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From the 9/17/2021 release of VAERS data:

Found 711,579 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 312 out of 7,116

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VAERS ID: 1538685 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESOGESTREL; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Dizziness; Swollen glands; Headache; Nausea; This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headache) and NAUSEA (Nausea) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included DESOGESTREL for Contraception, PARACETAMOL for Pain. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1538721 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319-L797 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort
SMQs:, Anaphylactic reaction (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 INC202100984820

Write-up: tight feeling in my chest; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the left arm on 31Jul2021 at 12:00 PM (Lot Number: FF3319-L797) at the age of 17-year-old as single dose for COVID-19 immunization. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included Combined pill. On 01Aug2021, one day after the vaccine, the patient experienced tight feeling in chest. No treatment was received. The outcome of event was not recovered.


VAERS ID: 1539093 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-08-01
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202100985880

Write-up: bell syndrome; This is a spontaneous report from a contactable consumer. An unspecified age male patient received an unspecified dose of BNT162B2 via an unspecified route of administration on 19Jul2021 (Batch/Lot Number: unknown) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 01Aug2021, the patient experienced bell''s palsy. The outcome of event was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1539310 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
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: 202108; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Positive
CDC Split Type: SIPFIZER INC202100995719

Write-up: the person was positive for COVID-19 (symptom: loss of taste, positive test).; the person was positive for COVID-19 (symptom: loss of taste, positive test).; This is a spontaneous report from a non-contactable consumer or other non hcp. A 21-year-old (adult) male patient received second dose of bnt162b2 (COMIRNATY; Solution for injection), via intramuscular route of administration, administered in Arm Left on an unknown date in Jun2021 (Batch/Lot Number: Unknown) as a dose 2, single and first dose, via intramuscular route of administration, administered in Arm Left on an unknown date in Jun2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation at Clinic/ facility. The patient medical history was none. Concomitant medications were reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination were None. Prior to vaccination, the patient was not diagnosed with COVID-19. after the vaccination, patient was tested for COVID-19. It was reported that, the patient was vaccinated with the second dose on an unknown date in Jun2021, in early of August (more than 1 month after receiving the 2nd dose of the vaccine), the patient was positive for covid-19 (symptom: loss of taste, positive test) on Aug2021. The patient underwent lab tests and procedures which included nasal swab that was positive on Aug2021. No treatment was received for the events. The outcome of event was reported as recovering. No follow-up attempts are possible. Vaccine lot cannot be obtained. No further information is expected in the case.


VAERS ID: 1540202 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hallucination
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: Hallucinations
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210815311

Write-up: INCREASED SYMPTOMS OF HALLUCINATIONS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: hallucinations. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C16-01 expiry: UNKNOWN) dose was not reported, 1 total administered on 01-AUG-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 01-Aug-2021, the patient had been complaining of increased symptoms of hallucination for a week since being vaccinated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased symptoms of hallucinations. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210813135- covid-19 vaccine ad26.cov2.s -INCREASED SYMPTOMS OF HALLUCINATIONS . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY


VAERS ID: 1541600 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / UNK RA / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Headache, Hyperhidrosis, Myalgia, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: Nasal Swab; Test Result: Negative ; Comments: Lateral flow test
CDC Split Type: GBPFIZER INC202100993266

Write-up: shortness of breath; Approx. 17h later woke up in the middle of the night with fever and puddle of sweat, my body was shaking. I took a shower, had 2off 500g paracetamol every 4/5 hours after this. During the day heavy he; puddle of sweat; body was shaking; headache; sore throat; muscle ache and shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 31Jul2021 10:00 (Age at vaccination29 years old) (Batch/Lot Number: Ff3319) at Dose number unknown single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Aug2021 03:00 the patient experienced shortness of breath Approx. 17h later woke up in the middle of the night with fever and puddle of sweat, patients body was shaking. Patient took a shower, had 2off 500g paracetamol every 4/5 hours after this. During the day heavy headache and sore throat started to develop, fever dropped and second night slept long. 2nd of August woke up with soar throat, all muscle ache and shortness of breath, patient was advised to take a covid PCR test, which on 03Aug came back negative. 03Aug feeling better, lost soar throat but still bit short of breath. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 27Jul2021 Lateral flow test. Therapeutic measures were taken as a result of shortness of breath, approx. 17h later woke up in the middle of the night with fever and puddle of sweat, my body was shaking. patient took a shower, had 2off 500g paracetamol every 4/5 hours after this. during the day heavy headache, puddle of sweat, body was shaking , headache, sore throat, muscle ache and shortness of breath. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination no. Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, has the patient been tested for COVID-19: Yes, and result was negative. Outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1541915 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: I have discharge letter
CDC Split Type:

Write-up: Myocarditus inflamation of heart


VAERS ID: 1544796 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyskinesia, Eye movement disorder, Facial paralysis
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202100984830

Write-up: the left side of the face was a little paralyzed, eye does not close completely and patient cannot even move completely the mouth on this side; the left side of the face was a little paralyzed, eye does not close completely and patient cannot even move completely the mouth on this side; the left side of the face was a little paralyzed, eye does not close completely and patient cannot even move completely the mouth on this side; This is a spontaneous report from a contactable consumer (patient) from Pfizer medical information team. A female patient of an unspecified age received bnt162b2 (Comirnaty solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 01Aug2021 (in the morning) as single dose for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 01Aug2021, the patient experienced the left side of the face was a little paralyzed, eye does not close completely and patient cannot even move completely the mouth on this side. The outcome of all the events was unknown. The batch number has been requested in follow-up activities.


VAERS ID: 1546092 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-08-01
   Days after vaccination:66
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Nasal Swab; Test Result: Positive
CDC Split Type: FIPFIZER INC202100995567

Write-up: patient had received two vaccinaton doses of Comirnaty and still got a positive result from COVID 19 test; patient had received two vaccinaton doses of Comirnaty and still got a positive result from COVID 19 test; This is a spontaneous report from a contactable consumer. A 39-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 06May2021(Age at vaccination 39 years) (Batch/Lot Number: ER9470; Expiration Date: 31Jul2021) as Dose 1, single and dose 2 via an unspecified route of administration on 27May2021 (Batch/Lot Number: ER9470; Expiration Date: 31Jul2021) as Dose 2, single for covid-19 immunization.The patient medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Workplace clinic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 01Aug2021, the patient has received two doses of Comirnaty, but still has a positive test result in a corona test. The seriousness criteria is medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: Nasal Swab positive on 01Aug2021. For this lot Adverse Event Safety Request for Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5832496 (see File attachment in this investigation record) The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ER9470. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. They conclude that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. The event outcome was recovering for COVID-19 and Unknown for vaccination failure.


VAERS ID: 1546659 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-08-01
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Fibrin D dimer, Hypercoagulation, Platelet count, SARS-CoV-2 test, Ultrasound scan
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLEXANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lumbar pain; Obesity; Pain in lumbar spine; Smoker
Allergies:
Diagnostic Lab Data: Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:D-dimer was $g4000; Test Date: 20210802; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:Unknown; Test Name: low platelet counts; Result Unstructured Data: Test Result:Before-326, After-342; Comments: the last platelet count before vaccine -326, the last platelet count after vaccine-342; Test Date: 20210801; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20210802; Test Name: USS scan; Result Unstructured Data: Test Result:Unknown
CDC Split Type: GBPFIZER INC202100992513

Write-up: Deep venous thrombosis proximal; underlying thrombophilia or malignancy; This is a spontaneous report from a contactable physician received from the RA. The regulatory authority report number is GB-MHRA-WEBCOVID-202108022042231690-ORQAW, Safety Report Unique Identifier GB-MHRA-ADR 25743609. A 19-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on 20Jul2021 as single dose for covid-19 immunization. Medical history included lumbar pain (one week history of mechanical lumbar back pain), obesity, pain in lumbar spine, smoking; all from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Concomitant medications included enoxaparin sodium (CLEXANE) taken for an unspecified indication, start and stop date were not reported. The patient previously took heparin and had no reaction. On 01Aug2021, the patient developed deep venous thrombosis proximal to inferior vena cava (IVC). On an unspecified date in 2021, the patient was reviewed by a hematologist and underlying thrombophilia or malignancy (anatomical variant) was identified. It was reported that the patient had recent immobilization due to lumbar spine injury- only 6 days ago. The patient was admitted with acute onset right limb swelling and pain. Patient had 7 days of reduced mobility prior to this secondary to lumbar pain. This was diagnosed with USS scan on 02Aug2021. On 02Aug2021, the platelet count was not < 150-109/L. It was unknown if anti-PF4 antibodies were identified. It was reported thrombophilia screen, infectious screen (eg HIV, hepatitis C/B, herpes zoster/ CMV) and autoimmune screen; all were awaited. PT: "15.0". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included fibrin d dimer: d-dimer was $g4000 on an unspecified date in 2021 and unknown on 02Aug2021; platelet count: before-326, after-342 (normal range 150-450) on an unspecified date in 2021 (the last platelet count before vaccine -326, the last platelet count after vaccine-342), sars-cov-2 test: negative on 01Aug2021 (No - Negative COVID-19 test), ultrasound scan: unknown on 02Aug2021. The outcome of event deep venous thrombosis proximal was not resolved and for underlying thrombophilia or malignancy the outcome was unknown. Reaction Does your report relate to possible blood clots or low platelet counts. If yes, we will ask you additional questions at the end of this report: "Yes" Suspect Reactions Please provide details of any relevant investigations or tests conducted: "D dimer 4.45, platelets Normal" No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1546661 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Arrhythmia, Insomnia, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998583

Write-up: palpitations; she felt very uncomfortable and anxious where she couldn''t sleep; she felt very uncomfortable and anxious where she couldn''t sleep; Arrhythmia; This is a spontaneous report from a contactable consumer (patient) or other non HCP. This is a report received from the regulatory authority report number [GB-MHRA-WEBCOVID-202108031716199840-FXMUS], Safety Report Unique Identifier [GB-MHRA-ADR 25748582]. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 31Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. On 01Aug2021, the patient experienced arrhythmia. On an unspecified date, patient experienced palpitations. Rapid heart palpitations. 24hrs after the 1st dose, she felt very uncomfortable and anxious where she couldn''t sleep. She was a healthy person no cardiovascular issues. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome and outcome of event arrhythmia was recovering, while outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1546668 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Investigation
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: DVT
Allergies:
Diagnostic Lab Data: Test Date: 20210405; Test Name: Clinical diagnosis; Result Unstructured Data: Test Result:Suspected DVT; Comments: Was the platelet count : Unknown ~Was the D-dimer : Unknown Were anti-PF4 antibodies identified: Unknown
CDC Split Type: GBPFIZER INC202101013006

Write-up: DVT of calf; dvt; This is a spontaneous report from a contactable physician received from MHRA, company number GB-MHRA-WEBCOVID-202108051612245990-XQVGW via the Regulatory Agency. A 78-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on 28Jul2021 as single dose for covid-19 immunization. Medical history included deep vein thrombosis (DVT) from an unknown date and unknown if ongoing; has had previous DVT in leg years ago. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On an unspecified date in 2021, the patient experienced DVT. On 01Aug2021, the patient experienced DVT of calf. It was reported 4 days following covid vaccination developed pain left leg. Clinically suspicious of DVT - would have further tests at hospital. Now the patient had involuntary movement of left leg when touching this. The patient underwent lab tests which included clinical diagnosis of result suspected DVT (it was unknown if platelet count was <150 ? 109/L, D-dimer $g4000 or anti-PF4 antibodies identified) on 05Apr2021. The outcome of event DVT of calf was not resolved and for another event it was unknown Reaction Does your report relate to possible blood clots or low platelet counts? If yes, we will ask you additional questions at the end of this report: "Yes" Suspect Reactions Please provide details of any relevant investigations or tests conducted: "Further tests currently arranged" No follow-up attempts are possible. No further information is expected.


VAERS ID: 1546747 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-21
Onset:2021-08-01
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: COVID-19 antibody test; Result Unstructured Data: Test Result: Blood specimen tested positive for anti-spike; Comments: Blood specimen tested positive for anti-spike protein antibody; Test Date: 20210714; Test Name: COVID-19 virus test; Test Result: Negative; Test Date: 20210801; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: positive with N501Y mutant strain.
CDC Split Type: HKPFIZER INC202101021271

Write-up: This is a spontaneous report from a non-contactable healthcare professional via Regulatory authority report number: not provided, based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS002883), license party for bnt162b2 (COMIRNATY). This is one of three reports. A 36-years-old female patient (case No #) received first dose of Tozinameran (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Mar2021 and the patient received second dose of Tozinameran (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history, concomitant medications and past product were not reported. On 12Jul2021, the patient''s blood specimen tested positive for anti-spike protein antibody. The patient departed on 16Jul2021 and her testing result on 14Jul2021 before she departure was negative. On 01Aug2021, the patient''s specimen collected on the same day tested positive with N501Y mutant strain. The patient was asymptomatic. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. The outcomes of the events was unknown. Per Reporter Causality for events was assessed as possible. Initial report was received on 03-Aug-2021. This is one of three reports received from the same reporter and this case has been linked with others. Link numbers are as follows: 2021FOS002878 (master case), 2021FOS002882 and 2021FOS002883. Follow-up closed, no further information is possible. Linked Report(s): HK-PFIZER INC-202101021252 same reporter, different patient.


VAERS ID: 1554640 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-08-01
   Days after vaccination:66
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstruation delayed
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984508

Write-up: Missed period after vaccine; Heavy periods; This is a spontaneous report from a contactable consumer received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202108012024151620-WOJ22, Safety Report Unique Identifier GB-RA-ADR 25738372. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number ET8885), dose 1 via an unspecified route of administration on 27May2021 as DOSE 1, SINGLE for covid-19 immunization. Patient was not pregnant at time of vaccination. Patient was not currently breastfeeding. Medical history included lactation decreased. Concomitant medications were not reported. No medication nothing else has changed. Patient has not had symptoms associated with covid-19. Not had a covid-19 test. Patient was not enrolled in clinical trial. On 01Aug2021, the patient experienced heavy periods. On unspecified date, the patient experienced missed period after vaccine. It was stated that missed period after vaccine then had a period heavier than normal for 8 days then 12 days later patient had bleed again to the. point of not being able to stand up as I would flood has calmed after 23 hrs but still very heavy. Since the vaccination, the patient had not been tested positive for covid-19. The events were serious (medically significant). Outcome of the event heavy periods was not recovered. Outcome of the event missed period after vaccine was unknown. No follow-up attempts are Possible. No further information is expected


VAERS ID: 1554659 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-08-01
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), 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: 20210801; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:confirmed to have COVID-19
CDC Split Type: HKPFIZER INC202101021270

Write-up: This is a spontaneous report received from a non-contactable Health Care Professional received via Regulatory Authority. The regulatory authority report number is not applicable. As of 0:00 am, 03-Aug-2021, Regulatory Authority announced that three confirmed cases of COVID-19 after vaccination. This case was split for 1 of 3 cases that confirmed COVID-19 after vaccination. A 33-year-old male patient received BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: Unknown), via an unspecified route of administration, on 06Jul2021, as Dose number Unknown, Single for COVID-19 immunization. The patient''s medical history, concomitant medications and past product were not reported. On 01Aug2021, the patient arrived by flight and confirmed to have COVID-19 by arrival testing. The patient was asymptomatic. The events COVID-19 and drug ineffective were considered as Important Medical Event. The outcome of all the events was unknown. Initial report was received on 04-Aug-2021. This is one of three reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS002911 (master case), 2021FOS002912 and 2021FOS002913. Follow-up closed, no further information is possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101026856 same reporter, different patient;HK-PFIZER INC-202101029792 same reporter, different patient


VAERS ID: 1555583 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101011653

Write-up: Bells Palsy paralysis on the left side of the face; This is a spontaneous report from a contactable consumer (Patient) via medical information team. A 44-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number: unknown), dose 2 via an unspecified route of administration on 02Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unspecified date in Aug 2021, the patient experienced bell''s palsy, paralysis on the left side of the face Started 24-36hours after the vaccine with outcome of not recovered.


VAERS ID: 1558015 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough variant asthma
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100977573

Write-up: Cough variant asthma; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 31-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in arm left on 01Aug2021 10:00 (at the age of 31-year-old) (Batch/Lot Number: FF0843; Expiration Date: 31Oct2021) as single dose for COVID-19 immunisation. Medical history included asthma. The patient had no allergies to medications, food, or other products. The patient''s concomitant medications were not reported. The patient was a non-pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 11Jul2021 the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization. On 01Aug2021 at 10:00 (the day of vaccination), the patient experienced cough variant asthma (medically significant) on 01Aug2021 10:00 with outcome of recovered in Aug2021. The reporter stated the events result in Emergency room/department or urgent care. The outcome of events was recovered with treatment including beta irritant inhalation. It was unknown since the vaccination, whether the patient has been tested for COVID-19 or not. No follow up attempts are possible. No further information is expected.


VAERS ID: 1565985 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-08-01
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: COVID-19 (Yes - Positive COVID-19 test); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20200723; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100984764

Write-up: Spotting between menses; This is a spontaneous report from a contactable consumer or other non hcp received from the Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011514454750-4IOY3. Safety Report Unique Identifier: GB-MHRA-ADR 25738155. A 26-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 29Jun2021 as dose 1, single for COVID-19 immunization. Medical history included Lactation decreased and Covid-19 on 23Jul2020. The patient concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. The patient experienced spotting between menses on 01Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 23Jul2020, Yes - Positive COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The case was reported as serious (medically significant). The outcome of the event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained


VAERS ID: 1565988 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Maternal exposure during breast feeding, Musculoskeletal chest pain, Off label use, Pain in extremity, Product use issue
SMQs:, Neonatal exposures via breast milk (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Rib pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984699

Write-up: Maternal exposure during breast feeding; Off-label use; Drug use in unapproved population; Rib pain; Calf pain; Armpit pain; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108020006444720-WR2FX. A 35-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 31Jul2021 (Batch/Lot Number: FE3380) as DOSE 2, SINGLE for covid-19 immunization. The patients medical history included ongoing breast feeding, musculoskeletal chest pain from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (PARACETAMOL) taken for musculoskeletal chest pain from 01Aug2021 to an unspecified stop date. The patient experienced maternal exposure during breast feeding (maternal exposure during breast feeding on an unspecified date, rib pain (musculoskeletal chest pain) on 01Aug2021 with outcome of not recovered, calf pain (pain in extremity) on 01Aug2021, armpit pain (axillary pain) on 01Aug2021, off-label use (off label use) on an unspecified date, drug use in unapproved population (product use issue) on an unspecified. Therapeutic measures were taken as a result of rib pain (musculoskeletal chest pain). The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The outcome of the event maternal exposure during breast feeding was unknown, rib pain, calf pain, armpit pain was not recovered, and unknown for off label use and drug use in unapproved population. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100998292 Mother-Baby case


VAERS ID: 1565990 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Stress, Tinnitus
SMQs:, Hearing impairment (narrow), COVID-19 (broad)

Life Threatening? Yes
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: SAYANA PRESS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asperger''s syndrome; Blood disorder; Dyslexia; Hay fever; Peanut allergy; Penicillin allergy; Tumor
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005963

Write-up: Tinnitus; stress; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041810351850-YAKWK, Safety Report Unique Identifier GB-MHRA-ADR 25755756. A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 04Aug2021 (at the age of 31-year-old) (Lot Number: FD8813) as single dose for COVID-19 immunisation. Medical history included Penicillin allergy, Peanut allergy, Dyslexia, asperger''s syndrome, hay-fever allergy, blood condition that makes bruising easily, benign tumor size of an apple above left rib cage. Concomitant medication included medroxyprogesterone acetate (SAYANA PRESS). The patient experienced tinnitus on 04Aug2021 (1 hour after vaccination), stress in Aug2021; all reported as disability, medically significant, life threatening. The clinical course was reported as follows: He knew for a fact the vaccine caused it after 1 hour from getting 2nd vaccine in his arm. His right ear exploded not even joking it literally like a bomb off boom in right ear hole then ringing started. The very extremely unheard of buzzing. Whistling hush sounds started to take over literally deaf from noise. His wife trying talk to him and unable hear his wife voice because his right ear was literally bombed out with noises all sorts of buzzing. 8 hours later buzzing gone down to more tolerate-able sounds. This experience has put his off vaccines for life. He nearly died from that noise stress of it all insane. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. The outcome of the event tinnitus was recovered in Aug2021 with sequelae, stress was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1571294 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Nausea, Pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Flu like symptoms; Ache; Nausea; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Ache), NAUSEA (Nausea) and PAIN IN EXTREMITY (Painful arm) in a 34-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown and PAIN (Ache), NAUSEA (Nausea) and PAIN IN EXTREMITY (Painful arm) had not resolved. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Flu like symptoms. Aches, nausea, painful arm at entry site Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1571358 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Ache; High temperature; Headache; This case was received via Regulatory AuthorityMHRA (Reference number: ADR 25738259) on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021.This regulatory authority case was reported by a consumer and describes the occurrence PAIN (Ache), PYREXIA (High temperature) and HEADACHE (Headache) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PAIN (Ache), PYREXIA (High temperature) and HEADACHE (Headache) had not resolved. Concomitant product was not provided by the reporter. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.


VAERS ID: 1571361 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Nausea, Photophobia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma (Mild asthma)
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: dizziness; nauseous; Nausea; Light sensitivity to eye; This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PHOTOPHOBIA (Light sensitivity to eye), NAUSEA (nauseous) and NAUSEA (Nausea) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Asthma (Mild asthma). On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced PHOTOPHOBIA (Light sensitivity to eye) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (dizziness) (seriousness criterion medically significant) and NAUSEA (nauseous) (seriousness criterion medically significant). On 01-Aug-2021, NAUSEA (Nausea) had resolved. At the time of the report, DIZZINESS (dizziness) and NAUSEA (nauseous) outcome was unknown and PHOTOPHOBIA (Light sensitivity to eye) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative Negative. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1571371 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Hyperhidrosis, Injection site pain, Pyrexia, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sweating; Spaced out; Drowsiness; Injection site pain; Fever chills; This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), FEELING ABNORMAL (Spaced out), SOMNOLENCE (Drowsiness), INJECTION SITE PAIN (Injection site pain) and PYREXIA (Fever chills) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), FEELING ABNORMAL (Spaced out) (seriousness criterion medically significant), SOMNOLENCE (Drowsiness) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). At the time of the report, HYPERHIDROSIS (Sweating), FEELING ABNORMAL (Spaced out), INJECTION SITE PAIN (Injection site pain) and PYREXIA (Fever chills) had not resolved and SOMNOLENCE (Drowsiness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications was not reported. The patient hasnot had symptoms associated with COVID-19, had a COVID-19 test and had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The treatment history was not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1571373 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Decreased appetite, Dizziness, Limb discomfort, Migraine, Myalgia, Pain, Presyncope, SARS-CoV-2 test, Sleep deficit
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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:
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.MOD20212

Write-up: pains; dizziness; Feel like passing out; Loss of sleep; Loss of appetite; Heaviness in arm; Migraine; Light-headed; General body pain; Pain muscle; This case was received via regulatory authority (Reference number: 25740398) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (pains), DIZZINESS (dizziness), LIMB DISCOMFORT (Heaviness in arm), MIGRAINE (Migraine), DIZZINESS (Light-headed), PAIN (General body pain) and MYALGIA (Pain muscle) in a 20-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced LIMB DISCOMFORT (Heaviness in arm) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant), DIZZINESS (Light-headed) (seriousness criterion medically significant), PAIN (General body pain) (seriousness criterion medically significant) and MYALGIA (Pain muscle) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN (pains) (seriousness criterion medically significant), DIZZINESS (dizziness) (seriousness criterion medically significant), PRESYNCOPE (Feel like passing out), SLEEP DEFICIT (Loss of sleep) and DECREASED APPETITE (Loss of appetite). At the time of the report, ABDOMINAL PAIN (pains) and DIZZINESS (dizziness) was resolving, LIMB DISCOMFORT (Heaviness in arm), MIGRAINE (Migraine), DIZZINESS (Light-headed), PAIN (General body pain) and MYALGIA (Pain muscle) had not resolved and PRESYNCOPE (Feel like passing out), SLEEP DEFICIT (Loss of sleep) and DECREASED APPETITE (Loss of appetite) outcome was unknown. 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 product use was not provided by the reporter. Treatment medication was not provided by the reporter. Patient reported: "Ever since I had the vaccine I feel awful and , pains everywhere , dizziness and feel like passing out , loss of sleep and appetite" Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event coded as [abdominal pain] was reported as "pains". Coding retained per Regulatory Authority case.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Eent coded as [abdominal pain] was reported as "pains". Coding retained per Regulatory Authority case.


VAERS ID: 1571382 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bedridden, Body temperature, Chills, Decreased appetite, Diarrhoea, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Sinus pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), 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:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Temperature; Result Unstructured Data: $g39.4 C; Test Date: 20210721; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: diarrhea; chills; Appetite lost; Sinus pain; Fever; Nausea; Myalgia; Stayed in bed for 2 days; This regulatory authority case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite lost), SINUS PAIN (Sinus pain), DIARRHEA (diarrhea), PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Myalgia), CHILLS (chills) and BEDRIDDEN (Stayed in bed for 2 days) in a 45-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and MYALGIA (Myalgia) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant) and SINUS PAIN (Sinus pain) (seriousness criterion medically significant). On an unknown date, the patient experienced DIARRHEA (diarrhea) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant) and BEDRIDDEN (Stayed in bed for 2 days) (seriousness criterion medically significant). On 03-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, DECREASED APPETITE (Appetite lost) had not resolved, SINUS PAIN (Sinus pain), NAUSEA (Nausea) and MYALGIA (Myalgia) was resolving and DIARRHEA (diarrhea), CHILLS (chills) and BEDRIDDEN (Stayed in bed for 2 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: $g39.4 c (High) $g39.4 C. On 21-Jul-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient reported high fever ($g39.4C). Treatment includes with anti-inflammatories was reported. Concomitant product was not provided. It was reported that events myalgia, nausea, Chills are severe , severe sinus pain. It was also reported that it was one of the worst experiences patient had in long time, patient was completely incapacitated and stayed in bed for two days Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1573526 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D020A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Cyanosis, Dyspnoea, Heart rate, Heart rate increased, Local reaction, Oxygen saturation, Oxygen saturation decreased, Rhonchi
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? Yes
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: Grass allergy (allergic diathesis, occasional CETIRIZIN administration); Hay fever
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: HF; Result Unstructured Data: Test Result:110-120; Test Date: 20210807; Test Name: saturation; Result Unstructured Data: Test Result:88-92 %
CDC Split Type: DEPFIZER INC202101027051

Write-up: sudden asthma attack; significant dyspnea; lip cyanosis; significant sibilant rhonchus; saturation 88-92 %; HF 110-120; local reaction after vaccination; This is a spontaneous report from a contactable physician based on information received by Pfizer from a regulatory authority, license party for Comirnaty. A 13-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via intramuscular on 06Aug2021 (Lot Number: 1D020A), at the age of 13-years-old, as single dose for COVID-19 immunisation. Medical history included allergic diathesis, hay fever, probably due to grass. Patient had no concomitant diseases, so far healthy child except for occasional CETIRIZIN administration with grass allergy. The patient''s concomitant medications were not reported. The patient previously took ibuprofen and experienced no adverse event. On 07Aug2021, about 33 hours after BIONTECH vaccination and about 6 hours after IBUPROFEN 300 mg for the first time sudden asthma attack, significant dyspnea, lip cyanosis, significant sibilant rhonchus, saturation 88-92 %, HF 110-120, no tachypnoea. The events were reported as serious (life threatening). Action taken as result of reaction: administration of 4x Salbutamol, 1 x Fultiform and Prednisolon 2x20mg p.o., than most stable for 1 hour. The patient received IBUPROFEN on 07Aug2021 at 300 mg oral for local reaction after vaccination (not specified). Comirnaty was never given before. There was no re-exposition. IBUPROFEN had been given before without any problems. There was no hospitalization performed, only prepared. The outcome of the events was resolved. A causal relationship to comirnaty was assessed as possible.; Sender''s Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1575111 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Laboratory test, Transient ischaemic attack
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (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 Name: Lab test; Result Unstructured Data: Did not find anything
CDC Split Type: BRJNJFOC20210819981

Write-up: TRANSITORY CVA; This spontaneous report received from a patient concerned a male of unspecified age, age group, race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821287 and expiry: 15/SEP/2021) dose was not reported, 1 total, administered on 12-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the patient experienced apparently transitory cerebrovascular accident (CVA) (patient was not sure for this diagnosis) and thrombo. On an unspecified date, laboratory data included: Lab test (NR: not provided) Did not find anything. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the transitory CVA was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210819981-covid-19 vaccine ad26.cov2.s -Transitory CVA. 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: 1575190 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Urinary incontinence
SMQs:, 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: CITALOPRAM; OMEPRAZOLE
Current Illness: Acid reflux (esophageal); Depression; Raynaud''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: Interstitial lung disease; Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210114; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Urine incontinence; This case was received via Regulatory Authority(Reference number: 25739776) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Urine incontinence) in a 36-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Interstitial lung disease, Lactation decreased and Suspected COVID-19 (Unsure when symptoms stopped) on 12-Jan-2021. Concurrent medical conditions included Raynaud''s disease, Acid reflux (esophageal) and Depression. Concomitant products included OMEPRAZOLE from 01-Jun-2019 to an unknown date for Acid reflux (esophageal), CITALOPRAM from 17-Dec-2017 to an unknown date for Depression. On 31-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced URINARY INCONTINENCE (Urine incontinence) (seriousness criterion medically significant). On 01-Aug-2021, URINARY INCONTINENCE (Urine incontinence) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient experienced no feeling of warning or need to pass urine, just happened and was not able to stop it to reach a bathroom. Patient was not enrolled in clinical trial. Treatment information was not provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1575192 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-08-01
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Dizziness, Headache, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Arthritis (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Dizziness; Joint ache; Fever; Chills; Head pain; Painful arm; This case was received via RA (Reference number: 25741182) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ARTHRALGIA (Joint ache), PYREXIA (Fever), PAIN IN EXTREMITY (Painful arm), CHILLS (Chills) and HEADACHE (Head pain) in a 38-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3002332 and 3003608) for COVID-19 vaccination. No Medical History information was reported. On 24-May-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 01-Aug-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and HEADACHE (Head pain) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness), ARTHRALGIA (Joint ache), PYREXIA (Fever), PAIN IN EXTREMITY (Painful arm), CHILLS (Chills) and HEADACHE (Head pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The concomitant medications were not provided. The Treatment information was not provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1575194 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Myalgia, Nausea, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Syncope vasovagal; Headache; Nausea; Muscle ache; Fever; This case was received via regulatory authority on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Syncope vasovagal), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Muscle ache) and PYREXIA (Fever) in a 32-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 01-Aug-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced SYNCOPE (Syncope vasovagal) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Syncope vasovagal), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Muscle ache) and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment details not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1575920 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Malaise, Musculoskeletal stiffness, Pyrexia, Vaccination site pain
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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pain relief
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976740

Write-up: stiff arm; Feeling sick; Chills; Fever; Site of vaccination painful; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108010155398680-SJX5R, Safety Report Unique Identifier is GB-MHRA-ADR 25737728. A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included lactation decreased and pain relief both from an unknown date. Concomitant medication included paracetamol (PARACETAMOL) taken for pain relief from 31Jul2021 to an unspecified stop date. It was reported that patient was on no medication. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The patient experienced stiff arm, feeling sick, chills, fever and site of vaccination painful all on 01Aug2021. The events were reported as serious (medically significant). Clinical course was reported as follows: Around 15 hours after vacation I have woken with a fever chills and feeling sick. Also a stiff arm and pain at vacation site. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient has not recovered from feeling sick, chills, fever and site of vaccination painful while outcome for stiff arm was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575950 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984453

Write-up: swollen armpit; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108011114090660-FLPUL, Safety Report Unique Identifier GB-MHRA-ADR 25737950. A 28-year-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Lot number: FF3319), via an unspecified route of administration at single dose on 30Jul2021 for COVID-19 immunization. The patient medical history included lactation decreased. The patient concomitant medication included paracetamol (PARACETAMOL) taken for immunization from 30Jul2021. The patient not had symptoms associated with COVID-19. The patient did not have a COVID-19 test. The patient was not pregnant. The patient was not currently breastfeeding. The patient not tested positive for COVID-19 since having the vaccine. The patient experienced swollen armpit, swollen lymph nodes on 01Aug2021. The events were reported as eventually serious. The outcome of the events was unknown for swollen armpit and not recovered for swollen lymph nodes. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575959 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chills, Dizziness, Electrocardiogram, Electrocardiogram ST segment depression, Heart rate, Hypertension, Malaise, Nausea, Oxygen saturation, Palpitations, Paraesthesia, Presyncope, Tachycardia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Migraine; Perimenopause; Tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Blood pressure; Result Unstructured Data: Test Result:180/120; Test Date: 20210801; Test Name: Blood pressure; Result Unstructured Data: Test Result:202/130; Test Date: 20210801; Test Name: ECG; Result Unstructured Data: Test Result:ECG showed very mild ST depression laterally (like; Test Date: 20210801; Test Name: PR; Result Unstructured Data: Test Result:180/min; Test Date: 20210801; Test Name: sats; Result Unstructured Data: Test Result:99%
CDC Split Type: GBPFIZER INC202100984649

Write-up: palpitations; lightheaded; unwell; sensation of about to pass out; nauseous; shivery; tingling fingers; Tachycardia; depression/ECG showed very mild ST depression; Hypertension; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108011210423380-FHKZG. Safety Report Unique Identifier GB-MHRA-ADR 25738010. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 (at the age of 56 years) (Batch/Lot Number: FF3319) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension, migraine, tachycardia and perimenopause. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. It was reported that within 10 mins of the first Pfizer vaccine, the patient felt sudden onset palpitations, lightheaded, very unwell, sensation of about to pass out, nauseous, shivery, tingling fingers (no chest pain/tightness, no oral swelling, no rash), no h/o medical problems other than migraine and a few, fleeting tachycardia episodes during perimenopause. No medication. No h/o allergies/anaphylaxis. BP initially 180/120, PR 180/min, sats 99%, chest clear, no rash, conscious throughout, talking sentences, no resp distress. BP repeated 202/130 (reported as "hypertension"). Sustained hypertension/tachycardia so ambulance called, ECG showed very mild ST depression laterally (likely to be rate related, normal QTi), taken to hospital. The events were assessed as serious (medically significant). The outcome of the events palpitations, lightheaded, unwell, nauseous, shivery, tingling fingers, ECG showed very mild ST depression was recovered on an unspecified date; event sensation of about to pass out was unknown; while not recovered for the rest of the events. No follow-up attempts are possible ,No further information is expected.


VAERS ID: 1575968 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Lymphadenopathy, Neck pain
SMQs:, 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984567

Write-up: Tiredness; Headache; Lymph nodes enlarged; Neck pain; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011241347060-NDWDK, Safety Report Unique Identifier GB-MHRA-ADR 25738020. A 26-year-old female patient received second dose of BNT162B2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FE3380), via an unspecified route of administration on 31Jul2021 as single dose for COVID-19 immunization. Medical history included lactation decreased. Concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. On 01Aug2021 patient experienced tiredness, headache, lymph nodes enlarged, neck pain. Events considered serious as medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient was recovering from the events. No follow up attempts are possible. No further information is expected.


VAERS ID: 1575970 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       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: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20200804; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100984538

Write-up: Vomiting; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011249423300-E7XV8 and Safety Report Unique Identifier is GB-MHRA-ADR 25738028 A 19-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 31Jul2021 (Batch/Lot Number: FD8813) as single dose for covid-19 immunisation. The patient medical history included COVID-19 04Aug2020. Concomitant medications were not reported. The patient experienced vomiting (medically significant) on 01Aug2021 with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 04Aug2020. Course of the event Had the vaccine at midday. Woke up in the middle of the night throwing up. I have not thrown up in 7 years so this is definitely the cause. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial No follow-up attempts are possible. No further information is expected..


VAERS ID: 1575972 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984503

Write-up: flu like symptoms; specific ache around injection site; Headache; Muscle ache; Tiredness; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108011309437250-GJKNM and Safety Report Unique Identifier is GB-MHRA-ADR 25738049. A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, batch/Lot number: FF3319) via an unspecified route of administration on 31Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date patient experienced flu like symptoms and specific ache around injection site. On 01Aug2021, the patient experienced headache, muscle ache and tiredness. Events were considered serious. Clinical course: Second Pfizer dose around midday, side effects began early next morning (1am). No other medications. Mild flu like symptoms and muscle ache, with additional specific ache around injection site. Negative Covid test 24h before 2nd dose. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 30Jul2021. Outcome of events headache, muscle ache and tiredness was not recovered. Outcome of event flu like symptoms was recovering. Outcome for event specific ache around injection site was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575983 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984477

Write-up: Fainting; This is a spontaneous report from a contactable consumer received from the Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011445182010-PDJ6B. Safety Report Unique Identifier GB-MHRA-ADR 25738130. A 40-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported), via an unspecified route of administration on 01Aug2021 (at the age of 40-years-old) as dose 2, single for COVID-19 immunization. The patient medical history included suppressed lactation. The patient had no current issues. The patient had not had symptoms associated with COVID-19, was not enrolled in clinical trial, was not pregnant and was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously received historical vaccine including bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and had no adverse effects to the 1st vaccine. On 01Aug2021, the patient experienced fainting. It was reported that the patient fainted shortly after receiving the 2nd vaccine. The patient felt well beforehand and had no adverse effects to the 1st vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 30Jul2021: No - Negative COVID-19 test. The patient had not tested positive for COVID-19 since having the vaccine. The case was reported as serious (medically significant). The outcome of the event was recovered with sequelae on 01Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575985 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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.MOD20212

Write-up: Blood clots; Headache; This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOSIS (Blood clots) in a 19-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). On 01-Aug-2021, HEADACHE (Headache) had resolved. At the time of the report, THROMBOSIS (Blood clots) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time


VAERS ID: 1575999 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Malaise, Nausea, Neck pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984496

Write-up: Nausea; Feeling unwell; Shoulder pain; Neck pain; Fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011712016530-A4H8U. Safety Report Unique Identifier GB-MHRA-ADR 25738231. A 33-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown), dose 2 via an unspecified route of administration on 31Jul2021 as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. On 01Aug2021, the patient experienced nausea, feeling unwell, shoulder pain, neck pain, fatigue. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. No - Negative COVID-19 test. The outcome of the events was reported as not recovered. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.


VAERS ID: 1576006 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Ear pain, Facial pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (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 INC202100984537

Write-up: Ear ache; Atypical face pain; Stomach ache; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011801384190-KFCID. Safety Report Unique Identifier GB-MHRA-ADR 25738267. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 31Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. On an unknown date the patient received the first dose of BNT162B2. The patient experienced ear ache (medically significant) on 01Aug2021 with outcome of not recovered, atypical face pain (medically significant) on 01Aug2021 with outcome of not recovered, stomach ache (medically significant) on 01Aug2021 with outcome of not recovered. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1576011 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Lethargy, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984473

Write-up: lack of energy; aching muscles; Lethargic; This is a spontaneous report from a contactable consumer. This is a report received from the Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202108011817124040-D5PNG, Safety Report Unique Identifier GB-MHRA-ADR 25738276. A 32-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: FD8813) via an unspecified route of administration on 31Jul2021 as dose 2, single for COVID-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Patient is not currently breastfeeding. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. On an unspecified date the patient experienced lack of energy, aching muscles and on 01Aug2021 lethargic. The outcome of event lethargic was not resolved and rest were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576019 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Malaise, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CYCLIZINE; DULOXETINE; ORAMORPH [MORPHINE SULFATE]; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression mental; Nausea; Pain; Pilonidal cyst pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984432

Write-up: Nausea; Fainting; Feeling unwell; Aching joints; Felt faint; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The Regulatory authority report number is (GB-MHRA-WEBCOVID-202108011902515250-XIZZM) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25738313). A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/lot member was not reported), via an unspecified route of administration on 31Jul2021, as dose 2, Single for COVID-19 immunization. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s medical history included nausea, depression mental, pilonidal cyst pain and pain from an unknown date and unknown if ongoing. Historical vaccination included that the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as dose 1 for COVID-19 immunisation. Concomitant medications included cyclizine taken for nausea, duloxetine taken for Depression mental, morphine sulfate (ORAMORPH [MORPHINE SULFATE]) taken for Pilonidal cyst pain and paracetamol taken for pain, start and stop date were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 01Aug2021, the patient experienced nausea, fainting, feeling unwell, aching joints and felt faint. All the events were serious (medically significant). The outcome of the event nausea was recovering and the outcome of the events fainting, feeling unwell, aching joints and felt faint was not recovered. No follow-up attempts are possible; No further information expected.


VAERS ID: 1576026 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hyperhidrosis, Insomnia, Muscle spasms, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (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: 20210801; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984743

Write-up: Fever; sweating; insomnia; full body spasms; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011948088790-ORJUO. Safety Report Unique Identifier is GB-MHRA-ADR 25738343. A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 31Jul2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On an unspecified date in 2021, the patient experienced sweating, insomnia, and full body spasms. On 01Aug2021, the patient experienced fever. The events were reported as serious per other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 01Aug2021. The clinical course was reported as follows: Went to bed 11:30. Suffered insomnia all night. Sweating profusely with full body spasms. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event fever was recovering. The outcome of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1576039 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984601

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108012044593900-2LUPP, safety report unique identifier is GB-MHRA-ADR 25738381. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 30Jul2021 (Lot Number: FD8813) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient experienced swollen lymph nodes on 01Aug2021 with outcome of not recovered. The patient underwent lab test which included Covid-19 virus test: negative on No - Negative COVID-19 test. The event was assessed as serious and medically significant by regulatory authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576053 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast pain, Chest pain, Neck pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Lipodystrophy (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984314

Write-up: painful breasts; Breast pain; Neck pain; Chest pain; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108012156307980-2S9XN. Safety Report Unique Identifier GB-MHRA-ADR 25738438. A 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 30Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient medical history included suppressed lactation from unknown start date and unknown if ongoing, suspected covid-19 from 06Oct2019 to 09Jan2020. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 03Jun2021 for COVID-19 immunisation with reaction breast pain, Onychalgia, Menstruation irregular. It was reported that on an unspecified date, the patient experienced painful breasts, on 01Aug2021, breast pain, neck pain. chest pain. The events were reported as serious, medically significant. Period came 2 weeks early after first vaccine dose, pain in toes with no sign of any rash or redness. Painful breasts. Neck pain, pain in chest area and pain in toes with no sign of any rash or redness. Painful breasts. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of event was painful breasts was unknown, for breast pain was recovering and for events neck pain, chest pain was not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100998084 same patient/same drug, different event/ dose.


VAERS ID: 1576056 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Lethargy, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: AVAMYS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic nasal congestion; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984381

Write-up: Sore throat; Chills; Headache; Tiredness; Lethargy; This is a spontaneous report from a contactable Consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108012207404010-OE667, Safety Report Unique Identifier GB-MHRA-ADR 25738444. A 29-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FE1510) via an unspecified route of administration on 31Jul2021 as dose 2, single dose for COVID-19 immunization and ibuprofen (IBUPROFEN) via route of administration, start and stop date, batch/lot number and dose were not reported for oropharyngeal pain. Medical history included suspected covid-19 from an unknown date and unknown if ongoing. Unsure when symptoms started. Unsure when symptoms stopped, nasal congestion from an unknown date and unknown if ongoing. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on unknown date as dose 1, single dose for COVID-19 immunization. Concomitant medication included fluticasone furoate (AVAMYS) taken for nasal congestion, start and stop date were not reported. The patient experienced headache on 01Aug2021 10:30, sore throat and chills on 01Aug2021 14:00, tiredness and lethargy on 01Aug2021. Patient received therapeutic measures for headache. Case summary: Felt fine on day on the vaccine. Had trouble waking up / getting out of bed the following day due to tiredness / lethargy, which persisted throughout the day. Headache began at around 10:30, getting worse until about 17:00 until I took ibuprofen. Sore throat and chills around 14:00, resolved around 17:00 (before taking ibuprofen). The patient underwent lab tests and procedures which included sars-cov-2 test: negative, No - Negative COVID-19 test. The clinical outcome of the events chills recovered on 01Aug2021 and Sore throat was on unspecified date 2021 and other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576065 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Condition aggravated, Confusional state, Decreased appetite, Diverticulitis, Fatigue, Haematochezia, Inappropriate schedule of product administration, Migraine, Mucous stools, Paraesthesia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Medication errors (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: CO-AMOXICLAV [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]; FLUCLOXACILLIN; MIRTAZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bowel obstruction; Depression; Diverticulosis; Fever; IBD (Unclassified IBD); Liver disorder (Suboptimal liver); Perianal fistula
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984564

Write-up: fatigue/ extreme fatigue; Dose 1, 17May2020/ Dose 2, 31Jul2021; Horrendous flare up; Diverticulitis; Swollen abdomen; Mucus stools; Blood stool; Migraine; Appetite lost; Pins and needles; Confusion state/ confusion; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108012246332280-DW9QG, Safety Report Unique Identifier is GB-MHRA-ADR 25738473. A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 31Jul2021 (lot number: Fe3380) as dose 2, single for COVID-19 immunisation. The patient''s medical history included liver disorder (suboptimal liver), perianal fistula, diverticulosis, narrowing of bowel, inflammatory bowel disease (unclassified IBD), depression, and pyrexia, all from unspecified date. Patient had not had symptoms associated with COVID-19. Concomitant medications included amoxicillin sodium/clavulanate potassium (CO-AMOXICLAV) taken for perianal fistula from 01Jul2021, flucloxacillin (FLUCLOXACILLIN) taken for perianal fistula from 01Jul2021 to 14Jul2021, mirtazapine taken for depression from 01Jan2016. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ew3143) on 17May2021 as dose 1, single for COVID-19 immunisation. The patient experienced fatigue on an unspecified date, diverticulitis, swollen abdomen, mucus stools, blood stool, migraine, appetite lost, pins and needles, and confusion state, all on 01Aug2021. It was reported that clinical history of unclassified IBD. Horrendous flare up one day after second vaccine (01Aug2021) after months of remission. Confusion, pins and needles, confusion present, extreme fatigue. No other clinical symptoms such as fever etc. (as reported). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test (negative, no - negative COVID-19 test) on 07Jul2021. The outcome of the events was unknown for fatigue and "Dose 1, 17May2020/ Dose 2, 31Jul2021" and not resolved for all other events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576076 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984498

Write-up: Fever chills; chills; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108020105289520-ATIKZ, Safety Report Unique Identifier GB-MHRA-ADR 25738528. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported), via an unspecified route of administration on 01Aug2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported.The previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number:Not reported) via unspecified route of administration on unspecified date as dose 1, single for covid-19 immunisation.The patient was not enrolled in clinical trial. The patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. In Aug2021, at about 1 AM, the patient experienced chills. On 02Aug2021, the patient experienced fever chills. The clinical course was as follows: The patient experienced severe chills beginning at about 1 AM, which subsided greatly following treatment with fluid and ibuprofen intake but not completely. Treatment received for the events included fluid intake and ibuprofen. The patient had not tested positive for COVID-19 since having the vaccine. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1576078 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984542

Write-up: stomachache; Diarrhea; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108020138179940-KYIY3, Safety Report Unique Identifier GB-MHRA-ADR 25738532. A 32-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported), via an unspecified route of administration at single dose on 29Jul2021 for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced stomachache (medically significant) on an unspecified date with outcome of not recovered, diarrhea (medically significant) on 01Aug2021 with outcome of not recovered. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient took antidiarrheal pills but still She had stomachache and diarrhoea. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1576080 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Fatigue, Pain in jaw, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Osteonecrosis (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; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984378

Write-up: This is a spontaneous report from a contactable consumer received from the Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108020306185710-JKEJQ. Safety Report Unique Identifier GB-MHRA-ADR 25738541. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: not reported), via an unspecified route of administration on 01Aug2021 (at the age of 33-year-old) as dose 2, single for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On 01Aug2021, the patient experienced earache, jaw pain, fever, and tiredness. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unspecified date. Patient was not enrolled in clinical trial. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1576082 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy, Musculoskeletal stiffness, Pain, SARS-CoV-2 test, Tenderness
SMQs:, 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: EVOREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Transgender hormonal therapy
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984399

Write-up: stiffness; supraclavicular lymph node; Supraclavicular lymph nodes enlarged; Pain; Tenderness; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108020321127710-KW6FK. A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: FC9001), via an unspecified route of administration on 31Jul2021 10:00 as dose 2, single for covid-19 immunization. Medical history included transgender hormonal therapy from an unknown date and unknown if ongoing. Concomitant medications included estradiol (EVOREL) taken for transgender hormonal therapy from 01Jan2017 to an unspecified stop date. The patient experienced stiffness, supraclavicular lymph node on an unspecified date, supraclavicular lymph nodes enlarged, pain, tenderness on 01Aug2021. Therapeutic measures were taken as a result of pain. Had the jab 10am 31Jul. Woke up 01Aug feeling very sore and stiff down my left arm and left upper and lower back. Stiffness/soreness improved throughout 01Aug, but noticed in the evening that base of the neck/above clavicle on the left side (injection site on left upper arm near shoulder) was still very sore and tender. Digital examination showed a small lump in area of the supraclavicular lymph node. Slightly mobile when pushed, but returning to one spot. About the size of an olive pit. Painful to the touch. Hoping it goes away, treating with ibuprofen and paracetamol. Patient has not tested positive for COVID-19 since having the vaccine, Patient was not enrolled in clinical trial. None, yet, but if it persists on Tuesday 03Aug, I will be seeing a medical examination of the mass. The events were assessed as serious. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Aug2021 No - Negative COVID-19 test. The outcome of event for Supraclavicular lymph nodes enlarged, Pain, Tenderness was not recovered on unknown date. Outcome of other events was recovering on unknown date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576088 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Malaise, Maternal exposure during breast feeding, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Neonatal exposures via breast milk (narrow), Medication errors (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: ASPIRIN [ACETYLSALICYLIC ACID]; OMEPRAZOLE; IRON
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210702; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984351

Write-up: feeling unwell; Chills; Off-label use; Drug use in unapproved population; Maternal exposure during breast feeding; This is a spontaneous report from a contactable consumer. This is a report received from the . Regulatory authority report number (GB-MHRA-WEBCOVID-202108020728332530-KPKBX), Safety Report Unique Identifier (GB-MHRA-ADR 25739167). This other healthcare professional reported information for both mother and baby. This is the maternal case. A 34-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on 01Aug2021 at 18:00 as dose 2,single for covid-19 immunization. Medical history included pregnancy, anaemia and ongoing breast feeding. It was reported that the patient was pregnant until the start of July and had her first vaccine dose whilst pregnant and all medications she was taking were in relation to her pregnancy. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Concomitant medications included aspirin [acetylsalicylic acid] taken for pregnancy, omeprazole taken for an unspecified indication from 15Apr2021 to 04Jul2021; iron taken for anaemia from 22Mar2021 to an unspecified stop date. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date in Jul2021 as dose 1,single for covid-19 immunization and had vaccine exposure during pregnancy. On an unspecified date in Aug2021, the patient had maternal exposure during breast feeding. On 02Aug2021, at about morning 06:00, the patient woke up with chills and feeling unwell. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests which included sars-cov-2 test: negative on 02Jul2021 (No - Negative COVID-19 test). The outcome of event chills was not resolved and for rest events it was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100999236 Baby case


VAERS ID: 1576093 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Myalgia, SARS-CoV-2 test, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (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: IBUPROFEN; MULTIVITAMINS [VITAMINS NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sleepy; Muscle aches; Headache; Muscular pains; Tiredness; Chills; This case was received via regulatory authority; (Reference number: 25739304) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), HEADACHE (Headache), MYALGIA (Muscular pains), FATIGUE (Tiredness), CHILLS (Chills) and MYALGIA (Muscle aches) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included IBUPROFEN and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscular pains) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced SOMNOLENCE (Sleepy) (seriousness criterion medically significant) and MYALGIA (Muscle aches) (seriousness criterion medically significant). At the time of the report, SOMNOLENCE (Sleepy) and MYALGIA (Muscle aches) had resolved and HEADACHE (Headache), MYALGIA (Muscular pains), FATIGUE (Tiredness) and CHILLS (Chills) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. Treatment information was not provided. Patient had pain in arm then tiredness and chills and muscle aches. She had a terrible headache at night. She took ibuprofen at night but nothing else. She went to bed at 8 as soon as she reached at home as she felt unable to do anything and felt very sleepy. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576101 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthma, Fatigue, Feeling of body temperature change, Migraine, Myalgia, Nasopharyngitis, Pain, Pyrexia, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SALBUTAMOL
Current Illness: Asthma; Wheeze
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: asthma; pain; cold; Feeling hot and cold; Wheeze; Wheeze; Chronic migraine; Muscle ache; Fatigue; Feverish; Joint pain; This regulatory authority case was reported by a consumer and describes the occurrence of ASTHMA (asthma), PAIN (pain), NASOPHARYNGITIS (cold), the first episode of WHEEZING (Wheeze), MIGRAINE (Chronic migraine), MYALGIA (Muscle ache), FATIGUE (Fatigue), PYREXIA (Feverish) and ARTHRALGIA (Joint pain) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: DEPO-MEDRONE. Concurrent medical conditions included Asthma and Wheeze. Concomitant products included SALBUTAMOL from 01-Aug-2021 to an unknown date for Asthma. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced the first episode of WHEEZING (Wheeze) (seriousness criterion medically significant), MIGRAINE (Chronic migraine) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHMA (asthma) (seriousness criterion medically significant), PAIN (pain) (seriousness criterion medically significant), NASOPHARYNGITIS (cold) (seriousness criterion medically significant), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and the second episode of WHEEZING (Wheeze). The patient was treated with PARACETAMOL for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHMA (asthma), PAIN (pain), NASOPHARYNGITIS (cold), MIGRAINE (Chronic migraine), MYALGIA (Muscle ache), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) had not resolved, PYREXIA (Feverish) was resolving and FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and the last episode of WHEEZING (Wheeze) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant information included steroid inhaler. The patient stated that she had similar reactions after first vaccination but not severe as the second vaccine. The patient had been up all night going hot and cold and with the pain in her body being so severe that paracetamol and ibuprofen are not resolving it. The patient also experienced a severe wheeze. She had this from the first dose and it failed to resolve for 2 weeks. She was concerned about this side effect as she had severe asthma. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576113 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Myalgia, Pain in extremity, 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: RIGEVIDON (28)
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Generalized muscle aches; Chills; Fever; Aches & pains in legs; This case was received via RA (Reference number: 25740180) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aches & pains in legs), MYALGIA (Generalized muscle aches), CHILLS (Chills) and PYREXIA (Fever) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (RIGEVIDON (28)) from 15-Jul-2021 to an unknown date for an unknown indication. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (Generalized muscle aches) (seriousness criterion medically significant). On 02-Aug-2021, CHILLS (Chills) had resolved with sequelae, PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Aches & pains in legs) and MYALGIA (Generalized muscle aches) had not resolved. Treatment details not provided. On an unknown date in Aug-2021, the patient experienced Generalized muscle aches. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576114 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Epistaxis, Eye swelling, Hypersensitivity, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (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: Medical History/Concurrent Conditions: Lactation decreased
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.MOD20212

Write-up: allergic reaction; my nose; Swollen eyes; This case was received via United Kingdom MHRA (Reference number: ADR 25740225) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), EPISTAXIS (my nose) and EYE SWELLING (Swollen eyes) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced EYE SWELLING (Swollen eyes) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction) (seriousness criterion medically significant) and EPISTAXIS (my nose) (seriousness criterion medically significant). At the time of the report, HYPERSENSITIVITY (allergic reaction) and EPISTAXIS (my nose) outcome was unknown and EYE SWELLING (Swollen eyes) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment medications were not reported Patients nose, cheeks and under eyes were badly swollen and painful and nose felt hot and red. Patient was not enrolled in Clinical trial Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Coding of the events was retained per Regulatory Authority case. The event of [epistaxis] was reported as "my nose"".; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Coding of the events was retained per Regulatory Authority case. The event of [epistaxis] was reported as "my nose"".


VAERS ID: 1576116 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Nausea, Pyrexia, SARS-CoV-2 test
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:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fever; Chills; Headache; Nausea; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-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 products were reported. No treatment information provided. Patient was not enrolled in clinical trial. He did not test positive for COVID-19 since having the vaccine. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness criteria for the events was captured by regulatory authority, however based on medical judgement the case is non serious. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness criteria for the events was captured by regulatory authority, however based on medical judgement the case is non serious. No further information is expected.


VAERS ID: 1576117 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-08-01
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Inappropriate schedule of product administration, Injection site pain, Maternal exposure during breast feeding, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Neonatal exposures via breast milk (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during breast feeding; Pain joint; Muscle ache; Headache; Inappropriate schedule of vaccine administarted; Pain injection site; This case was received via Agency Regulatory Authority (Reference number: 25740389) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding), ARTHRALGIA (Pain joint), MYALGIA (Muscle ache), INJECTION SITE PAIN (Pain injection site) and HEADACHE (Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003608 and 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Breast feeding. On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant). 01-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administarted). On 02-Aug-2021, the patient experienced ARTHRALGIA (Pain joint) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). On 01-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administarted) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown and ARTHRALGIA (Pain joint), MYALGIA (Muscle ache), INJECTION SITE PAIN (Pain injection site) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was given. No treatment medication was given. Company comment: This is a case of maternal exposure during breast feeding and inappropriate schedule of product administration. Based on the current available information and temporal association between the use of the product and the onset of the rest of the events, a causal relationship cannot be excluded.; Sender''s Comments: This is a case of maternal exposure during breast feeding and inappropriate schedule of product administration. Based on the current available information and temporal association between the use of the product and the onset of the rest of the events, a causal relationship cannot be excluded.


VAERS ID: 1576128 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Blood iron, Chills, Decreased appetite, Fatigue, Full blood count, Headache, Injection site pain, Lymphadenopathy, Nasopharyngitis, Nausea, Overdose, Pain, SARS-CoV-2 test, Temperature intolerance
SMQs:, Acute pancreatitis (broad), Drug abuse and dependence (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Medication errors (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: IRON; NEXPLANON; IMPLANON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraceptive implant (Regular periods); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood iron; Result Unstructured Data: per patient 112 g/l, however patient was not sure. Patient could not donate blood from summer last year, prescribed iron supplements; Test Date: 2021; Test Name: Full blood count; Test Result: Inconclusive ; Result Unstructured Data: 140 g/l, allowed to donate blood again last week, where tested at 140 g/l.; Test Date: 20210718; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: soreness; radiating heat; cold; shivering; tiredness; nauseated; dose; Appetite lost; Shivers; Nausea; Arthralgia; Swollen lymph nodes; Fatigue; Headache; Injection site pain; This regulatory authority case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite lost), PAIN (soreness), TEMPERATURE INTOLERANCE (radiating heat), NASOPHARYNGITIS (cold), ARTHRALGIA (Arthralgia), LYMPHADENOPATHY (Swollen lymph nodes), FATIGUE (Fatigue), HEADACHE (Headache), INJECTION SITE PAIN (Injection site pain), CHILLS (shivering), FATIGUE (tiredness), CHILLS (Shivers), NAUSEA (Nausea), NAUSEA (nauseated) and OVERDOSE (dose) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Contraceptive implant (Regular periods). Concomitant products included IRON from 01-Jul-2021 to an unknown date for Anaemia iron deficiency, ETONOGESTREL (NEXPLANON) from 03-Oct-2018 to an unknown date for Contraception, ETONOGESTREL (IMPLANON) for Contraceptive implant. On 01-Aug-2021 at 8:45 AM, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant), ARTHRALGIA (Arthralgia) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (soreness) (seriousness criterion medically significant), TEMPERATURE INTOLERANCE (radiating heat) (seriousness criterion medically significant), NASOPHARYNGITIS (cold) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant), FATIGUE (tiredness) (seriousness criterion medically significant), NAUSEA (nauseated) (seriousness criterion medically significant) and OVERDOSE (dose) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Adverse event, at an unspecified dose and frequency. On 02-Aug-2021, NAUSEA (Nausea) had resolved. At the time of the report, DECREASED APPETITE (Appetite lost), PAIN (soreness), TEMPERATURE INTOLERANCE (radiating heat), NASOPHARYNGITIS (cold), ARTHRALGIA (Arthralgia), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (shivering), FATIGUE (tiredness), CHILLS (Shivers), NAUSEA (nauseated) and OVERDOSE (dose) was resolving and FATIGUE (Fatigue), HEADACHE (Headache) and INJECTION SITE PAIN (Injection site pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood iron: 112 (Low) per patient 112 g/l, however patient was not sure. Patient could not donate blood from summer last year, prescribed iron supplements. In 2021, Full blood count: 140 (Inconclusive) 140 g/l, allowed to donate blood again last week, where tested at 140 g/l.. On 18-Jul-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient took the second dose of moderna COVID-19 vaccine on sunday 08:45. Patient felt adverse event after vaccine administration. Patient took 2 paracetamol around 9 pm and slept. Patient woke up feeling significantly better. Patient again took 1 paracetamol in the early morning next day. Adverse reactions are reducing through the day. Patient started to menstruate on Monday. Patient had minimal reactions to first dose some soreness, tiredness etc. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness were captured as per Regulatory Authority assessment in Source Document.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Events seriousness were captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1576129 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-08-01
   Days after vaccination:66
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Headache, Influenza like illness, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: vomiting; Vomited; Flu-like aching; Armpit pain; Headache; This case was received via RA (Reference number: ADR 25741470) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like aching), AXILLARY PAIN (Armpit pain), VOMITING (vomiting), VOMITING (Vomited) and HEADACHE (Headache) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant) and VOMITING (Vomited) (seriousness criterion medically significant). On an unknown date, the patient experienced VOMITING (vomiting) (seriousness criterion medically significant). On 02-Aug-2021, VOMITING (Vomited) and HEADACHE (Headache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like aching) and AXILLARY PAIN (Armpit pain) was resolving and VOMITING (vomiting) outcome was unknown. no concomitant and treatment medications reported. It was reported that the patient had flu-like symptoms from the first vaccination, and from the second also had flu-like symptoms alongside vomiting about 10 hours after the vaccination. The patient has not tested positive for COVID-19 since having the vaccine. The patient is not enrolled in clinical trial. Company Comment: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #3003651) with associated AEs: headache, vomiting, influenza like illness and axillary pain. Reportedly, the patient developed flu-like symptoms following the first vaccination, and following the second vaccination, the patient had these symptoms alongside vomiting. The remaining events were retained as per the source document. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The company causality for the event inappropriate schedule of vaccine administered is not applicable.; Sender''s Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #3003651) with associated AEs: headache, vomiting, influenza like illness and axillary pain. Reportedly, the patient developed flu-like symptoms following the first vaccination, and following the second vaccination, the patient had these symptoms alongside vomiting. The remaining events were retained as per the source document. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The company causality for the event inappropriate schedule of vaccine administered is not applicable.


VAERS ID: 1576133 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Disturbance in attention, Erythema, Myalgia, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: joint pain; fever; Pain at injection site; Redness of chest; Struggling to concentrate; Feel weak; Muscle pain; This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), ARTHRALGIA (joint pain), PYREXIA (fever), VACCINATION SITE PAIN (Pain at injection site), ERYTHEMA (Redness of chest), DISTURBANCE IN ATTENTION (Struggling to concentrate) and ASTHENIA (Feel weak) in a 23-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Suspected COVID-19 since 01-Aug-2021. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (joint pain) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant), VACCINATION SITE PAIN (Pain at injection site) (seriousness criterion medically significant), ERYTHEMA (Redness of chest) (seriousness criterion medically significant), DISTURBANCE IN ATTENTION (Struggling to concentrate) (seriousness criterion medically significant) and ASTHENIA (Feel weak) (seriousness criterion medically significant). The patient was treated with PARACETAMOL at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle pain) had not resolved, ARTHRALGIA (joint pain) and PYREXIA (fever) was resolving and VACCINATION SITE PAIN (Pain at injection site), ERYTHEMA (Redness of chest), DISTURBANCE IN ATTENTION (Struggling to concentrate) and ASTHENIA (Feel weak) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were given by the reporter. Muscle pain, joint pain, pain at the injection site, fever and redness on the chest. Struggling to concentrate. Feel weak- pain subsides only slightly with paracetamol. Symptoms started one day after the vaccine and continue to persist. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576149 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Injection site pain, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORATADINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: muscle aches; Fever; Shivers; Generalised muscle aches; Injection site pain; This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches), PYREXIA (Fever), CHILLS (Shivers), INJECTION SITE PAIN (Injection site pain) and MYALGIA (Generalised muscle aches) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included LORATADINE from 01-Sep-2006 to an unknown date for Hay fever. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant) and MYALGIA (Generalised muscle aches) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (muscle aches) (seriousness criterion medically significant). At the time of the report, MYALGIA (muscle aches) outcome was unknown and PYREXIA (Fever), CHILLS (Shivers), INJECTION SITE PAIN (Injection site pain) and MYALGIA (Generalised muscle aches) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Company comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576153 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Hyperhidrosis, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: pass out; Fainting; sweating; joint pain; This case was received via United Kingdom MHRA (Reference number: ADR 25743573) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (pass out), SYNCOPE (Fainting), HYPERHIDROSIS (sweating) and ARTHRALGIA (joint pain) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (pass out) (seriousness criterion medically significant), SYNCOPE (Fainting) (seriousness criterion medically significant), HYPERHIDROSIS (sweating) (seriousness criterion medically significant) and ARTHRALGIA (joint pain) (seriousness criterion medically significant). On 01-Aug-2021, SYNCOPE (Fainting) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (pass out), HYPERHIDROSIS (sweating) and ARTHRALGIA (joint pain) was resolving. The patient felt run down and was aching. They woke up 6am they following day and could not move due to joint pain. The patient''s heart started racing and they started sweating and reportedly passed out for a few minutes. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1576157 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cold sweat, Dizziness, Influenza, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decreased lactation.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This case was received via the regulatory authority (reference number: 25743864) on Aug 3, 2021 and forwarded to Moderna. This regulatory authority case reported by a consumer, describes the occurrence of syncope (fainting), influenza (flu), dizziness (felt faint), cold sweat and nausea in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Medical history included decreased lactation. On Jul 31, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 1, 2021, patient experienced syncope/fainting (medically significant), cold sweat (medically significant) and nausea (medically significant). On an unknown date, patient experienced influenza/flu (medically significant) and dizziness/felt faint (medically significant). On Aug 1, 2021, syncope (fainting) and cold sweat resolved. At the time of the report, influenza (flu), dizziness (felt faint) and nausea: resolving. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided. Vaccine given at 11:00 on Saturday, July 31st and had feeling flu-type symptoms. Went downstairs to get water, felt faint and cold sweat started, which lasted hours. Patient was not able to stay awake for more than hour period. Patient had not tested positive for COVID-19 since the vaccination. Sender''s comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded.


VAERS ID: 1576165 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, 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: CERELLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Pain in arm; Chills; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills) and FATIGUE (Fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included DESOGESTREL (CERELLE) from 31-Jan-2019 to an unknown date for Contraception. On 01-Aug-2021 at 11:30 AM, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). The patient was treated with PARACETAMOL ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Pain in arm), CHILLS (Chills) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Company comment- Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time


VAERS ID: 1576166 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Rash erythematous, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), 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: FEXOFENADINE; OMEPRAZOLE
Current Illness: Allergy; Esophageal reflux
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
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.MOD20212

Write-up: Red rash; Muscle pain; This case was received via the Regulatory Authority (Reference number: 25744118) on 03-Aug-2021 and was forwarded to the company on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) and MYALGIA (Muscle pain) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Esophageal reflux and Allergy. Concomitant products included FEXOFENADINE for Allergy, OMEPRAZOLE for Esophageal reflux. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). At the time of the report, RASH ERYTHEMATOUS (Red rash) and MYALGIA (Muscle 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. A large 4cm diameter red rash had appeared on the arm which was injected. It was very painful to touch. No treatment information was provided by the reporter. The patient not had symptoms associated with COVID-19 and the patient was not pregnant. The patient was not currently breastfeeding. The patient had not tested positive for COVID-19 since having the vaccine and the patient was not enrolled in clinical trial. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events doesn?t seem to be serious by medical judgement, but they were assessed as serious as per regulatory authority report.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events doesn?t seem to be serious by medical judgement, but they were assessed as serious as per regulatory authority report.


VAERS ID: 1576182 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Hyperhidrosis, Insomnia, Maternal exposure during breast feeding, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Neonatal exposures via breast milk (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: PARACETAMOL
Current Illness: Headache
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: SARS-CoV-2 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Shivering; hot sweats; Trouble sleeping; Fever; Chills; Headache; Maternal exposure during breast feeding; This case was received via the Regulatory AuthorityRA (Reference number: 202108031023512110) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (hot sweats), INSOMNIA (Trouble sleeping), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding), CHILLS (Shivering), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. Concurrent medical conditions included Headache. Concomitant products included PARACETAMOL from 01-Aug-2021 to 03-Aug-2021 for Headache. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (hot sweats) (seriousness criterion medically significant), INSOMNIA (Trouble sleeping) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On 01-Aug-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. On 03-Aug-2021, PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, HYPERHIDROSIS (hot sweats), INSOMNIA (Trouble sleeping) and CHILLS (Shivering) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, SARS-CoV-2 test: negative (Negative) SARS-CoV-2 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication information provided. Patient is not enrolled in clinical trial. Company Comment This is a case of product exposure during breastfeeding with some associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: This is a case of product exposure during breastfeeding with some associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576183 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30003651 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Dizziness, Headache, Nausea, Pyrexia
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)

Life Threatening? No
Birth Defect? No
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: Gilbert''s syndrome; Suspected COVID-19.
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Appetite lost; Dizziness; Feverish; Headache; Nausea; This case was received via Regulatory Authority (Reference number: 25745817) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite lost), DIZZINESS (Dizziness), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Feverish) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 30003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Suspected COVID-19 since 02-Aug-2021. Concurrent medical conditions included Gilbert''s syndrome. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On 02-Aug-2021, DECREASED APPETITE (Appetite lost), DIZZINESS (Dizziness) and PYREXIA (Feverish) had resolved. At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The Concomitant medications were not provided. The Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1576185 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Nausea, Pain in extremity, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sore arm; Rash; Neck rash; Tiredness; Nausea; Painful arm; This case was received via RA (Reference number: ADR 25746010) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH (Rash), FATIGUE (Tiredness), NAUSEA (Nausea), RASH (Neck rash) and PAIN IN EXTREMITY (Painful arm) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced RASH (Neck rash) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) (seriousness criterion medically significant) and RASH (Rash) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Pain in arm, at an unspecified dose and frequency and ZINGIBER OFFICINALE (GINGER [ZINGIBER OFFICINALE]) for Nausea, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), RASH (Rash), FATIGUE (Tiredness), NAUSEA (Nausea) and PAIN IN EXTREMITY (Painful arm) was resolving and RASH (Neck rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-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. The patient was prescribed with some antihistamine tablets. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment for the tiredness included coffee. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576192 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, Spinal pain, Swelling face, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Vomiting; Nausea; Swollen of face feeling; Pain in spine; This case was received via regulatory authority (Reference number: 25747010) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING FACE (Swollen of face feeling), SPINAL PAIN (Pain in spine), VOMITING (Vomiting) and NAUSEA (Nausea) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced SWELLING FACE (Swollen of face feeling) (seriousness criterion medically significant) and SPINAL PAIN (Pain in spine) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 02-Aug-2021, SWELLING FACE (Swollen of face feeling) had resolved. At the time of the report, SPINAL PAIN (Pain in spine), VOMITING (Vomiting) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provider by the reporter. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of events were based on the RA report received, which categorized them as other medically important conditions.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of events were based on the RA report received, which categorized them as other medically important conditions.


VAERS ID: 1576213 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Hyperhidrosis, Pyrexia, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORATADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fever
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: sweating; chills; In the morning my fever was gone but the entire day I felt groggy and tired; In the morning my fever was gone but the entire day I felt groggy and tired; Fever; This case was received via Regulatory Authority (Reference number: 25748771) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), CHILLS (chills) and PYREXIA (Fever) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Fever. Concomitant products included LORATADINE from 01-Jun-2021 to an unknown date for Hay fever. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced SOMNOLENCE (In the morning my fever was gone but the entire day I felt groggy and tired) and FATIGUE (In the morning my fever was gone but the entire day I felt groggy and tired). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant) and CHILLS (chills) (seriousness criterion medically significant). On 02-Aug-2021, PYREXIA (Fever) had resolved. On 03-Aug-2021, SOMNOLENCE (In the morning my fever was gone but the entire day I felt groggy and tired) and FATIGUE (In the morning my fever was gone but the entire day I felt groggy and tired) had resolved. At the time of the report, HYPERHIDROSIS (sweating) and CHILLS (chills) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was reported. About 6 hours after the second dose patient started to feel like patient was getting a head-cold. Throughout the night patient had fever between 38-39 accompanied by chills and sweating. In the morning fever was gone but the entire day patient felt groggy and tired. On the second day patient was back to normal. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1576228 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Oral herpes, Pain, SARS-CoV-2 test
SMQs:, Oropharyngeal infections (narrow), 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: L-THYROXINE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Herpes NOS (as child); Lactation decreased
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.MOD20212

Write-up: Herpes labialis; Ache; Chills; This case was received via regulatory authority (Reference number: ADR 25750207) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ORAL HERPES (Herpes labialis), PAIN (Ache) and CHILLS (Chills) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Herpes NOS (as child). Concomitant products included L-THYROXINE from 01-Jul-2018 to an unknown date for Hashimoto''s disease, PARACETAMOL from 01-Jun-2021 to an unknown date for Menstrual cramp. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced ORAL HERPES (Herpes labialis) (seriousness criterion medically significant). On 02-Aug-2021, PAIN (Ache) and CHILLS (Chills) had resolved. At the time of the report, ORAL HERPES (Herpes labialis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment included Paracetamol for aches. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further follow-up information is expected at this time; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further follow-up information is expected at this time.


VAERS ID: 1576233 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Menstrual disorder, Pelvic pain, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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: 20210731; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 virus test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Painful pelvic area like period pain; Painful pelvic area like period pain; Do not get periods normally; Vaginal bleeding; This regulatory authority case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSMENORRHOEA (Painful pelvic area like period pain), PELVIC PAIN (Painful pelvic area like period pain) and MENSTRUAL DISORDER (Do not get periods normally). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding) had not resolved and DYSMENORRHOEA (Painful pelvic area like period pain), PELVIC PAIN (Painful pelvic area like period pain) and MENSTRUAL DISORDER (Do not get periods normally) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 virus test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. The patient had Painful pelvic area like period pain but with spotting and slight discharge. do not get periods normally No treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company Comment Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576242 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: headache; chills; Muscle ache; Fever chills; Headache dull; High temperature; Fatigue; This case was received via RA (Reference number: ADR 25751064) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills), MYALGIA (Muscle ache), PYREXIA (Fever chills), HEADACHE (Headache dull), PYREXIA (High temperature) and FATIGUE (Fatigue) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), HEADACHE (Headache dull) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant) and CHILLS (chills) (seriousness criterion medically significant). On 01-Aug-2021, PYREXIA (Fever chills) had resolved. On 02-Aug-2021, MYALGIA (Muscle ache), HEADACHE (Headache dull) and PYREXIA (High temperature) had resolved. On 03-Aug-2021, FATIGUE (Fatigue) had resolved. At the time of the report, HEADACHE (headache) and CHILLS (chills) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. No concomitant medications were reported. No treatment information was provided. Rough nights sleep with muscle aches which lasted right through the following day along with chills or feeling very hot & mild headache. Still not 100% the day that followed these 2 but day after that was back to normal. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576251 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-08-01
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Body temperature, Fatigue, Headache, Inappropriate schedule of product administration, Lethargy, Neck pain, Organic erectile dysfunction, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (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: CERELLE
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: ?C; Test Name: Body temperature; Result Unstructured Data: ?C; Test Name: Body temperature; Result Unstructured Data: ?C; Test Date: 20210803; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: morning temperature; lethargic; Neck pain; Armpit pain; Headache; Tiredness; Second dose late (05-JUN-2021 and 01-AUG-2021, 57 days); Fever; This case was received via regulatory authority (Reference number: 25751927) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), ORGANIC ERECTILE DYSFUNCTION (morning temperature), LETHARGY (lethargic), PYREXIA (Fever), AXILLARY PAIN (Armpit pain), HEADACHE (Headache) and FATIGUE (Tiredness) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003651 and 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included DESOGESTREL (CERELLE) for Contraception. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). 01-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose late (05-JUN-2021 and 01-AUG-2021, 57 days)). On 03-Aug-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced ORGANIC ERECTILE DYSFUNCTION (morning temperature) (seriousness criterion medically significant) and LETHARGY (lethargic) (seriousness criterion medically significant). The patient was treated with PARACETAMOL at a dose of UNK, qid. On 01-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose late (05-JUN-2021 and 01-AUG-2021, 57 days)) had resolved. On 03-Aug-2021, PYREXIA (Fever) had resolved with sequelae. At the time of the report, NECK PAIN (Neck pain), AXILLARY PAIN (Armpit pain), HEADACHE (Headache) and FATIGUE (Tiredness) had not resolved and ORGANIC ERECTILE DYSFUNCTION (morning temperature) and LETHARGY (lethargic) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, SARS-CoV-2 test: negative (Negative) negative COVID-19 test. On an unknown date, Body temperature: 39 (Low) ?C, 38.2 (Low) ?C and 37.4 degrees (Low) ?C. Patient has not tested positive for COVID-19 since having the vaccine. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of the events are based on the Regulatory Report received, as per narrative and medical judgement the events for this case are non serious. There is a discrepancy regarding coding of the event morning temperature.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of the events are based on the Regulatory Report received, as per narrative and medical judgement the events for this case are non serious. There is a discrepancy regarding coding of the event morning temperature.


VAERS ID: 1576263 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Intermenstrual bleeding, Postmenopausal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MICROGYNON 21
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005792

Write-up: menstrual bleeding; Spotting; Intermenstrual bleeding; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108041218284790-KTEII. Safety Report Unique Identifier: GB-MHRA-ADR 25752965. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: fe3380 and expiry date was not reported), via an unspecified route of administration, on 01Aug2021, as a single dose for COVID-19 immunization. The patient''s medical history included contraception from an unknown date and unknown if ongoing. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. Concomitant medication included ethinylestradiol, levonorgestrel (MICROGYNON 21) taken for contraception, start and stop date were not reported. The patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. On an unspecified date, the patient experienced menstrual bleeding and spotting, then full menstrual bleeding despite being on the pill and not due on for another 1.5/2 weeks. On 01Aug2021, the patient experienced intermenstrual bleeding. Outcome of the event intermenstrual bleeding was not recovered and for all other events, it was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576266 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Cold sweat, Decreased appetite, Dizziness, Feeding disorder, Feeling abnormal, Loss of consciousness, Migraine
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ISOTRETINOIN
Current Illness: Acne; Migraine
Preexisting Conditions: Medical History/Concurrent Conditions: Bursitis (recently treated with steroid injections); Lactation decreased; Tendonitis (recently treated with steroid injections)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fuzzy head; Weakness; clammy; passed out once; lightheaded; Migraine; Appetite lost; unable to eat; This case was received via regulatory authority reference number: 25753161) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out once) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased, Tendonitis (recently treated with steroid injections) and Bursitis (recently treated with steroid injections). Previously administered products included for an unreported indication: DEPO-MEDRONE. Past adverse reactions to the above products included No adverse event with DEPO-MEDRONE. Concurrent medical conditions included Acne and Migraine. Concomitant products included ISOTRETINOIN from 01-Jul-2021 to an unknown date for Acne. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced FEEDING DISORDER (unable to eat). On 02-Aug-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced MIGRAINE (Migraine) and DECREASED APPETITE (Appetite lost). On 03-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out once) (seriousness criterion medically significant), COLD SWEAT (clammy) and DIZZINESS (lightheaded). 03-Aug-2021, the patient experienced ASTHENIA (Weakness). On 04-Aug-2021, the patient experienced FEELING ABNORMAL (Fuzzy head). On 03-Aug-2021, MIGRAINE (Migraine) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (passed out once), FEEDING DISORDER (unable to eat), COLD SWEAT (clammy) and DIZZINESS (lightheaded) outcome was unknown and FEELING ABNORMAL (Fuzzy head), ASTHENIA (Weakness) and DECREASED APPETITE (Appetite lost) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. On 02-Aug-2021, woke up with aches all over body. Did not shift all day, slept on and off throughout the day with no improvement. On 03-Aug-2021, aches had gone but felt very faint whenever stood up, became very hot. Not been able to eat since jab, 3 days ago. On 4th August, feeling very weak, still unable to eat and head was very fuzzy. The patient had not tested positive for COVID-19 since having the vaccine. No treatment information was provided by the reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576275 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Decreased lactation.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101006145

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202108041458247220-Q7UKE; safety report unique identifier: GB-MHRA-ADR 25754156). The 41-year-old (non-pregnant) female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# FF3319), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. The patient previously took the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Patient not enrolled in a clinical trial. On Aug 1, 2021, patient experienced heavy periods. Patient reported extraordinarily heavy period bleeding for days 1 and 2 of period. The outcome of the event recovered on Aug 3, 2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1576283 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-06
Onset:2021-08-01
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Inappropriate schedule of product administration, Pain in extremity, Pyrexia, Rash, Sensitive skin
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIAZEPAM; FLUOXETINE; PROPRANOLOL; TRAZODONE
Current Illness: Anxiety; Depression; Panic attack
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Rash; Pain legs; Chills; Diarrhea; Sensitive skin; Pain stomach; Fever; first dose 06 JUN 2021; 2nd dose 01 AUG 2021; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain legs), ABDOMINAL PAIN UPPER (Pain stomach), PYREXIA (Fever), CHILLS (Chills), DIARRHOEA (Diarrhea), SENSITIVE SKIN (Sensitive skin) and RASH (Rash) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003651 and 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and Suspected COVID-19 (Unsure when symptoms stopped) on 29-Dec-2019. Concurrent medical conditions included Panic attack, Depression and Anxiety. Concomitant products included PROPRANOLOL from 01-Aug-2017 to an unknown date and TRAZODONE from 01-May-2017 to an unknown date for Anxiety, FLUOXETINE from 01-Mar-2007 to an unknown date for Depression, DIAZEPAM for Panic attack. On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain stomach) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and SENSITIVE SKIN (Sensitive skin) (seriousness criterion medically significant). 01-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 06 JUN 2021; 2nd dose 01 AUG 2021). On 02-Aug-2021, the patient experienced PAIN IN EXTREMITY (Pain legs) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On 03-Aug-2021, ABDOMINAL PAIN UPPER (Pain stomach) and DIARRHOEA (Diarrhea) had resolved. On 04-Aug-2021, PAIN IN EXTREMITY (Pain legs) had resolved. At the time of the report, PYREXIA (Fever) and CHILLS (Chills) was resolving, SENSITIVE SKIN (Sensitive skin) and RASH (Rash) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 06 JUN 2021; 2nd dose 01 AUG 2021) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. This report refers to a case of inappropriate schedule of product administration for mRNA-1273, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of events was captured as assessed by Regulatory Authority in Source Document.; Sender''s Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, with associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of events was captured as assessed by Regulatory Authority in Source Document.


VAERS ID: 1576300 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Contusion, Erythema
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Bruising; Redness; Chest pressure; Chest heaviness; Tight chest; Chest tightness; Tightness in chest; This regulatory authority case was reported by a consumer and describes the occurrence of CONTUSION (Bruising), ERYTHEMA (Redness), CHEST DISCOMFORT (Chest pressure), CHEST DISCOMFORT (Chest heaviness), CHEST DISCOMFORT (Tight chest), CHEST DISCOMFORT (Chest tightness) and CHEST DISCOMFORT (Tightness in chest) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced CHEST DISCOMFORT (Chest pressure) (seriousness criteria disability and medically significant). 01-Aug-2021, the patient experienced CHEST DISCOMFORT (Chest heaviness) (seriousness criteria disability and medically significant), CHEST DISCOMFORT (Tight chest) (seriousness criteria disability and medically significant), CHEST DISCOMFORT (Chest tightness) (seriousness criteria disability and medically significant) and CHEST DISCOMFORT (Tightness in chest) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced CONTUSION (Bruising) (seriousness criteria disability and medically significant) and ERYTHEMA (Redness) (seriousness criteria disability and medically significant). At the time of the report, CONTUSION (Bruising) and ERYTHEMA (Redness) was resolving and CHEST DISCOMFORT (Chest pressure), CHEST DISCOMFORT (Chest heaviness), CHEST DISCOMFORT (Tight chest), CHEST DISCOMFORT (Chest tightness) and CHEST DISCOMFORT (Tightness in chest) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. After receiving the second dose, patient woke up with feeling tightness in the chest on the next day. Patient reported that the tightness intensified when walking from room to room, doing any physical activity. Patient also felt heavy like there is a stone even the patient is sitting. When the patient is bending over, it felt like everything inside the chest is falling out and pushing hard against the chest. Patient also experienced redness around the injection site. Patient reported that she didn''t had any side effects from the 1st dose other than sore arm around the injection are and a tiny bit of bruising in that area. Concomitant medications were not reported. No treatment details were provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576371 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Disorientation, Dizziness, Headache, Hyperhidrosis, Myalgia, Pustule, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: sweating; disoriented; dizzy; feverish; shivering; chills; Diarrhea; Pustule; Fever; Generalised muscle aches; Fever chills; Headache; This case was received via the Regulatory Authority RA (Reference number: ADR 25764294) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PUSTULE (Pustule), HYPERHIDROSIS (sweating), DISORIENTATION (disoriented), DIZZINESS (dizzy), DIARRHOEA (Diarrhea), HEADACHE (Headache), PYREXIA (feverish), CHILLS (shivering), CHILLS (chills), MYALGIA (Generalised muscle aches), PYREXIA (Fever chills) and PYREXIA (Fever) in a 39-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 02-Aug-2021, the patient experienced MYALGIA (Generalised muscle aches) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced PUSTULE (Pustule) (seriousness criterion medically significant) and DIARRHEA (Diarrhea) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant), DISORIENTATION (disoriented) (seriousness criterion medically significant), DIZZINESS (dizzy) (seriousness criterion medically significant), PYREXIA (feverish) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant) and CHILLS (chills) (seriousness criterion medically significant). On 04-Aug-2021, DIARRHOEA (Diarrhea), MYALGIA (Generalised muscle aches), PYREXIA (Fever chills) and PYREXIA (Fever) had resolved. On 05-Aug-2021, HEADACHE (Headache) was resolving. At the time of the report, PUSTULE (Pustule) was resolving and HYPERHIDROSIS (sweating), DISORIENTATION (disoriented), DIZZINESS (dizzy), PYREXIA (feverish), CHILLS (shivering) and CHILLS (chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Aug-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. Patient started shivering on 02-Aug-2021 and his heart rate was increased to 105-110 for around 7 hours. Felt disoriented and dizzy on that day. Patient had some headaches, chills, feverish, and sweating for 4 days. Feverish was at around 2-3 am , could not sleep afterwards, had body ache and pustule of the injection site No concomitant medications were reported No treatment medications provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No follow up is possible.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No follow up is possible.


VAERS ID: 1576376 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate increased, Myocarditis, Pain, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma (Very mild asthma growing up)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority MHRA (Reference number: ADR 25764353) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 23-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma (Very mild asthma growing up). On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (soreness) and HEART RATE INCREASED (Pronounced heart rate). At the time of the report, MYOCARDITIS (Myocarditis) was resolving, PAIN (soreness) had not resolved and HEART RATE INCREASED (Pronounced heart rate) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576385 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-08-01
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ectopic pregnancy, Haemorrhage, Muscle spasms, Scan, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? Yes
Birth Defect? Yes
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: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: Scan; Result Unstructured Data: Test Result:blood clot within womb and tubal ectopic pregnancy
CDC Split Type: GBPFIZER INC202101014873

Write-up: Ectopic pregnancy; Clot blood; cramping; bleeding; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061319180250-NQQ5S, Safety Report Unique Identifier GB-MHRA-ADR 25765596. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jun2021 as dose 1, single for COVID-19 immunisation. Medical history included pregnancy (Patient no longer pregnant at the time of reporting), ongoing suspected COVID-19 Unsure when symptoms started. No medical history Not had a COVID-19 test Patient is not currently breastfeeding. Previous natural pregnancy resulting in a live birth at full term. The patient''s concomitant medications were not reported. The patient experienced cramping and bleeding on 01Aug2021 with outcome of unknown, ectopic pregnancy on an unspecified date with outcome of recovering, clot blood on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included scan: unknown on 06Aug2021, further scan confirmed blood clot within womb and tubal ectopic pregnancy. 13Jun2021 1st Dose Pifzer Vaccine. 25Jun2021 conceived. 31Jul2021 confirmed pregnancy. 01Aug2021 bleeding and cramping went to clinic and the discovered tubal/ovarian ectopic pregnancy referred to consultant. 04Aug2021 consultant confirmed ectopic pregnancy. 06Aug2021 further scan confirmed blood clot within womb and tubal ectopic pregnancy. 06Aug2021 surgery to remove fallopian tube and blood clot in womb. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient is enrolled in clinical trial. The medicine has an adverse effect on the pregnancy. Pregnancy adverse effects details: Tubal Ectopic pregnancy. Patient was exposed to the medicine first-trimester (1-12 weeks). Scans confirmed tubal ectopic pregnancy at 6 weeks gestation, scan also indicated blood clot within the womb. The report was considered as serious as life threatening and Congenital anomaly from regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1576404 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Carotid artery dissection, Disease recurrence, Magnetic resonance imaging, SARS-CoV-2 test, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carotid artery dissection
Allergies:
Diagnostic Lab Data: Test Name: angiography; Result Unstructured Data: Test Result:Unknown results; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014505

Write-up: Carotid artery dissection; Carotid artery dissection; Collapse due to sub-arachnoid hemorrhage; This is a spontaneous report from a contactable consumer received from the regulatory authority, report number is GB-MHRA-WEBCOVID-202108061742405630-3NP2F. Safety Report Unique Identifier GB-MHRA-ADR 25766923. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included carotid artery dissection. Otherwise fit and well, no other medical diagnoses or medication. Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced carotid artery dissection on 01Aug2021 and sub-arachnoid hemorrhage in Aug2021. The case was reported as serious due to life threatening condition. It was reported that collapse due to sub-arachnoid hemorrhage caused by carotid artery dissection. Life threatening. Stented in privacy hospital. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date, magnetic resonance imaging and angiogram ("MRI & angiography"): unknown results on an unspecified date. The outcome of the event carotid artery dissection was recovered with sequel in Aug2021, outcome of the event subarachnoid hemorrhage was unknown. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.


VAERS ID: 1576480 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-08-01
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5456 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Maternal exposure during pregnancy, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (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: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 06Oct2021)
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984338

Write-up: Maternal exposure during pregnancy; Chills; Nausea; Muscle ache; vaccine card monitor This is a non-interventional report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-YCVM-202106051729379390-L6JBK, Safety Report Unique Identifier GB-MHRA-ADR 25739042. A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 05Jun2021 (Lot Number: EY5456) as single dose for COVID-19 immunisation. Medical history included ongoing pregnancy (Estimated due date: 06Oct2021), vitamin supplementation. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient does not think vaccination had an adverse effect on any aspect of the pregnancy. Patient was exposed to the vaccine Third-trimester (29-40 weeks). Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Concomitant medication(s) included folic acid taken for vitamin supplementation, start and stop date were not reported. On 01Aug2021, patient experienced chills, nausea, muscle ache. The mother reported she became pregnant while taking BNT162B2. The mother was 30 weeks pregnant at the onset of the event. The mother was due to deliver on 06Oct2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Jun2021. Outcome of events was recovered on 02Aug2021. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events Chills, Nausea and Myalgia and the suspect drug bnt162b2 (COMIRNATY) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1576533 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), 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: 20210801; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:confirmed to have COVID-19
CDC Split Type: HKPFIZER INC202101029792

Write-up: CONFIRMED TO HAVE COVID-19; CONFIRMED TO HAVE COVID-19; This is a spontaneous report from a non-contactable healthcare professional via department of health (Regulatory authority report number: not provided), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS002911), license party for bnt162b2 (COMIRNATY). This is one of three reports. This case has been linked with others. Link AER numbers are as follows: 2021FOS002911 (master case), 2021FOS002912 and 2021FOS002913. A 20-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot number: unknown), via an unspecified route of administration on 01Jul2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 01Aug2021, the patient was confirmed to have covid-19. It was reported that on 01-Aug-2021, the patient arrived by flight and confirmed to have COVID-19 by arrival testing. The patient was asymptomatic. The patient underwent lab tests and procedures which included sars-cov-2 test: confirmed to have covid-19 on 01Aug2021. Per reporter/ BioNTech SE (company), causality assessment between bnt162b2 and events was reported as possible. The outcome of events was unknown. Follow-up closed, no further information is possible.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101026856 same reporter, different patient;HK-PFIZER INC-202101021270 same reporter, different patient


VAERS ID: 1576534 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-08-01
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 20210801; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:confirmed to have COVID-19
CDC Split Type: HKPFIZER INC202101026856

Write-up: CONFIRMED TO HAVE COVID-19; CONFIRMED TO HAVE COVID-19; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority(Regulatory authority report number: not provided), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS002913), license party for bnt162b2 (COMIRNATY). This is one of three reports. A 28-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/lot number: unknown), via an unspecified route of administration on 09Jun2021 as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 01Aug2021, the patient arrived at Hong Kong by flight from Turkey and confirmed to have COVID-19 by arrival testing. The patient''s symptom onset was on 01Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: confirmed to have covid-19 on 01Aug2021. The outcome of the events was reported as unknown. Causality Assessment: Drug: bnt162b2 COVID-19, Drug ineffective Per Reporter = Possible Per Company (BioNTech SE) = Possible; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101021270 same reporter, different patient;HK-PFIZER INC-202101029792 same reporter, different patient


VAERS ID: 1576717 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Physical examination; Result Unstructured Data: Test Result:unknown results; Test Date: 20210806; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Positive
CDC Split Type: ITPFIZER INC202101014992

Write-up: COVID-19 confirmed by positive COVID-19 test; vaccination failure; flu like symptoms; This is a spontaneous report from a contactable consumer (patient) received via regulatory authority, from a Pfizer sponsored program. A 19-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EP9598, expiration date was not reported) via intramuscular, administered in left arm on 01Jun2021 16:00 (at the age of 19-years-old) as dose 2, single and received first dose (Lot number: EP9598, expiration date was not reported) via intramuscular, administered in left arm on 11May2021 16:00 (at the age of 19-years-old) as dose 1, single for COVID-19 immunization at workplace clinic. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. It was reported that, the patient experienced covid-19 confirmed by positive covid-19 test on 01Aug2021, vaccination failure, flu like symptoms on 01Aug2021, sars cov 2 molecular test positive on 06Aug2021. Covid-19 infection despite the two doses of Comirnaty vaccine administered approximately two months from the date of the event. The patient is her son, who has been vaccinated in Pfizer offices. He started to have flu-like symptoms on 01Aug2021 during a trip to country. On 06Aug2021 a molecular swab performed on return to country confirmed positivity to COVID -19. The patient underwent lab tests and procedures which included physical examination: unknown results on an unspecified date, sars-cov-2 test: positive on 06Aug2021. Therapeutic measures were taken for all events and included azithromycin. The outcome of the events was recovering. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.


VAERS ID: 1576749 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Oxygen saturation, Oxygen saturation decreased, Pallor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Infective pneumonia (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: INFLUENZA VACCINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: blood pressure; Result Unstructured Data: Test Result:90s; Comments: decreased; Test Date: 20210801; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210801; Test Name: O2 Sat; Result Unstructured Data: Test Result:94; Comments: decreased
CDC Split Type: JPPFIZER INC202100986236

Write-up: Blood pressure decreased; Complexion ill; O2 Sat decreased to 94; This is a spontaneous report from a contactable physician received from the Regulatory Authority (Regulatory Authority report number: v21119565). The patient was a 33-year and 6-month-old female. Body temperature on 01Aug2021 (before vaccination) was 36.8 degrees Centigrade. The patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included that had experienced rash with egg-white, but it was cured at the time of reporting. Also receiving influenza vaccine. On 01Aug2021 at 09:43 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FE8206, Expiration date: 31Oct2021) as dose 1, single, with route of administration unspecified, for COVID-19 immunization. The event onset date was reported as on 01Aug2021 (10:01) (the day of vaccination). The course of the event was as follows: During the 30 minutes observation, the patient experienced complexion ill and blood pressure decreased. BOSMIN (noradrenaline) 0.5A IM was administered. Blood pressure was in 90s showing no increase. O2 Sat decreased to 94. O2 3l was administered. Consciousness alert. Blood pressure gradually improving thereafter. The outcome of the events was recovering for blood pressure decreased; and was unknown for all the other events. The reporting physician classified the event as serious and assessed that the events were related to BNT162B2. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: The patient has egg allergy. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1576751 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Bradycardia, Dizziness, Hyperhidrosis
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), 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? Yes, ? days
   Extended hospital stay? 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: 20210801; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased; Comments: 5minutes after vaccination; Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100986284

Write-up: Anaphylaxis; Bradycardia; Light-headed feeling; sweaty; Blood pressure decreased; This is a spontaneous report from a contactable other health care professional (HCP) received from the RA. Regulatory authority report number is v21119558. A 55-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Aug2021 14:50 (Lot Number: FE8206; Expiration Date: 31Oct2021) as single dose (at age of 55-year-old) for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. On 01Aug2021 14:55 patient experienced anaphylaxis, bradycardia, light-headed feeling, sweaty, blood pressure decreased. Events required admission to hospital. The clinical course was as follows: The patient was a 55-year-old male. Body temperature before vaccination was 36.4 degrees Centigrade. The patient had no special family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 01Aug2021 at 14:50 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FE8206, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Aug2021 at 14:55 (5minutes after vaccination), the patient experienced light-headed feeling, sweaty, and anaphylaxis. The outcome of the event was not reported. The course of the event was as follows: 5minutes after vaccination, the symptoms appeared. Light-headed feeling, sweaty, Blood pressure decreased, and Bradycardia was admitted. EPIPEN intramuscular injection and emergency transported. Outcome of the events was unknown. The reporting other HCP classified the event as serious (hospitalized) and assessed that the event was related to bnt162b2.


VAERS ID: 1576779 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure immeasurable, Body temperature, Gaze palsy, Hyperhidrosis, Loss of consciousness, Tonic convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? 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: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202100993541

Write-up: Anaphylactic shock; Eyeball upturned; Loss of consciousness; Tonic convulsion; Excess sweating; Blood pressure impalpable; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21122273. A 49-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF0843, Expiration date 31Oct2021) via an unspecified route of administration on 01Aug2021 at 15:00 (at the age of 49-year-old) as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 01Aug2021 at 15:00 (same date as the vaccination), the patient experienced Anaphylactic shock. The course of the event was as follows: On 01Aug2021(the day of first vaccination), the patient received the first dose of comirnaty vaccination, 10 minutes passed, suddenly Eyeball upturned appeared, Loss of consciousness appeared, Excess sweating appeared, Tonic convulsion were observed. The patient Blood pressure impalpable, diagnosed as anaphylactic shock, Epipen 0.3mg intramuscularly injected. The outcome of the events was unknown. The reporting physician classified the event as serious (Hospitalized) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1576797 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Food allergy; Rhinitis allergic
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: blood pressure; Result Unstructured Data: Test Result:No decrease; Comments: during anaphylaxis (approximately 20 minutes after vaccination); Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210801; Test Name: SPO2; Result Unstructured Data: Test Result:No decrease; Comments: during anaphylaxis (approximately 20 minutes after vaccination)
CDC Split Type: JPPFIZER INC202101007587

Write-up: Anaphylaxis with redness generalised, pruritus, and breathing difficulty; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number v21122531. A 37-year and 11 month old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 01Aug2021 14:00 (at the age of 37 year and 11 month) (Lot Number: FE8162; Expiration Date: 30Nov2021) as dose 2, single for covid-19 immunization. Medical history included asthma, food allergy and rhinitis allergic. The patient''s concomitant medications were not reported. On 01Aug2021, prior to vaccination, the patient body temperature was 36.7 degree centigrade. The patient experienced anaphylaxis with redness generalized, pruritus, and breathing difficulty(medically significant) on 01Aug2021 14:25. The course of the event was as follows: approximately 20 minutes after corona vaccination, there were complaints of redness generalised, pruritus, and breathing difficulty. No decrease in SPO2, no decrease in blood pressure, clear consciousness. Immediately, patient was treated with Adrenaline 0.3 mg intramuscular injection route and arranged for emergency transportation. The reporting physician commented as follows: Transferred to the hospital, the progress after that was unknown. The outcome for the event of anaphylaxis was not reported. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576876 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram thorax, Drug ineffective, Nucleic acid test, SARS-CoV-2 antibody test, 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 Name: Chest CT; Result Unstructured Data: Test Result:showed inflammation in his lungs, but no worsening; Test Date: 20210802; Test Name: Nucleic acid test; Test Result: Positive ; Test Name: COVID-19 antibody test; Result Unstructured Data: Test Result:this diagnosis was basically locked to be related; Comments: this diagnosis was basically locked to be related to the Nanjing epidemic situation; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:this diagnosis was basically locked to be related; Comments: this diagnosis was basically locked to be related to the Nanjing epidemic situation; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:approximately 10; Comments: approximately 10
CDC Split Type: MOPFIZER INC202101026904

Write-up: TESTED POSITIVE FOR NUCLEIC ACID; TESTED POSITIVE FOR NUCLEIC ACID; This is a spontaneous report from a non-contactable healthcare professional via Health Authority (Regulatory authority report number: not provided), based on information received by Pfizer (manufacturer control number: MO-Fosun-2021FOS002908), license party for bnt162b2 (COMIRNATY). This is one of four reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS002908, 2021FOS002909, 2021FOS002930 and 2021FOS002931. A 51-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown) via unspecified route on an unspecified date for COVID-19 immunization. Medical history and concomitant medications were not reported. On 01-Aug-2021, patient experienced sore throat. On 02-Aug-2021, after preliminary test, the patient was positive in nucleic acid test. Patient''s CT value was approximately 10. Further diagnosis and treatment have been performed in the special emergency department of hospital. After epidemiological investigation, antibody test and virus content analysis, combined with the analysis results of gene homology, this diagnosis was basically locked to be related to the epidemic situation. As of 05-Aug-2021, the patient still had low-grade fever, sore throat, and cough, and his entire condition was stable without oxygen, CP showed inflammation in his lungs, but no worsening. On 08-Aug-2021, the general condition of patient was good. The patient had no fever after treatment. His cough and hyposmia symptoms reduced, and he did not require oxygen inhalation. Adverse event ''tested positive for nucleic acid'' was considered as Important Medical Event. The patient underwent lab tests and procedures which included computerised tomogram thorax: showed inflammation in his lungs, but no worsening on an unspecified date, nucleic acid test: positive on 02Aug2021, sars-cov-2 antibody test: this diagnosis was basically locked to be related to the epidemic situation , sars-cov-2 test: this diagnosis was basically locked to be related on this diagnosis was basically locked to be related to the Nanjing epidemic situation , sars-cov-2 test: approximately 10 on approximately 10. The outcome of the event covid-19 was resolving. Follow-up attempts completed, no further information expected.; Sender''s Comments: Linked Report(s) : MO-PFIZER INC-202101032516 Same reporter, drug, different patient, event.


VAERS ID: 1576887 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-08-01
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA-9094 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Hypoaesthesia, Hypoaesthesia oral, Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202101014022

Write-up: Peripheral neuropathy; numbness and loss of strength in both legs from mid-calf to feet, numbness and loss of strength in both hands from forearm to hands, and numbness in part of the face, mouth, and tongue; numbness and loss of strength in both legs from mid-calf to feet, numbness and loss of strength in both hands from forearm to hands, and numbness in part of the face, mouth, and tongue; numbness and loss of strength in both legs from mid-calf to feet, numbness and loss of strength in both hands from forearm to hands, and numbness in part of the face, mouth, and tongue; This is a spontaneous report from a contactable consumer (patient) received via COVAES. A 48-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: FA-9094, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 10Jun2021 (age at vaccination was 48 years) as dose 2, single for COVID-19 immunization. The patient''s medical history was not reported. Concomitant medication the patient received within 2 weeks of vaccination included Guava tea. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0221, Expiration date: unknown) via an unspecified route of administration, administered in right arm on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Aug2021, the patient experienced peripheral neuropathy numbness and loss of strength in both legs from mid-calf to feet, numbness and loss of strength in both hands from forearm to hands, and numbness in part of the face, mouth, and tongue. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment with medications and injections due to the events. The outcome of the events was resolving. Follow-up attempts are required; information about batch number will be obtained.


VAERS ID: 1577117 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Balance disorder, Chest X-ray, Dizziness, Laboratory test, Malaise, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: Lab test; Result Unstructured Data: Not reported; Test Date: 20210809; Test Name: Chest X-ray; Result Unstructured Data: Pneumonia
CDC Split Type: PHJNJFOC20210825179

Write-up: LOSS OF BALANCE; DIZZINESS; BODY MALAISE; JOINT PAIN; MILD FEVER; MUSCLE PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300097940] concerned a 79 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: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 28-JUL-2021 at 11:20 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, at unspecified time, the patient started to complain of body malaise, mild fever, joint pain, muscle pain, dizziness and loss of balance. On 07-AUG-2021 at 09:00, the patient was brought to doctor''s hospital due to continuous dizziness, body weakness and loss of balance. The patient underwent swab test but result was yet to be released next day of reporting. On 09-AUG-2021, the patient underwent chest X-ray, findings in the result was pneumonia. The patient was sent home on the same day but he was on oxygen inhalation. On 09-AUG-2021, Laboratory data included: Chest X-ray Pneumonia. On an unspecified date in AUG-2021, treatment medications included: oxygen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body malaise, mild fever, joint pain, muscle pain, dizziness, and loss of balance. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210825179-covid-19 vaccine ad26.cov2.s-loss of balance, dizziness. 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). 20210825179-covid-19 vaccine ad26.cov2.s-body malaise, joint pain, mild fever, muscle pain. This event(s) is labeled per RA and is therefore considered potentially related.


VAERS ID: 1577130 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Headache, Malaise, Rash pruritic, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210825464

Write-up: REDNESS; BODY MALAISE; RASH/ITCH; HEADACHE; LOCAL SITE PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300096157] concerned a 40 year old female 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 ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total administered on 30-JUL-2021 on 07:00 PM for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021 at 08:00 PM the patient experienced redness, body malaise, headache, local site pain, rash/itch. It was reported that the patient went to a doctor/healthcare professional for consultation, and an unspecified antihistamine was prescribed. The patient was advised and under monitoring. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body malaise, headache, local site pain, rash/itch, and redness. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210824935-covid-19 vaccine ad26.cov2.s-Redness. 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). 20210824935-covid-19 vaccine ad26.cov2.s-body malaise, headache, local site pain, rash/itch. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1577217 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101040404

Write-up: Tiredness; unspecified reactions; facial paralysis; This is a spontaneous report from a contactable consumer (herself). A female patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via intramuscular on 05Aug2021 as DOSE 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Since vaccination on 05Aug2021, the patient experienced many unspecified reactions including tiredness. In additional, on an unspecified date in Aug2021 the patient experienced facial paralysis with no apparent reason. At the time of the report, the outcome of the events was unknown. Information on batch number has been requested


VAERS ID: 1579288 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Angina pectoris, Fatigue, Headache, Hot flush, Malaise, Nausea, Pain, Vaccination site pain, Vaccination site swelling
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (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:
CDC Split Type: FRPFIZER INC202100997731

Write-up: Reduced aches; Vomiting sensation; Aches; Vomiting sensation; Hot flashes; At the limit of a malaise; Stomach aches; Tiredness; Pain in the heart/Resumption of "spikes" intermittently in the heart; pain and Swelling of the arm at the injection site; Headache; pain and Swelling of the arm at the injection site; This is a spontaneous report from a contactable consumer or other non-healthcare professional via COVAES. A 36-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 31Jul2021 10:45 AM (Batch/Lot Number: Unknown) at single dose for covid-19 immunisation. Medical history was none and no past drug event was reported. On 01Aug2021 at 09:00 AM the patient experienced pain and swelling of the arm at the injection site, headache, pain in the heart during more than 24 hours, resumption of this pain on Tuesday 03Aug2021 intermittently and tiredness. On 02Aug2021, 48 hours after the injection aches, vomiting sensation, intense headaches, hot flashes, at the limit of a malaise during the afternoon, stomach aches and tiredness occurred. On 03Aug2021, the patient complained resumption of ''spikes'' intermittently in the heart, hot flashes, tiredness, reduced aches, vomiting sensation. No fever episode since vaccine administration. At the time of the reporting events outcome was unknown. Moreover these events didn''t caused an hospitalization and no treatment was received. It was also informed that prior to vaccination the patient wasn''t diagnosed with COVID-19 and since the vaccination hasn''t been tested for COVID-19.


VAERS ID: 1579311 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, SARS-CoV-2 test, Tuberculin test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: TBC; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202100984693

Write-up: Chest pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority.The regulatory authority report number is GB-MHRA-WEBCOVID-202108011540436140-VTOXT, Safety Report Unique Identifier is GB-MHRA-ADR 25738174. A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included lactation decreased from an unknown date. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced chest pain on 01Aug2021. The event was reported as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included SARS-COV-2 test with No-Negative COVID-19 test result and tuberculin test with unknown results both on an unknown date. The patient recovered from chest pain on 01Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


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