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

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

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 1986148 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-01
Onset:2021-11-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014F21A / 3 LA / SYR

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

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

Write-up: First noticed itchy back. A few days later started to develop hive like reactions and welts along my back and torso. Red lines and wheels on torso, back, and arms consistent with dermatographia observed. 1.5 months have passed and still noticing hive like reactions on arms, legs, stomach, and back.


VAERS ID: 1988282 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Texas  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
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: booster doses administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (booster doses administered after expiration date) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment information was provided.


VAERS ID: 1989285 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033F21A / 3 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Urticaria, Vaccination complication
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: Fenofibrate (Tricor) 145 mg, Ramipril (hbp) 5 mg, 2 baby aspirin, Fish oil, Multivitamin, Lorazepam .5 mg
Current Illness: None
Preexisting Conditions: Pacemaker, elevated blood pressure and triglycerides.
Allergies: None
Diagnostic Lab Data: Have met with allergy specialist who also suspects that I am having a reaction to the third dosage. He has prescribed Zyrtec, 1 pill, two times a day.
CDC Split Type:

Write-up: 5 days after receiving the booster, I have since developed hives that randomly appear on my body, primarily the palms of my hands, feet soles, and upper trunk, arms, neck and head areas.


VAERS ID: 1989455 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Puerto Rico  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013F21A / 1 LA / IM

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

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

Write-up: ADMINISTRATION ERROR: PATIENT RECEIVES THE FIRST DOSE OF MODERN AT 16 YEARS OLD. ACCORDING TO THE INDICATION OF THE VACCINE, IT IS AUTHORIZED FOR EMERGENCY USE IN PATIENTS 18 YEARS OR OLDER.


VAERS ID: 1992127 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-10-01
Onset:2021-11-17
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Ear discomfort, Ear pain, Palpitations
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

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

Write-up: Fullness in ears, pain in ears, palpitations, dizziness. Going for CAT scan next month and allergy test, all started with first jab, then went away until after I got the third shot, the booster.


VAERS ID: 1992630 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Rhode Island  
Vaccinated:2021-11-10
Onset:2021-11-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5618 / 1 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyskinesia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Oxcarbazepine, Levothyroxine
Current Illness: None
Preexisting Conditions: Pachygyria
Allergies: None
Diagnostic Lab Data: We have an upcoming EEG scheduled 1/17/22.
CDC Split Type:

Write-up: Arms started to tremble and flail uncontrollably in the morning before breakfast for a little over five minutes. This has happened about four times -- twice after the first dose and twice after the second dose.


VAERS ID: 1992851 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blister, Discomfort, Erythema, Herpes zoster, Neuralgia, Oral herpes, Scab
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Oropharyngeal infections (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multiple medications
Current Illness: None
Preexisting Conditions: Diabetes, hypertension
Allergies: Sulfa
Diagnostic Lab Data: Classic pattern of grouped vesicles (later crusting) on an erythematous base. This is consistent with my mother''s Responsive to valtrex.
CDC Split Type:

Write-up: Reactivation of HSV (cold sores) and VZV (shingles). Initially there was low-level pain and discomfort involving multiple nerves of the head and neck and appearing soon after the vaccine. Ultimately, these progressed about a month later.


VAERS ID: 1995202 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-11-11
Onset:2021-11-17
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Swelling of eyelid, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CONCERTA; METHYLPHENIDATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy (Known allergies: Penicillin)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101624690

Write-up: Significant eyelid swelling and urticaria on her back day 6 post vaccination around 8 pm. Nothing prior. Day 7 more fulminant urticaria involving chest, eyelids and back, again around 8-9 pm; Significant eyelid swelling and urticaria on her back day 6 post vaccination around 8 pm. Nothing prior. Day 7 more fulminant urticaria involving chest, eyelids and back, again around 8-9 pm; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the parent. A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Nov2021 15:30 (Batch/Lot number: unknown) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: CONCERTA 27mg; Oral METHYLPHENIDATE 27 mg taken for attention deficit hyperactivity disorder (ongoing). The following information was reported: URTICARIA (non-serious), SWELLING OF EYELID (non-serious) all with onset 17Nov2021 20:00, outcome "recovered" (2021) and all described as "Significant eyelid swelling and urticaria on her back day 6 post vaccination around 8 pm. Nothing prior. Day 7 more fulminant urticaria involving chest, eyelids and back, again around 8-9 pm". Therapeutic measures were taken as a result of urticaria, swelling of eyelid. Additional information: adverse event; Significant eyelid swelling and urticaria on her back day 6 post vaccination around 8 pm. Nothing prior. Day 7 more fulminant urticaria involving chest, eyelids and back,again around 8-9 pm. Both resolved with antihistamine and prednisone. Today is day 8 now with urticaria of posterior right knee. Patient received treatment as antihistamine and prednisone for event. Upon Follow-up it was reported that Day 6 Post 1st Covid vaccine shot she developed bilateral eyelid swelling, Day 7-9 She had uitcaria of her torso arms and focally on her Right leg Benadryl, zyzal and prednisone 10 mg given each day, days 6-9 spentaneously resolved. Specific Relevant Test for thromboembolic event with Thrombocytopenia: None. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1995204 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101624960

Write-up: Armpit hurts - just outside of her armpit.; She was thinking maybe it was a swollen lymph node.; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 28 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (non-serious), outcome "not recovered", described as "Armpit hurts - just outside of her armpit."; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "She was thinking maybe it was a swollen lymph node.". Therapeutic measures were not taken as a result of axillary pain, lymphadenopathy. Additional information: Patient had no COVID prior vaccination, Patient had not tested COVID post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1995304 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 32030BD / 3 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Dyspnoea, Immunisation, Muscle fatigue, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy (Known allergies: Penecillin); Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101797685

Write-up: achy joints/deep joint pain; achy joints/muscles; breathing issues/difficulty breathing heavily during exercise (lungs dont feel like they expand or breath in enough).; Normal muscle fatigue; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 18:30 (Lot number: 32030BD) at the age of 35 years as dose 3, (booster) single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8780, Location of injection: Arm Right), administration date: 07Apr2021, when the patient was 35 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Right), administration date: 23Mar2021, when the patient was 35 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 18:30, outcome "unknown", described as "booster"; ARTHRALGIA (non-serious) with onset 18Nov2021, outcome "recovering", described as "achy joints/deep joint pain"; MYALGIA (non-serious) with onset 18Nov2021, outcome "recovering", described as "achy joints/muscles"; DYSPNOEA (non-serious) with onset 18Nov2021, outcome "recovering", described as "breathing issues/difficulty breathing heavily during exercise (lungs dont feel like they expand or breath in enough)."; MUSCLE FATIGUE (non-serious) with onset 18Nov2021, outcome "recovering", described as "Normal muscle fatigue". Therapeutic measures were not taken as a result of immunisation, arthralgia, myalgia, dyspnoea, muscle fatigue. Additional information: It was reported that beyond that 48 hour after the booster (3rd) shot, the patient continues to have achy joints, muscles plus some minor breathing issues. Normal muscle fatigue was normal with working out etc. However, the deep joint pain, difficulty breathing heavily during exercise (lungs don''t feel like they expand or breath in enough). The patient reported that the events are nothing severe however it was persistent and not normal based on her body before the booster vaccine. No issues persisting after initial, or 2nd dose. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1995634 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-03-21
Onset:2021-11-17
   Days after vaccination:241
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Suspected COVID-19, 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? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: suspect COVID breakthrough


VAERS ID: 1995942 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Vermont  
Vaccinated:2021-11-03
Onset:2021-11-17
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ADEN_4_7: ADENOVIRUS TYPES 4 & 7, LIVE, ORAL (NO BRAND NAME) / TEVA PHARMACEUTICALS 048A21A / 2 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0321A21A / 3 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030M20A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Blood test, Blood zinc decreased, Dysgeusia
SMQs:, Taste and smell disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pravastatin 90 mg, Metoprolo Succ 50 mg, Losartan Potassium 100 mg, Glipizide 5 mg, Torsemide 10 mg, Pravastatin Sodium 40 mg, Lorazepam 1 mg, Prilosec OTC 20 mg, Vitanin C 1000mg, Zinc 50 mg
Current Illness: None
Preexisting Conditions: Stage 4 renal failure
Allergies: Iodine, Sulfadoxine, Darvon, Macrobid, morphine, azithromycin
Diagnostic Lab Data: Blood work indicated low zinc. Doctor instructed using zinc suplement. Zinc does not seemed to help
CDC Split Type:

Write-up: Lost sense of taste all food has a sweet sugary taste


VAERS ID: 1996880 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Maine  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1620 / 3 RA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Immunisation, Lymphadenopathy, Rhinorrhoea, Vaccination site pain
SMQs:, 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: SIMVASTATIN
Current Illness: Gestational diabetes (Under control); Haemophilia A (from Birth Under control)
Preexisting Conditions: Medical History/Concurrent Conditions: Pre-diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101631436

Write-up: Now Lymph node swelling in armpit closest to jab site; Exhaustion; nose running; Sore arm at jab site/jab soreness; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Nov2021 (Lot number: FJ1620) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "gestational diabetes pre diabetes", start date: 2004 (ongoing), notes: Under control; "Haemophilia- A" (ongoing), notes: from Birth, Under control; "Pre-diabetes" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol increased, start date: 2021 (ongoing). Vaccination history included: Bnt162b2 (1st Dose, Anatomical site of injection: R upper arm, Route of administration: Intramuscular, batch/ Lot number: EW0150, 31Jul2021), administration date: 02Apr2021, when the patient was 55 years old, for Covid-19 Immunization; Bnt162b2 (2nd Dose, Anatomical site of injection: R upper arm, Route of administration: Intramuscular, batch/ Lot number: EW0176, 31Aug2021), administration date: 23Apr2021, when the patient was 55 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021 21:00, outcome "recovered" (19Nov2021), described as "Sore arm at jab site/jab soreness"; FATIGUE (non-serious) with onset 18Nov2021 08:00, outcome "recovered" (30Nov2021), described as "Exhaustion"; RHINORRHOEA (non-serious) with onset 18Nov2021 08:00, outcome "recovered" (21Nov2021), described as "nose running"; LYMPHADENOPATHY (non-serious) with onset 18Nov2021 10:00, outcome "recovered" (21Nov2021), described as "Now Lymph node swelling in armpit closest to jab site". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, rhinorrhoea, lymphadenopathy. Additional Information: Prior Vaccinations (within 4 weeks): None, Specific relevant tests for thromboembolic events with thrombocytopenia :None. Vaccination Facility Type was PHARMACY, Vaccine was not Administered at Facility. Route of Simvastatin: By Mouth and taken in early 2021. Event: Sore arm at jab site. Exhaustion and nose running began approximately 20 hrs later. Description of Event: Part 2 - yesterday I submitted exhaustion and jab soreness. Now Lymph node swelling in armpit closest to jab site. Follow-up attempts are completed and no further information is expected


VAERS ID: 1996923 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2590 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anosmia, Immunisation, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WILD YAMS; MACA [LEPIDIUM MEYENII]; SOYA LECITHIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism (HYPOTHYROID); Penicillin allergy; Polycystic ovary (PCOS)
Allergies:
Diagnostic Lab Data: Test Date: 20211002; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20211006; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC202101815991

Write-up: loss of smell after 2nd shot. consistent issues since that second series. never recovered prior enhanced smell since then; Dose Number:3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 08:30 (Lot number: FF2590) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HYPOTHYROID" (unspecified if ongoing), notes: HYPOTHYROID; "PCOS" (unspecified if ongoing), notes: PCOS; "Allery to Penicillan" (unspecified if ongoing). Concomitant medication(s) included: WILD YAMS; MACA [LEPIDIUM MEYENII]; SOYA LECITHIN. Past drug history included: Amoxicillian, reaction(s): "Amoxicillin: Drug Allergy", notes: AMOXICILLIAN; Doxycycline, reaction(s): "Doxycycline: Drug allergy"; Cephalosphorins, reaction(s): "Cephalosphorins: Drug allergy", notes: Cephalosphorins. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 10:45 AM), administration date: 25Feb2021, when the patient was 30 years old, for Covid-19 immunization, reaction(s): "Loss of smell"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN9581, Location of injection: Arm Left, Vaccine Administration Time: 04:30 PM), administration date: 29Jan2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021 08:30, outcome "unknown", described as "Dose Number:3"; ANOSMIA (non-serious), outcome "not recovered", described as "loss of smell after 2nd shot. consistent issues since that second series. never recovered prior enhanced smell since then". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anosmia. Additional information : It was reported that patient had loss of smell after 2nd shot and was consistent issues since that second series, never recovered prior enhanced smell since then. No prolonged hospitalization, No Congenital anomaly/birth defect, No Disabling/Incapacitating and was not Life threatening. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. 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 been tested for COVID-19. Treatment received for the adverse event was nasal spray. Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected


VAERS ID: 1997485 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-09-28
Onset:2021-11-17
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2022-01-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Blepharospasm
SMQs:, Dystonia (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atenolol,clonidine,triamterene
Current Illness: None
Preexisting Conditions: High blood pressure
Allergies: Penicillin,sulfa , vancomycin erythromycin,and milk
Diagnostic Lab Data:
CDC Split Type:

Write-up: Eye twitching continuous


VAERS ID: 1997683 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-11-11
Onset:2021-11-17
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8028 / 2 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Epistaxis, Extrasystoles, Heart rate irregular, Palpitations, Tinnitus
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Tachyarrhythmia terms, nonspecific (narrow), Hearing impairment (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: covid-19 pfizer, 10/6/21
Other Medications: one-a-day multi-vitamin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pounding heart, especially in bed at night. irregular heartbeat, like skipping every 3rd beat then double-beating the 4th beat. Nose bleeds and ears are ringing. i think my blood pressure might be high now. afraid to go to a doctor.


VAERS ID: 1998011 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0809 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Pain
SMQs:

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: Liletta IUD. Insertion date 2/14/2020; Biotin soft gel 2500mcg PO QD
Current Illness: None
Preexisting Conditions: None
Allergies: NKA, NKDA
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Pain at soft palate. Began morning following initial dose. Duration: 10 days. Pain scale: 6/10.


VAERS ID: 1999752 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-11-03
Onset:2021-11-17
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2022-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, X-ray
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

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

Write-up: Out of breath, tightness in chest.


VAERS ID: 1999772 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 RA / -

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

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

Write-up: Patient was given a Pfizer booster on 11/17/21, but had received her #2 Pfizer dose on 06/19/2021, 5 months prior. The booster was given 1 month too early. This was discovered when the entry into the employee''s health record was being completed. Booster dose was administered by an RN at an employee vaccination event held at a school campus on 11/17/21. On the consent form, the employee documented that she had received the Pfizer COVID-19 vaccine, but there were no dates listed. However, it is entered in the employee''s health record that the 1st dose of Pfizer was given on 5/29/2021 and the second dose was given on 06/19/2021, both at another medical facility. Regulatory authority confirms these dates and locations. Patient states she did not experience any side effects or complications post vaccination.


VAERS ID: 2000056 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Puerto Rico  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013F21A / 1 LA / IM

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

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

Write-up: ADMINISTRATION ERROR: 16 YEAR OLD MALE PATIENT RECEIVES MODERN DOSE AS FIRST DOSE (ACCORDING TO THE, "HALF DOSE"), THE MODERN VACCINE AUTHORIZATION IS FOR A PATIENT 18 YEARS OLD OR OLDER.


VAERS ID: 2000311 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 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: the booster dose was expired, two weeks prior.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the booster dose was expired, two weeks prior.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (the booster dose was expired, two weeks prior.). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (the booster dose was expired, two weeks prior.) had resolved. No concomitant medications was reported. No treatment drug details was reported.


VAERS ID: 2001472 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Michigan  
Vaccinated:2020-12-28
Onset:2021-11-17
   Days after vaccination:324
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025J208 / 1 UN / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 028L20A / 2 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Chest X-ray normal, Faeces discoloured, Gastrointestinal haemorrhage, Melaena, SARS-CoV-2 test positive, Tachycardia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: cholecalciferol, clopidogrel, dilTIAZem, ezetimibe, isosorbide mononitrate, melatonin, Nystop, pantoprazole
Current Illness: No
Preexisting Conditions: Dementia, A-fib, chronic renal failure, anemia, obese, hypertension, hyperlipidemia, carotid artery, kidney stones
Allergies: No
Diagnostic Lab Data: see above
CDC Split Type:

Write-up: 11/24 Pt to ED complaints of dark tarry stools. Per EMS, patient is also covid positive for the past week and has been tachycardic. 11/25 COVID-19 infection, tolerating very well. RA o2. GI Bleed. 11/27 No significant infiltrate noted on chest x-ray 11/30 Stable for transfer back to nursing home facility


VAERS ID: 2001735 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: California  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013F21A / 3 AR / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 81mg aspirin x2 daily
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Ringing in the ears, tinnitus. Started two days after the vaccine, and continues today, 7 weeks later).


VAERS ID: 2001788 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: New York  
Vaccinated:2021-11-12
Onset:2021-11-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8028 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Menstruation delayed, Menstruation irregular
SMQs:, Fertility 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: Pre-natal Vitamins, Vitamin E, D & B, Dhea 25, NeoQ10
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data:
CDC Split Type:

Write-up: Menstrual cycles after the vaccine reduced by half and also late. My body has still not regulated as my last menstrual cycle was over 2 weeks late and only lasted for 12 hours. I am also in the process of doing IVF cycles, which this adverse event has messed up, leading to my last 2 cycles cancelled.


VAERS ID: 2001905 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-10-29
Onset:2021-11-17
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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

Write-up: I have Heart Palpatations that occure atleast 5 times a week. They can last for an hour to 4-5 hours.


VAERS ID: 2005901 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-11-10
Onset:2021-11-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 071F21A / 3 RA / ID

Administered by: Pharmacy       Purchased by: ?
Symptoms: Burning sensation, Electromyogram normal, Nerve conduction studies normal, Pain in extremity, Sensory disturbance, Small fibre neuropathy
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (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: Vitamin B Complex, Lion"s Maine, Turkey Tail
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: NVC/EMG NORMAL on 01/04/1922.
CDC Split Type:

Write-up: Approximately a week after I received Moderna Covid booster, I started experience sharp pains in my both feet. The pain developed into small fiber neuropathy like symptoms (burning feet, pain everywhere in feet, unusual and bothersome sensations in feet). A trip to a podiatrist resulted in the doctor''s suggestion that I get a NVC/EMG tests. Both tests gave NORMAL results, I have no preexisting conditions, and, unfortunately only now found out that my symptoms could''ve been caused by the Covid Vaccine.


VAERS ID: 2010371 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-10-19
Onset:2021-11-17
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822809 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Chills, Condition aggravated, Depression, Headache, Hypoaesthesia, Muscle spasms, Pain, Paraesthesia, Psychotherapy, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Flu shot- unknown date- fever, chills, headache
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Outpatient psychotherapy - 11/2/2021; 11/10/2021; 11/22/2021; 11/23/2021; 11/30/2021; 12/6/2021; 12/7/2021
CDC Split Type:

Write-up: Initial Side effects within 24 hours- Fever, Chills, body aches, severe headache lasting 72 hours, Intense and frequent muscle cramping in legs beginning 4 days post injection lasting 4 weeks. Numbness and tingling in left side of face and entire right leg beginning 27 days post injection - on going and constant 24/7 still as of today.- 1/6/2022 Severe anxiety and depression beginning 10/19 /2021 and on going now as of 1/6/2022.


VAERS ID: 2014049 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026D21A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: C-reactive protein increased, Chills, Diplopia, Eye pain, Injection site pain, Lacrimation increased, Pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Lacrimal disorders (narrow), Ocular motility disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Severe muscle pain and stiffness in lower extremiafter first Covid Vaccine (Pfizer) in March 2021, age 58
Other Medications: Estradiol, biotin, B6, D3, magnesium
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: 12/10/21 - CRP 41 (High), Sed rate normal 12/21/21 - CRP 19 (High), Sed rate normal, ANA negative, rheumatoid factor normal,
CDC Split Type:

Write-up: On 11/17/21 I started having pain at the injection site. On 11/18/21 I started having very serious chills and whole body aches in addition to more painful and tender injection site area. Pains in lower extremities started to increase. On 12/8/21 I started having pain above and behind my left eye - stabbing, piercing like pain with tearing. This pain continued until Wednesday 12/14 and only was reduced due to steroid therapy started the day before. On 12/12/21 I started experiencing double vision which lasted through 12/15/21.


VAERS ID: 2014190 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-11-12
Onset:2021-11-17
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033T 21A / 3 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Computerised tomogram head, Fear, Migraine, Movement disorder, Vomiting
SMQs:, Acute pancreatitis (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: High cholesterol
Allergies: Allergic to bees and mushrooms
Diagnostic Lab Data: Brain CT scan
CDC Split Type:

Write-up: I received the moderna booster and 5 days later I experienced the most severe migraine I have ever had in my life. I thought I was having a brain aneurysm. I was vomiting and couldn?t move from the pain. I went to the ER in fear of my life.


VAERS ID: 2017791 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: New York  
Vaccinated:2021-04-02
Onset:2021-11-17
   Days after vaccination:229
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025B21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspepsia, Ear pruritus, Mechanical urticaria, Oral pruritus, Paraesthesia, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (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: YAZ; ADDERALL; VITAMIN D [VITAMIN D NOS]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20224

Write-up: dermatographia; heartburn; intense itchiness; tingling; itching of mouth and lips; itchy inner ear canal/ it "feels like anaphylaxis but its not, it is a immune response"; fully body hives; This spontaneous case was reported by a non-health professional and describes the occurrence of MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling) and ORAL PRURITUS (itching of mouth and lips) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 025B21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced URTICARIA (fully body hives). On an unknown date, the patient experienced MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling), ORAL PRURITUS (itching of mouth and lips) and EAR PRURITUS (itchy inner ear canal/ it "feels like anaphylaxis but its not, it is a immune response"). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling), ORAL PRURITUS (itching of mouth and lips) and EAR PRURITUS (itchy inner ear canal/ it "feels like anaphylaxis but its not, it is a immune response") outcome was unknown and URTICARIA (fully body hives) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Adderall 5mg (stopped due to suspected reaction), 4x recommended dose level of allergy OTC medications, 5 days of prednisone steroid.


VAERS ID: 2018208 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL007 / 1 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Cough, Dizziness, Feeling abnormal, Hypersensitivity, Investigation, Lip swelling, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: 19 Test; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210212; Test Name: NAAT covid; Test Result: Positive
CDC Split Type: USPFIZER INC202101641429

Write-up: diagnosed with covid; bit unstable; allergic reaction; The lips of her mouth swelled; rash appeared on his body/in special on the face; A little dizzy; constant coughing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 8 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 17:30 (Lot number: FL007) at the age of 8 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "known_allergies: Alimentos" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu vaccine (Manufacturer: Sanofi pauster , Batch lot no: UT7397LA, Route: Intramuscular , anatomical site of injection: Right deltoid), administration date: 03Nov2021. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "diagnosed with covid"; HYPERSENSITIVITY (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "allergic reaction"; LIP SWELLING (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "The lips of her mouth swelled"; RASH (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "rash appeared on his body/in special on the face"; DIZZINESS (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "A little dizzy"; COUGH (non-serious) with onset 17Nov2021 21:45, outcome "recovering", described as "constant coughing"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "bit unstable". The events "allergic reaction", "the lips of her mouth swelled", "rash appeared on his body/in special on the face", "a little dizzy" and "constant coughing" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: (12Feb2021) unknown result; sars-cov-2 test: (12Feb2021) positive. It was unknown if therapeutic measures were taken as a result of hypersensitivity, lip swelling, rash, dizziness, cough. Clinical course: Facility where the most recent COVID-19 vaccine was administered at pharmacy or drug store. Patient was not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient received Other vaccine in four weeks. Patient was diagnosed with covid. My son life was at risk from the vaccine. Follow-up attempts are completed. No further information is expected.


VAERS ID: 2019703 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 071F21A / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Influenza like illness, Insomnia, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxin, multi-vitamin, vitamin D, Zinc, B Complex, Zyrtec
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Began running a fever overnight. I had chills all night and didn''t sleep well. I realized why in the morning when I took my temperature and it was 100.4. I was achy and felt like I had the flu all day. My fever went as high as 102.2 before I finally took Advil which brought it down to about 100 before it started going up again. By evening I was fever free and felt better the next day.


VAERS ID: 2019819 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Idaho  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 076C21A / 2 AR / IM

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

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

Write-up: The second vaccine dose was given at day 21 instead of day 28 as recommended. First vaccination date was 10/27/2021 and second was 11/17/2021. Both were Moderna and the same lot number: 076C21A.


VAERS ID: 2020734 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Male  
Location: Puerto Rico  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: In the first 15 min I developed a redness of the area with slight swelling around the place of administration of the vaccine injection, no other symptoms, fever or pain.


VAERS ID: 2021146 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 066F21A / 2 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Headache, Neck pain, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: The client received the 1st COVID vaccine Moderna (Lot #011F21A and expiration date 01/19/2022) on 10/17/21. The client notified
Other Medications: Vitamin D
Current Illness: Unknown
Preexisting Conditions: diverticulitis and alopecia
Allergies: allergy to penicillin but did not know the reaction that occurred, panic attacks with Vicodin and "feeling worse" after taking sulfa medications
Diagnostic Lab Data:
CDC Split Type:

Write-up: The client did not report any symptoms during the 30 minute observation period. As the client was leaving the vaccination site, the client reported, "tingling in my genitals, headache, arm ache, and a neck ache" to RN.


VAERS ID: 2021788 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: California  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abdominal distension, Fatigue, Influenza, Intermenstrual bleeding, Muscle spasms
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: I have had no medical tests by this date.
CDC Split Type:

Write-up: I''m not sure of the Flu shot so I just checked the top one. I had both shots the same day. By the next morning I felt like I had the flu and was extremely tired. I also started experiencing menstrual cycle symptoms. I had bloating, cramps, headache and spotting for 5 days. Almost exactly a month later it came back and I had spotting for 8 days. My doctor was contacted (not my primary but my Nurse Practitioner) and she suggested I let her know if it continues. After the second month they made an appointment to do another PAP. I have not had a period in 15 years. This happened the next day after my 3rd shot which is too coincidental.


VAERS ID: 2022015 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-11-10
Onset:2021-11-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822811 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Muscle spasms, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Fertility 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: Collagen
Current Illness: None
Preexisting Conditions: None
Allergies: No
Diagnostic Lab Data: I didn?t got to the doctor. Soonest appointment available was February when I scheduled in November.
CDC Split Type:

Write-up: 1 week after vaccine injection, I started my period 2 weeks early. I bled for a month. The first two weeks, I had an extremely heavy period. 5 of those days there was very heavy clotting with painful cramping. I had blood clots the size of half my fist come out in the shower. Too many to count. I clogged my drain. I was using 2 ultra tampons and a pad every hour. The bleeding continued to be heavy from weeks 2-4 but manageable.


VAERS ID: 2024783 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-03-28
Onset:2021-11-17
   Days after vaccination:234
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6202 / 2 - / -

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

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

Write-up: Patient is COVID positive and fully vaccinated including a 3rd booster dose. 63-year-old female presents complaining of anxiety. Patient states that her husband recently died and she watched him die and she had driven about it and she woke up very anxious. She has known covert and tested positive on 11?11. She is supposed to have the infusion today in downtown, however she has not driven in 14 years and is nervous about going there.Patient was given a home dose of her Xanax. She was given a referral for Dr. clinic for the infusion. Patient told to return to ED for new, worsening, changing or persistent symptoms.


VAERS ID: 2025530 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-11-01
Onset:2021-11-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211D21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Chills, Dizziness, Fatigue, Heart rate increased, Hypoacusis, Loss of personal independence in daily activities, Pain, Pyrexia, Tinnitus
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Hypertension (narrow), Hearing impairment (narrow), Vestibular disorders (broad), 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? No
Previous Vaccinations: Hep B, in the early 2000s Back pain, head ache, arm/hand weakness/numbness
Other Medications: Multi vitamin, probiotic
Current Illness: None Recovered from Covid November 2020 - still had detectable antibodies week before vaccine
Preexisting Conditions: None
Allergies: Allergic to Sulfa Adverse reaction to Ketek Adverse reaction Heb B vaccine (did not complete series)
Diagnostic Lab Data: Scheduling appointment regarding tinnitus, dizziness and fatigue.
CDC Split Type:

Write-up: 3 days of : Fever over 102, aches, chills, elevated blood pressure and heart rate. Decrease in hearing . Tinnitus, fatigue are some dizziness started within 5-7 days It has been almost 2 months since shot and tinnitus is still significant, disrupting daily life.


VAERS ID: 2027065 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site pain, Medication error
SMQs:, Extravasation events (injections, infusions and implants) (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 INC202101847313

Write-up: The unblinded injector inadvertently went into the wrong exam room and then further failed to ask the patient to confirm name; Injection site tenderness; This is a spontaneous report from a contactable physician. This is a report based on information received by Pfizer from LLP-Biontech SE [Other Case identifier(s): US-BNTAG-1581 (BNTAG), license party for Comirnaty]. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Injection site tenderness". Additional information: On 17Nov2021, a dose was drawn up by the pharmacist for a subject in study BNT162-17. The unblinded injector inadvertently went into the wrong exam room and then further failed to ask the patient to confirm name and DOB per site process. The dose of BNT162b2 was then administered to a non-study patient, not in the study. (The patient was on site for a Covid-19 vaccine booster dose). The patient that was not trial participant was observed post dose and had been followed up via phone calls for monitoring of any symptoms. The originally intended trial participant received the correct dose according to randomization assignment. The patient that inadvertently had received study medication/vaccine with phone calls and the non-study patient has had only an expected post injection site tenderness. At time of reporting, the events have resolved with date of 17Nov2021. No further information was available at that time. Additional information had been requested. Reporter comment: The reporting physician considers the event to be non-serious. The company agrees to the physician''s assessment. Hence, the case was assessed as unexpected on case level. The reporting physician assessed the event as related to treatment with BNT162b2. The sponsor agreed to the investigator''s assessment as injection site pain was expected for parent vaccine BNT162b2 (Comirnaty). Medication error was not considered an adverse drug reaction in this case, as only consequences of medication error are considered to be adverse drug reactions. Therefore, seriousness, expectedness and causality are assessed as not applicable. The benefit-risk profile of BNT162b2was not affected by this event and no change in the reference safety information was required at that time. Causality Assessments: Drug: COMIRNATY Injection site tenderness, Medication error Per Reporter: Possible Per Company (BioNTech SE): Possible. Bnt162b2 (COMIRNATY) is under agreement with Biontech. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2027219 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Rhode Island  
Vaccinated:2021-01-06
Onset:2021-11-17
   Days after vaccination:315
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026L20A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary mass, Feeling abnormal, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20224

Write-up: felt weird,like everything in his body was shutting down/ booster shot really screwed him up; a lump in his left armpit; felt really sore/body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (felt weird,like everything in his body was shutting down/ booster shot really screwed him up), AXILLARY MASS (a lump in his left armpit) and MYALGIA (felt really sore/body aches) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 029L20A and 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient experienced FEELING ABNORMAL (felt weird,like everything in his body was shutting down/ booster shot really screwed him up) and MYALGIA (felt really sore/body aches). 17-Nov-2021, the patient experienced AXILLARY MASS (a lump in his left armpit). At the time of the report, FEELING ABNORMAL (felt weird,like everything in his body was shutting down/ booster shot really screwed him up), AXILLARY MASS (a lump in his left armpit) and MYALGIA (felt really sore/body aches) outcome was unknown. 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. This case was linked to MOD-2022-447062 (Patient Link).


VAERS ID: 2027685 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-03-17
Onset:2021-11-17
   Days after vaccination:245
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Abnormal behaviour, COVID-19, Dizziness, Leukocytosis, SARS-CoV-2 test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Patient is COVID positive 11/17/2021. Fully vaccinated. Presented to the ED for dizziness and "not acting himself" + for leukocytosis. Decision to discharge patient. Patient told to return to ED for any worsening symptoms.


VAERS ID: 2027687 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-20
Onset:2021-11-17
   Days after vaccination:211
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT AVAILABLE / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Chest pain, Dyspnoea, Dyspnoea exertional
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: 50-year-old female complaining of worsening shortness of breath with activity and mild chest pain for the past 2 days. Patient was diagnosed with Covid 19 on 11/11. She is fully vaccinated. Vital signs within normal limits.Patient discharged home with a pulse oximeter, referral for monoclonal antibody infusion. Instructed to return to the emergency room for worsening chest pain, shortness of breath, hypoxia.aspirin chew tab 324 mg given.


VAERS ID: 2027692 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-07-14
Onset:2021-11-17
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078C21A / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19, COVID-19 pneumonia, Dyspnoea, Hypomagnesaemia, Hypoxia, Mental status changes, SARS-CoV-2 test positive, Troponin increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (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), Dementia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient is COVID + 11/17/2021. Patient is fully vaccinated. Admitted dx: hypomagnesemia, shortness of breath, hypoxia, elevated troponin, Pneumonia due to COVID. Patient is a known case of COPD and CHF who presented to the hospital acute on chronic respiratory failure related to COVID pneumonia. Patient is status post been started on continuous AVAPS and patient''s have change in mental status which responded to IV steroid and breathing treatment. Patient started on IV remdesivir and p.o. oluminate and patient condition improved. Patient noted to have acute kidney injury responded really well to gentle hydration. Plan for the patient to be discharged to go LTAC.


VAERS ID: 2027865 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-06
Onset:2021-11-17
   Days after vaccination:103
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002F21A / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Acute kidney injury, Ageusia, Anosmia, Arthropathy, Asthenia, Bladder scan, COVID-19, Cough, Decreased appetite, Diarrhoea, Fall, Feeling abnormal, Headache, Hyponatraemia, Myalgia, Refusal of treatment by patient, Renal failure, SARS-CoV-2 test positive, Urinary retention
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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 is COVID + 11/17/2021. Patient is fully vaccinated. Admitted dx: Hyponatremia, AKI, COVID urinary retention. Presented for generalized weakness.Patient reports a "few days ago" she began feeling under the weather. She admitted to having a headache, myalgias, diarrhea, decreased appetite, cough, loss of taste/smell. Additionally she endorses increased generalized weakness. At day of hospitalization, she felt too weak and her legs gave out and she fell on carpet. Denied that she hit her head/loss consciousness. Patient reports she then crawled to her phone and then called emergency to be taken to the hospital. Decadron and SQ heparin were ordered and patient declined these. Spoke to patient at length about these medications and she made the informed decision to refuse them. On bladder scan she was found to have $g1L urine and patient declined straight catheterization despite being informed that urinary retention could be contributing to her kidney failure. She was eventually able to urinate by herself, however, and her kidney function improved.Remdesivir was ordered however patient was able to go back to her baseline oxygen requirements prior to it being administered. Given that she was at her baseline O2 requirements and that her kidney function had improved, she was deemed stable for discharge.


VAERS ID: 2031737 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 320308D / 3 UN / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood magnesium normal, Blood thyroid stimulating hormone, C-reactive protein normal, Chest pain, Echocardiogram abnormal, Full blood count normal, Metabolic function test, Palpitations, Pericardial effusion, Pericarditis, Red blood cell sedimentation rate normal
SMQs:, Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Azelastine nasal spray, hydroxyzine prn, cetirizine, albuterol prn, lactobacillus probiotic
Current Illness: None
Preexisting Conditions: chronic allergic rhinits, mild intermittent asthma w/o complication
Allergies: None
Diagnostic Lab Data: CBC/CMP/Mag/TSH/ESR/CRP all wnl. Echo revealing trivial pericardial effusion.
CDC Split Type:

Write-up: Pt w/sharp chest pain 1 day after vaccination + palpitations. Chest pain worse with laying back. Symptoms persisting into 1/13/22, though much improved. Echo 1/13/22 reveals trivial pericardial effusion. Suspect vaccine-induced pericarditis.


VAERS ID: 2034313 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Unknown  
Vaccinated:2020-10-01
Onset:2021-11-17
   Days after vaccination:412
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 3303080 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental exposure to product, Exposure via skin contact, Immunisation, Injection site haemorrhage, Injury associated with device, Vaccination site pain, Wrong technique in product usage process
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; AMBIEN; SKYRIZI [RISANKIZUMAB]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Atrial fibrillation; Insomnia; Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101885504

Write-up: not noticed green button, turned pen upside down/applied pressure/depressing white needle sleeve to thumb; the patient experienced needle stick injury; not noticed green button, turned pen upside down/applied pressure/depressing white needle sleeve to thumb; not noticed green button, turned pen upside down/applied pressure/depressing white needle sleeve to thumb; bleeding thumb; Injection site pain; He received 3rd dose COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4207813-00 (MFR. CONTROL NO). A 75 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Nov2021 (Lot number: 3303080) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), first regimen subcutaneous from Oct2020 (Batch/Lot number: unknown) to 18Dec2021 at 150 mg (150 mg (1 in 12 wk)) and second regimen subcutaneous since 18Dec2021 (ongoing) (Batch/Lot number: unknown) at 150 mg (150 mg (1 in 12 wk)) for psoriasis. Relevant medical history included: "Atrial fibrillation", start date: 1996 (unspecified if ongoing); "Non-Smoker" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation; AMBIEN taken for insomnia. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3249, Expiration date: May2021), administration date: 15Feb2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "injection site pain"; Bnt162b2 (DOSE 2, SINGLE, Lot number EN9581, Expiration date: May2021), administration date: 09Mar2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "injection site pain". The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "He received 3rd dose COVID-19 Vaccine"; INJECTION SITE HAEMORRHAGE (non-serious) with onset 18Dec2021, outcome "recovered" (18Dec2021), described as "bleeding thumb"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Injection site pain"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 18Dec2021, outcome "recovered" (18Dec2021), INJURY ASSOCIATED WITH DEVICE (non-serious) with onset 18Dec2021, outcome "recovered" (18Dec2021) and all described as "the patient experienced needle stick injury"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious) all with onset 18Dec2021, outcome "unknown" and all described as "not noticed green button, turned pen upside down/applied pressure/depressing white needle sleeve to thumb". The action taken for risankizumab was dosage not changed. Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient had no known allergy. On 17Nov2021, the patient received the third dose COVID-19 Vaccine manufactured by Pfizer, lot number 3303080. The patient did not had the expiration date of the third COVID-19 vaccine because it was not written in the vaccination card. On 18Dec2021, the patient experienced needle stick injury/not noticed green button, turned pen upside down/applied pressure/depressing white needle sleeve to thumb/all medication squirted out/bleeding thumb. On 18Dec2021, the patient had issue with one risankizumba (SKYRIZI) pen. The patient checked the window before injection and it was clear. He removed gray cap. Pen was not dropped, cap was not twisted and was not recapped. He pinched his skin and placed the pen firmly at a 90 degree angle at the injection site. The patient did not notice the green button and turned the pen upside down. He applied pressure and depressing the white needle sleeve to his thumb until the green button was pressed. All medication squirted out and went everywhere according. yellow indicator was observed. The causality for events needle stick injury/not noticed green button, turned pen upside down/applied pressure/depressing white needle sleeve to thumb/all medication squirted out/bleeding thumb onset 18Dec2021 with risankizumba was not provided. The reporter''s causality for the event of injection site pain after COVID-19 vaccine onset 17Nov2021 with risankizumba was no reasonable possibility. The reporter considered "bleeding thumb" and "the patient experienced needle stick injury" not related to bnt162b2. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a role of role of the suspect product BNT162B2 to the development of events needle stick injury and injection site hemorrhage was considered unrelated.


VAERS ID: 1880387 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-11
Onset:2021-11-17
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 31060BD / 2 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal pain upper
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Unknown
Diagnostic Lab Data: Not Yet I have no money to pay the bill
CDC Split Type:

Write-up: Severe Abdominal Pain upper. Feels like someone is squeezing my stomach


VAERS ID: 1881090 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Androgen deficiency, Erectile dysfunction, Loss of libido
SMQs:, Sexual dysfunction (narrow)

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

Write-up: testosterone depletion, ED, no libido after 2 days


VAERS ID: 1884999 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 27-007-DK / 2 RA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Contrave vitamin D, calcium, multi vitamin, acidophilis, vitamin c
Current Illness: None
Preexisting Conditions: PCOS
Allergies: None
Diagnostic Lab Data: Dr said allergic reaction no test done
CDC Split Type:

Write-up: Painful itchy trash on entire back


VAERS ID: 1889137 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-13
Onset:2021-11-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5109 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blister, Electric shock sensation, Herpes zoster, Paraesthesia, Rash, Rash erythematous, Scar, Sensitive skin
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

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

Write-up: First dose of Pfizer-BioNTech vaccine was taken on 13th of Nov. 2 days later (15th of Nov) skin started becoming sensitive. When I touch on my left arm like I was giving electric to my skin, like sticking so many needles. 17th of Nov skin started becoming red like rash clusters on the skin. 19th of Nov blisters started becoming. Especially under armpit and inner arm, left chest and left back side of my body. 21th of Nov I called ( online doctor appointment ). Doctor said scars on my skin are shingles and she (Dr) prescribed me with Valacyclovir HCL 500mg. 2 tablets 3 times in a day.


VAERS ID: 1895026 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-11-17
   Days after vaccination:124
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: COPFIZER INC202101619245

Write-up: covid-19; antigens Sars-Cov-2 test with a positive confirmation/ covid -19; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Jun2021 (Lot Number: EW4109) as DOSE 1, SINGLE; dose 2 via an unspecified route of administration on 16Jul2021 (Lot Number: EW4109) as DOSE 2, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced COVID-19 on 17Nov2021. The patient reported that yesterday, Wednesday 17Nov2021 at 18:47, the antigens Sars-Cov-2 test with a positive confirmation was received. On an unspecified date, the patient had presented nasal congestion, headache, among other symptoms. The patient was vaccinated against COVID-19 with the Pfizer / BioNTech vaccine under the company program on the following dates with the following batches (vaccination card attached): 25Jun2021 - Lot EW4109, 16Jul2021 - Lot EW4109. Outcome of the events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1895305 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: fever; Result Unstructured Data: Test Result:high
CDC Split Type: DKPFIZER INC202101623934

Write-up: High fever; Severe headache; Fainted in connection with the injection; This is a spontaneous report from a contactable consumer via Pfizer colleague. A 12-year-old male patient received bnt162b2 (COMIRNATY), at vaccination age of 12-year-old via an unspecified route of administration on 17Nov2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 17Nov2021, the patient experienced fainted in connection with the injection. On 18Nov2021, the patient had high fever and severe headache. It was further reported that the reporter reported a case with the son of one of the reporter''s personal friends who had the Pfizer covid 19 vaccine 2 days ago (17Nov2021) and fainted in connection with the injection but was subsequently fine. The patient however (1-day post-vaccination) suffered from high fever and severe headache. As far as the reporter understand, the medical person treating him in the vaccine center already reported the acute episode there as an adverse event but the fever and headache occurring at home has not been reported to the reporter''s knowledge. The outcome of fainting was recovered on an unspecified date in 2021 while the outcome of the other events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1898663 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / OT
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chills, Decreased appetite, Flatulence, Headache, Malaise, Nausea, Pain in extremity, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSA2021SA387214

Write-up: Shaking headache nausea chills back pain trapped gas; Shaking headache nausea chills back pain trapped gas; Shaking headache nausea chills back pain trapped gas; Shaking headache nausea chills back pain trapped gas; Shaking headache nausea chills back pain trapped gas; Shaking headache nausea chills back pain trapped gas; Shaking headache nausea chills back pain trapped gas; Shaking headache nausea chills back pain trapped gas; Shaking headache nausea chills back pain trapped gas; Initial information received on 19-Nov-2021 regarding an unsolicited valid serious case received from consumer via Regulatory Authority. This case involved a 21-year-old female patient (167 cm and 87.99 kg) who experienced shaking headache nausea chills back pain trapped gas (tremor), (headache), (nausea), (chills), (back pain), (flatulence), (malaise), (decreased appetite), (pain in extremity) after receiving SARS-COV-2 VACCINE [SARS-COV-2 VIRUS] and INFLUENZA VACCINE. The patient medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On 16-Nov-2021, the patient received a dose 3c of suspect SARS-COV-2 VACCINE not produced by Sanofi Pasteur lot number and expiration date not reported via parenteral route at an unknown administration site for prophylactic vaccination. On 16-Nov-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via parenteral route at an unknown administration site for prophylactic vaccination. On 17-NOV-2021 the patient developed a serious shaking headache nausea chills back pain trapped gas (tremor), (headache), (nausea), (chills), (back pain), (flatulence), (malaise), (decreased appetite), (pain in extremity), 1 day following the administration of INFLUENZA VACCINE and SARS-COV-2 VACCINE. These all events were assessed as medically significant. Woke up shaking, feeling sick, loss of appetite, aching arm, sore back, head ache. No relevant laboratory details were provided. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Resolved for all the events. There would be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 21-year-old female patient who experienced tremor, headache, nausea, chills, back pain, flatulence, malaise, decreased appetite, pain in extremity after receiving SARS-COV-2 VACCINE not produced by Sanofi Pasteur and INFLUENZA VACCINE produced by unknown manufacturer and concomitant medication not reported. The time to onset is not compatible. There is no further information regarding patient''s medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.


VAERS ID: 1898945 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-14
Onset:2021-11-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness: Prophylaxis
Preexisting Conditions: Comments: None of the above. Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GB0095075132111GBR007438

Write-up: Swollen lymph nodes; Information has been received from regulatory authority (E2B Authority Number # GB-MHRA-WEBCOVID-202111181355576430-LZXGR) on 19-NOV-2021. This spontaneous report was received from a 32-year-old female patient reporting on herself. Concomitant therapies included covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA). The patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On 14-NOV-2021, the patient was vaccinated with tozinameran (COVID-19 MRNA VACCINE BIONTECH), lot number FK0112, dose 3b for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). The patient stated she had the booster vaccine in the left arm. On 17-NOV-2021 (reported as "three days later"), the patient developed swollen subclavicular lymph nodes on the left side (Lymphadenopathy), where the collarbone was. The patient had never had that happen before so she tried reporting to my general practitioner (GP), nevertheless, they could not see her until next "Tuesday", therefore, the patient wanted to make sure she had reported this side effect somewhere at least. The patient mentioned that it hurts a very small amount when she touched the area and it was very swollen. The patient could not turn her head comfortably to the left without it hurting. Patient had not tested positive for COVID-19 since having the vaccine. On 18-NOV-2021, the patient had performed a COVID-19 virus test and the result was reported as no - negative. The patient was not enrolled in clinical trial. The reporter did not report relate to possible inflammation of the heart (myocarditis or pericarditis). The outcome of the event lymphadenopathy was reported as not resolved. The action taken with hepatitis a vaccine, inactivated (manufacturer unknown) and tozinameran (COVID-19 MRNA VACCINE BIONTECH) was reported as unknown with negative rechallenge result. The causality between the suspect products and the event was not reported. Upon internal review, lymphadenopathy was determined to be medically significant.


VAERS ID: 1901496 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA B004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Headache dull; Fatigue; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26217972) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache) and HEADACHE (Headache dull) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. B004675) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and HEADACHE (Headache dull) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue) had not resolved and HEADACHE (Headache) and HEADACHE (Headache dull) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient did not had symptoms associated with COVID-19. Concomitant product use was not provided by the reporter. Treatment information was not provided. It was stated that patient experienced unusual fatigue and slight headache which was started 1 hour after booster and continued rest of day. The patient had not tested positive for COVID-19 since having the vaccine. Company comment: This case concerns an unknown age and gender patient with no relevant medical history reported who experienced the unexpected and serious events of fatigue and headache (reported as headache and headache dull). The events occurred the same day after a third dose of mRNA-1273 vaccine was administered. The rechallenge was not applicable since only information of one dose is disclosed and no further dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns an unknown age and gender patient with no relevant medical history reported who experienced the unexpected and serious events of fatigue and headache (reported as headache and headache dull). The events occurred the same day after a third dose of mRNA-1273 vaccine was administered. The rechallenge was not applicable since only information of one dose is disclosed and no further dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1901499 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blister, Capillary leak syndrome, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: blisters; Capillary leak syndrome; This case was received via RA (Reference number: GB-MHRA-ADR 26220289) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of BLISTER (blisters) and CAPILLARY LEAK SYNDROME (Capillary leak syndrome) in a 62-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: AMLODIPINE and RAMIPRIL. Past adverse reactions to the above products included No adverse event with AMLODIPINE and RAMIPRIL. Concurrent medical conditions included Hypertension. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced CAPILLARY LEAK SYNDROME (Capillary leak syndrome) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced BLISTER (blisters) (seriousness criterion disability). At the time of the report, BLISTER (blisters) outcome was unknown and CAPILLARY LEAK SYNDROME (Capillary leak syndrome) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient developed blisters on right hand on fingers and forearm a day after which cant be explained otherwise. Patient is not enrolled in clinical trial. Company comment: This case concerns a 62-year-old, female patient with a medical history of hypertension and had symptoms associated with Covid-19, who experienced the unexpected events of blister and capillary leak syndrome. The events occurred approximately 1 day after the third dose of mRNA � 1273 vaccine. Events are reported as disabling and at the time of report had not resolved The rechallenge was unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 62-year-old, female patient with a medical history of hypertension and had symptoms associated with Covid-19, who experienced the unexpected events of blister and capillary leak syndrome. The events occurred approximately 1 day after the third dose of mRNA � 1273 vaccine. Events are reported as disabling and at the time of report had not resolved The rechallenge was unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1901500 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received via regulatory authority (Reference number: -MHRA-ADR 26220632) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criteria hospitalization, medically significant and life threatening). On 18-Nov-2021, ANAPHYLACTIC REACTION (Anaphylaxis) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was on various medications. It would not allow her to add them. But none made her immune sufficient. Patient had not had symptoms associated with COVID-19 and was needed numerous adrenalin shots and blue lighted to hospital. She was not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No treatment information was provided. This case concerns a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) with no relevant medical history who experienced the serious expected event (AESI) of anaphylactic reaction the same day after the third dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report; Sender''s Comments: This case concerns a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) with no relevant medical history who experienced the serious expected event (AESI) of anaphylactic reaction the same day after the third dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report


VAERS ID: 1901503 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-CODAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211114; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Migraine; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26221486) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Concomitant products included CO-CODAMOL for Neck pain. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced MIGRAINE (seriousness criterion medically significant). At the time of the report, MIGRAINE had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) On 14-Nov-2021, SARS-CoV-2 test negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) was unknown. Patient had not tested positive for COVID-19 since having the vaccine. No treatment medication were provided. This case concerns a 64-year-old male patient taking codeine and paracetamol for neck pain, who experienced the unexpected events of migraine. The events occurred approximately 2 days after the third dose of mRNA � 1273 vaccine. Migraine was re[ported as medically significant and at the time of report had not resolved. The rechallenge was unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1901507 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Influenza, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Joint ache; Shivering; Flu symptoms; High temperature; Muscle pain; This case was received via RA (Reference number: GB-MHRA-ADR 26224242) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint ache), CHILLS (Shivering), INFLUENZA (Flu symptoms), PYREXIA (High temperature) and MYALGIA (Muscle pain) in a 47-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Patient has not had symptoms associated with COVID-19. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 01-Mar-2021 to an unknown date for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced ARTHRALGIA (Joint ache) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), INFLUENZA (Flu symptoms) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Joint ache), INFLUENZA (Flu symptoms) and PYREXIA (High temperature) was resolving, CHILLS (Shivering) had resolved and MYALGIA (Muscle pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (normal) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided. Vaccine administered at 0915. Pain at injection site started approx 90 mins later. Remaining symptoms started at 2200 hrs on day of vaccination and whilst they''re improving are still present at 2130 the following day. Unable to work the day after and stayed in bed. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial This case concerns a 47-year-old male patient with interchange of vaccine products who experienced the serious unexpected events of Arthralgia, Chills, Influenza, Pyrexia, Myalgia. The events occurred on the same day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. The events doesn''t seem to be serious by medical judgement and from a clinical or regulatory standpoint, but it was assessed as serious as per regulatory authority report and retained for consistency.; Sender''s Comments: This case concerns a 47-year-old male patient with interchange of vaccine products who experienced the serious unexpected events of Arthralgia, Chills, Influenza, Pyrexia, Myalgia. The events occurred on the same day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. The events doesn''t seem to be serious by medical judgement and from a clinical or regulatory standpoint, but it was assessed as serious as per regulatory authority report and retained for consistency.


VAERS ID: 1904754 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness postural, Head discomfort, Oropharyngeal pain, SARS-CoV-2 test, Tinnitus
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hearing impairment (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2
Current Illness: Arthritis (Age related bits of arthritis.)
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperparathyroidism (Have mild hyperparathyroidism.)
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: sore throat; Head pressure; Tinnitus aggravated; Dizzy on standing; This case was received via Regulatory Authority RA (Reference number: GB-MHRA-ADR 26214335) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), HEAD DISCOMFORT (Head pressure), TINNITUS (Tinnitus aggravated) and DIZZINESS POSTURAL (Dizzy on standing) in a 61-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Hyperparathyroidism (Have mild hyperparathyroidism.). Concurrent medical conditions included Arthritis (Age related bits of arthritis.). Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 15-Feb-2021 to an unknown date for an unknown indication. On 15-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced HEAD DISCOMFORT (Head pressure) (seriousness criterion medically significant), TINNITUS (Tinnitus aggravated) (seriousness criterion medically significant) and DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL PAIN (sore throat) was resolving and HEAD DISCOMFORT (Head pressure), TINNITUS (Tinnitus aggravated) and DIZZINESS POSTURAL (Dizzy on standing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had a sore throat which still had but this responded to paracetamol which was ok and arm was sore and lymph glands swollen. Company comment: This is a regulatory case concerning a 61 year-old female patient, with medical history of Hyperparathyroidism, arthritis and previous vaccination with BNT162B2 (TOZINAMERAN) on February 2021, who experienced the serious unexpected events of OROPHARYNGEAL PAIN, HEAD DISCOMFORT, TINNITUS and DIZZINESS POSTURAL two days after receiving a dose of mRNA-1273 . The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory authority reporting; Sender''s Comments: This is a regulatory case concerning a 61 year-old female patient, with medical history of Hyperparathyroidism, arthritis and previous vaccination with BNT162B2 (TOZINAMERAN) on February 2021, who experienced the serious unexpected events of OROPHARYNGEAL PAIN, HEAD DISCOMFORT, TINNITUS and DIZZINESS POSTURAL two days after receiving a dose of mRNA-1273 . The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory authority reporting


VAERS ID: 1904762 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Nausea, Peripheral swelling, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Swelling arm; Muscle ache; Headache; Vomited; Nausea; Fatigue; This case was received via regulatory authority (Reference number: -MHRA-ADR 26216219) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), MYALGIA (Muscle ache), HEADACHE (Headache), VOMITING (Vomited), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 46-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), VOMITING (Vomited) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 17-Nov-2021, VOMITING (Vomited) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling arm) was resolving and MYALGIA (Muscle ache), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No Concomitant medication details were provided. No Treatment medication details were provided. Patient was not currently breastfeeding. Patient was type 1 diabetic and her blood glucose levels was raised since the early hours of the morning of the 17-Nov-2021. Patient was not tested positive for COVID-19 since having the vaccine and was also not enrolled in clinical trial. Company Comment: This case concerns a 46-year-old female patient, with medical history of diabetes mellitus type 1, who experienced serious unexpected events of peripheral swelling, headache, vomiting, nausea, myalgia and fatigue after third dose of mRNA-1273. The events occurred 2 days after vaccination. The re-challenge is not applicable since further dose is not expected. Patient�s high blood glucose levels remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 46-year-old female patient, with medical history of diabetes mellitus type 1, who experienced serious unexpected events of peripheral swelling, headache, vomiting, nausea, myalgia and fatigue after third dose of mRNA-1273. The events occurred 2 days after vaccination. The re-challenge is not applicable since further dose is not expected. Patient�s high blood glucose levels remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 1904766 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Chest pain; This case was received via RA (Reference number: GB-MHRA-ADR 26216659) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a 22-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. No medical history was reported. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 16-Feb-2021 to an unknown date for Vaccination. On 15-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Chest pain) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. It was reported that patient have been having these chest pains all day, and it is just a general pain around his heart and lungs though he was not having trouble breathing. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. No treatment medications were provided. Company comment: This case concerns a 22-year-old male patient, with no medical history reported, who experienced serious unexpected event of chest pain after third dose of mRNA-1273. The event occurred 3 days after vaccination. The re-challenge is not applicable since further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Patient received previously 2 doses from COVID-19 vaccine AstraZeneca.; Sender''s Comments: This case concerns a 22-year-old male patient, with no medical history reported, who experienced serious unexpected event of chest pain after third dose of mRNA-1273. The event occurred 3 days after vaccination. The re-challenge is not applicable since further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Patient received previously 2 doses from COVID-19 vaccine AstraZeneca.


VAERS ID: 1904769 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, Migraine, Photophobia, SARS-CoV-2 test
SMQs:, Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210920; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: generally feeling unwell; Migraine; Light sensitivity to eye; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26216897) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (generally feeling unwell), MIGRAINE (Migraine) and PHOTOPHOBIA (Light sensitivity to eye) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 20-Sep-2021 to 28-Sep-2021. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant) and PHOTOPHOBIA (Light sensitivity to eye) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (generally feeling unwell) (seriousness criterion medically significant). At the time of the report, MALAISE (generally feeling unwell) had not resolved and MIGRAINE (Migraine) and PHOTOPHOBIA (Light sensitivity to eye) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided by the reporter. Treatment medications was not provided by the reporter. Patient felt unwell, lethargic and Odd taste and smell of the vaccine. Company Comment: This case concerns a patient of an unknown age and gender, with a history of suspected COVID-19, who experienced the serious unexpected events of MIGRAINE and PHOTOPHOBIA. The events occurred on the following day of the third dose of the mRNA-1273 vaccine. The rechallenge is not applicable since no information about further dosing has been disclosed. The history of suspected COVID-19 remains a confounder. A SARS-COV-2 TEST POSITIVE was performed four days after the third dose. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a patient of an unknown age and gender, with a history of suspected COVID-19, who experienced the serious unexpected events of MIGRAINE and PHOTOPHOBIA. The events occurred on the following day of the third dose of the mRNA-1273 vaccine. The rechallenge is not applicable since no information about further dosing has been disclosed. The history of suspected COVID-19 remains a confounder. A SARS-COV-2 TEST POSITIVE was performed four days after the third dose. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1904770 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: Tingling sensation; Hot feeling in feet; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26217301) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling sensation) and FEELING HOT (Hot feeling in feet) in a 66-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced FEELING HOT (Hot feeling in feet) (seriousness criterion medically significant). On an unknown date, the patient experienced PARAESTHESIA (Tingling sensation) (seriousness criterion medically significant). At the time of the report, PARAESTHESIA (Tingling sensation) and FEELING HOT (Hot feeling in feet) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had terrible burning tingling sensation at the inside sides of both feet. The sensation builds up over a few seconds, reaches a peak at which it remains for several seconds and then subsides. This pattern has continued over several hours at frequent intermittent intervals. No concomitant medications were reported No treatment information was provided. Company comment: This case concerns a 66-year-old male patient with no medical history reported who experienced serious unexpected events of paraesthesia (in both feet) and feeling hot (in feet) after a third dose of mRNA-1273. The events occurred the same day after vaccination. The re-challenge is not applicable since further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 66-year-old male patient with no medical history reported who experienced serious unexpected events of paraesthesia (in both feet) and feeling hot (in feet) after a third dose of mRNA-1273. The events occurred the same day after vaccination. The re-challenge is not applicable since further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 1904782 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lymphoma (non-Hodgkin''s); Comments: Non Hodgkin lymphoma Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Painful arm; Headache; High temperature; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26219901) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache) and PYREXIA (High temperature) in a 56-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Non Hodgkin lymphoma Patient has not had symptoms associated with COVID-19. Concurrent medical conditions included Lymphoma (non-Hodgkin''s). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from an unknown date to 06-May-2021 for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache) and PYREXIA (High temperature) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information were included. Company Comment: This regulatory authority case concerns a 56-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Painful arm, Headache and Pyrexia after mRNA- 1273 Moderna vaccine. The events occurred on the day after the dose of mRNA- 1273 vaccine, third dose of the vaccination schedule (dosage unknown). The patient had received dose of AstraZeneca COVID-19 vaccine 6 months and 12 days before. Vaccination site pain, Headache and Pyrexia are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge is not applicable, since the events were reported exclusively after the third dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report; Sender''s Comments: This regulatory authority case concerns a 56-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Painful arm, Headache and Pyrexia after mRNA- 1273 Moderna vaccine. The events occurred on the day after the dose of mRNA- 1273 vaccine, third dose of the vaccination schedule (dosage unknown). The patient had received dose of AstraZeneca COVID-19 vaccine 6 months and 12 days before. Vaccination site pain, Headache and Pyrexia are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge is not applicable, since the events were reported exclusively after the third dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report


VAERS ID: 1904783 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-14
Onset:2021-11-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; SERTRALINE
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Diarrhoea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26220169) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) and SERTRALINE for an unknown indication. On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced DIARRHOEA (Diarrhoea) (seriousness criterion medically significant). On 18-Nov-2021, DIARRHOEA (Diarrhoea) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient had stomach pains, as if wearing a very tight belt, the day before diarrhoea started. The patient had diarrhoea on and off nearly all day - extreme urgency, followed by very liquid stools. Started on waking at approximately 6:30am and last episode was approximately at 10:30pm. Company comment: This case concerns a 43-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of diarrhoea. The event occurred 3 days after the third dose (unknown dosage) of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. Concomitant medication sertraline could be potentially confounder for diarrhoea. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting. The patient last menstrual period date was 12-Nov-2021. No treatment medications were reported.; Sender''s Comments: This case concerns a 43-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of diarrhoea. The event occurred 3 days after the third dose (unknown dosage) of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. Concomitant medication sertraline could be potentially confounder for diarrhoea. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1904784 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26221332) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675-L1058) for COVID-19 vaccination. Concurrent medical conditions included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response). On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related. No concomitant medication was provided. The patient suffered a reaction 10 minutes after her booster dose, she fainted and was given Adrenaline. She fainted again and another shot of Adrenaline admitted. Patient was blue lighted to the hospital. The reporter rang the patient on 18Nov2021 at 11.00am and she is out of the hospital and okay (not perfect but okay). Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient is enrolled in clinical trial. Company comment This regulatory case concerns a 32-year-old, female patient with no relevant medical history, who experienced the expected, serious event of anaphylactic reaction. The event occurred on the same day after administration of the third dose of the Moderna mRNA-1273. The patient suffered a reaction 10 minutes after vaccine administration. She fainted and was given Adrenaline. She fainted again and another shot of Adrenaline was given. The patient was brought to the hospital. It was not clear if the patient was admitted but the reporter mentioned that she rang the patient the following day, and the patient was out of the hospital and was doing okay. The rechallenge was unknown as per Regulatory Authority report. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory case concerns a 32-year-old, female patient with no relevant medical history, who experienced the expected, serious event of anaphylactic reaction. The event occurred on the same day after administration of the third dose of the Moderna mRNA-1273. The patient suffered a reaction 10 minutes after vaccine administration. She fainted and was given Adrenaline. She fainted again and another shot of Adrenaline was given. The patient was brought to the hospital. It was not clear if the patient was admitted but the reporter mentioned that she rang the patient the following day, and the patient was out of the hospital and was doing okay. The rechallenge was unknown as per Regulatory Authority report. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.


VAERS ID: 1904786 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bone pain, Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Osteonecrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; INFLUENZA VIRUS; MIRTAZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: myocarditis; Bone pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26223445) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain) and MYOCARDITIS (myocarditis) in a 52-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 15-Dec-2020 to 20-Jan-2021. Concomitant products included IBUPROFEN from 03-Nov-2021 to an unknown date for Broken bones, MIRTAZAPINE from 01-Sep-2020 to an unknown date for Insomnia, INFLUENZA VACCINE (INFLUENZA VIRUS) from 07-Nov-2021 to an unknown date for Vaccination. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced BONE PAIN (Bone pain) (seriousness criterion medically significant). On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, BONE PAIN (Bone pain) was resolving and MYOCARDITIS (myocarditis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient has been taking Ibuprofen for ''broken bones'' since 03Nov2021. Patient is not pregnant. Patient is not currently breastfeeding. Company Comment: This regulatory case concerns a 52-year-old, female patient with medical history of ''(unspecified) broken bones'', who experienced the expected, serious AESI of myocarditis and the unexpected, serious event of bone pain. The event bone pain occurred on 17Nov2021 after administration of an unspecified dose of the Moderna mRNA-1273. No further information was provided. The event was resolving at the time of the report. The start date of the event myocarditis was not provided. No further information was provided. The event had not resolved at the time of the report. The rechallenge was unknown as the dose number was not provided. The medical history of ''broken bones'' remains a confounder for the event bone pain. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory case concerns a 52-year-old, female patient with medical history of ''(unspecified) broken bones'', who experienced the expected, serious AESI of myocarditis and the unexpected, serious event of bone pain. The event bone pain occurred on 17Nov2021 after administration of an unspecified dose of the Moderna mRNA-1273. No further information was provided. The event was resolving at the time of the report. The start date of the event myocarditis was not provided. No further information was provided. The event had not resolved at the time of the report. The rechallenge was unknown as the dose number was not provided. The medical history of ''broken bones'' remains a confounder for the event bone pain. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.


VAERS ID: 1904791 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Depression, Fatigue, Feeling abnormal, Headache, Photophobia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (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:
Current Illness: Hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: within; fatigue; headache; two; hours; Ice pick headache; Shaking of hands; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26224119) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (within), FATIGUE (fatigue), HEADACHE (headache), DEPRESSION (two), FEELING ABNORMAL (hours), HEADACHE (Ice pick headache) and TREMOR (Shaking of hands) in a 62-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced HEADACHE (Ice pick headache) (seriousness criterion medically significant) and TREMOR (Shaking of hands) (seriousness criterion medically significant). On an unknown date, the patient experienced PHOTOPHOBIA (within) (seriousness criterion medically significant), FATIGUE (fatigue) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant), DEPRESSION (two) (seriousness criterion medically significant) and FEELING ABNORMAL (hours) (seriousness criterion medically significant). At the time of the report, PHOTOPHOBIA (within), FATIGUE (fatigue), HEADACHE (headache), DEPRESSION (two), FEELING ABNORMAL (hours) and HEADACHE (Ice pick headache) had not resolved and TREMOR (Shaking of hands) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was given. No treatment medication was given. Within two hours of vaccination patient had headache, also uncontrollable massive shaking of hands and rest of body for about 5-10 mins, cold to the touch, but feeling warm , feeling of weakness, all over body aches, fatigue. Company comment This regulatory case concerns a 64-year-old, female patient with medical history of hypothyroidism, who experienced the unexpected, serious events of photophobia (reported as "within"), fatigue, headache, depression (reported as "two"), feeling abnormal (reported as "hours"), headache and tremor. Patient reported suffering from Headache within two hours of third dose of mRNA-1273 vaccine, also uncontrollable massive shaking of hands and rest of body for about 5-10 mins 1 day after vaccination, cold to the touch, but feeling warm, feeling of weakness, all over body aches and fatigue. Regulatory authority captured rechallenge as unknown, however, no information about further dosing is disclosed. The medical history of hypothyroidism remain as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 64-year-old, female patient with medical history of hypothyroidism, who experienced the unexpected, serious events of photophobia (reported as "within"), fatigue, headache, depression (reported as "two"), feeling abnormal (reported as "hours"), headache and tremor. Patient reported suffering from Headache within two hours of third dose of mRNA-1273 vaccine, also uncontrollable massive shaking of hands and rest of body for about 5-10 mins 1 day after vaccination, cold to the touch, but feeling warm, feeling of weakness, all over body aches and fatigue. Regulatory authority captured rechallenge as unknown, however, no information about further dosing is disclosed. The medical history of hypothyroidism remain as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1904798 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-11-17
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PV46674 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: GBMODERNATX, INC.MOD20213

Write-up: Fever; Headache; Nauseous; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26231878) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nauseous) in a 67-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. No Medical History information was reported. On 21-May-2021, the patient COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nauseous) (seriousness criterion medically significant). On 17-Nov-2021, PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nauseous) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. Concomitant medication were not reported. Treatment medication were not reported. Company Comment: This case concerns a 67-year-old male patient with no relevant medical history reported, who experienced the unexpected events of pyrexia nausea, and headache. The events occurred approximately 1 day after the third dose of mRNA � 1273 vaccine. Events were reported as medically significant but all the events resolved after a day. The rechallenge was unknown since the first two doses were of a different brand. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 67-year-old male patient with no relevant medical history reported, who experienced the unexpected events of pyrexia nausea, and headache. The events occurred approximately 1 day after the third dose of mRNA � 1273 vaccine. Events were reported as medically significant but all the events resolved after a day. The rechallenge was unknown since the first two doses were of a different brand. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1904936 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza, Nausea, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: flu symptoms, aches, nausea, vomiting; flu symptoms, aches, nausea, vomiting; flu symptoms, aches, nausea, vomiting; flu symptoms, aches, nausea, vomiting; This case was received via Regulatory Authority RA (Reference number: GB-MHRA-ADR 26221975) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms, aches, nausea, vomiting), VOMITING (flu symptoms, aches, nausea, vomiting), NAUSEA (flu symptoms, aches, nausea, vomiting) and PAIN (flu symptoms, aches, nausea, vomiting) in a 67-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. Concomitant products included PROPRANOLOL and AMITRIPTYLINE for an unknown indication. On 16-Nov-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 17-Nov-2021, the patient experienced INFLUENZA (flu symptoms, aches, nausea, vomiting) (seriousness criterion medically significant), VOMITING (flu symptoms, aches, nausea, vomiting) (seriousness criterion medically significant), NAUSEA (flu symptoms, aches, nausea, vomiting) (seriousness criterion medically significant) and PAIN (flu symptoms, aches, nausea, vomiting) (seriousness criterion medically significant). At the time of the report, INFLUENZA (flu symptoms, aches, nausea, vomiting), VOMITING (flu symptoms, aches, nausea, vomiting), NAUSEA (flu symptoms, aches, nausea, vomiting) and PAIN (flu symptoms, aches, nausea, vomiting) was resolving. Treatment medications was not reported. This case concerns a 67-year-old female patient with no relevant medical history, who experienced the unexpected events of Influenza, Vomiting, Nausea and Pain. The events occurred 1 day after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 67-year-old female patient with no relevant medical history, who experienced the unexpected events of Influenza, Vomiting, Nausea and Pain. The events occurred 1 day after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1904961 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; This case was received via regulatory authority (Reference number: -MHRA-ADR 26221554) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Patient has not had symptoms associated with COVID-19. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 18-Nov-2021, PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Treatment medication was not provided by the reporter. Company comment: This case concerns a 57-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of pyrexia. The event is unexpected as it is retained as serious per the source document Authority reporting. The event occurred 1 day after the third dose (unknown dosage) of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 57-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of pyrexia. The event is unexpected as it is retained as serious per the source document Authority reporting. The event occurred 1 day after the third dose (unknown dosage) of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1904965 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Cough, Disturbance in attention, Fatigue, Headache, Photophobia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Concentration impairment; Light sensitivity to eye; Dry cough; Joint ache; Headache; Fever; Shivering; Fatigue; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26222161) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DISTURBANCE IN ATTENTION (Concentration impairment), PHOTOPHOBIA (Light sensitivity to eye), COUGH (Dry cough), ARTHRALGIA (Joint ache), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Shivering) and FATIGUE (Fatigue) in a 65-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Previously administered products included for Product used for unknown indication: INFLUENZA. Past adverse reactions to the above products included No adverse event with INFLUENZA. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced DISTURBANCE IN ATTENTION (Concentration impairment) (seriousness criterion medically significant), PHOTOPHOBIA (Light sensitivity to eye) (seriousness criterion medically significant), COUGH (Dry cough) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 18-Nov-2021, DISTURBANCE IN ATTENTION (Concentration impairment), PHOTOPHOBIA (Light sensitivity to eye), COUGH (Dry cough), ARTHRALGIA (Joint ache), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Shivering) and FATIGUE (Fatigue) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment Medication use information was not provided by reporter. Reactions were started about 14 hours after vaccination and all continued for about 24 hours. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Company comment This case concerns a 65-year-old, female patient, with no relevant medical history, who experienced the serious, unexpected events of Disturbance in attention, photophobia and cough. The events occurred 12 hours after third dose of mRNA 1273 vaccine and resolved. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 65-year-old, female patient, with no relevant medical history, who experienced the serious, unexpected events of Disturbance in attention, photophobia and cough. The events occurred 12 hours after third dose of mRNA 1273 vaccine and resolved. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1904971 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

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

Write-up: Diarrhea recurrent; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26223718) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea recurrent) in a 53-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced DIARRHOEA (Diarrhea recurrent) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Diarrhea recurrent) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The Patient did not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. No concomitant medication were reported. The treatment information were unknown. Company comment This regulatory case concerns a 53-year-old female patient, with unknown medical history, who experienced the serious unexpected event of DIARRHOEA (reported as diarrhea recurrent). The event occurred on the same day after receiving a third dose of mRNA-1273. Further information about previous doses of the vaccination schedule was not provided. The rechallenge was captured as unknown as per the Regulatory Authority assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory case concerns a 53-year-old female patient, with unknown medical history, who experienced the serious unexpected event of DIARRHOEA (reported as diarrhea recurrent). The event occurred on the same day after receiving a third dose of mRNA-1273. Further information about previous doses of the vaccination schedule was not provided. The rechallenge was captured as unknown as per the Regulatory Authority assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1904976 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Heart rate, Nausea, Pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20200918; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Pain; Heart rate; Dizziness; Nausea; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26224708) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain), HEART RATE (Heart rate), DIZZINESS (Dizziness) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 16-Sep-2020 and Clinical trial participant. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant), HEART RATE (Heart rate) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 18-Nov-2021, DIZZINESS (Dizziness) and NAUSEA (Nausea) had resolved. At the time of the report, PAIN (Pain) had not resolved and HEART RATE (Heart rate) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2020, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. concomitant drug details not provided. Treatment information was not provided. Patient has not tested positive for COVID-19 since having the vaccine. Clinical trial participant. Company comments This case concerns a male patient with no relevant medical history, who experienced the unexpected serious events of pain, dizziness, and nausea. Additionally, Heart rate is reported as an event in the case. The event nausea is unexpected as it is retained as serious per the source document Authority reporting. The events occurred on the same day after the third dose (unknown dosage) of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a male patient with no relevant medical history, who experienced the unexpected serious events of pain, dizziness, and nausea. Additionally, Heart rate is reported as an event in the case. The event nausea is unexpected as it is retained as serious per the source document Authority reporting. The events occurred on the same day after the third dose (unknown dosage) of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1904981 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Herpes zoster, Nasopharyngitis, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Shingles (patient got recurring shingles but only when particularly run down.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: cold; rash; headache; Shingles; This case was received via regulatory report RA (Reference number: GB-MHRA-ADR 26230175) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), RASH (rash), HEADACHE (headache) and HERPES ZOSTER (Shingles) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Shingles (patient got recurring shingles but only when particularly run down.). On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced HERPES ZOSTER (Shingles) (seriousness criterion medically significant). On an unknown date, the patient experienced NASOPHARYNGITIS (cold) (seriousness criterion medically significant), RASH (rash) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). At the time of the report, NASOPHARYNGITIS (cold), RASH (rash) and HEADACHE (headache) was resolving and HERPES ZOSTER (Shingles) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications was not reported. Treatment medications was not reported. Day after jab felt feverish, cold, shivery. Skin felt tingly. Thought it was just the jab. Then the next day absolutely stinking headache, and even more tired than usual. Then the 3rd day rash appeared on right buttocks. This case concerns a 35-year-old female patient with medical history of shingles who experienced the unexpected and serious events of nasopharyngitis, rash, headache and herpes zoster. The event herpes zoster occurred the following day after a third dose of mRNA-1273 vaccine was administered, the rest of the events occurred on an unknown day after vaccine was given. The rechallenge was not applicable since the events happened after the third dose and only information of one dose is disclosed and no further dose is expected. Medical history of shingles remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 35-year-old female patient with medical history of shingles who experienced the unexpected and serious events of nasopharyngitis, rash, headache and herpes zoster. The event herpes zoster occurred the following day after a third dose of mRNA-1273 vaccine was administered, the rest of the events occurred on an unknown day after vaccine was given. The rechallenge was not applicable since the events happened after the third dose and only information of one dose is disclosed and no further dose is expected. Medical history of shingles remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1906899 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse drug reaction
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: ANASTROZOLE
Current Illness: Allergy to vaccine (Patient was allergic to the tetanus vaccine)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Large swelling, redness 8 to 10 cms across, itching at the injection site; This case was received via RA (Reference number: GB-MHRA-ADR 26226273) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Large swelling, redness 8 to 10 cms across, itching at the injection site) in a 64-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for Ill-defined disorder. Concurrent medical conditions included Allergy to vaccine (Patient was allergic to the tetanus vaccine). Concomitant products included ANASTROZOLE for Ill-defined disorder. On 15-Nov-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) 1 dosage form. On 17-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ADVERSE DRUG REACTION (Large swelling, redness 8 to 10 cms across, itching at the injection site) (seriousness criterion medically significant). At the time of the report, ADVERSE DRUG REACTION (Large swelling, redness 8 to 10 cms across, itching at the injection site) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) was unknown. The patient was taking Moderna vaccine for: COVID Booster. Treatment information was not provided. Company Comment: This case concerns a 64 year-old, female patient with a history of Allergy to tetanus vaccine, who experienced the serious unexpected event of Adverse drug reaction (reported as Large swelling, redness 8 to 10 cms across, itching at the injection site). The event occurred approximately 2 days after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The medical history, of Allergy to tetanus vaccine remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 64 year-old, female patient with a history of Allergy to tetanus vaccine, who experienced the serious unexpected event of Adverse drug reaction (reported as Large swelling, redness 8 to 10 cms across, itching at the injection site). The event occurred approximately 2 days after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the booster dose. The medical history, of Allergy to tetanus vaccine remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1907228 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Myalgia, Pyrexia, SARS-CoV-2 test
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211028; Test Name: COVID-19 virus test; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Muscle pain; Fatigue; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26219614) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Muscle pain) and FATIGUE (Fatigue) in a 52-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 17-Mar-2021 to an unknown date for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) was resolving and MYALGIA (Muscle pain) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, SARS-CoV-2 test: inconclusive test (Inconclusive) Inconclusive test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment history was not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 52-year-old male patient, with no medical history reported, who experienced serious unexpected events of pyrexia, myalgia and fatigue after a third dose of mRNA-1273. The events occurred 2 days after vaccination. The re-challenge is not applicable since further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 52-year-old male patient, with no medical history reported, who experienced serious unexpected events of pyrexia, myalgia and fatigue after a third dose of mRNA-1273. The events occurred 2 days after vaccination. The re-challenge is not applicable since further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 1907229 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

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

Write-up: shivering; sweating; aching joints; High temperature; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26219805) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivering), HYPERHIDROSIS (sweating), ARTHRALGIA (aching joints) and PYREXIA (High temperature) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant), HYPERHIDROSIS (sweating) (seriousness criterion medically significant) and ARTHRALGIA (aching joints) (seriousness criterion medically significant). At the time of the report, CHILLS (shivering), HYPERHIDROSIS (sweating), ARTHRALGIA (aching joints) and PYREXIA (High temperature) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications were not reported. Patient felt dreadful. She had aching joints, shivering, sweating, and painful arm. Patient stated she wished she had never had this booster and would not be having any further vaccines. This has poisoned her. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Company Comment - This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious unexpected events of chills, hyperhidrosis, arthralgia and pyrexia. The event pyrexia occurred the day after the third dose of mRNA-1273. The events chills, hyperhidrosis, arthralgia occurred on an unknown date after the third dose of mRNA-1273. The rechallenge was unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious unexpected events of chills, hyperhidrosis, arthralgia and pyrexia. The event pyrexia occurred the day after the third dose of mRNA-1273. The events chills, hyperhidrosis, arthralgia occurred on an unknown date after the third dose of mRNA-1273. The rechallenge was unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1907231 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Immunisation, Oxygen saturation, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: O2 saturation; Result Unstructured Data: Test Result:96%; Test Date: 20211117; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101625590

Write-up: Breathlessness; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111180856309050-IDWBC. Other Case identifier(s): GB-MHRA-ADR 26220232. A 61 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0596) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (Dose 1, Single, Batch/Lot number: Unknown), for COVID-19 immunisation; Bnt162b2 (Dose 2, Single, Batch/Lot number: Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; DYSPNOEA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Breathlessness" (Mild). This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: oxygen saturation: (unspecified date) 96%; SARS-CoV-2 test: (17Nov2021) no - negative COVID-19 test. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1907232 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Diarrhoea, Dysmenorrhoea, Migraine, Myalgia, Peripheral swelling, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Diarrhea; Period pains; Muscle ache; Joint ache; Chills; Migraine; Swollen arm; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26220319) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), PERIPHERAL SWELLING (Swollen arm), DIARRHOEA (Diarrhea), DYSMENORRHOEA (Period pains), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache) and CHILLS (Chills) in a 37-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 28-Dec-2020 to 22-Jan-2021. On 17-Nov-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant) and DYSMENORRHOEA (Period pains) (seriousness criterion medically significant). At the time of the report, MIGRAINE (Migraine), PERIPHERAL SWELLING (Swollen arm), DIARRHOEA (Diarrhea), DYSMENORRHOEA (Period pains), MYALGIA (Muscle ache), ARTHRALGIA (Joint ache) and CHILLS (Chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Took 3x500mg paracetamol for pain in the last 12h with slight effect on pain. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. company comment: This case concerns a 37-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Migraine, Peripheral Swelling, Myalgia, Arthralgia, Chills, Diarrhea, Dysmenorrhoea. The events Migraine, Peripheral Swelling, Myalgia, Arthralgia, Chills, occurred the same day after the first dose of mRNA-1273. The events Diarrhea, Dysmenorrhoea occurred the after the first dose of mRNA-1273. The rechallenge was unknown according to RA. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 37-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Migraine, Peripheral Swelling, Myalgia, Arthralgia, Chills, Diarrhea, Dysmenorrhoea. The events Migraine, Peripheral Swelling, Myalgia, Arthralgia, Chills, occurred the same day after the first dose of mRNA-1273. The events Diarrhea, Dysmenorrhoea occurred the after the first dose of mRNA-1273. The rechallenge was unknown according to RA. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1907234 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Headache, Night sweats, Pyrexia, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE; SERTRALINE HCL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: teeth chattering; wooziness; Headache; Tiredness; Vaccination site pain; Fever chills; Night sweats; Shivering; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26220550) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (teeth chattering), DIZZINESS (wooziness), HEADACHE (Headache), FATIGUE (Tiredness), VACCINATION SITE PAIN (Vaccination site pain), PYREXIA (Fever chills), NIGHT SWEATS (Night sweats) and CHILLS (Shivering) in a 41-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No medical history was provided by the reporter. Concomitant products included SERTRALINE HCL from 01-Feb-2018 to an unknown date for Anxiety, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), VACCINATION SITE PAIN (Vaccination site pain) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), NIGHT SWEATS (Night sweats) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (teeth chattering) (seriousness criterion medically significant) and DIZZINESS (wooziness) (seriousness criterion medically significant). On 18-Nov-2021, NIGHT SWEATS (Night sweats) and CHILLS (Shivering) had resolved. At the time of the report, CHILLS (teeth chattering), DIZZINESS (wooziness), HEADACHE (Headache), FATIGUE (Tiredness) and VACCINATION SITE PAIN (Vaccination site pain) had not resolved and PYREXIA (Fever chills) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Vaccine administered at 9.41am. Tiredness commenced about 2 hours later and continued for the rest of the day. Around 9.30pm uncontrollable shivering and teeth chattering and a feeling of not being able to get warm. Paracetamol taken and began to take affect. At various intervals in the night awoke with nightclothes drenched in sweat. Awoke with headache and wooziness in the morning. Felt unable to go to work. Company comment: This case concerns a 41-year old female patient with no relevant medical history, who experienced the serious unexpected events of Headache, fatigue, Vaccination site pain, Pyrexia, Night Sweats,dizziness, Chills. The events Chills and Dizziness occurred on an unknown date after the third dose of mRNA-1273. The events Headache, fatigue, Vaccination site pain, Pyrexia, Night Sweats occurred the same day after the third dose of mRNA-1273. The rechallenge was not applicable since the AEs occurred after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 41-year old female patient with no relevant medical history, who experienced the serious unexpected events of Headache, fatigue, Vaccination site pain, Pyrexia, Night Sweats,dizziness, Chills. The events Chills and Dizziness occurred on an unknown date after the third dose of mRNA-1273. The events Headache, fatigue, Vaccination site pain, Pyrexia, Night Sweats occurred the same day after the third dose of mRNA-1273. The rechallenge was not applicable since the AEs occurred after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1907242 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Lethargy, Nausea, Pain in extremity, Sensitive skin
SMQs:, Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: Nausea; Headache; Hypersensitive skin; Lethargy; Joint pain; Aching in limb; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26222430) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache), SENSITIVE SKIN (Hypersensitive skin), LETHARGY (Lethargy), ARTHRALGIA (Joint pain) and PAIN IN EXTREMITY (Aching in limb) in a 23-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PAIN IN EXTREMITY (Aching in limb) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), SENSITIVE SKIN (Hypersensitive skin) (seriousness criterion medically significant), LETHARGY (Lethargy) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea) and ARTHRALGIA (Joint pain) was resolving and HEADACHE (Headache), SENSITIVE SKIN (Hypersensitive skin), LETHARGY (Lethargy) and PAIN IN EXTREMITY (Aching in limb) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient last menstrual period date was 1-Oct-2021. The patient was not pregnant and not breastfeeding during the time of reporting. No concomitant product use was provided by the reporter. No treatment medications were reported. Company comment: This regulatory case concerns a 23-year-old female patient, with unknown medical history who experienced the serious unexpected events of NAUSEA, HEADACHE, SENSITIVE SKIN, LETHARGY, ARTHRALGIA and PAIN IN EXTREMITY. Event of pain in extremity occurred on the same day after receiving a third dose of mRNA-1273. Other reported events occurred one day after receiving that dose. Further information about previous doses of the vaccination schedule was not provided. The rechallenge was captured as unknown as per the Regulatory Authority assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory case concerns a 23-year-old female patient, with unknown medical history who experienced the serious unexpected events of NAUSEA, HEADACHE, SENSITIVE SKIN, LETHARGY, ARTHRALGIA and PAIN IN EXTREMITY. Event of pain in extremity occurred on the same day after receiving a third dose of mRNA-1273. Other reported events occurred one day after receiving that dose. Further information about previous doses of the vaccination schedule was not provided. The rechallenge was captured as unknown as per the Regulatory Authority assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1907243 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-11
Onset:2021-11-17
   Days after vaccination:220
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Breast swelling, Lymph node pain
SMQs:, Angioedema (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: Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: swelling around my arm pit and into surrounding areas ie breast and back swelling; Breast swelling; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26228312) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (swelling around my arm pit and into surrounding areas ie breast and back swelling) and BREAST SWELLING (Breast swelling) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. Concurrent medical conditions included Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)). On 11-Apr-2021, the patient started COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) at an unspecified dose. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced BREAST SWELLING (Breast swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced LYMPH NODE PAIN (swelling around my arm pit and into surrounding areas ie breast and back swelling) (seriousness criterion medically significant). At the time of the report, LYMPH NODE PAIN (swelling around my arm pit and into surrounding areas ie breast and back swelling) had not resolved and BREAST SWELLING (Breast swelling) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication reported Patient did not experience any COVID-19 Symptoms and not had COVID-19 test since having the vaccine. Patient was not currently breastfeeding. She took unspecified medicines for inflammatory bowel disease. The patient had swelling around arm pit and into surrounding areas that was breast and back swelling. No treatment information reported. Company Comment: This case concerns a 48 year-old, female patient with a history of AstraZeneca vaccination (considered as a suspect drug), who experienced the serious unexpected events of Lymph node pain and Breast swelling. The event Breast swelling occurred the same after the booster dose of mRNA-1273 vaccine and the event Lymph node pain on an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The medical history, of AstraZeneca vaccination (considered as a suspect drug) remains a confounder. The patient received the second dose on AstraZeneca vaccine on 11-apr-2021. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 48 year-old, female patient with a history of AstraZeneca vaccination (considered as a suspect drug), who experienced the serious unexpected events of Lymph node pain and Breast swelling. The event Breast swelling occurred the same after the booster dose of mRNA-1273 vaccine and the event Lymph node pain on an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The medical history, of AstraZeneca vaccination (considered as a suspect drug) remains a confounder. The patient received the second dose on AstraZeneca vaccine on 11-apr-2021. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1907246 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE MRNA
Current Illness:
Preexisting Conditions: Comments: No medical history reported. Patient has not had symptoms associated with COVID-19 and Not had a COVID-19 test.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26223490) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle pain) and INJECTION (Injection) in a 60-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. No medical history reported. Patient has not had symptoms associated with COVID-19 and Not had a COVID-19 test. Concomitant products included COVID-19 VACCINE MRNA from 26-Feb-2021 to an unknown date for Vaccination. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant) and INJECTION (Injection) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) was resolving and MYALGIA (Muscle pain) and INJECTION (Injection) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. It was reported that patient had Pain at vaccination site at 17.40 Wednesday 17th ,Bad night sleep, Terrific headache paracetamol did not resolve. Slept most of the next day, started feeling better 18.00 18th, Still very dead arm at injection site Patient is not enrolled in clinical trial. Company Comment: This regulatory case concerns a 60-year-old female patient, with unknown medical history, who experienced the serious unexpected events of HEADACHE and MYALGIA. INJECTION was also reported as an event. The events occurred the day after receiving a dose of mRNA-1273. This is the third vaccine against COVID-19 administered to the patient, and it is reported that she previously received a dose of COVID-19 mRNA VACCINE BIOTECH (26 February 2021). The rechallenge was considered as unknown by the regulatory authority. On the source document narrative, it is mentioned that the patient experienced injection site pain. The benefit-risk relationship of mRNA 1273 is not affected by this report.; Sender''s Comments: This regulatory case concerns a 60-year-old female patient, with unknown medical history, who experienced the serious unexpected events of HEADACHE and MYALGIA. INJECTION was also reported as an event. The events occurred the day after receiving a dose of mRNA-1273. This is the third vaccine against COVID-19 administered to the patient, and it is reported that she previously received a dose of COVID-19 mRNA VACCINE BIOTECH (26 February 2021). The rechallenge was considered as unknown by the regulatory authority. On the source document narrative, it is mentioned that the patient experienced injection site pain. The benefit-risk relationship of mRNA 1273 is not affected by this report.


VAERS ID: 1907247 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-01
Onset:2021-11-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Headache, Intermenstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20211113; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was initially received via regulatory authority (Reference number: GB-MHRA-ADR 26223912) on 19-Nov-2021. The most recent information was received on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (Intermenstrual bleeding), DYSMENORRHOEA (Pain menstrual) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. No medical history was reported. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from October 2021 to an unknown date for Flu vaccination, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 01-May-2021 to an unknown date for Vaccination and COVID-19 vaccination. In November 2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced INTERMENSTRUAL BLEEDING (Intermenstrual bleeding) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced DYSMENORRHOEA (Pain menstrual) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 18-Nov-2021, HEADACHE (Headache) had resolved. At the time of the report, INTERMENSTRUAL BLEEDING (Intermenstrual bleeding) and DYSMENORRHOEA (Pain menstrual) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was provided. Unsure if patient had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious unexpected events of intermenstrual bleeding, dysmenorrhea, headache. The events occurred an unknown date on the same month after a dose of mRNA-1273. The rechallenge was not applicable since the AEs occurred after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Additional information includes, case seriousness upgraded to serious and added concomitant new dosage regimens with indication.; Sender''s Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious unexpected events of intermenstrual bleeding, dysmenorrhea, headache. The events occurred an unknown date on the same month after a dose of mRNA-1273. The rechallenge was not applicable since the AEs occurred after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1907249 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Neuralgia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (narrow), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: shooting pains cross both shoulders down arms to hands; Neuralgia; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26224081) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NEURALGIA (Neuralgia) and ARTHRALGIA (shooting pains cross both shoulders down arms to hands) in a 41-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 07-Jun-2021 to 20-Jun-2021. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced NEURALGIA (Neuralgia) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (shooting pains cross both shoulders down arms to hands) (seriousness criterion medically significant). At the time of the report, NEURALGIA (Neuralgia) and ARTHRALGIA (shooting pains cross both shoulders down arms to hands) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medication use was not reported. Treatment history was not reported. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. company comment: This case concerns a 41-year old female patient with no relevant medical history, who experienced the serious unexpected events of neuralgia and arthralgia. The event arthralgia occurred on an unknown date after the third dose of mRNA-1273. The event neuralgia occurred the day after the third dose of mRNA-1273. The rechallenge was unknown as per RA. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 41-year old female patient with no relevant medical history, who experienced the serious unexpected events of neuralgia and arthralgia. The event arthralgia occurred on an unknown date after the third dose of mRNA-1273. The event neuralgia occurred the day after the third dose of mRNA-1273. The rechallenge was unknown as per RA. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1907252 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cold sweat, Headache, Influenza like illness, Malaise, Pain, Photophobia, SARS-CoV-2 test
SMQs:, Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: within hours of having moderna vaccine; clammy; flu like symptoms; unwell; severe body aches; headache; Body temperature; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26225504) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (within hours of having moderna vaccine), COLD SWEAT (clammy), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (unwell), PAIN (severe body aches), HEADACHE (headache) and BODY TEMPERATURE (Body temperature) in a 67-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Previously administered products included for Product used for unknown indication: OESTROGEN. Past adverse reactions to the above products included No adverse event with OESTROGEN. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 16-Feb-2021 to 08-May-2021 for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced BODY TEMPERATURE (Body temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced PHOTOPHOBIA (within hours of having moderna vaccine) (seriousness criterion medically significant), COLD SWEAT (clammy) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion medically significant), MALAISE (unwell) (seriousness criterion medically significant), PAIN (severe body aches) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). On 18-Nov-2021, BODY TEMPERATURE (Body temperature) had resolved. At the time of the report, PHOTOPHOBIA (within hours of having moderna vaccine), COLD SWEAT (clammy), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (unwell), PAIN (severe body aches) and HEADACHE (headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medications was not provided by the reporter. Patient had uncontrollable body shakes,to the point of almost passing out, no appetite and a horrible metallic taste in mouth. Patient has not tested positive for COVID-19 since having the vaccine. Company Comment: This regulatory authority case concerns a 67-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Cold sweat, Influenza like illness, Malaise, Pain (reported as body aches) and Headache after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule (dosage unknown). The patient had received two doses of COVID-19 CHADOX-1 AstraZeneca Vaccine as the initial schedule of vaccination approximately 6 months and 8 days before. The events occurred at an unknown date after the third dose of mRNA- 1273 vaccine. Additionally, body temperature was reported. Clinical manifestations included chills, loss of appetite and metallic taste in mouth. Body aches and headache are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge was reported as unknown, only one dose of mRNA- 1273 Moderna vaccine was administered. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 67-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Cold sweat, Influenza like illness, Malaise, Pain (reported as body aches) and Headache after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule (dosage unknown). The patient had received two doses of COVID-19 CHADOX-1 AstraZeneca Vaccine as the initial schedule of vaccination approximately 6 months and 8 days before. The events occurred at an unknown date after the third dose of mRNA- 1273 vaccine. Additionally, body temperature was reported. Clinical manifestations included chills, loss of appetite and metallic taste in mouth. Body aches and headache are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge was reported as unknown, only one dose of mRNA- 1273 Moderna vaccine was administered. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report


VAERS ID: 1907255 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site pain, Migraine, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211024; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Migraine; Myalgia; Injection site pain; Nausea; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26226054) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), MYALGIA (Myalgia), INJECTION SITE PAIN (Injection site pain) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced MYALGIA (Myalgia) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant). At the time of the report, MIGRAINE (Migraine), MYALGIA (Myalgia), INJECTION SITE PAIN (Injection site pain) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications reported No treatment medications provided. Company Comment: This case concerns a 63-year-old female with no relevant medical history reported in the case, who experienced the serious unexpected events of Migraine, Myalgia, Nausea and Injection site pain. The events Myalgia, Nausea and Injection site pain occurred on the same day after the administration of the third dose of the mRNA-1273 vaccine and the event of Migraine occurred one day after the administration of the third dose of the mRNA-1273 vaccine. At the time of the report, the outcome of the events was Not Recovered/Not Resolved. The rechallenge is not applicable since the events occurred after the third dose of the vaccine and another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 63-year-old female with no relevant medical history reported in the case, who experienced the serious unexpected events of Migraine, Myalgia, Nausea and Injection site pain. The events Myalgia, Nausea and Injection site pain occurred on the same day after the administration of the third dose of the mRNA-1273 vaccine and the event of Migraine occurred one day after the administration of the third dose of the mRNA-1273 vaccine. At the time of the report, the outcome of the events was Not Recovered/Not Resolved. The rechallenge is not applicable since the events occurred after the third dose of the vaccine and another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1907259 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Peripheral swelling, Pruritus, SARS-CoV-2 test, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANASTROZOLE
Current Illness:
Preexisting Conditions: Comments: No medical history was reported
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: swelling; Swollen arm; Redness; Itching; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26226359) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Redness), PRURITUS (Itching) and SWELLING (swelling) in a 64-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No medical history was reported. Concomitant products included ANASTROZOLE from 01-Jun-2016 to an unknown date for Breast cancer. On 15-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), ERYTHEMA (Redness) (seriousness criterion medically significant) and PRURITUS (Itching) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING (swelling) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Redness) and PRURITUS (Itching) had not resolved and SWELLING (swelling) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information mentioned. Company comment- This case concerns a 64-year-old female patient with no relevant medical history reported who experienced the unexpected and serious events of peripheral swelling, erythema, swelling and pruritus. The event swelling occurred on an unknown day after a third dose of mRNA-1273 vaccine was administered, the rest of the events occurred 2 days after vaccine was given. The rechallenge was not applicable since the events happened after the third dose and only information of one dose is disclosed and no further dose is expected. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 64-year-old female patient with no relevant medical history reported who experienced the unexpected and serious events of peripheral swelling, erythema, swelling and pruritus. The event swelling occurred on an unknown day after a third dose of mRNA-1273 vaccine was administered, the rest of the events occurred 2 days after vaccine was given. The rechallenge was not applicable since the events happened after the third dose and only information of one dose is disclosed and no further dose is expected. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1907265 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Insomnia, Pain in extremity, SARS-CoV-2 test
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Joint ache; Insomnia; Painful arm; Exhaustion; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26226867) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Exhaustion), ARTHRALGIA (Joint ache), INSOMNIA (Insomnia) and PAIN IN EXTREMITY (Painful arm) in a 53-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 03-Mar-2021 to an unknown date for Vaccination. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced FATIGUE (Exhaustion) (seriousness criterion medically significant), INSOMNIA (Insomnia) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) was resolving and FATIGUE (Exhaustion), ARTHRALGIA (Joint ache), INSOMNIA (Insomnia) and PAIN IN EXTREMITY (Painful arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient was suffering with pain at the site of the vaccination and was feeling exhausted. Also he had strange tingling sensations across his skin and broken sleep. It was also reported that he had a headache, aching armpits, back shoulders and a generally melancholy demeanour. The patient had thick head and feel like he need to sleep constantly. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company Comment : This case concerns a 53-year-old, male patient with no relevant medical history reported, who experienced the unexpected events of headache, fatigue, arthralgia, insomnia and pain in extremity. The events occurred the same day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 53-year-old, male patient with no relevant medical history reported, who experienced the unexpected events of headache, fatigue, arthralgia, insomnia and pain in extremity. The events occurred the same day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1907266 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Fatigue, Headache, Hyperhidrosis, Injection site pain, Lymphadenopathy, Myalgia, Nausea, Rash, SARS-CoV-2 test, Thirst
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS; PREMIQUE; COVID-19 MRNA VACCINE BNT162B2; COVID-19 MRNA VACCINE BNT162B2
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test was negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Appetite absent; Weakness; Sweating; Rash; Swollen lymph nodes; Fatigue; Diarrhea; Nausea; Headache; Pain injection site; Pain muscle; Increased thirst; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26226876) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite absent), ASTHENIA (Weakness), HYPERHIDROSIS (Sweating), THIRST (Increased thirst), RASH (Rash), INJECTION SITE PAIN (Pain injection site), MYALGIA (Pain muscle), LYMPHADENOPATHY (Swollen lymph nodes), HEADACHE (Headache), FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included ESTROGENS CONJUGATED, MEDROXYPROGESTERONE ACETATE (PREMIQUE) for Menopause, TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 27-Feb-2021 to an unknown date for Vaccination, INFLUENZA VACCINE (INFLUENZA VIRUS) from 07-Nov-2021 to an unknown date and TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from May 2021 to an unknown date for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced THIRST (Increased thirst) (seriousness criterion medically significant), INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant), MYALGIA (Pain muscle) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced DECREASED APPETITE (Appetite absent) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), RASH (Rash) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, DECREASED APPETITE (Appetite absent), ASTHENIA (Weakness), MYALGIA (Pain muscle), LYMPHADENOPATHY (Swollen lymph nodes), HEADACHE (Headache) and FATIGUE (Fatigue) was resolving, HYPERHIDROSIS (Sweating), THIRST (Increased thirst), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had resolved and RASH (Rash) and INJECTION SITE PAIN (Pain injection site) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, SARS-CoV-2 test: negative (Negative) COVID-19 virus test was negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Treatment medications was provided. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 Company comment: This regulatory authority case concerns a female patient with no relevant medical history who experienced serious unexpected events of injection site pain, myalgia, headache, rash, lymphadenopathy, fatigue, decreased appetite, asthenia, diarrhoea, nausea, hyperhidrosis. The events occurred approximately within 24 hours from the third dose of the Moderna COVID-19 vaccine. Rechallenge was not applicable since the events occurred after the third dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a female patient with no relevant medical history who experienced serious unexpected events of injection site pain, myalgia, headache, rash, lymphadenopathy, fatigue, decreased appetite, asthenia, diarrhoea, nausea, hyperhidrosis. The events occurred approximately within 24 hours from the third dose of the Moderna COVID-19 vaccine. Rechallenge was not applicable since the events occurred after the third dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report.


VAERS ID: 1907267 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chills, Nausea
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Acute back pain; Nausea; Chills; This case was received(Reference number: GB-MHRA-ADR 26226907) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Acute back pain), NAUSEA (Nausea) and (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced BACK PAIN (Acute back pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 19-Nov-2021, NAUSEA (Nausea) and CHILLS (Chills) had resolved. At the time of the report, BACK PAIN (Acute back pain) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The Patient has not had symptoms associated with COVID-19 and Not had a COVID-19 test The report was not related to possible inflammation of the heart ,myocarditis or pericarditis company comment: This case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected events of back pain, nausea and chills. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected events of back pain, nausea and chills. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1907268 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 39.8; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; This case was received via (Reference number: GB-MHRA-ADR 26226963) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. No Medical History information was reported. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 17-Nov-2021, PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 39.8 (High) 39.8. On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. Concomitant medications were not provided. No Treatment information was provided. Patient has not had symptoms associated with COVID-19 Patient noticed temperature 12 hours after booster and it went up to 39.8 degrees and patient could barely move. Company comment: This regulatory authority case concerns a patient with no relevant medical history who experienced serious unexpected event of pyrexia. The events occurred approximately one day after the third dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow up received on 23-NOV-2021 as live follow up, Significant information of lab data and Action taken updated.; Sender''s Comments: This regulatory authority case concerns a patient with no relevant medical history who experienced serious unexpected event of pyrexia. The events occurred approximately one day after the third dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report.


VAERS ID: 1907270 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Heart rate increased, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Arthritis (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS; COVID-19 VACCINE ASTRAZENECA
Current Illness: Multiple sclerosis (Taking medicines for multiple sclerosis)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Heart rate high; Joint ache; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26227054) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint ache), HEADACHE (Headache) and HEART RATE INCREASED (Heart rate high) in a 60-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Concurrent medical conditions included Multiple sclerosis (Taking medicines for multiple sclerosis). Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 18-Sep-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 20-Feb-2021 to 08-May-2021 for Vaccination. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced ARTHRALGIA (Joint ache) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced HEART RATE INCREASED (Heart rate high) (seriousness criterion medically significant). On 18-Nov-2021, HEADACHE (Headache) had resolved. On 19-Nov-2021, HEART RATE INCREASED (Heart rate high) had resolved. At the time of the report, ARTHRALGIA (Joint ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had not tested positive for COVID-19 since having the vaccine. No treatment details were provided. Company Comment: This case concerns a 60-year-old, female patient with relevant medical history of multiple sclerosis, who experienced the unexpected events of headache, arthralgia and heart rate increased. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by regulatory Authority. The medical history of multiple sclerosis remains a confounder. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 60-year-old, female patient with relevant medical history of multiple sclerosis, who experienced the unexpected events of headache, arthralgia and heart rate increased. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by regulatory Authority. The medical history of multiple sclerosis remains a confounder. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1907273 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Decreased appetite, Headache, Pain in extremity, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: loss of appetite; achy; Painful arm; Chills; Faint; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26227425) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), HEADACHE (achy), PAIN IN EXTREMITY (Painful arm), CHILLS (Chills) and SYNCOPE (Faint) in a 59-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 13-Mar-2021 to an unknown date for COVID-19 vaccination. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and SYNCOPE (Faint) (seriousness criterion medically significant). On an unknown date, the patient experienced DECREASED APPETITE (loss of appetite) (seriousness criterion medically significant) and HEADACHE (achy) (seriousness criterion medically significant). On 18-Nov-2021, CHILLS (Chills) and SYNCOPE (Faint) had resolved. At the time of the report, DECREASED APPETITE (loss of appetite) and HEADACHE (achy) had not resolved and PAIN IN EXTREMITY (Painful arm) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Felt so cold and unable to warm up like bad case of flu. Only with Morderna booster as never had with AZ jab or any other jab. loss of appetite as so ill. Feeling faint and achy. Bedridden. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This case concerns a 59-year-old female patient, with medical history of having received COVID-19 Vaccine Astrazeneca as a previous dose, who experienced the unexpected serious events of DECREASED APPETITE, HEADACHE, PAIN IN EXTREMITY, CHILLS and SYNCOPE. The events started on the same day of after the administration of the third dose (unknown dosage) of mRNA-1273 vaccine. The rechallenge was unknown. Patient�s medical history of having received COVID-19 Vaccine Astrazeneca as a previous dose, remains as a confounder. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 59-year-old female patient, with medical history of having received COVID-19 Vaccine Astrazeneca as a previous dose, who experienced the unexpected serious events of DECREASED APPETITE, HEADACHE, PAIN IN EXTREMITY, CHILLS and SYNCOPE. The events started on the same day of after the administration of the third dose (unknown dosage) of mRNA-1273 vaccine. The rechallenge was unknown. Patient�s medical history of having received COVID-19 Vaccine Astrazeneca as a previous dose, remains as a confounder. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1907288 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Decreased appetite, Fatigue, Hallucination, Headache, Limb discomfort, Pyrexia, SARS-CoV-2 test, Xanthopsia
SMQs:, Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Hallucination; Feverish; Taste loss; Vision yellow; Tired all the time; Headache; Appetite lost; Arm discomfort; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26229960) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucination), PYREXIA (Feverish), AGEUSIA (Taste loss), XANTHOPSIA (Vision yellow), FATIGUE (Tired all the time), HEADACHE (Headache), DECREASED APPETITE (Appetite lost) and LIMB DISCOMFORT (Arm discomfort) in a 55-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant), AGEUSIA (Taste loss) (seriousness criterion medically significant), XANTHOPSIA (Vision yellow) (seriousness criterion medically significant), FATIGUE (Tired all the time) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant) and LIMB DISCOMFORT (Arm discomfort) (seriousness criterion medically significant). On 19-Nov-2021, HALLUCINATION (Hallucination) and HEADACHE (Headache) had resolved, PYREXIA (Feverish) was resolving. At the time of the report, AGEUSIA (Taste loss), XANTHOPSIA (Vision yellow), FATIGUE (Tired all the time), DECREASED APPETITE (Appetite lost) and LIMB DISCOMFORT (Arm discomfort) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: postive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient had usual flu like symptoms but worst part was the anxiety based dreams and hallucinations. Patient actually fell out of bed to escape the giant alien spiders. Patient had not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No treatment information was provided. Company Comment; This case concerns a 55-year-old, male patient with no relevant medical history, who experienced the unexpected events of Hallucination, Pyrexia, Ageusia, Xanthopsia, Fatigue, Headache, Decreased Appetite, and Limb Discomfort. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19). The rechallenge was unknown not applicable as events occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19) is not affected by this report.; Sender''s Comments: This case concerns a 55-year-old, male patient with no relevant medical history, who experienced the unexpected events of Hallucination, Pyrexia, Ageusia, Xanthopsia, Fatigue, Headache, Decreased Appetite, and Limb Discomfort. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19). The rechallenge was unknown not applicable as events occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19) is not affected by this report.


VAERS ID: 1907289 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Feeling cold, Headache, Oral herpes, Pyrexia, SARS-CoV-2 test, Somnolence, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Bisoprolol 2.5mg one a day Lisinopril 10mg one a day Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: feeling cold; Cold sores; Headache; Loss of energy; High temperature; Shaking; Sleepy; This case was received via RA (Reference number: GB-MHRA-ADR 26230080) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), ASTHENIA (Loss of energy), FEELING COLD (feeling cold), PYREXIA (High temperature), TREMOR (Shaking), SOMNOLENCE (Sleepy) and ORAL HERPES (Cold sores) in a 53-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. Bisoprolol 2.5mg one a day Lisinopril 10mg one a day Patient has not had symptoms associated with COVID-19. Previously administered products included for Product used for unknown indication: Bisoprolol (2.5mg one a day) and Lisinopril (10mg one a day). Past adverse reactions to the above products included No adverse event with Bisoprolol and Lisinopril. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), ASTHENIA (Loss of energy) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), TREMOR (Shaking) (seriousness criterion medically significant) and SOMNOLENCE (Sleepy) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced ORAL HERPES (Cold sores) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING COLD (feeling cold) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) had not resolved, ASTHENIA (Loss of energy) had resolved with sequelae, FEELING COLD (feeling cold), PYREXIA (High temperature), SOMNOLENCE (Sleepy) and ORAL HERPES (Cold sores) was resolving and TREMOR (Shaking) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication provided. The patient had the injection all fine about 1.5 hours later arm started to hurt, went to work at 15:00 felt something was hang about me at 17:00 couldn''t get warm started to shake feeling cold, 18:00 couldn''t eat my tea at 19:00 neck started to feel stiff along with a high temperature went home at 23:00 went to bed at 00:00 very very hot to touch all over (thought I had covid again ) woke up for toilet 5 time for a wee not usual very orange in colour drank water each time patient been woke at 06:00 for all was up still very sleepy hard to walk down stairs, went back to bed at 09:00 slept till 12:00 felt a bit better at 17:00 had tea got some down me slept in chair most of the night went to bed at 01:00 woke at 06:50 had breakfast still aches and pains along with a headache which still have been taking paracetamol for headaches now at 19/11/2021 at 21:20 still got the headaches hopefully fully recovered in morning . Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This regulatory authority case concerns a 53-year-old male patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Oral herpes, Somnolence, Tremor, Feeling cold, Asthenia, Headache and Pyrexia after mRNA- 1273 Moderna vaccine. The events Somnolence, Tremor, Feeling cold, Asthenia, Headache and Pyrexia occurred on the day after the third dose of mRNA- 1273 vaccine (dosage unknown) and Oral herpes occurred approximately 1 day after the third dose. The rechallenge was reported as unknown, only information about the third dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 53-year-old male patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Oral herpes, Somnolence, Tremor, Feeling cold, Asthenia, Headache and Pyrexia after mRNA- 1273 Moderna vaccine. The events Somnolence, Tremor, Feeling cold, Asthenia, Headache and Pyrexia occurred on the day after the third dose of mRNA- 1273 vaccine (dosage unknown) and Oral herpes occurred approximately 1 day after the third dose. The rechallenge was reported as unknown, only information about the third dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 1907290 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abnormal dreams, Arthralgia, Axillary pain, Fatigue, Feeding disorder, Feeling cold, Gait disturbance, Joint stiffness, Lymphadenopathy, Pain in extremity, SARS-CoV-2 test, Swelling, Tremor
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: stiff joints; Armpit pain; Neck swelling; Swollen lymph nodes; Fatigue extreme; Stumbling; Bizarre dreams; Feeling cold; Unable to eat; Joint pain; Shaking; Pain in arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26230113) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (stiff joints), TREMOR (Shaking), SWELLING (Neck swelling), FEELING COLD (Feeling cold), FEEDING DISORDER (Unable to eat), ARTHRALGIA (Joint pain), LYMPHADENOPATHY (Swollen lymph nodes), FATIGUE (Fatigue extreme), GAIT DISTURBANCE (Stumbling), ABNORMAL DREAMS (Bizarre dreams), AXILLARY PAIN (Armpit pain) and PAIN IN EXTREMITY (Pain in arm) in a 60-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 19-Feb-2021 to an unknown date for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced TREMOR (Shaking) (seriousness criterion medically significant), FEELING COLD (Feeling cold) (seriousness criterion medically significant), FEEDING DISORDER (Unable to eat) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), FATIGUE (Fatigue extreme) (seriousness criterion medically significant), GAIT DISTURBANCE (Stumbling) (seriousness criterion medically significant) and ABNORMAL DREAMS (Bizarre dreams) (seriousness criterion medically significant). On 19-Nov-2021, the patient experienced SWELLING (Neck swelling) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant) and AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant). On an unknown date, the patient experienced JOINT STIFFNESS (stiff joints) (seriousness criterion medically significant). On 18-Nov-2021, TREMOR (Shaking) had resolved. At the time of the report, JOINT STIFFNESS (stiff joints), FEELING COLD (Feeling cold), FEEDING DISORDER (Unable to eat), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue extreme) was resolving, SWELLING (Neck swelling), LYMPHADENOPATHY (Swollen lymph nodes), AXILLARY PAIN (Armpit pain) and PAIN IN EXTREMITY (Pain in arm) had not resolved, GAIT DISTURBANCE (Stumbling) had resolved and ABNORMAL DREAMS (Bizarre dreams) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was unsure if she had symptoms associated with COVID-19. She had initial pain at injection point then general aching. Day after, she felt ill and very cold 24 hours after booster whole body started shaking violently and she was stumbling when walking around house kept walking into things and felt freezing cold even with heating warm clothes and hot water bottle. She fell asleep at 6pm . Had no appetite. Had weird dream at night normally never dream. She felt ill in morning and still had no appetite. She felt sick at thought of food and pain under arm on side of jab. During the day of 19th, she had swollen glands above collar bone and continuing in arm pit . She had stiff joints after sitting for a while. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company Comment: This case concerns a 60-year-old, female patient with a history of COVID-19 VACCINE ASTRAZENECA (9 months before the dose of mRNA-1273 vaccine), who experienced the unexpected serious events of Joint stiffness, Arthralgia, Tremor, Gait disturbance, Pain in extremity, Abnormal dreams, Swelling (neck swelling), with LYMPHADENOPATHY and AXILLARY PAIN , Feeding disorder, Fatigue, and other events. The events occurred approximately during the same day and through the following 2 days after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable since the events happened after the third dose and no information on additional dosing is expected. The medical history of COVID-19 VACCINE ASTRAZENECA (9 months before the dose of mRNA-1273 vaccine), remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to important medical event.; Sender''s Comments: This case concerns a 60-year-old, female patient with a history of COVID-19 VACCINE ASTRAZENECA (9 months before the dose of mRNA-1273 vaccine), who experienced the unexpected serious events of Joint stiffness, Arthralgia, Tremor, Gait disturbance, Pain in extremity, Abnormal dreams, Swelling (neck swelling), with LYMPHADENOPATHY and AXILLARY PAIN , Feeding disorder, Fatigue, and other events. The events occurred approximately during the same day and through the following 2 days after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable since the events happened after the third dose and no information on additional dosing is expected. The medical history of COVID-19 VACCINE ASTRAZENECA (9 months before the dose of mRNA-1273 vaccine), remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to important medical event.


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