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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 535 out of 10,317

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VAERS ID: 1944403 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-10-01
Onset:2021-11-19
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Acute kidney injury, Echocardiogram abnormal, Hypotension, Left ventricular dysfunction, Troponin increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), 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), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Obesity
Allergies: NKDA
Diagnostic Lab Data: Echocardiogram demonstrating dysfunction, troponin elevation
CDC Split Type:

Write-up: Patient presented with hypotension, moderate LV dysfunction, Troponin elevation, acute renal failure


VAERS ID: 1944467 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-03
Onset:2021-11-19
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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

Write-up: Hospitalized patient with confirmed COVID-19 infection post vaccination


VAERS ID: 1946723 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8730 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 2 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3527 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Extra dose administered, Head discomfort, Headache, Muscle tightness, Nausea, Sleep disorder, Vision blurred
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Pfizer shot round 2, about 6-8 hours after my 6pm shot, I woke up in the middle of the night and my arms felt like they were bu
Other Medications: every other day or so I put a scoop of vital proteins/collagen powder into my coffee
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: I called my doctor after week 2 and she said to watch it and call if it doesn''t get better as everything happened immediately after the booster. I will call her again and have her report my symptoms as well.
CDC Split Type:

Write-up: Terrible headache all day, all night for 2 weeks straight. I had it when I woke up and when I went to bed and when I woke up in the middle of the night. No over the counter medicine could take the pain away. It was still there in week 3 but not as debilitating. The first few days after the booster, I was useless for work or my kids as my head hurt to move. I was a little dizzy, nauseous and the headache wasn''t like a caffeine headache, it was like pressure in my head. My neck to the base of my skull and shoulders were tight and felt like I had whiplash. I got massages and now 4 weeks later, that still hurts the same and the headaches come and go randomly. My vision is blurrier as well.


VAERS ID: 1947085 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FK5127 / 1 LA / -

Administered by: Public       Purchased by: ?
Symptoms: Pain in extremity, Product administered to patient of inappropriate age, Vaccination site warmth
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101630528

Write-up: Patient age : 10 Years; Feeling warm at injection site for 10 min; arm soreness 1 day; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 18:00 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE WARMTH (non-serious) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Feeling warm at injection site for 10 min"; PAIN IN EXTREMITY (non-serious) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "arm soreness 1 day"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 19Nov2021 18:00, outcome "unknown", described as "Patient age : 10 Years". Therapeutic measures were not taken as a result of vaccination site warmth, pain in extremity. Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1947086 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FE3590 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling hot, Vaccination site erythema, Vaccination site mass, 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: Medical History/Concurrent Conditions: Penicillin allergy (known_allergies Penicillin)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101630671

Write-up: Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.; Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.; Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.; Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 42-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Nov2021 10:45 (Lot number: FE3590) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies Penicillin" (unspecified if ongoing), notes: known allergies Penicillin. The patient''s concomitant medications were not reported. Past drug history included: Amoxicillin for Allergy. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE MASS (non-serious), VACCINATION SITE ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 19Nov2021 15:30, outcome "not recovered" and all described as "Within 5 hours of receiving injection in LT upper arm, a golf ball sized red, hot and painful knot appeared. 24 hours later, knot still the same.". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site mass, vaccination site erythema, feeling hot. Additional information: Prior to the vaccination, the patient was 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. Facility type vaccine was Pharmacy or Drug Store. Device Date was 20Nov2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1947090 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: New York  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FG3527 / 3 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pain, Pruritus, Vaccination site mass
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101638617

Write-up: the bump area itches; red bump at the injection site, like a big circle; it only hurts when she touches it; red bump at the injection site, like a big circle; it only hurts when she touches it; Off label use; booster; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A 23-year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 19Nov2021 16:00 (Lot number: FG3527, Expiration Date: 31May2022) at the age of 24 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: Janssen (1st dose: 10Mar2021, Lot: 1805018, Expiry: 25May2021), administration date: 10Mar2021, for COVID-19 immunizatiion; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 19Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; VACCINATION SITE MASS (non-serious), PAIN (non-serious) all with onset 20Nov2021, outcome "not recovered" and all described as "red bump at the injection site, like a big circle; it only hurts when she touches it"; PRURITUS (non-serious), outcome "unknown", described as "the bump area itches". Follow-up attempts are completed. No further information is expected.


VAERS ID: 1947091 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FD0809 / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Immunisation, Mobility decreased, Pain in extremity
SMQs:, Parkinson-like events (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101639614

Write-up: difficulty lifting her arm; sore arm; Stated that she received the booster at 4pm on 19 Nov; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 27 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 19Nov2021 16:00 (Lot number: FD0809, Expiration Date: 22Jan2022) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Lot: EP6955 , Expiration date: 30Jun2021, Route: Intramuscular), administration date: 20Mar2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Second dose, Lot: EP6955 , Expiration date: 30Jun2021, Route: Intramuscular), administration date: 10Apr2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 16:00, outcome "unknown", described as "Stated that she received the booster at 4pm on 19 Nov"; MOBILITY DECREASED (non-serious) with onset 20Nov2021, outcome "recovering", described as "difficulty lifting her arm"; PAIN IN EXTREMITY (non-serious) with onset 19Nov2021 21:00, outcome "recovering", described as "sore arm". Therapeutic measures were taken as a result of mobility decreased, pain in extremity. Additional information: There was no patient history. It was reported that the patient could lift her arm more easily last night and that she took Tylenol on 19Nov2021 and she iced her arm on Saturday. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1947095 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 LA / -

Administered by: School       Purchased by: ?
Symptoms: Immunisation, Mass
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: INFLUENZA VACCINE
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 INC202101641993

Write-up: Booster dose: Has a lump on left side under arm, on the side received the booster dose Pfizer Covid 19 Vaccine; Booster; 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation. Past drug history included: Penicillin for Hives, notes: she has had hives/hives were from a medicine /medicine was Penicillin. Vaccination history included: Bnt162b2 (Dose 1, single, lot number: EP6955, Route of administration: left arm, Time the Vaccination Was Given: First dose: AM), administration date: 20Mar2021, when the patient was 65 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, single, lot umber: ER8731, Route of administration: left arm , Time the Vaccination Was Given: Second dose: AM, The caller states she received the vaccines in the left arm because the caller had a fall on 02Aug2021 and fell on right hand side and had to get an operation on right shoulder.), administration date: 10Apr2021, when the patient was 65 years old, for Covid-19 Immunization, reaction(s): "had a fall". The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster"; MASS (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Booster dose: Has a lump on left side under arm, on the side received the booster dose Pfizer Covid 19 Vaccine". Additional Information: Provided Lot Number for the suspect product (Booster dose) was FJ8757 or FJB757. The concomitant Products Flu vaccine: The caller states she received her flu vaccine a week prior to receiving booster dose Pfizer Covid 19 Vaccine. The caller was not sure of the date received the flu vaccine. Caller does not have an NDC. The caller was a consumer reporting she received the booster dose, first and second dose Pfizer Covid 19 Vaccine. The caller received the booster dose Pfizer Covid 19 Vaccine on Friday, 19Nov2021. The caller had a lump on left side under arm, on the side the caller received the booster did Pfizer Covid 19 Vaccine. Reporter details: The caller did not wish to provide email. HCP: The caller did not wish to provide name, address, telephone number or email. The caller was seeing her doctor on Wednesday, 24Nov2021 and wanted to clarify about the lump. Booster dose: Had a lump on left side under arm, on the side received the booster dose Pfizer Covid 19 Vaccine: The caller reports the lump began on 20Nov2021, the day after received the booster dose Pfizer Covid 19 Vaccine and was persisiting. history: The caller states she received her flu vaccine a week prior to receiving booster dose Pfizer Covid 19 Vaccine. The caller was not sure of the date received the flu vaccine. Caller did not have an NDC/lot/expiration date to provide for flu vaccine received. Caller states the flu vaccine was administered to caller at a (Withheld) on (Withheld) in (Withheld) in the caller left arm. additional Information did any AE require a visit to: Emergency Room Physician Office: No, The caller figured what was the use in going to the emergency room, if the caller died, the caller died, the caller really did not care. The caller was going to the doctor on wednesday, 24Nov2021 and thought the doctor could look at the caller then. No additional vaccines administered on same date of the Pfizer Suspect. Patient''s Medical History (including any illness at time of vaccination) reported none. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines: Vaccine Name: no adverse events following prior vaccinations: Caller report she had hives. Caller then clarify the hives were from a medicine not a vaccine. Caller specified the medicine that the caller had hives after taking was an antibiotic. Caller specified the medicine was Penicillin. The caller did not had an NDC/lot/expiration date to provide for penicillin. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1947096 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FH8030 / 3 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature, Chills, Erythema, Headache, Hyperaesthesia, Immunisation, Pain, Pain of skin, Product use issue, Pyrexia, Rash erythematous, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: BREO ELLIPTA; SINGULAIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to nuts (Tree Nuts); Appendectomy; Asthma; Hemiplegic migraine; Lymphadenectomy (Gangrene lymph node removal with appendectomy)
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: Fever; Result Unstructured Data: Test Result:$g103 Fahrenheit; Test Date: 202111; Test Name: Fever; Result Unstructured Data: Test Result:100 Fahrenheit
CDC Split Type: USPFIZER INC202101647055

Write-up: Swollen, red, painful deltoid; Swollen, red, painful deltoid; Swollen, red, painful deltoid; Skin painful to the touch, and warm; Skin painful to the touch, and warm; Skin painful to the touch, and warm; swollen red rash moved to bicep; Fever $g103�F/ 100�F fever; Headaches; chills; Other vaccine same date vaccine date 19Nov2021; Dose number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 12:15 (Lot number: FH8030) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX 23), administered in arm right, administration date 19Nov2021 12:15 PM as (Batch/Lot number: unknown) at Pharmacy or Drug Store. Relevant medical history included: "Tree Nuts Allergy" (unspecified if ongoing), notes: Tree Nuts; "Asthma" (unspecified if ongoing); "Hemiplegic Migraines" (unspecified if ongoing); "Gangrene lymph node removal with appendectomy" (unspecified if ongoing), notes: Gangrene lymph node removal with appendectomy; "Gangrene lymph node removal with appendectomy", start date: 2004 (unspecified if ongoing). Concomitant medication(s) included: BREO ELLIPTA; SINGULAIR. Past drug history included: Amoxicillin, reaction(s): "Amoxicillin: Drug Allergy"; Cefaclor, reaction(s): "Cefaclor: Drug Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6206, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 06Mar2021, when the patient was 30 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 27Mar2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: SWELLING (non-serious), ERYTHEMA (non-serious), PAIN (non-serious) all with onset 19Nov2021 21:00, outcome "recovering" and all described as "Swollen, red, painful deltoid"; PAIN OF SKIN (non-serious), HYPERAESTHESIA (non-serious), SKIN WARM (non-serious) all with onset 19Nov2021 21:00, outcome "recovering" and all described as "Skin painful to the touch, and warm"; RASH ERYTHEMATOUS (non-serious) with onset 19Nov2021 21:00, outcome "recovering", described as "swollen red rash moved to bicep"; PYREXIA (non-serious) with onset 19Nov2021 21:00, outcome "recovering", described as "Fever $g103 degree F/ 100 degree F fever"; HEADACHE (non-serious) with onset 19Nov2021 21:00, outcome "recovering", described as "Headaches"; CHILLS (non-serious) with onset 19Nov2021 21:00, outcome "recovering", described as "chills"; PRODUCT USE ISSUE (non-serious) with onset 19Nov2021 21:00, outcome "recovering", described as "Other vaccine same date vaccine date 19Nov2021"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Dose number: 3". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of swelling, erythema, pain, pain of skin, hyperaesthesia, skin warm, rash erythematous, pyrexia, headache, chills, product use issue. Additional information: It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient have not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1947118 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FD0809 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cardiomyopathy, Chest pain, Dyspepsia, Immunisation, Laboratory test, Muscle spasms
SMQs:, Dystonia (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dairy intolerance; Food intolerance; Gluten intolerance; Thrombophilia (genetic blood clotting, the caller only has one of 2 genes)
Allergies:
Diagnostic Lab Data: Test Name: Test; Result Unstructured Data: Test Result:unknown result; Comments: They did a lot of tests on the caller today and didn''t find anything of concern.
CDC Split Type: USPFIZER INC202101686099

Write-up: weird pain in the middle of her chest; feels like heartburn; Third Dose: muscle spams in the heart; Third Dose: Back muscle spasms; Pfizer covid vaccine the third dose, the booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (upper left arm), administration date 19Nov2021 14:30 (Lot number: FD0809) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "food intolerances like gluten" (unspecified if ongoing); "food intolerances like dairy" (unspecified if ongoing); "food intolerances like corn" (unspecified if ongoing). Family history included: "genetic blood clotting: thrombophilia" (unspecified if ongoing), notes: genetic blood clotting, the caller only has one of 2 genes. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose: lot ER2613, NDC and expiration date unknown.), administration date: 18Mar2021, when the patient was 56 years old, for COVID-19 Immunization, reaction(s): "sore arm" and "lightheaded"; Bnt162b2 (Second Dose: lot ER8737, NDC and expiration date unknown.), administration date: 08Apr2021, when the patient was 56 years old, for COVID-19 Immunization, reaction(s): "sore arm" and "lightheaded", reported as the only thing that happened after the first two doses of the Pfizer covid vaccine is that the caller got lightheaded like she got unplugged and plugged back in. This happened 3 days after getting the vaccines and that was the only thing that happened other than the sore arm. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Pfizer covid vaccine the third dose, the booster dose"; CARDIOMYOPATHY (medically significant) with onset 29Nov2021 07:50, outcome "recovering", described as "Third Dose: muscle spams in the heart"; MUSCLE SPASMS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Third Dose: Back muscle spasms"; CHEST PAIN (non-serious), outcome "unknown", described as "weird pain in the middle of her chest"; DYSPEPSIA (non-serious), outcome "unknown", described as "feels like heartburn". The events "third dose: muscle spams in the heart" and "third dose: back muscle spasms" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: laboratory test: unknown result, notes: They did a lot of tests on the caller today and didn''t find anything of concern. Therapeutic measures were taken as a result of cardiomyopathy, muscle spasms. Clinical courses: The caller just got back for the emergency room because she had muscle spams in the heart, it was gripping. The caller has been dealing with back spasms all last week and chocked it up to throwing out her back. The back muscle spasms go up her back and along her spine. They did all sorts of tests at the hospital. It seemed really strange that this happened because she is otherwise healthy. The doctors didn''t see any abnormal heart activity and the caller has 3 baby aspirins just in case. The caller doesn''t know if the back and heart muscle spasms are related. On 19Nov2021 the caller got her third dose and its strange that something like this would happen 10 days later and it may not be related to the vaccine. The caller has been standing because when she sits on a hard surface that''s when the spasms go up her back, its really painful its worse than childbirth. The caller''s heart muscle spasms happened at 7:50 this morning, it happened every minute for approximately 15 minutes and had someone drive her to the hospital. The caller was never admitted as a patient but was seen in the emergency room. The caller still feels some weird pain in the middle of her chest and it feels like heartburn even though she didn''t eat anything spicy.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101686201 similar report from same reporter


VAERS ID: 1947925 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-11-17
Onset:2021-11-19
   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 - / 3 UN / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, COVID-19, General physical health deterioration, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 26 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: stint put in heart
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: lost alot of energy, sweaty, going downhill quickly, diagnosed with covid


VAERS ID: 1948095 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: New York  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FF8841 / 1 RA / IM

Administered by: Public       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: UNKNOWN
Current Illness: UNKNOWN
Preexisting Conditions: UNKNOWN
Allergies: UNKNOWN
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Mom requested that her child, who was 12yrs old at the time of the vaccination, receive a pediatric dose because of his small size. The vaccinator administered the pediatric dose instead of the adult dose that he should have received.


VAERS ID: 1948169 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-05
Onset:2021-11-19
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 058F21A / 2 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Electrocardiogram, 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: losartan, Benicar, ibuprofren (as needed for back pain)
Current Illness: sciatic nerve pain
Preexisting Conditions: hypertension
Allergies: erythromycin (nausea), penicillin
Diagnostic Lab Data: EKG; heart palpitations
CDC Split Type: vsafe

Write-up: 11/5/2021 04:00PM vaccination About 2 weeks after vaccination, I started to experience heart palpitations. It got progressively worse, prompting my visit to Dr. Increase dose of hypertension medications. He changed my medications to metoprolol-titrate. He scheduled me for an EKG later in 12/2021 (I do not have the date) and follow up visit with Dr.; TBD. He has also ordered blood work.


VAERS ID: 1948218 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-11-12
Onset:2021-11-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039F21A / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Cough, Myalgia, Oropharyngeal pain, Pain, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Streptococcus test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: finasteride
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: 11/22: Rapid COVID-19 test: Negative result 11/24: PCR COVID-19 test: Negative result 11/24: Strep culture test: Negative result 12/1: At home COVID-19 Binax test: Negative result 12/5: PCR COVID-19 test: Positive result
CDC Split Type:

Write-up: I received my first two Moderna doses in February 2021. My Moderna booster was 11/12/2021, as reported earlier on this form. Evening of 11/19 symptoms started: sore throat, muscle aches, runny nose, cough. Negative rapid COVID-19 test on Monday, 11/22. Symptoms persisted, sought care from PCP on Wednesday, 11/24. Tested negative for COVID-19 (PCR test) and negative for strep. Cough, congestion, aches persisted. Had another PCR test on Sunday, 12/5, prior to traveling which came back positive for COVID-19.


VAERS ID: 1949022 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-11-08
Onset:2021-11-19
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Pruritus, Rash macular, 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:
CDC Split Type:

Write-up: 11 days after the Moderna booster 3rd shot I developed all over body itching and hives. Mostly on my back, stomach, legs , arms and feet. Intense spontaneous itching usually around evening time but sometimes during the day. Red spots and hives will occur near and around the itchy areas. Still persisting today. Have never had allergies or hives in my life before.


VAERS ID: 1950511 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abscess neck, Body temperature, Computerised tomogram thorax, Discomfort, Empyema, Laboratory test, Lymphadenopathy, Malaise, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Body temperature; Result Unstructured Data: Low grade fever; Test Date: 20211123; Test Name: Body temperature; Result Unstructured Data: Fever; Test Date: 20211126; Test Name: CT scan of neck and chest; Result Unstructured Data: CT scan of chest and neck showed-Large abscess forming in the deep portion of the left side of his neck, where the swollen lymph nodes were adjacent to his spine. The abscess was communicating to the left lung and caused empyema (puss).; Test Date: 20211126; Test Name: Lab work; Result Unstructured Data: Abnormal
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Empyema (Puss); Large abscess forming in the deep portion of the left side of his neck; Under his armpit the lymph nodes were swollen and hard.; Fever/ low grade fever; Malaise; Uncomfortable; Body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of EMPYEMA (Empyema (Puss)) and ABSCESS NECK (Large abscess forming in the deep portion of the left side of his neck) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced MALAISE (Malaise), DISCOMFORT (Uncomfortable), MYALGIA (Body aches) and PYREXIA (Fever/ low grade fever). On 26-Nov-2021, the patient experienced EMPYEMA (Empyema (Puss)) (seriousness criteria hospitalization and medically significant), ABSCESS NECK (Large abscess forming in the deep portion of the left side of his neck) (seriousness criterion hospitalization) and LYMPHADENOPATHY (Under his armpit the lymph nodes were swollen and hard.). The patient was hospitalized on 26-Nov-2021 due to ABSCESS NECK and EMPYEMA. The patient was treated with Surgery (chest surgery for the infection) for Empyema and Surgery (Drainage) for Abscess neck. At the time of the report, EMPYEMA (Empyema (Puss)), ABSCESS NECK (Large abscess forming in the deep portion of the left side of his neck), MALAISE (Malaise), DISCOMFORT (Uncomfortable), MYALGIA (Body aches), LYMPHADENOPATHY (Under his armpit the lymph nodes were swollen and hard.) and PYREXIA (Fever/ low grade fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2021, Body temperature: fever (High) Low grade fever. On 23-Nov-2021, Body temperature: fever (High) Fever. On 26-Nov-2021, Computerised tomogram thorax: abnormal (abnormal) CT scan of chest and neck showed-Large abscess forming in the deep portion of the left side of his neck, where the swollen lymph nodes were adjacent to his spine. The abscess was communicating to the left lung and caused empyema (puss).. On 26-Nov-2021, Laboratory test: abnormal (abnormal) Abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not provided Patient was treated with aggressive antibiotics when patient was admitted to the hospital. Company comment : This case concerns a 47-year-old, male patient with no relevant medical history, who experienced the serious unexpected events Abscess Neck and empyema. The events occurred approximately 8 days after the booster dose of mRNA-1273. Patient had a large abscess forming in the deep portion of the left side of his neck. The abscess was communicating to the left hemithorax and caused empyema. Patient was admitted to hospital and was treated with antibiotics and surgery to drain out abscess and empyema. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report. Nurse Practitioner on behalf of his husband reported that patient had received his booster dose. On 23-NOV-2021 patient also had fever. On 26-NOV-2021 patient had went to Emergency Department for evaluation. Patient had chest surgery for infection where they opened up patients left lung to clean up and drain infection and they also made an incision in his neck to drain out abscess. Patient was currently recovering in hospital. Patient had tubes coming out of his chest and drains coming out of his neck. Nurse practitioner did not felt the vaccine had anything to do with abscess but was wondered if the mRNA in the vaccine created a strong signaling immune response to alert the body that there was an abscess.; Sender''s Comments: This case concerns a 47-year-old, male patient with no relevant medical history, who experienced the serious unexpected events Abscess Neck and empyema. The events occurred approximately 8 days after the booster dose of mRNA-1273. Patient had a large abscess forming in the deep portion of the left side of his neck. The abscess was communicating to the left hemithorax and caused empyema. Patient was admitted to hospital and was treated with antibiotics and surgery to drain out abscess and empyema. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 1950663 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FG3527 / 3 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Angina pectoris, Arthralgia, Fatigue, Heart rate, Heart rate decreased, Immunisation, Pain
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Other ischaemic heart disease (narrow), Arthritis (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: Synthroid; Zolpidem; Amitriptyline; Zyrtec [Cetirizine Hydrochloride]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Exercise induced asthma (otherwise, generally healthy for my age); Knee arthritis (otherwise, generally healthy for my age); Thyroid nodule removal.
Allergies:
Diagnostic Lab Data: Test Name: heart rate/pulse; Result Unstructured Data: Test Result: 44-48 bpm; Comments: Slow; Test Name: heart rate/pulse; Result Unstructured Data: Test Result: 67 bpm; Comments: midnight; Test Name: heart rate/pulse; Result Unstructured Data: Test Result: 68-75; Comments: usually resting heart rate.
CDC Split Type: USPFIZER INC202101698087

Write-up: mild heart pain; I took my pulse on an oximeter and it said my pulse was only 44-48bpm; feeling very achy and fatigued; feeling very achy and fatigued; joint pain; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 15:15 (Lot number: FG3527) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Left side of thyroid was removed, due to a noncancerous nodule." (unspecified if ongoing); "Arthritis in my knees" (unspecified if ongoing), notes: otherwise, generally healthy for my age.; "exercise induced asthma" (unspecified if ongoing), notes: otherwise, generally healthy for my age. Concomitant medication(s) included: SYNTHROID; ZOLPIDEM; AMITRIPTYLINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Protonix, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 06:30 PM), administration date: 29Mar2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Right, Vaccine Administration Time: 08:00 PM), administration date: 08Mar2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "booster"; ANGINA PECTORIS (medically significant) with onset 20Nov2021 17:00, outcome "recovered" (24Nov2021), described as "mild heart pain"; HEART RATE DECREASED (medically significant) with onset 20Nov2021 17:00, outcome "recovered" (24Nov2021), described as "I took my pulse on an oximeter and it said my pulse was only 44-48bpm"; PAIN (non-serious), FATIGUE (non-serious) all with onset 20Nov2021 17:00, outcome "recovered" (24Nov2021) and all described as "feeling very achy and fatigued"; ARTHRALGIA (non-serious) with onset 20Nov2021 17:00, outcome "recovered" (24Nov2021), described as "joint pain". The patient underwent the following laboratory tests and procedures: heart rate: 44-48 bpm, notes: Slow; 67 bpm, notes: midnight; 68-75, notes: usually resting heart rate. Therapeutic measures were not taken as a result of immunisation, angina pectoris, heart rate decreased, pain, fatigue, arthralgia. Clinical course: facility type vaccine: Other. No other vaccine in four weeks. Adverse event: I woke up the day following the vaccination feeling very achy and fatigued for most of the day. Later that afternoon, the joint pain and achy feeling subsided, but I noticed my heart rate seemed very slow. I took my pulse on an oximeter and it said my pulse was only 44-48bpm, where usually my resting heart rate is about 68-75. I checked my heart rate on different devices, and they all were indicating that my heart rate was between 44-48bpm. I had debated going to the hospital, but I didn''t. I went to sleep around 10:00pm that night with still a low heart rate. I woke up around midnight and took my heart rate on the oximeter at that point and my heart rate was back to 67. The next couple of days I still had a very very mild heart pain, but by 24Nov, I felt pretty normal and resumed all of my normal activities. Covid not tested post vaccination.


VAERS ID: 1950744 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FJ1620 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blindness unilateral, Chills, Eye pain, Headache, Immunisation, Investigation, Pain assessment, Poor quality sleep
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (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: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Lab tests; Result Unstructured Data: Test Result:Unknown result; Comments: had plenty of lab tests in the hospital on the 19th, 20th, and 21st; Test Date: 20211120; Test Name: Lab tests; Result Unstructured Data: Test Result:Unknown result; Comments: had plenty of lab tests in the hospital on the 19th, 20th, and 21st; Test Date: 20211121; Test Name: Lab tests; Result Unstructured Data: Test Result:Unknown result; Comments: had plenty of lab tests in the hospital on the 19th, 20th, and 21st; Test Date: 20211119; Test Name: Eye pain; Result Unstructured Data: Test Result:9; Comments: It was about in 9 on a scale of 1 to 10
CDC Split Type: USPFIZER INC202101699575

Write-up: loosing sight in her left eye/ had no vision in the left eye; left eye pain/ pain was severe/ about in 9 on a scale of 1 to 10; Booster; Didn''''t sleep well; Headache; Chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 13:00 (Lot number: FJ1620) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "recurrent PE" (unspecified if ongoing). Concomitant medication(s) included: XARELTO taken for pulmonary embolism. Vaccination history included: Bnt162b2 (1st dose, lot#EL3247), administration date: 31Jan2021, when the patient was 55 years old, for COVID-19 Immunization, reaction(s): "headache", "chills"; Bnt162b2 (2nd dose, lot#EN5318), administration date: 21Feb2021, when the patient was 55 years old, for COVID-19 Immunization, reaction(s): "headache", "chills"; Tdap vaccine (tdap vaccine), administration date: Sep2021. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021 13:00, outcome "unknown", described as "Booster"; BLINDNESS UNILATERAL (medically significant) with onset 20Nov2021, outcome "unknown", described as "loosing sight in her left eye/ had no vision in the left eye"; EYE PAIN (medically significant) with onset 20Nov2021, outcome "unknown", described as "left eye pain/ pain was severe/ about in 9 on a scale of 1 to 10"; HEADACHE (non-serious) with onset 19Nov2021, outcome "unknown", described as "Headache"; CHILLS (non-serious) with onset 19Nov2021, outcome "unknown", described as "Chills"; POOR QUALITY SLEEP (non-serious) with onset 19Nov2021, outcome "unknown", described as "Didn''''t sleep well". The events "loosing sight in her left eye/ had no vision in the left eye", "left eye pain/ pain was severe/ about in 9 on a scale of 1 to 10", "headache", "chills" and "didn''''t sleep well" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: (19Nov2021) unknown result, notes: had plenty of lab tests in the hospital on the 19th, 20th, and 21st; (20Nov2021) unknown result, notes: had plenty of lab tests in the hospital on the 19th, 20th, and 21st; (21Nov2021) unknown result, notes: had plenty of lab tests in the hospital on the 19th, 20th, and 21st; pain assessment (1-10): (19Nov2021) 9, notes: It was about in 9 on a scale of 1 to 10. Therapeutic measures were taken as a result of blindness unilateral, eye pain, headache, chills, poor quality sleep included: given Tylenol 650 milligrams, one tablet. Clinical course: The patient received the Pfizer COVID-19, booster shot on the recommendation of doctor, she got it at 1 O''clock in the afternoon and she went to bed about 9 O''clock or 9:30 in the evening with a headache. She had a few chills. She really didn''t sleep well and woke up about 6:30 in the morning with a really bad headache and left eye pain. The pain was severe. It was about in 9 on a scale of 1 to 10. She was loosing sight in her left eye and called doctor and he told to go to the emergency room and the patient did that and after close to 48 hours. She had no vision in the left eye. She didn''t know if this was a side effect but you know she had the vaccine and in less than 24 hours she lost her sight in her left eye.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101700060 same patient/drug, different event (dose 1 and dose 2)


VAERS ID: 1951708 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FH8030 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Muscle contractions involuntary, Oral discomfort, Spinal pain
SMQs:, Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Arthritis (broad)

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

Write-up: tired, spine hurting, lip quivering.


VAERS ID: 1951768 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-19
Onset:2021-11-19
   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: Immunisation, No adverse event, Wrong technique in product usage process
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-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: 1951774 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-19
Onset:2021-11-19
   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: 1951872 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 EW0175 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Burning sensation, Magnetic resonance imaging abnormal, Magnetic resonance imaging neck, Muscle spasms, Muscular weakness, Pain, Paraesthesia, Syringomyelia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Congenital, familial and genetic disorders (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

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

Write-up: Received covid shot on a Friday 11/19/2021 a 7:45am. By 9:30 I was haveing severe burning and pins and needles in my feet and buring in my legs. By 12:30 I had lost weakenss in my left hand along with the other symptoms listed above. The symptoms continued to get worse for the next couple of days. On Tuesday 11/23 the pain was significantly worse and I started to get uncontrollable muscle spasms in my left arm and left leg. The spasms went on through the night and into the next day. I had lost complete strength in my left leg and left arm. I went to the ER and they evaluated me and referred me to Neurology. MRI''s were ordered and discovered I have developed a syrinx in my T spine which i have never had before.


VAERS ID: 1951899 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 EW0173 / 3 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Medications: Blisovi Fe 1/20 (28) 1 mg-20 mcg (21)/75 mg (7) tablet
Current Illness:
Preexisting Conditions: PMH: Nonallopathic Lesion of Cervicothoracic Region, findings of esophagus, findings of cardiovascular measurement, vitamin D deficiency, Abnormal Prolactin, irregular periods, pain in pelvis, ferritin level low
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: 9 mins post vaccination pt states that she is having "pressure" on her chest. VS WNL. Nothing remarkable upon assessment. Vitals: 119/80, 86, 20, 99% Pt stable and released from the vaccination site


VAERS ID: 1952421 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039F21A / 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: PATIENT IS UNDER 18 AND RECEIVED MODERNA. PATIENT HAD NO ADVERSE EVENTS OTHER THANUNDER AGE


VAERS ID: 1952425 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039F21A / 1 LA / IM

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

Write-up: PATIENT IS UNDER 18 AND RECEIVED MODERNA VACCINE. NOT ADVERSE EVENTS OTHER THAN UNDER AGE


VAERS ID: 1954142 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Arkansas  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 034F21A / 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.MOD20213

Write-up: Moderna vial was punctured more than 20 times; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vial was punctured more than 20 times) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vial was punctured more than 20 times). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Moderna vial was punctured more than 20 times) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporter No treatment medications provided by the reporter.


VAERS ID: 1954734 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-11-18
Onset:2021-11-19
   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 - / 3 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Joint injection, Joint swelling
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zeljanz; Prednisone; Voltaren.
Current Illness: Uti.
Preexisting Conditions: RA.
Allergies: Placquenil; Methotrexate; Contrast dye.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe swelling and pain of right knee, unable to wear slacks. Swelling of right ankle. Pain in left elbow.Swelling and pain in right and left wrists. Steroid injection in right knee Dec 8. Nov 23 1 round of prednisone burst 10 mg, starting second round Dec 16. Still having pain in elbow, swelling in right knee and right ankle.


VAERS ID: 1954787 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-11-19
Onset:2021-11-19
   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
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: 1954815 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-11-19
Onset:2021-11-19
   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: Pharmacy       Purchased by: ?
Symptoms: Back pain, Headache, Influenza like illness, Lymph node pain, Pain, Renal pain, Sensitive skin
SMQs:, Retroperitoneal fibrosis (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: Isosorbide; Atorvastatin; Aspirin; One a Day Men''s Formula vitamin.
Current Illness: None.
Preexisting Conditions: Liver cirrhosis.
Allergies: None.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: 48 hours of extreme flulike conditions. Consisting mostly of severe headaches, body aches, and skin sensitivity. Glandular pain & soreness. Lower back pain, possibly kidney pain.


VAERS ID: 1954988 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 EW0173 / 3 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Medications: Sertraline 50mgPO Daily Rosuvastatin 20mg PO QHS
Current Illness:
Preexisting Conditions: PMH: HTN, Stress Incontinence, s/p hysterectomy for precancer 30yrs ago, abnormal pap smear
Allergies: Allergies: Escitalopram (headache)
Diagnostic Lab Data:
CDC Split Type:

Write-up: 5mins post vaccination pt reported dizziness. Vitals: 184/94, 59, 20, 97% -- $g 166/90, 57, 20, 97% Educated pt to record BP and to take it to her PCP. Pt stable and released from the vaccination site.


VAERS ID: 1955349 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Montana  
Vaccinated:2021-11-03
Onset:2021-11-19
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8028 / 2 LA / IM

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

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

Write-up: Patient diagnosed and hospitalized with COVID while vaccinated


VAERS ID: 1955602 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-17
Onset:2021-11-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 058F21A / 3 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Dyskinesia, Hypoaesthesia, Musculoskeletal stiffness, Neurological symptom, Oral pain, Paraesthesia, Toothache
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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: Tamoxifen; Prozac; Xanax.
Current Illness: None.
Preexisting Conditions: Breast Cancer; Lower Back Surgery; Anaemia.
Allergies: None.
Diagnostic Lab Data: Done.
CDC Split Type: vsafe

Write-up: Very stiff neck. Mouth hurt, my teeth hurt, I couldn''t open up my mouth wide. My whole left side of my body was numb and tingling, it felt like I was getting a stroke. Went to the doctor on 11/23/2021 he gave me a steroid shot in my neck.


VAERS ID: 1955637 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-27
Onset:2021-11-19
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822809 / 1 - / IM

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

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

Write-up: Patient was admitted to Hospital on 11/19/2021 for COVID related symptoms after receiving the COVID19 Vaccine. This is considered a breakthrough case.


VAERS ID: 1955734 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-11-18
Onset:2021-11-19
   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 FF8839 / 3 RA / IM

Administered by: Military       Purchased by: ?
Symptoms: Incorrect route of product administration, Shoulder injury related to vaccine administration
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

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

Write-up: SIRVA - Rt shoulder pain. Likely related to improper administration technique into subdeltoid bursa.


VAERS ID: 1955870 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1855194 KCHD / N/A LL / IM

Administered by: Public       Purchased by: ?
Symptoms: Dyspnoea, Erythema, Oral pruritus, Pruritus, Swelling, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Flu vaccine (two formulas) Tetanus vaccine. Same symptoms as noted plus severe inner ear itching and with addition of EpiPen use
Other Medications: Montelukast, Xyzal, Flonase nasal spray, Advair HFA, Benedryl, OTC decongestants
Current Illness: None
Preexisting Conditions: Idiopathic anaphylaxis, reactive airway disease
Allergies: Flu vaccine (two formulas), tetanus vaccine, Keflex, dry powder inhalers, formaldehyde, unknown RX excipients, some cleaning products, some beauty products, wasp venom.
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 50mg Benadryl taken prophylactically at 1030 and again at 1600. At approx 2330 experienced itching in throat and roof of mouth and some shortness of breath. Took another 50mg Benadryl, OTC decongestant and 2 puffs Xopenex MDI. No relief with worsening symptoms and shortness of breath noted 1 hour later. Took 1 Duoneb nebulizer treatment. Took 1 Duoneb approx 45 minutes after that. Started to feel some relief at that time. Symptoms reappeared mid morning on 12/20/21. Continued regimen of Benadryl, Duoneb and decongestants in addition to my regular daily medications. Dr. was contacted on Monday 12/22/2021 and received Prednisone prescription. Attempted to taper Prednisone dose without success. Had symptoms appear as before with addition of swelling, reddened and itchy palms and soles of feet. Re-started Prednisone and am currently doing a very slow taper.


VAERS ID: 1955947 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-11-02
Onset:2021-11-19
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0391214 / 3 AR / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: sertraline estradiol Coreg valsartan equate allergy relief (Zyrtec) 1 aspirin every other day atorvastatin fluticasone Tolterodine Azelastine Afrin nasal decongestant eye drops refresh optic advance Opti-con A eye drops calcium cit
Current Illness: no
Preexisting Conditions: high blood pressure high cholesterol bladder control allergies
Allergies: hydrocodone I have a problem taking Benadryl- I don''t feel good after I do
Diagnostic Lab Data: blood work will be done the next time I come in
CDC Split Type: vsafe

Write-up: I notice it on 11/19/2021, it could have started earlier, but I did not notice it. It started as an itch and I did not pay a lot of attention. On 11/19/2021, all across my back was itching and I could not scratch it. It just so bad that I finally got my son to look at my back. He took pictures and I had red welts from where I had been scratching. It kept going. I went to see my ENT on 12/06/2021-and I mentioned it to them and showed them the pictures and they told me it was definitely hives and they referred me to an allergist. On 12/13/2021- I saw my allergist and she told me it was hives. It was big red welts. It did not hurt or anything. She prescribed medication, Zyrtec 10 mg, twice a day, morning and evening and Pepcid 20 mg to take that twice a day for 4 weeks. And I have to do blood work and I have to go back and see her again and she will tell me what to do from there. I just started the medication and the itching is not as bad. The welts will come and go away. I have not been itching as much. The hives and itchiness are on my arms, neck, and back and sometimes my legs are itching.


VAERS ID: 1955979 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FH8028 / 3 RA / IM

Administered by: Public       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: Pfizer vaccine vial punctured at 0825 gave Pfizer vaccine to Pt at 1555. Vaccine was expired by 90. No symptoms seen and no tx given at this time. Observation of 20 minutes


VAERS ID: 1955982 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FH8028 / 3 LA / IM

Administered by: Public       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: Pfizer vaccine vial punctured at 0825 gave Pfizer vaccine to Patient at 1555. Vaccine was expired by 90. No symptoms seen and no tx given at this time. Observation of 20 minutes


VAERS ID: 1955984 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FH8028 / 3 LA / IM

Administered by: Public       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: Pfizer vaccine vial punctured at 08:25. Gave Pfizer vaccine to patient at 15:55. Vaccine expired upon administration. No symptoms seen and no treatment given at this time. Observation of 20 minutes.


VAERS ID: 1956178 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-19
Onset:2021-11-19
   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 FK5127 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: After 1st dose vaccine, patient stated his left arm was numb with tingling, but no pain.


VAERS ID: 1956193 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Heart rate increased, Heart rate irregular, Immediate post-injection reaction, Lethargy, Non-cardiac chest pain, Pain, Palpitations, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Still waiting for results
CDC Split Type:

Write-up: Immediate headache and expected lethargy; Next day - fever and aches; Nov. 23 - Sore chest - as if it were bruised; racing erratic pulse - felt like my heart would fly out of my chest; pounding, especially at night time. These symptoms lasted until Dec 3-4, then gradually subsided.


VAERS ID: 1957829 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-01-21
Onset:2021-11-19
   Days after vaccination:302
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 028L20A / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Anosmia, Cough, Decreased appetite, Headache, Pain in extremity, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Lost his taste; Lost his smell; has a cough; got the sniffles; felt better but had a headache; his appetite was down.; he got a sore arm/stayed in bed until Sunday; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost his taste), ANOSMIA (Lost his smell), COUGH (has a cough), RHINORRHOEA (got the sniffles) and DECREASED APPETITE (his appetite was down.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006D21A, 028L20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced DECREASED APPETITE (his appetite was down.) and PAIN IN EXTREMITY (he got a sore arm/stayed in bed until Sunday). On 21-Nov-2021, the patient experienced HEADACHE (felt better but had a headache). On 22-Nov-2021, the patient experienced RHINORRHOEA (got the sniffles). On 23-Nov-2021, the patient experienced AGEUSIA (Lost his taste), ANOSMIA (Lost his smell) and COUGH (has a cough). At the time of the report, AGEUSIA (Lost his taste), ANOSMIA (Lost his smell), COUGH (has a cough), RHINORRHOEA (got the sniffles), DECREASED APPETITE (his appetite was down.), PAIN IN EXTREMITY (he got a sore arm/stayed in bed until Sunday) and HEADACHE (felt better but had a headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable No concomitant medications reported. No treatment reported. Company Comment: This spontaneous case concerns a 64 year old male with no reported medical history who experienced, Non-serious , unexpected , AESI event of Anosmia and Ageusia which occurred 5 days after the vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) , Other non-serious , unexpected events include pain in extremity, decreased appetite, rhinorrhea , cough and expected event of headache was also experienced by the patient after receiving the 3rd dose of the vaccine. The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be administered and also the outcome of th events were reported as unkown, The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report; Sender''s Comments: This spontaneous case concerns a 64 year old male with no reported medical history who experienced, Non-serious , unexpected , AESI event of Anosmia and Ageusia which occurred 5 days after the vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) , Other non-serious , unexpected events include pain in extremity, decreased appetite, rhinorrhea , cough and expected event of headache was also experienced by the patient after receiving the 3rd dose of the vaccine. The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be administered and also the outcome of th events were reported as unkown, The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 1957832 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-01-08
Onset:2021-11-19
   Days after vaccination:315
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026L20A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Flushing, Rash, Rash macular, Rash pruritic, Urticaria, Varicose vein
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MULTIVITAMINS [VITAMINS NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Joint injury
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20214

Write-up: Swelling of the veins; Chest tightness; Shortness of breath; Face starts to flush; Acute urticaria/urticaria; Full body rash/rash came back with more severity than before/rashes appear at random places in his body at random times/rashes last around 60 minutes and then disappear; Red blotches/blotches in his throat, face, armpits and legs; Itchy rash began to grow on his groin and arm pits/rash incredibly itching; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH PRURITIC (Itchy rash began to grow on his groin and arm pits/rash incredibly itching), VARICOSE VEIN (Swelling of the veins), CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Shortness of breath) and RASH MACULAR (Red blotches/blotches in his throat, face, armpits and legs) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Joint injury. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced RASH PRURITIC (Itchy rash began to grow on his groin and arm pits/rash incredibly itching). On 22-Nov-2021, the patient experienced RASH MACULAR (Red blotches/blotches in his throat, face, armpits and legs) and RASH (Full body rash/rash came back with more severity than before/rashes appear at random places in his body at random times/rashes last around 60 minutes and then disappear). On an unknown date, the patient experienced VARICOSE VEIN (Swelling of the veins), CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Shortness of breath) and FLUSHING (Face starts to flush). an unknown date, the patient experienced URTICARIA (Acute urticaria/urticaria). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash began to grow on his groin and arm pits/rash incredibly itching), VARICOSE VEIN (Swelling of the veins), CHEST DISCOMFORT (Chest tightness), DYSPNOEA (Shortness of breath), RASH MACULAR (Red blotches/blotches in his throat, face, armpits and legs), FLUSHING (Face starts to flush) and URTICARIA (Acute urticaria/urticaria) outcome was unknown and RASH (Full body rash/rash came back with more severity than before/rashes appear at random places in his body at random times/rashes last around 60 minutes and then disappear) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication included Joint Supplement (unspecified). Patient had got a blood panel yesterday, but he was still waiting the results. Today, 30-Nov-2021, patient had a follow up with his primary care physician. Treatment information included antihistamine (unspecified). Company Comment - This case concerns a 40 year old male patient with no relevant medical history, who experienced the non-serious unexpected event of rash pruritic, varicose vein, chest discomfort, dyspnoea and rash macular, flushing and urticaria, and the expected event of rash. The event rash pruritic, occurred approximately 10 days after the third dose of mRNA-1273 vaccine. The events rash macular, rash occurred approximately 13 days after the third dose of mRNA-1273 vaccine. The events varicose vein, chest discomfort, dyspnoea, flushing and urticaria occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as this is the third dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. This case was linked to MOD-2021-402794 (Patient Link).; Sender''s Comments: This case concerns a 40 year old male patient with no relevant medical history, who experienced the non-serious unexpected event of rash pruritic, varicose vein, chest discomfort, dyspnoea and rash macular, flushing and urticaria, and the expected event of rash. The event rash pruritic, occurred approximately 10 days after the third dose of mRNA-1273 vaccine. The events rash macular, rash occurred approximately 13 days after the third dose of mRNA-1273 vaccine. The events varicose vein, chest discomfort, dyspnoea, flushing and urticaria occurred on an unknown date after the third dose of mRNA-1273 vaccine.The rechallenge was not applicable as this is the third dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1958269 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental overdose, Vaccination site erythema
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

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

Write-up: small area of redness at the injection site; received the primary vaccine series dose instead of the booster dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (small area of redness at the injection site) and ACCIDENTAL OVERDOSE (received the primary vaccine series dose instead of the booster dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (small area of redness at the injection site) and ACCIDENTAL OVERDOSE (received the primary vaccine series dose instead of the booster dose). In November 2021, VACCINATION SITE ERYTHEMA (small area of redness at the injection site) had resolved. On 19-Nov-2021, ACCIDENTAL OVERDOSE (received the primary vaccine series dose instead of the booster dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were given. No treatment information were given. 0.5ml were administered instead of 0.25ml doses to patient.


VAERS ID: 1958270 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental overdose, Pain in extremity
SMQs:, Drug abuse and dependence (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

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

Write-up: Pain in arm; Received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose). In November 2021, PAIN IN EXTREMITY (Pain in arm) had resolved. On 19-Nov-2021, ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.


VAERS ID: 1958271 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental overdose
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

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

Write-up: Received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Patient denied any side effects following vaccine at the time of report.


VAERS ID: 1958303 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-01-08
Onset:2021-11-19
   Days after vaccination:315
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 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: Vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. No treatment information was provided. This case was linked to MOD-2021-395985 (Patient Link).


VAERS ID: 1958316 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Alabama  
Vaccinated:2020-12-30
Onset:2021-11-19
   Days after vaccination:324
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: Vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) in a 27-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 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication were provided. This case was linked to MOD-2021-395985 (Patient Link).


VAERS ID: 1958629 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-03
Onset:2021-11-19
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016E21A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 016E21A / 2 - / SYR

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiac stress test abnormal, Chest X-ray, Dyspnoea, Electrocardiogram, Electrocardiogram ambulatory, Heart rate increased, Lipids, Palpitations, Supraventricular extrasystoles
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Other ischaemic heart disease (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NAC
Current Illness: None
Preexisting Conditions: None whatsoever
Allergies: None
Diagnostic Lab Data: Nov 24 - Emergency visit: ECG, chest x-ray, blood work. Nov 30 - lipid blood work
CDC Split Type:

Write-up: Nov 19 morning - Talking to husband when suddenly had to stop as could not catch my breath. Symptoms went away after a couple of minute. Nov 20 - noted that I could feel my heart beating. It is not extra fast but harder. This worsened and I presented to Emergency on evening of Nov 24. Nov 29 - Holter monitor Nov 30 - Stress test. Dec 7 - Phone consult with cardiologist who did my stress test and he said that I had PAC (premature atrial contractions). Dec 8 - in-office meeting with family physician. Current - still experiencing palpitations.


VAERS ID: 1958655 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-19
Onset:2021-11-19
   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.


VAERS ID: 1958852 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212A71A / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain upper, Chills, Constipation, Diarrhoea, Dysuria, Feeling of body temperature change, Insomnia, Interchange of vaccine products, Myalgia, Neuralgia, Stress, Temperature regulation disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Moderna age 75 (previous Vaers report) Tdap 4/16/08- localized sev.reaction, arm swelling, tachycardia
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Because I had adverse reactions to my first 2 Moderna injections, I was advised to avoid another MRNA booster by two doctors. However they suggested a J&J might be a better choice. My reaction was milder initially, slight chills , muscle aches, stomach pain and on day 3 post vaccine, diarrhea. I also experienced problems with temperature regulation, hot and cold spells Then I developed nerve pain in my hip and upper leg that became excruciating. When I couldn''t sleep, I needed to seek help on day 7 post-booster. I was unable to reach my PCP during this time and talked with another specialist I see regularly She ordered Gabapentin 300 mg bid and Diazepam 5 mg tid prn, which helped. During the nerve pain, I also experienced abdominal pain, constipation and difficulty urinating. I have greatly improved as of 12/17/2021, but still need to take gababpentin 100 mg BID for hip pain. I am back to my usual course of low dose naltrexone,Tylenol Arthritis Strength 2 tabs bid, and alprazaolam 1/2 tab .25mg tid. This has been extremely stressful, especially since the J&J is no longer being recommended as a booster. I have underlying fibromyalgia and an hypersensitivity to medications, often needing 1/2 doses of many medications. Not sure I can tolerate more vaccinations. I developed an autoimmune skin condition as an adverse reaction to Moderna 2nd shot. This is ongoing with new breakouts of annulare granulomas which my dermatologist treats with steroid injections.(See previous Vaers report)


VAERS ID: 1959466 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939909 / 1 LA / IM

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

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

Write-up: Pharmacist gave 1st shot to a 13year old. She should have received Pfizer. We have spoken with the mother of the child. The child was okay physically.


VAERS ID: 1960107 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-11-12
Onset:2021-11-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Balance disorder, Dizziness, Tinnitus, Vertigo
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hearing impairment (narrow), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lipitor, Ambien, Seroquel, Multi-Vitamin, Vitamin-D, Calcium
Current Illness: None
Preexisting Conditions: CVA, migraines, SOD Type 2
Allergies: Reglan, Demerol
Diagnostic Lab Data: Hospital admission 11/19/21 Moderna Booster given on 11/12/21. Hospitalized for 8 days.
CDC Split Type:

Write-up: Ringing in the ears, vertigo, dizziness, balance issues. Worsening after dose #3


VAERS ID: 1961125 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-01-08
Onset:2021-11-19
   Days after vaccination:315
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 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: vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 13 days post expiry) in a 47-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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, 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 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 13 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. This case was linked to MOD-2021-395985 (Patient Link).


VAERS ID: 1961130 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental overdose
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

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

Write-up: received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported


VAERS ID: 1961170 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental overdose
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

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

Write-up: recieved 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (recieved 0.5ml Moderna instead of 0.25ml booster dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (recieved 0.5ml Moderna instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (recieved 0.5ml Moderna instead of 0.25ml booster dose) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by reporter No treatment medications provided by the reporter. This case was linked to MOD-2021-396492 (Patient Link).


VAERS ID: 1961171 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental overdose
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

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

Write-up: received 0.5ml dose instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (received 0.5ml dose instead of 0.25ml booster dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (received 0.5ml dose instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (received 0.5ml dose instead of 0.25ml booster dose) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.


VAERS ID: 1961172 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental overdose
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

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

Write-up: received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication details were reported. No treatment medication details were reported. This case was linked to MOD-2021-396492 (Patient Link).


VAERS ID: 1961173 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental overdose, Fatigue, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: tactile Fever; Fatigue; received 0.5ml Moderna instead of a 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (tactile Fever), FATIGUE (Fatigue) and ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of a 0.25ml booster dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced PYREXIA (tactile Fever), FATIGUE (Fatigue) and ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of a 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of a 0.25ml booster dose) had resolved. At the time of the report, PYREXIA (tactile Fever) and FATIGUE (Fatigue) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reports tactile fever and fatigue for the first 12-24 hours following vaccine. No relevant concomitant medications were provided. No treatment information was provided.


VAERS ID: 1961174 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / 3 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental overdose, Pain in extremity
SMQs:, Drug abuse and dependence (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

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

Write-up: This spontaneous case reported by a nurse, describes the occurrence of accidental overdose (received 0.5mL Moderna instead of 0.25mL booster dose) and pain in extremity (pain in arm) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 012H21B) for COVID-19 immunization. No medical history reported. On Nov 19, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. In November 2021, patient experienced pain in extremity (pain in arm). On Nov 19, 2021, patient experienced an accidental overdose (received 0.5mL Moderna instead of 0.25mL booster dose). In November 2021, pain in extremity (pain in arm) resolved. On Nov 19, 2021, accidental overdose (received 0.5mL Moderna instead of 0.25mL booster dose) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.


VAERS ID: 1961175 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental overdose, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Drug abuse and dependence (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Rash pruritic from elbow to shoulder on injection site arm; received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a health care professional and describes the occurrence of RASH PRURITIC (Rash pruritic from elbow to shoulder on injection site arm) and ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose). On 20-Nov-2021, the patient experienced RASH PRURITIC (Rash pruritic from elbow to shoulder on injection site arm). On 19-Nov-2021, ACCIDENTAL OVERDOSE (received 0.5ml Moderna instead of 0.25ml booster dose) had resolved. At the time of the report, RASH PRURITIC (Rash pruritic from elbow to shoulder on injection site arm) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported.


VAERS ID: 1961176 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental overdose
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

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

Write-up: Received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported.


VAERS ID: 1961179 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental overdose
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

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

Write-up: Received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant Medications were provided by the reporter. No Treatment Information were provided by the reporter.


VAERS ID: 1961241 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-01-12
Onset:2021-11-19
   Days after vaccination:311
Submitted: 0000-00-00
Entered: 2021-12-18
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 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) in a 26-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) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. This case was linked to MOD-2021-395985 (Patient Link).


VAERS ID: 1961256 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 3 - / -

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: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (vaccine given 13 days post expiry) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 046C21A and 011L20A) for COVID-19 immunization. No medical history reported. On Jan 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 19, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 19, 2021, patient administered expired product (vaccine given 13 days post expiry). On Nov 19, 2021, administered expired product (vaccine given 13 days post expiry) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-395985 (patient link).


VAERS ID: 1961293 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-01-13
Onset:2021-11-19
   Days after vaccination:310
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041L20A / 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 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. This case was linked to MOD-2021-395985 (Patient Link).


VAERS ID: 1961296 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-01-12
Onset:2021-11-19
   Days after vaccination:311
Submitted: 0000-00-00
Entered: 2021-12-18
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: Vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) in a 58-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) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 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. No treatment medications were reported. The patient had no adverse events. This case was linked to MOD-2021-395985 (Patient Link).


VAERS ID: 1961325 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-01-14
Onset:2021-11-19
   Days after vaccination:309
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041L20A / 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: Vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient did not experience any adverse event. No concomitant medications were reported. No treatment information was reported. This case was linked to MOD-2021-395985 (Patient Link).


VAERS ID: 1961331 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-01-13
Onset:2021-11-19
   Days after vaccination:310
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041L20A / 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 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications information was not reported No treatment medications were provided This case was linked to MOD-2021-395985.


VAERS ID: 1961345 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-01-13
Onset:2021-11-19
   Days after vaccination:310
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041L20A / 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 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. The patient was given vaccine 13 days post expiry No treatment medication information was provided This case was linked to MOD-2021-395985.


VAERS ID: 1961373 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-01-14
Onset:2021-11-19
   Days after vaccination:309
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041L20A / 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 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient did not experience any adverse event- vaccine given 13 days post expiry No concomitant medications were reported No treatment drugs were reported This case was linked to (Patient Link).


VAERS ID: 1961405 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Alabama  
Vaccinated:2020-12-30
Onset:2021-11-19
   Days after vaccination:324
Submitted: 0000-00-00
Entered: 2021-12-18
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 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for an unknown indication. 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 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 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: 1961430 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046C21A / 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: Vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Pfizer (Lot no. EW0171) on 05-Aug-2021. Past adverse reactions to the above products included No adverse event with Pfizer. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter. No treatment medication was reported by the reporter. This case was linked to MOD-2021-395985 (Patient Link).


VAERS ID: 1961431 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Alabama  
Vaccinated:2020-12-28
Onset:2021-11-19
   Days after vaccination:326
Submitted: 0000-00-00
Entered: 2021-12-18
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 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) in a 27-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 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 13 days post expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication list was not provided. Treatment information was not provided. This case was linked to MOD-2021-395985 (Patient Link).


VAERS ID: 1961927 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-07-03
Onset:2021-11-19
   Days after vaccination:139
Submitted: 0000-00-00
Entered: 2021-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Acute myocardial infarction, Atrial fibrillation, Blood test, Cardiac failure, Chest X-ray, Computerised tomogram, Deep vein thrombosis, Dyspnoea, Electrocardiogram abnormal, Essential hypertension, Peripheral swelling, Pulmonary embolism, Pulmonary infarction, Swelling
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: ekg, ct-scans, chest ex-rays, blood work,etc. 12/13-12/15 2021
CDC Split Type:

Write-up: approx. nov. 19 acute shortness of breath, swelling of rt. arm and side. went to walk in clinic, sent home no treatment. symptoms became more severe, admitted to er on12/15/21. hospitalized for acute pulmonary embolism without acute cor pulmonale. diagnoses: acute heart failutre with preserved ejection fraction (Hfpef), atrial fibrillation by electrocardiogram, primary hypertension, type 2(myocardial infarction), pulmonary infarct, acute deep vein thrombosis (DVT) of axillary vein of right upper extremity.


VAERS ID: 1962514 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-11-12
Onset:2021-11-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood creatine phosphokinase increased, Blood glucose increased, C-reactive protein normal, Full blood count normal, Gait disturbance, Herpes simplex test negative, Metabolic function test, Myalgia, Myositis, Pain in extremity, Upper respiratory tract infection, Vaginal ulceration
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No illnesses at the time of vaccination. She had a URI around 11/19/21, about 1 wk. after vaccination.
Preexisting Conditions: History of Hydronephrosis as an infant.
Allergies: None
Diagnostic Lab Data: On 12/10/21 I checked labs. These were notable for CK being slightly elevated at 151 (normal is <143). Glucose was slightly high at 109 - I suspect due to stress from the blood draw. The remaining labs were normal - remainder of CMP, as well as CBC and CRP. I swabbed the ulcer and HSV PCR was negative.
CDC Split Type:

Write-up: I saw the patient on 12/10/21 with complaints of muscle aches, as well as a vaginal ulcer. She received her COVID vaccines on 11/12/21, then 12/4/21. Mom reported that after her first vaccine, she had muscle aches in her forearms, shins, and feet - Mom was vague on the exact date this started. This resolved, then after her 2nd COVID vaccine, she again had muscle aches. On 12/8/21 she had trouble walking and arm pain. Also, she also had a vaginal ulcer that appeared around 12/1/21. Of note, Mom reported that everyone in the house had a URI around 11/19/21. Her exam on 12/10/21 was normal, aside from the vaginal ulcer. When I called Mom to discuss the labs on 12/14/21, pt.''s muscle pain and vaginal ulcer had resolved. I suspect she had myositis, but it''s not clear if that was due to the vaccine or the URI that Mom reported. It''s not clear if the vaginal ulcer is related to the myalgias or not.


VAERS ID: 1962537 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-11-17
Onset:2021-11-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / 1 AR / IM

Administered by: Work       Purchased by: ?
Symptoms: Migraine, Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROXYCHLOROQUINE 200MG 2X A DAY, TRAMADOL 50MG 1TAB 3X DAY,ESZOPICLONE 3MG AT BEDTIME (LUNESTA), FOLIC ACID,VIT D3.
Current Illness:
Preexisting Conditions: Fibromyalgia,chronic back pain, DDD, IBS,Osteo-erosive arthritis,
Allergies: Macrobid- Caused hives
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tinnitus-High pitched humming/whistle that started after about 48 hours after vaccine. Able to cover ears and thump lower back of head at same time with fingers to relax muscle (dentist recommended online). After doing maneuver intermittently over few hours it would go away, but come back over time. I''m a nurse and looked up and saw it was a possible side affect and most went away after 2 weeks. It continued to come and go and would cause migraine when it continued for long periods. Tylenol and IBU didnt help so had to keep ice pack on head to get some relief. At first could drown out with alarms noise and people at work and with TV at home to sleep. Length of time it continued without a break got worst with time. Now it''s been a month and it seems to be getting worst. Will see Dr soon as possible knowing there''s nothing for them to do unfortunately. I don''t know if this is permanent or there''s still time for it to go away only time will tell.


VAERS ID: 1963323 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PFIZERFH8028 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Hypoaesthesia eye, Immediate post-injection reaction, Monoplegia, Movement disorder, Pain, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Corneal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

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

Write-up: Immediate paralysis of left arm. +2-12 hours, left eye socket numbness +6 hours - persisting today, loss of left hand small finger control +12-48 hours, violent chills/shaking, body aches


VAERS ID: 1963491 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: New York  
Vaccinated:2021-11-16
Onset:2021-11-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Cellulitis, Joint swelling, Loss of personal independence in daily activities, Mobility decreased, Pain, Pain in extremity, Pyrexia, Tendonitis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Began with body aches and mild fever on day 2. Day 3 and 4 started to notice pain in my hands, fingers and wrists. Progressively became worse daily until I could not turn door knobs, lift objects, cook, button clothing, drive. Eventually left wrist became swollen and I lost the ability to use my left hand for days. Went to the ER and was told I had tendinitis and cellulitis. ER doctor told me he''d seen other cases of this response after vaccine. He treated me with antibiotics which I am still taking.


VAERS ID: 1963521 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Underdose
SMQs:, Medication errors (broad)

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

Write-up: Patient given Pfizer for 5 to 11-year-old, instead of Pfizer 12 and older. Patient is 15 years old. She declined any symptoms or any allergic reaction.


VAERS ID: 1963522 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8027 / 2 LA / IM

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

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

Write-up: 9 -year-old Client was given an adult dose of Pfizer upon arrival for 1st dose. Administration error was detected during the visit for the 2nd dose of Pfizer on 12/10/2021. No adverse reaction occurred.


VAERS ID: 1963558 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Severe vomiting and acute stomach pain for 10 hours, 100.1 fever for 12 hours, and body aches.


VAERS ID: 1964010 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-11-05
Onset:2021-11-19
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039F21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Chest X-ray abnormal, Computerised tomogram, Deep vein thrombosis, Dyspnoea, Pain in extremity, Peripheral swelling, Pulmonary thrombosis, Thrombosis, Ultrasound Doppler abnormal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Omeprazole 40mg
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Ultrasound, chest x-ray, Cat Scan, cardio.
CDC Split Type:

Write-up: Patient noticed joint pain in all joints and weakness within 24 hours of second shot. The symptoms left for two weeks, then patient noticed pain in left leg and shortness of breath two weeks after second Moderna shot. Symptoms were mild at first, so patient monitored and didn''t think they were related to vaccine. Persisted till 12/10/2021 with new symptom of swelling of left leg; follow-on Dr. appt. on 12/15. Test results showed blood clot in left leg (calf) with DVT and three blood clots in right lung (upper, middle, and lower lobe).


VAERS ID: 1966872 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Autism spectrum disorder, Poor quality product administered, Product storage error, Social anxiety disorder, Therapeutic product effect variable
SMQs:, Lack of efficacy/effect (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101626009

Write-up: child had high functioning autism. He had oral and auditory symptoms, and speech symptoms including a stutter.; her son was given a dose of the orange cap Pfizer Covid-19 vaccine that was "left out" for more than 12 hours; social anxiety; efficacy issue; her son was given a dose of the orange cap Pfizer Covid-19 vaccine that was "left out" for more than 12 hours; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (002191). The reporter is the parent. A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 08:45 (Lot number: FK5127) at the age of 6 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: AUTISM SPECTRUM DISORDER (medically significant), outcome "unknown", described as "child had high functioning autism. He had oral and auditory symptoms, and speech symptoms including a stutter."; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 19Nov2021 08:45, outcome "unknown", PRODUCT STORAGE ERROR (non-serious), outcome "unknown" and all described as "her son was given a dose of the orange cap Pfizer Covid-19 vaccine that was "left out" for more than 12 hours"; SOCIAL ANXIETY DISORDER (non-serious), outcome "unknown", described as "social anxiety"; THERAPEUTIC PRODUCT EFFECT VARIABLE (non-serious), outcome "unknown", described as "efficacy issue". The nurse said in the state of (state withheld), they have reported this same situation 3 times. It was beyond 12 hours. The patient did not have an official diagnosis of autism disorder, but mother thought her child had high functioning autism. The patient had appointment at 08:30 so he probably received the vaccine at 08:45. The nurse said it was just an efficacy issue. The nurse said everything was fine, and that he wouldn''t have to get a 3rd shot. It was out of the 12 hour window. He is to return 10Dec2021 for his second dose. He got it in his right arm. There was nothing medically connected to it. She was just fearful of him might having autism and vaccines. The vaccine was not administered at Military Facility. The patient did not have previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not visit emergency room and physician office. The patient did not have prior vaccinations (within 4 weeks). The patient did not have diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient did not have following tests: blood tests, cerebrospinal fluid culture, bacterial sero-type and diagnostic imaging (e.g., chest X-ray, MRI). Follow-Up (29Nov2021): Follow-up attempts are completed. No further information is expected.


VAERS ID: 1967672 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1855197 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Chest discomfort, Feeling abnormal, Heart rate increased, Laboratory test abnormal, Leukocytosis, Rash, Respiratory distress, Tachycardia, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Hypertension (narrow), Hypersensitivity (narrow), Respiratory failure (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? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Medications: acetaminophen (TYLENOL) 500 MG tablet Take 1 tablet by mouth every 6 (six) hours as needed for Pain. cetirizine (ZYRTEC) 10 MG tablet Take 1 tablet by mouth daily. ibuprofen (ADVIL,MOTRIN) 600 MG tablet Take 1 tablet by mouth e
Current Illness:
Preexisting Conditions: PMH: HTN, eczema, gestational diabetes, Bell''s palsy, cerebral aneurysm, Depression
Allergies: Allergies: HCTZ (arrhythmia), Lisinopril (arrhythmia), Losartan (arrhythmia), Latex (hives, Aquasonic ultrasound gel (Rash at application site)
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt vaccinated @11:18 and reaction started @ 11:50. Pt reported respiratory distress. She felt her airways are closing off, along with chest tightness. Also starting developing facial rash. BP and HR increased -$g 156/116, HR 106, RR 20, sats 100% RA. S/p Benadryl 50 mg IM -$g EpiPen 0.3 mg x1 Benadryl 50mg IM was administered @11:56. EpiPen 0.3mg was administered @12:11. 911 was called @12:14 and pt was taken to the ER. In ER: Pt presents with throat itchiness and facial rash after receiving the J&J vaccine for COVID. No diarrhea, abd pain, vomiting. No wheeze or SOB. ED/Hospital course: Temp 98.1, HR 120, RR 18?22, BP Max 179 systolic, sats 98% RA Labs unremarkable except for leukocytosis, possibly reactive 2 L NS bolus Benadryl 25 mg IV Pepcid 20 mg IV Solu-Medrol 125 mg IV Potassium and magnesium IV supplements Patient remained persistent tachycardic in 120s. Pt admitted for observation. 11/20: Prescribed Epi- pen and Prednisone 40mg daily upon discharge. Pt w/o any more resp distress, tachycardia. Cleared by PT for discharge.


VAERS ID: 1967702 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
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: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: Unknown
Diagnostic Lab Data:
CDC Split Type:

Write-up: This 13-year-old patient received the 5-to 11-year-old dose of Pfizer (0.2 mL) on 11/19/21 and 12/10/21. After difficulty billing for the vaccine on 12/20/21, the pharmacy realized that this patient received a dose that was too low per ACIP/CDC. Pharmacist called Pfizer to make them aware of the mistake and report the incident. Pharmacist called the parent of the patient to let her know of the mistake. The patient''s mother said that she intentionally signed her daughter up for the lower dose based on a recommendation from a physician in Kansas. The mother refused to give the name of the physician for fear of the physician getting in trouble for making this recommendation. The mother said that this recommendation was based on the patient''s medical conditions. There are no symptoms or issues noted from getting a lower dose of the vaccine.


VAERS ID: 1967898 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 RA / IM

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

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

Write-up: COVID 19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00am.


VAERS ID: 1967907 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM

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

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

Write-up: COVID-19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00am


VAERS ID: 1967913 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Puerto Rico  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM

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

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

Write-up: COVID-19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00 am.


VAERS ID: 1967922 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM

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

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

Write-up: COVID-19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00 am.


VAERS ID: 1967925 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM

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

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

Write-up: COVID-19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00 am.


VAERS ID: 1967928 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM

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

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

Write-up: COVID-19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00 am.


VAERS ID: 1967933 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Puerto Rico  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM

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

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

Write-up: COVID-19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00 am.


VAERS ID: 1967940 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Puerto Rico  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM

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

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

Write-up: Vaccine is administered COVID-19, Pfizer BioNTech past its useful life. Shelf life date 11/17/2021 7:00 am.


VAERS ID: 1967949 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Puerto Rico  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM

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

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

Write-up: COVID-19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00am.


VAERS ID: 1967953 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM

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

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

Write-up: COVID-19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00 am.


VAERS ID: 1967959 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM

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

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

Write-up: COVID-19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00 am.


VAERS ID: 1967962 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM

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

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

Write-up: COVID-19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00 am.


VAERS ID: 1969106 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-11-09
Onset:2021-11-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020F21A / 3 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Mechanical urticaria
SMQs:, Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Cefzil, Amoxicillin, penicillin
Diagnostic Lab Data: Visit to Urgent Care, Teladoc visit and visit to Allergist and Immunologist.
CDC Split Type:

Write-up: Dermatographia for over a month now. Started a rigorous regimen of anti-histamine therapy on 12/21/21 with the anticipation of completing 2-3 months from now. Visited Urgent Care at start of reaction in November. Started with prednisone 50mg at start of reaction for 5 days. Reaction kept happening and visted Teladoc appointment have gone on a 12 day tapering prednisone dose starting at 50mg working down to 10mg. No improvement so starting the antihistamine treatment after visit to Dr.


VAERS ID: 1970630 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8030 / 3 RA / OT
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Headache, Immunisation, Nausea, Pain, Pain assessment, Product use issue, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: pain; Result Unstructured Data: Test Result:Grade 1; Comments: Grade 1 body ache, Grade 1 pain at site of injection and Grade 1 headache
CDC Split Type: USPFIZER INC202101632875

Write-up: patient experience Grade 1 body ache; Grade 1 nausea; Grade 1 pain at site of injection; Grade 1 headache; Fatigue G1; Received COMINARTI booster shot on 19Nov2021. Flu shot was also administered on the same day; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 54 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Nov2021 (Lot number: FH8030) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 19Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "Asthma", start date: 1978 (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Intramuscular, left arm, Lot number: EL3248), administration date: 04Mar2021, for COVID-19 immunization; Bnt162b2 (Dose 1, Single, Intramuscular, Left arm, Lot number: EL3248, Lot number: EP655), administration date: 25Mar2021, for COVID-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 19Nov2021, outcome "unknown", described as "Received COMINARTI booster shot on 19Nov2021. Flu shot was also administered on the same day"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "patient experience Grade 1 body ache"; NAUSEA (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Grade 1 nausea"; VACCINATION SITE PAIN (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Grade 1 pain at site of injection"; HEADACHE (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Grade 1 headache"; FATIGUE (non-serious) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Fatigue G1". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, vaccination site pain, headache. Therapeutic measures were not taken as a result of nausea, fatigue. Addition information: The patient took 400mg Ibuprofen on 19Nov2021 orally for Grade 1 body ache, Grade 1 headache, and on morning of 20Nov2021. It was unknown if the patient had received any other vaccine within 4 weeks of Covid-19 vaccine. No relevant test was performed for thromboembolic events with thrombocytopenia. Follow-up attempts are completed. No further information is expected.


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