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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 386 out of 8,010

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VAERS ID: 1687599 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Cough, Dry throat, Headache, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118893

Write-up: General body pain; Shivering; Cough; Head pain; Dry throat; Fever; This is a spontaneous report from a contactable consumer.This is a report received from the Regulatory Agency (RA).Regulatory authority report number is GB-MHRA-WEBCOVID-202108280042170520-KBX4L, Safety Report Unique Identifier GB-MHRA-ADR 25862840. A 37-year-old male patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine),via an unspecified route of administration on Aug2021 (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation.Medical history included clinical trial participant .The patient''s concomitant medications were not reported.The patient experienced fever (pyrexia) (medically significant) on 26Aug2021 with outcome of not recovered, general body pain (medically significant) on an unspecified date with outcome of not recovered, shivering (medically significant) on an unspecified date with outcome of not recovered, cough (medically significant) on an unspecified date with outcome of not recovered, head pain (medically significant) on an unspecified date with outcome of not recovered, dry throat (medically significant) on an unspecified date with outcome of not recovered.The clincal course :Its been 4 days I have taken Vaccines but still I have above problems Patient has not tested positive for COVID-19 since having the vaccine Clinical trial participant The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Aug2021 No - Negative COVID-19 test.Additional information :the has not tested positive for COVID-19 since having the vaccine Clinical trial participant.Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687600 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Dyspnoea, Headache, Influenza like illness, Migraine, Nausea, Pain in extremity, Palpitations, Pyrexia, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Lactation decreased; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201207; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101118905

Write-up: arm pain; fever; headache; flu like symptoms; very swollen; Migraine headache; pain in my armpit; Heart racing; Shortness of breath; Nausea; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108280120361460-TYJ1V, Safety Report Unique Identifier GB-MHRA-ADR 25862856. A 22-year-old female patient of received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FE8087 and Expiration date was unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suppressed lactation, headache and suspected covid-19 (Unsure when symptoms started. Unsure when symptoms stopped). Patient is not pregnant, patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced arm pain with outcome of recovering, fever with outcome of recovering, headache with outcome of recovering, flu like symptoms with outcome of recovering, migraine headache on 26Aug2021 with outcome of recovered on 28Aug2021, pain in my armpit on 26Aug2021 with outcome of not recovered, heart racing on 26Aug2021 with outcome of not recovered, shortness of breath on 26Aug2021 with outcome of not recovered, nausea on 26Aug2021 with outcome of not recovered, very swollen on an unspecified date with outcome of unknown. All the events were medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: yes - positive covid-19 test on 07Dec2020. Therapeutic measures were taken as a result of headache.The clinical course was reported as follows:Arm pain occurred first, the day after the vaccine I had a headache that could n (special characters) t be relieved by medications. This was followed by flu like symptoms, a fever and nausea. I then started to feel pain in my armpit which has turned very swollen and uncomfortable. Additional information :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: 1687620 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache, Heavy menstrual bleeding, Hypoaesthesia, Memory impairment, Myalgia, Nausea, Night sweats, Pain in extremity, Polymenorrhoea, Pyrexia, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Covid-19 virus test; Test Result: Negative ; Comments: Patient has not tested positive for COVID-19 since having the vaccine
CDC Split Type: GBPFIZER INC202101118787

Write-up: made my period start 2 weeks early and it is extremely heavy and painful with a lot of clots; made my period start 2 weeks early and it is extremely heavy and painful with a lot of clots; Extreme arm pain; numbness in left side of my face that lasted over 24 hours,; loss of appetite; Vaginal bleeding; fever; night sweats; chills; nausea; muscle pain; headache; exhaustion; dizziness; forgetfulness; This is a spontaneous report from a contactable consumer. This report is received from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108281027400790-M339T. Safety Report Unique Identifier GB-MHRA-ADR 25864143. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 25Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient had not had symptoms associated with COVID-19.The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. It was reported that the patient experienced extreme arm pain, fever, chills, night sweats, nausea, headache, exhaustion, muscle pain, numbness in left side of her face that lasted over 24 hours, dizziness, forgetfulness, loss of appetite, made her period start 2 weeks early and it was extremely heavy and painful with a lot of clots all on an unspecified date in 2021. The patient also experienced vaginal bleeding on 26Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date (Patient has not tested positive for COVID-19 since having the vaccine). Outcome of the events fever, chills, night sweats, nausea, headache, exhaustion, muscle pain, dizziness, forgetfulness was reported as recovered on an unspecified date in 2021. Outcome of the event vaginal bleeding was reported as not recovered. Outcome of the events extreme arm pain, numbness in left side of her face that lasted over 24 hours, loss of appetite, made her period start 2 weeks early and it was extremely heavy and painful with a lot of clots were reported as Unknown at this time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687622 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Decreased appetite, Delirium, Fatigue, Headache, Muscle spasms, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: IBUPROFEN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Period pains
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118902

Write-up: Lack of appetite; Muscle spasms; Delirium; Fatigue; Aching joints; Headache; Fever; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108281053106390-3ZTND, Safety Report Unique Identifier GB-MHRA-ADR 25864416. A 18-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE),via an unspecified route of administration on 24Aug2021 (Lot number was not reported) as single dose for COVID-19 immunization. Medical history included suppressed lactation, headache, dysmenorrhoea. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, patient was not currently breastfeeding. Concomitant medication included ibuprofen taken for headache, start and stop date were not reported; paracetamol taken for dysmenorrhoea, start and stop date were not reported. The patient experienced fever on 26Aug2021 with outcome of not recovered , muscle spasms on 28Aug2021 with outcome of recovering , aching joints on 26Aug2021 with outcome of not recovered , headache on 26Aug2021 with outcome of not recovered , delirium on 27Aug2021 with outcome of recovering , fatigue on 26Aug2021 with outcome of not recovered , lack of appetite on an unspecified date with outcome of unknown. The patient underwent lab test which included sars-cov-2 test: negative on an unspecified date. Patient was not enrolled in clinical trial. The events were assessed as serious, medically significant. No follow-up attempts are possible, Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687628 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Heavy menstrual bleeding, Menstruation irregular, Polymenorrhoea, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118993

Write-up: Excessive menstruation; Irregular menstrual cycle; Shortening of menstrual cycle; bleeding; This is a spontaneous report from a contactable consumer (patient). This is a report received from the RA. Regulatory authority report number GB-MHRA-WEBCOVID-202108281125244710-T683V, Safety Report Unique Identifier GB-MHRA-ADR 25864484. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 25Aug2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date in 2021, the patient experienced bleeding. On 26Aug2021, she experienced excessive menstruation, irregular menstrual cycle, and shortening of menstrual cycle. Patient reported 36 hours after her second dose of the Pfizer vaccine she began bleeding. She was not due her next period for 2 weeks - she was half-way through her normal menstrual cycle. She tracks her menstrual cycle using a smartphone app so know that this was irregular. She was now bleeding consistently as if it were a normal period. On 22Aug2021, the patient underwent SARS-COV-2 test which resulted negative. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687657 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118822

Write-up: fever; Painful sensation all over my body; Hypersensation skin; This is a spontaneous report received from a contactable consumer (patient). This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202108281850582300-YEHZK, Safety Report Unique Identifier is GB-MHRA-ADR 25865059. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), on 25Aug2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history included lactation decreased. No other patient''s relevant medical history was reported. Patient had not had symptoms associated with COVID-19. She had not had a COVID-19 test. Patient was not pregnant, and she was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced fever on unspecified date and hypersensation skin on 26Aug2021, both reported as serious with medically significant criterion. It was reported that alongside a very high fever the skin all over her body became extremely sensitive and even the touch from clothes or bed sheets sent a really painful sensation all over her body. This hypersensitivity would come in waves alongside the fever. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was resolved on 28Aug2021 for hypersensation skin and unknown for the other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687658 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vision blurred
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118755

Write-up: Dizziness; Nausea; Blurred vision; Aches & pains in legs; Fever; This is a spontaneous report from a contactable consumer. This is a report received from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108281910186670-T7EBS. Safety Report Unique Identifier: GB-MHRA-ADR 25865101. A 33-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection), dose 2 via an unspecified route of administration on 25Aug2021 (Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. the patient received the historic vaccine BNT162B2 (lot no: unknown) Dose 1, single for COVID-19 immunization. The patient experienced dizziness, nausea, blurred vision, aches & pains in legs, fever on 26Aug2021.All the events was reported as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 28Aug2021 No - Negative COVID-19 test. The outcome of all events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1687661 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaginal 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118532

Write-up: This is a spontaneous report from a contactable consumer. This is report received from the Regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108281931306690-3IAKY, Safety Report Unique Identifier number is (GB-MHRA-ADR 25865109). A 28-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration on 22Aug2021 (Lot Number: FE3380) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications included oral contraceptive pill (unspecified). The patient experienced vaginal bleeding on 26Aug2021, 4 days after receiving the vaccine. Patient had sudden heavy vaginal bleeding experienced 3 weeks before next expected period and while taking oral contraceptive pill. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The event was assessed as serious- medically significant. The outcome of the event was resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687673 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Body temperature increased, Chills, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BECOTIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118521

Write-up: raised temp; headache; shivering; Nausea; Abdominal pain; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108282300277650-1SZZO, safety report unique identifier is GB-MHRA-ADR 25865254. A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection; Lot Number: FE3380, Expiry date was not reported), via an unspecified route of administration on 25Aug2021 as dose 2, single for COVID-19 immunization. Medical history included Asthmatic from an unknown date and unknown if ongoing. Concomitant medication(s) included BECOTIDE was taken for Asthmatic (asthma) from 01Apr2018 to an unspecified stop date. Patient was not enrolled in clinical trial. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number, Expiration date was not reported), via an unspecified route of administration on unknown date as dose 1, single for COVID-19 immunization. On 26Aug2021, patient experienced raised temp, Headache, shivering, nausea and abdominal pain. Patient was not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient was not tested positive for COVID-19 since having the vaccine. The events were serious (medically significant). The outcome of the events raised temp, Headache, shivering was recovered on 27Aug2021; outcome of the events nausea and abdominal pain was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687678 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118569

Write-up: Armpit pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108290024443950-MJG2F, Safety Report Unique Identifier GB-MHRA-ADR 25865277. A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 26Aug2021 as dose 2, single for COVID-19 immunization (at the age of 31-years-old). 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. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced armpit pain on 26Aug2021, swollen armpit size of golf ball. Time between drug administration and start of reaction/event was 1 day. The patient underwent lab tests and procedures which included sars-cov-2 test: no, negative on an unspecified date in 2021. The clinical outcome for the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1687681 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chills, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: GBPFIZER INC202101118881

Write-up: Armpit pain; Muscle ache; Chills; This is a spontaneous report from a contactable consumer received from the regulatory authority. Regulatory Authority report number GB-MHRA-WEBCOVID-202108290629057450-QNQUJ. Safety Report Unique Identifier GB-MHRA-ADR 25865321. A 35-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on 25Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history was none. Patient was a fit and healthy adult, no conditions. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test, was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced armpit pain (medically significant) on 26Aug2021 with outcome of not recovered, muscle ache (medically significant) on 26Aug2021 with outcome of recovered on 27Aug2021, chills (medically significant) on 26Aug2021 with outcome of recovered on 27Aug2021. Therapeutic measures were taken as a result of muscle ache and included treatment with paracetamol from 26Aug2021 to 28Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687723 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-08-26
   Days after vaccination:90
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 LA / -

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: 20210826; Test Name: lateral flow test; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: GBPFIZER INC202101108921

Write-up: positive for covid on the 26Aug2021; positive for covid on the 26Aug2021; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A 27-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: et1813, Expiration date was not reported), via an unspecified route of administration in the left arm on 07May2021 at 15:00 (at the age of 27-years-old) as dose 1, single and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: er7812, Expiration date was not reported), via an unspecified route of administration in the left arm on 28May2021 at 13:00 (at the age of 27-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 26Aug2021 at 09:00, the patient experienced positive for COVID-19. Patient did not received treatment for events. The patient underwent lab tests and procedures which included lateral flow test (Sars-Cov-2 test) Nasal swab was positive on 26Aug2021. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1688100 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Cold sweat, Depressed level of consciousness, Shock
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: BP; Result Unstructured Data: Test Result:80s; Test Date: 20210826; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101112181

Write-up: Depressed level of consciousness; shock; cold sweat; Blood pressure dropped to 80s; This is a spontaneous report from a contactable physician received from the regulatory agency. Regulatory authority report number is v21124878. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Aug2021 11:08 (Batch/Lot Number: FF3620; Expiration Date: 30Nov2021) (at the age of 30 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included influenza vaccine for immunization that caused shock symptoms. The patient experienced depressed level of consciousness (medically significant), shock (medically significant), cold sweat, blood pressure dropped to 80s on 26Aug2021 11:18, all with outcome of recovering. The patient underwent lab tests and procedures which included blood pressure measurement: 80s on 26Aug2021, body temperature: 36.7 centigrade on 26Aug2021 before vaccination. On 26Aug2021 at 11:18 (10 minutes after vaccination), the patient experienced shock. On 26Aug2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: About 10 minutes after the vaccination, there was cold sweat and Depressed level of consciousness. Blood pressure dropped to 80s. 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: 1688108 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Feeling abnormal, Heart rate, Nausea, Oxygen saturation, Shock
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: BP; Result Unstructured Data: Test Result:105/68; Comments: at 15:20; Test Date: 20210826; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210826; Test Name: PR; Result Unstructured Data: Test Result:70; Comments: at 15:20; Test Date: 20210826; Test Name: SAT; Test Result: 98 %; Comments: at 15:20
CDC Split Type: JPPFIZER INC202101112265

Write-up: Shock; queasy; fuzzy head; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21124946. A 28-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Aug2021 15:05 at 28-years-old (Batch/Lot Number: FF0843; Expiration Date: 31Oct2021) as DOSE 1, SINGLE for covid-19 immunisation. There was no medical history. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.8 degrees Centigrade. 15 minutes after the vaccination, the patient experienced fuzzy head. On 26Aug2021 15:20, BP 105/68, PR 70, SAT 98%. There was no rash. The patient felt better after lying down, however, the patient experienced a little queasy as standing up. The patient was under observation for a while as lying down. The patient experienced shock on 26Aug2021 15:20 (15 minutes after the vaccination) with outcome of recovered on 26Aug2021, queasy on 26Aug2021 with outcome of recovered on 26Aug2021, fuzzy head on 26Aug2021 with outcome of recovered on 26Aug2021. The reporting physician classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. Other possible cause of the event was not provided. The reporting physician commented as follows: It was unknown whether or not the symptoms above were caused by the vaccine or the action of injection. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: It was unknown whether or not the symptoms above were caused by the vaccine or the action of injection.


VAERS ID: 1688116 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Feeling abnormal, Headache, Vital signs measurement
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210826; Test Name: Vital signs; Result Unstructured Data: Test Result:did not change
CDC Split Type: JPPFIZER INC202101112820

Write-up: Giddiness; headache; feels poorly; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21124932. A 27-year and 1-month-old female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Aug2021 14:40 (Lot Number: FF9944; Expiration Date: 30Nov2021) as single dose (at the age of 27) for covid-19 immunisation. Medical history was none. The patient''s concomitant medications were not reported. During the observation, on 26Aug2021 14:53 (13 minutes after vaccination), at the time about to go home, giddiness, headache, feels poorly occurred. Vital signs did not change. Intravenous infusion treatment received. Symptoms improved. Headache remained, painkiller prescribed and went home. The patient underwent lab tests and procedures which included body temperature: 36.7 centigrade on 26Aug2021, before vaccination. On 26Aug2021 (the day of vaccination), the outcome of the event was recovering. 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 needed. No further information is expected


VAERS ID: 1688120 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Hypotension, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:Blood pressure decreased to around 90; Test Date: 20210826; Test Name: body temperature; Result Unstructured Data: Test Result:36 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101112896

Write-up: Blood pressure decreased to around 90; the patient experienced preshock; he patient feeling queasy about 15 minutes after vaccination; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21124877. A 40-years-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Aug2021 11:06 (Lot Number: FF3620; Expiration Date: 30Nov2021) as single dose (at the age of 40) for covid-19 immunisation. Medical history was none. The patient''s concomitant medications were not reported. On 26Aug2021 at 11:21 (15 minutes after the vaccination), the patient experienced preshock. On 26Aug2021 at 11:21 (15 minutes after the vaccination), the patient feeling queasy about 15 minutes after vaccination. Blood pressure decreased to around 90 on 26Aug2021. Body temperature: 36 centigrade on 26Aug2021 before vaccination. On 26Aug2021 (the day of vaccination), the outcome of the event was recovered. 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.


VAERS ID: 1688123 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Body temperature decreased, Dizziness, Feeling cold, Heart rate, Nausea, Oxygen saturation, Presyncope
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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: Pollinosis
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: BP; Result Unstructured Data: Test Result:143/87; Test Date: 20210826; Test Name: BP; Result Unstructured Data: Test Result:175/102; Test Date: 20210826; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before the vaccination.; Test Date: 20210826; Test Name: Body temperature; Result Unstructured Data: Test Result:31.7 Centigrade; Test Date: 20210826; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Test Date: 20210826; Test Name: P; Result Unstructured Data: Test Result:93; Test Date: 20210826; Test Name: P; Result Unstructured Data: Test Result:85; Test Date: 20210826; Test Name: Sat; Test Result: 98 %; Test Date: 20210826; Test Name: Sat; Test Result: 99 %
CDC Split Type: JPPFIZER INC202101113118

Write-up: BP 143/87 / 175/102; BT 31.7centigrade; Vasovagal reflex/Vagal reflex; mild Giddiness; Queasy; felt Chilliness / Feeling cold of lower body; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21124951. A 56-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Aug2021 14:00 (at the age of 56-years-old) (Batch/Lot Number: FF3620; Expiration Date: 30Nov2021) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Pollinosis. The patient''s concomitant medications were not reported. On 26Aug2021 14:00 (same day of the vaccination), the patient experienced queasy, giddiness, vasovagal reflex. The course of the event was as follows: Immediately after the patient received the COMIRNATY, mild Giddiness and Queasy were occurred. The patient felt Chilliness (Feeling cold of lower body). At 14:10, BP 143/87, Sat 98%, P 93, BT 31.7centigrade (as reported). At 14:40 BP 175/102, Sat 99%, P85, BT 36.5 centigrade. The event blood pressure increased was assessed as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 143/87 on 26Aug2021, blood pressure measurement: 175/102 on 26Aug2021, body temperature: 36.2 centigrade on 26Aug2021 before the vaccination, body temperature: 31.7 centigrade on 26Aug2021, body temperature: 36.5 centigrade on 26Aug2021, heart rate: 93 on 26Aug2021, heart rate: 85 on 26Aug2021, oxygen saturation: 98 % on 26Aug2021, oxygen saturation: 99 % on 26Aug2021. The outcome of the events was recovering. The reporting physician classified the event as non-serious. The causality between the event and bnt162b2 as unassessable. The reporter comment as: Suspected Vagal reflex.


VAERS ID: 1688129 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dysphonia
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101113849

Write-up: Anaphylaxis symptom; Hoarseness (hard to make a sound); This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 48-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 26Aug2021 (Batch/Lot number was not reported) as dose 1, single (at the age of 48 years old) for prevention of COVID-19 infection. The patient medical history and concomitant medications were not reported. On 26Aug2021 (the day of vaccination), 15 minutes after the vaccination, the patient experienced hoarseness (hard to make a sound). BOSMIN at a dose of 0.5 ml was injected intramuscularly as treatment. After about 90 minutes, the patient walked home himself. On the same day, about 3 hours later, it was confirmed that patient was recovered by the phone. The doctor considered the symptom as anaphylaxis symptom. The reporter stated that the events probably related to the BNT162B2. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: A contributory role of BNT162B2 to event anaphylaxis and hoarseness cannot be excluded based on temporal association and available information.


VAERS ID: 1688173 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Headache, Heart rate, Hypersensitivity, Nausea, Oxygen saturation
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety (Taking oral antianxiety agents)
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: BP (blood pressure); Result Unstructured Data: Test Result:154/104 mmHg; Test Date: 20210826; Test Name: BP (blood pressure); Result Unstructured Data: Test Result:146/94 mmHg; Test Date: 20210826; Test Name: HR (heart rate); Result Unstructured Data: Test Result:60; Test Date: 20210826; Test Name: SpO2; Test Result: 97 %
CDC Split Type: JPPFIZER INC202101119916

Write-up: suspected of having allergic reactions; occipital headache; queasy; BP (blood pressure)154/104mmHg / BP146/94mmHg; This is a spontaneous report from a contactable physician received from the Regulatory authority. A 38-year-old male patient received BNT162B2 (COMIRANTY, Solution for injection, Lot number FF2782, Expiration date 30Nov2021), via an unspecified route of administration on 26Aug2021 at 11:40 (at the age of 38-year-old) as dose 1, single for COVID-19 immunisation. The patient''s medical history included anxiety and ongoing hypertension. The patient was taking unspecified concomitant medications reported as oral antianxiety agents and other drugs. On 26Aug2021 (also reported as 26Aug2021 at 12:00, 20 minutes after the vaccination), the patient experienced headache. On 26Aug2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: 15 minutes after receiving the COVID-19 vaccine (26Aug2021 at 11:55), the patient experienced occipital headache and queasy. Blood pressure (BP) 154/104 mmHg. No obvious paralysis was noted. The patient was suspected of having allergic reactions and was administered an IV drip of prednisolone (PREDONINE) 220 mg. 1 hour after vaccination, the headache tended to improve. Queasy improved. At the time of completion of drip infusion, BP 146/94mmHg. SpO2 was 97%. Heart rate (HR) was 60. Headache did not relapse in a sitting and standing postures. The patient had no light-headed feeling. The patient went home. The outcome of the events was resolving. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2.


VAERS ID: 1688187 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dysphoria, Heart rate, Loss of consciousness, Oxygen saturation, Pallor, Presyncope
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), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Dysphoria
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:118/80; Test Date: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:122-126/70-81; Test Date: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:136/81; Comments: 18:00; Test Date: 20210826; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination.; Test Date: 20210826; Test Name: pulse rate; Result Unstructured Data: Test Result:60; Test Date: 20210826; Test Name: pulse rate; Result Unstructured Data: Test Result:71; Comments: 18:00; Test Date: 20210826; Test Name: Oxygen saturation; Test Result: 95 %; Test Date: 20210826; Test Name: Oxygen saturation; Test Result: 97 %
CDC Split Type: JPPFIZER INC202101120593

Write-up: vasovagal reflex; Dysphoria; Pallor facial; Loss of consciousness; This is a spontaneous report from a contactable other health professional received from a regulatory authority. Regulatory authority report number is v21125135. A 47-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Aug2021 17:23 (Batch/Lot Number: FF2782; Expiration Date: 30Nov2021) (at the age of 47-year-old) as DOSE1, SINGLE for COVID-19 immunisation. Medical history included dysphoria and anxiety. The patient''s concomitant medications were not reported. The patient was a 47years old male. Body temperature before vaccination was 36.4 degrees Centigrade. 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) included history of dysphoria to vaccination. On 26Aug2021 at 17:23 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF2782, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 26Aug2021 at 17:25 (3minutes after the vaccination), the patient experienced vasovagal reflex. On 26Aug2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: Anxious about injections even before vaccination. Dysphoria from waiting after vaccination. Observed by nurse. The patient was found pallor facial and loss of consciousness. Secured the blood vessels as soon as possible. Blood pressure was 118/80, pulse rate(PR)60, oxygen saturation(SPO2)95%. The patient regained consciousness quickly. After that, the blood pressure was 122-126/70-81. At 18:00, needle removal. Blood pressure 136/81, pulse rate(P)71, oxygen saturation(SPO2)97%. Walking home alone. The reporting other health professional classified the event as non-serious and assessed that the event was unrelated to bnt162b2. Other possible causes of the event such as any other diseases was anxiety. The reporting other health professional commented as follows: Temporary loss of consciousness due to the inoculated person''s constitution (mental).; Sender''s Comments: The events of loss of consciousness, presyncope, dysphoria and pallor are unrelated to the suspect product of BNT162B2. The patient''s anxious and dysphoric mental constitution is the causative factor for the events 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: 1688194 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Choking sensation, Palpitations, Rash
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: BP; Result Unstructured Data: Test Result:183/114, 101; Test Date: 20210826; Test Name: BP; Result Unstructured Data: Test Result:168/90, 82; Test Date: 20210826; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101121014

Write-up: Blood pressure reading high; palpitations; skin eruption; Pharynx strangled sensation of; This is a spontaneous report from a contactable other HCP received from a regulatory authority. Regulatory authority report number is v21125156. A 57-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Aug2021 11:00 (Batch/Lot Number: FE8206; Expiration Date: 31Oct2021) as DOSE 1, SINGLE (at the age of 57 years) for covid-19 immunisation. Medical history was none. The patient''s concomitant medications were not reported. The patient experienced blood pressure reading high on 26Aug2021 11:00 with outcome of recovered, palpitations on 26Aug2021 11:00 with outcome of recovered, skin eruption on 26Aug2021 11:00 with outcome of recovered, pharynx strangled sensation of, on 26Aug2021 11:00 with outcome of recovered. The patient underwent lab tests and procedures which included blood pressure measurement: 183/114, 101 on 26Aug2021, blood pressure measurement: 168/90, 82 on 26Aug2021, body temperature: 36.4 centigrade on 26Aug2021 before vaccination. Therapeutic measures were taken as a result of blood pressure reading high, palpitations, skin eruption, pharynx strangled sensation of. Treatment included Drip infusion of saline 100 and SOLU-CORTEF 200 mg. BP: 168/90, and 82 (as reported). There were no points to be considered on the vaccine screening questionnaire. The reporter 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.


VAERS ID: 1688197 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Decreased appetite, Dyspnoea, Electrocardiogram, Headache, Hypoaesthesia, Malaise, Pain, Pyrexia, Renal function test, Rhabdomyolysis, Troponin I
SMQs:, Rhabdomyolysis/myopathy (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: CK; Result Unstructured Data: Test Result:$g10000; Test Date: 20210827; Test Name: CK; Result Unstructured Data: Test Result:$g10000 continued; Test Date: 20210827; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:no ST change; Test Date: 20210826; Test Name: renal function; Result Unstructured Data: Test Result:normal; Test Date: 20210827; Test Name: Troponin I; Result Unstructured Data: Test Result:<1.0
CDC Split Type: JPPFIZER INC202101121142

Write-up: Malaise; Headache; Pyrexia; Pantalgia; Numbness in hands; could barely eat; suspected of muscle dissolution; Dyspnoea; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21125122. A 14-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection; Batch/Lot Number: FF4204; Expiration Date: 31Oct2021) via an unspecified route of administration on 25Aug2021 17:30 (the day of vaccination) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Aug2021 at 08:00 (14 hours 30 minutes after the vaccination), the patient experienced dyspnoea, malaise, headache and pyrexia. The course of the event was as follows: on 25Aug2021, second corona vaccination. On 26Aug2021, pyrexia from morning, pantalgia from noon, dyspnoea and numbness in hands from evening (as reported), could barely eat and some moisture. Patient visited emergency outpatient department with the above symptoms blood creatine phosphokinase (CK)$g10,000 on blood collection and patient was suspected of muscle dissolution on 26Aug2021. The patient returned home after refusing hospitalization by himself due to normal renal function on 26Aug2021. For outpatient follow-up policy. On 27Aug2021, symptoms were alleviated (as reported), CK$g10,000 continued with blood collection with Troponin I <1.0 and electrocardiogram was no ST change. The patient was scheduled to see the doctor again later in the week. The reporting physician classified the events as serious (medically significant) and assessed that the events was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The events resulted in emergency room and physician office visit. It was also reported that since patient was able to urinate, there was no AKI merger. Carefully follow up until CK settles down. The outcome of the events was not recovered. Reporter Comment: Since was able to urinate, there was no AKI merger. Carefully follow up until CK settles down. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Since was able to urinate, there was no AKI merger. Carefully follow up until CK settles down.


VAERS ID: 1688200 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9873 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Dyspnoea, Feeling abnormal, Headache, Oropharyngeal pain
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Blood pressure; Result Unstructured Data: Test Result:92/69 mmHg
CDC Split Type: JPPFIZER INC202101121557

Write-up: Anaphylaxis; Blood pressure decreased to 92/69; headache; feels poorly; Pharyngodynia; Dyspnoea; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21125200. A 21-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Aug2021 15:00 (Batch/Lot Number: FC9873; Expiration Date: 30Sep2021) as DOSE 1, SINGLE (age at vaccination 21 years old) for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. 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 26Aug2021 at 15:10 (after the vaccination), the patient experienced anaphylaxis, blood pressure was 92/69, headache, feels poorly, pharyngodynia and dyspnoea. The course of the event was as follows: At 15:00, the patient received the vaccination. At 15:10, the patient experienced headache, feels poorly, pharyngodynia and dyspnoea. The patient''s blood pressure decreased to 92/69. The patient was diagnosed with Anaphylaxis. At 15:15, the patient received BOSMIN 0.3 mg intramuscular on the thigh. After that, the symptoms were recovering (as reported). Therapeutic measures were taken as a result of anaphylaxis, blood pressure decreased to 92/69, headache, feels poorly, pharyngodynia, dyspnoea. The patient underwent lab tests and procedures which included blood pressure: 92/69 mmhg on 26Aug2021. Outcome of the events were recovered in 2021. ("On 26Aug2021 (the day after the vaccination), the outcome of the event was recovered (as reported)". The reporting physician classified the event Anaphylaxis as serious (Life-threatening) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Anaphylaxis caused by the vaccination.


VAERS ID: 1688291 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005240 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Depressed level of consciousness, Seizure
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Depressed level of consciousness; Convulsive seizure; This case was received via Regulatory Autthority (Reference number: 2021TJP086821) on 31-Aug-2021 and was forwarded to Moderna on 31-Aug-2021. This case, initially reported to the regulatory authority by a (physician), was received via the regulatory authority (Ref, v21125238). Precautions in Prevaccination Screening Questionnaire (underlying diseases, allergies, vaccinations or diseases within the last month, drugs being taken, past history of adverse reactions, condition of growing, etc.): Yes (bipolar disorder, fibromyalgia, diabetes mellitus) The patient had a history of convulsive seizure, loss of consciousness. On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.6 degrees Celsius. On 26-Aug-2021, at 13:24, the patient received the 2nd dose of this vaccine intramuscularly into the left triceps brachii. At 13:28, the patient did not respond to a calling, and convulsive seizure in the left upper arm developed. Although the convulsion gradually disappeared, the consciousness level was slow to improve, and thus the patient was urgently transported. Eventually, vital signs were stabilized, and the level of consciousness improved. The outcome of decreased level of consciousness and convulsive seizure was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: When the patient was asked again about the medical history, it was revealed that convulsive seizure and loss of consciousness had developed each time. The patient may have had undiagnosed epilepsy as a medical history.; Sender''s Comments: The patient had a history of convulsive seizure, loss of consciousness which could be a confounding factor. However, based on 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: 1688301 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Myocarditis; This case was received via regulatory authority (Reference number: 2021TJP087713) on 02-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This case, initially reported to the regulatory authority by a physician, was received via the regulatory authority (Ref, v21125539). Myocarditis was assessed as serious by the Agency. On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.7 degrees Celsius. On 22-Aug-2021, at 13:30, the patient received the 2nd dose of this vaccine. On 25-Aug-2021, chest pain developed. The patient visited a nearby physician, but electrocardiogram showed no abnormality. On 26-Aug-2021, at 12:00, chest pain recurred, and the patient visited the reporting hospital. Electrocardiogram showed ST elevation, and data showed increased troponin T and CK. The patient was diagnosed with myocarditis. The symptom was rapidly resolving only by symptomatic treatment with oral aspirin. On 31-Aug-2021, recovery from the symptom was confirmed. The outcome of myocarditis was reported as resolved. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship; Sender''s Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.


VAERS ID: 1690271 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Pain in jaw, Palpitations, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101141462

Write-up: Heart racing; Jaw pain; Felt faint; Syncope vasovagal; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number GB-MHRA-EYC 00259307 Safety Report Unique Identifier GB-MHRA-ADR 25854994. A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose (dose number unknown) for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced heart racing, jaw pain, felt faint. On 26Aug2021, the patient experienced syncope vasovagal (medically significant). The outcome of syncope vasovagal was recovered on 26Aug2021. The outcome of the events heart racing, jaw pain, felt faint was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1690302 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Muscle spasms, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 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
CDC Split Type: GBPFIZER INC202101117850

Write-up: muscle cramping; tiredness; Diarrhoea; Leg cramps; Stomach cramps; This is a spontaneous report from a contactable consumer. This is report received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108261538066080-QNBVY, Safety Report Unique Identifier number is (GB-MHRA-ADR 25854664). A 37-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: FE3380), via an unspecified route of administration on 24Aug2021 as dose 1, single for COVID-19 immunization. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient experienced muscle cramping in arms and legs, extreme tiredness and diarrhoea on an unspecified date, leg cramps and stomach cramps on 26Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: no- negative covid-19 test on an unspecified date. The outcome of the events muscle cramping, leg cramps, tiredness and diarrhoea was unknown, stomach cramps was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1690345 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Dry mouth, Electric shock sensation, Headache, Insomnia, Nasopharyngitis, SARS-CoV-2 test, Sensory overload, Sleep disorder, Tremor, Visual snow syndrome
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: ELVANSE; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD; Social anxiety disorder; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210603; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes-Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101118706

Write-up: cold; I began to feel cold and shakey; Every sensation felt like an electric shock; I found it hard to sleep; I woke up multiple times during sleep; I never felt comfortable; Headache; Sensory overload; Visual snow syndrome; Xerostomia; 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-202108271149062160-2K5CF. Safety Report Unique Identifier: GB-MHRA-ADR 25859023. A patient of unspecified age and gender received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection), via an unspecified route of administration on 26Aug2021 at 12:00 as dose 2, single for COVID-19 immunization. Medical history included suspected covid-19 from 03Jun2021, social anxiety disorder and attention deficit hyperactivity disorder. Patient was received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient has not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. Concomitant medications included lisdexamfetamine mesilate (ELVANSE) for attention deficit hyperactivity disorder from 01Jan2019 and sertraline (SERTRALINE) for social anxiety disorder from 01Jun2021. On an unspecified date, the patient experienced cold, patient began to feel cold and shakey, every sensation felt like an electric shock, patient found it hard to sleep, patient woke up multiple times during sleep, patient was never felt comfortable and on 26Aug2021, the patient had headache, sensory overload, visual snow syndrome and xerostomia. Clinical course was patient vaccine taken at 12:00pm morning of Thursday 26Aug2021. By 1:00am of Friday, patient began to feel cold and shakey. patient began to feel sensory overload al over patient body. Every sensation felt like an electric shock. Patient found it hard to sleep. Patient mouth was scorching dry. Patient woke up multiple times during sleep - and patient never felt comfortable. At about 8am patient woke up with an incredibly bad headache, that would get worse depending on which position patient was in. This prompted patient to call NHS 111. This headache subsided by 11:30am. Patient felt general calmness and a heightened sense of confidence and motivation. Patient felt more focused and less socially anxious. Patient felt significantly less sensory overload. The case classified as serious (medically significant). On 03Jun2021, the patient underwent lab tests and procedures which included SARS-COV-2 test: positive (Yes-Positive COVID-19 test). The outcome of the events cold was resolving, event headache, sensory overload, visual snow syndrome and xerostomia was resolved 27Aug2021 and events I began to feel cold and shakey, every sensation felt like an electric shock, I found it hard to sleep, I woke up multiple times during sleep and I never felt comfortable was resolved on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1690346 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Lethargy, Myalgia, Nausea, Neck pain, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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.MOD20213

Write-up: Muscle pain; Nausea; Fever; Lethargy; Neck pain; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25859067) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), NECK PAIN (Neck pain), HEADACHE (Headache), MYALGIA (Muscle pain), NAUSEA (Nausea) and PYREXIA (Fever) in a 31-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 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced LETHARGY (Lethargy) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, LETHARGY (Lethargy), MYALGIA (Muscle pain), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved and NECK PAIN (Neck pain) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment information was not provided. It was reported that the Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. 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: 1690351 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema of eyelid, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118839

Write-up: Skin loss; Peely skin; the skin on my eyes is red and flaky; the skin on my eyes is red and flaky; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108271335441120-Z92BM, Safety Report Unique Identifier GB-MHRA-ADR 25859519. A 44-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FE3380), via an unspecified route of administration on 26Aug2021 at 11:00AM ( at the age of 44-years-old) at single dose for COVID-19 immunization. Relevant medical history included suspected COVID-19 from 27Aug2021 and ongoing (as reported). 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. Concomitant medications were not reported. On 26Aug2021 the patient experienced skin loss, peely skin, the skin on her eyes was red and flaky. The events were medically significant. Clinical course was provided as follows. She had the vaccine at 11AM and went straight back to work. When finishing and changing at 20000 (as reported), she noticed the skin on her feet had started to peel off in large volumes. In addition, the skin on her eyes was red and flaky. Skin loss and peely skin were not resolved, outcome for the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1690365 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Erythema, Fatigue, Headache, Myalgia, SARS-CoV-2 test, Vaccination site warmth
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: NAPROXEN; SERTRALINE
Current Illness: Depressed mood; Fibromyalgia
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: headache; fatigue; joint aches; hot at injection site; muscle aches; Redness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25861950) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), HEADACHE (headache), FATIGUE (fatigue) and ARTHRALGIA (joint aches) in a 33-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. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Fibromyalgia and Depressed mood. Concomitant products included SERTRALINE from November 2019 to an unknown date for Depressed mood, NAPROXEN from 2020 to an unknown date for Fibromyalgia. On 25-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 26-Aug-2021, the patient experienced ERYTHEMA (Redness) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant), FATIGUE (fatigue) (seriousness criterion medically significant), ARTHRALGIA (joint aches) (seriousness criterion medically significant), VACCINATION SITE WARMTH (hot at injection site) and MYALGIA (muscle aches). At the time of the report, ERYTHEMA (Redness) had not resolved and HEADACHE (headache), FATIGUE (fatigue), ARTHRALGIA (joint aches), VACCINATION SITE WARMTH (hot at injection site) and MYALGIA (muscle aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 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. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Regulatory Authority reporting. Events seriousness per overall case assessment by Authority. Non-serious events of vaccination site warmth and myalgia added per information in RA narrative.; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Regulatory Authority reporting. Events seriousness per overall case assessment by Authority. Non-serious events of vaccination site warmth and myalgia added per information in RA narrative.


VAERS ID: 1690372 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-26
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
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.MOD20213

Write-up: Nausea; Muscle ache; Fever; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 25862758) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache), PYREXIA (Fever) and NAUSEA (Nausea) in a 28-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-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 27-Aug-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle ache), PYREXIA (Fever) and NAUSEA (Nausea) was resolving. 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.; 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: 1690383 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache, Nausea, Pain, Pharyngeal swelling, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Throat Swelling; nauseous; Nausea; Light-headed; Ache; Headache; This case was received via RA (Reference number: GB-MHRA-ADR 25864508) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Throat Swelling), DIZZINESS (Light-headed), PAIN (Ache), NAUSEA (nauseous), NAUSEA (Nausea) 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 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced DIZZINESS (Light-headed) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced PHARYNGEAL SWELLING (Throat Swelling) (seriousness criterion medically significant) and NAUSEA (nauseous) (seriousness criterion medically significant). At the time of the report, PHARYNGEAL SWELLING (Throat Swelling) and NAUSEA (nauseous) outcome was unknown and DIZZINESS (Light-headed), PAIN (Ache), NAUSEA (Nausea) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient was not currently breastfeeding. The patient was not enrolled in clinical trial. The patient was on the feminine pill. Day after patient whole body was really aching, really bad headache with a strain on the eyes, swollen throat that is really sore, feeling nauseous, feeling lightheaded when get out of bed or try to walk. Phoned the gp but he wasn''t interested and said what was supposed to do. No treatment medication details was provided. For mRNA-1273 (Moderna CoviD-19 Vaccine), the reporter did not provide any causality assessments. Company Comment: This case concerns a 32-year-old female subject, who experienced the unexpected events of headache, dizziness, nausea, pharyngeal swelling, nausea. The events occurred one day after the second dose of Moderna COVID-19 Vaccine. The reporter''s assessment was not provided for the events. 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 benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report. Events onset dates captured per Regulatory Authority reporting and differ from what is described on the narrative.; Sender''s Comments: This case concerns a 32-year-old female subject, who experienced the unexpected events of headache, dizziness, nausea, pharyngeal swelling, nausea. The events occurred one day after the second dose of Moderna COVID-19 Vaccine. The reporter''s assessment was not provided for the events. 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 benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report. Events onset dates captured per Regulatory Authority reporting and differ from what is described on the narrative.


VAERS ID: 1690385 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Chills, Headache, Hyperhidrosis, Injection site pain, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: sweating; shivering; nauseous; alternating; Vomiting; Headache; Fever; Chills; Armpit pain; Nausea; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25864642) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), CHILLS (shivering), NAUSEA (nauseous), INJECTION SITE PAIN (alternating), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), AXILLARY PAIN (Armpit pain), NAUSEA (Nausea) and VOMITING (Vomiting) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. 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''s past medical history included Lactation decreased. Concomitant products included PARACETAMOL from 26-Aug-2021 to 27-Aug-2021 for Headache. On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant), NAUSEA (nauseous) (seriousness criterion medically significant) and INJECTION SITE PAIN (alternating) (seriousness criterion medically significant). On 26-Aug-2021, CHILLS (Chills) had resolved. On 27-Aug-2021, PYREXIA (Fever), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, HYPERHIDROSIS (sweating), CHILLS (shivering), NAUSEA (nauseous), INJECTION SITE PAIN (alternating), HEADACHE (Headache) and AXILLARY PAIN (Armpit pain) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Had the vaccine at 9.30am on 26th August, felt fine all day except an achy arm where the vaccine went in and some armpit pain in the same arm. Then at around 5.30pm I just started shivering and struggling to regulate my body temperature, and also got a headache. Throughout the night I kept waking up every half hour/hour shivering and sweating alternating, and feeling nauseous. I was then sick at 4.30am on 27th August. Went back to sleep and felt better, though still with a headache. Now it is the 28th August and I just have a very low level headache and minor armpit pain. Patient had not tested positive for COVID-19 since having the vaccine. 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. Events seriousness captured as per Regulatory Authority assessment in the 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 captured as per Regulatory Authority assessment in the Document.


VAERS ID: 1690386 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Injection, 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: Medical History/Concurrent Conditions: Lactation decreased.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: injection; head ache; Headache dull; Muscle pain; Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25864646) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), PYREXIA (Fever), INJECTION (injection), HEADACHE (head ache) and HEADACHE (Headache dull) in a 19-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 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache dull) (seriousness criterion medically significant). On an unknown date, the patient experienced INJECTION (injection) (seriousness criterion medically significant) and HEADACHE (head ache) (seriousness criterion medically significant). On 27-Aug-2021, HEADACHE (Headache dull) had resolved. At the time of the report, MYALGIA (Muscle pain) had not resolved, PYREXIA (Fever) was resolving and INJECTION (injection) and HEADACHE (head ache) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Relevant concomitant product usage were not reported by the reporter. No treatment details were added. 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 assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered 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. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious. No further information is expected.


VAERS ID: 1690395 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, Rash, SARS-CoV-2 test, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRTAZAPINE; SERTRALINE
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: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Rash; Skin warm; Pain; This case was received via the RA (Reference number: GB-MHRA-ADR 25864979) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash), SKIN WARM (Skin warm) and PAIN (Pain) in a 24-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 MIRTAZAPINE and SERTRALINE for Depression. On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant), SKIN WARM (Skin warm) (seriousness criterion medically significant) and PAIN (Pain) (seriousness criterion medically significant). At the time of the report, RASH (Rash), SKIN WARM (Skin warm) and PAIN (Pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The treatment information was not provided. Post vaccination patient not tested positive for COVID-19..Also patient was not enrolled in any clinical trials.Patient was not pregnant and was not breastfeeding at the time of reporting. It was reported that patient had no symptoms associated with COVID-19. 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: 1690397 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal behaviour, Diarrhoea, Headache, Hyperhidrosis, Myalgia, Nausea, Peripheral swelling, Pruritus, Pyrexia, Swelling, Urticaria, Vaccination site vesicles
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
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 INC202101118778

Write-up: clothes drenched; muscle pain; diarrhea; swollen arm; nauseated; Hives; Sweating; Application site blister; Diarrhoea; Headache; Swelling; Nausea; Itching; Fever; 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-202108281828046840-8R2ZM, safety report unique identifier is GB-MHRA-ADR 25865057. A 20-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: FE8087), dose 2 via an unspecified route of administration on 26Aug2021 13:00 (Age at time of vaccination 20-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1, via an unspecified route of administration on an unspecified date for COVID-19 immunization.The patient medical history, concomitant medications were not reported. Patient has not 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. On an unspecified date The patient experienced clothes drenched, muscle pain, diarrhea, swollen arm, nauseated. On 26Aug2021 fever. On 27Aug2021 itching, diarrhoea, headache, swelling, nausea. On 28Aug2021 hives, sweating, application site blister. Events were consider as medical significant. The outcome of events fever, itching, headache, swelling, nausea, hives, sweating, application site blister were resolved On 28Aug2021, diarrhoea was resolved on 27Aug2021 and rest all were resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1690421 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Diarrhoea, Eye swelling, Headache, Hypoaesthesia, Mass excision, Musculoskeletal stiffness, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Paracetamol
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Paracetamol (Painful arm).
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101126347

Write-up: wet eye; heavy head; Numb; stiff; lump; Palsy Bells; Loose bowel; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108291142424970-2RFUR. Safety Report Unique Identifier GB-MHRA-ADR 25865522. A 46-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3380, Expiry date: unknown, at the age of 46-year-old), DOSE 2 via an unspecified route of administration on 25Aug2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Historical vaccine included first dose for COVID-19 immunisation. Concomitant medications included paracetamol taken for pain in extremity from 25Aug2021 to an unspecified stop date. The patient experienced loose bowel (medically significant) on 26Aug2021 and palsy bells (medically significant) on 27Aug2021. The patient experienced wet eye (medically significant), heavy head (medically significant), numb (medically significant), stiff (medically significant) and lump (medically significant) on an unspecified date. Patient reported that numb feeling to my right side of face and a heavy feeling in my head my right eye feels slightly wet in the corner but no drooping. My arm where I had vaccination went very stiff and patient had a red lump and very sore and hot then 4 days after its starting to go down and not do hot but my face still felt strange. Patient was told to sit and wait and just keep taking paracetamol and fluids. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (no-negative COVID-19 test) on an unspecified date. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The clinical outcome of events palsy bells, loose bowel was not recovered and clinical outcome of other all events was unknown. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "None". No follow-up attempts are possible. No further information is expected.


VAERS ID: 1690433 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dermatitis allergic, Hypersensitivity, Lymphadenopathy, Miliaria, Platelet count, Pyrexia, Rash erythematous, Rash pruritic, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: FOSTAIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Asthma; Clinical trial participant (Study details: Ipsos mori covid-19 study); Depression; Irritable bowel syndrome; Lactation decreased; Peanut allergy (Peanut allergy (serious, IgE mediated))
Allergies:
Diagnostic Lab Data: Test Name: platelet count; Result Unstructured Data: Test Result:low; Test Date: 20210824; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101126422

Write-up: anaphylaxis; allergic reaction; big red welts/rash which was heated and itchy; big red welts/rash which was heated and itchy; big red welts/rash which was heated and itchy; Allergic rash; Fever; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108291834436580-XYIRI. Safety Report Unique Identifier GB-MHRA-ADR 25865848. A 29-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: FE3380), dose 2 via an unspecified route of administration on 26Aug2021 (Age at vaccination 29 years) as dose 2, single for covid-19 immunisation. Medical history included peanut allergy (Peanut allergy (serious, IgE mediated)), lactation decreased, depression, asthma, clinical trial participant (Study details: Ipsos mori covid-19 study), IBS and anxiety. Concomitant medication(s) included beclometasone dipropionate, formoterol fumarate (FOSTAIR) taken for asthma from 20Jul2021 to an unspecified stop date. The patient previously took peanut (known anaphylaxis with peanuts) and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number : Not reported), via an unknown route of administration on an unknown date as dose 1, single for covid-19 immunisation. On an unspecified date, the patient experienced anaphylaxis; allergic reaction; big red welts/rash which was heated and itchy; On 26Aug2021, swollen lymph nodes and fever; On 29Aug2021, allergic rash. The patient underwent lab tests and procedures which included platelet count: low on, sars-cov-2 test: negative on 24Aug2021 No - Negative COVID-19 test. Patient was received treatment for event fever. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. It was reported that patient had an allergic reaction on her skin to her shampoo today - she had been using the same shampoo for over 18 months but when she used it today (first time since having the vaccine) her chest and back (areas that had most contact with the shampoo) came out in big red welts/rash which was heated and itchy. FYI she had known anaphylaxis with peanuts. The clinical outcome of event fever was recovered on 29Aug2021; allergic rash was recovering; swollen lymph nodes was not recovered; while other events outcome were unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1690493 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-26
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Persistent vomiting; Fatigue; Feverish; Vomiting; Headache; This case was received via RA (Reference number: GB-MHRA-ADR 25880983) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Persistent vomiting), FATIGUE (Fatigue), PYREXIA (Feverish), VOMITING (Vomiting) and HEADACHE (Headache) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). On 28-Aug-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion hospitalization). On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion hospitalization), VOMITING (Persistent vomiting) (seriousness criterion hospitalization) and FATIGUE (Fatigue) (seriousness criterion hospitalization). On 31-Aug-2021, VOMITING (Vomiting) had resolved. At the time of the report, NAUSEA (Nausea), VOMITING (Persistent vomiting) and FATIGUE (Fatigue) had resolved and PYREXIA (Feverish) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-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 medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. SD- Initially started with headaches and nausea. Developed into extreme fatigue, fevers of 42degC and persistent vomiting. Lab results were reported as Bloods and urine analysis carried out and both were all clear. ECG normal. Chest clear. Blood pressure OK.O2 levels 100 percent. 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: 1690767 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214024 / UNK - / OT

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

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

Write-up: This case was received via Regulatory Agency (Reference number: IT-MINISAL02-777487) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN in a 20-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214024) for SARS-CoV-2 immunization. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced CHEST PAIN (seriousness criterion hospitalization prolonged). At the time of the report, CHEST PAIN outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not reported. Treatment history was not reported. Very limited information regarding this event has been provided at this time. Further information will not be requested. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Translation recieved on08Sep2021 contains no new information .; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information will not be requested.


VAERS ID: 1690884 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005240 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Depressed level of consciousness, Presyncope
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? 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: JPMODERNATX, INC.MOD20213

Write-up: Consciousness clouding; Vasovagal reaction (on the verge of syncope); This case was received via Regulatory Authority (Reference number: 2021TJP086988) on 31-Aug-2021 and was forwarded to Moderna on 09-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the (Ref, v21125239). Consciousness clouding was assessed as serious by the agency. On an unknown date, the patient''s blood pressure before the prevaccination screening was 126/66, pulse was 56, and SPO2 was 93, which were measured in the sitting position. On an unknown date, body temperature before vaccination: 36.2 degrees Celsius. On 26-Aug-2021, at 16:02, the patient received the 1st dose of this vaccine n a sitting position. At 16:04, the vasovagal reaction developed, and the patient was on the verge of syncope. At 16:06, blood pressure 84/55, pulse 114, SPO2 99, consciousness clouding. The patient was placed supine. At 16:09, blood pressure 92/42, pulse 46, SPO2 99, consciousness clear. At 16:15, blood pressure 117/71, pulse 55, SPO2 99, consciousness clear. At 16:50, blood pressure 117/76, pulse 45, SPO2 99. Vital signs were checked in the sitting position. At 17:00, the patient was able to confirm the recovery of the symptoms and went home. The outcome of vasovagal reaction (on the verge of syncope) and consciousness clouding was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 27-year-old male with a serious unexpected event of depressed level of consciousness, and non-serious presyncope. Event latency 2 minutes after first dose mRNA-1273. Events resolved. Based on 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: 1690898 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Difficulty breathing; Pyrexia; Chills; This case was received via regulatory authority (Reference number: 2021TJP087773) on 02-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This case, initially reported to the regulatory authority by a physician, was received via the PMDA (Ref, v21125491). On an unknown date, the patient received the 1st dose of the vaccine. On 25-Aug-2021, the patient received the 2nd dose of the vaccine. On 26-Aug-2021, in the morning, chills developed. At 13:00, the patient had difficulty breathing that was as if there were weights all over the body, and pyrexia. The patient called an ambulance. The outcome of pyrexia, chills, and difficulty breathing was unknown. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; 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: 1694025 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bacille Calmette-Guerin scar reactivation, Erythema, Headache, Influenza, Influenza like illness, Pain, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DELMOSART
Current Illness: ADHD
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Unsure if patient has had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: flu type reaction; headache; Stinging; Pain; Swollen arm; Redness; Flu symptoms; BCG scar activation; This case was received via the RA (Reference number: GB-MHRA-ADR 25864455) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACILLE CALMETTE-GUERIN SCAR REACTIVATION (BCG scar activation), PAIN (Stinging), PAIN (Pain), PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Redness), INFLUENZA LIKE ILLNESS (flu type reaction), HEADACHE (headache) and INFLUENZA (Flu symptoms) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003607) for COVID-19 vaccination. Unsure if patient has had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased. Previously administered products included for an unreported indication: BCG. Concurrent medical conditions included ADHD. Concomitant products included METHYLPHENIDATE HYDROCHLORIDE (DELMOSART) from 12-Aug-2021 to an unknown date for ADHD. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced BACILLE CALMETTE-GUERIN SCAR REACTIVATION (BCG scar activation) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), ERYTHEMA (Redness) (seriousness criterion medically significant) and INFLUENZA (Flu symptoms) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced PAIN (Stinging) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu type reaction) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). On 28-Aug-2021, INFLUENZA (Flu symptoms) had resolved. At the time of the report, BACILLE CALMETTE-GUERIN SCAR REACTIVATION (BCG scar activation), PAIN (Stinging), PAIN (Pain), PERIPHERAL SWELLING (Swollen arm) and ERYTHEMA (Redness) had not resolved and INFLUENZA LIKE ILLNESS (flu type reaction) and HEADACHE (headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No treatment medications were 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. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.; 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 assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.


VAERS ID: 1697310 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7210 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Blood test, Body temperature, Computerised tomogram head, Dizziness, Eye pain, Headache, Loss of consciousness, Nausea, Pain in extremity, Pyrexia, Seizure, Urine analysis, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210828; Test Name: pressure; Result Unstructured Data: Test Result:dropped a lot; Test Date: 202108; Test Name: Blood test; Result Unstructured Data: Test Result:no change; Test Date: 20210826; Test Name: body temperature; Result Unstructured Data: Test Result:37.3; Test Date: 202108; Test Name: cranial tomography; Result Unstructured Data: Test Result:no change; Test Date: 202108; Test Name: urine test; Result Unstructured Data: Test Result:no change
CDC Split Type: BRPFIZER INC202101133868

Write-up: lost consciousness; convulsed / closed his hands, became rigid, trembling, with his eyes upwards; he couldn''t see; pressure dropped a lot; calf pain; weakness/ weakness in his arms and legs; dizziness/ he saw everything spinning; nausea; aching eyes; aching head; internal fever that was not high (measured on the thermometer until 37.3); This is a spontaneous report received by Medical Information Team from a contactable consumer (patient''s mother). An 18-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 19Aug2021 (Lot Number: FD7210) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient took Comirnaty on 19Aug2021, on a Thursday (26Aug2021, also reported as 10 days later), he began to experience calf pain, weakness, dizziness, nausea, aching eyes, aching head, internal fever that was not high (measured on the thermometer until 37.3). He spent Wednesday, Thursday, Friday and when it was Saturday (28Aug2021) night he saw everything spinning, lost consciousness and convulsed. He closed his hands, became rigid, trembling, with his eyes upwards, he stayed like that for about 10 minutes and then slowly returned, pale and with a white mouth. The pressure dropped a lot. He said he couldn''t see. Sunday him was took to the hospital and there they said it might or might not be a vaccine reaction. Blood, urine and cranial tomography were performed in Aug2021 and there was no change. He was taking Norfloxacin because it could be a urinary infection, according to the physician, because of something that happened in the urine test, but it wasn''t. He had never had a seizure before. He was now in follow-up. He still had pain in his calf, weakness in his arms and legs.


VAERS ID: 1697450 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-08-26
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6924 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Pain, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARVEDILOL; TANSULOSINA; ACETYLSALICYLIC ACID; LANZOPRAZOL; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disorder (Patient had a pacemaker); Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: test for covid 19; Result Unstructured Data: Test Result:Positive
CDC Split Type: COPFIZER INC202101138433

Write-up: On Sep2021 a test for COVID19 was performed and the result was positive; On Sep2021 a test for COVID19 was performed and the result was positive; cough; fever; body pain; This is a spontaneous report from a non-measurable supplier. A contactable consumer reported that a 68-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER4449 and expiration date was not reported), dose 1 via intramuscular route of administration, administered in Arm Right on 16Apr2021 (at the age of 68 years) as dose 1, 0.3 ml single and Patient also took bnt162b2 (BNT162B2, Solution for injection, Lot Number: ET6924 and expiration date was not reported) dose 2 via intramuscular route of administration, administered in Arm Right on 11May2021, dose 2, 0.3 ml single for covid-19 immunization. Medical history included hypertension and cardiovascular disorder (the patient had a pacemaker). Concomitant medication included carvedilol, tamsulosin hydrochloride (TANSULOSINA), acetylsalicylic acid, lansoprazole, atorvastatin taken for an unspecified indication, start and stop date were not reported. On 26Aug2021 at noon, the patient presented a cough and at night he already presented a little fever and a little body pain. On Sep2021 a test for COVID19 was performed and the result was positive. The patient underwent lab tests and procedures which included test for covid 19 found to be positive on unspecified Sep2021.The patient took acetaminophen and ipratropium bromide as treatment for adverse events. Outcome of vaccination failure was unknown. Outcome of rest of the events was recovering.


VAERS ID: 1698153 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-26
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Chills, Cold sweat, Eye irritation, Facial pain, Fatigue, Feeling cold, Feeling hot, Headache, Muscular weakness, Nasal congestion, Pyrexia, Sensitive skin, Tachycardia, Underdose
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: 0.3ml vaccine administered vaccine; This case was received via Regulatory Agency (Reference number: ES-AEMPS-987971) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN, NASAL CONGESTION, CHEST DISCOMFORT, FACIAL PAIN, FEELING HOT, EYE IRRITATION, TACHYCARDIA, MUSCULAR WEAKNESS), FEELING COLD, COLD SWEAT, SENSITIVE SKIN, HEADACHE, FATIGUE, CHILLS and PYREXIA in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214020) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .3 milliliter. On 26-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .3 milligram. On 26-Aug-2021, the patient experienced CHEST PAIN (seriousness criterion medically significant), NASAL CONGESTION (seriousness criterion medically significant), CHEST DISCOMFORT (seriousness criterion medically significant), FACIAL PAIN (seriousness criterion medically significant), FEELING HOT (seriousness criterion medically significant), EYE IRRITATION (seriousness criterion medically significant), TACHYCARDIA (seriousness criterion medically significant), MUSCULAR WEAKNESS (seriousness criterion medically significant), FEELING COLD (seriousness criterion medically significant), COLD SWEAT (seriousness criterion medically significant), SENSITIVE SKIN (seriousness criterion medically significant), HEADACHE (seriousness criterion medically significant), FATIGUE (seriousness criterion medically significant), CHILLS (seriousness criterion medically significant) and PYREXIA (seriousness criterion medically significant). On an unknown date, the patient experienced UNDERDOSE (0.3ml vaccine administered vaccine). At the time of the report, CHEST PAIN, NASAL CONGESTION, CHEST DISCOMFORT, FACIAL PAIN, FEELING HOT, EYE IRRITATION, TACHYCARDIA, MUSCULAR WEAKNESS, FEELING COLD, COLD SWEAT, SENSITIVE SKIN, HEADACHE, FATIGUE, CHILLS and PYREXIA had not resolved and UNDERDOSE (0.3ml vaccine administered vaccine) had resolved. 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: 1698172 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Insomnia
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101133951

Write-up: terrible headache. She could barely open her eyes / pain was too intense; did not really sleep; This is a spontaneous report from a contactable consumer (patient) received through COVAES. A 40-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration, administered in Arm Left on 25Aug2021 10:45 (at the age of 40 years old) (Lot Number: unknown) as dose 1, single for COVID-19 immunisation. Medical history was reported as none. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Aug2021 10:45, 24h after the jab, the patient experienced terrible headache. She could barely open her eyes. She went to bed at 11am and rested until 3am the day after (did not really sleep) just could not do anything as the pain was too intense. Patient took 1g of paracetamol which never helped at all. She woke up at 8am on 27Aug2021 and the headache was gone. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event headache was recovered on 27Aug2021 08:00, for difficulty sleeping was recovered on an unspecified date. The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1698247 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Hodgkin lymphoma treated with multiple drug chemotherapy (2000), Chronic obstructive pulmonary disease, Anxiety-depressive syndrome, Amputation right toes, Patient Gravida 2 Para 2, Menopause at 47 years of age, chemotherapy, No personal Early Venous Thromboembolism history, Family history Deep Vein Thrombosis and Breast Neoplasia. Mammographic monitoring without particularities (2018), gynecological follow up with familial cancer visibility without particularities (2018), asthma with penicillin, Active smoking greater than 50 Pack Year, dyslipidemia, No hypertension, Diabetes, Terbutaline 500 mcg, Fenofibrate 160 mg
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210923326

Write-up: PULMONARY EMBOLISM; This spontaneous report received from a pharmacist by a Regulatory Authority (EVHUMAN Vaccines, FR-AFSSAPS-CN20212921) was received on 13-SEP-2021 and concerned a 68 year old female. The patient''s weight was 58 kilograms, and height was 167 centimeters. The patient''s pre-existing medical conditions included: Hodgkin lymphoma treated with multiple drug chemotherapy (2000), Chronic obstructive pulmonary disease, Anxiety-depressive syndrome, Amputation right toes, Patient Gravida 2 Para 2, Menopause at 47 years of age, chemotherapy, No personal Early Venous Thromboembolism history, Family history Deep Vein Thrombosis and Breast Neoplasia. Mammographic monitoring without particularities (2018), gynecological follow up with familial cancer visibility without particularities (2018), asthma with penicillin, Active smoking greater than 50 Pack Year, dyslipidemia, No hypertension, Diabetes, Terbutaline 500 mcg, Fenofibrate 160 mg. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 dosage forms, 1 total administered on 28-JUL-2021 for covid-19 vaccination. Drug start period and last period was 30 days and duration of drug administration was 1 day. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 26-AUG-2021, the patient experienced pulmonary embolism, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1698631 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Back pain, Gait disturbance, Pain in extremity, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101132938

Write-up: After 3 days she could barely walk; Back pain; Painful arm; Stomach upset; This is a spontaneous report from a contactable consumer. This report is received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-APPCOVID-20210831045651. Safety Report Unique Identifier GB-MHRA-ADR 25871917. A 26-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: FF3319) dose unspecified, via an unspecified route of administration on 26Aug2021 (at the age of 26-year-old) as single dose for COVID-19 immunisation. The patient medical history included suppressed lactation and headache from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN) taken for headache from 16Aug2021 to 16Aug2021. The patient previously took ether. No known illnesses or allergies. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. On 26Aug2021, the patient experienced stomach upset, on 27Aug2021, she had painful arm, on 28Aug2021, she had back pain and on 29Aug2021, after 3 days she could barely walk. Apart from common side effects a mild lower back pain has started a day after a vaccine even though nothing else has been done to cause it. The pain was hardly noticeable at first, but it was getting progressively worse. After 3 days she could barely walk, painkillers were not helping much and she was starting to feel some pain/numbness going down her legs. Pain did not feel like a pulled muscle, more like inflammatory, could not pin-point an exact location. She found multiple other people describing similar symptoms after receiving either first or second dose on online forums. (reddit more precise if you are willing to look into it). Patient was not enrolled in clinical trial. The patient underwent lab tests which showed SARS-CoV-2 test as no, negative covid-19 test on 02Feb2021, no - negative COVID-19 test. Outcome was not resolved for event back pain, resolved on 27Aug2021 for stomach upset, resolved on 30Aug2021 for painful arm and unknown for after 3 days she could barely walk. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1698670 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Pain, 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: RIGEVIDON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101145301

Write-up: Vomiting; Ache; Headache; This is a spontaneous report from a contactable consumer or other non HCP. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108261537514180-JWUDF. Safety Report Unique Identifier is GB-MHRA-ADR 25854672. A 16-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for Injection, Lot number: not reported), dose 1 via an unspecified route of administration on 25Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included birth control from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, levonorgestrel (RIGEVIDON) taken for birth control from 28Jul2021 to an unspecified stop date. The patient had not had symptoms associated with COVID-19. The patient was not currently breastfeeding. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient experienced vomiting, ache and headache on 26Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 24Aug2021. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1698674 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Chest pain, Dyspnoea, Heart rate increased, Malaise, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: YASMINELLE; BENADRYL ALLERGY RELIEF
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to nuts; Hay fever (Also have hay fever during summer which I occasionally take antihistamine for.); Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Name: Raised blood pressure; Result Unstructured Data: Test Result:Unknown results; Test Name: High pulse rate; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210822; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101145351

Write-up: Malaise; High pulse rate; Raised blood pressure; Chest pain; Short of breath; Facial rash; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108271313512250-54BFY. Safety Report Unique Identifier GB-MHRA-ADR 25859431. A 18-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER- BIOTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 25Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history included seasonal allergy (Also have hay fever during summer which I occasionally take antihistamine for), food allergy, Allergy to nuts, Penicillin allergy from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. The patient previously received Benadryl Allergy Relief on an unspecified date for unknown indication. Concomitant medication(s) included drospirenone, ethinylestradiol betadex clathrate (YASMINELLE) taken for contraception from 01Aug2020 to an unspecified stop date; acrivastine (BENADRYL ALLERGY RELIEF) taken for seasonal allergy, start and stop date were not reported. On 26Aug2021 the patient experienced high pulse rate, raised blood pressure, chest pain, short of breath, facial rash. Malaise on an unspecified date. The event was reported as serious with seriousness criteria other medically important condition. It was reported that No side effects on the day of getting the second dose of Pfizer. However, the day after around 9pm Chest pain, Facial rash, High pulse rate, Raised blood pressure and Short of breath. All the reactions listed above occurred while sitting down watching a movie (no physical activity, no stress). I called 111 and was advised to lay down and relax and to drink water. It was now the third day and I still do not feel well, and my chest pain has gotten worse. Every time I get up and move, I can feel my heart beating faster. I have never usually been able to feel it. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 22Aug2021 No - Negative COVID-19 test , heart rate increased: unknown results , blood pressure increased: unknown results. Outcome of event was not recovered while for facial rash was recovering and for malaise was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1698675 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chills, 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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101118627

Write-up: Drug ineffective; COVID-19; Chills; This is a spontaneous report from a contactable consumer received from the Regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108271502339500-CHZMW. Safety Report Unique Identifier [GB-MHRA-ADR 25859954]. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Aug2021 as single dose for COVID-19 immunization. The patient''s medical history included suspected COVID-19 from 15Mar2021 to an unknown date It was unsure when symptoms stopped. The patient''s concomitant medications were not reported. The patient experienced chills on 26Aug2021. On an unknown date, the patient experienced COVID-19 and exhibited drug ineffective. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date 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 outcome of event was unknown. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1698686 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BB / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (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 INC202101118537

Write-up: Back pain; This is a spontaneous report from a contactable consumer received from the Regulatory A.The regulatory authority report number is GB-MHRA-WEBCOVID-202108280705405860-8YFNT.Safety Report Unique Identifier GB-MHRA-ADR 25863075. The 12-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection and Lot Number: Bb) via an unspecified route of administration on 26Aug2021 (at the age of 12-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. It was unsure if patient had symptoms associated with COVID-19. On 26Aug2021 the patient experienced back pain with 12 hours of vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No-Negative COVID-19 test. Therapeutic measures were taken as a result of back pain. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1698695 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-26
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MARVELON
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 INC202101138151

Write-up: Heavy periods; 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-202108290035190340-A7VFF. Sender''s (Case) Safety Report Unique Identifier -GB-MHRA-ADR 25865283. A 27-year-old non-pregnant female patient received Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: not reported) via an unspecified route of administration on 03Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included desogestrel, ethinylestradiol (MARVELON) taken for an unspecified indication, start and stop date were not reported. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The patient experienced heavy periods (medically significant) on 26Aug2021. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test: negative (No - Negative COVID-19 test). The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1698743 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Diarrhoea, Dyspnoea, Malaise, SARS-CoV-2 test, Seizure
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (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: RIVAROXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: DVT of legs; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101126241

Write-up: generally feeling ill; Night; Chest pain; Short of breath/shortness of breath; Diarrhoea; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority). The regulatory authority report number is GB-MHRA-WEBCOVID-202108291601131140-NGZJD. Safety Report Unique Identifier GB-MHRA-ADR 25865749. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Aug2021 (Batch/Lot Number: FE3380) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lactation decreased and DVT of legs. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medication included rivaroxaban taken for DVT of legs from 09Apr2021 to an unspecified stop date. The patient experienced chest pain and shortness of breath on 29Aug2021 (also reported as "night of vaccine"). Went away but returned around 02:00 - 03:00 today (unspecified date). Eased a little until around 08:00 then worsened. Eased a little hour but returned after lunch (after repotting a plant in the garden), and SOB and chest pain worsened substantially. Generally feeling ill on an unspecified date. The patient also experienced diarrhea on 26Aug2021 and seizure (reported as "night) on an unspecified date. The events were assessed as serious (medically significant). Lab data includes COVID-19 virus test: No - Negative COVID-19 test on 02Apr2021. The outcome of the events chest pain, shortness of breath, diarrhoea was not recovered; while unknown for the rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1698849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest discomfort, Dyspnoea, Heart rate increased, Hypertension, Myocarditis, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: blood pressure; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC202101133126

Write-up: sensation of heavy chest; sensation of rapid heart beating; Myocarditis; Blood pressure high; Shortness of breath; Tight chest; Pain in arm; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108301401290490-GKI5P, Safety Report Unique Identifier GB-MHRA-ADR 25868800. A 29-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number: FE8087; expiration date not provided) via an unspecified route of administration on 25Aug2021 as DOSE 1, SINGLE for COVID-19 immunization. Patient''s medical history included lactation decreased from an unspecified date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not pregnant and is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced myocarditis, blood pressure high, shortness of breath, and ''tight chest'' on 27Aug2021''; pain in arm on 26Aug2021; ''sensation of heavy chest'' and ''sensation of rapid heart beating'' on unspecified dates. Patient''s clinical course is as follows: It was reported that patient experienced high blood pressure, sensation of heavy chest, shortness of breath, sensation of rapid heart beating, and tight chest. The events were assessed as serious (medically significant). The patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included blood pressure with result of high on 27Aug2021. Outcome of the event pain in arm was recovered/resolved with sequel on 28Aug2021; outcome of the events myocarditis, blood pressure high, shortness of breath, and tight chest was not recovered; outcome of the events ''sensation of heavy chest'' and ''sensation of rapid heart beating'' was unknown. No follow-up attempts are Possible. No further information is expected.


VAERS ID: 1698890 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Axillary pain, Chest discomfort, Decreased appetite, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), 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: BECONASE AQUEOUS; ACETIC ACID;BENZETHONIUM CHLORIDE;HYDROCORTISONE;PROPYLENE GLYCOL DIACETATE; ETHINYLESTRADIOL/LEVONORGESTREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Eczema; Heavy periods; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101133130

Write-up: Nausea/nauseous; Vomited; Stomach pain; Appetite lost; Armpit pain; Tightness in chest; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. This case was downloaded from the Regulatory authority-WEBCOVID-202108301850096360-ADZOY Safety Report Unique Identifier GB-MHRA-ADR 25870779. This is the first of two reports. A 19-year-old female patient (not pregnant, not currently breastfeeding) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FE3380), via an unspecified route of administration on 25Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included decreased lactation, allergic rhinitis, eczema and heavy periods menstrual bleeding from an unknown date and unknown if ongoing. She had her dose 1 of BNT162B2 (lot unknown) on unspecified date and experienced pain in armpit, top of the left arm and in chest. Concomitant medications included beclometasone dipropionate (BECONASE AQUEOUS) taken for rhinitis allergic, start and stop date were not reported; acetic acid;benzethonium chloride;hydrocortisone;propylene glycol diacetate for eczema, start and stop date were not reported; ethinylestradiol, levonorgestrel for heavy menstrual bleeding from 2016 to an unspecified stop date. The patient experienced nauseous/nausea, vomited (threw up), stomach pain, appetite lost (had no appetite, never felt like eating), armpit pain and tightness in chest on 26Aug2021, all events were reported as serious medically significant. The patient underwent laboratory test which included Sars-cov-2 test: negative on an unspecified date. The outcome of armpit pain was recovered on 29Aug2021; for appetite lost, tight chest was not recovered; for other events was recovered on 27Aug2021. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101140755 Same patient and product/ different dose and event.


VAERS ID: 1698914 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-26
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysuria, Vaginal haemorrhage, Vulvovaginal swelling
SMQs:, Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (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; PARACETAMOL; NORGESTON
Current Illness: Headache (regular ibuprofen or paracetamol to help with regular headaches)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 virus test (Negative COVID-19 test)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: swollen/inflamed/sensitive skin on vagina; extreme burning when urinating; Vaginal bleeding; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 25871455) on 31-Aug-2021 and was forwarded to Moderna on 31-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included COVID-19 virus test (Negative COVID-19 test) on 01-Aug-2021. Concurrent medical conditions included Headache (regular ibuprofen or paracetamol to help with regular headaches). Concomitant products included IBUPROFEN and PARACETAMOL for Headache, LEVONORGESTREL (NORGESTON) for an unknown indication. On 08-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 26-Aug-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) (seriousness criterion medically significant). On an unknown date, the patient experienced VULVOVAGINAL SWELLING (swollen/inflamed/sensitive skin on vagina) and DYSURIA (extreme burning when urinating). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding) was resolving and VULVOVAGINAL SWELLING (swollen/inflamed/sensitive skin on vagina) and DYSURIA (extreme burning when urinating) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Reportedly, the patient had only finished previous period the week before and usually the period are very regular. Patient experienced swollen/ inflamed/ sensitive skin on vagina causing extreme burning when urinating. Patient had not had symptoms associated with COVID-19. Patient had not tested 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. 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. No further information is expected.


VAERS ID: 1698937 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004222 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, Pruritus, SARS-CoV-2 test, Swelling, Vaccination site rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (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
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: itchy; bruising; Swelling; Started off as a rash below the vaccination site; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25871677) on 31-Aug-2021 and was forwarded to Moderna on 31-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (itchy), CONTUSION (bruising) and SWELLING (Swelling) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004222) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and Lactation decreased. On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant) and VACCINATION SITE RASH (Started off as a rash below the vaccination site). On an unknown date, the patient experienced PRURITUS (itchy) (seriousness criterion medically significant) and CONTUSION (bruising) (seriousness criterion medically significant). At the time of the report, PRURITUS (itchy) and CONTUSION (bruising) was resolving and SWELLING (Swelling) and VACCINATION SITE RASH (Started off as a rash below the vaccination site) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications provided. No treatment medication reported. 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: 1698995 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Dyspnoea, Fatigue, Pruritus, Rash, SARS-CoV-2 test, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Comments: Positive COVID-19 test.
CDC Split Type: GBPFIZER INC202101138322

Write-up: shortness of breath; swelling; tiredness; itching; puss filled blisters; Rash on leg; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108311316214690-KEMAC. Safety Report Unique Identifier is GB-MHRA-ADR 25873960. A 24-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported) via an unknown route of administration on 23Aug2021 as dose 1, single for COVID-19 immunization. Medical history included lactation decreased, suspected covid-19 from 02Aug2021 to 12Aug2021. The patient''s concomitant medications were not reported. Patient was not currently breastfeeding. The patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unknown date, the patient experienced shortness of breath, swelling, tiredness, itching and puss filled blisters. On 26Aug2021, the patient had rash on leg. The patient underwent lab tests and procedures which included COVID-19 virus test positive on 04Aug2021. The outcome of the event rash on leg was reported as not resolved while the outcome of events shortness of breath, swelling, tiredness, itching and blisters was unknown. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1699001 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA LOT3003651 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Angioedema, Axillary pain, Feeling of body temperature change, Headache, Nausea, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: hives; Giant hives; Headache; Feeling hot and cold; Armpit pain; Nausea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25874428) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA (hives), HEADACHE (Headache), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), AXILLARY PAIN (Armpit pain), NAUSEA (Nausea) and ANGIOEDEMA (Giant hives) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. LOT3003651) for COVID-19 vaccination. Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test. Concomitant products included PARACETAMOL for Period pains. On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced NAUSEA (Nausea). On 27-Aug-2021, the patient experienced HEADACHE (Headache), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and AXILLARY PAIN (Armpit pain). On 31-Aug-2021, the patient experienced ANGIOEDEMA (Giant hives) (seriousness criterion medically significant). On an unknown date, the patient experienced URTICARIA (hives). On 28-Aug-2021, NAUSEA (Nausea) had resolved. On 29-Aug-2021, FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and AXILLARY PAIN (Armpit pain) had resolved. At the time of the report, URTICARIA (hives) was resolving and HEADACHE (Headache) and ANGIOEDEMA (Giant hives) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. Company comment: 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.; 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: 1699004 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain upper, Diarrhoea, Flatulence, Inappropriate schedule of product administration, Malaise
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tooth extraction
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101138004

Write-up: Stomach ache; diarrhoea; Inappropriate schedule of vaccine administered; bloating; feeling sick; gas; stomach pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108311411557190-WPMK5, Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25874446. A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: FE8087), via an unspecified route of administration on 26Aug2021 (at the age of 34 years old), as dose2, single for COVID-19 immunisation. Medical history included tooth extraction. Concomitant medication included amoxicillin taken for tooth extraction from 11Aug2021 to 18Aug2021. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), on 02Jul2021 for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not enrolled in clinical trial. On an unspecified date in 2021, the patient experienced bloating, feeling sick, gas, stomach pain, diarrhoea and inappropriate schedule of vaccine administered was reported for her. On 26Aug2021, she experienced stomachache. Outcome for Stomachache was not resolved and was unknown for rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1699027 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Eye pain, Fatigue, Headache, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Glaucoma (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Tired out; Ache; Muscle ache; Headache; Eye pain; This case was received via Regulatory Authority. (RA) (Reference number: GB-MHRA-ADR 25875616) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Tired out), PAIN (Ache), MYALGIA (Muscle ache), HEADACHE (Headache) and EYE PAIN (Eye pain) in a 25-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced FATIGUE (Tired out) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and EYE PAIN (Eye pain) (seriousness criterion medically significant). At the time of the report, FATIGUE (Tired out), PAIN (Ache), MYALGIA (Muscle ache), HEADACHE (Headache) and EYE PAIN (Eye pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. There was no concomitant medication reported. There was no treatment medication reported. Had my vaccine on the Wednesday mid day and I felt fine until around 10pm then started to feel very tired and woke up the next morning and could not really stand up without feeling exhausted. Still feel exhausted now 6 days later and very tired and achey, does not seem to be getting any better either 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. 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. No further information is expected.


VAERS ID: 1699039 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Pain
SMQs:

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

Write-up: shivers; Headache; Tiredness; Ache; This case was received via (Reference number: GB-MHRA-ADR 25876619) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), CHILLS (shivers), HEADACHE (Headache) and FATIGUE (Tiredness) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivers) (seriousness criterion medically significant). On 28-Aug-2021, HEADACHE (Headache) had resolved. On 29-Aug-2021, PAIN (Ache) and FATIGUE (Tiredness) had resolved. At the time of the report, CHILLS (shivers) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events Headache, Fatigue and Pain, a causal relationship cannot be excluded. Very limited information regarding the event Chills has been provided at this time. No further information is expected. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.; 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 Headache, Fatigue and Pain, a causal relationship cannot be excluded. Very limited information regarding the event Chills has been provided at this time. No further information is expected. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.


VAERS ID: 1699045 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210816; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; This case was received via regulatory authority on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 27-Aug-2021, NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-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 reported. Treatment information was not provided by reporter. 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. Very limited information regarding this event has been provided at this time. No further information is expected. Of note, the event was assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the event is not considered serious.; 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. Very limited information regarding this event has been provided at this time. No further information is expected. Of note, the event was assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the event is not considered serious.


VAERS ID: 1699147 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache, Nausea, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEMOSTON; LANSOPRAZOL; PROGYNOVA [ESTRADIOL]
Current Illness: Dizziness; Headache; Nausea; Swollen arm
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210901; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: dizziness; nausea; Swollen arm; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25895508) on 05-Sep-2021 and was forwarded to Moderna on 05-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache) and NAUSEA (nausea) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Swollen arm, Dizziness, Headache and Nausea. Concomitant products included LANSOPRAZOL from 01-Jan-2019 to an unknown date for Hiatus hernia, DYDROGESTERONE, ESTRADIOL (FEMOSTON) from 06-Jun-1991 to an unknown date and ESTRADIOL (PROGYNOVA [ESTRADIOL]) from 06-Jun-2020 to an unknown date for Hormone replacement therapy. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 03-Sep-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (dizziness) (seriousness criterion medically significant) and NAUSEA (nausea) (seriousness criterion medically significant). At the time of the report, DIZZINESS (dizziness) and NAUSEA (nausea) had resolved and PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had continuous headache from the day of vaccination. 8 days out vaccine, Patient had developed a red swollen arm hot to touch. Patient blood checked and came back normal. Treatment information was not 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. However Swollen arm, Dizziness, Headache and Nausea are reported in the medical history section of the source document, onset date and clinical course not specified.; 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. However Swollen arm, Dizziness, Headache and Nausea are reported in the medical history section of the source document, onset date and clinical course not specified.


VAERS ID: 1699226 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101138070

Write-up: Tiredness; Shoulder soreness; This is a solicited report from the RA from a contactable Consumer or other non hcp received from the Regulatory Authority (RA). The Regulatory authority report number GB-MHRA-YCVM-202108312315353440-6EYI7, Safety Report Unique Identifier GB-MHRA-ADR 25877547. A 48-year-old male patient received bnt162b2 (BNT162B2, Batch/Lot Number: FE3380) via an unspecified route of administration on 26Aug2021 as dose 1, single (age at vaccination: 48-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Aug2021, The patient experienced tiredness. On 26Aug2021,the patient experienced shoulder soreness. The outcome of the events (tiredness and Shoulder soreness) was recovered on 28Aug2021. No follow-up attempts are possible. No further information is expected. Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events fatigue, arthralgia and suspect drug BNT162B2 cannot be excluded.


VAERS ID: 1699426 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210826; Test Name: COVID-19 Nasal Swab; Test Result: Positive
CDC Split Type: IEPFIZER INC202101144128

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/lot number: EK9788), as dose 2, single; and via an unspecified route of administration, on an unspecified date (Batch/lot number not reported), as dose 1, single, for COVID-19 immunisation, at a workplace clinic. The patient was not pregnant at the time of vaccination. Relevant medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 26Aug2021, 5 months after the second vaccination, the patient experienced COVID-19 confirmed by positive COVID-19 test which resulted to physician''s office visit. The patient tested positive for COVID-19 via COVID-19 nasal swab on 26Aug2021. The patient did not receive treatment for the events. The patient was recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1699691 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214024 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial necrosis marker increased, Myocarditis, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-778338) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL NECROSIS MARKER INCREASED , PERICARDITIS and MYOCARDITIS in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214024) for COVID-19 vaccination. No Medical History information was reported. On 22-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 26-Aug-2021, the patient experienced MYOCARDIAL NECROSIS MARKER INCREASED , PERICARDITIS and MYOCARDITIS . At the time of the report, MYOCARDIAL NECROSIS MARKER INCREASED , PERICARDITIS and MYOCARDITIS outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Relevant concomitant product usage were not reported by the reporter. No treatment details were added. Company comment: This is a RA report of Myocarditis/Pericarditis in a young male of 23 years old, after an unknown period of having received an unknown doses of the product. Medical history was not 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: This is a RA report of Myocarditis/Pericarditis in a young male of 23 years old, after an unknown period of having received an unknown dosis of the product. Medical history was not 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.


VAERS ID: 1699707 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data: Test Name: Mechanical ventilation; Result Unstructured Data: Test Result:needed; Test Date: 20210826; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC202101175522

Write-up: vaccination failure; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable physician who reported similar events for six patients. This is the third of six reports. A 81-year-old patient of an unspecified gender received second dose of bnt162b2 (COMIRANTY, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date as a single dose and first dose of bnt162b2 (COMIRANTY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included systemic arterial hypertension. Concomitant medications were not reported. On 26Aug2021, the patient experienced COVID-19 confirmed by positive COVID-19 test. It was reported that I was sending you the file with the data relating to 6 patients hospitalized for COVID-19, all after a complete course of Pfizer vaccination. As you can see, for 4 of these the anti-S BAU (Diasorin) titre was high (column X). In any case, it was a Delta variant. Hospitalization date: on 11Aug2021. Patient underwent lab test and procedure which included Mechanical ventilation with unknown result on unspecified date and SARS-CoV-2 test which was positive on 26Aug2021.; Sender''s Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to vaccination failure cannot be ruled out.


VAERS ID: 1699739 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Confusional state, Hyperpyrexia, Nausea, Pain, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Body temperature; Result Unstructured Data: Test Result:41.8 Centigrade; Comments: on admission; Test Date: 20210826; Test Name: COVID-19 Antigen qualitative; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: JPPFIZER INC202101125830

Write-up: Body temperature 41.8 degrees centigrade; Confusional state; Chills/Shivering; Pantalgia; Nausea; Vomiting; This is a spontaneous report from a contactable physician received via Regulatory Authority. The patient was a non-pregnant 59-year-old female adult. On an 26Aug2021 at 14: 30 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FE8206, Expiration date 31Oct2021) intramuscular in the left arm 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. The patient had overreaction to influenza vaccine. The patient had no other medical history. On 26Aug2021 around 15: 30 (1 hour after the vaccination), the patient went home and experienced chills/shivering, pantalgia, nausea and vomiting at that moment. At 18: 10 (3 hour 40 minutes after the vaccination), the patient visited hospital with body temperature 41.8 degrees centigrade and confusional state. The patient was hospitalized and treated with fluid replacement, steroid and Acetaminophen via drip intravenous injection. The outcome of the events was recovered. The reporter classified the events as serious (Hospitalized) and stated the events result in hospitalization. Duration of hospitalization was 4 days. It was also informed that since the vaccination, the patient has been tested for COVID-19. On 26Aug2021, the patient had a test of COVID-19 antigen qualitative, test type was nasal swab and the result was negative. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on plausible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported events 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: 1699759 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cold sweat, Contusion, Heart rate, Loss of consciousness, Nausea, Oropharyngeal discomfort, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Blood pressure; Result Unstructured Data: Test Result:126/75; Comments: After vaccination At 09:08; Test Date: 20210826; Test Name: Blood pressure; Result Unstructured Data: Test Result:118/83; Comments: After vaccination; Test Date: 20210826; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210826; Test Name: Pulse rate; Result Unstructured Data: Test Result:67; Comments: After vaccination At 09:13
CDC Split Type: JPPFIZER INC202101128118

Write-up: vasovagal reflex; Cold sweat; Discomfort in the throat; Feeling queasy; Bruise the front of head; Loss of consciousness; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21125191. A 21-years-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Aug2021 09:01 (Lot Number: FF3622; Expiration Date: 30Nov2021) as single dose (at the age of 21) for covid-19 immunisation. Medical history was none. The patient''s concomitant medications were not reported. On 26Aug2021 at 09:01 (same day of vaccination), the patient experienced vasovagal reflex. The course of the event was as follows: Lost of consciousness (about 20 minutes illegible characters), cold sweat, recovery of consciousness. At 09:08, blood pressure was 126/75 to 118/83, at 09:13, pulse rate was 67. The patient felt discomfort in the throat, feeling queasy(immediately after vaccination), lost of consciousness, fell off the chair and bruised the front of head. At 09:20, went home. Body temperature: 36.5 centigrade on 26Aug2021 before vaccination. On 26Aug2021 (same day of vaccination), the outcome of the events was recovered. The reporting physician classified the event as non-serious and assessed that the event was unrelated to bnt162b2. The reporting physician commented as follows: it was considered that when receiving the second vaccination, treatment for shock may be required, and supine vaccination was recommended.; Reporter''s Comments: it was considered that when receiving the second vaccination, treatment for shock may be required, and supine vaccination was recommended.; Sender''s Comments: Based on the information available and reporter comment , a possible contributory role of the suspect BNT162B2 can be excluded for the reported events . The case will be reassessed once new information is available.


VAERS ID: 1699809 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Bundle branch block right, Electrocardiogram, Heart rate, Oxygen saturation, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? 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: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:115/74; Comments: after vaccination; Test Date: 20210826; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210826; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:NSR; Comments: Incomplete right bundle branch block; Test Date: 20210826; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:normal; Comments: no finding about suspected orthostatic hypotension due to haemorrhage was found; Test Date: 20210826; Test Name: HR; Result Unstructured Data: Test Result:48; Comments: after vaccination; Test Date: 20210826; Test Name: Sat; Test Result: 96 %; Comments: after vaccination
CDC Split Type: JPPFIZER INC202101131129

Write-up: vasovagal reflex; Incomplete right bundle branch block; Syncope; This is a spontaneous report from a contactable physician received from the RA. Regulatory authority report number is v21125248. The patient was a 44-year-old male, on 26Aug2021 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FE8162, Expiration date 30Nov2021) at 44-year-old, via an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature (26Aug2021) before vaccination was 36.7 degrees Centigrade. 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). Medical history was none. Concomitant medication was not reported. On 26Aug2021 at 12:30 (the day of the vaccination), the patient experienced vasovagal reflex. On 26Aug2021 (the day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: After vaccination, around 5minutes, the patient experienced Syncope. The patient regained consciousness in a few seconds and consciousness clear in about a minute. No pulmonary murmur; clear heart sounds, no murmur sound and no Lower leg oedema. BP 115/74, Sat 96% HR 48, Electrocardiogram NSR, Incomplete right bundle branch block, ECG normal, no finding about suspected orthostatic hypotension due to haemorrhage was found. It was diagnosed as vasovagal reflex. Outcome of the event was recovered on 26Aug2021. The reporting physician classified the event as non-serious and assessed that that the event was unrelated 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.; Sender''s Comments: Based on strong temporal relationship the role of the suspect vaccine BNT162B2 in triggering/contributing to the reported events syncope, vasovagal reflex and incomplete bundle branch block cannot be completely excluded. The case will be reassessed once additional information is available. 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 RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1699824 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Dyspnoea, Feeling abnormal, Feeling hot, Hypoaesthesia, Nausea, Pruritus, Rash
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101134128

Write-up: Anaphylaxis; Numbness in left upper limb; skin eruption; Generalised itching sensation; feeling hot in the pharynx; feeling strange; dyspnoea; queasy; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21125366. The patient was a 32-year and 10-month-old female. On 26Aug2021 at 14:40 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FC9880, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.9 degrees Centigrade. The patient had kiwifruit allergy, melon allergy, peach allergy and mango allergy. Concomitant medications were not reported. On 05Aug2021, the patient received the first dose of bnt162b2 (COMIRNATY, Lot# FC9880, Expiration date 30Sep2021) at single 0.3 mL, on left shoulder and experienced itching sensation when vaccinated. On 26Aug2021, (the day of vaccination) at 14:25 considered the symptoms of the first dose, the patient was given Antihistamine 15 minutes before the second dose, and the second dose was given on the left shoulder. On 26Aug2021 at 14:45 (5 minutes after the vaccination), the patient experienced numbness in left upper limb at first, immediately after that, generalised itching sensation with skin eruption spread rapidly. At the same time, because of feeling strange with feeling hot in the pharynx, the physician was judged to be anaphylaxis equivalent to Brighton classification level 2 to 3, with stable circulatory dynamics, and no oxygen needed to be given, but the patient felt dyspnoea and had queasy of digestive symptom. The patient was immediately injected with Adrenaline, and the symptoms tended to be recovering. The patient was considered to be second attack of anaphylaxis, so given steroid and admitted to the hospital for observation. On 30Aug2021 (4 days after the vaccination), the outcome of the event was recovered. The reporting physician classified the event as non-serious. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The same symptoms (itching sensation) occurred immediately after the first vaccination and the second vaccination, and this symptom was judged to be related to the vaccination. The second dose of the vaccination showed skin and respiratory symptom, so the physician was judged as anaphylaxis, stable respiratory and circulatory function, and the symptoms immediately recovering after administration of Adrenaline, so it was non-serious.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101149552 same reporter/patient/product; different doses/AE.


VAERS ID: 1699979 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dry mouth, Facial paralysis, Flushing, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Hypersensitivity (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139636

Write-up: Facial paralysis; Dry mouth; Flushing; Paraesthesia; Chills; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 611430. As per source verbatim, a 69-years-old female patient received bnt162b2 (COMIRNATY; Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as a DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Aug2021, the patient experienced facial paralysis, chills, dry mouth, flushing and paraesthesia. Outcome of all the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1700001 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139801

Write-up: Pericarditis; This is a spontaneous report from a contactable other healthcare professional (HCP) via the Regulatory Authority. Regulatory authority report number is 612125. A 32-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date in Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Aug2021, the patient experienced pericarditis. Onset time in days was reported as 19 days. The outcome of the event was not recovered/not resolved/ongoing. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1700009 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Petit mal epilepsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139988

Write-up: Petit mal epilepsy; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 613149. A 20-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced petit mal epilepsy on 26Aug2021 with outcome of recovered in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1700980 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (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: TWYNSTA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139776

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 612176. A 34-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included amlodipine besilate, telmisartan (TWYNSTA) taken for an unspecified indication, start and stop date were not reported. The patient experienced abortion spontaneous on 26Aug2021 with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1701007 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5029 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Extensive swelling of vaccinated limb, Maternal exposure during pregnancy, Pyrexia, Vaccination site reaction
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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: DAFALGAN
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: BEPFIZER INC202101142527

Write-up: Fever; Extensive swelling of the arm; injection site reaction; Maternal exposure during pregnancy, second trimester; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB [BE-FAMHP-DHH-N2021-105858]. A 29-year-old pregnant female patient received the second dose of BNT162b2 (COMIRNATY, Lot number: FC5029) via unspecified route on 26Aug2021 at 16:40 (at the age of 29-years-old) as a single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medication included paracetamol (DAFALGAN). The patient was pregnant at time of vaccination: 2nd trimester. On 27Aug2021, the patient experienced injection site reaction, fever, and extensive swelling of arm. These events were reported as serious for disability. Paracetamol (DAFALGAN) 1g was taken before vaccination at 16:30 (vaccination at 16:40) and another paracetamol (DAFALGAN) 1g at 21:30. The patient started getting fever at 03:00 at night along with swelling in the arm. There was no treatment received for the events. The clinical outcome of the events was recovering. Reporter comment: Treatment - No Evolution of the adverse drug reaction - Recovering More information on the temporal relation (adverse drug reaction) - Dafalgan 1g taken before vaccination at 4:30 pm (vaccination at 04:40pm) and another dafalgan 1g at 09:30pm. Started getting fever at 03:00 at night along with swelling in the arm. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatment - No Evolution of the adverse drug reaction - Recovering More information on the temporal relation (adverse drug reaction) - Dafalgan 1g taken before vaccination at 4:30 pm (vaccination at 04:40pm) and another dafalgan 1g at 09:30pm. Started getting fever at 03:00 at night along with swelling in the arm.


VAERS ID: 1701020 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Epilepsy, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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: BRPFIZER INC202101138714

Write-up: This is a spontaneous report from a contactable consumer. A 20-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# not reported), via an unspecified route of administration, on Aug 24, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. Thursday (Aug 26, 2021) to Friday (Aug 27, 2021), patient experienced the first episode of epilepsy in his life. The patient was taken to the physician and tests were done. Sunday to Monday (Aug 29, 2021 to Aug 30, 2021), he experienced a second case of epilepsy. From yesterday to today (Aug 31, 2021 to Sep 1, 2021), he experienced another case of seizure. The outcome of the events: unknown. The lot number for BNT162B2, not provided and will be requested during follow-up.


VAERS ID: 1701403 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Erythema migrans, Migraine
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101138171

Write-up: Erythema migrans; Dizziness; migraines; This is a spontaneous report from a contactable consumer received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108280830293640-KUCLO, Safety Report Unique Identifier GB-MHRA-ADR 25863508. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Aug2021 (lot number: FF319) as dose 2, single for COVID-19 immunisation. Medical history included suspected COVID-19 from 17Jun2021 to 28Jun2021 and was not ongoing. The patient didn''t had a COVID-19 test. Patient is not pregnant. Concomitant medication included ethinylestradiol, levonorgestrel (RIGEVIDON) taken for contraception from 2020. On 26Aug2021, the patient experienced erythema migrans, dizziness, and migraine. The events were medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1701423 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Disturbance in attention, Initial insomnia, Tinnitus
SMQs:, Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Noninfectious diarrhoea (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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101138077

Write-up: Ear buzzing; can''t fully focus on work; Diarrhea; problem with falling asleep (or waking up after couple hours and can''t fall asleep again); This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108311150501770-VX4RO and Safety Report Unique Identifier GB-MHRA-ADR 25873464. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FE3380), via an unspecified route of administration on 25Aug2021 as dose 1, single (at the dose of vaccination 28Years old) for COVID-19 immunization. Medical history included lactation decreased. 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''s concomitant medications were not reported. On 26Aug2021, the patient experienced problem with falling asleep (or waking up after couple hours and can''t fall asleep again) and focus, can''t fully focus on work or even everyday household tasks, and diarrhea after meals (40min after she eat anything). On 27Aug2021, the patient had ear buzzing. Constant buzzing in the both ears and constantly hear the noise. The outcome of the events was not recovered. The events were assessed as serious (medically significant). 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: 1701424 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 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
CDC Split Type: GBPFIZER INC202101138075

Write-up: Rash on Inner right arm, Hands, stomach and neck; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108311205049540-YDYWA, Safety Report Unique Identifier GB-MHRA-ADR 25873538. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 26Aug2021 (at the age of 39 years old) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and is not currently breastfeeding. The patient''s concomitant medications were not reported. On 26Aug2021, the patient experienced rash on inner right arm, hands, stomach and neck. The event was medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was no - negative COVID-19 test on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1701439 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Glossodynia, Oropharyngeal pain, SARS-CoV-2 test, Tongue discomfort, Tongue erythema
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (infrequently uses steroid inhaler); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101138116

Write-up: Tongue sores were not resolved and has multiple punched out areas of redness causing burning sensation; Tongue sores were not resolved and has multiple punched out areas of redness causing burning sensation; sore throat; Tongue sore; This is a spontaneous report from a contactable physician. This report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108311617385510-ENU9I. Safety Report Unique Identifier GB-MHRA-ADR 25875210. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Aug2021 with unspecified Batch/Lot number as dose 2, single for COVID-19 immunization. Medical history included lactation decreased and (asthma) infrequently uses steroid inhaler. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications included ethinylestradiol, levonorgestrel (MICROGYNON) taken for contraception from 01Aug2017 to an unspecified stop date. The patient previously took depo-medrone. 2-3 days after receiving the vaccine, on 26Aug2021, she developed sore throat and sores on tongue. On an unknown date, tongue sores were not resolved and has multiple punched out areas of redness causing burning sensation. No tongue swelling or signs angioedema. The outcome of the events was not recovered and the events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included negative COVID-19 virus test on an unspecified date. 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: 1701593 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Illness, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diarrhea; Stomach ache
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.MOD20213

Write-up: Diarrhea; Shivers; Sickness; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25901301) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ILLNESS (Sickness) and CHILLS (Shivers) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Stomach ache and Diarrhea. On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced ILLNESS (Sickness). On an unknown date, the patient experienced DIARRHOEA (Diarrhea) and CHILLS (Shivers). On 28-Aug-2021, ILLNESS (Sickness) had resolved. At the time of the report, DIARRHOEA (Diarrhea) and CHILLS (Shivers) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No-Negative COVID-19 test.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. On an unknown date, after 12 hours injection, the patient felt shivers and could not sleep at night with feeling of too hot to sleep. The patient felt stomach aches and diarrhea. The patient had not tested positive for COVID-19 after vaccination. The patient was not enrolled in clinical trial. Treatment information was not provided.; 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. Of note, there was no mention in the case narrative that the event ''illness'' occurred; however, the event was retained per Regulatory Authority report. Moreover, the events Chills, Diarrhoea and Illness were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.


VAERS ID: 1701833 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Anxiety, Blood test, Diabetes mellitus management, Electrocardiogram, Loss of consciousness, Myocardial infarction, Oxygen saturation, Oxygen saturation decreased, Physical examination
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension arterial; Tabaquism
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: blood chemistry; Test Result: 95 mg/dl; Comments: normal; Test Date: 20210826; Test Name: Glycaemia control; Result Unstructured Data: Test Result:unknown results; Test Date: 20210826; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:normal; Test Date: 20210826; Test Name: oxygen saturation; Result Unstructured Data: Test Result:desaturation; Test Date: 20210826; Test Name: Physical examination; Result Unstructured Data: Test Result:normal
CDC Split Type: ITPFIZER INC202101136013

Write-up: Lipothymia/blackout; desaturation; sense of epigastric weight/Stomach feeling heavy; anxiety crisis; heart attack; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number is IT-MINISAL02-776931. A 59-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration, administered in left arm on 26Aug2021 at 17:00 (Batch/Lot Number: FG7387; Expiration Date: 30Nov2021) (at the age of 59-years-old) as dose 1, single for COVID-19 immunisation. Medical history included tabaquism, hypertension arterial and diabetes. The patient''s concomitant medications were not reported. The patient experienced lipothymia/blackout, desaturation, sense of epigastric weight/sense of epigastric weight/stomach feeling heavy occurring about 10-15 minutes after administration of Comirnaty vaccine on 26Aug2021. The patient was sent to the emergency room for investigations. On 26Aug2021, the tests carried out: blood chemistry tests (95 mg/dl), electrocardiogram and physical examination were found to be normal; glycaemia control with results unknown. The discharge diagnosis was a probable anxiety crisis. The patient was hospitalized on 26Aug2021 due to the events and was discharged on the same day. Outcome of anxiety crisis was recovered on an unspecified date while remaining events was unknown. The reporter assessed anxiety crisis as serious, medically significant. Reporter''s comments: Sending to the emergency room in suspicion of a possible heart attack. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Sending to the emergency room in suspicion of a possible heart attack


VAERS ID: 1701834 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-08-26
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Chest pain, Computerised tomogram thorax, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy; Deep vein thrombosis; Diffuse large B-cell lymphoma
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: chest ct; Result Unstructured Data: Test Result:Subjected to chest Computer tomography with contra; Comments: Subjected to chest Computer tomography with contrast medium: some pulmonary striae thickened at the bases, pericardial effusion of 18 mm (non-buffering), non-pulmonary embolism, alc; Test Date: 20210826; Test Name: C reactive protein; Result Unstructured Data: Test Result:rise
CDC Split Type: ITPFIZER INC202101134975

Write-up: clinical, ultrasound and CT diagnosis of pericarditis without myocarditis.; chest pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB: IT-MINISAL02-776999. A 62-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 22Jul2021 (Lot Number: FF3318; Expiration Date: 31Oct2021) as single for COVID-19 immunisation. Medical history included diffuse large B-cell lymphoma from 01Oct2020 to 01Apr2021 (judged to be in remission by aspiration) and right deep vein thrombosis on anticoagulant therapy until April (from unknown date and unknown if ongoing). The patient''s concomitant medications were not reported. The patient had clinical, ultrasound and CT diagnosis of pericarditis without myocarditis and chest pain on 26Aug2021. On 26Aug2021, patient went to the emergency room for chest pain, there were finding of leukocytosis and rise in C reactive protein, right deep vein thrombosis (perhaps lack of recanalization of the previous deep vein thrombosis). Subjected to chest computer tomography with contrast medium: some pulmonary striae thickened at the bases, pericardial effusion of 18 mm (non-buffering), non-pulmonary embolism, alc (as reported). The patient goes to the ER today for chest pain with clinical, ultrasound and CT diagnosis of pericarditis without myocarditis. Outcome of the events not recovered. Initiated therapy with high dose NSAIDs-Non-steroidal anti-inflammatory drugs. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Summary of reporter comment: first dose of Comirnaty on 22Jul2021. On 26Aug he went to the emergency room for chest pain, finding of leukocytosis and rise in C reactive protein, right Deep vein thrombosis (perhaps lack of recanalization of the previous Deep vein thrombosis?). chest Computer tomography with contrast medium: some pulmonary striae thickened at the bases, pericardial effusion of 18 mm (non-buffering), non-pulmonary embolism, alc


VAERS ID: 1701837 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypertensive crisis, Palatal oedema, Tongue oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101135952

Write-up: Tongue and soft palate edema, hypertensive crisis; Tongue and soft palate edema, hypertensive crisis; Tongue and soft palate edema, hypertensive crisis; This is a spontaneous report from a contactable physician, downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-777066. A 55-year-old female patient received the first dose of BNT162B2 (COMIRNATY), intramuscular on 26Aug2021 (Batch/Lot Number: unknown) single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced tongue and soft palate edema, and hypertensive crisis on 26Aug2021. Outcome of the events was recovering. The lot number for BNT162B2 was not provided and will be requested during follow-up.


VAERS ID: 1701931 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Chills, Pain in extremity, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Atopic dermatitis; Perthes disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101149997

Write-up: shaking in the left hand also occurred.; Left arm pain; generalized shivering; Chest pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional downloaded from a Regulatory Authority, regulatory authority number IT-MINISAL02-777978. A 23-year-old male patient received second dose of bnt162b2 (COMIRNATY; Formulation: Solution for injection; Lot Number: FG4493), intramuscularly administered in right arm (reported as right shoulder) on 25Aug2021 as dose 2, single for COVID-19 immunization. Medical history included atopic dermatitis, asthma and perthes disease; all from unknown dates and unknown if ongoing. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY; Batch/Lot Number was not reported), via unspecified route of administration on 01Aug2021 as dose 1, single for COVID-19 immunization and experienced rash. On 26Aug2021, the patient experienced left arm pain, generalized shivering, chest pain and shaking in the left hand also occurred. The patient consulted with the treating physician who prescribed a therapy based on Tachipirina (paracetamol) and rest. It was reported that patient had Impact on quality of life (10/10). Therapeutic measures were taken as a result of events. The outcome of events reported as not recovered at the time of report. From the application of the WHO algorithm the causal link resulted: indeterminate comirnaty / Chest pain, Tremor; correlable for comirnaty / Chills, Pain in a limb. Health Authority Comment: Atopic dermatitis, asthma and Perthes disease. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1701933 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Exposure via breast milk, Hyperpyrexia, Infantile vomiting
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal exposures via breast milk (narrow), Neonatal disorders (narrow), Noninfectious diarrhoea (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101149963

Write-up: Diarrhoea; Hyperpyrexia; Vomiting; Vaccine exposure via breast milk; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-778010. A 7-months-old male patient received BNT162B2 (COMIRNATY, solution for injection, (Batch/Lot Number: FG4686; Expiration Date: 30Nov2021)), dose 1 transmammary, administered in Deltoid Left on 22Aug2021 11:59 as dose 1, single for COVID-19 immunisation. The breastfed child of a woman received the first dose of the comirnaty vaccine currently in ER(emergency room) (30Aug2021), waiting for post discharge report from ER. The patient''s medical history and concomitant medications were not reported. On 26Aug2021, the patient experienced diarrhoea, hyperpyrexia, vomiting, vaccine exposure via breast milk. At the time of this report, the outcome of events was not recovered. No follow-up attempts are possible. No further information expected. Regulatory authority comment: SUSPECTED ADVERSE REACTIONS FROM FIRST DOSE OF COMIRNATY: 22Aug2021-11:59 am-FG4686 (30Nov2021) -LEFT SHOULDER


VAERS ID: 1701992 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diarrhoea, Malaise, Nausea, Vomiting
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: Test Date: 20210826; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101134878

Write-up: General malaise; Vomiting; queasy; Diarrhoea; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21125320. A 50-year-old female patient received the second dose of bnt162b2 (COMIRNATY solution for injection, Lot number: FE8162, Expiration date 30Nov2021) via an unspecified route of administration on 26Aug2021 at 13:30 (the day of vaccination) (at the age of 50 years old) as a dose 2, single for COVID-19 immunization. Body temperature before vaccination was 36.3 degrees Centigrade. The patient medical history and concomitant medications were not reported. 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). Historical vaccine includes 1st dose COMINARTY on 05Aug2021 (Lot number: Unknown) for COVID-19 immunization and patient experienced headache and diarrhea. On 26Aug2021, the patient experienced quesy and diarrhea. On 27Aug2021 18:00, patient had vomiting. On an unspecified date, the patient also experienced general malaise. The clinical course was reported as follows: On 05Aug2021, the patient received the first dose of Pfizer corona virus vaccine. The next day, the patient experienced headache and diarrhea. On 26Aug2021 (second vaccination), ended with nausea and diarrhea from the evening of the same day. Vomiting and diarrhea continued even on 27Aug2021. On 27Aug2021, patient was transported to hospital and treatment of Sollacto 250 + Linorosar 2 mg infusion illegible Tsumura No. 11 illegible. The event onset date and time was reported as 27Aug2021 around 18:00 (1 day after vaccination). The reporting physician classified the event as serious (Medically significant) and assessed that the events was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Symptoms: nausea, vomiting, diarrhea, general malaise, headache, with every slight movement, nausea becomes stronger. The outcome for the events vomiting, queasy, diarrhea and general malaise was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702259 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005235 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bradycardia, Presyncope
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Bradycardia; Vasovagal reflex; This case was received via Regulatory Authority (Reference number: 2021TJP088159) on 03-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the (Ref, v21125622). Bradycardia was assessed as serious by the agency. On 26-Aug-2021, at 15:35, the patient received the 1st dose of this vaccine. At 15:40, during follow-up, the patient experienced queasy, decreased blood pressure, and bradycardia, which were considered as vasovagal reflex. The symptoms resolved. The outcome of bradycardia and vasovagal reflex was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; 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. Event bradycardia was assessed by RA as medically significant, however, based on medical judgement and the lack of evidence of seriousness from a clinical standpoint, event is deemed non serious.


VAERS ID: 1702667 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Pericarditis, X-ray
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: cardiac bloods; Result Unstructured Data: Test Result:no indications found of a heart attack; Test Name: cardiac CT scan; Result Unstructured Data: Test Result:no indications found of a heart attack; Test Name: Xrays; Result Unstructured Data: Test Result:no indications found of a heart attack
CDC Split Type: NZPFIZER INC202101152666

Write-up: suspected pericarditis; This is a spontaneous report from a contactable consumer (patient wife) received via regulatory authority. Regulatory authority report number is AEFI-A-012812. A 39-year-old male patient received BNT162B2 (COMIRNATY; lot number and expiration date were not reported), via an unspecified route of administration on 23Aug2021 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced suspected pericarditis (hospitalization) on 26Aug2021 09:15. It was reported that the patient experienced serious chest pain twice one day before this report and was sent back to the hospital in an ambulance last night at 8.30 pm after having been discharged at 3pm. The event caused emergency room visit. He again has severe chest pain, left arm weakness, and pins and needles. The patient underwent lab tests and procedures which included cardiac bloods, cardiac CT scan and X-rays twice, with no indications found of a heart attack. They have put in his notes that they suspect he has developed pericarditis as a result of the COVID vaccine. Outcome of event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1702674 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101152677

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional Regulatory authority report number AEFI-A-012956. A 17-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 26Aug2021, as DOSE 1, SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis which associated with tight chest with shortness of breath, wheezing and tachycardia on 26Aug2021 at 22:50. It was reported that event result in Emergency Care. The outcome of the event was recovering at time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1702696 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:190/100
CDC Split Type: PHPFIZER INC202101146378

Write-up: Elevated BP; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. The regulatory authority report number is PH-PHFDA-300102628. A 59-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 26Aug2021 (Batch/Lot Number: FD5996) as DOSE NUMBER UNKNOWN, SINGLE (at the age of 59 years) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated bp on 26Aug2021 10:50. The patient underwent lab tests and procedures which included blood pressure measurement: 190/100 on 26Aug2021. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected. information about batch number already obtained.


VAERS ID: 1702697 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:160/100 mmHg
CDC Split Type: PHPFIZER INC202101146381

Write-up: Elevated BP; This is a spontaneous report from a contactable other health professional. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300102662. A 36-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 26Aug2021 (Lot Number: FD0350) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Aug2021 15:45, the patient experienced elevated BP. The patient had a blood pressure measurement of 160/100 mmHg on 26Aug2021. Outcome of the event was recovered in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702698 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:180/110 mmHg
CDC Split Type: PHPFIZER INC202101146382

Write-up: Elevated BP (180/110); This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102667. A 45-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 26Aug2021 (Batch/Lot Number: FD0350) (at the age of 45 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced elevated bp (180/110) (assessed as medically significant) on 26Aug2021 13:13 with outcome of recovered. The patient underwent lab tests and procedures which included blood pressure measurement: 180/110 mmhg on 26Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702699 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:161/118
CDC Split Type: PHPFIZER INC202101146383

Write-up: Elevated BP:161/118; This is a spontaneous report from a contactable healthcare professional received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102668. A 32-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 26Aug2021 at the age of 32 year old (Lot Number: FD0350) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated BP:161/118 on 26Aug2021 14:25 with outcome of recovered on unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702700 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:170/110 mmHg
CDC Split Type: PHPFIZER INC202101146384

Write-up: Elevated BP; This is a spontaneous report from a contactable other healthcare professional (hcp). This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102672. A 29-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FD0350, expiry date not reported), intramuscular on 26Aug2021 (at the age of 29 years old) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated BP, which was reported as medically significant, on 26Aug2021 14:45. The patient underwent lab tests and procedures which included blood pressure measurement: 170/110 mmhg on 26Aug2021. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.


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