as tv static when falling asleep)


VAERS ID: 1955316 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Montana  
Vaccinated:2021-04-16
Onset:2021-11-18
   Days after vaccination:216
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 2 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Diagnosed and hospitalized with COVID while fully vaccinated


VAERS ID: 1955513 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, Product preparation issue, Product storage error, Underdose
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 received a dose of Pfizer COVID-19 Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


VAERS ID: 1955582 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939909 / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Lethargy, Loss of personal independence in daily activities, Pain, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: Atorvastatin 40 mg, magnesium, zinc, krill oil, D3
Current Illness: None
Preexisting Conditions: None - minor cholesterol control
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient awoke at 11:30 PM after going to sleep at around 9:30. She was gravely chilled, shaking uncontrollably and nearly unintelligible. She was achy but no serious fever to the touch of my cheek. She wanted ibuprofen which I got for her and she took two pills. She went back to sleep after covering completely with a heavy comforter for warmth. The following day she was lethargic and physically unable to perform anything other than basic non-physical actions. She took a long, hot bath for an hour. She slept normally that night and the following day was feeling mostly normal.


VAERS ID: 1958180 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: None- vaccine given 12 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. This case was linked to MOD-2021-395985 (Patient Link).


VAERS ID: 1958185 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-01-12
Onset:2021-11-18
   Days after vaccination:310
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011L20A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: None- vaccine given 12 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. This case was linked to MOD-2021-395985 (Patient Link).


VAERS ID: 1958286 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Alabama  
Vaccinated:2020-12-30
Onset:2021-11-18
   Days after vaccination:323
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011J20A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: None- vaccine given 12 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 12 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment and concomitant medications were provided. This case was linked to MOD-2021-395985 (Patient Link).


VAERS ID: 1958694 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Unknown  
Location: Michigan  
Vaccinated:2021-11-18
Onset:2021-11-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, Product preparation issue, Product storage error, Underdose
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 received a dose of Pfizer COVID-19 Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.


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