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From the 1/21/2022 release of VAERS data:

Found 1,049,249 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 150 out of 10,493

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VAERS ID: 2032140 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-12-16
Onset:2021-12-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032H21A / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypersensitivity, Pyrexia, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Propanol Alprazolam Vitamin D supplement
Current Illness: N/A
Preexisting Conditions: Factor V Leiden
Allergies: Vicodin
Diagnostic Lab Data: COVID-19 test: 01/06/2022
CDC Split Type: vsafe

Write-up: On Sunday at 4:30pm, I noticed hives. Later in the evening around 9pm, I noticed I was having hives so I went and got Benadryl. That Tuesday, the hives were getting worse so I went to urgent care and they told me I was having an allergic reaction to the booster shot. They prescribed Albuterol and Protozoan steroid pills on 12/28/2021. That Thursday night, I had a fever that seemed abnormal and wasn''t listed as a side effect to the steroid. So I contacted my PCP who told me to get off the Protozoan because it could compromise my immune system and told me to get a COVID-19 test. I went back to urgent care on 01/04/2022 because I still wasn''t recovering, but I had an appointment with my PCP on 01/06/2022 so I was advised to take the Protozoan again until my appointment. I began taking it again after a follow-up appointment with my PCP on 01/08/2022 and was told to take it for 6 consecutive days (01/08/2022-01/14/2022) until I see an allergist on 01/18/2022. As of now, it''s on and off, it varies day to day on when I feel side effects and symptoms.


VAERS ID: 2032296 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-01-12
Onset:2021-12-26
   Days after vaccination:348
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
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: 12/27/2021 positive COVID-19 test
CDC Split Type:

Write-up: Breakthrough COVID-19. I had symptoms starting on 12/26/2021 and tested positive on 12/27/2021.


VAERS ID: 2034564 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-04-26
Onset:2021-12-26
   Days after vaccination:244
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 antibody 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: Medical History/Concurrent Conditions: Allergy to nuts
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: Nasal Swab; Test Result: Positive
CDC Split Type: USPFIZER INC202200009050

Write-up: Got covid; Got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 25 year-old male patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Lot number: EW0172) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "All nuts allergy" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1 , Batch/Lot No: ER8737), administration date: 02Apr2021, for Covid-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "Got covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (30Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Additional information: The patient got covid with the following symptoms: cough, sore throat, fatigue, stuffy nose. There was no prolonged hospitalization. No treatment was received. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has been tested for COVID-19.


VAERS ID: 2034565 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-22
Onset:2021-12-26
   Days after vaccination:248
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient History: No Allergies: No known Allergies.
Allergies:
Diagnostic Lab Data: Test Date: 20220103; Test Name: COVID-19; Test Result: Negative ; Test Date: 20211226; Test Name: Rapid Test; Test Result: Positive
CDC Split Type: USPFIZER INC202200009101

Write-up: Tested positive Covid-19 virus; Tested positive Covid-19 virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group for a Pfizer sponsored program (159558). The reporter is the patient. A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Lot number: EP7533) at the age of 52 years as dose 2, single and administered in arm left, administration date 01Apr2021 (Lot number: EP7533) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovered" (03Jan2022) and all described as "Tested positive Covid-19 virus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) negative; (26Dec2021) positive. Patient tested positive for the Covid virus on the Day after Christmas 26Dec2021, quarantined then for 10 days, tested negative on 03Jan2022, wants to know when is the soonest time to get the booster. It was unknown if other products were administered or not. Investigation assessment was reported as no. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2037439 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-12-14
Onset:2021-12-26
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032HZ1A / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Blood test abnormal, Cardiomegaly, Chest pain, Electrocardiogram abnormal, Myocardial infarction, Urticaria, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Effexor XR 75mg, Klonopin 1mg, Propranolol 40mg
Current Illness: None
Preexisting Conditions: High BP, High Cholesterol
Allergies: None
Diagnostic Lab Data: Blood work that showed high white blood cell count, EKG that showed possible enlargement in heart both completed on January 10, 2022. I have also been to the ER for chest pain and another urgent care facility for chest pain and hives. I have an appointment to have an ultrasound on my heart coming soon.
CDC Split Type:

Write-up: Hives all over body that come and go and appear in different areas, chest pain all the time that mimics heart attack symptoms, stomach pain


VAERS ID: 2037559 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 029H21B / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Maternal exposure during breast feeding, Pain in extremity
SMQs:, Neonatal exposures via breast milk (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the left arm with 1st shot) and MATERNAL EXPOSURE DURING BREAST FEEDING (Patient breastfeeding administered with first 2 shots) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination. Concomitant products included MAGNESIUM and ZINC for Supplementation therapy. On 26-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Patient breastfeeding administered with first 2 shots). On 27-Dec-2021, the patient experienced PAIN IN EXTREMITY (Pain in the left arm with 1st shot). On 26-Dec-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Patient breastfeeding administered with first 2 shots) had resolved. On 29-Dec-2021, PAIN IN EXTREMITY (Pain in the left arm with 1st shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication use was not provided by the reporter. Patient had accidentally got second dose on 10Jan2022, 2 weeks after first shot, earlier and out of the normal indications to get vaccinated, 1 month apart. She realized of that mistake and went to see 3 different physicians to ask them if there was anything wrong about it. All of the 3 HCPs told her there was no problem. Still, she was concern and mentioned currently breastfeeding when vaccinated and experienced just pain in left arm 1 day following vaccination, and it stopped 1 or 2 days after every shot. This case was linked to MOD-2022-449534 (Patient Link).


VAERS ID: 2037750 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-12-16
Onset:2021-12-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046A21A / UNK LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027B21A / UNK LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059H21A / UNK UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Dyspnoea, Mouth swelling, Pharyngeal swelling, Rash, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Amlodipine/Olmesartan 5/40 Fish oil Multi vitamin 50+ age BioTE ADK-5 Testosterone Gel 1.62% 4 pumps a day
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Unknown at this time.
CDC Split Type:

Write-up: Severe rash spread all over body. Controle by clinic visit and steroid shots. Rash and swelling made it to mouth, tongue and throat which ended up putting me in hospital due to breathing problems.


VAERS ID: 2037886 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-12-16
Onset:2021-12-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026B21A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038B21AA / 2 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032H21A / 3 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspepsia, Ear discomfort, Fatigue, Flushing, Injection site pain, Pruritus, Sensitive skin, Skin warm, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (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: Zyrtec D
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: I have not been able to get an appointment with a doctor yet.
CDC Split Type:

Write-up: Received Moderna booster on Dec 16. Felt arm soreness at injection site and fatigue for a couple of days. Only mild reaction. On Dec 26, noticed very itchy scalp and ears. Dec 27, broke out in hives all over body with intense itchy and warm skin. Skin has remained sensitive and itchy since then, managed a bit with antihistamines. Intense itchiness flairs up randomly in different regions of the body -- ears, wrists, elbows, palms, bottom of feet, etc. But skin all over often feels flushed and easily irritated. Any scratching leaves bright red streaks and can set off raised wheals. Any scratching creates intensified itchiness. I''ve also been suffering from intense bouts of heartburn. I have never experienced this or hives before. I do have seasonal allergies, but no known allergies to foods or medications. I''m now taking Pepcid AC at morning and night, as well as Zyrtec D every morning. Itchiness is most intense at night and early morning when 24 hour antihistamine is wearing off. Trying to manage histamine levels by avoiding high histamine foods.


VAERS ID: 2038061 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-04-16
Onset:2021-12-26
   Days after vaccination:254
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046A21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (broad)

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

Write-up: Bell''s Palsy


VAERS ID: 2038208 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-12-18
Onset:2021-12-26
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2022-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 058H21A / 3 RA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022B21A / 2 RA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002C21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angiogram cerebral normal, Asthenia, Back pain, Blood test, Coccydynia, Computerised tomogram head abnormal, Headache, Intensive care, Magnetic resonance imaging normal, Neck pain, Scan with contrast abnormal, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Arthritis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: I had a sudden Subarachnoid Hemorrhage (SAH). I experienced this as a massive, debilitating, instant headache on 12/26/21. -- The local hospital emergency room performed a quick CT scan, diagnosed the likely SAH and sent me by abulance to Facility Nuero-ICU -- Daily blood tests in neuro-ICU. Stroke functional and other tests at least every 4 hours. -- 12/26/21-1/5/22: Symptoms progressed-- massive headache moderated over days. Pain descended from top of head to neck, down back and into my tail bone. -- 12/26/21 CT Scan with contrast at Facility. Possible but very hard to see aneurysm found. -- 12/27/21 Angiogram with contrast and intent to treat. No aneurysm or other SAH cause found. -- 12/28/21 MRI. Nothing found. -- Nuero-ICU through12/30/21 -- Normal observation in hospital through 12/31/21. Released 12/31/21 -- Course of nimodipine 12/27/21-1/16/22 -- Follow-up angiogram with contrast 1/12/22 at Facility. Nothing found.
CDC Split Type:

Write-up: I had a sudden Subarachnoid Hemorrhage (SAH). I experienced this as a massive, debilitating, instant headache on 12/26/21. -- The local hospital emergency room performed a quick CT scan, diagnosed the likely SAH and sent me by abulance to Facility Nuero-ICU -- Daily blood tests in neuro-ICU. Stroke functional and other tests at least every 4 hours. -- 12/26/21-1/5/22: Symptoms progressed-- massive headache moderated over days. Pain descended from top of head to neck, down back and into my tail bone. -- 12/26/21 CT Scan with contrast at Facility. Possible but very hard to see aneurysm found. -- 12/27/21 Angiogram with contrast and intent to treat. No aneurysm or other SAH cause found. -- 12/28/21 MRI. Nothing found. -- Nuero-ICU through12/30/21 -- Normal observation in hospital through 12/31/21. Released 12/31/21 -- Course of nimodipine 12/27/21-1/16/22 -- Follow-up angiogram with contrast 1/12/22 at Facility. Nothing found.


VAERS ID: 2038356 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Vermont  
Vaccinated:2021-12-23
Onset:2021-12-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 071F21A / 3 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: flovent hfa Losartan simvastatin esomperazole famotidine nabumetone
Current Illness: none that they know of
Preexisting Conditions:
Allergies: codeine penicillin sulfa
Diagnostic Lab Data: none known of
CDC Split Type:

Write-up: First two COVID-19 vaccinations were Pfizer - patient complained that left arm was "lame" from the elbow down. They could not lift their arm and it "felt swollen" and heavy.


VAERS ID: 2038436 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 330368D / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Nausea, Pain in extremity, SARS-CoV-2 test negative
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Pfizer Covid-19, 2nd shot, 5/1/21. I reported those side effects on VAERS.
Other Medications: Spironolactone for hormonal acne, Imvexxy, Progesta-Care OTC
Current Illness:
Preexisting Conditions:
Allergies: Gluten, egg, dairy, garlic, onion
Diagnostic Lab Data: At home Covid-19 test, negative on 1/15/22.
CDC Split Type:

Write-up: 12/26/21 to 12/27/21 - Nausea, headache, fatigue, chills, and arm hurt. Two weeks later, side effects re-occurred for 24 hours. Three weeks later, arm still hurts (never stopped) and fatigue has been back since week 2.


VAERS ID: 2038897 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-01
Onset:2021-12-26
   Days after vaccination:269
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031B21A / 2 RA / OT

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

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

Write-up: Itching all over the body two weeks after booster; Hives move around on the body two weeks after booster; Rash all over body two weeks after booster; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body two weeks after booster), URTICARIA (Hives move around on the body two weeks after booster) and RASH (Rash all over body two weeks after booster) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062e21a, 031B21A and 014C21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, the patient experienced PRURITUS (Itching all over the body two weeks after booster), URTICARIA (Hives move around on the body two weeks after booster) and RASH (Rash all over body two weeks after booster). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching all over the body two weeks after booster), URTICARIA (Hives move around on the body two weeks after booster) and RASH (Rash all over body two weeks after booster) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitants medications was reported. The doctor ordered blood tests for patient to check if he was allergic to anything. This case was linked to MOD-2022-450402, MOD-2022-450393 (Patient Link).


VAERS ID: 2039268 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-09-30
Onset:2021-12-26
   Days after vaccination:87
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822809 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anticoagulant therapy, Cardiac failure, Cardiac ventricular thrombosis, Catheterisation cardiac, Cerebrovascular accident, Computerised tomogram, Echocardiogram, Hypertension, Magnetic resonance imaging, Malaise, Myocarditis, X-ray
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Hypertension (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NOT AWARE
Preexisting Conditions: NOT AWARE
Allergies: NONE
Diagnostic Lab Data: 12/26/21 CAT scan and x-ray, 12/27/21 echocardiogram, 12/28/21 cath, 12/29/31 MRI.
CDC Split Type:

Write-up: Had a stroke 12/26/2021. Had not been feeling well for several weeks & possibly even a few months in hind sight. Did have COVID in August one month before the vaccine, which has been shown to increase adverse events, so am including that information here. Was flown to and admitted to hospital. Diagnosed with Myocarditis, extremely high blood pressure, heart failure, and a clot in his left ventricle. Was given TPA, placed on multiple blood pressure meds, diuretics, and additional blood thinners over the course of several days.


VAERS ID: 2042825 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-12-14
Onset:2021-12-26
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011F21A / 3 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Laboratory test, 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Motrin, Vitamin D 2000 UI, Lexipro 5mg daily, Multi-Vitamin
Current Illness: None
Preexisting Conditions: Anxiety
Allergies: None
Diagnostic Lab Data: The Allergist did a scrape test of my skin to see if it would generate hives. The scrap test (done with just a little stick) did generate hives in a few minutes time and it was diagnosed as Dermatographic Urticaria
CDC Split Type:

Write-up: Skin rash in the form of hives started in 1 area (waist band area across width of body and about 3 inches in height) then over the course of 24 hours spread to most of the body. Hives were itchy and initially treated with Cortizone Cream and Benadryl. Primary Dr was consulted and prescribed 50mg of predisone for 2 days then tapering down 10mg every 2 days. After the first 2 doses of 50mg predisone the symptoms were no better and possibly worse. Visited Urgent care who prescribed 2 days of 60mg predisone with a taper down of 10mg every 2 days. This time the dose was split to be taken 2 times a day to give more relief. Also told to take 10mg of Zyrtec once a day and 25mg of Benadryl once a day before bedtime. Any flair ups could be treated with coritizone cream. This series of medication got the rash under control and the flair ups slowly started to fade away. After 14 days of steroids the benadryl and zyrtec continued for 2 more days when the benadryl was stopped, then 2 days after that the zyrtec was reduced to only needing when flair ups happen, which seems to be about every ew days at this point. The flair ups that now occur now seem to be when pressure is applied to the skin (water from a shower, rubbing around mouth with napkin, etc). Met with allergist to determine if this was a result of an allergic reaction to something else, or what the cause might be. There were no food or environment changes during the course of the event. The Allergist felt the hives were caused by my immune system being on high alert and not by an allergy (she advised me to continue getting any future vaccines that might come out).


VAERS ID: 2043089 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-02-12
Onset:2021-12-26
   Days after vaccination:317
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / UNK - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6199 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 12/26/21 SARS-CoV-2 (COVID-19) detected
CDC Split Type:

Write-up: 12/26/21 presents to ED for "dyspnea". PMHx of "HTN, HLD, AS s/p bioprosthetic replacement"


VAERS ID: 2043399 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-05-01
Onset:2021-12-26
   Days after vaccination:239
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 2 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain lower, Abdominal pain upper, Abdominal rebound tenderness, Chills, Fatigue, Hypertension, Nausea, Pelvic pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Patient''s Medications New Prescriptions No medications on file Previous Medications DIPHENHYDRAMINE (BENADRYL) 25 MG PO TAB take 1 Tab by mouth every 6 hours as needed for FOR ITCHING or FOR RASH. METOPROLOL (LOPRESSOR) 25 MG PO T
Current Illness: Anemia ? Ectopic pregnancy 2009 s/p MTXx2 with Lap salpingectomy ? Endometriosis stage IV ? Endometriosis ? History of DVT (deep vein thrombosis) provoked after surgeries ? Hypertension 12/26/2021 ? Kidney stones ? Ovarian torsion 2008? s/p lap detorsion ? PID (pelvic inflammatory disease) 2006 ? Pulmonary embolism (CMS/HCC) ? Syphilis 2003 ? Trichomonas infection 2004 Pertinent Negatives - Past Medical History Diagnosis Date Noted ? Asthma 12/11/2016 ? CAD (coronary artery disease) 12/11/2016 ? Cancer 12/11/2016 ? Chronic obstructive pulmonary disease (CMS/HCC) 12/11/2016 ? CVA (cerebrovascular accident) (CMS/HCC) 12/11/2016 ? Diabetes mellitus (CMS/HCC) 12/11/2016 ? Dialysis patient 12/11/2016 ? Fibromyalgia 12/11/2016 ? Hypothyroidism 12/11/2016 ? Immune disorder (CMS/HCC) 12/11/2016 ? Restrictive lung disease 12/11/2016 ? Vascular disease
Preexisting Conditions: Anemia ? Ectopic pregnancy 2009 s/p MTXx2 with Lap salpingectomy ? Endometriosis stage IV ? Endometriosis ? History of DVT (deep vein thrombosis) provoked after surgeries ? Hypertension 12/26/2021 ? Kidney stones ? Ovarian torsion 2008? s/p lap detorsion ? PID (pelvic inflammatory disease) 2006 ? Pulmonary embolism (CMS/HCC) ? Syphilis 2003 ? Trichomonas infection 2004 Pertinent Negatives - Past Medical History Diagnosis Date Noted ? Asthma 12/11/2016 ? CAD (coronary artery disease) 12/11/2016 ? Cancer 12/11/2016 ? Chronic obstructive pulmonary disease (CMS/HCC) 12/11/2016 ? CVA (cerebrovascular accident) (CMS/HCC) 12/11/2016 ? Diabetes mellitus (CMS/HCC) 12/11/2016 ? Dialysis patient 12/11/2016 ? Fibromyalgia 12/11/2016 ? Hypothyroidism 12/11/2016 ? Immune disorder (CMS/HCC) 12/11/2016 ? Restrictive lung disease 12/11/2016 ? Vascular disease
Allergies: Imported_Misc_Allergy D limonene flavor- unknown rx- listed on allergy list from HOSPITAL ? Codeine Hives and Hives ? Ibuprofen Itching and Hives ? Iodinated Diagnostic Agents Hives, Itching and Hives Patient had a breakthrough reaction on 1/28/20 after being premedicated for CT Abdomen Pelvis. Severe itching and Radiologist administered Benadryl. ? Ketorolac Tromethamine Hives ? Metoclopramide In outside record from another facility - doesn''t know reaction ? Metrizamide Other Comment from MD in CT note states possible anaphylaxis reaction to iodine ? Nsaids Told due to ketoralac allergy
Diagnostic Lab Data: ? Abdominal Pain "It feels like my stomach just hit a wall and I had instant pain, I think I popped a cyst or something" RLQ and pelvis, fever and nausea x2 days, +rebound tenderness ? Pelvic Pain HPI Pt is a 37-year-old female presenting to our ED with chief complaint of right lower quadrant abdominal pain. Past medical history significant for endometriosis, right sided ovarian torsion, left-sided ectopic pregnancy. Past surgical history significant for left sided oophrectomy, hysterectomy, laparoscopic cyst removal of right ovary with torsion. Patient reports earlier today she was having intercourse with her husband approximately an hour prior to arrival, when suddenly she began to have sharp stabbing right lower quadrant pain. Patient went to the ER right away, stating symptoms are similar to prior ovarian torsion, similar presentation too. Patient denies history of appendectomy. Over the past few days she has had nausea, chills, fatigue and temp of 99?F. Denies taking any medications for her symptoms. Pt further denies any vaginal bleeding, changes in vaginal discharge, urinary sx, flank pain. Review of Systems Constitutional: Negative for fever, + chills HEENT: Negative for recent URI symptoms Respiratory: Negative for shortness of breath Cardiovascular: Negative for chest pain Gastrointestinal: + abdominal pain, + nausea Genitourinary: Negative for urinary symptoms Musculoskeletal: Negative for trauma Skin: Negative for rash Neurological: Negative for weakness or paresthesias Psychiatric/Behavioral: Negative for agitation
CDC Split Type:

Write-up: ? Abdominal Pain "It feels like my stomach just hit a wall and I had instant pain, I think I popped a cyst or something" RLQ and pelvis, fever and nausea x2 days, +rebound tenderness ? Pelvic Pain HPI Pt is a 37-year-old female presenting to our ED with chief complaint of right lower quadrant abdominal pain. Past medical history significant for endometriosis, right sided ovarian torsion, left-sided ectopic pregnancy. Past surgical history significant for left sided oophrectomy, hysterectomy, laparoscopic cyst removal of right ovary with torsion. Patient reports earlier today she was having intercourse with her husband approximately an hour prior to arrival, when suddenly she began to have sharp stabbing right lower quadrant pain. Patient went to the ER right away, stating symptoms are similar to prior ovarian torsion, similar presentation too. Patient denies history of appendectomy. Over the past few days she has had nausea, chills, fatigue and temp of 99?F. Denies taking any medications for her symptoms. Pt further denies any vaginal bleeding, changes in vaginal discharge, urinary sx, flank pain. Review of Systems Constitutional: Negative for fever, + chills HEENT: Negative for recent URI symptoms Respiratory: Negative for shortness of breath Cardiovascular: Negative for chest pain Gastrointestinal: + abdominal pain, + nausea Genitourinary: Negative for urinary symptoms Musculoskeletal: Negative for trauma Skin: Negative for rash Neurological: Negative for weakness or paresthesias Psychiatric/Behavioral: Negative for agitation


VAERS ID: 2043525 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-07-28
Onset:2021-12-26
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040B21A / 2 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Dizziness, Headache, Influenza A virus test negative, Influenza B virus test, Respiratory syncytial virus test negative, SARS-CoV-2 test negative, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: divalproex (DEPAKOTE) 250 MG PO Tablet Delayed Response take 1 Tab by mouth 3 times daily. Med Note (KHAN, UZAIR Sun Dec 26, 2021 5:12 PM) Medication last filled on 11/01/21 with day supply 30 via Sure Scripts emtricitabine
Current Illness: ? Brain mass left frontal ? Neuropathy ? Nonclassic congenital adrenal hyperplasia due to 21-hydroxylase deficiency (CMS/HCC) Non-salt wasting ? Type 1 diabetes (CMS/HCC)
Preexisting Conditions: ? Brain mass left frontal ? Neuropathy ? Nonclassic congenital adrenal hyperplasia due to 21-hydroxylase deficiency (CMS/HCC) Non-salt wasting ? Type 1 diabetes (CMS/HCC)
Allergies: ? Penicillins Other unknown
Diagnostic Lab Data: Specimen Information: Nasopharyngeal; Swab 0 Result Notes Ref Range & Units Influenza A Not Detected Not Detected Influenza B Not Detected Not Detected RSV Not Detected Not Detected SARS-CoV-2 (COVID-19) by NAA, Micro Not Detected Detected Abnormal Narrative Methodology: Nucleic Acid Amplification(NAA)/Polymerase Chain Reaction(PCR) The SARS-CoV-2 (COVID-19) test is for in vitro diagnostic use under the FDA Emergency Use Authorization (EUA) for US laboratories certified under CLIA to perform high complexity testing. This test has not been FDA cleared or approved. Specimen Collected: 12/26/21 12:52 PM Last Resulted: 12/26/21 1:
CDC Split Type:

Write-up: This is a 43y.o. male with a history of congenital adrenal hyperplasia, diabetes type 1, history of substance abuse, left frontal inferior mass (s/p craniotomy), seizure disorder, mood disorder and urinary retention who presents to BFH-ED with a chief complaint of possible syncopal episode. Patient states that he does not recall the episode, but often gets lightheaded when he is hypotensive or hypoglycemic. Per chart review, patient was at a care facility and had a possible syncopal episode after getting up to go to the bathroom. Patient admits to lightheadedness, headaches, chills, vomiting and loose stools for the past week He received his COVID booster vaccine 4 days ago. Denies cough, chest pain, shortness of breath, fevers, abdominal pain, lower extremity edema. Patient has a history of meth and cocaine use and reports that he last used them $g1 year ago. He also states that he stopped drinking alcohol 2 years ago and tobacco use 8 months ago. Patient had an ankle fracture 2 months ago and is currently wearing a cast, which was changed 12/23/21.


VAERS ID: 2045776 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 070H21A / 3 LA / IM

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

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

Write-up: Error: Wrong Dose of Vaccine - Too Low-


VAERS ID: 2047674 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-12-13
Onset:2021-12-26
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069H21A / 3 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthritis, Condition aggravated
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Severe arthritis flare-up in lower extremedies


VAERS ID: 2047986 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: California  
Vaccinated:2021-02-25
Onset:2021-12-26
   Days after vaccination:304
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011A21A / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Angiogram pulmonary, Arthralgia, Arthritis infective, Aspiration joint, Aspiration joint abnormal, Blood culture negative, COVID-19, Condition aggravated, Cough, Hypoxia, Incisional drainage, Joint effusion, Joint swelling, Knee arthroplasty, Pain, Positive airway pressure therapy, Purulent discharge, Pustule, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Sleep apnoea syndrome, Staphylococcal infection, Staphylococcus test positive, Synovial fluid analysis abnormal, Upper respiratory tract infection, X-ray limb abnormal
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Arthritis (narrow), Respiratory failure (broad), Tendinopathies and ligament 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Outpatient Medications: confirmed with Patient Prior to Admission Medications Outpatient Home Medications Taking? Amoxicillin-Pot Clavulanate (AUGMENTIN) 875-125 mg Oral Tab Takes Regularly Sig: Take 1 tablet by mouth 2 times a day for 10 d
Current Illness:
Preexisting Conditions: HTN, sleep apnea on CPAP qhs, premenstrual dysphoric disorder on celexa, h/o L knee replacement at outside hospital 7/2020
Allergies: nka
Diagnostic Lab Data:
CDC Split Type:

Write-up: 53 Y female with HTN, sleep apnea on CPAP qhs, premenstrual dysphoric disorder on celexa, h/o L knee replacement at outside hospital 7/2020 who was in hospital until 12/22 when noted onset of L knee pain, and 2 pustules at inferior end of healed L knee incision. She presented to ED today due to worsening pain and L knee swelling. Knee xray showed large left knee joint effusion. Pt was seen in ED by ortho, arthrocentesis performed with aspiration of 60 cc thick purulent synovial fluid. LEFT KNEE ARTHROPLASTY INFECTION - no s/sx sepsis. Admitted per ortho team. S/p L knee I&D with vancomycin powder on 12/28. - Appreciate ortho recs: WBAT - Knee Cx grew MSSA. Blood Cx on 12/23 was negative. - Appreciate ID recs: Stopped IV Vanc. Continue IV Cefazolin and started BID Rifampin. 6 Weeks of therapy would put duration of therapy from 12/28/21 - 2/8/21. PICC line placed and outpatient IV therapy arranged. - PT rec: HHPT. COVID- Recent URI about 2 weeks prior to admission. COVID test 12/17/21 negative. S/sx largely resolved except for mild residual dry cough. -Repeat COVID test on 12/26/21 positive this admission, though URI symptoms were resolving. -Case d/w ID regarding need for inpt COVID isolation given sx were mild, onset 12/11, usual isolation would be 10 days (thourgh 12/21). Per Dr., when she tested for COVID on 12/17, ~6 days after onset of sx, test should have had high yield and returned positive if her URI sx were due to COVID, unless test was poorly performed. Query possibility of new asymptomatic community COVID infection after onset of viral URI. Recommend COVID isolation x 10 days from positive test 12/26/21. - Given pt uses CPAP at night for osa, placed in airborne isolation. - Was borderline hypoxic without significant respiratory symptoms initially but this resolved and now satting fine on RA. - 12/30: d/w Dr. of ID and got CTA chest to r/o PE. CT completed and showed no PE and no infiltrate. - 12/31: d/w another Dr. of ID who recommended 3 day course of IV Remdesivir (but no steroids) (per named trial) to reduce risk of progression of COVID. - Finish 3 day course or Remdesivir today. Should remain in isolation after discharge through 1/5/22.


VAERS ID: 2048119 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-12-23
Onset:2021-12-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 33130BA / 3 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pulmicort flexhaler
Current Illness: none
Preexisting Conditions: asthma
Allergies: gluten-free, dairy free
Diagnostic Lab Data: doctor looks in ears and says there is fluid buildup in the eustachian tubes
CDC Split Type:

Write-up: Tinnitus, ringing in ears, full feeling sound like noise outside of ears started shortly after the booster, and is continuing into week 4 post booster. Gets better with neti pot treatment but still there.


VAERS ID: 2050826 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-12-16
Onset:2021-12-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Hypoaesthesia oral, Paraesthesia oral, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: On 12/26 I began itching in my scalp, uncontrollably. Once I became aware of how frequently I was itching when I went to sleep that night, I tried stopping itching. Then I became itchy on other parts of my body (legs, arms, lower abdomen, lower back). I woke up in the morning and tried showering, which did not help. I tried hydrocortisone cream, which helped only temporarily. I had to reapply throughout the day to keep the itching at bay. I took Benadryl before bed on the 27th. The next morning, (12/28) I noticed a tightness in my chest and later that day, a feeling as though the side of my mouth was tingling/going numb, which went away after a little bit. I went to a walk-in clinic later that night and was prescribed a 6 day course of prednisone, tapered (3 pills for 2 days, 2 for 2 days and 1 for 2 days). I saw no changes in the hives that were breaking out on my body, but I did experience less itching. On Monday 1/3, I saw a doctor who prescribed me another course of prednisone (a higher dose than the first time), and then again 5 days later when my condition had gotten a little bit better but not gone away completely. I stopped taking prednisone on 1/14/22 and my hives have not gone away. The itchiness comes and goes now but I am taking Xyzal every day and Hydroxyzine every night for as long as I have pills.


VAERS ID: 2051278 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-10-08
Onset:2021-12-26
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Asthma, COVID-19, Chest pain, Chills, Cough, Disturbance in attention, Feeling abnormal, Headache, Illness, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test positive, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Not adverse effect of vaccine. on 12/26/2021 I started getting sick and tested positive for Covid on 12/27/21. I had headaches, chills , fever , muscle pain, weakness, nausea, cough, chest pain, asthma symptoms, brain fog and trouble focusing. I?m on steroid inhaler and still feel that my breathing is not back to normal.


VAERS ID: 1993163 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Overdose, Product preparation error
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension; Stent placement
Allergies:
Diagnostic Lab Data:
CDC Split Type: EGPFIZER INC202101859644

Write-up: Patient received 2 doses previously of Sino pharm Vaccine one year ago and went today to receive the 3rd dose (Pfizer Vaccine); Patient received 2 doses previously of Sino pharm Vaccine one year ago and went today to receive the 3rd dose (Pfizer Vaccine); booster; Patient recieved accidently the whole vial of pfizer vaccine (multiple dose vial); The vial was not diluted with saline; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Pharmacist) from medical information team. A 62 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 26Dec2021 11:00 (Lot number: Unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "3 stents" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Sinopharm vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 03Feb2021, for COVID-19 immunisation; Sinopharm vaccine (Dose Number: 1), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization), INTERCHANGE OF VACCINE PRODUCTS (hospitalization) all with onset 26Dec2021 15:00 and all described as "Patient received 2 doses previously of Sino pharm Vaccine one year ago and went today to receive the 3rd dose (Pfizer Vaccine)"; IMMUNISATION (hospitalization) with onset 26Dec2021 15:00, described as "booster"; OVERDOSE (hospitalization) with onset 26Dec2021 15:00, described as "Patient recieved accidently the whole vial of pfizer vaccine (multiple dose vial)"; PRODUCT PREPARATION ERROR (hospitalization) with onset 26Dec2021 15:00, described as "The vial was not diluted with saline". The patient was hospitalized for off label use, interchange of vaccine products, immunisation, overdose, product preparation error (hospitalization duration: 1 day(s)). It was unknown if therapeutic measures were taken as a result of off label use, interchange of vaccine products, immunisation, overdose, product preparation error. Clinical information- : Patient accidently received the multiple dose vial (6 doses) instead of 1 dose , also the vial was not diluted with saline. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1999127 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA ORG-100031184 / 3 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Aphasia, Facial paralysis
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Alfuzosine
Current Illness: Prostate problem not yet diagnosed
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Visited my Doctor on the 27th December and he performed a facial exam and determined that it was not a stroke as I had feeling all over my face, prescribed 80mg of Prednisolone for 7 days as well as vitamin B1-B6 also arranged for a visit to Ophthalmologist to check for cataracts. Visited on the 28th December and after tests ascertained that no cataracts, prescribed eye wash, lubricating drops and gel for the nighttime and taping closed of the eye at night. Visited a consultant today 3rd January 2022, checked hearing and proceeded to syringe them, checked face and instructed me to continue with vitamins, massage face twice a day and also chew gum on the right side of my mouth to help exercise the muscles. Arranging for MRI . I think that this is a case of Bells Palsy brought on by the vaccine
CDC Split Type:

Write-up: The right side of my face dropped and became paralysed, speech impaired and unable to close my right eye.


VAERS ID: 1999967 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-26
   Days after vaccination:5
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: COVID-19, Heavy menstrual bleeding, Myocarditis, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: myocarditis; SARS-CoV-2 infection; Menstrual flooding; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26396120) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 (SARS-CoV-2 infection), HEAVY MENSTRUAL BLEEDING (Menstrual flooding) and MYOCARDITIS (myocarditis) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Suspected COVID-19 since 26-Dec-2021. On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant) and HEAVY MENSTRUAL BLEEDING (Menstrual flooding) (seriousness criterion medically significant). On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, COVID-19 (SARS-CoV-2 infection), HEAVY MENSTRUAL BLEEDING (Menstrual flooding) and MYOCARDITIS (myocarditis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient was not breastfeeding. Patient was not enrolled in clinical trial. Treatment information was not provided. Company Comment: This case concerns a 29 year-old female patient with a history of suspected COVID-19 and positive SARS-CoV-2 test in December 2021 who experienced the unexpected serious adverse event of special interest of COVID-19 and the unexpected serious event of heavy menstrual bleeding which occurred 6 days after vaccination with mRNA-1273 administered as a third dose, and the AESI myocarditis which occurred on an unknown date relative to vaccination. The medical history of suspected COVID-19 remains a confounder for the events. 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 29 year-old female patient with a history of suspected COVID-19 and positive SARS-CoV-2 test in December 2021 who experienced the unexpected serious adverse event of special interest of COVID-19 and the unexpected serious event of heavy menstrual bleeding which occurred 6 days after vaccination with mRNA-1273 administered as a third dose, and the AESI myocarditis which occurred on an unknown date relative to vaccination. The medical history of suspected COVID-19 remains a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2009704 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-26
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: LFT; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: GBPFIZER INC202101881949

Write-up: Booster; Positive covid result; Positive covid result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 49 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 26Dec2021, outcome "not recovered" and all described as "Positive covid result". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, drug ineffective. Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. Device date was 28Dec2021. The lot number for bnt162b2 was not provided and will be requested during follow


VAERS ID: 2010931 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-12-26
   Days after vaccination:196
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211006; Test Name: Antigen; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab
CDC Split Type: CRPFIZER INC202200015747

Write-up: Positive COVID / headache and throat pain; Positive COVID / headache and throat pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Jun2021 09:15 (Lot number: Er1741) at the age of 35 years as dose 2, single and intramuscular, administered in arm left, administration date 23May2021 09:15 (Lot number: Et0384) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021 15:30, outcome "recovered" and all described as "Positive COVID / headache and throat pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Oct2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Additional information: The most recent COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and no other medications received within 2 weeks of vaccination. The reported event was positive COVID with headache and throat pain. Prior to vaccination, the patient was not diagnosed with COVID-19.


VAERS ID: 2012579 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-16
Onset:2021-12-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Dizzy spells; This case was received via RA (Reference number: GB-MHRA-ADR 26395732) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced DIZZINESS (Dizzy spells) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizzy spells) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-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. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. Patient had no symptoms associated with COVID-19. Patient was not enrolled in clinical trial.; Sender''s Comments: This case concerns a 41-year-old female patient, with medical history not reported, who experienced the serious unexpected event(s) dizziness. The event(s) started occurring approximately within 10 day(s) after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2012585 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Candida infection
SMQs:, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Thrush; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26395794) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CANDIDA INFECTION (Thrush) in a 19-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced CANDIDA INFECTION (Thrush) (seriousness criterion medically significant). At the time of the report, CANDIDA INFECTION (Thrush) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. It was reported the next day patient had a sore arm as expected the day after random waves of heat throughout the forearm third day (today), patient had a water infection. Patient had not tested positive for COVID-19 since having the vaccine. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. No concomitant medications reported. No treatment information reported. Company Comment - This case concerns a 19 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected event of candida infection. The event occurred 3 days after the third dose of mRNA-1273 vaccine and had not resolved at the time of the report. The rechallenge was not applicable as t here are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 19 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected event of candida infection. The event occurred 3 days after the third dose of mRNA-1273 vaccine and had not resolved at the time of the report. The rechallenge was not applicable as t here are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012604 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chills, Headache, SARS-CoV-2 test, Seizure
SMQs:, Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), 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; TEGRETOL
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.MOD20214

Write-up: Shivering; Back pain; Headache; Seizure; This case was received (Reference number: GB-RA-ADR 26396277) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivering), BACK PAIN (Back pain), HEADACHE (Headache) and SEIZURE (Seizure) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included CARBAMAZEPINE (TEGRETOL) for Seizures, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant), BACK PAIN (Back pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, CHILLS (Shivering), BACK PAIN (Back pain) and HEADACHE (Headache) had not resolved and SEIZURE (Seizure) outcome was unknown. 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 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were provided. It was reported that, it was unsure if patient had symptoms associated with COVID-19, however patient did not tested positive for COVID-19 after taking the vaccine. Patient was not enrolled in clinical trial. It was reported that, patients reaction was not related to possible inflammation of the heart (myocarditis or pericarditis). This is a regulatory case concerning a male patient of an unknown age with a history of treatment with carbamazepine (Tegretol) for seizures, who experienced the serious unexpected AESI event of seizure and serious per reported severity unexpected events of chills, back pain and headache. The event of seizure occurred 4 days after the third dose of mRNA-1273 vaccine administration and the events of chills, back pain and headache occurred on unknown date. The events were assessed as related to the product administration. The rechallenge was reported as unknown; however, could be considered as not applicable since the events occurred after the third dose and no further dosing is expected. The medical history of treatment with carbamazepine (Tegretol) considered as confounder for the event of seizure. The patient was given a dose of AstraZeneca COVID-19 vaccine on unknown date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a male patient of an unknown age with a history of treatment with carbamazepine (Tegretol) for seizures, who experienced the serious unexpected AESI event of seizure and serious per reported severity unexpected events of chills, back pain and headache. The event of seizure occurred 4 days after the third dose of mRNA-1273 vaccine administration and the events of chills, back pain and headache occurred on unknown date. The events were assessed as related to the product administration. The rechallenge was reported as unknown; however, could be considered as not applicable since the events occurred after the third dose and no further dosing is expected. The medical history of treatment with carbamazepine (Tegretol) considered as confounder for the event of seizure. The patient was given a dose of AstraZeneca COVID-19 vaccine on unknown date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2012643 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-20
Onset:2021-12-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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
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.MOD20214

Write-up: Bruising; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26395661) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CONTUSION (Bruising) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19. On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced CONTUSION (Bruising) (seriousness criterion medically significant). At the time of the report, CONTUSION (Bruising) 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 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication were reported Patient had Bruising on the left bicep and pain down left arm (feels like a dead arm). Company Comment: This case refers to a 48-year-old female patient with no known medical history who experienced the unexpected event of Contusion approximately 6 days after the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. 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 refers to a 48-year-old female patient with no known medical history who experienced the unexpected event of Contusion approximately 6 days after the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2016330 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-26
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Body temperature, Erythema, Headache, Hypothermia, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (broad), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: body temperature; Result Unstructured Data: Test Result:low grade fever (unknown temeprature); Test Date: 20211227; Test Name: body temperature; Result Unstructured Data: Test Result:35.2
CDC Split Type: GRPFIZER INC202101885477

Write-up: pinching to the heart; intense itchiness; redness under the chest and on abdomen; headache; hypothermia 35.2; low grade fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 68 year-old female patient received bnt162b2 (COMIRNATY) (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: ANGINA PECTORIS (medically significant), outcome "unknown", described as "pinching to the heart"; HYPOTHERMIA (medically significant) with onset 27Dec2021, outcome "unknown", described as "hypothermia 35.2"; PYREXIA (non-serious) with onset 26Dec2021, outcome "unknown", described as "low grade fever"; PRURITUS (non-serious), outcome "unknown", described as "intense itchiness"; ERYTHEMA (non-serious), outcome "unknown", described as "redness under the chest and on abdomen"; HEADACHE (non-serious), outcome "unknown", described as "headache". The patient underwent the following laboratory tests and procedures: body temperature: (26Dec2021) low grade fever (unknown temeprature); (27Dec2021) 35.2. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : -PFIZER INC-202101871754 same reporter, different patient


VAERS ID: 2020164 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

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

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

Write-up: Fatigue/unusual tiredness; Light-headed; Dizziness; This case was received via Regulatory authority. This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Light-headed), DIZZINESS (Dizziness) and FATIGUE (Fatigue/unusual tiredness) in a 28-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. No Medical History information was reported. On 24-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced DIZZINESS (Light-headed) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Light-headed) and DIZZINESS (Dizziness) had not resolved and FATIGUE (Fatigue/unusual tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19 and not had a COVID-19 test. Concomitant medications were not provided. Treatment medication was not provided. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Patient reported thet report was relate to possible nflammation of the heart myocarditis or pericarditis but no symptoms lead to a hospital stay,a diagnosis made by a medical professional and any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken were provided.; Sender''s Comments: This is a regulatory case concerning a 28-year-old male patient with no medical history reported, who experienced the serious expected events of Dizziness (2 episodes) and Fatigue(seriousness criterion medically significant). All events occurred 2 days after the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The rechallenge was unknown since there''s no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2020185 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-17
Onset:2021-12-26
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), 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: Negative ; Result Unstructured Data: No, Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Skin rash; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26401071) on 28-Dec-2021 and was forwarded to Moderna on 28-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Skin rash) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002621) for an unknown indication. No Medical History information was reported. On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced RASH (Skin rash) (seriousness criterion medically significant). At the time of the report, RASH (Skin rash) had not 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 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Concomitant medication were not provided. No treatment medications was reported. Patient was not enrolled in Clinical trial. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding; Sender''s Comments: This case concerns a 29-year-old female patient with no medical history, who experienced the unexpected serious event of Rash. The event was medically significant as reported by the regulatory authority. The event occurred approximately 9 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was reported as unknown by the regulatory authority. No clinical or treatment details were given. It was reported that the outcome of the events had not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2020202 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Electrocardiogram, Fatigue, Myocarditis, Palpitations, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Results not reported
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Myocarditis; This case was received (Reference number: GB-RA-ADR 26401489) on 28-Dec-2021 and was forwarded to Moderna on 28-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)) and MYOCARDITIS (Myocarditis) in a 52-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for COVID-19 immunisation. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Heart palpitations) (seriousness criteria hospitalization and medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criteria hospitalization and medically significant). At the time of the report, FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown and MYOCARDITIS (Myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: results not reported Results not reported. No concomitant medication reported. No Treatment Medication reported. It was reported that patient had chest pain, fatigue, myocarditis, palpitations, shortness of breath and tachycardia. Patient not tested positive for COVID-19 since he had the vaccine Patient was not enrolled in clinical trial It was reported that the event was related to possible inflammation of the heart (myocarditis or pericarditis). Patient was admitted to the hospital and 3 hours were lasted the hospital stay. He consulted a cardiologist and done ECG. The blood tests, such as for certain proteins (called troponin) that signal heart muscle damage was taken. Company Comment: This case refers to a 52-year-old male patient with no known medical history who experienced the unexpected events of Fatigue, Chest pain, Dyspnoea, Palpitations, Tachycardia and expected event of Myocarditis. Myocarditis occurred approximately 4 days after the third dose of mRNA-1273 vaccine while the events of Fatigue, Chest pain, Dyspnoea, Palpitations, Tachycardia occurred after an unspecified number of days post exposure to the vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2021: Follow up document received contains, lab investigation and suspect drug indication was added. Seriousness criteria and action taken were updated.; Sender''s Comments: This case refers to a 52-year-old male patient with no known medical history who experienced the unexpected events of Fatigue, Chest pain, Dyspnoea, Palpitations, Tachycardia and expected event of Myocarditis. Myocarditis occurred approximately 4 days after the third dose of mRNA-1273 vaccine while the events of Fatigue, Chest pain, Dyspnoea, Palpitations, Tachycardia occurred after an unspecified number of days post exposure to the vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2020217 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-16
Onset:2021-12-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004737 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Menstruation delayed, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility 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: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Late period; Fatigue; Nausea; Shivers; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Late period), FATIGUE (Fatigue), NAUSEA (Nausea) and CHILLS (Shivers) in a 42-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004737) for an unknown indication. No Medical History information was reported. On 16-Dec-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced MENSTRUATION DELAYED (Late period) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and CHILLS (Shivers) (seriousness criterion medically significant). At the time of the report, MENSTRUATION DELAYED (Late period), FATIGUE (Fatigue), NAUSEA (Nausea) and CHILLS (Shivers) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications was not reported. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient not had a late period in 3 years. Period was due 25/12. No period till now, instead Patient was shivering, constantly tired, nauseous and vomiting. This started on the night of the 26th. This case concerns a 42-year-old female patient with no medical history, who experienced the unexpected serious event of Menstrual Delayed, Fatigue, Nausea, and Chills, the events were reported as medically significant by the regulatory authority. The events occurred 10 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was reported as unknown by the regulatory authority. No clinical or treatment details were given. It is reported that the outcome of the events has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 42-year-old female patient with no medical history, who experienced the unexpected serious event of Menstrual Delayed, Fatigue, Nausea, and Chills, the events were reported as medically significant by the regulatory authority. The events occurred 10 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was reported as unknown by the regulatory authority. No clinical or treatment details were given. It is reported that the outcome of the events has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2022763 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-16
Onset:2021-12-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005686 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy, Paraesthesia oral, SARS-CoV-2 test
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hearing impairment (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: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Feeling tongue; Palsy Bells; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26403573) on 29-Dec-2021 and was forwarded to Moderna on 29-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Feeling tongue) and BELL''S PALSY (Palsy Bells) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005686) for an unknown indication. Patient has not had symptoms associated with COVID-19. On 16-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced BELL''S PALSY (Palsy Bells) (seriousness criterion medically significant). On an unknown date, the patient experienced PARAESTHESIA ORAL (Feeling tongue) (seriousness criterion medically significant). At the time of the report, PARAESTHESIA ORAL (Feeling tongue) outcome was unknown and BELL''S PALSY (Palsy Bells) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It stared with numb feeling tongue. This led on to a reduced mobility to the left side of the face. Patient visited doctor to seek advise and was diagnosed as Bells Palsy. Was given a 10 day course of Prednisolone tablets to try and resolved. It was unknown whether this was a reaction to the moderna vaccine, but patient was reporting it for records and information. Patient was not enrolled in clinical trial Company comment: This is a regulatory authority case concerning a 37-year-old, male patient with no reported medical history, who experienced the unexpected, serious event of paraesthesia oral (tongue abnormal feeling) and expected, serious, AESI event of Bell''s palsy. The event Bell''s Palsy occurred 10 days after the unknown dose number of mRNA-1273 vaccine administration. The events were described as, started with numb feeling of the tongue and led to a reduced mobility of the left side of the patient''s face, patient sought consult and was diagnosed with Bell''s palsy and was given 10-day course of Prednisolone tablets. The outcome of the event paraesthesia oral (tongue abnormal feeling) was unknown while Bell''s palsy the outcome was resolving from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 37-year-old, male patient with no reported medical history, who experienced the unexpected, serious event of paraesthesia oral (tongue abnormal feeling) and expected, serious, AESI event of Bell''s palsy. The event Bell''s Palsy occurred 10 days after the unknown dose number of mRNA-1273 vaccine administration. The events were described as, started with numb feeling of the tongue and led to a reduced mobility of the left side of the patient''s face, patient sought consult and was diagnosed with Bell''s palsy and was given 10-day course of Prednisolone tablets. The outcome of the event paraesthesia oral (tongue abnormal feeling) was unknown while Bell''s palsy the outcome was resolving from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2022903 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstrual disorder, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: Clotting disorder; Delivery; Miscarriage (clotting issues were ruled out at the time of miscarriages (antiphospholipid etc))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101863182

Write-up: Menstrual clotting. Big clots found on sanitary towels.; Clot blood; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112261950413270-YYKS4. Other Case identifier(s): GB-MHRA-ADR 26396050. A 38 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Miscarriage" (unspecified if ongoing), notes: clotting issues were ruled out at the time of miscarriages (antiphospholipid etc); "have two children naturally" (unspecified if ongoing). Family history included: "Clotting disorder" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for Covid-19 immunisation. The following information was reported: MENSTRUAL DISORDER, outcome "unknown", described as "Menstrual clotting. Big clots found on sanitary towels."; THROMBOSIS with onset 26Dec2021, outcome "not recovered", described as "Clot blood". Clinical courses: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2022967 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101870465

Write-up: Off label use; Interchange of vaccine products; booster; Bleeding menstrual heavy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112270913137120-IWQKO (RA). Other Case identifier: GB-MHRA-ADR 26397188 (RA). A 45-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 21Dec2021 (Lot number: Fk9706) as dose 3 (booster), single for covid-19 immunisation. Date of last menstrual period: 25Dec2021. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", described as "booster"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 26Dec2021, outcome "recovered" (27Dec2021), described as "Bleeding menstrual heavy". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The events were not related to possible inflammation of the heart (myocarditis or pericarditis). Patient has not had symptoms associated with COVID-19. The patient has not had a COVID-19 test. Patient is not pregnant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2023109 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Migraine, Myalgia, Neck pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101870235

Write-up: Migraine; Muscle ache; Painful arm; Neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112272118075370-PVULD. Other Case identifier(s): GB-MHRA-ADR 26400931. A female patient received bnt162b2 (COMIRNATY), administration date 26Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), for COVID-19 immunization. The patient has not had symptoms associated with COVID-19. The patient is not enrolled in clinical trial. The following information was reported: PAIN IN EXTREMITY (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Painful arm"; NECK PAIN (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Neck pain"; MIGRAINE (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Migraine"; MYALGIA (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Muscle ache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) negative. The patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2023237 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-20
Onset:2021-12-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA COVID 19 VACCIN / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Hyperhidrosis, Malaise, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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; COVID-19 VACCINE ASTRAZENECA
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: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: sweating; feeling sick; Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; Chest pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26407993) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of the first episode of CHEST PAIN (Chest pain), HYPERHIDROSIS (sweating), MALAISE (feeling sick), FATIGUE (Fatigue/unusual tiredness), the second episode of CHEST PAIN (Chest pain), PYREXIA (Fever) and DYSPNOEA (Shortness of breath) in a 56-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Covid 19 vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 10-Mar-2021 to 24-Mar-2021. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 26-Mar-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 26-Mar-2021 to an unknown date for COVID-19. On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant), MALAISE (feeling sick) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). At the time of the report, HYPERHIDROSIS (sweating), MALAISE (feeling sick), FATIGUE (Fatigue/unusual tiredness), the last episode of CHEST PAIN (Chest pain), PYREXIA (Fever) and DYSPNOEA (Shortness of breath) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication was not provided. Patient experienced feeling sick, sweating a lot, then chest pain that was in sternum radiating to the left. Unable to sleep properly because of pain. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Patient reported that report relate to possible inflammation of the heart myocarditis or pericarditis and no diagnosis was made by the medical professional. Company comment This case concerns a 56-year-old male patient, with no reported medical history, who experienced the unexpected serious events of CHEST PAIN, HYPERHIDROSIS, MALAISE, FATIGUE, the second episode of CHEST PAIN, PYREXIA and DYSPNOEA. First episode of Event CHEST PAIN occurred approximately 6 days after the administration of the third dose of mRNA-1273 vaccine. The rest of events occurred on an unknown date. Patient had received COVID-19 VACCINE ASTRAZENECA as previous vaccination. Patient reported the report relate to possible inflammation of the heart myocarditis or pericarditis and no diagnosis was made by the medical professional. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 56-year-old male patient, with no reported medical history, who experienced the unexpected serious events of CHEST PAIN, HYPERHIDROSIS, MALAISE, FATIGUE, the second episode of CHEST PAIN, PYREXIA and DYSPNOEA. First episode of Event CHEST PAIN occurred approximately 6 days after the administration of the third dose of mRNA-1273 vaccine. The rest of events occurred on an unknown date. Patient had received COVID-19 VACCINE ASTRAZENECA as previous vaccination. Patient reported the report relate to possible inflammation of the heart myocarditis or pericarditis and no diagnosis was made by the medical professional. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023263 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, 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? Yes
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: 20211226; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Headache; Chills; Muscle ache; Fever; This case was received (Reference number: GB-RA-ADR 26408292) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), MYALGIA (Muscle ache) and PYREXIA (Fever) in a 49-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion disability), CHILLS (Chills) (seriousness criterion disability), MYALGIA (Muscle ache) (seriousness criterion disability) and PYREXIA (Fever) (seriousness criterion disability). On 27-Dec-2021, CHILLS (Chills) had resolved. On 28-Dec-2021, HEADACHE (Headache), MYALGIA (Muscle ache) and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, 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. No relevant concomitant medications were reported. No treatment medications were reported. The late evening of the 26/12, patient got fever and chills. The day after he had a strong headache, aching limbs and the temperature rose to up to 39.6 degrees. All got a bit better with Paracetamol. The next day the temperature was lower and the headache less severe. 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 49-year-old male patient with no medical history provided who experienced serious unexpected events of Headache, Chills, Myalgia and Pyrexia. The events occurred four days after the third dose of mRNA-1273. Highest measured temperature was 39.6 degrees, as per SD. The patient was treated with Paracetamol and symptoms improved. At the time of the report, all the events resolved and no further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. 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. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 49-year-old male patient with no medical history provided who experienced serious unexpected events of Headache, Chills, Myalgia and Pyrexia. The events occurred four days after the third dose of mRNA-1273. Highest measured temperature was 39.6 degrees, as per SD. The patient was treated with Paracetamol and symptoms improved. At the time of the report, all the events resolved and no further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. 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. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2023289 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Erythema, Fatigue, Muscle strain, Myalgia, SARS-CoV-2 test, Tenderness
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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: PFIZER BIONTECH COVID-19 VACCINE; VITAMIN C [ASCORBIC ACID]
Current Illness: Asperger''s disorder (Autistic); Eczema
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Muscle pain; Pulled muscle; Chills; Fatigue; Redness; Tenderness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26409208) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), MUSCLE STRAIN (Pulled muscle), CHILLS (Chills), FATIGUE (Fatigue), ERYTHEMA (Redness) and TENDERNESS (Tenderness) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. The patient''s past medical history included Clinical trial participant. Concurrent medical conditions included Eczema and Asperger''s disorder (Autistic). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 20-Jun-2021 to an unknown date and VITAMIN C [ASCORBIC ACID] from 26-Dec-2021 to 26-Dec-2021 for an unknown indication. On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced TENDERNESS (Tenderness) (seriousness criterion medically significant). On 27-Dec-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and ERYTHEMA (Redness) (seriousness criterion medically significant). On 28-Dec-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant) and MUSCLE STRAIN (Pulled muscle) (seriousness criterion medically significant). On 28-Dec-2021, CHILLS (Chills) had resolved. On 29-Dec-2021, FATIGUE (Fatigue), ERYTHEMA (Redness) and TENDERNESS (Tenderness) had resolved. At the time of the report, MYALGIA (Muscle pain) and MUSCLE STRAIN (Pulled muscle) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. The patient''s other concomitant products included CO-OP PARACETAMOL from 26-Dec-2021 to 27-Dec-2021 for Muscle pain. Muscle pain on upper back and shoulders was not felt until the late afternoon, evening and night of Tuesday 28-Dec-2021. The pain made it impossible to sleep on any side. The patient could not lie on the left side as the patient had the jab in the left arm. The patient could not lie on the back or on the right side, as this was where the muscle pain felt worse. Unsure if patient had symptoms associated with COVID-19. The treatment information was unknown. Company Comment: This case concerns a 27-year-old male patient, with medical history of eczema, who experienced the unexpected and serious events of Myalgia, Muscle strain, Chills, Fatigue, Erythema, and Tenderness. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred within the first tow days after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. Previous doses of COVID-19 vaccine given with Tozinameran (Interchange of vaccine products). The medical history of eczema remains confounder for Erythema. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 27-year-old male patient, with medical history of eczema, who experienced the unexpected and serious events of Myalgia, Muscle strain, Chills, Fatigue, Erythema, and Tenderness. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred within the first tow days after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. Previous doses of COVID-19 vaccine given with Tozinameran (Interchange of vaccine products). The medical history of eczema remains confounder for Erythema. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023307 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No, Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Vomiting; Diarrhea; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and DIARRHOEA (Diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. No Medical History information was reported. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On an unknown date, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On 27-Dec-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, VOMITING (Vomiting) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-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. Patient had no symptoms associated with COVID-19 Concomitant medication were not provided.Treatment medications were not provided. Company Comment This case concerns a male patient, of unknown age, with no relevant medical history reported, who experienced the unexpected events of vomiting and diarrhoea. The events occurred between 3 and an unknown number of days after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and 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 meet the criteria to be medically significant. Patient after 30 hours of Booster Moderna vaccine, had woke up with stomach pains, first it was diarrhea and then violent vomiting ( three times) in 2 hours. The patient had rested for the day-slept and then was OK the next day. At no time there was no any headache. Patient was not enrolled in Clinical trial.; Sender''s Comments: This case concerns a male patient, of unknown age, with no relevant medical history reported, who experienced the unexpected events of vomiting and diarrhoea. The events occurred between 3 and an unknown number of days after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and 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 meet the criteria to be medically significant.


VAERS ID: 2023328 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-12-26
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: Period pains; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26411317) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Period pains) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 25-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced DYSMENORRHOEA (Period pains) (seriousness criterion medically significant). On 29-Dec-2021, DYSMENORRHOEA (Period pains) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication list was not provided. Treatment medication information was not provided by the reporter. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. After all 3 of her jabs Astra Zenica for first and second, moderna for her booster. She had suffered excessive menstrual pains. Patient had not tested positive for COVID-19 since having the vaccine. Patient not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis).; Sender''s Comments: This is an RA case concerning a female patient of unknown age, with no relevant medical history reported, who experienced dysmenorrhea. Event seriousness was captured as provided by the Regulatory Authority. Event occurred 1 approximately 1 month after receiving the booster dose of mRNA1273. Primary vaccination completed with AZ vaccine and in the SD narrative patient states " After all 3 of my jabs, Astra Zeneca for first and second, moderna for my booster, I have suffered excessive menstrual pains" which is unclear if this event has occurred after all 3 doses or just after the last one. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 2023333 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-12-26
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Allergies:
Diagnostic Lab Data: Test Date: 20211222; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Urticaria; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26411805) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA (Urticaria) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. 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 26-Dec-2021, the patient experienced URTICARIA (Urticaria) (seriousness criteria disability and medically significant). At the time of the report, URTICARIA (Urticaria) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-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 concomitant medication were reported. No history of urticaria or allergies previously. Patient not had symptoms associated with COVID-19. Patient was not breastfeeding. Intense itching, redness and burning started on hands 26th. Symptoms proceed to get worse with no relief from over the counter antihistamine. Flares ups appeared in random places all over the body including face since 27th.The flare ups last about 3 - 4hrs with no relief. Prescribed fexofenadine 180g 28th by a doctor. Visited GP on 29th who advised to take 2 fexofenadine morning and night with over the counter antihistamine midday but the tablets did not provide relief. A blood tests was booked for 30th Dec. Patient had not tested positive for COVID-19 since she had received the vaccine. No treatment information was provided. This is a regulatory case concerning a 32-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected event of urticaria. The event occurred 1 month 11 days after the third dose of mRNA-1273 vaccine administration. The event was assessed as related to the product administration. The event was assessed as serious per disability criterion by the Regulatory Authority. The rechallenge was reported as unknown; however, could be considered as not applicable since the event occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 32-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected event of urticaria. The event occurred 1 month 11 days after the third dose of mRNA-1273 vaccine administration. The event was assessed as related to the product administration. The event was assessed as serious per disability criterion by the Regulatory Authority. The rechallenge was reported as unknown; however, could be considered as not applicable since the event occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023335 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-12
Onset:2021-12-26
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004737 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lethargy, Vomiting
SMQs:, Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: lethargic; vomiting; Vomited; This case was received via a Regulatory Authority (Reference number: GB-MHRA-ADR 26411768) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), VOMITING (vomiting) and VOMITING (Vomited) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004737) for an unknown indication. No Medical History information was reported. On 12-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced VOMITING (Vomited) (seriousness criterion medically significant). On an unknown date, the patient experienced LETHARGY (lethargic) (seriousness criterion medically significant) and VOMITING (vomiting) (seriousness criterion medically significant). At the time of the report, LETHARGY (lethargic) and VOMITING (vomiting) outcome was unknown and VOMITING (Vomited) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment information were reported. It was reported that during the patient''s menstrual week this month patient had sharp stomach pains, muscle aches and felt dizzy. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Company Comment: This regulatory case concerns a 40-year-old female patient with no medical history reported, who experienced the unexpected serious events of Lethargy, vomiting and vomiting. The events lethargy and vomiting occurred on an unknown date and event vomiting occurred 14 days after the third dose of mRNA-1273 vaccine. The outcome of the events lethargy and vomiting was reported as unknown and vomiting as not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.; Sender''s Comments: This regulatory case concerns a 40-year-old female patient with no medical history reported, who experienced the unexpected serious events of Lethargy, vomiting and vomiting. The events lethargy and vomiting occurred on an unknown date and event vomiting occurred 14 days after the third dose of mRNA-1273 vaccine. The outcome of the events lethargy and vomiting was reported as unknown and vomiting as not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.


VAERS ID: 2023569 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-12-26
   Days after vaccination:270
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Gene sequencing, 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: 202112; Test Name: Gene sequencing; Result Unstructured Data: Test Result:Carried the Variant of Concern Omicron; Test Date: 202112; Test Name: COVID-19 virus test; Test Result: Positive.
CDC Split Type: HKPFIZER INC202200020667

Write-up: This is a spontaneous report received from non-contactable reporter (Other HCP) from Regulatory Authority (BioNTech) and Regulatory Authority. Other Case identifier: HK-Fosun-2021FOS007598 (RA). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority (RA). The regulatory authority report number is not applicable. As of 0:00 am, 27-Dec-2021, RA announced that seven additional confirmed cases of COVID-19 after Comirnaty vaccination. This report was split for 1 of 7 patients that confirmed COVID-19 after Comirnaty vaccination. A 39-year-old male patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 10-Mar-2021 and 31-Mar-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization in Qatar. Medical history, concomitant medication(s) and past product were not reported. On 25-Dec-2021, the patient arrived at via flight. On 26-Dec-2021, the patient developed symptoms. In Dec-2021, the patient tested positive. He was confirmed as COVID-19 with mutant strains of N501Y and T478K. In Dec-2021, whole genome sequencing analysis conducted by the RA confirmed that the patient carried the Variant of Concern Omicron. The adverse event ''confirmed case of COVID-19/imported case with mutant strains of N501Y and T478K/carried the Variant of Concern Omicron'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 28-Dec-2021 and 31-Dec-2021. This case was split from AER 2021FOS007543 due to same reporter/product, different event/patient. Follow-up closed; no further information is possible. Reporter''s and company''s (BIONTECH SE) assessment of causal relationship for COMIRNATY with the events COVID-19 and Vaccination failure were reported as possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Follow-up closed, no further information is possible. Sender''s Comments: Linked Report(s): HK-PFIZER INC-202101884323 same reporter/product, different event/patient.


VAERS ID: 2023571 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-12-26
   Days after vaccination:224
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Gene sequencing, 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: 202112; Test Name: Gene sequencing; Result Unstructured Data: Test Result:carried the Variant of Concern Omicron; Test Date: 202112; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202200020666

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K/CARRIED THE VARIANT OF CONCERN OMICRON; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K/CARRIED THE VARIANT OF CONCERN OMICRON; This is a spontaneous report received from non-contactable reporter (Other HCP) from Regulatory Authority. Other Case identifier(s): HK-Fosun-2021FOS007601. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. As of 0:00 am, 27-Dec-2021, Regulatory Authority announced that seven additional confirmed cases of COVID-19 after Comirnaty vaccination. A 55-year-old female patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 14-Apr-2021 and 16-May-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication, and past product were not reported. On 24-Dec-2021. On 26-Dec-2021, the patient developed symptoms. In Dec-2021, the patient tested positive. She was confirmed as COVID-19 with mutant strains of N501Y and T478K. In Dec-2021, whole genome sequencing analysis conducted by the Regulatory Authority confirmed that the patient carried the Variant of Concern Omicron. The adverse event confirmed case of COVID-19/imported case with mutant strains of N501Y and T478K/carried the Variant of Concern Omicron'' was considered as Important Medical Event. At the time of the report, the outcome of the events was unknown. Initial report was received on 28-Dec-2021 and 31-Dec-2021. The reporter and the company assessed causal relationship between the events and suspect drug as possible. Bnt162b2 (COMIRNATY) is under agreement. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101884323 same reporter/product, different event/patient


VAERS ID: 2023618 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Cerebrovascular accident, Dyspnoea, Fatigue, Headache, Immunisation, Off label use, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC202101872644

Write-up: I felt like I stroke; difficulties to breathe; very tired feeling; fewer, very bad back pain starter in the lower back; dose number-3; dose number-3; hand pain; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38 year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in arm right, administration date 26Dec2021 17:00 (Lot number: Unknown) at the age of 38 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Comirnaty (Dose Number: 2, Batch/Lot No: ET2838, Location of injection: Arm Left), administration date: 30May2021 at the age of 37-years, for COVID-19 immunisation; Comirnaty (Dose Number: 1, Batch/Lot No: ET2838, Location of injection: Arm Left), administration date: 09May2021 at the age of 37 years, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (life threatening), IMMUNISATION (life threatening) all with onset 26Dec2021 17:00, outcome "unknown" and all described as "dose number-3"; CEREBROVASCULAR ACCIDENT (life threatening) with onset 28Dec2021, outcome "not recovered", described as "I felt like I stroke"; DYSPNOEA (life threatening) with onset 28Dec2021, outcome "not recovered", described as "difficulties to breathe"; PAIN IN EXTREMITY (non-serious) with onset 26Dec2021, outcome "unknown", described as "hand pain"; HEADACHE (non-serious) with onset 26Dec2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 27Dec2021, outcome "unknown", described as "very tired feeling"; BACK PAIN (non-serious) with onset 27Dec2021, outcome "unknown", described as "fewer, very bad back pain starter in the lower back". Therapeutic measures were not taken as a result of cerebrovascular accident, dyspnoea. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On the evening of vaccination on 26Dec2021, the patient had hand pain and headache. The next day, on 27Dec2021, the patient felt tired and had very bad back pain that stated in the lower back. The backpain continued on the fourth day. In the night of 28Dec2021, the patient felt like he had a stroke and had difficulty in breathing. It was unknown if patient has known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2023738 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0595 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Dyspnoea, Malaise, Nausea, Oxygen saturation, Tremor, Vital signs measurement
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: Blood collection; Result Unstructured Data: Test Result:unknown results; Comments: After vaccination At 13:13; Test Date: 20211226; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20211226; Test Name: Oxygen saturation; Test Result: 100 %; Comments: After vaccination At 13:13; Test Date: 20211226; Test Name: Oxygen saturation; Test Result: 100 %; Comments: At 13:25; Test Date: 20211226; Test Name: Blood pressure; Result Unstructured Data: Test Result:120/67 mmHg; Comments: After vaccination At 13:13; Test Date: 20211226; Test Name: Blood pressure; Result Unstructured Data: Test Result:114/64 mmHg; Comments: At 13:25; Test Date: 20211226; Test Name: Heart rate; Result Unstructured Data: Test Result:81 times/minute; Comments: After vaccination At 13:13; Test Date: 20211226; Test Name: Heart rate; Result Unstructured Data: Test Result:81 times/minute; Comments: At 13:25
CDC Split Type: JPPFIZER INC202200005487

Write-up: Dyspnoea; Nausea; Tremors in both limbs; Felt sick; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority, number: v21133020 (PMDA). A 14-year and 8-month-old female patient received bnt162b2 (COMIRNATY), administration date 26Dec2021 12:51 (Lot number: FK0595, Expiration Date: 31May2022) at the age of 14 years and 8-month-old as dose 2, single for covid-19 immunisation. The patient family history was no special mention. The patient''s relevant medical history and concomitant medications were not reported. The vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status): Vaccination history included: Bnt162b2, administration date: 05Dec2021, for COVID-19 immunisation, reaction(s): "Had a felt of dyspnoea (Hyperpnoea)", "Had a felt of dyspnoea (Hyperpnoea)." The course of the event was as follows: At 12:51, second dose vaccinated. On 26Dec2021 at 13:06 (15 minutes after the vaccination), the patient experienced Dyspnoea, Nausea, Tremors in both limbs. At 13:06, the patient said felt sick. (Had dyspnoea, trembling in both limbs). At 13:13; body temperature: (26Dec2021) 36.7 Centigrade, notes: Before vaccination. At 13:13, vital measurement (blood pressure 120/67mmHg, heart rate 81 times/minute, oxygen saturation 100%) route secured in the emergency medical care, and blood collection was performed at the same time. At 13:14, oxygen (3L) administration started. At 13:18, adrenaline injection 0.1% syringe "Terumo" 1ml IM. At 13:25, vital measurement (blood pressure 114/64 mmHg, heart rate 81 times / minute, oxygen saturation 100%). At 13:45, oxygen OFF, drip removal. On 26Dec2021 (same day of vaccination), the outcome of the event was recovering. Other possible cause(s) of the event such as any other diseases was some people become hyperpnoea due to psychological factors. It''s a psychological factor, not a vaccine adverse reaction. The reporting Other Health Professional commented as follows: As the doctor thoughts, it strongly suspect psychological factors. On this day''s examination, the second dose, as directed by the doctor, tends to have a relatively stronger adverse reaction. If the patient was convinced that vaccinated after considering the risks, the patient might vaccinated. If the patient felt more comfortable lying down for the vaccination, it was better to vaccinated it in bed. The reporting Other Health Professional classified the event as non-serious and assessed that the event was unrelated to bnt162b2. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available and a possible contributory role of the suspect BNT162B2 to the reported events of Dyspnoea, Nausea, Tremors in both limbs,malaise can be completely excluded/unrelated,Linked Report(s) : JP-PFIZER INC-202200016915 same reporter/patient, different dose/events.


VAERS ID: 2023913 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-12-26
   Days after vaccination:146
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: covid test; Test Result: Positive; Comments: Nasal Swab
CDC Split Type: SEPFIZER INC202101868639

Write-up: Positive Covid PCR despite receiving 2 doses of comirnaty; Positive Covid PCR despite receiving 2 doses of comirnaty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 44 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 02Aug2021 (Lot number: FE8235) at the age of 44 years as dose 2, single and intramuscular, administered in arm left, administration date 16Jun2021 (Lot number: FD4555) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Patient had no known allergies. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination. The following information was reported DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome recovering. Adverse event included Positive Covid PCR despite receiving 2 doses of comirnaty. Developed symptoms of muscle ache, headache, and tiredness. Patient had been tested with positive result for covid test since the vaccination. The patient underwent the following laboratory tests and procedures sars-cov-2 test (26Dec2021) positive, Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Conclusion: The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FE8235. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, and stability. Concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected. Linked Report(s) SE-PFIZER INC-202101868717 Same reporter, patient, and product. Different doses. Similar events


VAERS ID: 2025700 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-12-26
   Days after vaccination:261
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001652 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Sleep disorder, Vaccination site bruising, Vaccination site haemorrhage, Vaccination site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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

Write-up: A bruise at the site; Bleeding at the site, which was unusual; left arm was sore to raise above shoulder; uncomfortable to sleep; This spontaneous case was reported by an other health care professional and describes the occurrence of SLEEP DISORDER (uncomfortable to sleep), VACCINATION SITE BRUISING (A bruise at the site), VACCINATION SITE HAEMORRHAGE (Bleeding at the site, which was unusual) and VACCINATION SITE PAIN (left arm was sore to raise above shoulder) in a 55-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 019J21A, 3002182 and 3001652) for COVID-19 vaccination. Concurrent medical conditions included Asthma (childhood asthma). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Feb-1986 to an unknown date for an unknown indication. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021 at 4:30 PM, received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, the patient experienced SLEEP DISORDER (uncomfortable to sleep). On 26-Dec-2021 at 10:00 PM, the patient experienced VACCINATION SITE PAIN (left arm was sore to raise above shoulder). On an unknown date, the patient experienced VACCINATION SITE BRUISING (A bruise at the site) and VACCINATION SITE HAEMORRHAGE (Bleeding at the site, which was unusual). On 29-Dec-2021, VACCINATION SITE PAIN (left arm was sore to raise above shoulder) had resolved. At the time of the report, SLEEP DISORDER (uncomfortable to sleep) was resolving and VACCINATION SITE BRUISING (A bruise at the site) and VACCINATION SITE HAEMORRHAGE (Bleeding at the site, which was unusual) outcome was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter considered VACCINATION SITE PAIN (left arm was sore to raise above shoulder) to be related. No further causality assessments were provided for SLEEP DISORDER (uncomfortable to sleep), VACCINATION SITE BRUISING (A bruise at the site) and VACCINATION SITE HAEMORRHAGE (Bleeding at the site, which was unusual). Reported approx.6 hours post vaccine, left arm was sore to raise above shoulder and uncomfortable to sleep on. It has been reported feels better wed am. Treatment medications were not provided by the reporter. This case was linked to MOD-2022-438310 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2022: Significant Follow-up received included, Reporter information, Patient demographics, medical history, dose information, concomitant medication and event information was updated.


VAERS ID: 2026057 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, COVID-19, Immunisation, SARS-CoV-2 test, Tremor, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211227; Test Name: Body temperature increased; Result Unstructured Data: Test Result:37.6 Centigrade; Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: DKPFIZER INC202101861268

Write-up: He was tested positive on 29Dec2021. He was infected with Corona.; He was tested positive on 29Dec2021. He was infected with Corona.; During the night, around 3 am, shaking, oral temperature measured to 37.6; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 27 year-old male patient received bnt162b2 (COMIRNATY), administration date 26Dec2021 14:30 (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single, administration date 02Aug2021 (Batch/Lot number: unknown) as dose 2, single and administration date 08Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 26Dec2021, outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "He was tested positive on 29Dec2021. He was infected with Corona."; TREMOR (non-serious) with onset 27Dec2021 03:00, outcome "recovering", described as "During the night, around 3 am, shaking, oral temperature measured to 37.6". The patient underwent the following laboratory tests and procedures: body temperature increased: (27Dec2021) 37.6 Centigrade; sars-cov-2 test: (30Dec2021) positive. Clinical course: No vomiting and no changes in the sense of taste or smell. Narrative as received: "We were informed of the positive Corona test on the 30Dec2021." The lot number for bnt162b2 was not provided and will be requested during follow up. Follow-up 30Dec2021 and 02Jan2022: This is a spontaneous follow-up report received from contactable consumer via a Pfizer colleague. Updated information included: lab test (SARS-CoV-2 test), Historical vaccines (Comirnaty first and second dose) removed and added as suspect drugs; additional events Vaccination failure and Covid-19. The lot number for Comirnaty was not provided and will be requested during follow up.


VAERS ID: 2026214 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymph node pain, 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Lymph node pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26398397) on 28-Dec-2021 and was forwarded to Moderna on 28-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Lymph node pain) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. The patient''s past medical history included Clinical trial participant. On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain) (seriousness criterion medically significant). At the time of the report, LYMPH NODE PAIN (Lymph node pain) 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 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. Company Comment: This RA case concerns a 32 year old female with relevant medical history of clinical trail participant, who experienced Serious ( medically significant ) , unexpected event of lymph node pain which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case was captured as unknown by this RA report. The history of the patient being a clinical trial participant may be considered as a confounder for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender''s Comments: This RA case concerns a 32 year old female with relevant medical history of clinical trail participant, who experienced Serious ( medically significant ) , unexpected event of lymph node pain which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case was captured as unknown by this RA report. The history of the patient being a clinical trial participant may be considered as a confounder for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 2026298 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-26
Onset:2021-12-26
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Headache, Immunisation, Interchange of vaccine products, Myalgia, Off label use, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101877563

Write-up: Headache; Armpit pain; Generalised muscle aches; Tiredness; Injection site pain; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from The Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112280916164380-NTUMP (MHRA). Other Case identifier(s): GB-MHRA-ADR 26402257 (MHRA). A 35 year-old male patient received bnt162b2 (COMIRNATY), administration date 26Dec2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1, SINGLE), administration date: 01May2021, for COVID-19 Immunisation; Covid-19 vaccine astrazeneca (DOSE 2, SINGLE), administration date: 26Jun2021, for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 26Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 26Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 27Dec2021, outcome "recovering", described as "Headache"; AXILLARY PAIN (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Armpit pain"; VACCINATION SITE PAIN (medically significant) with onset 26Dec2021, outcome "recovered" (28Dec2021), described as "Injection site pain"; MYALGIA (medically significant) with onset 27Dec2021, outcome "recovering", described as "Generalised muscle aches"; FATIGUE (medically significant) with onset 27Dec2021, outcome "recovering", described as "Tiredness". Patient has not tested positive for COVID-19 since having the vaccine. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026414 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-17
Onset:2021-12-26
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Rash pruritic, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), 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: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Itchy rash; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26405406) on 29-Dec-2021 and was forwarded to Moderna on 29-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced RASH PRURITIC (Itchy rash) (seriousness criterion medically significant). At the time of the report, RASH PRURITIC (Itchy rash) had not 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 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported. Patient has not had symptoms associated with COVID-19. It was reported that the patient experienced widespread red, raised and itchy rash. Large clusters. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.; Sender''s Comments: This case concerns a patient, with medical history not reported, who experienced the serious unexpected event(s) of Rash pruritic. The event(s) started occurring approximately within 9 day(s) after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2026481 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-26
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Gastroenteritis, Immunisation, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), Noninfectious diarrhoea (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: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101877553

Write-up: Booster; back pain; Gastroenteritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112290108068680-42X00 Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26406100 Regulatory Authority. A 24 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 16Jun2021, for COVID-19 Immunisation; Comirnaty (DOSE 2, SINGLE), administration date: 16Aug2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; GASTROENTERITIS (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Gastroenteritis"; BACK PAIN (medically significant), outcome "unknown", described as "back pain". Clinical course: patient experienced significant back pain in addition to the normal symptoms of gastroenteritis. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reporter did not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) negative, notes: No - Negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026618 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deep vein thrombosis, Fibrin D dimer, SARS-CoV-2 test, Venous thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Fibrin D dimer; Result Unstructured Data: D-dimer was $g4000; Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: venous thrombosis; Deep venous thrombosis proximal; This case was received via RA (Reference number: GB-MHRA-ADR 26417921) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of VENOUS THROMBOSIS (venous thrombosis) and DEEP VEIN THROMBOSIS (Deep venous thrombosis proximal) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced DEEP VEIN THROMBOSIS (Deep venous thrombosis proximal) (seriousness criterion medically significant). On an unknown date, the patient experienced VENOUS THROMBOSIS (venous thrombosis) (seriousness criterion medically significant). At the time of the report, VENOUS THROMBOSIS (venous thrombosis) outcome was unknown and DEEP VEIN THROMBOSIS (Deep venous thrombosis proximal) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. On an unknown date, Fibrin D dimer: $g4000 D-dimer was $g4000. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No medical history was provided by the reporter Treatment Information was not provided. Unprovoked large proximal DVT (Extensive unprovoked proximal lower limb DVT) in close temporal proximity to jab. It was diagnosed by Ultrasound doppler Patient is not enrolled in clinical trial Patient stated that report related to possible blood clots or low platelet counts. Patient has not had symptoms associated with COVID-19 Company comment This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected serious events of VENOUS THROMBOSIS (AESI) and DEEP VEIN THROMBOSIS (AESI). The events occurred approximately 5 days after the administration of the third dose of mRNA-1273 vaccine. Patient had received COVID-19 VACCINE ASTRAZENECA as previous vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected serious events of VENOUS THROMBOSIS (AESI) and DEEP VEIN THROMBOSIS (AESI). The events occurred approximately 5 days after the administration of the third dose of mRNA-1273 vaccine. Patient had received COVID-19 VACCINE ASTRAZENECA as previous vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2026625 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Fatigue, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), 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: Coronavirus infection (Had previous covid infection (delta variant) in June. Since recovered.)
Allergies:
Diagnostic Lab Data: Test Date: 20211225; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: shortness of breath; very light headed; Swelling of fingers; Breath shortness; Fatigue; This case was received via RA (Reference number: GB-MHRA-ADR 26418527) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), DIZZINESS (very light headed), DYSPNOEA (Breath shortness), FATIGUE (Fatigue) and PERIPHERAL SWELLING (Swelling of fingers) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. The patient''s past medical history included Coronavirus infection (Had previous covid infection (delta variant) in June. Since recovered.). On 26-Dec-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced DYSPNOEA (Breath shortness) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 27-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swelling of fingers) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion medically significant) and DIZZINESS (very light headed) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (shortness of breath), DIZZINESS (very light headed), DYSPNOEA (Breath shortness) and FATIGUE (Fatigue) had not resolved and PERIPHERAL SWELLING (Swelling of fingers) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2021, 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 product use was not provided by the reporter. Patient was very light headed, low blood pressure and shortness of breath 15 mins after receiving dose. Blood pressure shortly back to normal. Remaining symptoms are shortness of breath and fatigue. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company Comment: This case refers to a male patient of unspecified age with no relevant medical history who experienced the unexpected events of Dyspnoea, Dizziness, Dyspnoea, Fatigue and Peripheral swelling. Dyspnoea and Fatigue occurred on the same day after receiving the first dose of mRNA-1273 vaccine and the event occurred 1 day later while the events of Dyspnoea and Dizziness occurred after an unspecified number of days post exposure to the vaccine. No causality assessment was provided by the reporter. 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 refers to a male patient of unspecified age with no relevant medical history who experienced the unexpected events of Dyspnoea, Dizziness, Dyspnoea, Fatigue and Peripheral swelling. Dyspnoea and Fatigue occurred on the same day after receiving the first dose of mRNA-1273 vaccine and the event occurred 1 day later while the events of Dyspnoea and Dizziness occurred after an unspecified number of days post exposure to the vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2026840 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-02
Onset:2021-12-26
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0161 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Pain of skin
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gilbert''s syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202200014093

Write-up: Arrhythmia ended after a few hours; Left side scalp pain. Touching the part I feel pain that also radiates near the ear.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: IT-MINISAL02-825830. A 40 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 02Nov2021 (Lot number: FH0161) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "gilbert syndrome" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant) with onset 26Dec2021, outcome "recovered" (Dec2021), described as "Arrhythmia ended after a few hours"; PAIN OF SKIN (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Left side scalp pain. Touching the part I feel pain that also radiates near the ear.". Reporter Comment: Gilbert''s syndrome; Reporter''s Comments: Gilbert''s syndrome


VAERS ID: 2029679 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Interchange of vaccine products, Off label use, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101882913

Write-up: armpit swelling; Armpit pain; Booster; Off label use; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112291410221180-WUONW. Other Case identifier: GB-MHRA-ADR 26409166. A 45 year-old patient received bnt162b2 (COMIRNATY), administration date 26Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The following information was reported: IMMUNISATION (medically significant) with onset 26Dec2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 26Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Dec2021, outcome "unknown", described as "Interchange of vaccine products"; AXILLARY PAIN (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Armpit pain"; SWELLING (medically significant), outcome "unknown", described as "armpit swelling". Therapeutic measures were taken as a result of axillary pain that included paracetamol. Clinical course: Following day armpit swelling followed by pain, paracetamol taken No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029763 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101882725

Write-up: Heavy periods; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the RA. Regulatory number: GB-MHRA-WEBCOVID-202112292035309060-KVZEB. Other Case identifier(s): GB-MHRA-ADR 26411558. A 34 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant, Patient is not currently breastfeeding. Patient last menstrual period date was 27Nov2021. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Heavy periods". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030146 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-17
Onset:2021-12-26
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Neck pain, Oropharyngeal pain, Rash erythematous, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Arthritis (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 Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: spread to neck; joint pain; Joint ache; Sore throat; Red rash; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26421948) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), NECK PAIN (spread to neck), OROPHARYNGEAL PAIN (Sore throat), ARTHRALGIA (joint pain) and ARTHRALGIA (Joint ache) in a 39-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant). On 28-Dec-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). On an unknown date, the patient experienced NECK PAIN (spread to neck) (seriousness criterion medically significant) and ARTHRALGIA (joint pain) (seriousness criterion medically significant). At the time of the report, RASH ERYTHEMATOUS (Red rash) had not resolved and NECK PAIN (spread to neck), OROPHARYNGEAL PAIN (Sore throat), ARTHRALGIA (joint pain) and ARTHRALGIA (Joint ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-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 concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter Patient had a rash which was started appearing on 26th December around groin area. Spread to neck, hands, face and arms the following day, Very itchy and scratching leads to raised and inflammed areas of skin and Sore throat and joint pain also followed on the 28th. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Company comment This is a regulatory case concerning a 39-year-old male patient with no medical history reported, who experienced the serious unexpected, according to , events of rash erythematous, neck pain, oropharyngeal pain and arthralgia (joint pain and joint ache). The event rash erythematous occurred approximately 9 days after the third dose of mRNA-1273. The events oropharyngeal pain and arthralgia (joint ache) occurred approximately 11 days after the third dose of mRNA-1273. Neck pain and arthralgia (joint pain) occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was assessed as unknown according to . 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 is a regulatory case concerning a 39-year-old male patient with no medical history reported, who experienced the serious unexpected, according to , events of rash erythematous, neck pain, oropharyngeal pain and arthralgia (joint pain and joint ache). The event rash erythematous occurred approximately 9 days after the third dose of mRNA-1273. The events oropharyngeal pain and arthralgia (joint ache) occurred approximately 11 days after the third dose of mRNA-1273. Neck pain and arthralgia (joint pain) occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was assessed as unknown according to . The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030239 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Infection, 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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started. Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201230; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Infection; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424189) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This Regulatory Authority case was reported by a consumer and describes the occurrence of INFECTION (Infection) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started. Unsure when symptoms stopped). On 24-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced INFECTION (Infection) (seriousness criterion medically significant). At the time of the report, INFECTION (Infection) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test. Concomitant product use was not provided by the reporter. Treatment information was not provided. It was reported that patient had infection. It was unsure if patient was enrolled in clinical trial. It was reported that, patient reaction was not related to possible inflammation of the heart (myocarditis or pericarditis). Re-challenge was reported as unknown. Company comment: This Regulatory Authority case concerns a 27-year-old, male patient, with medical history of suspected COVID-19, who experienced the unexpected, serious (Medically significant) event of infection. The event occurred 2 days after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. It was not reported if the previous two doses of his COVID-19 vaccination schedule were mRNA-1273 vaccines as well. Regulatory authority captured the rechallenge as unknown. The medical history of suspected COVID-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Significant follow-up received wherein event (myocarditis) was removed and action taken updated from unknown to NA; Sender''s Comments: This Regulatory Authority case concerns a 27-year-old, male patient, with medical history of suspected COVID-19, who experienced the unexpected, serious (Medically significant) event of infection. The event occurred 2 days after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. It was not reported if the previous two doses of his COVID-19 vaccination schedule were mRNA-1273 vaccines as well. Regulatory authority captured the rechallenge as unknown. The medical history of suspected COVID-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030346 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, SARS-CoV-2 test
SMQs:, 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: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Flu like symptoms; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26425019) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No medical history was provided by the reporter. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 04-Jul-2021 to an unknown date for Vaccination. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criteria disability and medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-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. Patient last menstruation period date was 25-Nov-2021. After vaccination patient were experienced with Site arm and a bit of temperature 1 to 2 days after the vaccine. 3rd day, running nose and watery eyes. patient could not hold head up because needed to blow the nose every 10 seconds. This lasted 4 days, accompanied with temperature up to 37.8 and general fatigue and sleepiness. After 4 days, were not able to get off bed and the sinus continued to be blocked with more thick mucus that had yellow or orange color. 10 days after the vaccine and still cannot breathe from the nose. This was the only side effect left. Maybe unrelated to the booster, but patient was working from home the days before the vaccine and did not came in contact with anyone, so not sure how this could have been a cold. Patient was not had symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. The laboratory exam was done that includes Daily Covid lateral flow self-tests and PCR on the 29th and the result was found to be all negative. Treatment Medication use information was not provided by reporter.; Sender''s Comments: This case concerns a patient, with medical history (not reported), who experienced the serious unexpected event(s) of Influenza like illness and cough. The event(s) started occurring approximately within 3 day(s) after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2030511 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-12-26
   Days after vaccination:216
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Gene sequencing, 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: 202112; Test Name: Gene sequencing; Result Unstructured Data: Test Result:carried the Variant of Concern Omicron; Test Date: 202112; Test Name: Gene sequencing; Result Unstructured Data: Test Result:this case and another three confirmed cases of; Comments: this case and another three confirmed cases of COVID-19 had identical genetic sequences; Test Date: 20211217; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: in the city; Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: upon arrival in the Centre at International Airport; Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: in Centre
CDC Split Type: HKPFIZER INC202200021369

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K/CARRIED THE VARIANT OF CONCERN OMICRON; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K/CARRIED THE VARIANT OF CONCERN OMICRON; This is a spontaneous report received from non-contactable reporter (Other HCP) from License Party(BioNTech) and Regulatory Authority. Other Case identifier: HK-Fosun-2021FOS007605. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. A 45-year-old male patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 03-May-2021 and 24-May-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization in the city. The patient received one dose of COVID-19 vaccination (CORONAVAC) (lot number: unknown) on 13-Dec-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization in the city. Medical history, concomitant medications and past product were not reported. On 17-Dec-2021, the patient tested negative in the city. On 21-Dec-2021, he left the city for the country by flight. On 24-Dec-2021, he returned to the city by flight from the country. His specimen collected upon arrival in the Centre at International Airport tested negative for COVID-19. The patient underwent medical surveillance and regular compulsory testing in accordance with the relevant requirements for exempted persons. According to the patient, except from buying food in the community for a short duration of time and going to a Centre to collect sample for testing, he stayed at home during the rest of the time. On 26-Dec-2021, His sample collected at a Centre tested positive for COVID-19 with Ct value about 16 to 22. The patient developed symptoms including headache, runny nose and cough on the same day. The patient was confirmed as COVID-19 with mutant strains of N501Y and T478K. The epidemiological investigations revealed that a preliminary positive imported case had contact at residence with the patient on 25-Dec-2021. In Dec-2021, the whole genome sequencing analysis conducted by the Laboratory confirmed that the patient carried the Variant of Concern Omicron. The whole genome sequencing analysis conducted by the Laboratory confirmed that this case and another three confirmed cases of COVID-19 had identical genetic sequences. The adverse events ''confirmed case of COVID-19/imported case with mutant strains of N501Y and T478K/carried the Variant of Concern Omicron'' and ''received two doses of COVID-19 vaccination (Comirnaty) in the city on May 3 and May 24 and one dose of COVID-19 vaccination (CoronaVac) in the city on December 13'' were considered as Important Medical Event. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcome of the events was unknown. Initial report was received on 28-Dec-2021, 29-Dec-2021, 31-Dec-2021 and 02-Jan-2022. This case was split from AER 2021FOS007595 due to same reporter/product, different event/patient. This case was split to AER 2021FOS007605, 2021FOS007606, 2021FOS007607 and 2021FOS007608 due to same reporter/product, different event/patient. This case was cross-linked with above cases. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. The reporter and Company (BioNTech) causality assessments for the events COVID-19, Vaccination failure were reported as possible.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200016784 same reporter, different event/patient/suspect drug;HK-PFIZER INC-202200021237 same reporter, different event/patient/suspect drug


VAERS ID: 2030512 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-12-26
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Gene sequencing, 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: 202112; Test Name: Gene sequencing; Result Unstructured Data: Test Result:carried the Variant of Concern Omicron; Test Date: 20211214; Test Name: COVID-19 virus test; Test Result: Negative ; Comments; Test Date: 202112; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Ct value of less than 30 involving N501Y and T478K; Comments: mutant strains; Test Date: 20211225; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: in the Collection Center; Test Date: 20211227; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: at a community testing center; Test Date: 20220103; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202200023006

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y + T478K/IMPORTED CASE WITH VARIANT OF CONCERN OMICRON; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y + T478K/IMPORTED CASE WITH VARIANT OF CONCERN OMICRON; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2021FOS007611. This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is not applicable. As of 0:00 am, 28-Dec-2021, RA announced that four additional confirmed cases of COVID-19 after Comirnaty vaccination. This case was split for 1 of 4 cases that confirmed COVID-19 after Comirnaty vaccination. A 44-year-old male patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 29-May-2021 and 19-Jun-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 14-Dec-2021, he tested negative for COVID-19 and left Traveled on December 22. On 25-Dec-2021, he arrived home via flight. His specimen collected upon arrival in the testing center; tested negative for COVID-19. On 27-Dec-2021, his sample collected at a CTC tested preliminary positive for COVID-19. The whole genome sequencing analysis conducted by the RA''s Public Health Laboratory Services Branch confirmed that the patient carried the Variant of Concern Omicron, the genetic sequences of patient was highly similar to previously confirmed cases of COVID-19. On 03-Jan-2022, the patient tested positive. Patient was epidemiologically linked with an earlier confirmed imported cases. He was confirmed as COVID-19 with a Ct value of less than 30 involving N501Y and T478K mutant strains. This case was a close contact of another confirmed case of COVID-19. The adverse event ''confirmed case of COVID-19/imported case with mutant strain of N501Y + T478K/imported case with Variant of Concern Omicron'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 29-Dec-2021, 30-Dec-2021, 31-Dec-2021, 01-Jan-2022, 02-Jan-2022, 03-Jan-2022 and 05-Jan-2022. This case was split due to same reporter/product, different event/patient. Follow-up closed, no further information is possible. Causality Assessments: COVID-19, Vaccination failure Per Reporter and per Company (BioNTech): Possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200010736 same reporter/product, different event/patient;HK-PFIZER INC-202200048294 same reporter/product, different event/patient


VAERS ID: 2030538 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-12-26
   Days after vaccination:173
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Nasal Swab, PCR test, Verified as COVID-19 positive on Thur 30Dec21 (State administered PCR test); Test Date: 20220103; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: IEPFIZER INC202200018692

Write-up: COVID-19 positive on Thur 30Dec21 (State administered PCR test)/Test performed Wed 29Dec21 (1st available appointment) following positive Antigen test 27Dec21; COVID-19 positive on Thur 30Dec21 (State administered PCR test)/Test performed Wed 29Dec21 (1st available appointment) following positive Antigen test 27Dec21; very mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 15 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 06Jul2021 (Lot number: EW6126) at the age of 15 years as dose 2, single and intramuscular, administered in arm left, administration date 15Jun2021 (Lot number: EW6126) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 26Dec2021, outcome "recovered", COVID-19 (medically significant) with onset 26Dec2021, outcome "recovered" and all described as "COVID-19 positive on Thur 30Dec21 (State administered PCR test)/Test performed Wed 29Dec21 (1st available appointment) following positive Antigen test 27Dec21"; HEADACHE (medically significant) with onset 26Dec2021, outcome "recovered", described as "very mild headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive; (29Dec2021) positive, notes: Nasal Swab, PCR test, Verified as COVID-19 positive on Thur 30Dec21 (State administered PCR test); (03Jan2022) negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Therapeutic measures were taken as a result of headache. Additional information: Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. Reported Event: Clinical symptom included experienced very mild headache on 26Dec21 only treated with single dose of 500mg paracetamol. Antigen test performed on 27Dec as precaution. Verified as COVID-19 positive on Thur 30Dec21 (State administered PCR test). Test performed Wed 29Dec21 (1st available appointment) following positive Antigen test 27Dec21. Remained completely asymptomatic from 27Dec onwards. Prior to vaccination, was the patient diagnosed with COVID-19?: No. Since the vaccination, has the patient been tested for COVID-19?: Yes.


VAERS ID: 2031088 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-10
Onset:2021-12-26
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual 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: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Heavy periods; This case was received via the RA (Reference number: GB-MHRA-ADR 26423217) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy periods) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) for an unknown indication. On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy periods) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, 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. Treatment medication was not provided by the reporter. Patient experienced blood spotting soon after vaccination and very heavy period, losing large blood clots and a lot of pain in the back, legs and stomach. It was reported that heavy periods in the past appeared to have triggered again. Patient took ibuprofen and tranexamic acid but not eased blood clots. Patient has not tested positive for COVID-19 since having the vaccine, and not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Company Comment: This regulatory case concerns a patient, of unknown age and gender, with history of concomitant administration of Influenza vaccine, who experienced the unexpected, serious event of heavy menstrual bleeding. The event occurred 16 days after administration of the third dose of the Moderna mRNA-1273 vaccine. The patient took ibuprofen and tranexamic acid (unspecified dosage, frequency and duration) affording no relief of symptoms. The event had not resolved at the time of the report. The history of concomitant administration of Influenza vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a patient, of unknown age and gender, with history of concomitant administration of Influenza vaccine, who experienced the unexpected, serious event of heavy menstrual bleeding. The event occurred 16 days after administration of the third dose of the Moderna mRNA-1273 vaccine. The patient took ibuprofen and tranexamic acid (unspecified dosage, frequency and duration) affording no relief of symptoms. The event had not resolved at the time of the report. The history of concomitant administration of Influenza vaccine remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2033422 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-25
Onset:2021-12-26
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis bacterial, SARS-CoV-2 test
SMQs:, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000234

Write-up: Myocarditis bacterial; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority; GB-MHRA-WEBCOVID-202201012101465880-IVJFI. Other Case identifier(s): GB-MHRA-ADR 26424379. A female patient received bnt162b2 (COMIRNATY), administration date 25Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The following information was reported: MYOCARDITIS BACTERIAL (hospitalization, medically significant) with onset 26Dec2021, outcome "recovered with sequelae", described as "Myocarditis bacterial". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) no - negative covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033548 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-20
Onset:2021-12-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Headache, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003614

Write-up: Persistent vomiting; Diarrhea; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202201022231094280-FMMP7. Other Case identifier(s): GB-MHRA-ADR 26425305. A 13 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Persistent vomiting"; DIARRHOEA (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Diarrhea"; HEADACHE (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033562 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-08
Onset:2021-12-26
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: COVID-19 VACCINE ASTRAZENECA
Current Illness: Caffeine consumption (fairly high caffeine intake (2 cans of Red Bull per day and occasional pre-workout caffeine stimulant drinks))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211219; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: racing heart; Heart palpitations; Racing heart (tachycardia); Heart pounding; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26426054) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (racing heart), PALPITATIONS (Heart pounding), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) in a 51-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Previously administered products included for Product used for unknown indication: CAFFEINE. Past adverse reactions to the above products included No adverse event with CAFFEINE. Concurrent medical conditions included Caffeine consumption (fairly high caffeine intake (2 cans of Red Bull per day and occasional pre-workout caffeine stimulant drinks)). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 08-Apr-2021 to an unknown date for COVID-19 immunisation. On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced PALPITATIONS (Heart pounding) (seriousness criterion medically significant). On an unknown date, the patient experienced PALPITATIONS (racing heart) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (racing heart) and PALPITATIONS (Heart pounding) had not resolved and PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Dec-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. Patient has not had symptoms associated with COVID-19. He experienced severe heart fluttering and irregular heartbeats lasting up to one hour. He had not tested positive for COVID-19 since having the vaccine. He was not enrolled in clinical trial. It was reported that, his reaction was related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay and the diagnosis was not made by a medical professional. No imaging or any blood tests were carried out. No treatment drugs were reported. Company comment: This is a regulatory case concerning a 51-year-old male patient with medical history of high caffeine intake who experienced the unexpected and serious events of palpitations and tachycardia. The event tachycardia occurred on an unknown day after a third dose of mRNA-1273 vaccine was administered while the event palpitations occurred 18 days after vaccine was given. Patient experienced severe heart fluttering and irregular heartbeats lasting up to one hour. It was reported that, his reaction was related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay and the diagnosis was not made by a medical professional. No imaging or any blood tests were carried out. No treatment drugs were reported. Medical history of high caffeine intake remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 51-year-old male patient with medical history of high caffeine intake who experienced the unexpected and serious events of palpitations and tachycardia. The event tachycardia occurred on an unknown day after a third dose of mRNA-1273 vaccine was administered while the event palpitations occurred 18 days after vaccine was given. Patient experienced severe heart fluttering and irregular heartbeats lasting up to one hour. It was reported that, his reaction was related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay and the diagnosis was not made by a medical professional. No imaging or any blood tests were carried out. No treatment drugs were reported. Medical history of high caffeine intake remains as a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2033714 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-26
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Eczema (Had eczema previously but it has gotten worse since having booster and having caught corona virus)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200026867

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter (Other HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202201062058585270-CG7LH. Other Case identifier(s): GB-MHRA-ADR 26446077. A female patient received bnt162b2 (COMIRNATY), administration date 20Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing), notes: Had eczema previously but it has gotten worse since having booster and having caught corona virus. The patient''s concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovered" and all described as "SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: yes - positive covid-19 test. The patient did not have symptoms associated with COVID-19 and was not enrolled in a clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis), blood clots or low platelet counts. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2034031 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-02
Onset:2021-12-26
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pre-eclampsia (Pregnancy at 31+2 weeks with severe preeclampsia); Pregnancy (Pregnancy at 31+2 weeks with severe preeclampsia)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20224

Write-up: Thrombocytopenia; This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOCYTOPENIA (Thrombocytopenia) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. Concurrent medical conditions included Pre-eclampsia (Pregnancy at 31+2 weeks with severe preeclampsia) and Pregnancy (Pregnancy at 31+2 weeks with severe preeclampsia). On 02-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criterion hospitalization). At the time of the report, THROMBOCYTOPENIA (Thrombocytopenia) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that patient received the Moderna vaccine on 14-SEP-2021 and 02-NOV-2021. Patient visited ER on 26-DEC-2021. There was a sudden onset right eye left visual field deficit for 1 day, no diplopia, no visual loss, no EOM limitation, no blurred vision RAPD. On 27-DEC-2021 Ophthalmology: Macular edema secondary to pre-eclampsia. No noted thrombotic event. On 27-DEC-2021 Hematology and oncology: Thrombocytopenia, favor ITP or other autoimmune causes, also need to rule out TTP On 27-DEC-2021 Rheumatology: 1. thrombocytopenia, r/o TTP secondary to AIR dz, r/o VITT?, r/o aHUS, etc. 2.blurred vision, suspect TIA, r/o APS or APS related SLE. On 29-DEC-2021 Cardiology: normal LV EF and normal diastolic function according to formal cardiac echo. Pregnancy at 31+1 with preeclampsia with severe features and severe thrombocytopenia. D.D: ITP, TTP, HELLP, MAHA, uHUS, Lupus/APS. s/p IVIG 1g/kg on 28-DEC-2021. s/p methylprednisolone 40mg on 27-DEC-2021 and 28-DEC-2021. s/p Lst-C/S on 28-DEC-2021. On 28-DEC-2021 operation went smoothly, closely follow up postpartum change in preeclampsia profile and thrombocytopenia, under intubation and yet stable condition. Company comment: This regulatory authority case concerns a 31-year-old female patient who experienced serious due to hospitalization, unexpected AESI of thrombocytopenia, that occurred approximately 1.5 months after the 2nd dose of the mRNA-1273 . Reportedly, the patient was pregnant at the time of vaccination. The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 31-year-old female patient who experienced serious due to hospitalization, unexpected AESI of thrombocytopenia, that occurred approximately 1.5 months after the 2nd dose of the mRNA-1273 . Reportedly, the patient was pregnant at the time of vaccination. The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2034732 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0000141A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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? 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: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Spotting menstrual; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26438232) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (Spotting menstrual) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 0000141A) for an unknown indication. No Medical History information was reported. On 24-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced INTERMENSTRUAL BLEEDING (Spotting menstrual) (seriousness criterion medically significant). On 02-Jan-2022, INTERMENSTRUAL BLEEDING (Spotting menstrual) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had no symptoms associated with COVID-19. Patient was not pregnant and not currently on breastfeeding. Patient had spotting and bleeding in the middle of menstrual cycle. Very unusual, as until now have had regular periods. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient have had vaginal examination, results were not provided. Relevant concomitant medications were not reported. Treatment information was not provided. Company Comment: This case refers to a 24-year-old female patient with no known medical history who experienced the unexpected event of Intermenstrual bleeding approximately 2 days after the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. 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 refers to a 24-year-old female patient with no known medical history who experienced the unexpected event of Intermenstrual bleeding approximately 2 days after the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2036869 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200003822

Write-up: Off label use; Interchange of vaccine products; Booster; Painful arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201021005301550-IMSM0 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26424742 (MHRA). A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 26Dec2021 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 26Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 26Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Painful arm". I can''t lift my arm without being in pain. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2036946 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Insomnia, SARS-CoV-2 test, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210814; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200003599

Write-up: insomnia/ chronic insomnia; Seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the parent. Regulatory number: GB-MHRA-WEBCOVID-202201030726035890-0YEB3 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26426007 (MHRA). A 15 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Dec2021 (Lot number: FK9706) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 16Aug2021, stop date: 22Aug2021. The patient''s concomitant medications were not reported. The following information was reported: INSOMNIA (hospitalization, medically significant), outcome "not recovered", described as "insomnia/ chronic insomnia"; SEIZURE (hospitalization, medically significant) with onset 26Dec2021, outcome "recovered" (02Jan2022), described as "Seizure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (14Aug2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: He felt a charge in his head, has had chronic insomnia ever since the vaccine, has had these seizures and still has not recovered. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2037007 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-02
Onset:2021-12-26
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: HRI WATER BALANCE
Current Illness: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Had covid this time last year and was admitted to ICU for two weeks)
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.MOD20224

Write-up: Neck rash; Rash all over; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26428877) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Neck rash) and RASH (Rash all over) in a 69-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 immunisation. The patient''s past medical history included COVID-19 (Had covid this time last year and was admitted to ICU for two weeks). Concurrent medical conditions included Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...). Concomitant products included HRI WATER BALANCE from 06-Sep-2021 to 06-Sep-2021 for Swelling of legs. On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced RASH (Neck rash) (seriousness criteria disability and medically significant) and RASH (Rash all over) (seriousness criteria disability and medically significant). At the time of the report, RASH (Neck rash) and RASH (Rash all over) had not 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 patient takes statins, blood pressure tablets and water tablets. Patient had booster on second Dec. She had rash on the 26th Dec and painful skin and weeping and still ongoing. No tests were completed. She has been given antihistamines. Patient has not had symptoms associated with COVID-19 and was not tested positive for COVID-19 since had the vaccine. She was not enrolled in clinical trial. Company comment: This Regulatory Authority case concerns a 69-year-old, female patient, with no relevant medical history, who experienced the unexpected, serious (Disabling/ Medically significant) event of rash (reported as "neck rash" and "rash all over"). The event occurred 24 days after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule, along with painful skin and weeping. It was not reported if the previous two doses of her COVID-19 vaccination schedule were mRNA-1273 vaccines as well. By the time of the report, the patient was not recovered. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Regulatory authority reported the event as serious per disability seriousness criteria, however, with available information it is difficult to assess which type of disability the event brought to the patient.; Sender''s Comments: This Regulatory Authority case concerns a 69-year-old, female patient, with no relevant medical history, who experienced the unexpected, serious (Disabling/ Medically significant) event of rash (reported as "neck rash" and "rash all over"). The event occurred 24 days after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule, along with painful skin and weeping. It was not reported if the previous two doses of her COVID-19 vaccination schedule were mRNA-1273 vaccines as well. By the time of the report, the patient was not recovered. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Regulatory authority reported the event as serious per disability seriousness criteria, however, with available information it is difficult to assess which type of disability the event brought to the patient.


VAERS ID: 2037091 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-20
Onset:2021-12-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005686 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual 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: PFIZER BIONTECH COVID-19 VACCINE
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.MOD20224

Write-up: Heavy periods; Painful periods; Prolonged periods; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26432936) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy periods), DYSMENORRHOEA (Painful periods) and HEAVY MENSTRUAL BLEEDING (Prolonged periods) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005686) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant), DYSMENORRHOEA (Painful periods) (seriousness criterion medically significant) and HEAVY MENSTRUAL BLEEDING (Prolonged periods) (seriousness criterion medically significant). On 03-Jan-2022, HEAVY MENSTRUAL BLEEDING (Heavy periods) and DYSMENORRHOEA (Painful periods) had resolved with sequelae and HEAVY MENSTRUAL BLEEDING (Prolonged periods) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical history was reported. Treatment medication were not reported. Period started on expected date, but was extremely painful, lasted days longer than usual and was way heavier than normal. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This is a regulatory case concerning a 39 year-old, female patient with no relevant medical history and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine BioNTech approximately 5 months prior), who experienced the serious (due to medically important condition) unexpected, according CCDS, events of Heavy menstrual bleeding (reported as Heavy periods), Dysmenorrhoea and Heavy menstrual bleeding (reported as Prolonged periods). Events were assessed as serious by the Regulatory Authority. The events occurred approximately 6 days after the third dose of mRNA-1273 vaccine. The outcome of the events Heavy menstrual bleeding (reported as Heavy periods) and Dysmenorrhoea was reported as recovered with sequelae and the event Heavy menstrual bleeding (reported as Prolonged periods) as recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 39 year-old, female patient with no relevant medical history and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine BioNTech approximately 5 months prior), who experienced the serious (due to medically important condition) unexpected, according CCDS, events of Heavy menstrual bleeding (reported as Heavy periods), Dysmenorrhoea and Heavy menstrual bleeding (reported as Prolonged periods). Events were assessed as serious by the Regulatory Authority. The events occurred approximately 6 days after the third dose of mRNA-1273 vaccine. The outcome of the events Heavy menstrual bleeding (reported as Heavy periods) and Dysmenorrhoea was reported as recovered with sequelae and the event Heavy menstrual bleeding (reported as Prolonged periods) as recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2041364 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-15
Onset:2021-12-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005686 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Insomnia, 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 Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Insomnia; Decreased appetite; This case was received via RA (Reference number: GB-MHRA-ADR 26445984) on 07-Jan-2022 and was forwarded to Moderna on 07-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) and DECREASED APPETITE (Decreased appetite) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005686) for an unknown indication. No Medical History information was reported. On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced DECREASED APPETITE (Decreased appetite) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced INSOMNIA (Insomnia) (seriousness criterion medically significant). At the time of the report, INSOMNIA (Insomnia) and DECREASED APPETITE (Decreased appetite) had not 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 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant products were reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No treatment drugs were reported. Company comment: This is a regulatory case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected, according RA, events of Insomnia and Decreased appetite. The event Decreased appetite occurred approximately 11 days after the third dose of mRNA-1273 vaccine. The event Insomnia occurred approximately 17 days after the third dose of mRNA-1273 vaccine. The rechallenge was unknown according to RA. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected, according RA, events of Insomnia and Decreased appetite. The event Decreased appetite occurred approximately 11 days after the third dose of mRNA-1273 vaccine. The event Insomnia occurred approximately 17 days after the third dose of mRNA-1273 vaccine. The rechallenge was unknown according to RA. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2042507 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Tinnitus
SMQs:, 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:
Current Illness: Suspected COVID-19
Preexisting Conditions:
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.MOD20224

Write-up: Tinnitus aggravated; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26452863) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus aggravated) in a 56-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Suspected COVID-19 since 26-Dec-2021. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced TINNITUS (Tinnitus aggravated) (seriousness criterion medically significant). At the time of the report, TINNITUS (Tinnitus aggravated) had not 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 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Concomitant medication provided. No treatment medication reported. Patient had no current medication. A few days after the booster patient suffered from Tinnitus, no previous ear infection etc. or hearing problems. It been now14 days and no sign of change. Patient did not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Patient had an health check by Locum. Company comment: This case concerns a 56-year-old male patient, with no relevant medical history, who experienced the serious (medically significant according to Authority report), unexpected event of tinnitus. The event occurred 4 days after the third dose of mRNA 1273 COVID-19 vaccine. Patient denies previous ear infection or hearing problems. At the time or report, event had not resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 56-year-old male patient, with no relevant medical history, who experienced the serious (medically significant according to Authority report), unexpected event of tinnitus. The event occurred 4 days after the third dose of mRNA 1273 COVID-19 vaccine. Patient denies previous ear infection or hearing problems. At the time or report, event had not resolved. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 2044527 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-12-26
   Days after vaccination:148
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment: Other Medical History: No. Known Allergies: No
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: PCR TEST; Test Result: Positive
CDC Split Type: AUPFIZER INC202200064408

Write-up: PCR tested positive to COVID -19; PCR tested positive to COVID -19; This is a spontaneous report received from a contactable reporter(s) (Pfizer Employee) via RA. The reporter is the patient. A 46 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Jul2021 (Lot number: Unknown) at the age of 46 years as dose 2, single and administration date 10Jul2021 (Lot number: unknown) as dose 1, single for covid-19 immunisation in Pfizer. The patient was not pregnant when administration. The patient had no relevant medical history (Other Medical History: No. Known Allergies: No). There were no concomitant medications. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine and didn''t receive 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 been tested for COVID-19. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Dec2021, outcome "recovering" and all described as "PCR tested positive to COVID -19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The events didn''t result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2044817 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abscess limb, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), 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: DESOGESTREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne (mild acne)
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Insect bite; Urticarial rash; This case was received via Regulatory Authority, MHRA (Reference number: GB-MHRA-ADR 26450121) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA (Urticarial rash) and ABSCESS LIMB (Insect bite) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Acne (mild acne). Previously administered products included for Acne: LYMECYCLINE (Episodic lymecycline for treatment of mild acne for 2 years.). Past adverse reactions to the above products included No adverse event with LYMECYCLINE. Concomitant products included DESOGESTREL for Contraception. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced URTICARIA (Urticarial rash) (seriousness criterion medically significant). On an unknown date, the patient experienced ABSCESS LIMB (Insect bite) (seriousness criterion medically significant). At the time of the report, URTICARIA (Urticarial rash) had not resolved and ABSCESS LIMB (Insect bite) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had 2 episodes of widespread urticaria over torso, limbs and neck.First episode was 72 hours after vaccine.Second episode was more severe and 96 hours after vaccine.Lasted more than an hour after taking loratadine and using topical antihistamines 1st episode. Lasted more than 3 hours and more severe with 2nd episode, even after use of 20mg loratadine and topical antihistamines and topical 1% hydrocortisone. Patient had no history of allergy. No obvious trigger e.g. food type, insect bite, contact with new material/product. Patient had no reaction at injection site in left deltoid. Had no co-morbidity. Doctor said it was severe urticaria in patient with no history of allergy or atopy. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial The patient had no report related to possible myocarditis or pericarditis. Patient had Desogestrel as contraception for 18 months. Company comment: This case concerns a 19-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of urticaria and abscess limb. The events occurred 3 days after the booster dose of mRNA-1273. The patient had 2 episodes of widespread urticaria over torso, limbs, and neck. The first episode was 72 hours after vaccination, lasted for about an hour and was treated with loratadine and local antihistamines. The second episode was 96 hours after vaccination, lasted more than 3 hours and was treated with loratadine, topical antihistamines and topical hydrocortisone. The patient''s parent (a physician) reports that there was no history of allergy or atopy, and no obvious triggers like food, insect bite, or contact with new material/product. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 19-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of urticaria and abscess limb. The events occurred 3 days after the booster dose of mRNA-1273. The patient had 2 episodes of widespread urticaria over torso, limbs, and neck. The first episode was 72 hours after vaccination, lasted for about an hour and was treated with loratadine and local antihistamines. The second episode was 96 hours after vaccination, lasted more than 3 hours and was treated with loratadine, topical antihistamines and topical hydrocortisone. The patient''s parent (a physician) reports that there was no history of allergy or atopy, and no obvious triggers like food, insect bite, or contact with new material/product. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2044968 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-16
Onset:2021-12-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Herpes zoster, SARS-CoV-2 test
SMQs:, 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; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210917; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Shingles; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26447733) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) in a 56-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 16-Mar-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced HERPES ZOSTER (Shingles) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (Shingles) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-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. Company comment: This is a regulatory case concerning a 56-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected event herpes zoster. The event occurred approximately 10 days after the booster dose of mRNA-1273. (third dose of COVID-19 vaccine; previous vaccination with Chadox1 NCOV-19 Aztrazeneca). Event seriousness captured as per Regulatory Authority assessment in Source Document. The benefit-risk relationship of mRNA-1273 is not affected by this report. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial The patients report was not related to possible myocarditis or pericarditis No treatment medication information was mentioned by reporter; Sender''s Comments: Company comment: This is a regulatory case concerning a 56-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected event herpes zoster. The event occurred approximately 10 days after the booster dose of mRNA-1273. (third dose of COVID-19 vaccine; previous vaccination with Chadox1 NCOV-19 Aztrazeneca). Event seriousness captured as per Regulatory Authority assessment in Source Document. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2045912 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-25
Onset:2021-12-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049F21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Decreased appetite, Dizziness, Fatigue, Heart rate, Mean arterial pressure, Oxygen saturation, Respiratory rate, Syncope, Vertigo positional, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus (receiving medications in the first hospital); Hypertension (receiving medications in the first hospital)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: BP1: 209/105 mmHg,; Test Name: Blood pressure; Result Unstructured Data: BP2:195/102 mmHg; Test Name: body temperature; Result Unstructured Data: 36.2 degree celsius; Test Name: pulse rate; Result Unstructured Data: 86 bpm; Test Name: Mean arterial pressure; Result Unstructured Data: 130; Test Name: oxygen saturation; Result Unstructured Data: 98%; Test Name: Respiratory rate; Result Unstructured Data: 20 bpm
CDC Split Type: THMODERNATX, INC.MOD20224

Write-up: Fainting; ICD : H81.1 Benign paroxysmal vertigo; Dizziness; Vomiting; Fatigue; could not eat; This case was received via Regulatory Authority (Reference number: MOD-2022-278) on 10-Jan-2022 and was forwarded to Moderna on 11-Jan-2022. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Fainting), VERTIGO POSITIONAL (ICD : H81.1 Benign paroxysmal vertigo), DIZZINESS (Dizziness), VOMITING (Vomiting), FATIGUE (Fatigue) and DECREASED APPETITE (could not eat) in a 77-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 049F21A) for an unknown indication. Concurrent medical conditions included Hypertension (receiving medications in the first hospital) and Diabetes mellitus (receiving medications in the first hospital). On 25-Dec-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), VERTIGO POSITIONAL (ICD : H81.1 Benign paroxysmal vertigo) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and DECREASED APPETITE (could not eat) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting), VERTIGO POSITIONAL (ICD : H81.1 Benign paroxysmal vertigo), DIZZINESS (Dizziness), VOMITING (Vomiting), FATIGUE (Fatigue) and DECREASED APPETITE (could not eat) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) BP1: 209/105 mmHg, and high (High) BP2:195/102 mmHg. On an unknown date, Body temperature: low (Low) 36.2 degree celsius. On an unknown date, Heart rate: 86 bpm 86 bpm. On an unknown date, Mean arterial pressure: 130 130. On an unknown date, Oxygen saturation: 98% 98%. On an unknown date, Respiratory rate: 20 bpm 20 bpm. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. Patient medical history was DLP, other diagnostic tests include CS: 15 score, PS score:0, BW: Unmeasurable Kgs, BMI: 0. Symptoms increased and could not eat where patient went to the hospital. Patient underwent following examinations. PE: E4V5M6, No aphasia CN: pupils 2 mm RTLBE, full EOM, no facial palsy, no dysartria Motor: grade 5 all FTN: intact nystagmus + admit. Suspect product serial number was TSH071221M015 Date of treatment was reported as 26-DEC-2021. Patient type was reported as IPD. Company Comment: This is a regulatory case concerning a 77-year-old female patient with medical history of diabetes mellitus and hypertension, who experienced the serious expected event of syncope and serious per reported severity unexpected events of vertigo positional, dizziness, vomiting, fatigue and decreased appetite. The events occurred 2 days after the second dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The rechallenge not applicable since the events occurred after the second dose and no further dosing is expected. The medical history of diabetes mellitus and hypertension considered as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 77-year-old female patient with medical history of diabetes mellitus and hypertension, who experienced the serious expected event of syncope and serious per reported severity unexpected events of vertigo positional, dizziness, vomiting, fatigue and decreased appetite. The events occurred 2 days after the second dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The rechallenge not applicable since the events occurred after the second dose and no further dosing is expected. The medical history of diabetes mellitus and hypertension considered as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2049013 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness bilateral, Immunisation, SARS-CoV-2 test
SMQs:, 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thyroxine decreased (Under control)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200015824

Write-up: Booster; Deafness bilateral; This is a spontaneous report received from a contactable consumer from the RA. Regulatory number: GB-MHRA-WEBCOVID-202201041954238110-GZXF5. Other Case identifier(s): GB-MHRA-ADR 26435866. An 83-year-old female patient received BNT162B2 (COMIRNATY), administration date 26Dec2021 (Lot number: FN3543) at the age of 83 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Thyroxine deficit" (unspecified if ongoing), notes: Under control. The patient''s concomitant medications were not reported. Past drug history included: Thyroxine. Vaccination history included: BNT162B2 (DOSE 1) and BNT162B2 (DOSE 2), both for COVID-19 immunization. The patient has not had symptoms associated with COVID-19. The patient is not enrolled in clinical trial. The following information was reported: IMMUNISATION, outcome "unknown", described as "Booster"; DEAFNESS BILATERAL, outcome "not recovered"; both are considered medically significant with onset 26Dec2021. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative. The patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2049059 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-19
Onset:2021-12-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Chills, Constipation, Diarrhoea, Limb mass, Nausea, Night sweats, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200019234

Write-up: arm with swollen red lump; arm with aches and pains; Shivering; Stomach pain; Constipation; Diarrhoea; Nausea; Night sweat; Bloating; Stomach fullness; Abdominal cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201051121549300-MXQDG. Other Case identifier(s): GB-MHRA-ADR 26438402. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 19Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. The following information was reported: ABDOMINAL PAIN UPPER (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Stomach pain"; CONSTIPATION (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Constipation"; DIARRHOEA (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Diarrhoea"; NAUSEA (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Nausea"; NIGHT SWEATS (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Night sweat"; ABDOMINAL DISTENSION (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Bloating"; ABDOMINAL DISTENSION (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Stomach fullness"; ABDOMINAL PAIN (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Abdominal cramps"; CHILLS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Shivering"; LIMB MASS (medically significant), outcome "unknown", described as "arm with swollen red lump"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "arm with aches and pains". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The patient waiting to see a doctor. The patient abdominal symptoms feel as though the digestive system has stopped working. The patient had a sever reaction to the vaccine in the arm with swollen red lump and aches and pains. The patient had not tested positive for COVID-19 since having the vaccine. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2049225 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-04
Onset:2021-12-26
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Menopause, SARS-CoV-2 test
SMQs:, 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Menopause; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26453778) on 10-Jan-2022 and was forwarded to Moderna on 10-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MENOPAUSE (Menopause) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 04-Oct-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Dec-2021, the patient experienced MENOPAUSE (Menopause) (seriousness criterion disability). At the time of the report, MENOPAUSE (Menopause) 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 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was healthy person. Overcame covid twice prior to vaccine with no hospitalisation or significant effects. The vaccine has affected body in a major way and will have long term hormonal and health implications. Regular menstrual flow prior to vaccine. Experienced heavy flow period after following which the flow has stopped altogether. Patient is not currently breastfeeding Patient is not enrolled in clinical trial No concomitant medications were provided by reporter No treatment medications were provided by reporter Company comment: This case concerns a 45-year-old female patient, with no reported medical history, who experienced the serious (disability according to Authority report), unexpected event of menopause. The event occurred 83 days after the second dose of the mRNA 1273 COVID -19 vaccine. The patient experienced heavy flow period on unspecified date after the vaccine, then the flow stopped altogether. The patient''s age remains as a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 45-year-old female patient, with no reported medical history, who experienced the serious (disability according to Authority report), unexpected event of menopause. The event occurred 83 days after the second dose of the mRNA 1273 COVID -19 vaccine. The patient experienced heavy flow period on unspecified date after the vaccine, then the flow stopped altogether. The patient''s age remains as a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 2052124 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-18
Onset:2021-12-26
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FM4289 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202200029425

Write-up: Facial paralysis; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: FR-AFSSAPS-TO20219946 (AFSSAPS). A 25-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Dec2021 (Lot number: FM4289) as dose 1, single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Facial paralysis". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2052126 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-17
Onset:2021-12-26
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COMIRNATY
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20224

Write-up: Pericarditis; This case was received via regulatory authority (Reference number: FR-AFSSAPS-TO20219961) on 12-Jan-2022 and was forwarded to Moderna on 12-Jan-2022. This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (Pericarditis) in a 31-year-old male patient who received mRNA-1273 (Spikevax) for Revaccination with different COVID-19 vaccine. No Medical History information was reported. Concomitant products included TOZINAMERAN (COMIRNATY) for Revaccination with different COVID-19 vaccine. On 17-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Dec-2021, after starting mRNA-1273 (Spikevax), the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion hospitalization). At the time of the report, PERICARDITIS (Pericarditis) was resolving. No treatment medications were reported. Company comment: This case concerns a 31-year-old male patient with unknown medical history who experienced serious expected PERICARDITIS nine days after the first dose of mRNA-1273. No treatment details were disclosed and outcome was resolving. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 31-year-old male patient with unknown medical history who experienced serious expected PERICARDITIS nine days after the first dose of mRNA-1273. No treatment details were disclosed and outcome was resolving. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2052537 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Electrocardiogram, Fatigue, Fluid retention, Heart rate, Heart rate increased, Hyperhidrosis, Hypersomnia, Myocarditis, Night sweats, Palpitations, Pericarditis, Pyrexia, Rash, SARS-CoV-2 test, Tachycardia, Troponin
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: ECG; Result Unstructured Data: Test Result:Normal; Test Date: 20211230; Test Name: Heart rate; Result Unstructured Data: Test Result:high; Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20211231; Test Name: Troponin; Result Unstructured Data: Test Result:Normal less than 3
CDC Split Type: GBPFIZER INC202200028218

Write-up: Myocarditis; Pericarditis; Tachycardia; Fatigue; Fever; Heart rate high; Palpitations/ racing heart; Rash face; Heavy sweating; Night sweat; Weakness/ feeling of total lack of energy; Sleep excessive; Water retention; This is a spontaneous report received from a contactable reporter (Other HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201070855578760-L5TVR (RA). Other Case identifier: GB-MHRA-ADR 26447682 (RA). A 39-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 24Dec2021 (Lot number: FN3543) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient was not breast feeding at the time of this report. The patient''s last menstrual date was reported as 02Jan2022. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis"; PERICARDITIS (medically significant), outcome "unknown", described as "Pericarditis"; TACHYCARDIA (medically significant), outcome "unknown", described as "Tachycardia"; HEART RATE INCREASED (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Heart rate high"; FLUID RETENTION (medically significant) with onset 26Dec2021, outcome "not recovered", described as "Water retention"; PALPITATIONS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Palpitations/ racing heart"; RASH (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Rash face"; HYPERHIDROSIS (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Heavy sweating"; NIGHT SWEATS (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Night sweat"; ASTHENIA (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Weakness/ feeling of total lack of energy"; HYPERSOMNIA (non-serious) with onset 26Dec2021, outcome "not recovered", described as "Sleep excessive"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; PYREXIA (non-serious), outcome "unknown", described as "Fever". The events "myocarditis", "pericarditis", "tachycardia", "heart rate high", "water retention" and "palpitations/ racing heart" were evaluated at the emergency room visit (attended accident and emergency on 31Dec2021 for ECG). Results came back normal at the time but still experiencing racing heart periodically. The report of the patient was related to possible inflammation of the heart, myocarditis and pericarditis but not related to possible blood clots or low platelet counts. Patient was not admitted to hospital and not seen by a cardiologist. Chest computed tomography, cardiac MRI, cardiac biopsy and coronary angiography were not carried out. It was unknown there was presence of pericardial rub or changes in heart sounds. The patient underwent the following laboratory tests and procedures: electrocardiogram: (31Dec2021) normal; heart rate: (30Dec2021) high; sars-cov-2 test: (30Dec2021) negative; troponin (0-14): (31Dec2021) normal less than 3. The patient had not been tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2053214 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-12-26
   Days after vaccination:214
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Heart rate irregular
SMQs:, Lack of efficacy/effect (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; BISOPROLOL
Current Illness: Breast feeding; Pregnancy (Estimated due date:10Aug2021)
Preexisting Conditions: Medical History/Concurrent Conditions: Abnormal ECG; Folic acid supplementation; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: heartbeat; Result Unstructured Data: Test Result:abnormal; Comments: bigemini heartbeat
CDC Split Type: GBPFIZER INC202200095905

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; a Regulatory Authority This is a solicited report received from a contactable reporter(s) (Consumer or other non HCP) from a Regulatory Authority for a sponsored program. A 34 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administration date 21Jul2021 (Lot number: FD5613) as dose 2, single and administration date 26May2021 (Lot number: EW4109) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pregnancy" (ongoing), notes: Estimated due date:10Aug2021; "Suspected COVID-19", start date: 03Feb2020 (unspecified if ongoing), notes: Unsure when symptoms stopped; "Folic acid supplementation" (unspecified if ongoing); "Abnormal ECG" (unspecified if ongoing); "immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response and i...; "Breast feeding" (ongoing). Date of last menstrual period: 01Nov2020. The patient was 45 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 08Aug2021. Concomitant medication(s) included: FOLIC ACID taken for vitamin supplementation, vitamin supplementation; BISOPROLOL taken for electrocardiogram abnormal, electrocardiogram abnormal, start date: 05Aug2021. Vaccination history included: Influenza virus, for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 26Dec2021, outcome "recovered" (01Jan2022) and all described as "SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: heart rate irregular: abnormal, notes: bigemini heartbeat. Clinical course: whooping cough vaccine also given on 24Feb2021 for pregnancy (was not an option on the list). Patient is not enrolled in clinical trial. Patient does not think vaccination had an adverse effect on any aspect of the pregnancy. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on limited information in the case , a possible causal association between the reported event Drug ineffective , COVID 19 and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : GB-PFIZER INC-202100934172 same patient/product, different event/dose


VAERS ID: 2053357 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-26
Onset:2021-12-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Amnesia, Asthenia, Computerised tomogram head, Confusional state, Delusion, Dysmetria, Feeling hot, Hyperhidrosis, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: Brain CT; Test Result: Inconclusive ; Result Unstructured Data: Result not provided
CDC Split Type: ITMODERNATX, INC.MOD20224

Write-up: confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation; confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation; confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation; confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation; confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation; confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation; confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation; confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation; This case was received via Regulatory authority (Reference number: IT-MINISAL02-826390) on 13-Jan-2022 and was forwarded to Moderna on 13-Jan-2022. This regulatory authority case was reported by a physician and describes the occurrence of ASTHENIA (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation), CONFUSIONAL STATE (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation), HYPOAESTHESIA (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation), FEELING HOT (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation), HYPERHIDROSIS (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation), DELUSION (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation), AMNESIA (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation) and DYSMETRIA (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation) in a 36-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 26-Dec-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .25 ml. On 26-Dec-2021, the patient experienced ASTHENIA (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation) (seriousness criterion hospitalization), CONFUSIONAL STATE (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation) (seriousness criterion hospitalization), HYPOAESTHESIA (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation) (seriousness criterion hospitalization), FEELING HOT (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation) (seriousness criterion hospitalization), HYPERHIDROSIS (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation) (seriousness criterion hospitalization), DELUSION (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation) (seriousness criterion hospitalization), AMNESIA (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation) (seriousness criterion hospitalization) and DYSMETRIA (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation) (seriousness criteria hospitalization and medically significant). At the time of the report, ASTHENIA (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation), CONFUSIONAL STATE (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation), HYPOAESTHESIA (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation), FEELING HOT (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation), HYPERHIDROSIS (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation), DELUSION (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation), AMNESIA (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation) and DYSMETRIA (confusion state amnesia sweating algid feeling of heat in the head deficit extension of the fingers left hand hypoesthesia hyposthenia dysmetria in left hemisome delirious ideation) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, Computerised tomogram head: result not provided (Inconclusive) Result not provided. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication was reported. No treatment medications were reported. Company Comment: This case concerns a 36 year-old male patient with a history of head trauma and residual hypoesthesia who experienced the unexpected serious events of asthenia, confusional state, hypoaesthesia, feeling hot, hyperhidrosis, delusion, amnesia, and dysmetria which occurred 1 day after vaccination with mRNA-1273 vaccine. The medical history of head trauma and hypoaesthesia remain confounders for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting. It was not possible to find the vaccine lot. The patient was discharged on 27/12/2021. In youth, an accident with head trauma and malacic brain outcomes residue hemi-hyposthenia and left hemi-hypoesthesia. The adverse reaction occurred after 20 minutes after administration as soon as he left the vaccine center.; Sender''s Comments: This case concerns a 36 year-old male patient with a history of head trauma and residual hypoesthesia who experienced the unexpected serious events of asthenia, confusional state, hypoaesthesia, feeling hot, hyperhidrosis, delusion, amnesia, and dysmetria which occurred 1 day after vaccination with mRNA-1273 vaccine. The medical history of head trauma and hypoaesthesia remain confounders for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1980891 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-12-15
Onset:2021-12-25
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032H21A / 3 - / -

Administered by: Private       Purchased by: ?
Symptoms: Blood test abnormal, C-reactive protein increased, COVID-19, Chest pain, Cough, Dyspnoea, Fibrin D dimer, Hypoxia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (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? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: tylenol lipitor tessalon dulcolax robitussin lovenox insulin
Current Illness: diabetes issues
Preexisting Conditions: diabetes
Allergies: none
Diagnostic Lab Data: d-dimer (.71) covid pcr (positive) c-reactive protein (85.9) additional testing may have been done after pt was admitted
CDC Split Type:

Write-up: Pt. presented to the emergency department with shortness of breath, chest pain and cough. He was hypoxic in the 80''s on room air and was placed on 02. Bloodwork showed pt had a positive d-dimer and a covid-19 pcr test showed positive for covid. pt had booster dose 9 days ago. pt is currently admitted in hospital


VAERS ID: 1980908 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-12-22
Onset:2021-12-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL0007 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Fatigue, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu shots, generally increased maladaptive and unusual behaviors for the following ~2 weeks accompanied with minor physical disc
Other Medications: None
Current Illness: None
Preexisting Conditions: Pediatric encephalopathy, autism
Allergies: Mold allergy
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Chest pain starting about 55 hours after second Pfizer shot. Patient described it as medium pain and it?s not constant but hurts when his heart beats. No other symptoms. Other symptoms from about 36-48 hours post second shot included fatigue, low grade fever, and head pain. Course of treatment for chest pain, per pediatrician, administer ibuprofen to see if improves chest pain and go to hospital if symptoms worsen.


VAERS ID: 1980936 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-12-12
Onset:2021-12-25
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Atrial fibrillation, Electrocardiogram, Laboratory test
SMQs:, Supraventricular tachyarrhythmias (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Chlorthalidone
Current Illness: None
Preexisting Conditions: HTN
Allergies: NKA
Diagnostic Lab Data: EKG and cardiac labs.
CDC Split Type:

Write-up: New onset atrial fibrillation requiring hospitalization.


VAERS ID: 1980963 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-12-22
Onset:2021-12-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 33025BD / 3 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Tinnitus, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (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: Thyroid medication-stable for 20+ years with no side effects, Zolpidem (only used while traveling, so not used in the last 2 weeks).
Current Illness: None.
Preexisting Conditions: No current health conditions.
Allergies: Pennicilin
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: I have developed an uncomfortable ringing in my left ear . I received my Pfizer Covid booster vaccine. It is hard to read the lot # " 33025bd" or "3302SB0".


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