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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 135 out of 10,493

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VAERS ID: 2043597 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-08
Onset:2021-12-28
   Days after vaccination:264
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802068 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Influenza A virus test negative, Influenza B virus test, Nucleic acid test, Respiratory distress, Respiratory syncytial virus test negative, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: acetaminophen (TYLENOL) 325 MG PO Tab take 650 mg by mouth every 4 hours as needed. Unknown Unknown time aspirin 81 MG PO Chew Tab take 81 mg by mouth once daily. Unknown Unknown time atorvastatin (LIPITOR) 80 MG PO Tab take 80 mg by mouth
Current Illness: ? Coronary artery disease ? Diabetes mellitus ? Hyperlipidemia ? Hypertension ? ICD (implantable cardioverter-defibrillator) in place ? Ischemic cardiomyopathy ? Systolic heart failure, chronic ? Urethral stricture in male
Preexisting Conditions: ? Coronary artery disease ? Diabetes mellitus ? Hyperlipidemia ? Hypertension ? ICD (implantable cardioverter-defibrillator) in place ? Ischemic cardiomyopathy ? Systolic heart failure, chronic ? Urethral stricture in male
Allergies: none
Diagnostic Lab Data: Status: Final result Visible to patient: No (inaccessible) Next appt: None Specimen Information: Nasopharyngeal; Swab 0 Result Notes Ref Range & Units Influenza A Not Detected Not Detected Influenza B Not Detected Not Detected RSV Not Detected Not Detected SARS-CoV-2 (COVID-19) by NAA, Micro Not Detected Detected Abnormal Narrative Methodology: Nucleic Acid Amplification(NAA)/Polymerase Chain Reaction(PCR) The SARS-CoV-2 (COVID-19) test is for in vitro diagnostic use under the FDA Emergency Use Authorization (EUA) for laboratories certified to perform high complexity testing. This test has not been FDA cleared or approved. Specimen Collected: 12/28/21 10:54 PM Last Resulted: 12/29/21 2:33 AM Order Details View Encounter Lab and Collection Details Routing Result History Result Care Coordination Patient Communication Released Not seen Back to Top
CDC Split Type:

Write-up: This is a 71y.o. male with significant past medical history of HTN, T2DM, CAD, IHD, chronic systolic HF, and S/P AICD that presented to the hospital from clinic with chief complaint of shortness of breath. He was noted by clinic staff to be in mild respiratory distress with complaints of dyspnea. He was found to be 91% on room air and transferred to the ED for further evaluation. In the ED, patient normotensive, afebrile, stable SPO2 on 2 L nasal cannula COVID positive. Elevated acute phase level reactants. He has been admitted for further evaluation and management with ID consultation. Patient seen and examined only by the attending physician; NP only responsible for chart review in an effort to limit exposure given the patient''s COVID positive status.


VAERS ID: 2043794 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-12-10
Onset:2021-12-28
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030H21B / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Cough, Injection site pain, Nasal congestion, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Sneezing
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sulfasalazine; methotrexate; folic acid; hydroxychloroquine; methotrexate; multivitamin over 50; vitamin E; LONGEVID; bone plus; MEGASPOREBIOTIC
Current Illness: N/a
Preexisting Conditions: Seronegative Rheumatoid Arthritis
Allergies: Penicillin
Diagnostic Lab Data: Covid-19 Positive 01/02/2022; Dose 1-004M20A:02/04/2021; Dose 2-010A21A:03/4/2021
CDC Split Type: vsafe

Write-up: After I got the third dose of my vaccine the places where I got the first two doses of the vaccine were tender. Three weeks after getting the third dose of the vaccine I started to have a sore throat that lasted for one day. I started to run a low-grade fever and I tested Negative. I tested Negative the next day on a home test. My temperature was never over 99.7. I tested positive on day six which was the day that I started to sneeze consistently. Those symptoms lasted two weeks. I still have a little lingering cough. It was an antigen test. I had nasal congestion, coughing and sneezing that persisted. I did not lose my sense of taste or smell.


VAERS ID: 2046098 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Kansas  
Vaccinated:2021-12-14
Onset:2021-12-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 1 - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Adverse event, Feeling cold
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: Anemia; Back disorder; Ulcer
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20220121712

Write-up: DID HAVE A REACTION; FEELING EXTREMELY COLD; This spontaneous report received from a patient concerned a male of unspecified age race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: ulcer, anemia, and lower back issue. The patient received covid-19 vaccine ad26.cov2.s (dose number in series:1) (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 total administered on 18-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. On an unspecified date (after J&J vaccine), the patient did have a reaction (adverse event) which lasted almost 2 months.(dose number in series:1) Non-company suspect vaccine included: bnt 162 (dose number in series:2) (form of admin, route of admin, and batch number were not reported) dose was not reported, 1 total booster dose administered on 14-DEC-2021 for an unspecified indication. No concomitant medications were reported. Starting on 28-DEC-2021, the patient was feeling cold. At the time of report, the patient was feeling extremely cold even though being fully dressed (dose number in series:2). The action taken with covid-19 vaccine ad26.cov2.s, and bnt 162 was not applicable. The patient recovered from did have a reaction, and had not recovered from feeling extremely cold. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious.


VAERS ID: 2046271 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-12-10
Onset:2021-12-28
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine 50mcg, lexapro 20 mg, paragard
Current Illness: none
Preexisting Conditions: hypothyroidism
Allergies: none
Diagnostic Lab Data: rapid covid test - negative
CDC Split Type:

Write-up: cough, congestion, sore throat, fever all lasting for 2 weeks


VAERS ID: 2046389 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Incorrect dose administered
SMQs:, Medication errors (narrow)

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

Write-up: Nurse (PRIVATE-RN) gave a pediatric dose for dose #1.


VAERS ID: 2047580 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-23
Onset:2021-12-28
   Days after vaccination:127
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

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

Write-up: Breakthrough COVID


VAERS ID: 2047585 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-23
Onset:2021-12-28
   Days after vaccination:96
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

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

Write-up: Breakthrough COVID


VAERS ID: 2048084 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-03-10
Onset:2021-12-28
   Days after vaccination:293
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNK / 2 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Aphasia, Blood magnesium, COVID-19, Chest X-ray, Computerised tomogram head, Condition aggravated, Full blood count, International normalised ratio, Metabolic function test, Prothrombin time, Troponin
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Ibrance letrozole keppra zocor
Current Illness: Breast cancer benign brain tumor seizure disorder
Preexisting Conditions: seizure disorder
Allergies: NKA
Diagnostic Lab Data: 12/24/21: Chest xray Ct of head/brain without contrast CBC CMP Magnesium level PTT PT/INR Troponin
CDC Split Type:

Write-up: Pt on the phone with sister when she suddenly could not speak, she had similar episode is the past when she had a grand mal seizure. Pt did not take her dose of keppra on 12/24./21, was diagnosed with covid19 on 12/16/21


VAERS ID: 2048180 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: New York  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 33036BD / 1 LA / IM

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

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

Write-up: The next day after vaccine had a very bad pounding headache, which made her right eye start to twitch. She became very ill.


VAERS ID: 2050121 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental underdose
SMQs:, Medication errors (narrow)

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

Write-up: This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised and didn''t get the full third dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised and didn''t get the full third dose). On 28-Dec-2021, ACCIDENTAL UNDERDOSE (immunocompromised and didn''t get the full third dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not provided. Patient received the half dose booster on 28-Dec-2021 after receiving the first two primary series. Reporter did not allow further contact


VAERS ID: 2050355 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-12-28
Onset:2021-12-28
   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 - / 3 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Back pain, Immunisation, Pain in extremity, Product administered at inappropriate site, Vaccination site pain
SMQs:, Retroperitoneal fibrosis (broad), Drug abuse and dependence (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Open heart surgery (He has had open heart surgery 7-8 years ago.); Shooting pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101872854

Write-up: pain that was shooting on the right arm (injection site) and shut down to the right leg; shooting on the right arm (injection site); joint pain; back pain; booster; Injected into Right arm. Unable to confirm if given in the muscle.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. A 72-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Dec2021 12:30 (Batch/Lot number: unknown) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "open heart surgery", start date: Jun2014 (unspecified if ongoing), notes: He has had open heart surgery 7-8 years ago.; "shooting pain down arms and legs" (unspecified if ongoing), notes: They had the shooting pain down arms and legs because they have a bad back. That was prior to getting the vaccines.; "bad back" (unspecified if ongoing), notes: They had the shooting pain down arms and legs because they have a bad back. That was prior to getting the vaccines. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose:01, Lot Number / Expiry Date: Unknown/unknown, Route, Anatomical Location: not provided), administration date: 06Mar2021, when the patient was 71 years old, for COVID-19 Immunization, reaction(s): "They had the shooting pain down arms and legs because they have a bad back. That was prior to getting the vaccines"; Bnt162b2 (Dose:02, Lot Number / Expiry Date: Unknown/unknown, Route, Anatomical Location: not provided), administration date: 04Apr2021, when the patient was 71 years old, for COVID-19 Immunization, reaction(s): "They had the shooting pain down arms and legs because they have a bad back. That was prior to getting the vaccines". The following information was reported: IMMUNISATION (non-serious) with onset 28Dec2021, outcome "unknown", described as "booster"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 28Dec2021, outcome "unknown", described as "Injected into Right arm. Unable to confirm if given in the muscle."; PAIN IN EXTREMITY (non-serious) with onset 28Dec2021 14:00, outcome "unknown", described as "pain that was shooting on the right arm (injection site) and shut down to the right leg"; VACCINATION SITE PAIN (non-serious) with onset 28Dec2021, outcome "unknown", described as "shooting on the right arm (injection site)"; ARTHRALGIA (non-serious) with onset 28Dec2021, outcome "unknown", described as "joint pain"; BACK PAIN (non-serious) with onset 28Dec2021, outcome "unknown", described as "back pain". Additional information: Reporter was a consumer, calling on behalf of her husband. Reporter mentioned that her husband received the Pfizer covid-19 vaccine booster today, after an hour and a half, he experienced pain that was shooting on the right arm (injection site) and shut down to the right leg. Reporter wanted to know if anyone else experienced the same side effects. She and her husband both got Pfizer COVID booster shot today. He got arm pain and it shot down to his leg on right side and that is the side he got the vaccine on. She wanted to find out if that has been reported or not. Reporter stated we have that anyway, the joint pain cause we have a third back, or very bad back, and weve had them before, the day we got shot, he got back pain and pain shooting on his legs after we got them. Injected into Right arm. Reporter was unable to confirm if given in the muscle, Concomitant information: He is on heart medications, blood pressure medication, and a pain pill, which he had been on prior to getting vaccines, Vaccination Facility information. Reporter first stated the pain started almost 3 hours after they took the booster shot. She later stated it was 1 1/2 - 2 hours after getting it. He has a bad back anyway and the pain shooting down to legs was bad. It just happened after the shot and was an hour and a half or two hours after getting it. He is taking a nap now, so she does not know if he should stay up. He has had open heart surgery 7-8 years ago. They both got their booster today. They got all 3 of the Pfizer COVID vaccines. They both have joint pain and bad backs. That was before the vaccine for years anyway. They had the shooting pain down arms and legs because they have a bad back. That was prior to getting the vaccines. She did not have any today. She has shooting pains over the years from a bad back before the vaccines. The date they received their 2nd one was 04Apr2021 and today was the 3rd one. She did not have his card with her to provide lot or expiration for any of them. He is on heart medications, blood pressure medication, and a pain pill, which he had been on prior to getting vaccines. She did not provide any further details. He said it is nothing hurting him or nothing. She did not know if he needed to take a nap or not. The patient receive any other vaccines within four weeks prior to the COVID vaccine was none. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2050376 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-12-28
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, Body temperature increased, Decreased appetite, Diarrhoea, Immunisation, Joint stiffness, Malaise, Nausea, Oropharyngeal pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:101.4 Fahrenheit
CDC Split Type: USPFIZER INC202101885777

Write-up: joint stiffness; nausea; diarrhea; sore throat; Temperature of 101. 4 degrees Fahrenheit; Bad feeling all over; No appetite; Temperature of 101.4 degrees Fahrenheit; Booster; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 73 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 73 years as dose number unknown (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown.), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Dec2021, outcome "unknown", described as "Booster"; ASTHENIA (non-serious) with onset 28Dec2021, outcome "unknown", described as "weakness"; JOINT STIFFNESS (non-serious), outcome "unknown", described as "joint stiffness"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Temperature of 101. 4 degrees Fahrenheit"; MALAISE (non-serious), outcome "unknown", described as "Bad feeling all over"; DECREASED APPETITE (non-serious), outcome "unknown", described as "No appetite"; PYREXIA (non-serious), outcome "recovering", described as "Temperature of 101.4 degrees Fahrenheit". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Additional Information: According to agent, caller is a consumer inquiring about the adult formulation Pfizer BioNTech Covid-19 vaccine. Caller would like to know if any of the following side effects have been reported after receiving the vaccine, weakness, joint stiffness, nausea, diarrhea, sore throat and a temperature? Caller has a follow-up question and he would like know if the effects mentioned are also associated with the Covid-19 virus? further context: The patient was calling about the Pfizer Covid 19 booster shot, states he took the booster shot on Tuesday. The patient states by the evening, he was weak, and could not get up to his bed and he was so weak he had to crawl up the stairs. He states he had a bad feeling all over, his joints were stiff by Wednesday, he had an episode of nausea, no appetite, diarrhea, sore throat temperature of 101.4 degrees Fahrenheit, and he took some Theraflu and he was feeling better now. The patient decline to complete a report. He thought the vaccine gave him the Covid virus. He read a long list of side effects on his vaccine information sheet. He asks could his symptoms be the Covid virus? have other people reported his symptoms and asking if these symptoms could possible lead to getting the Covid virus. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 2050872 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031H21A / 4 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE 10MG, PLAVIX 75MG, LISINOPRIL 20MG, METOPROLOL 25MG, HYDRALAZINE 25MG, TRESIBA FLEXTOUCH, FOLIC ACID, CELEXA 20MG, CRESTOR 20MG, GABAPENTIN 100MG
Current Illness: SEVERE BURN ON ARM
Preexisting Conditions: HYPTERTENSION, DIABETES, HIGH CHOLESTEROL
Allergies: NKDA
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: NO ADVERSE EVENT REPORTED BY PATIENT - PATIENT RECEIVED A HIGH DOSE FLU SHOT AND 1/2 DOSE MODERNA BOOSTER ON 12/09/2021 AND ANOTHER 1/2 DOSE MODERNA 12/28/2021- WHEN KEYING HER INFOMATION INTO THE COMPUTER IT WAS DISCOVERED THAT ACCORDING OUR SYSTEM, THE PATIENT HAD ALREADY RECEIVED HER BOOSTER WHEN SHE CAME IN FOR HER FLU SHOT EARLIER THAT MONTH BUT BY THE TIME OF THE DISCOVERY, THE PATIENT ALREADY RECEIVED THE 2ND BOOSTER VACCINE.


VAERS ID: 2051033 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-12-10
Onset:2021-12-28
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / IM

Administered by: Military       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Polymenorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad)

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

Write-up: Irregular and more frequent and heavy periods two weeks after the second (PEDS) pediatric dose of the Pfizer vaccine.


VAERS ID: 2051542 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-12-28
Onset:2021-12-28
   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 - / 3 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Choking, Dysphagia, Muscle spasms, Pharyngeal swelling, Pruritus
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Benadryl
Current Illness:
Preexisting Conditions: Asthma
Allergies: Peanuts Penicillin Aspirin Contrast Dye Feathers
Diagnostic Lab Data: Went to ER and was given IV prednisone orally. Symptoms subsided in about an hour.
CDC Split Type:

Write-up: Started with extreme itching contolled by Benadryl. Next day throat spasms and swelling. Choked on food. Hard time swallowing.


VAERS ID: 1985231 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3594 / 3 LA / IM

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

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

Write-up: No adverse effects noted, but on review vaccine was discovered to be given approx. four weeks too early.


VAERS ID: 1991105 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Headache, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Same but even worse, and also fever
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headache, feel tired,arm pain, swelling, and armpit pain


VAERS ID: 2003112 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
Submitted: 0000-00-00
Entered: 2022-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: Positive for covid; Test Result: Positive.
CDC Split Type: COPFIZER INC202101881349

Write-up: COVID-19/ her symptoms were mild, such as joint pain, headache and nasal congestion; she tested positive for COVID-19; 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 36 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 16Jul2021 (Batch/Lot number: unknown) as dose 2, single and (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 COVID-19 (medically significant) with onset 28Dec2021, outcome unknown; DRUG INEFFECTIVE (medically significant) with onset 28Dec2021, outcome unknown. She indicated that she was infected in another place and returned on 25Dec2021. She indicated that he had no comorbidities. The patient underwent the following laboratory tests and procedures sars-cov-2 test (28Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2010915 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-12-28
   Days after vaccination:228
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN1196 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, 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: 20211228; Test Name: Antig?ne; Test Result: Positive ; Comments: Other
CDC Split Type: CAPFIZER INC202101885510

Write-up: COVID-19 positive; COVID-19 positive; 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 26 year-old male patient received bnt162b2 (BNT162B2), administration date 14May2021 (Lot number: EN1196) at the age of 26 years as dose 2, single and administration date 22Apr2021 (Lot number: EN1194) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Past drug history included: Amoxycilline, reaction(s): "Allergy". The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 28Dec2021, outcome "recovering" and all described as "COVID-19 positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive: (28Dec2021) positive, notes: Other. Clinical course: The patient did not receive other vaccine in two or four weeks. The patient did not have covid prior to and post vaccination. No follow up attempts are possible. No further information is expected.


VAERS ID: 2010919 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-12-28
   Days after vaccination:223
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6775 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Polymerase chain reaction, 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 (Name of Drug as Reported :No)
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: PCR; Test Result: Positive; Comments: Nasal Swab.
CDC Split Type: CAPFIZER INC202200009751

Write-up: Tested positive for Covid-19 December 28. 2021. Tested positive for Covid-19 December 28. 2021.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A 56 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19May2021 11:15 (Lot number: EP6775) at the age of 56 years as dose 2, single and intramuscular, administered in arm left, administration date 28Apr2021 11:15 (Lot number: EP6775) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Name of Drug as Reported :No. The patient''s concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 28Dec2021 20:00, outcome "unknown", VACCINATION FAILURE (medically significant) with onset 28Dec2021, outcome "unknown" and all described as "Tested positive for Covid-19 December 28. 2021.". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (28Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19. Facility where the most recent COVID-19 vaccine was administered was clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received by the patient within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2011201 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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? Yes
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: SARS-CoV-2 PCR test; Test Result: Positive; Comments: Nasal Swab.
CDC Split Type: FRPFIZER INC202101871650

Write-up: vaccination failure (positive Corona PCR test); vaccination failure (positive Corona PCR test); This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient. A 57 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 08Dec2021 (Lot number: ACB4694) at the age of 57 years as dose 3 (booster), single, administration date 11Jun2021 (Lot number: FC3143) as dose 2, single and (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 VACCINATION FAILURE (medically significant) with onset 28Dec2021, outcome unknown, COVID-19 (medically significant) with onset 28Dec2021, outcome recovering. The event vaccination failure (positive corona pcr test) and vaccination failure (positive corona pcr test) was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures sars-cov-2 test (28Dec2021) positive, Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Chlorhexamed Forte. The patient had no known allergies. Facility where the most recent COVID-19 vaccine was administered was reported as doctor''s office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient visited doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow up. Based on the description given in the narrative, there is reasonable possibility of causal association between the events and the suspect BNT162B2 cannot be excluded.


VAERS ID: 2012810 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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: APIXABAN
Current Illness:
Preexisting Conditions: Atrial fibrillation; Congestive cardiac failure; COPD
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: antigen LFT; Test Result: Positive.
CDC Split Type: IEPFIZER INC202101876628

Write-up: Tested positive by rapid antigen LFT on 28/12; Tested positive by rapid antigen LFT on 28/12; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 87 year-old male patient received bnt162b2 (COMIRNATY,Solution for injection) (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; APIXABAN (Batch/Lot number: unknown). Relevant medical history included CCF (unspecified if ongoing); atrial fibrillation (unspecified if ongoing); COPD (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 28Dec2021, outcome unknown. The patient underwent the following laboratory tests and procedures sars-cov-2 test (28Dec2021) positive. The action taken for apixaban was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2016203 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CINNARIZINE; GLYCEROL; PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211111; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Body temperature increased; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26402279) 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 BODY TEMPERATURE INCREASED (Body temperature increased) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000050A) for an unknown indication. Concomitant products included PARACETAMOL from 28-Dec-2021 to an unknown date for Body temperature increased, GLYCEROL from 26-Dec-2021 to 28-Dec-2021 for Cough, CINNARIZINE from 24-Dec-2021 to an unknown date for Travel sickness. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced BODY TEMPERATURE INCREASED (Body temperature increased) (seriousness criterion medically significant). At the time of the report, BODY TEMPERATURE INCREASED (Body temperature increased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-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. It was unsure if patient has had symptoms associated with COVID-19. The patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No treatment information was provided. COMPANY COMMENT: This is a regulatory case concerning a 30-year-old male patient with no clinical history who experienced the unexpected event of Body temperature increased The event occurred 2 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the regulatory Authority; Sender''s Comments: COMPANY COMMENT: This is a regulatory case concerning a 30-year-old male patient with no clinical history who experienced the unexpected event of Body temperature increased The event occurred 2 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the regulatory Authority


VAERS ID: 2016207 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Fatigue, Headache, Oropharyngeal pain, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Suspected COVID-19 (Unsure when symptoms started)
Allergies:
Diagnostic Lab Data: Test Date: 20201028; 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: Headache; Back ache; Sore throat; Tiredness; Swollen arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26402337) 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 HEADACHE (Headache), BACK PAIN (Back ache), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Tiredness) and PERIPHERAL SWELLING (Swollen arm) in a 20-year-old female 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). On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), BACK PAIN (Back ache) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), BACK PAIN (Back ache), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Tiredness) and PERIPHERAL SWELLING (Swollen arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2020, 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 relevant concomitant and treatment medications were reported. Patient had the vaccine on the early afternoon of the 27th. Arm ached initially but did not hurt for long. Then went to sleep very early on the night of the 27th due to being overly tired. Woke up on the morning of the 28th with back ache, arm ache, sore throat and head ache. Patient''s arm was also slightly swollen at the top where she received the vaccine. Company Comment:This case concerns a 20-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of headache, back pain, oropharyngeal pain, fatigue and peripheral swelling. The events occurred approximately on the next day after the third dose of mRNA-1273 vaccine. 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 case concerns a 20-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of headache, back pain, oropharyngeal pain, fatigue and peripheral swelling. The events occurred approximately on the next day after the third dose of mRNA-1273 vaccine. 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: 2016223 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Muscular weakness, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: 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: fever; nauseous; muscle weakness; Breathlessness; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26403031) 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 PYREXIA (fever), NAUSEA (nauseous), MUSCULAR WEAKNESS (muscle weakness) and DYSPNOEA (Breathlessness) in a 56-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced DYSPNOEA (Breathlessness) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) (seriousness criterion medically significant), NAUSEA (nauseous) (seriousness criterion medically significant) and MUSCULAR WEAKNESS (muscle weakness) (seriousness criterion medically significant). At the time of the report, PYREXIA (fever), NAUSEA (nauseous) and MUSCULAR WEAKNESS (muscle weakness) had not resolved and DYSPNOEA (Breathlessness) was resolving. 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. No concomitant medication was provided. Patient experienced Fever, nauseous and muscle weakness Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. No treatment information was provided. Company Comment: This case concerns a 56-year-old, female patient with no medical history reported, who experienced the unexpected serious event of Dyspnoea, one day after the third dose of mRNA-1273 vaccine, which was resolving at the time of the report. The patient also experienced pyrexia, nausea and muscular weakness at an unknown day that had not resolved at the time of the report. 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 case concerns a 56-year-old, female patient with no medical history reported, who experienced the unexpected serious event of Dyspnoea, one day after the third dose of mRNA-1273 vaccine, which was resolving at the time of the report. The patient also experienced pyrexia, nausea and muscular weakness at an unknown day that had not resolved at the time of the report. 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: 2016226 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Adverse reaction, Back pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: stomach pain; back pain; shortness of breath; Adverse reaction; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26403566) 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 ABDOMINAL PAIN UPPER (stomach pain), BACK PAIN (back pain), DYSPNOEA (shortness of breath) and ADVERSE REACTION (Adverse reaction) in a 57-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040a) for an unknown indication. The patient''s past medical history included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced ADVERSE REACTION (Adverse reaction) (seriousness criterion disability). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) (seriousness criterion disability), BACK PAIN (back pain) (seriousness criterion disability) and DYSPNOEA (shortness of breath) (seriousness criterion disability). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain), BACK PAIN (back pain) and DYSPNOEA (shortness of breath) was resolving and ADVERSE REACTION (Adverse reaction) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Patient was experience of back pain , stomach pain , tired , feel shattered, some shortness of breath ,pounding head ache .Patient Can''t think straight. Patient had not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 57-year-old male patient, with medical history of immunodeficiency, who experienced the unexpected and serious events of Adverse reaction, Abdominal pain upper, Back pain, and Dyspnoea. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a disabling condition. The events of Abdominal pain upper, Back pain, and Dyspnoea, occurred on an unknown day after the third dose of mRNA-1273 vaccine. The event of Adverse reaction occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The medical history remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 57-year-old male patient, with medical history of immunodeficiency, who experienced the unexpected and serious events of Adverse reaction, Abdominal pain upper, Back pain, and Dyspnoea. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a disabling condition. The events of Abdominal pain upper, Back pain, and Dyspnoea, occurred on an unknown day after the third dose of mRNA-1273 vaccine. The event of Adverse reaction occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The medical history remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2016231 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Headache, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)

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

Write-up: Painful joints; Swelling; Weakness; Headache; This case was received via RA (Reference number: GB-MHRA-ADR 26404321) 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 ARTHRALGIA (Painful joints), SWELLING (Swelling), ASTHENIA (Weakness) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Suspected COVID-19 since 28-Dec-2021. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced ARTHRALGIA (Painful joints) (seriousness criterion medically significant), SWELLING (Swelling) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Painful joints), SWELLING (Swelling), ASTHENIA (Weakness) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment information was provided. Patient last menstrual period date was 15-DEC-2021. Not had a COVID-19 test Patient is not pregnant, Patient is not currently breastfeeding. Patient experienced painful, aching limbs & joints, weakness, headache, temperature, puffy swelling, very tender arm. 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 38-year-old female patient, with current condition of suspected COVID-19 , who experienced the unexpected and serious events of Arthralgia, Swelling, Asthenia, and Headache. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in RA. Current condition of suspected COVID-19 remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 38-year-old female patient, with current condition of suspected COVID-19 , who experienced the unexpected and serious events of Arthralgia, Swelling, Asthenia, and Headache. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in RA. Current condition of suspected COVID-19 remains confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2016249 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-15
Onset:2021-12-28
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: 20211228; 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: Shivers; Nausea; Fatigue; This case was received via the RA (Reference number: GB-MHRA-ADR 26405765) 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 CHILLS (Shivers), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) 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 28-Dec-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, CHILLS (Shivers) and NAUSEA (Nausea) was resolving and FATIGUE (Fatigue) had not resolved. 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. Concomitant and treatment medications were not reported. The patient had side effects 36 hour vaccine, which were quite severe and debilitating. Shivers, shaking, fever. Patient recovered and felt normal until the above side effects resumed on 28-Dec-2021. Cold hands. Patient was Lay down for a few hours and starting to feel a bit better. Felt like a a?minia version of the vaccine side effects. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No relate to possible inflammation of the heart myocarditis or pericarditis. COMPANY COMMENT: This is a regulatory case concerning a 37-year-old female patient with no clinical history who experienced the unexpected events of CHILLS, NAUSEA and FATIGUE The events occurred 14 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the regulatory Authority; Sender''s Comments: COMPANY COMMENT: This is a regulatory case concerning a 37-year-old female patient with no clinical history who experienced the unexpected events of CHILLS, NAUSEA and FATIGUE The events occurred 14 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the regulatory Authority


VAERS ID: 2016251 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy, Dizziness, Eye pain, Fatigue, Oropharyngeal pain, Palpitations, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Cardiomyopathy (broad), Hearing impairment (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anemia
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: Palsy Bells; Heart pounding; Fever chills; Sore eyes; High temperature; Sore throat; Dizzy spells; Tiredness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26405961) 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 BELL''S PALSY (Palsy Bells), PALPITATIONS (Heart pounding), PYREXIA (Fever chills), EYE PAIN (Sore eyes), PYREXIA (High temperature), OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (Dizzy spells) and FATIGUE (Tiredness) in a 20-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. Concurrent medical conditions included Anemia. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced BELL''S PALSY (Palsy Bells) (seriousness criterion medically significant), PALPITATIONS (Heart pounding) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), EYE PAIN (Sore eyes) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), DIZZINESS (Dizzy spells) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 28-Dec-2021, BELL''S PALSY (Palsy Bells) was resolving, PALPITATIONS (Heart pounding) and EYE PAIN (Sore eyes) had resolved with sequelae and PYREXIA (Fever chills), PYREXIA (High temperature), OROPHARYNGEAL PAIN (Sore throat), DIZZINESS (Dizzy spells) and FATIGUE (Tiredness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was reported No treatment medication information was reported The patient waited 5 minutes after jab and a hour later after leaving the vaccination site heart rate increased, started to feel faint, temperature had risen. After fainting the patient felt exhausted and proceded to sleep and woke up to left side of face drooping, sore eyes, sore throat, fever spells and even higher temperature. Patient had not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial The report is not relate to possible inflammation of the heart (myocarditis or pericarditis) Company comment: This is a regulatory authority case concerning a 20-year-old female patient with concurrent medical condition of anemia; who experienced events of pyrexia, oropharyngeal pain, dizziness, fatigue, palpitations, eye pain and Bell''s palsy (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). On 28-Dec-2021 the patient received third dose of mRNA-1273 vaccine, an hour later after leaving the vaccination site, she experienced heart rate increased, started to feel faint, temperature had risen. After fainting she felt exhausted and proceded to sleep. She woke up to left side of face drooping, sore eyes, sore throat, fever spells and higher temperature. Treatment details were not provided. Concurrent medical condition of anemia remains a confounder for events fatigue, dizziness and palpitations. 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 20-year-old female patient with concurrent medical condition of anemia; who experienced events of pyrexia, oropharyngeal pain, dizziness, fatigue, palpitations, eye pain and Bell''s palsy (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). On 28-Dec-2021 the patient received third dose of mRNA-1273 vaccine, an hour later after leaving the vaccination site, she experienced heart rate increased, started to feel faint, temperature had risen. After fainting she felt exhausted and proceded to sleep. She woke up to left side of face drooping, sore eyes, sore throat, fever spells and higher temperature. Treatment details were not provided. Concurrent medical condition of anemia remains a confounder for events fatigue, dizziness and palpitations. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2016255 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Lymphadenopathy, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: headache; nauseous; Glands swollen; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26406016) 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 HEADACHE (headache), NAUSEA (nauseous) and LYMPHADENOPATHY (Glands swollen) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced LYMPHADENOPATHY (Glands swollen) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant) and NAUSEA (nauseous) (seriousness criterion medically significant). At the time of the report, HEADACHE (headache) and NAUSEA (nauseous) was resolving and LYMPHADENOPATHY (Glands swollen) 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. Concomitant medications were not reported. It was stated that the patient experienced during the night with uncomfortable sleep due to pain in injection site, woke up following morning with awful headache and horrendous pain in the right armpit during the day got significantly worse and couldn''t lift the arm at all. Throbbing pains start under the armpit and shoot down to fingers. Patient was so uncomfortable to sleep. Also feel extremely nauseous and unable to eat. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment medications were not reported. Company Comment: This case concerns a 26-year-old, female patient with no medical history reported, who experienced the unexpected serious events of headache, nausea and lymphadenopathy. She began with pain in injection site on the night after the third dose of mRNA-1273 vaccine. The following morning, she presented headache and axillary pain with irradiation to the fingers, which worsened, with limitation of arm movements and difficulty to sleep. 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 case concerns a 26-year-old, female patient with no medical history reported, who experienced the unexpected serious events of headache, nausea and lymphadenopathy. She began with pain in injection site on the night after the third dose of mRNA-1273 vaccine. The following morning, she presented headache and axillary pain with irradiation to the fingers, which worsened, with limitation of arm movements and difficulty to sleep. 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: 2016256 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Hypersensitivity, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211216; 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; nausea; fatigue; Allergy; This case was received via regulatory authoruty (Reference number: GB-MHRA-ADR 26406045) 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 HEADACHE (headache), NAUSEA (nausea), FATIGUE (fatigue) and HYPERSENSITIVITY (Allergy) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HYPERSENSITIVITY (Allergy) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant), NAUSEA (nausea) (seriousness criterion medically significant) and FATIGUE (fatigue) (seriousness criterion medically significant). At the time of the report, HEADACHE (headache), NAUSEA (nausea), FATIGUE (fatigue) and HYPERSENSITIVITY (Allergy) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, SARS-CoV-2 test: negetive (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. After vaccination patient experienced Swelling to arm ? cellulitis, Bruising deep to skin, Temp of 38.9, Headache, Body fatigue, Nausea. Patient is not currently breastfeeding This report is not related to myocarditis or pericarditis. Patient seen by 3 GPS and given antibiotics for 10 days " Company comment; This is a regulatory authority case concerning a 25-year-old female patient with no medical history, who experienced the unexpected and serious events of headache, nausea, fatigue and hypersensitivity. The event hypersensitivity occurred the same day after a third dose of mRNA-1273 vaccine was administered while the rest of the events occurred on an unknown day after vaccine was given. Patient experienced swelling to arm-cellulitis and temperature; she was seen by 3 GPS and given antibiotics for 10 days. 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 25-year-old female patient with no medical history, who experienced the unexpected and serious events of headache, nausea, fatigue and hypersensitivity. The event hypersensitivity occurred the same day after a third dose of mRNA-1273 vaccine was administered while the rest of the events occurred on an unknown day after vaccine was given. Patient experienced swelling to arm-cellulitis and temperature; she was seen by 3 GPS and given antibiotics for 10 days. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2016266 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Feeling hot, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
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: feeling hot; Dizziness; Fever; Pain in arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26406810) 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 FEELING HOT (feeling hot), DIZZINESS (Dizziness), PYREXIA (Fever) and PAIN IN EXTREMITY (Pain in arm) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 01-May-2020. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING HOT (feeling hot) (seriousness criterion medically significant). At the time of the report, FEELING HOT (feeling hot) was resolving and DIZZINESS (Dizziness), PYREXIA (Fever) and PAIN IN EXTREMITY (Pain in arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID 19 Test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient says four hours after taking vaccine, she was feeling light headed and dizzy. Her arm was painful around injection site and down arm and round back. Next day pain in arm was the same and dizziness worse. She had difficulty walking. She was also feeling hot and cold. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Concomitant medication was not provided Treatment information was not provided Company Comment: This case concerns a 50-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of dizziness, pyrexia and pain in extremity, on the same day after the third dose of mRNA-1273 vaccine. She also experienced feeling hot. On the next day after vaccination, dizziness worsened with walking difficulties. 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 case concerns a 50-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of dizziness, pyrexia and pain in extremity, on the same day after the third dose of mRNA-1273 vaccine. She also experienced feeling hot. On the next day after vaccination, dizziness worsened with walking difficulties. 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: 2016272 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Allergic oedema, Immunisation, Interchange of vaccine products, Myocarditis, Off label use
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101885959

Write-up: myocarditis; Allergic edema; 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 (RA). Regulatory number: GB-MHRA-WEBCOVID-202112300933164850-CUFE4. Other Case identifier(s): GB-MHRA-ADR 26414476. A female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: Fk9706) 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, MAFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2, MAFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 28Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 28Dec2021, outcome "unknown", described as "Booster"; MYOCARDITIS (medically significant), outcome "not recovered", described as "myocarditis"; ALLERGIC OEDEMA (non-serious) with onset 29Dec2021, outcome "not recovered", described as "Allergic edema". Clinical course: Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2020214 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

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

Write-up: pain; Foot pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26405455) 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 PAIN (pain) and PAIN IN EXTREMITY (Foot pain) in a 34-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 27-Dec-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PAIN IN EXTREMITY (Foot pain) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant). At the time of the report, PAIN (pain) and PAIN IN EXTREMITY (Foot pain) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No Concomitant medications were reported. Patient had not had symptoms associated with COVID-19 Not had a COVID-19 test Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had pain in left foot while walking (had jab in left arm). Patient did not had pain while sitting or laying. but had severe pain when weight was put on the foot. patient also stated that he had no previous injuries to the foot. No Treatment medications were reported. Company comment: This case concerns a 34-year-old male patient with no medical history reported, who experienced the unexpected serious events of Pain and Pain in Extremity. The events occurred approximately 1 day after the third dose of mRNA-1273 (COVID 19 Vaccine Moderna). Treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 34-year-old male patient with no medical history reported, who experienced the unexpected serious events of Pain and Pain in Extremity. The events occurred approximately 1 day after the third dose of mRNA-1273 (COVID 19 Vaccine Moderna). Treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2020392 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Depression, SARS-CoV-2 test
SMQs:, Depression (excl suicide and self injury) (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: CITALOPRAM; COVID-19 MRNA VACCINE BNT162B2; DESOGESTREL; MEFENAMIC ACID
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
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: Depression; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26405521) 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 DEPRESSION (Depression) in a 20-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Suspected COVID-19 (Unsure when symptoms started). Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 04-Jul-2021 to an unknown date for COVID-19 vaccination, CITALOPRAM from 01-Oct-2021 to an unknown date for Depression NOS, DESOGESTREL from 01-Oct-2018 to an unknown date for Oral contraceptive, MEFENAMIC ACID from 01-Jul-2021 to an unknown date for Period pains. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced DEPRESSION (Depression) (seriousness criterion medically significant). At the time of the report, DEPRESSION (Depression) 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 treatment medication reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment:This RA case concerns a female patient of 20 years with medical history of Interchange of vaccine products (was with TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) before current vaccination) , experienced the unexpected serious event of Depression (Medically significant) which occurred same day after the third dose of mRNA1273 vaccine(28- Dec- 2021) and outcome was reported not resolved .The Citalopram (01- Oct -2021) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.The case was assessed as serious as per Regulatory Authority''s report due to important medical event. This report was not related to possible inflammation of the heart (myocarditis or pericarditis).; Sender''s Comments: This RA case concerns a female patient of 20 years with medical history of Interchange of vaccine products (was with TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) before current vaccination) , experienced the unexpected serious event of Depression (Medically significant) which occurred same day after the third dose of mRNA1273 vaccine(28- Dec- 2021) and outcome was reported not resolved .The Citalopram (01- Oct -2021) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.The case was assessed as serious as per Regulatory Authority''s report due to important medical event.


VAERS ID: 2020455 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bone pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Osteonecrosis (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: Medical History/Concurrent Conditions: Chest infection (with antibiotics leading up to vaccine (2 months), generally recovered before having vaccine); Cold (with antibiotics leading up to vaccine (2 months), generally recovered before having vaccine); Cough (with antibiotics leading up to vaccine (2 months), generally recovered before having vaccine)
Allergies:
Diagnostic Lab Data: Test Date: 20210914; 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: sore arm; Bone pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26402349) 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 PAIN IN EXTREMITY (sore arm) and BONE PAIN (Bone pain) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. The patient''s past medical history included Chest infection (with antibiotics leading up to vaccine (2 months), generally recovered before having vaccine), Cough (with antibiotics leading up to vaccine (2 months), generally recovered before having vaccine) and Cold (with antibiotics leading up to vaccine (2 months), generally recovered before having vaccine). On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced BONE PAIN (Bone pain) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (sore arm) had not resolved and BONE PAIN (Bone pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-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. No concomitant drugs were reported. The patient had bone aches across body, hips, ribs and jaw. Hurt to breathe like indigestion in back of ribs. Sore arm. Treatment medication included paracetamol. Previous vaccine (1&2) included Pfizer with no side effects except sore arm. 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 39-year-old female patient with no relevant medical history reported, who experienced the unexpected serious events of Pain in extremity and Bone Pain. The events occurred approximately 1 day after the third dose of mRNA-1273 (COVID 19 Vaccine Moderna). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 39-year-old female patient with no relevant medical history reported, who experienced the unexpected serious events of Pain in extremity and Bone Pain. The events occurred approximately 1 day after the third dose of mRNA-1273 (COVID 19 Vaccine Moderna). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2020458 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Pain, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210717; 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: Fainting; Ache; Dizziness; Fever; This case was received via Regulatory Authority, MHRA (Reference number: GB-MHRA-ADR 26406082) 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 SYNCOPE (Fainting), PAIN (Ache), DIZZINESS (Dizziness) and PYREXIA (Fever) in a 20-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 28-Dec-2021, SYNCOPE (Fainting) had resolved. At the time of the report, PAIN (Ache) had not resolved, DIZZINESS (Dizziness) was resolving and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jul-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. No concomitant and treatment medications were reported. Patient woke up at night with fever, fainted twice. Aching throughout body within 4 hours of vaccination. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This regulatory authority case concerns a 20-year-old male patient, with no reported medical history, who experienced the serious (medically significant) unexpected events of SYNCOPE, PAIN, DIZZINESS and PYREXIA. The events occurred on the same day after receiving a third dose of mRNA-1273. No information about previous vaccination schedule was provided. No further clinical information regarding details of the events, treatment received or medical consultations, was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory authority case concerns a 20-year-old male patient, with no reported medical history, who experienced the serious (medically significant) unexpected events of SYNCOPE, PAIN, DIZZINESS and PYREXIA. The events occurred on the same day after receiving a third dose of mRNA-1273. No information about previous vaccination schedule was provided. No further clinical information regarding details of the events, treatment received or medical consultations, was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2020460 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 00014A / 3 - / OT

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

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

Write-up: joint pain; feverish; nausea; Chest pain; Ache; Fever; Vomiting; This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), PYREXIA (feverish), NAUSEA (nausea), VOMITING (Vomiting), CHEST PAIN (Chest pain), PAIN (Ache) and PYREXIA (Fever) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 00014A) for an unknown indication. Concomitant products included ESTRADIOL for Hormone replacement therapy, IBUPROFEN for Joint pain. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (joint pain) (seriousness criterion medically significant), PYREXIA (feverish) (seriousness criterion medically significant), NAUSEA (nausea) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 28-Dec-2021, VOMITING (Vomiting) had resolved. At the time of the report, ARTHRALGIA (joint pain), PYREXIA (feverish) and NAUSEA (nausea) was resolving and CHEST PAIN (Chest pain), PAIN (Ache) and PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided by the reporter. Patient reported that she only had pain at injection site on day of injection. On next morning , patient woke up with nausea and vomiting along with feverish for entire day and night, and chronic joint pain was greatly exasperated. Patient had chest pain on night that was mostly gone when sat up but very painful when lying down. The symptoms are mostly gone and patient recovering. Patient has not had any symptoms associated with COVID-19 nor had a COVID-19 test. Patient was not currently breastfeeding and not had any heart related inflammation. This case concerns a 22-year-old female patient with no medical history, who experienced the unexpected serious events of Vomiting, Arthralgia, Pyrexia, Nausea, Chest Pain, Pain, and Pyrexia, the event was medically significant as reported by the regulatory authority. The event of Vomiting occurred 1 day after receiving the third dose of mRNA-1273 while the rest of the events occurred on an unknown interval. 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 event has resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 22-year-old female patient with no medical history, who experienced the unexpected serious events of Vomiting, Arthralgia, Pyrexia, Nausea, Chest Pain, Pain, and Pyrexia, the event was medically significant as reported by the regulatory authority. The event of Vomiting occurred 1 day after receiving the third dose of mRNA-1273 while the rest of the events occurred on an unknown interval. 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 event has resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2020465 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041321A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Blood glucose increased, Dehydration, Dizziness, Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: Blood pressure high (High blood pressure, all controlled with medication and exercise); High cholesterol (all controlled with medication and exercise); Metabolic syndrome (all controlled with medication and exercise)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Dehydration; Fever chills; Dizziness; Sugar blood increased; Headache; Armpit pain; Generalized muscle aches; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26415663) 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 AXILLARY PAIN (Armpit pain), DEHYDRATION (Dehydration), PYREXIA (Fever chills), DIZZINESS (Dizziness), BLOOD GLUCOSE INCREASED (Sugar blood increased), MYALGIA (Generalized muscle aches) and HEADACHE (Headache) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 041321A) for an unknown indication. Concurrent medical conditions included Blood pressure high (High blood pressure, all controlled with medication and exercise), Metabolic syndrome (all controlled with medication and exercise) and High cholesterol (all controlled with medication and exercise). On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant) and MYALGIA (Generalized muscle aches) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced DEHYDRATION (Dehydration) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), BLOOD GLUCOSE INCREASED (Sugar blood increased) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, AXILLARY PAIN (Armpit pain), DEHYDRATION (Dehydration), PYREXIA (Fever chills), DIZZINESS (Dizziness), BLOOD GLUCOSE INCREASED (Sugar blood increased) and MYALGIA (Generalized muscle aches) had not resolved and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided but reported that all the medical history of patient was controlled with medication and exercise. Treatment information was not provided. The patient had no symptoms associated with COVID-19, had not done a COVID 19 test and was not currently breastfeeding. The side effects were still happening and reported as it was almost 48 hours. The arm pain, armpit pain was extreme and caused loss of movement. Blood sugar was higher than ever seen in the year of morning monitoring and had a hope that it will return to normal. The patient was not enrolled clinical trial and had not tested positive for COVID 19 since vaccine administration. The report does not relate to possible inflammation of the heart like myocarditis or pericarditis. Company comment: This case concerns a 50-year-old female patient, with medical history of metabolic syndrome, who experienced the serious, unexpected events of axillary pain, dehydration, pyrexia, dizziness, blood glucose increased, myalgia, and headache after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The patient had axillary pain and myalgia on the same day of the vaccine, and dehydration, pyrexia, dizziness, blood sugar increased and headache 1 day after the vaccine. The arm pain, armpit pain was extreme and caused loss of movement. Blood sugar was higher than ever seen in the year of morning monitoring At the time of report, only headache was resolving and the rest of the events had not resolved. The patient''s history of metabolic syndrome remain as confounder to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 50-year-old female patient, with medical history of metabolic syndrome, who experienced the serious, unexpected events of axillary pain, dehydration, pyrexia, dizziness, blood glucose increased, myalgia, and headache after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The patient had axillary pain and myalgia on the same day of the vaccine, and dehydration, pyrexia, dizziness, blood sugar increased and headache 1 day after the vaccine. The arm pain, armpit pain was extreme and caused loss of movement. Blood sugar was higher than ever seen in the year of morning monitoring At the time of report, only headache was resolving and the rest of the events had not resolved. The patient''s history of metabolic syndrome remain as confounder to the events. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 2020469 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Neck pain, Renal pain, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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? 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 Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Diarrhea; Kidney pain; Neck pain; Vomiting; This case was received via RA (Reference number: GB-MHRA-ADR 26416088) 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 DIARRHOEA (Diarrhea), RENAL PAIN (Kidney pain), NECK PAIN (Neck pain) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. No medical history was provided by the reporter. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 28-May-2021 to an unknown date for COVID-19 vaccination. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced RENAL PAIN (Kidney pain) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On 29-Dec-2021, VOMITING (Vomiting) had resolved. On 30-Dec-2021, NECK PAIN (Neck pain) had resolved. At the time of the report, DIARRHOEA (Diarrhea) had not resolved and RENAL PAIN (Kidney pain) was resolving. 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 also had a hard swollen lump at the injection site that is very painful, but most concerning was the kidney pain and vomiting. Sequence of events was Heat in whole of arm, Head and neck pain,Very cold and shivery very nauseous, Vomiting, Diarrhoea that had not gone away Kidney pain that had dulled but not gone away Treatment product was not provided by the reporter Company comment:This RA case concerns a female patient of unknown age with medical history of Interchange of vaccine products (was with 2 doses of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) 28-May-2021 to an unknown date before current vaccination), experienced the unexpected serious event of Renal pain, Neck pain, Vomiting and Diarrhea(Medically significant) .The events Renal pain, Neck pain and Vomiting occurred same day after and Diarrhea occurred one day after the third dose of mRNA1273 vaccine. The outcome was reported as vomiting and neck pain resolved, not resolved for Diarrhea and resolving for Renal pain. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority''s report due to important medical event.; Sender''s Comments: This RA case concerns a female patient of unknown age with medical history of Interchange of vaccine products (was with 2 doses of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) 28-May-2021 to an unknown date before current vaccination), experienced the unexpected serious event of Renal pain, Neck pain, Vomiting and Diarrhea(Medically significant) .The events Renal pain, Neck pain and Vomiting occurred same day after and Diarrhea occurred one day after the third dose of mRNA1273 vaccine. The outcome was reported as vomiting and neck pain resolved, not resolved for Diarrhea and resolving for Renal pain. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority''s report due to important medical event.


VAERS ID: 2021260 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Oedema peripheral, Pyrexia, Sleep disorder, Swollen tongue
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: no
Preexisting Conditions: Fallot tetralogy - 2 heart surgeries for this
Allergies: no
Diagnostic Lab Data:
CDC Split Type:

Write-up: Had swollen arm pit, very painful. My tongue was slightly swollen as well. Had fever. Difficulties to sleep for few day.


VAERS ID: 2022749 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-18
Onset:2021-12-28
   Days after vaccination:10
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: 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Heavy periods; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26412773) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy periods) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-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 29-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-. 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. Concomitant medication was not provided by reporter. Patient last menstruation period date was 29 December 2021. Patient had Extremely heavy menstrual bleeding with very large blood clots which was required changing sanitary products several times within an hour. The laboratory included Pregnancy test and result was negative. Company Comment This case concerns a 28-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of heavy menstrual bleeding. The event occurred 12 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 event meets the criteria to be medically significant. Patient did not relate the report to possible blood clots or low platelet counts or possible inflammation of the heart (myocarditis or pericarditis). Treatment Medication use information was not provided by reporter.; Sender''s Comments: This case concerns a 28-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of heavy menstrual bleeding. The event occurred 12 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 event meets the criteria to be medically significant.


VAERS ID: 2022781 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse drug reaction
SMQs:

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

Write-up: Fever Dreams; This regulatory authority case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Fever Dreams) in a 23-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for Ill-defined disorder. No Medical History information was reported. On 28-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 28-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ADVERSE DRUG REACTION (Fever Dreams) (seriousness criterion medically significant). On 28-Dec-2021, ADVERSE DRUG REACTION (Fever Dreams) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) was unknown. Concomitant product use was not provided by the reporter. The patient experienced fever sleep, going hot and cold, weird and vivid dreams, achy body and fatigued. The patient was taking Moderna Booster Vaccine for: Booster jab for covid. Treatment information was not provided. This is a regulatory authority case concerning a 23-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Adverse drug reaction. The event occurred approximately on the same day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The event was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 23-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Adverse drug reaction. The event occurred approximately on the same day after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The event was reported as resolving. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2022782 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-28
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse drug reaction
SMQs:

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

Write-up: Tinnatus in left ear.; This regulatory authority case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Tinnatus in left ear.) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Ill-defined disorder. No Medical History information was reported. On 22-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 28-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ADVERSE DRUG REACTION (Tinnatus in left ear.) (seriousness criterion medically significant). At the time of the report, ADVERSE DRUG REACTION (Tinnatus in left ear.) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) was unknown. Patient had Pfizer injection in 2021 feb then SSNHL and tinnatus in right ear, now exacerbated after above injection. Seek Advice Details: Since booster of Moderna have tinnatus in Left ear, headaches and pressure in head. The patient was taking Moderna for: Front line worker needed booster as requirement of work. Concomitant product usage were not provided. Treatment details were also not provided This is a regulatory authority case concerning a 50-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Adverse drug reaction. The event occurred approximately 6 days after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The event was reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 50-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Adverse drug reaction. The event occurred approximately 6 days after the unknown dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as information about further dosing was not disclosed. The event was reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2023181 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
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: Chest pain, Dyspnoea, 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), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CHLORPHENAMINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Chest pain; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26404715) 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 the first episode of CHEST PAIN (Chest pain), the second episode of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) in a 23-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 Suspected COVID-19 (Unsure when symptoms stopped) on 14-Nov-2020. Concomitant products included CHLORPHENAMINE from 23-Dec-2021 to 26-Dec-2021 for Allergic rhinitis. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced the first episode of CHEST PAIN (Chest pain) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced the second episode of 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, last episode of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had Chest Pain, shortness of breath, palpitations, rapid pulse on waking 28th December about midday which was about 23 hours post Moderna booster vaccine. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Report relate to possible inflammation of the heart (myocarditis or pericarditis) ECG was normal but CRP/troponin were not tested. Symptoms lead to a hospital for 2 hours in A&E. It was unknown if diagnosis was made by a medical professional. A&E nurse and doctor provided the diagnosis. No treatment was given because of your symptoms, No imaging carried out such as, but not limited to, chest X-ray, echocardiogram, cardiac MRI, chest computerized tomography (CT). No blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken. Company comment This case concerns a 23-year-old male patient, with no reported medical history, who experienced the unexpected serious events of CHEST PAIN, the second episode of CHEST PAIN, DYSPNOEA, PALPITATIONS and TACHYCARDIA. The events started on the following day after the administration of the third dose of mRNA-1273 vaccine. It was reported related to possible inflammation of the heart (myocarditis or pericarditis). Symptoms lead to a hospital for 2 hours in A&E. Emergency nurse and doctor provided the diagnosis. No treatment was given because of patient?s symptoms, no imaging or blood tests were carried out. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 23-year-old male patient, with no reported medical history, who experienced the unexpected serious events of CHEST PAIN, the second episode of CHEST PAIN, DYSPNOEA, PALPITATIONS and TACHYCARDIA. The events started on the following day after the administration of the third dose of mRNA-1273 vaccine. It was reported related to possible inflammation of the heart (myocarditis or pericarditis). Symptoms lead to a hospital for 2 hours in A&E. Emergency nurse and doctor provided the diagnosis. No treatment was given because of patient?s symptoms, no imaging or blood tests were carried out. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023184 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
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, Deafness, Hyperhidrosis, Pyrexia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Sweaty; Shivers; Fever; Deafness; Fainting; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26405489) 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 SYNCOPE (Fainting), HYPERHIDROSIS (Sweaty), CHILLS (Shivers), PYREXIA (Fever) and DEAFNESS (Deafness) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (Sweaty) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and DEAFNESS (Deafness) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting), HYPERHIDROSIS (Sweaty), CHILLS (Shivers), PYREXIA (Fever) and DEAFNESS (Deafness) had 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 incident lasted about 10 minutes 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 24-year-old female, with no relevant reported medical history in this case, who experienced the serious unexpected events of Syncope, Hyperhidrosis, Chills, Pyrexia and Deafness. The event Syncope occurred one day after the administration of the mRNA-1273 vaccine and the outcome at the time of the report was Recovered/Resolved. The events Hyperhidrosis, Chills, Pyrexia and Deafness occurred in an unknown date after the administration of the Second dose of mRNA-1273 vaccine and at the time of the report, the outcome for these events was Recovered/Resolved. The rechallenge could be considered not applicable since the events occurred after the 2nd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 24-year-old female, with no relevant reported medical history in this case, who experienced the serious unexpected events of Syncope, Hyperhidrosis, Chills, Pyrexia and Deafness. The event Syncope occurred one day after the administration of the mRNA-1273 vaccine and the outcome at the time of the report was Recovered/Resolved. The events Hyperhidrosis, Chills, Pyrexia and Deafness occurred in an unknown date after the administration of the Second dose of mRNA-1273 vaccine and at the time of the report, the outcome for these events was Recovered/Resolved. The rechallenge could be considered not applicable since the events occurred after the 2nd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023196 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Fibromyalgia, 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: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fibromyalgia; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26405813) on 29-Dec-2021 and was forwarded to Moderna on 29-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of FIBROMYALGIA (Fibromyalgia) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced FIBROMYALGIA (Fibromyalgia) (seriousness criterion disability). At the time of the report, FIBROMYALGIA (Fibromyalgia) 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. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that patient had severe flare of fibromyalgia symptoms No concomitant medication information was provided. No treatment medication was provided. Company comment: This regulatory authority case concerns a 32-year-old female patient, with no reported medical history, who experienced the serious (disability) unexpected event of FIBRIOMYALGIA. The event occurred one day after receiving a third dose of mRNA-1273 and had not resolved by the time of this report. No information about previous vaccination schedule was provided. Source document narrative states that patient experienced a flare of fibromyalgia; hence, it can be supposed that patient had fibromyalgia prior to vaccination and that history of disease could be considered as a confounder. No further clinical information, including treatment or details on permanent disability were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory authority case concerns a 32-year-old female patient, with no reported medical history, who experienced the serious (disability) unexpected event of FIBRIOMYALGIA. The event occurred one day after receiving a third dose of mRNA-1273 and had not resolved by the time of this report. No information about previous vaccination schedule was provided. Source document narrative states that patient experienced a flare of fibromyalgia; hence, it can be supposed that patient had fibromyalgia prior to vaccination and that history of disease could be considered as a confounder. No further clinical information, including treatment or details on permanent disability were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2023203 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
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: Breast swelling
SMQs:, Angioedema (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: DULOXETINE; TELFAST
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Breast swelling; This case was received via RA (Reference number: GB-MHRA-ADR 26406009) 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 BREAST SWELLING (Breast swelling) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included DULOXETINE for Fibromyalgia, FEXOFENADINE HYDROCHLORIDE (TELFAST) for Multiple allergies. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced BREAST SWELLING (Breast swelling) (seriousness criterion medically significant). At the time of the report, BREAST SWELLING (Breast swelling) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient was not pregnant, Patient was not currently breastfeeding patient lymph nodes are enlarged and right breast was very swollen and painful. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Company Comment: This case concerns a 36-year-old female patient, with relevant medical history of Fibromyalgia, who experienced the unexpected serious (medically significant) event of Breast swelling. The event occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was not resolved. The rechallenge is unknown as per Agency. The patient''s medical history of Fibromyalgia remain a confounder for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 36-year-old female patient, with relevant medical history of Fibromyalgia, who experienced the unexpected serious (medically significant) event of Breast swelling. The event occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the event was not resolved. The rechallenge is unknown as per Agency. The patient''s medical history of Fibromyalgia remain a confounder for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2023209 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 00002A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chest discomfort, Chills, Dizziness, Headache, Hypoaesthesia, Injection site pain, Insomnia, Myalgia, Nausea, Neck pain, Night sweats, Paraesthesia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210605; 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: Headache; Shivers; Night sweats; Tingling of extremity; Body numbness; High temperature; Neck pain; Muscle pain; Injection site pain; Difficulty sleeping; Dizziness; Nausea; Back pain; Chest tightness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26406284) 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 HEADACHE (Headache), CHILLS (Shivers), NIGHT SWEATS (Night sweats), PARAESTHESIA (Tingling of extremity), HYPOAESTHESIA (Body numbness), PYREXIA (High temperature), NECK PAIN (Neck pain), MYALGIA (Muscle pain), INJECTION SITE PAIN (Injection site pain), INSOMNIA (Difficulty sleeping), DIZZINESS (Dizziness), NAUSEA (Nausea), BACK PAIN (Back pain) and CHEST DISCOMFORT (Chest tightness) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 00002A) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), NIGHT SWEATS (Night sweats) (seriousness criterion medically significant), PARAESTHESIA (Tingling of extremity) (seriousness criterion medically significant), HYPOAESTHESIA (Body numbness) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant), INSOMNIA (Difficulty sleeping) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), BACK PAIN (Back pain) (seriousness criterion medically significant) and CHEST DISCOMFORT (Chest tightness) (seriousness criterion medically significant). On 29-Dec-2021, BACK PAIN (Back pain) had resolved. At the time of the report, HEADACHE (Headache), NIGHT SWEATS (Night sweats), PARAESTHESIA (Tingling of extremity), HYPOAESTHESIA (Body numbness), PYREXIA (High temperature), NECK PAIN (Neck pain), MYALGIA (Muscle pain), INJECTION SITE PAIN (Injection site pain), INSOMNIA (Difficulty sleeping), DIZZINESS (Dizziness), NAUSEA (Nausea) and CHEST DISCOMFORT (Chest tightness) had not resolved and CHILLS (Shivers) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-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. No concomitant medications were reported. Patient has not had symptoms associated with COVID-19 and Patient is not currently breastfeeding. Company Comment This case concerns a 22-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of headache, chills, night sweats, paraesthesia, hypoaesthesia, pyrexia, neck pain, myalgia, injection site pain, insomnia, dizziness, nausea, back pain and chest discomfort. The events occurred the same day 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 has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. No treatment information was reported.; Sender''s Comments: This case concerns a 22-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of headache, chills, night sweats, paraesthesia, hypoaesthesia, pyrexia, neck pain, myalgia, injection site pain, insomnia, dizziness, nausea, back pain and chest discomfort. The events occurred the same day 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: 2023211 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
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: Ear pain, Fatigue, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Earache; Tiredness; Headache; Muscle ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26407007) 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 EAR PAIN (Earache), FATIGUE (Tiredness), HEADACHE (Headache) and MYALGIA (Muscle ache) in a 41-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 14-Jan-2020 to 20-Jan-2020. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced EAR PAIN (Earache) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On 28-Dec-2021, EAR PAIN (Earache), HEADACHE (Headache) and MYALGIA (Muscle ache) had resolved. On 29-Dec-2021, FATIGUE (Tiredness) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No concomitant product use was provided by the reporter. No treatment medications were reported.; Sender''s Comments: This is an RA case concerning a 41-year-old, male patient with no relevant medical history reported, who experienced the events of ear pain, fatigue, headache and myalgia. The events occurred 2 days after the booster dose. Event seriousness was captured as provided by the Regulatory Authority. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 2023215 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Migraine, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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.MOD20214

Write-up: Migraine headache; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headache) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced MIGRAINE (Migraine headache) (seriousness criterion medically significant). On 29-Dec-2021, MIGRAINE (Migraine headache) 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. Patient says she had a very strong headache, general pain all over the articulation such as arms, legs, back. Very sore arm where vaccine was injected, She had flu after about 12 hours and not had these reactions with the primary vaccines. Concomitant medication was not provided. Treatment information was not provided. Company comment: This regulatory authority case concerns a 31-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Migraine after mRNA- 1273 vaccine. The onset of the event occurred on the day after the third dose of mRNA- 1273 vaccine (reported as 3b dose) and had a duration of 1 day. Very strong headache was reported. Headache is consistent with the known safety profile of the vaccine, but since it was reported with a seriousness criterion and specifically as Migraine, it is considered unexpected. Additionally, the expected events of arthralgia, vaccination site pain and the unexpected event of influenza like symptoms were reported. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19. Adverse reaction did not occur as a result of an exposure during pregnancy.; Sender''s Comments: This regulatory authority case concerns a 31-year-old female patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Migraine after mRNA- 1273 vaccine. The onset of the event occurred on the day after the third dose of mRNA- 1273 vaccine (reported as 3b dose) and had a duration of 1 day. Very strong headache was reported. Headache is consistent with the known safety profile of the vaccine, but since it was reported with a seriousness criterion and specifically as Migraine, it is considered unexpected. Additionally, the expected events of arthralgia, vaccination site pain and the unexpected event of influenza like symptoms were reported. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2023217 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Dizziness, Fatigue, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210919; 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: Dizziness; Nausea; Fatigue; Fever chills; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26407312) 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 FATIGUE (Fatigue), PYREXIA (Fever chills), DIZZINESS (Dizziness) and NAUSEA (Nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue) had not resolved and PYREXIA (Fever chills), DIZZINESS (Dizziness) and NAUSEA (Nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-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. The patient was not pregnant and not breastfeeding at the time of report. No concomitant product use was provided by the reporter. No treatment medications were reported. The patient not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. The report was not related to possible inflammation of the heart myocarditis or pericarditis. Company comment: This Regulatory Authority case concerns a 33-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) events of fatigue, pyrexia, dizziness and nausea. The events fatigue and pyrexia occurred on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved the next day with dizziness and nausea. Regulatory authority captured the rechallenge as unknown. It was not reported if the previous two doses of her COVID-19 vaccination schedule were mRNA-1273 vaccines as well.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This Regulatory Authority case concerns a 33-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) events of fatigue, pyrexia, dizziness and nausea. The events fatigue and pyrexia occurred on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved the next day with dizziness and nausea. Regulatory authority captured the rechallenge as unknown. It was not reported if the previous two doses of her COVID-19 vaccination schedule were mRNA-1273 vaccines as well.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 2023222 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pain, SARS-CoV-2 test, Skin burning sensation
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EVOREL
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: Muscle ache; Burning skin; Fatigue; Nausea; Pain; Headache; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26407485) 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 MYALGIA (Muscle ache), SKIN BURNING SENSATION (Burning skin), FATIGUE (Fatigue), NAUSEA (Nausea), PAIN (Pain) and HEADACHE (Headache) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. Concomitant products included ESTRADIOL (EVOREL) from 21-May-2021 to an unknown date for HRT. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant), SKIN BURNING SENSATION (Burning skin) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle ache), SKIN BURNING SENSATION (Burning skin), FATIGUE (Fatigue), NAUSEA (Nausea), PAIN (Pain) and HEADACHE (Headache) was resolving. 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 medical history information was provided. The patient felt fine for twelve hours after the vaccine, then by midnight she was unable to sleep. This continued all night as she was hurting all over. Her joints, muscles, head, every part of her were tingling or throbbing, best described as being like sunburn all over. She also felt intermittently very cold or very warm. This continued for the following day and then started to ease by the morning of 29th December. She took paracetamol but this seemed to have a limited effect. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Company Comment: This case concerns a 44-year-old female patient, with no medical history reported, who experienced the unexpected and serious events of Myalgia, Skin burning sensation, Fatigue, Nausea, Pain, and Headache. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 44-year-old female patient, with no medical history reported, who experienced the unexpected and serious events of Myalgia, Skin burning sensation, Fatigue, Nausea, Pain, and Headache. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023238 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chills, Ear pain, Headache, Injection site pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Headache; Shivers; High temperature; Backache; Earache; Injection site pain; This case was received via RA (Reference number: GB-MHRA-ADR 26407995) 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 (Shivers), PYREXIA (High temperature), BACK PAIN (Backache), EAR PAIN (Earache) and INJECTION SITE PAIN (Injection site pain) in a 52-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), BACK PAIN (Backache) (seriousness criterion medically significant), EAR PAIN (Earache) (seriousness criterion medically significant) and INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), CHILLS (Shivers), PYREXIA (High temperature), BACK PAIN (Backache), EAR PAIN (Earache) and INJECTION SITE PAIN (Injection site pain) 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 medications were provided. No treatment medications were provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 52-year-old female patient with no medical history provided who experienced serious unexpected events of Headache, Chills, Pyrexia, Back pain, Ear pain and Injection site pain. The events occurred on the same day after the third dose of mRNA-1273. At the time of the report, the events were still ongoing 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 terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 52-year-old female patient with no medical history provided who experienced serious unexpected events of Headache, Chills, Pyrexia, Back pain, Ear pain and Injection site pain. The events occurred on the same day after the third dose of mRNA-1273. At the time of the report, the events were still ongoing 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 terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2023252 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   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, Diarrhoea, Fatigue, Injection site pain, Nausea, Pain in extremity, Paraesthesia, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Shivers; Shaking; Teeth chattering; Fever; Nauseous; Fatigue; Pain in leg; Injection site pain; Diarrhoea NOS; Pins and needles; Tingling; This case was received via RA (Reference number: GB-MHRA-ADR 26414507) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CHILLS (Shivers), TREMOR (Shaking), CHILLS (Teeth chattering), PYREXIA (Fever), NAUSEA (Nauseous), FATIGUE (Fatigue), PAIN IN EXTREMITY (Pain in leg), INJECTION SITE PAIN (Injection site pain), DIARRHOEA (Diarrhoea NOS), PARAESTHESIA (Pins and needles) and PARAESTHESIA (Tingling) in a 53-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant), TREMOR (Shaking) (seriousness criterion medically significant), CHILLS (Teeth chattering) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nauseous) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in leg) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea NOS) (seriousness criterion medically significant), PARAESTHESIA (Pins and needles) (seriousness criterion medically significant) and PARAESTHESIA (Tingling) (seriousness criterion medically significant). On 28-Dec-2021, DIARRHOEA (Diarrhoea NOS) had resolved. On 29-Dec-2021, CHILLS (Shivers), TREMOR (Shaking), CHILLS (Teeth chattering), PAIN IN EXTREMITY (Pain in leg), PARAESTHESIA (Pins and needles) and PARAESTHESIA (Tingling) had resolved, PYREXIA (Fever) was resolving. At the time of the report, NAUSEA (Nauseous) and FATIGUE (Fatigue) was resolving and INJECTION SITE PAIN (Injection site pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. 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. Concomitant products were not provided. It was reported that reaction to the first injection was also reported. Effects began 12 PM after the injection. Lab data included: LFT completed on 29/12/21. Treatment medication were not reported. Company comment: This regulatory case concerns a 53-year-old female patient, with no medical history reported, who experienced the serious unexpected events of INJECTION SITE PAIN, NAUSEA, FATIGUE, PYREXIA, CHILLS, TREMOR, CHILLS, PAIN IN EXTREMITY, DIARRHOEA, PARAESTHESIA and PARAESTHESIA. The events occurred on the same day of the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.; Sender''s Comments: This regulatory case concerns a 53-year-old female patient, with no medical history reported, who experienced the serious unexpected events of INJECTION SITE PAIN, NAUSEA, FATIGUE, PYREXIA, CHILLS, TREMOR, CHILLS, PAIN IN EXTREMITY, DIARRHOEA, PARAESTHESIA and PARAESTHESIA. The events occurred on the same day of the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.


VAERS ID: 2023256 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
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, Ear pain, Feeling abnormal, Oral herpes, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal infections (narrow), Cardiomyopathy (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
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.MOD20214

Write-up: Floating feeling; Fever sore; Shivers; Ear ache; Heart pounding; This case was received via RA (Reference number: GB-MHRA-ADR 26405595) 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 FEELING ABNORMAL (Floating feeling), ORAL HERPES (Fever sore), CHILLS (Shivers), EAR PAIN (Ear ache) and PALPITATIONS (Heart pounding) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Previously administered products included for Product used for unknown indication: Sertraline (Sertraline 200mg). Past adverse reactions to the above products included No adverse event with Sertraline. Concurrent medical conditions included Suspected COVID-19 since 28-Dec-2021. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced FEELING ABNORMAL (Floating feeling) (seriousness criterion medically significant), ORAL HERPES (Fever sore) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), EAR PAIN (Ear ache) (seriousness criterion medically significant) and PALPITATIONS (Heart pounding) (seriousness criterion medically significant). At the time of the report, FEELING ABNORMAL (Floating feeling) and ORAL HERPES (Fever sore) had not resolved, CHILLS (Shivers) and EAR PAIN (Ear ache) was resolving and PALPITATIONS (Heart pounding) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-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 concomitant medications reported by reporter. No treatment medications provided by the reporter. Patient last menstruation period date was 12 Oct 2021. Patient started off with a sore arm then it spread to patient''s whole body, it felt like whole body was weak and fragile. During the night, patient had very bad shivers and heart pounding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This Regulatory Authority case concerns a 24-year-old, female patient, with no relevant medical history, who experienced the unexpected, serious (Medically significant) events of feeling abnormal, oral herpes, chills, ear ache and palpitations. The patient developed sore arm, that later spread to her whole body, along with shivers and heart pounding 1 day 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 her COVID-19 vaccination schedule were mRNA-1273 vaccines as well. One day after vaccination, the patient tested negative for COVID-19. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This Regulatory Authority case concerns a 24-year-old, female patient, with no relevant medical history, who experienced the unexpected, serious (Medically significant) events of feeling abnormal, oral herpes, chills, ear ache and palpitations. The patient developed sore arm, that later spread to her whole body, along with shivers and heart pounding 1 day 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 her COVID-19 vaccination schedule were mRNA-1273 vaccines as well. One day after vaccination, the patient tested negative for COVID-19. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 2023262 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000059A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dry mouth, Dysgeusia, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Allergies:
Diagnostic Lab Data: Test Date: 20211215; 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: dry mouth; Taste metallic; This case was received (Reference number: GB-RA-ADR 26408257) 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 DRY MOUTH (dry mouth) and DYSGEUSIA (Taste metallic) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000059A) for an unknown indication. The patient''s past medical history included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). Previously administered products included for Hypothyroidism: LEVOTHYROXINE (Taking levothyroxine for underactive thyroid). Past adverse reactions to the above products included No adverse event with LEVOTHYROXINE. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 22-Apr-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced DYSGEUSIA (Taste metallic) (seriousness criterion medically significant). On an unknown date, the patient experienced DRY MOUTH (dry mouth) (seriousness criterion medically significant). On 28-Dec-2021, DYSGEUSIA (Taste metallic) had resolved. At the time of the report, DRY MOUTH (dry mouth) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-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 relevant treatment medication information provided. It was reported that patient was taking levothyroxine for underactive thyroid. Patient experienced metallic taste in mouth approximately 30 minutes after vaccine. It was cleared after approximately 2 hours. Patient experienced problem with swallowing and very dry mouth which was causing issues. They were resolved by taking small sips of water to lubricate the mouth and allow swallowing action. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Company Comment: This regulatory case concerns a female patient of an unknown age with no relevant medical history reported, with an Interchange of vaccine products (two doses was with COVID-19 VACCINE ASTRAZENECA, 5 month 17 days before current vaccination), who experienced the unexpected serious events of Dry mouth and Dysgeusia. The event dry mouth occurred on an unknown day and Dysgeusia occurred on the same day after the third dose of mRNA-1273 vaccine. The outcome of the events Dysgeusia and Dry mouth was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report.; Sender''s Comments: This regulatory case concerns a female patient of an unknown age with no relevant medical history reported, with an Interchange of vaccine products (two doses was with COVID-19 VACCINE ASTRAZENECA, 5 month 17 days before current vaccination), who experienced the unexpected serious events of Dry mouth and Dysgeusia. The event dry mouth occurred on an unknown day and Dysgeusia occurred on the same day after the third dose of mRNA-1273 vaccine. The outcome of the events Dysgeusia and Dry mouth was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report.


VAERS ID: 2023271 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
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: Body temperature decreased, Headache, Hyperhidrosis, Myalgia, Paraesthesia, Petit mal epilepsy, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness: Fainting
Preexisting Conditions: Medical History/Concurrent Conditions: Cold; Dog bite
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Tested negative for COVID-19
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Absence seizure; Localised tingling; Body temperature decreased; Heavy sweating; High temperature; Vomiting; Headache; Muscle ache; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26408575) 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 PETIT MAL EPILEPSY (Absence seizure), PARAESTHESIA (Localised tingling), BODY TEMPERATURE DECREASED (Body temperature decreased), HYPERHIDROSIS (Heavy sweating), PYREXIA (High temperature), VOMITING (Vomiting), HEADACHE (Headache) and MYALGIA (Muscle ache) in a 29-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. The patient''s past medical history included Dog bite and Cold. Concurrent medical conditions included Fainting. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 19-Jun-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PETIT MAL EPILEPSY (Absence seizure) (seriousness criterion medically significant), PARAESTHESIA (Localised tingling) (seriousness criterion medically significant), BODY TEMPERATURE DECREASED (Body temperature decreased) (seriousness criterion medically significant), HYPERHIDROSIS (Heavy sweating) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On 29-Dec-2021, PETIT MAL EPILEPSY (Absence seizure), PARAESTHESIA (Localised tingling), BODY TEMPERATURE DECREASED (Body temperature decreased), HYPERHIDROSIS (Heavy sweating), PYREXIA (High temperature) and VOMITING (Vomiting) had resolved. At the time of the report, HEADACHE (Headache) and MYALGIA (Muscle ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, SARS-CoV-2 test: negative (Negative) Tested negative for COVID-19. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The treatment history was not provided. Patient is not tested positive for COVID-19 since having the vaccine, not enrolled in clinical trial. Patient woke up at 3 am, freezing went for wee and got back on bed and instantly felt sick and started sweating, went to bathroom and tried to be sick, ended up laying on the floor for like a minute not really moving but eyes were open apparently and eventually came round after 10-30 seconds was sick but only a little bit and then felt nauseous anymore, just a banging head and leg muscle ache like hell. Oh also tingly feelings in left arm and left leg. Company Comment: This case concerns a 29-year-old male patient, with relevant medical history of Fainting and previous vaccination with PFIZER BIONTECH COVID-19 VACCINE, who experienced the unexpected serious (medically significant) events of Petit mal epilepsy, Paraesthesia, Body temperature decreased, Hyperhidrosis, Pyrexia, Headache, Vomiting, and Myalgia . The events occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was resolving. The rechallenge is unknown as per SD. The patient''s medical history of Fainting and previous vaccination with PFIZER BIONTECH COVID-19 VACCINE remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 29-year-old male patient, with relevant medical history of Fainting and previous vaccination with PFIZER BIONTECH COVID-19 VACCINE, who experienced the unexpected serious (medically significant) events of Petit mal epilepsy, Paraesthesia, Body temperature decreased, Hyperhidrosis, Pyrexia, Headache, Vomiting, and Myalgia . The events occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was resolving. The rechallenge is unknown as per SD. The patient''s medical history of Fainting and previous vaccination with PFIZER BIONTECH COVID-19 VACCINE remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2023272 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0000KA / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Hyperhidrosis, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), 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:
Current Illness: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; 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: Rash; Sweating; Weakness; This case was received via RA (Reference number: GB-MHRA-ADR 26408459) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This case was received via RA (Reference number: GB-MHRA-ADR 26408459) 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 RASH (Rash), HYPERHIDROSIS (Sweating) and ASTHENIA (Weakness) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 0000KA) for an unknown indication. Concurrent medical conditions included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant) and ASTHENIA (Weakness) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On 29-Dec-2021, HYPERHIDROSIS (Sweating) and ASTHENIA (Weakness) had resolved. At the time of the report, RASH (Rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-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. No Concomitant medication provided. No treatment medication reported. Patient Just completed an unsuccessful round of IVF. Patients sister has had the same reaction but not on any other medications. After 12 hours, weak, nauseous, hot/cold and shivers. Spent 24 hours in bed. 36 hours red rash on arm which is hot. 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.; Sender''s Comments: This is a regulatory case concerning a 39-year-old female patient with no relevant medical history provided, who experienced the unexpected serious events of Rash, Hyperhidrosis, and Asthenia(seriousness criterion medically significant). These events occurred 1 day after the patient received their 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: 2023274 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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 Date: 20210703; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Vomiting; This case was received via RA (Reference number: GB-MHRA-ADR 26408466) 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 VOMITING (Vomiting) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomiting) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No reported medical history. No treatment medication were reported Company comment: This regulatory authority case concerns a 38 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of vomiting. The event occurred on the same day after the third dose of mRNA-1273 vaccine. Outcome was reported as not resolved. The rechallenge was not applicable as there 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 regulatory authority case concerns a 38 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of vomiting. The event occurred on the same day after the third dose of mRNA-1273 vaccine. Outcome was reported as not resolved. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023279 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   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: SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Shortness of breath; Suspected COVID-19 (Unsure when symptoms stopped); Tiredness
Allergies:
Diagnostic Lab Data: Test Date: 20211103; 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: Vomiting aggravated; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26408937) 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 VOMITING (Vomiting aggravated) in a 53-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 Shortness of breath, Suspected COVID-19 (Unsure when symptoms stopped) on 30-Oct-2021 and Tiredness. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced VOMITING (Vomiting aggravated) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomiting aggravated) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-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. The patient had covid in 2020 and this feels similar to the symptoms had then. Since Covid suffer with some memory issues when tired and on times shortness of breath. No concomitant medications were reported. Treatment information was not provided Within 3 hours of receiving vaccine patient started vomiting had chills and fatigue. It continues throughout the night being sick now at the point of heaving but nothing left to come up and pain in the top of head. This is a regulatory case concerning a 53-year-old male patient with relevant medical history of suspected COVID-19, fatigue and dyspnoea, who experienced the serious per reported severity unexpected event of vomiting. The event occurred on the same day after the third dose of mRNA-1273 vaccine administration. The event was assessed as related to the product administration. 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 medical history of suspected COVID-19, fatigue and dyspnoea 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 53-year-old male patient with relevant medical history of suspected COVID-19, fatigue and dyspnoea, who experienced the serious per reported severity unexpected event of vomiting. The event occurred on the same day after the third dose of mRNA-1273 vaccine administration. The event was assessed as related to the product administration. 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 medical history of suspected COVID-19, fatigue and dyspnoea considered as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023281 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Insomnia, Myalgia, Renal pain, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Kidney pain; Insomnia; Vomiting; Muscle pain; This case was received (Reference number: GB-RA-ADR 26408887) 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 RENAL PAIN (Kidney pain), INSOMNIA (Insomnia), VOMITING (Vomiting) and MYALGIA (Muscle pain) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced RENAL PAIN (Kidney pain) (seriousness criterion medically significant), INSOMNIA (Insomnia) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). At the time of the report, RENAL PAIN (Kidney pain), INSOMNIA (Insomnia), VOMITING (Vomiting) and MYALGIA (Muscle pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. Patient had vomiting. Patient had not tested positive for COVID-19 post vaccination.Patient was not enrolled in clinical trial.It was reported that patient had no symptoms associated with COVID-19 and also patient had not tested for covid-19. This is a regulatory case concerning a 24-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of renal pain, insomnia, vomiting and myalgia. The events occurred on the same day after the third dose of mRNA-1273 vaccine administration. The events were assessed as related, per temporal association with 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 benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 24-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of renal pain, insomnia, vomiting and myalgia. The events occurred on the same day after the third dose of mRNA-1273 vaccine administration. The events were assessed as related, per temporal association with 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 benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023304 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003625 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, Injection site mass, Sleep disorder
SMQs:, Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad)

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

Write-up: burning sensation; interrupted sleep; Injection site lump; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26410427) 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 BURNING SENSATION (burning sensation), SLEEP DISORDER (interrupted sleep) and INJECTION SITE MASS (Injection site lump) in a 36-year-old female patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) (batch no. 3003625) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced INJECTION SITE MASS (Injection site lump) (seriousness criterion medically significant). On an unknown date, the patient experienced BURNING SENSATION (burning sensation) (seriousness criterion medically significant) and SLEEP DISORDER (interrupted sleep) (seriousness criterion medically significant). At the time of the report, BURNING SENSATION (burning sensation), SLEEP DISORDER (interrupted sleep) and INJECTION SITE MASS (Injection site lump) had not resolved. The action taken with mRNA-1273 (MODERNA COVID-19 Vaccine) (Unknown) was unknown. The lump appeared a few hours after receiving the vaccine. It felt like a large marble under the skin. The skin itself was red, with a hot burning sensation and the mark is approx 4.5cm across by 2cm down in size. Struggling to lift the arm. Really unpleasant side effect. Not taking any medication . Patient has not had symptoms associated with COVID-19 and Not had a COVID-19 test Patient was not currently breastfeeding Company Comment: This case concerns a 36-year-old female patient, with no medical history reported, who experienced the unexpected serious (medically significant) events of Burning sensation, Sleep disorder, Injection site mass. The events occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was not resolved. The rechallenge is unknown as per Regulatory Authority. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 36-year-old female patient, with no medical history reported, who experienced the unexpected serious (medically significant) events of Burning sensation, Sleep disorder, Injection site mass. The events occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was not resolved. The rechallenge is unknown as per Regulatory Authority. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2023305 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Feeling cold, Headache, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210125; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Result: Positive
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Headache; Feeling cold; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26410602) 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 FEELING COLD (Feeling cold) and HEADACHE (Headache) in a 75-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 stopped) on 21-Jan-2021. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 04-Oct-2021 to an unknown date for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced FEELING COLD (Feeling cold) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 29-Dec-2021, FEELING COLD (Feeling cold) had resolved and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Result: Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication information provided It was reported that the patient experienced cold and shivering followed by headache and lethargy. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial . Company comment: This Regulatory Authority case concerns a 75-year-old, male patient, with no relevant medical history, who experienced the unexpected, serious (Medically significant) events of feeling cold and headache. The patient developed Cold and shivering on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Followed by headache and lethargy the day after. 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 benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This Regulatory Authority case concerns a 75-year-old, male patient, with no relevant medical history, who experienced the unexpected, serious (Medically significant) events of feeling cold and headache. The patient developed Cold and shivering on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Followed by headache and lethargy the day after. 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 benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 2023309 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: 20211129; 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: Nausea; Vomited; Shivering; Headache; This case was received via RA (Reference number: GB-MHRA-ADR 26410577) 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), NAUSEA (Nausea), VOMITING (Vomited) and CHILLS (Shivering) 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 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), VOMITING (Vomited) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) had not resolved, NAUSEA (Nausea) and CHILLS (Shivering) was resolving and VOMITING (Vomited) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Nov-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Patient has not had symptoms associated with COVID-19 and has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Treatment information was not provided. Company comment: This case concerns a female patient of an unknown age with no medical history provided who experienced serious unexpected events of Headache, Chills, Vomiting and Nausea. The event Headache occurred on the same day after the third dose of mRNA-1273. The precise temporal relationship for the remaining events cannot be determined, having in mind that the exact start date of the reported events was not provided. At the time of the report, Headache was still ongoing, Chills and Nausea were resolving and Vomiting had resolved. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a female patient of an unknown age with no medical history provided who experienced serious unexpected events of Headache, Chills, Vomiting and Nausea. The event Headache occurred on the same day after the third dose of mRNA-1273. The precise temporal relationship for the remaining events cannot be determined, having in mind that the exact start date of the reported events was not provided. At the time of the report, Headache was still ongoing, Chills and Nausea were resolving and Vomiting had resolved. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2023310 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
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: Cluster headache, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201213; 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: Cluster headache; Nausea; This case was received via RA (Reference number: GB-MHRA-ADR 26410594) 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 CLUSTER HEADACHE (Cluster headache) and NAUSEA (Nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 12-Dec-2020. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced CLUSTER HEADACHE (Cluster headache) (seriousness criterion medically significant). On 29-Dec-2021, NAUSEA (Nausea) had resolved. At the time of the report, CLUSTER HEADACHE (Cluster headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Dec-2020, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was not breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. No concomitant medication was reported. No treatment information was provided. Company comment: This case concerns a 33-year-old, female patient with no relevant medical history, who experienced the unexpected events of nausea and cluster headache. The events occurred approximately 1 day after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 33-year-old, female patient with no relevant medical history, who experienced the unexpected events of nausea and cluster headache. The events occurred approximately 1 day after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2023311 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METHOTREXAT [METHOTREXATE]
Current Illness: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Diarrhea NOS; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26410654) 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 DIARRHOEA (Diarrhea NOS) in a 70-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022a) for an unknown indication. Concurrent medical conditions included Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...). Concomitant products included METHOTREXATE (METHOTREXAT [METHOTREXATE]) from 21-Dec-2021 to an unknown date for Rheumatoid arthritis. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced DIARRHOEA (Diarrhea NOS) (seriousness criterion medically significant). On 29-Dec-2021, DIARRHOEA (Diarrhea NOS) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient did not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient had diarrhoea for 24 hours. Patient had not tested positive for COVID-19 since he had received the vaccine Treatment information was not reported Company comment:This RA case concerns a male patient of 70-years-old with medical history of Rheumatoid arthritis, experienced the unexpected serious event Diarrhea (Medically significant) which occurred same day after the third dose of mRNA1273 vaccine. The outcome was reported resolving. The concomitant medication of Methotrexate remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority''s report due to important medical event.; Sender''s Comments: This RA case concerns a male patient of 70-years-old with medical history of Rheumatoid arthritis, experienced the unexpected serious event Diarrhea (Medically significant) which occurred same day after the third dose of mRNA1273 vaccine. The outcome was reported resolving. The concomitant medication of Methotrexate remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority''s report due to important medical event.


VAERS ID: 2023317 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Dry skin, Paraesthesia, Pyrexia, Somnolence
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Sleepy; Pins and needles; Fever chills; Hot dry skin; This case was received via RA (Reference number: GB-MHRA-ADR 26410785) 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 PARAESTHESIA (Pins and needles), PYREXIA (Fever chills), DRY SKIN (Hot dry skin) and SOMNOLENCE (Sleepy) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PARAESTHESIA (Pins and needles) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and DRY SKIN (Hot dry skin) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced SOMNOLENCE (Sleepy) (seriousness criterion medically significant). On 29-Dec-2021, PARAESTHESIA (Pins and needles) was resolving. At the time of the report, PYREXIA (Fever chills), DRY SKIN (Hot dry skin) and SOMNOLENCE (Sleepy) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial Company comment: This regulatory authority case concerns a 37-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of PARAESTHESIA, PYREXIA, DRY SKIN and SOMNOLENCE. All the events except for somnolence occurred on the same day after receiving a third dose of mRNA-1273. The event of somnolence occurred 2 days after vaccination. The event of paraesthesia was recovering at the time of the report, while other reported events had not recovered. No information about previous vaccination schedule was provided. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory authority case concerns a 37-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of PARAESTHESIA, PYREXIA, DRY SKIN and SOMNOLENCE. All the events except for somnolence occurred on the same day after receiving a third dose of mRNA-1273. The event of somnolence occurred 2 days after vaccination. The event of paraesthesia was recovering at the time of the report, while other reported events had not recovered. No information about previous vaccination schedule was provided. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2023326 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Dizziness, Headache, Hyperhidrosis, Muscular weakness, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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: unable to move arm; body aches; headache; fever; sweating; Dizziness; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26411111) 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 MUSCULAR WEAKNESS (unable to move arm), PAIN (body aches), HEADACHE (headache), PYREXIA (fever), HYPERHIDROSIS (sweating) and DIZZINESS (Dizziness) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULAR WEAKNESS (unable to move arm) (seriousness criterion medically significant), PAIN (body aches) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant) and HYPERHIDROSIS (sweating) (seriousness criterion medically significant). At the time of the report, MUSCULAR WEAKNESS (unable to move arm), PAIN (body aches), HEADACHE (headache), PYREXIA (fever) and HYPERHIDROSIS (sweating) outcome was unknown and DIZZINESS (Dizziness) 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. The patient experienced body aches, hot and cold (fever), sweating and headache. She was unable to move arm, red and swollen. She has not had symptoms associated with COVID-19 and has not tested positive for COVID-19 since having the vaccine. She was not enrolled in clinical trial. No concomitant medication details were provided. No treatment details were provided. Company Comment: This is a regulatory case concerning a 25-year-old female patient with no medical history, who experienced the unexpected serious events of Muscular weakness, Pain, Headache, Pyrexia, Hyperhidrosis and Dizziness. The event Dizziness occurred on the same day and Muscular weakness, Pain, Headache, Pyrexia and Hyperhidrosis on an unknown date after the third dose of mRNA-1273 vaccine. The outcome of the events Dizziness was reported as not resolved and Muscular weakness, Pain, Headache, Pyrexia and Hyperhidrosis as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report.; Sender''s Comments: This is a regulatory case concerning a 25-year-old female patient with no medical history, who experienced the unexpected serious events of Muscular weakness, Pain, Headache, Pyrexia, Hyperhidrosis and Dizziness. The event Dizziness occurred on the same day and Muscular weakness, Pain, Headache, Pyrexia and Hyperhidrosis on an unknown date after the third dose of mRNA-1273 vaccine. The outcome of the events Dizziness was reported as not resolved and Muscular weakness, Pain, Headache, Pyrexia and Hyperhidrosis as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report.


VAERS ID: 2023331 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Influenza like illness, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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 stopped.)
Allergies:
Diagnostic Lab Data: Test Date: 20211202; 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: Fever; Chills; Vomiting; Flu-like aching; Headache; This case was received via Regulatory Authority) 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 PYREXIA (Fever), CHILLS (Chills), VOMITING (Vomiting), INFLUENZA LIKE ILLNESS (Flu-like aching) and HEADACHE (Headache) in a female patient of an unknown age 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 stopped) on 26-Nov-2021. On 28-Dec-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 29-Dec-2021, PYREXIA (Fever), CHILLS (Chills), VOMITING (Vomiting) and INFLUENZA LIKE ILLNESS (Flu-like aching) had resolved. At the time of the report, HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, SARS-CoV-2 test: yes (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.Patient was not tested positive for COVID-19 since had the vaccine.Patient was not enrolled in clinical trial. This report is not related to possible inflammation of the heart (myocarditis or pericarditis)"Company Comment: This is a regulatory case concerning a female patient of unknown age with a medical history of recent Suspected COVID-19 (one month before vaccination), who experienced the unexpected serious events of pyrexia, chills, vomiting, influenza like illness and headache. The events occurred approximately 1 day after the second dose of mRNA-1273 vaccine. The medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition. Sender''s Comments: This is a regulatory case concerning a female patient of unknown age with a medical history of recent Suspected COVID-19 (one month before vaccination), who experienced the unexpected serious events of pyrexia, chills, vomiting, influenza like illness and headache. The events occurred approximately 1 day after the second dose of mRNA-1273 vaccine. The medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.


VAERS ID: 2023349 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Chills, Cold sweat, Dizziness, Dyspepsia, Fatigue, Nausea, Pain in extremity, SARS-CoV-2 test, Sensitive skin
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; CLARITHROMYCIN; PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE; COVONIA BRONCHIAL; IBUPROFEN LYSINE; RIGEVIDON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201230; 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: Nausea; Dizziness; Hypersensitive skin; Heartburn; Pain in arm; Fatigue; Chills; Cold sweat; This case was received via the RA (Reference number: GB-MHRA-ADR 26412796) 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 CHILLS (Chills), COLD SWEAT (Cold sweat), NAUSEA (Nausea), DIZZINESS (Dizziness), FATIGUE (Fatigue), SENSITIVE SKIN (Hypersensitive skin), PAIN IN EXTREMITY (Pain in arm) and DYSPEPSIA (Heartburn) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 28-Dec-2020 to 14-Jan-2021. Concomitant products included CLARITHROMYCIN from 11-Dec-2021 to 18-Dec-2021 and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, MENTHOL (COVONIA BRONCHIAL) for Chest infection, ETHINYLESTRADIOL, LEVONORGESTREL (RIGEVIDON) for Contraception, IBUPROFEN LYSINATE (IBUPROFEN LYSINE) for Migraine, CITALOPRAM for Mixed anxiety and depressive disorder, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 20-May-2021 to 24-Jun-2021 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant), COLD SWEAT (Cold sweat) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), SENSITIVE SKIN (Hypersensitive skin) (seriousness criterion medically significant) and DYSPEPSIA (Heartburn) (seriousness criterion medically significant). On 29-Dec-2021, DIZZINESS (Dizziness) had resolved. At the time of the report, CHILLS (Chills), COLD SWEAT (Cold sweat), NAUSEA (Nausea) and DYSPEPSIA (Heartburn) was resolving and FATIGUE (Fatigue), SENSITIVE SKIN (Hypersensitive skin) and PAIN IN EXTREMITY (Pain in arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding, Patient''s last menstrual period date was on 24-Dec-2021 Treatment information was not provided. Patient had Chills, Cold sweat, Nausea, Dizziness, Fatigue, Hypersensitive skin, Pain in arm, Heartburn. 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 27-year-old, female patient with a history of Suspected COVID-19, Mixed anxiety and depressive disorder, Lower respiratory tract infection and Migraine, who experienced the serious unexpected, according CCDS, events of Fatigue, Sensitive skin, Pain in extremity, Chills, Cold sweat, Nausea, Dyspepsia, Dizziness. The events chills, cold sweat, fatigue and pain in extremity, occurred approximately the same day after the third dose of mRNA-1273 vaccine. The events nausea, dizziness, Sensitive skin, and Dyspepsia, occurred approximately one day after the third dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. The medical history of Suspected COVID-19 (COVID-19 virus test positive on 30-dec) , Mixed anxiety and depressive disorder, Lower respiratory tract infection and Migraine, and the use of concomitant medication covonia brochial, Rigevidon and cytalopram, remain as confounders. No treatment was provided for reported events. The case was assessed as serious as per Regulatory Authority?s report due important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 27-year-old, female patient with a history of Suspected COVID-19, Mixed anxiety and depressive disorder, Lower respiratory tract infection and Migraine, who experienced the serious unexpected, according CCDS, events of Fatigue, Sensitive skin, Pain in extremity, Chills, Cold sweat, Nausea, Dyspepsia, Dizziness. The events chills, cold sweat, fatigue and pain in extremity, occurred approximately the same day after the third dose of mRNA-1273 vaccine. The events nausea, dizziness, Sensitive skin, and Dyspepsia, occurred approximately one day after the third dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. The medical history of Suspected COVID-19 (COVID-19 virus test positive on 30-dec) , Mixed anxiety and depressive disorder, Lower respiratory tract infection and Migraine, and the use of concomitant medication covonia brochial, Rigevidon and cytalopram, remain as confounders. No treatment was provided for reported events. The case was assessed as serious as per Regulatory Authority?s report due important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023350 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   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: Asthenia, Chest pain, Chills, Headache, Pain in extremity, Palpitations, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE MODERNA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Heart racing; Chest pain; Leg pain; Fever; Chills; Headache; Weakness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26412784) 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 PALPITATIONS (Heart racing), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Leg pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and ASTHENIA (Weakness) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. Concomitant products included ELASOMERAN (COVID-19 VACCINE MODERNA) from 03-May-2021 to an unknown date for COVID-19 vaccination. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PALPITATIONS (Heart racing) (seriousness criteria disability and medically significant), CHEST PAIN (Chest pain) (seriousness criteria disability and medically significant), PAIN IN EXTREMITY (Leg pain) (seriousness criteria disability and medically significant), PYREXIA (Fever) (seriousness criteria disability and medically significant), CHILLS (Chills) (seriousness criteria disability and medically significant), HEADACHE (Headache) (seriousness criteria disability and medically significant) and ASTHENIA (Weakness) (seriousness criteria disability and medically significant). At the time of the report, PALPITATIONS (Heart racing) had resolved with sequelae, CHEST PAIN (Chest pain) had resolved and PAIN IN EXTREMITY (Leg pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and ASTHENIA (Weakness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was not tested positive for COVID-19 since had the vaccine Patient was not enrolled in clinical trial LMP of patient was 14-DEC-2021. Adverse reaction was not occurred as a result of an exposure during pregnancy Company comment: This is a regulatory case concerning a 41-year-old female patient with no medical history reported who experienced the unexpected and serious events of palpitations, chest pain, pyrexia, chills, headache, asthenia and pain in extremity. The events occurred the same day after a third dose of mRNA-1273 vaccine was administered. 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 41-year-old female patient with no medical history reported who experienced the unexpected and serious events of palpitations, chest pain, pyrexia, chills, headache, asthenia and pain in extremity. The events occurred the same day after a third dose of mRNA-1273 vaccine was administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023351 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
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: Nausea, SARS-CoV-2 test, Vertigo
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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 ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Vertigo; Nausea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26412788) 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 VERTIGO (Vertigo) and NAUSEA (Nausea) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced VERTIGO (Vertigo) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, VERTIGO (Vertigo) and NAUSEA (Nausea) 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. Concomitant medications were not provided. Treatment information was not provided. Patient did not had symptoms associated with COVID-19 Patient was not pregnant and patient was not currently breastfeeding. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.; Sender''s Comments: This case concerns a 39-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Vertigo and Nausea. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2023362 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   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, Diarrhoea, Insomnia, Myalgia, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2
Current Illness:
Preexisting Conditions:
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.MOD20214

Write-up: Chills; Diarrhea; Muscle pain; Insomnia; Painful arm; This case was received (Reference number: GB-RA-ADR 26412985) 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 MYALGIA (Muscle pain), CHILLS (Chills), DIARRHOEA (Diarrhea), INSOMNIA (Insomnia) and PAIN IN EXTREMITY (Painful arm) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 21-May-2021 to an unknown date for Vaccination. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced INSOMNIA (Insomnia) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant) and DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle pain), CHILLS (Chills) and INSOMNIA (Insomnia) had not resolved and DIARRHOEA (Diarrhea) and PAIN IN EXTREMITY (Painful arm) 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. No medical history was provided by the reporter No treatment medication details were provided. Patient last menstrual period date was 23-DEC-2021. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. It was reported that symptoms started with pain at injection site which is to be expected but over the 36 hours have progressed got worse, She is in agony across both arms neck back chest and legs she has a struggle to walk, also have chills and difficulty sleeping for two nights due to discomfort. Patient also had a couple of brief episodes on diorrrea on day 1. 24 hours after the jab which may be unrelated but seems strange. Patient feel like she have a nasty bout of flu or cold but she is not covid positive as tested. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 39-year-old female patient, with no medical history reported, who experienced the unexpected and serious events of Myalgia, Chills, Diarrhoea, Insomnia, and Pain in extremity. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred the first two days after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. Previous dose of COVID-19 vaccine given with Tozinameran (Interchange of vaccine products). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 39-year-old female patient, with no medical history reported, who experienced the unexpected and serious events of Myalgia, Chills, Diarrhoea, Insomnia, and Pain in extremity. The events are assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The events occurred the first two days after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. Previous dose of COVID-19 vaccine given with Tozinameran (Interchange of vaccine products). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023363 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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, Dehydration, Maternal exposure during pregnancy, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: FOLIC ACID
Current Illness: Pneumonia (Recently and still recovering from Pneumonia); Pregnancy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211130; 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: fever; chills; dehydration; Maternal exposure during pregnancy; Vomiting; This case was received via Regulatory authority. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), DEHYDRATION (dehydration), VOMITING (Vomiting) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Pneumonia (Recently and still recovering from Pneumonia) and Pregnancy. Concomitant products included FOLIC ACID for Folic acid supplementation. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. The patient''s last menstrual period was on an unknown date. On 28-Dec-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant), DEHYDRATION (dehydration) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). On 30-Dec-2021, VOMITING (Vomiting) was resolving. At the time of the report, PYREXIA (fever), CHILLS (chills) and DEHYDRATION (dehydration) was resolving and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided Patient was exposed to the medicine Third-trimester (29-40 weeks). Company Comment: This case concerns a 43-year-old female patient with concurrent medical conditions of Pneumonia (Recently and still recovering) who experienced the serious unexpected events of Pyrexia, Chills, Dehydration and Vomiting. Maternal exposure during pregnancy was also coded for this case, It was reported that the patient was exposed to the medicine on the Third-trimester (29-40 weeks). The events of Vomiting and dehydration occurred on the same day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273), Pyrexia and chills onset dates were not reported. Events seriousness assessed as per Regulatory Authority report and retained for consistency. Concurrent medical condition of Pneumonia could remain as a confounder for pyrexia, chills and dehydration. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender''s Comments: This case concerns a 43-year-old female patient with concurrent medical conditions of Pneumonia (Recently and still recovering) who experienced the serious unexpected events of Pyrexia, Chills, Dehydration and Vomiting. Maternal exposure during pregnancy was also coded for this case, It was reported that the patient was exposed to the medicine on the Third-trimester (29-40 weeks). The events of Vomiting and dehydration occurred on the same day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273), Pyrexia and chills onset dates were not reported. Events seriousness assessed as per Regulatory Authority report and retained for consistency. Concurrent medical condition of Pneumonia could remain as a confounder for pyrexia, chills and dehydration. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 2023374 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Headache, Lymphadenopathy, Myalgia, Nausea, Oral herpes, Pain in extremity, Paraesthesia oral, Rhinorrhoea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA; EVENING PRIMROSE OIL [OENOTHERA BIENNIS]; VITAMIN D NOS
Current Illness: Myalgic encephalomyelitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Swollen glands; Cold sores lip; Tingling lips; Headache; Runny nose; Muscle ache; Nauseous; Painful arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26414167) 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 HEADACHE (Headache), RHINORRHOEA (Runny nose), LYMPHADENOPATHY (Swollen glands), MYALGIA (Muscle ache), NAUSEA (Nauseous), PAIN IN EXTREMITY (Painful arm), ORAL HERPES (Cold sores lip) and PARAESTHESIA ORAL (Tingling lips) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Myalgic encephalomyelitis. Concomitant products included OENOTHERA BIENNIS (EVENING PRIMROSE OIL [OENOTHERA BIENNIS]) from 1995 to an unknown date for Pre-menstrual tension syndrome, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 30-Mar-2021 to an unknown date, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) and VITAMIN D NOS from 2018 to an unknown date for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), RHINORRHOEA (Runny nose) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), NAUSEA (Nauseous) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and PARAESTHESIA ORAL (Tingling lips) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant) and ORAL HERPES (Cold sores lip) (seriousness criterion medically significant). On 28-Dec-2021, PARAESTHESIA ORAL (Tingling lips) had resolved. On 29-Dec-2021, NAUSEA (Nauseous) had resolved. On 30-Dec-2021, HEADACHE (Headache), RHINORRHOEA (Runny nose), LYMPHADENOPATHY (Swollen glands) and MYALGIA (Muscle ache) had resolved. At the time of the report, PAIN IN EXTREMITY (Painful arm) was resolving and ORAL HERPES (Cold sores lip) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Unsure if patient had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Tingling in lips within 10 mins of injection, resolved within 30 mins. Other side effects began within 2 hours of getting vaccine. No Treatment medication was provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 43-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of paraesthesia oral and oral herpes. The events started 10 minutes after the booster dose of mRNA-1273. The event oral paraesthesia resolved spontaneously 30 minutes after vaccine administration. The rest of the events developed 2 hours after vaccine administration. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 43-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of paraesthesia oral and oral herpes. The events started 10 minutes after the booster dose of mRNA-1273. The event oral paraesthesia resolved spontaneously 30 minutes after vaccine administration. The rest of the events developed 2 hours after vaccine administration. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2023388 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000059A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life 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:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fatigue; High temperature; Inappetence; Headache; Muscle ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26414752) 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 HEADACHE (Headache), MYALGIA (Muscle ache), FATIGUE (Fatigue), PYREXIA (High temperature) and DECREASED APPETITE (Inappetence) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000059A) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 10-Mar-2021 to 11-Jun-2021 for COVID-19 vaccination. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and DECREASED APPETITE (Inappetence) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), MYALGIA (Muscle ache), FATIGUE (Fatigue) and PYREXIA (High temperature) had not resolved and DECREASED APPETITE (Inappetence) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical history was provided by the reporter. About 5 minutes post vaccination, patient started to get a headache right on top of her head that migrated to the front. Her whole body started aching that evening with her legs suffering the most. The next day it was the same but she also had a high temperature and was sweating all day and night. Took paracetamol regularly but it didn''t help much with the aches. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant, Patient is not currently breastfeeding COMPANY COMMENT: This is a regulatory case concerning a 27-year-old female patient with no clinical history who experienced the unexpected events of HEADACHE, MYALGIA, FATIGUE, PYREXIA and DECREASED APPETITE The events occurred 1 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority; Sender''s Comments: COMPANY COMMENT: This is a regulatory case concerning a 27-year-old female patient with no clinical history who experienced the unexpected events of HEADACHE, MYALGIA, FATIGUE, PYREXIA and DECREASED APPETITE The events occurred 1 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority


VAERS ID: 2023391 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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, Hyperhidrosis, Influenza like illness, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Shivering; Sweating; Flu-like aching; Shooting pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26415034) 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 CHILLS (Shivering), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like aching) and PAIN (Shooting pain) in a 43-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant) and PAIN (Shooting pain) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant). On 29-Dec-2021, HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Flu-like aching) and PAIN (Shooting pain) had resolved. On 30-Dec-2021, CHILLS (Shivering) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Taking co-codamol eased the aching but would return once they wore off. Company comment: This is a regulatory case concerning a 43 year-old, male patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according RA, events of chills, Hyperhidrosis, Influenza like illness and pain. Events were assessed as serious by the Regulatory Authority. The events occurred the same day to 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the events was reported as recovered. The patient received treatment with codeine phosphate and paracetamol. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 43 year-old, male patient with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according RA, events of chills, Hyperhidrosis, Influenza like illness and pain. Events were assessed as serious by the Regulatory Authority. The events occurred the same day to 1 day after the booster dose of mRNA-1273 vaccine. The outcome of the events was reported as recovered. The patient received treatment with codeine phosphate and paracetamol. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023398 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Body temperature, Chills, Decreased appetite, Diarrhoea, Fatigue, Illness, SARS-CoV-2 test
SMQs:, 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: ACALABRUTINIB; ALLOPURINOL; CO-TRIMOXAZOLE; LISINOPRIL
Current Illness: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy).)
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: Diarrhea; Body temperature; Shivers; Appetite lost; Tiredness; Sickness; This case was received (Reference number: GB-RA-ADR 26415539) 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 ILLNESS (Sickness), DIARRHOEA (Diarrhea), BODY TEMPERATURE (Body temperature), CHILLS (Shivers), DECREASED APPETITE (Appetite lost) and FATIGUE (Tiredness) in a 72-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040a) for an unknown indication. The patient''s past medical history included Clinical trial participant and Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy).). Concurrent medical conditions included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). Concomitant products included LISINOPRIL from 06-Oct-2008 to an unknown date for Blood pressure, ACALABRUTINIB from 17-Jun-2021 to an unknown date, ALLOPURINOL from 17-Jun-2021 to an unknown date and SULFAMETHOXAZOLE, TRIMETHOPRIM (CO-TRIMOXAZOLE) from 17-Jun-2021 to an unknown date for Cancer. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant), BODY TEMPERATURE (Body temperature) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). At the time of the report, ILLNESS (Sickness), DIARRHOEA (Diarrhea), BODY TEMPERATURE (Body temperature), CHILLS (Shivers), DECREASED APPETITE (Appetite lost) and FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient started shivering on the evening and had a temperature went to bed because patient was feeling tired, stayed in bed for 2 days during which time patient was sick and had diarrhoea Patient was Clinical trial participant. Patient had not had symptoms associated with COVID-19.Patient had not tested positive for COVID-19 since having the vaccine. Re-challenge was reported as unknown. Company Comment: This case concerns a 72-year-old male, who is a Clinical trial participant, with relevant reported medical history of Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response), Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)), who experienced the serious unexpected events of Illnes, Diarrhoea, Body temperature, Chills, Decreased appetite and Fatigue. The events occurred approximately one day after the administration of the 3rd dose of mRNA-1273 vaccine and at the time of the report, the outcome for the event was Recovering/Resolving. The rechallenge could be considered not applicable since the events occurred after the 3rd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 72-year-old male, who is a Clinical trial participant, with relevant reported medical history of Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response), Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)), who experienced the serious unexpected events of Illnes, Diarrhoea, Body temperature, Chills, Decreased appetite and Fatigue. The events occurred approximately one day after the administration of the 3rd dose of mRNA-1273 vaccine and at the time of the report, the outcome for the event was Recovering/Resolving. The rechallenge could be considered not applicable since the events occurred after the 3rd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023418 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fever; Headache; This case was received (Reference number: GB-RA-ADR 26416710) 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 PYREXIA (Fever) and HEADACHE (Headache) in a 28-year-old female 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 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) had not 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. Concomitant drug details not provided. Date of LMP: 23-DEC-2021. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial.Patient is not pregnant, Patient is not currently breastfeeding. Does your report relate to possible inflammation of the heart (myocarditis or pericarditis) If yes, we will ask you some additional questions at the end of this report: No. Treatment details not provided. Company comment This is a regulatory case concerning a 28-year-old female with medical history of suspected COVID-19 (unsure when symptoms started and stopped), who experienced the serious unexpected, according CCDS, events of headache and pyrexia. The events occurred on the same day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown according to SD. The medical history of suspected COVID-19 remains a confounder. 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 28-year-old female with medical history of suspected COVID-19 (unsure when symptoms started and stopped), who experienced the serious unexpected, according CCDS, events of headache and pyrexia. The events occurred on the same day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown according to SD. The medical history of suspected COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2023422 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
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: Hypoaesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
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: Numbness in leg; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26416886) 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 HYPOAESTHESIA (Numbness in leg) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HYPOAESTHESIA (Numbness in leg) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (Numbness in leg) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications was not reported. Company Comment: This case concerns a 38-year-old female, with no relevant reported medical history in this case, who experienced the serious unexpected event of Hypoaesthesia. The event Hypoaesthesia occurred one day after the administration of the 3rd dose of mRNA-1273 vaccine and at the time of the report, the outcome for the event was Not Recovered/Not Resolved. The rechallenge could be considered not applicable since the events occurred after the 23rd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 38-year-old female, with no relevant reported medical history in this case, who experienced the serious unexpected event of Hypoaesthesia. The event Hypoaesthesia occurred one day after the administration of the 3rd dose of mRNA-1273 vaccine and at the time of the report, the outcome for the event was Not Recovered/Not Resolved. The rechallenge could be considered not applicable since the events occurred after the 23rd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023423 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-01
Onset:2021-12-28
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Presyncope, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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:
Current Illness:
Preexisting Conditions:
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.MOD20214

Write-up: dizzy; Near fainting; This case was received via regulatory authority 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 DIZZINESS (dizzy) and PRESYNCOPE (Near fainting) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. No Medical History information was reported. In December 2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PRESYNCOPE (Near fainting) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (dizzy) (seriousness criterion medically significant). At the time of the report, DIZZINESS (dizzy) was resolving and PRESYNCOPE (Near fainting) 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. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient last menstrual period date included 23-DEC-2021. It was stated that in the morning as the patient got up and went downstairs for a drink, felt dizzy, then went upstairs to lay down, was unable to walk straight and see straight to the point patient just reached bed before fainting. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had no symptoms associated with COVID-19 , patient was not currently breastfeeding. Treatment information was not provided. Company comment: This regulatory authority case concerns an 18-year-old female patient, with no reported medical history who experienced the serious (medically significant) unexpected events of DIZZINESS and PRESYNCOPE. Time of latency cannot be assessed since exact vaccination date is not reported; however, the event of presyncope occurred on the same month that a third dose of mRNA-1273 was administered. For the event of dizziness, no onset date was provided. No information about previous vaccination schedule was provided. Source document narrative states that patient actually fainted; however, event terms are captured as provided. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory authority case concerns an 18-year-old female patient, with no reported medical history who experienced the serious (medically significant) unexpected events of DIZZINESS and PRESYNCOPE. Time of latency cannot be assessed since exact vaccination date is not reported; however, the event of presyncope occurred on the same month that a third dose of mRNA-1273 was administered. For the event of dizziness, no onset date was provided. No information about previous vaccination schedule was provided. Source document narrative states that patient actually fainted; however, event terms are captured as provided. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2023425 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Abdominal pain, Arthralgia, Chills, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; 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: Shivering; Chills; Aching joints; Fever; Headache; Abdominal pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26416955) 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 CHILLS (Shivering), CHILLS (Chills), ARTHRALGIA (Aching joints), PYREXIA (Fever), HEADACHE (Headache) and ABDOMINAL PAIN (Abdominal pain) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Suspected COVID-19 since 28-Nov-2021. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, CHILLS (Shivering) and CHILLS (Chills) was resolving and ARTHRALGIA (Aching joints), PYREXIA (Fever), HEADACHE (Headache) and ABDOMINAL PAIN (Abdominal pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-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 medications were not reported . Patient had received the vaccine at approximately 11am on the 28th of December. Patient mentioned that the arm on which vaccine was administered was very sore and the injection site is slightly swollen. Patient had 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 concerns a 32-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of CHILLS (reported as chills and shivering), ARTRHALGIA, PYREXIA, HEADACHE and ABDOMINAL PAIN. All events, but chills, occurred on the same day after receiving a third dose of mRNA-1273. No onset date was provided for chills. No information about previous vaccination schedule was provided. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This case concerns a 32-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of CHILLS (reported as chills and shivering), ARTRHALGIA, PYREXIA, HEADACHE and ABDOMINAL PAIN. All events, but chills, occurred on the same day after receiving a third dose of mRNA-1273. No onset date was provided for chills. No information about previous vaccination schedule was provided. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2023427 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Arthralgia, Fatigue, Headache, Musculoskeletal stiffness, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), 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: COVID-19 MRNA VACCINE BNT162B2
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: Neck stiff; Joint pain; Fever; Headache; Fatigue; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26416983) 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 PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), MUSCULOSKELETAL STIFFNESS (Neck stiff) and ARTHRALGIA (Joint pain) in a 26-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 24-Jun-2021 to an unknown date for Vaccination. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck stiff) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) and ARTHRALGIA (Joint pain) was resolving and HEADACHE (Headache), FATIGUE (Fatigue) and MUSCULOSKELETAL STIFFNESS (Neck stiff) 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 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was verbally reported that, Constant headache all hours of the day, stiff joints especially neck, feeling fatigued and unable to do much except lie down or keep head still. Patient is not enrolled in clinical trial The reporter responded to, Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No" No Treatment information were reported. Company Comment: This case concerns a 26-year-old male patient, with no medical history reported, who experienced the unexpected and serious events of Musculoskeletal stiffness, Headache, Fatigue, Pyrexia, and Arthralgia. 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 day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown. Previous dose of COVID-19 vaccine given with Tozinameran (Interchange of vaccine products). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 26-year-old male patient, with no medical history reported, who experienced the unexpected and serious events of Musculoskeletal stiffness, Headache, Fatigue, Pyrexia, and Arthralgia. 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 day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown. Previous dose of COVID-19 vaccine given with Tozinameran (Interchange of vaccine products). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023432 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   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: Headache, Hyperhidrosis, Nausea, SARS-CoV-2 test, Tinnitus
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (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: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
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.MOD20214

Write-up: Sweating; Nausea; Ear ringing; Headache; This case was received via Regulatory Authority, MHRA (Reference number: GB-MHRA-ADR 26417367) 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 HEADACHE (Headache), HYPERHIDROSIS (Sweating), NAUSEA (Nausea) and TINNITUS (Ear ringing) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 21-May-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and TINNITUS (Ear ringing) (seriousness criterion medically significant). On 29-Dec-2021, NAUSEA (Nausea) and TINNITUS (Ear ringing) had resolved. On 30-Dec-2021, HYPERHIDROSIS (Sweating) had resolved. At the time of the report, HEADACHE (Headache) 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 Medical History information was reported. Patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was vaccinated on 28-Dec-2021, 16:30 in the afternoon and in the evening headache and some body ache were began. He slept as usual but woke up with very sweaty. The next day on 29-Dec-2021, He got up and felt, need to back to bed due to pounding headache and nausea, including ringing in ears. He had paracetamol in the form of a Lemsip drink. Nausea and ear ringing stopped. Headache persisted. Second day on 30-Dec-2021, sweated again but managed to get up. Headache was still present but more tolerable.; Sender''s Comments: COMPANY COMMENT: This is a regulatory case concerning a 38-year-old male patient with no clinical history who experienced the unexpected events of HEADACHE, HYPERHIDROSIS, NAUSEA and TINNITUS The events occurred 2 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority


VAERS ID: 2023441 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
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, Pruritus, Rash, SARS-CoV-2 test, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), 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: CITALOPRAM; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
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.MOD20214

Write-up: itchy; shaking; rash all over; Rash; Headache; Chills; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26417998) 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 PRURITUS (itchy), TREMOR (shaking), RASH (rash all over), RASH (Rash), HEADACHE (Headache) and CHILLS (Chills) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included CITALOPRAM for Anxiety, INFLUENZA VACCINE (INFLUENZA VIRUS) from 02-Oct-2021 to an unknown date for an unknown indication. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (itchy) (seriousness criterion medically significant), TREMOR (shaking) (seriousness criterion medically significant) and RASH (rash all over) (seriousness criterion medically significant). On 29-Dec-2021, CHILLS (Chills) had resolved. At the time of the report, PRURITUS (itchy), TREMOR (shaking), RASH (rash all over) and RASH (Rash) was resolving and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-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. Patient''s last menstrual period date was ??-DEC-2021. Patient had a headache from the morning of 28.12.21, manageable with ibuprofen and paracetamol. During the night of 28.12.21 she woke up with really bad chills, shaking from head to toe and couldn''t get warm. Even the weight of the duvet was painful on her arm. When she went in the shower on the morning of 29.12.21 she noticed a rash all over her torso (front and back). This is fading but is still a bit itchy. Company comment: This case concerns a 46-year-old female patient with relevant medical history of Anxiety who experienced serious unexpected events of Headache, Rash, reported as rash and rash all over, Chills, Pruritus and Tremor. As per Case narrative of the SD, all the events occurred one or two days after the vaccination with the third dose of mRNA-1273. It was reported that the patient experienced a rash all over her torso. Furthermore, it was reported that the patient was treated with paracetamol and ibuprofen for the event of Headache, however, at the time of the report, the event Headache was still ongoing whereas the events Pruritus, Tremor and Rash were resolving while Chills had resolved. No further information regrading clinical course of the events was provided. It was also reported that even the weight of the duvet was painful for the patient''s arm. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. Causality is confounded with patient''s reported medical history. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 46-year-old female patient with relevant medical history of Anxiety who experienced serious unexpected events of Headache, Rash, reported as rash and rash all over, Chills, Pruritus and Tremor. As per Case narrative of the SD, all the events occurred one or two days after the vaccination with the third dose of mRNA-1273. It was reported that the patient experienced a rash all over her torso. Furthermore, it was reported that the patient was treated with paracetamol and ibuprofen for the event of Headache, however, at the time of the report, the event Headache was still ongoing whereas the events Pruritus, Tremor and Rash were resolving while Chills had resolved. No further information regrading clinical course of the events was provided. It was also reported that even the weight of the duvet was painful for the patient''s arm. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. Causality is confounded with patient''s reported medical history. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2023443 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy, SARS-CoV-2 test
SMQs:, 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: Palsy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; 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: Palsy Bells; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26418088) 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 BELL''S PALSY (Palsy Bells) in a 23-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concurrent medical conditions included Palsy. On 21-Dec-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced BELL''S PALSY (Palsy Bells) (seriousness criterion medically significant). At the time of the report, BELL''S PALSY (Palsy Bells) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-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. Patient was diagnosed with Bells palsy just over a week after having booster vaccine, Patient was on steroids for this. Patient had not tested positive for COVID-19 since having the vaccine, Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19, Patient was not currently breastfeeding Company comment: This is a regulatory authority case concerning a 23-year-old, female patient with relevant medical history of palsy, who experienced the expected, serious, AESI event of Bell''s palsy. The event Bell''s Palsy occurred just over a week after the booster dose of mRNA-1273 vaccine administration and was treated with steroids. The outcome of the event was resolving from the time of last observation. The medical history of palsy remain confounder. 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 23-year-old, female patient with relevant medical history of palsy, who experienced the expected, serious, AESI event of Bell''s palsy. The event Bell''s Palsy occurred just over a week after the booster dose of mRNA-1273 vaccine administration and was treated with steroids. The outcome of the event was resolving from the time of last observation. The medical history of palsy remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023463 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), COVID-19 (broad)

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

Write-up: Pain in arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26418558) 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 PAIN IN EXTREMITY (Pain in arm) in a 26-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Pain in arm) was resolving. 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. Concomitant medications were not provided. Patient had a pain in his armpit after the booster, could only explain it as having dried glue on skin and it hurt when patient lifts his arm. Otherwise didn''t really notice it. Patient has not had symptoms associated with COVID-19 and was not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial Patient did not had possible inflammation of the heart like myocarditis or pericarditis Treatment information was not provided. Company comment: This case concerns a 26-year-old male patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of pain in extremity. The event occurred the same day after the booster dose of mRNA-1273. Patient describes having vaccination site pain when lifting his arm, but otherwise not noticing it. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 26-year-old male patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of pain in extremity. The event occurred the same day after the booster dose of mRNA-1273. Patient describes having vaccination site pain when lifting his arm, but otherwise not noticing it. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2023464 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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, Fatigue
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped); Unwell (still felt unwell on day of vaccine); UTI (Recent UTI, taking antibiotics until the day before vaccine.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Chills; Fatigue; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26418565) 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 CHILLS (Chills) and FATIGUE (Fatigue) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Unwell (still felt unwell on day of vaccine), UTI (Recent UTI, taking antibiotics until the day before vaccine.) and Suspected COVID-19 (Unsure when symptoms stopped) on 01-Feb-2020. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 29-Dec-2021, CHILLS (Chills) had resolved. On 30-Dec-2021, FATIGUE (Fatigue) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. LMP date was reported as 17-DEC-2021. Patient had Chills and body aches all over the night, about 14 hours after jab. Could not sleep.Intense fatigue started about two hours, and lasted for two and a half days. Tired standing up in the shower, or walking a few metres. Mentally tired as well. 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 is a regulatory case concerning a 33 year-old, female patient with a history of suspected COVID-19 and antibiotic treatment until the day before vaccination, who experienced the serious (due to medically important condition) unexpected, according CCDS, events of chills and fatigue. Events were assessed as serious by the Regulatory Authority. The events occurred the same day after the booster dose of mRNA-1273 vaccine. The outcome of the events was reported as recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The medical history, of suspected COVID-19 and antibiotic treatment until the day before vaccination remain 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 33 year-old, female patient with a history of suspected COVID-19 and antibiotic treatment until the day before vaccination, who experienced the serious (due to medically important condition) unexpected, according CCDS, events of chills and fatigue. Events were assessed as serious by the Regulatory Authority. The events occurred the same day after the booster dose of mRNA-1273 vaccine. The outcome of the events was reported as recovered. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The medical history, of suspected COVID-19 and antibiotic treatment until the day before vaccination remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023470 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-16
Onset:2021-12-28
   Days after vaccination:12
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: 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Heavy periods; This case was received (Reference number: GB-RA-ADR 26418720) 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 HEAVY MENSTRUAL BLEEDING (Heavy periods) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) 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 28-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 an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had really heavy periods; gone through three times as many pads as usual, and have no energy. Patient was not tested positive for COVID-19 s.ince having the vaccine. Relevant concomitant medications were not reported. Company Comment This case concerns a 24-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of heavy menstrual bleeding. The event occurred 12 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 event meets the criteria to be medically significant. Treatment information was not provided.; Sender''s Comments: This case concerns a 24-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of heavy menstrual bleeding. The event occurred 12 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 event meets the criteria to be medically significant.


VAERS ID: 2023493 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200015761

Write-up: COVID-19 test positive/SARS-CoV-2 infection; COVID-19 test positive/SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201040909004310-VVT6J (RA). Other Case identifier(s): GB-MHRA-ADR 26431962 (RA). A 28 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine), administration date 22Aug2021 (Lot number: FE3380) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Nothing to report. Patient was healthy. Patient did not have symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "COVID-19 test positive/SARS-CoV-2 infection". In Dec2021, she caught covid for the second time. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) yes - positive covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2023989 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
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: Dizziness, Fatigue, Headache, Injection site joint erythema, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Muscle ache; Nauseous; Dizziness; Injection site joint redness; Headache; Tiredness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26411799) 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 INJECTION SITE JOINT ERYTHEMA (Injection site joint redness), MYALGIA (Muscle ache), FATIGUE (Tiredness), NAUSEA (Nauseous), HEADACHE (Headache) and DIZZINESS (Dizziness) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced INJECTION SITE JOINT ERYTHEMA (Injection site joint redness) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant), NAUSEA (Nauseous) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 29-Dec-2021, FATIGUE (Tiredness) had resolved. At the time of the report, INJECTION SITE JOINT ERYTHEMA (Injection site joint redness) had not resolved and MYALGIA (Muscle ache), NAUSEA (Nauseous), HEADACHE (Headache) and DIZZINESS (Dizziness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has been taking regular anti depressants . Patient has not had symptoms associated with COVID-19 and Not had a COVID-19 test. Patient experienced sore arm with large red mark around injection site, tiredness but trouble sleeping, feeling dizzy and sick and aching muscles The treatment information was unknown Company comment: This regulatory case concerns a female patient of an unknown age, with no medical history reported, who experienced the serious unexpected events of INJECTION SITE JOINT ERYTHEMA, MYALGIA, NAUSEA, HEADACHE, DIZZINESS and FATIGUE. The events occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory case concerns a female patient of an unknown age, with no medical history reported, who experienced the serious unexpected events of INJECTION SITE JOINT ERYTHEMA, MYALGIA, NAUSEA, HEADACHE, DIZZINESS and FATIGUE. The events occurred after an unknown time interval after the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 2024001 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure congestive, Chronic obstructive pulmonary disease, Pneumonia, Pulmonary tuberculosis
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (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: PHJNJFOC20220111112

Write-up: This spontaneous report received from a health care professional by a Regulatory Authority (PHIFDA, PH-PHFDA-300129761) and concerned a 72-year-old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, (Dose number in series was 1) administered 1 in total on 08-AUG-2021 for an unspecified indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 28-DEC-2021, 02.40 hours the patient experienced pulmonary tuberculosis, pneumonia moderate risk, congestive heart failure, and congestive heart failure (Chronic obstructive pulmonary disease) (Dose number in series was 1). The action taken with covid-19 vaccine was not applicable. The patient was recovering from pulmonary tuberculosis, pneumonia moderate risk, congestive heart failure, and congestive heart failure (Chronic obstructive pulmonary disease). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20220111112-JANSSEN COVID-19 VACCINE Pulmonary tuberculosis, Pneumonia moderate risk, Congestive heart failure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 2024319 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
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: Axillary pain, Fatigue, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; SERTRALINE
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: Swollen lymph nodes; Fatigue; Armpit pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26412964) 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 AXILLARY PAIN (Armpit pain), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and SERTRALINE for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). At the time of the report, AXILLARY PAIN (Armpit pain), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no-negative covid-19 test (Negative) No-Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical history was provided. Unsure if patient had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No treatment medications were reported. Company comment: This is a regulatory case concerning a female patient of an unknown age with no medical history reported who experienced the unexpected serious events of Axillary pain, Lymphadenopathy and Fatigue. As reported, the patient experienced events on the same day and one day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the patient received third dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a female patient of an unknown age with no medical history reported who experienced the unexpected serious events of Axillary pain, Lymphadenopathy and Fatigue. As reported, the patient experienced events on the same day and one day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the patient received third dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2024332 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-28
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20220111173

Write-up: ACUTE APPENDICITIS; NAUSEA; This spontaneous report received from a health care professional by a Regulatory Authority (regulatory authority, PH-PHFDA-300129722) on 06-JAN-2022 and concerned a 29 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry date: unknown) dose was not reported, 1 total administered on 27-JUL-2021 for an unspecified indication (dose number in series: 1). The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 28-DEC-2021 at 02:10, the patient experienced acute appendicitis, and nausea (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from acute appendicitis, and nausea on 28-DEC-2021 at 02:15. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20220111173-covid-19 vaccine ad26.cov2.s- acute appendicitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 2025706 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   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 EXO438 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness, Immunisation, 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acoustic neuroma (Not on any meds); Allergy (Name of Drug as Reported No); Endometrial cancer (Not on any meds); Surgery (Not on any meds)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101882062

Write-up: difficulty hearing/sound muted/ can''t judge how loudly I''m speaking; The day after my vaccination I woke up with severe tinnitus in both ears; Dose 3,Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Dec2021 12:15 (Lot number: EXO438) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Acoustic neuroma surgery" (unspecified if ongoing), notes: Not on any meds; "Acoustic neuroma surgery" (unspecified if ongoing), notes: Not on any meds; "endometrial cancer surgery" (unspecified if ongoing), notes: Not on any meds; "endometrial cancer surgery" (unspecified if ongoing), notes: Not on any meds; "Allergy" (unspecified if ongoing), notes: Name of Drug as Reported No. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1 Batch/Lot No: FL3203 Location of injection: Arm Left Vaccine Administration Time: 11:00 AM), administration date: 14Apr2021, for Covid- 19 immunization; Bnt162b2 (Dose Number: 2 Batch/Lot No: EW0221 Location of injection: Arm Left Vaccine Administration Time: 03:00 PM), administration date: 06Jun2021, for Covid- 19 immunization. The following information was reported: DEAFNESS (medically significant) with onset 29Dec2021 07:00, outcome "not recovered", described as "difficulty hearing/sound muted/ can''t judge how loudly I''m speaking"; TINNITUS (medically significant) with onset 29Dec2021 07:00, outcome "not recovered", described as "The day after my vaccination I woke up with severe tinnitus in both ears"; IMMUNISATION (medically significant) with onset 28Dec2021 12:15, outcome "unknown", described as "Dose 3, Booster". Therapeutic measures were not taken as a result of deafness, tinnitus. Clinical course: The patient was not diagnosed with covid-19 prior to vaccination. The patient was not tested for covid-19 after vaccination. The patient did not received any other vaccine within 4 weeks prior to Covid vaccine and he did not received any other medications within two weeks of vaccination.


VAERS ID: 2026220 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Hypoacusis, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210707; 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; Pins and needles; Hearing reduced; Dizzy; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26407609) 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 HYPERHIDROSIS (Sweating), PARAESTHESIA (Pins and needles), HYPOACUSIS (Hearing reduced) and DIZZINESS (Dizzy) in a 32-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 28-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), PARAESTHESIA (Pins and needles) (seriousness criterion medically significant), HYPOACUSIS (Hearing reduced) (seriousness criterion medically significant) and DIZZINESS (Dizzy) (seriousness criterion medically significant). On 28-Dec-2021, HYPERHIDROSIS (Sweating), PARAESTHESIA (Pins and needles), HYPOACUSIS (Hearing reduced) and DIZZINESS (Dizzy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-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. No treatment medications were reported Patient reported that all happened within 5 minutes of the injection. Stayed sitting down and all passed after 15 minutes. Was given a cup of water and a glucose tablet. Patient has not had symptoms associated with COVID-19 Patient was not enrolled in clinical trial Company Comment This RA case concerns a 32 year old male with no relevant medical history reported , vaccinated for primary series using Tozinameran for two doses , who experienced Serious ( Medically significant ) , unexpected events of hyperhidrosis , paresthesia , hypoacusis and dizziness which occurred on the same day after vaccination with an unknown dose number of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case was captured as unknown by this RA report.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 male with no relevant medical history reported , vaccinated for primary series using Tozinameran for two doses , who experienced Serious ( Medically significant ) , unexpected events of hyperhidrosis , paresthesia , hypoacusis and dizziness which occurred on the same day after vaccination with an unknown dose number of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case was captured as unknown by this RA report.The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 2026310 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   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: Immunisation, SARS-CoV-2 test, Sciatica
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: AMITRIPTYLINE; CODEIN; ORAMORPH; PARACETAMOL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Depression; Nerve compression; Prediabetes; Slipped disc; Spinal stenosis (Severe spinal stenosis with slipped disk and nerve impingement); Spondylolisthesis (due to bilateral pars defect); Spondylolysis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101877818

Write-up: Booster; Sciatica aggravated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The Regulatory Authority number GB-MHRA-WEBCOVID-202112281016389590-7BKUO, other case identifier(s) GB-MHRA-ADR 26402515. A 34 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (also reported as 28Dec2020) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Spondylolisthesis (unspecified if ongoing), due to bilateral pars defect; bilateral pars defect (unspecified if ongoing); Spinal stenosis (unspecified if ongoing); slipped disk (unspecified if ongoing); nerve impingement (unspecified if ongoing); Depression (unspecified if ongoing); Anxiety (unspecified if ongoing); Pre diabetic (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication(s) included AMITRIPTYLINE taken for spinal stenosis; CODEIN; ORAMORPH; PARACETAMOL; SERTRALINE. Vaccination history included Bnt162b2 (DOSE 1, SINGLE, Batch/lot no: unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Batch/lot no: unknown), for COVID-19 immunization. The following information was reported IMMUNISATION (medically significant) with onset 28Dec2021 (also reported as 28Dec2020), outcome unknown; SCIATICA (medically significant) with onset 28Dec2021 (also reported as 28Dec2020), outcome not recovered. The patient underwent the following laboratory tests and procedures COVID-19 virus test No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The report does 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: 2026325 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-28
   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 FK9706 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, 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? Yes
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:
CDC Split Type: GBPFIZER INC202101877758

Write-up: Vomiting; Lethargy; Tiredness; 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-202112281119562390-AFXYP (MHRA). Other Case identifier(s): GB-MHRA-ADR 26402661 (MHRA). A 43 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: FK9706) at the age of 43 years as single dose for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 19Nov2019 (ongoing). Not had a COVID-19 test. The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE NUMBER UNKNOWN), administration date: 02Nov2021, for COVID-19 immunisation. The following information was reported: VOMITING (disability) with onset 28Dec2021, outcome "not recovered", described as "Vomiting"; LETHARGY (disability) with onset 28Dec2021, outcome "not recovered", described as "Lethargy"; FATIGUE (disability) with onset 28Dec2021, outcome "not recovered", described as "Tiredness". Additional information: Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026334 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dehydration, Flatulence, Headache, SARS-CoV-2 test
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (narrow), 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: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101877480

Write-up: Gas; Gas pain; Headache; Dehydration; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112281158180160-BM3N2 (RA). Other Case identifier(s): GB-MHRA-ADR 26402751 (RA). A 14 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Lot number: FN5254) 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; MANUFACTURER UNKNOWN). The following information was reported: FLATULENCE (disability, medically significant) with onset 28Dec2021, outcome "recovering", described as "Gas"; FLATULENCE (disability, medically significant) with onset 28Dec2021, outcome "recovering", described as "Gas pain"; HEADACHE (disability, medically significant) with onset 28Dec2021, outcome "recovering", described as "Headache"; DEHYDRATION (disability, medically significant) with onset 28Dec2021, outcome "recovering", described as "Dehydration". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Dec2021) no - negative covid-19 test. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


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