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

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

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 146 out of 10,493

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VAERS ID: 2029731 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9707 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Feeling of body temperature change, Headache, Hot flush, Hyperhidrosis, Immunisation, Interchange of vaccine products, Malaise, Myalgia, Neck pain, Off label use, Pain in extremity, Pain in jaw, Pyrexia, SARS-CoV-2 test, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882895

Write-up: pain in armpit; felt drained, tired/ tired all the time; Sickness/ felt sick; sleepy; Pain from arm up to neck and jaw; Pain from arm up to neck and jaw; Pain from arm up to neck and jaw; Headache; Off label use; interchange of vaccine products; Booster; Hot and cold; Hot flushes; Drenching sweats/ sweating; Muscle ache/ muscle pain; Fever; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional) from the Regulatory Authority (UK-MHRA). The Regulatory number is GB-MHRA-WEBCOVID-202112291845235870-PKY3G (MHRA) and the Other Case identifier is GB-MHRA-ADR 26411014 (MHRA). A 44-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 27Dec2021 (batch/lot number: Fk9707) at the age of 44 years old, as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Vaccination history included: Covid-19 vaccine Astrazeneca (first dose (batch/lot number: unknown) as DOSE 1, SINGLE), administration date: 17Feb2021, for COVID-19 immunization; Covid-19 vaccine Astrazeneca (second dose (batch/lot number: unknown) as DOSE 2, SINGLE), administration date: 05May2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown" described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown" described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown" described as "Booster"; FATIGUE (medically significant) with onset 28Dec2021, outcome "recovering" described as "felt drained, tired/ tired all the time"; MALAISE (medically significant) with onset 28Dec2021, outcome "recovering" described as "Sickness/ felt sick"; SOMNOLENCE (medically significant) with onset 28Dec2021, outcome "not recovered" described as "sleepy"; PAIN IN EXTREMITY (medically significant), PAIN IN JAW (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "Pain from arm up to neck and jaw"; NECK PAIN (medically significant) with onset 28Dec2021, outcome "recovering" described as "Pain from arm up to neck and jaw"; AXILLARY PAIN (medically significant), outcome "not recovered" described as "pain in armpit"; FEELING OF BODY TEMPERATURE CHANGE (medically significant) with onset 27Dec2021, outcome "recovering" described as "Hot and cold"; HOT FLUSH (medically significant) with onset 27Dec2021, outcome "recovering" described as "Hot flushes"; HYPERHIDROSIS (medically significant) with onset 27Dec2021, outcome "recovering" described as "Drenching sweats/ sweating"; MYALGIA (medically significant) with onset 27Dec2021, outcome "recovering" described as "Muscle ache/ muscle pain"; PYREXIA (medically significant) with onset 27Dec2021, outcome "recovering" described as "Fever"; and HEADACHE (medically significant) with onset 28Dec2021, outcome "recovering" described as "Headache." The patient underwent the following laboratory tests and procedures: COVID-19 virus test (SARS-CoV-2 test): (27Dec2021) negative, notes: No - Negative COVID-19 test. The clinical course was reported as follows: Felt drained, tired, sick, sleepy. Pain from arm up to neck and jaw. As well as pain in armpit. Hot & cold and sweating. Muscle pain. Patient has not tested positive for COVID-19 since having the vaccine Additional information: Reaction: Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No." No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029775 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Headache, Immunisation, Interchange of vaccine products, Malaise, Off label use, SARS-CoV-2 test, Swelling, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRENA; TRAMADOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20211205; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882818

Write-up: has a lot of pain in the vaccinated arm; large swelling under armpit; armpit pain; headache; feeling sick; off label use; interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter consumer or other non HCP from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112292150244870-54YNT (RA). Other Case identifiers: GB-MHRA-ADR 26412210 (RA). A 44 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (batch/lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "fibromyalgia syndrome" (unspecified if ongoing). The patient has not had symptoms associated with COVID-19, not currently breastfeeding, not enrolled in clinical trial. Concomitant medications included: MIRENA, start date: 01Aug2011; TRAMADOL taken for fibromyalgia syndrome, start date: 08Apr2019. Vaccination history included: Covid-19 vaccine Astrazeneca (dose 1), administration date: 06Apr2021, for COVID-19 immunisation; Covid-19 vaccine Astrazeneca (dose 2), administration date: 25Jun2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "booster"; AXILLARY PAIN (medically significant) with onset 28Dec2021, outcome "not recovered", described as "armpit pain"; HEADACHE (medically significant) with onset 28Dec2021, outcome "not recovered", described as "headache"; MALAISE (medically significant) with onset 27Dec2021, outcome "not recovered", described as "feeling sick"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "has a lot of pain in the vaccinated arm"; SWELLING (medically significant), outcome "not recovered", described as "large swelling under armpit". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (05Dec2021) no - negative covid-19 test. The patient has not tested positive for COVID-19 since having the vaccine. Additional information: The reporter did not relate the report to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029794 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882928

Write-up: Booster; Headache; Ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112292323462010-ZIFJJ. Other Case identifier(s): GB-MHRA-ADR 26412765. A female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 27Dec2021, outcome "recovered" (27Dec2021), described as "Headache"; PAIN (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Ache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Additional information: Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Case reported as serious by health authority (other medically important condition). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029803 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Hypoaesthesia, Immunisation, Interchange of vaccine products, Limb injury, Nerve injury, Neuralgia, Off label use, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (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:
CDC Split Type: GBPFIZER INC202101882898

Write-up: from the moment of the injection i ? ve had pain radiating down my arm through my wrist; injury to a nerve; injury to shoulder; Wrist pain; pain radiating down her thumb, index, and middle finger; Tingling; Numbness; Shoulder pain; Nerve pain; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (consumer) from Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112300026022290-K6UPE. Other Case identifier: GB-MHRA-ADR 26412926. A 43 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, ((also reported as ''Shoulder''), administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "from the moment of the injection I''ve had pain radiating down my arm through my wrist"; NEURALGIA (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Nerve pain"; PARAESTHESIA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Tingling"; HYPOAESTHESIA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Numbness"; ARTHRALGIA (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Shoulder pain"; NERVE INJURY (medically significant), outcome "unknown", described as "injury to a nerve"; LIMB INJURY (medically significant), outcome "unknown", described as "injury to shoulder"; ARTHRALGIA (medically significant), outcome "unknown", described as "Wrist pain"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "pain radiating down her thumb, index, and middle finger". Therapeutic measures were taken as a result of from the moment of the injection I''ve had pain radiating down my arm through my wrist, Shoulder pain, Wrist pain and pain radiating down her thumb, index, and middle finger. Clinical course: Injection was administered much higher up her shoulder than expected. It felt wrong instantly. Her shoulder hurt. It didn''t feel like previous vaccine injections. Normally it feels like it''s going into the muscle but this felt different, like it was hitting something else. She jumped back at the pain of it. From the moment of the injection, she had pain radiating down her arm through her wrist, thumb, index, and middle finger. After 48 hrs tingling and numbness began along the same pathway and has not resolved. The pain eases with ibuprofen then returns. She did not have this issue before the injection. She believed the vaccine was administered incorrectly and an injury to a nerve and her shoulder has occurred as a result. She knows a sore arm was expected with this vaccine but this was different. Patient intends to seek professional help to rehabilitate the injury. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029806 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Nausea, Poor quality sleep, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882911

Write-up: nausea; tiredness; poor sleep; booster; This is a spontaneous report received from a contactable reporter consumer or other non HCP from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112300139349280-7UFH5 (RA). Other Case identifiers: GB-MHRA-ADR 26412941 (RA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (batch/lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19, not enrolled in clinical trial. Vaccination history included: Comirnaty (dose 1), for Covid-19 immunisation; Comirnaty (dose 2), for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "booster"; NAUSEA (medically significant) with onset 28Dec2021, outcome "not recovered", described as "nausea"; FATIGUE (medically significant) with onset 28Dec2021, outcome "not recovered", described as "tiredness"; POOR QUALITY SLEEP (medically significant) with onset 27Dec2021, outcome "recovering", described as "poor sleep". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: no - negative covid-19 test. The patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029816 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymph node pain, Lymphadenopathy, Off label use
SMQs:, Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101882740

Write-up: Lymph node pain; Swelling in lymph node under left arm and breast; Off label use; Booster; Interchange of vaccine products; This is a spontaneous report received from a contactable consumer the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112300700574880-ECSSK. Other Case identifier(s): GB-MHRA-ADR 26413576. A female patient received BNT162B2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN) and COVID-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), both for COVID-19 immunization. The patient has not had symptoms associated with COVID-19. The patient had not had a COVID-19 test. The patient is not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Interchange of vaccine products"; LYMPH NODE PAIN (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Lymph node pain"; LYMPHADENOPATHY (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Swelling in lymph node under left arm and breast". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029824 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Inflammation, Interchange of vaccine products, Lymphadenitis, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211216; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885762

Write-up: Very painful armpit; lymphnode inflammation; Inflammation; dose 1, dose 2 covid-19 vaccine manufactuerer unknown and dose 3 BNT162b2; dose 1, dose 2 covid-19 vaccine manufactuerer unknown and dose 3 BNT162b2; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112300839376180-HFE1G (MHRA). Other Case identifier: GB-MHRA-ADR 26414169 (MHRA). A 30 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient last menstrual period date on 30Dec2021. 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. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: the patient received dose 1, dose 2 covid-19 vaccine manufactuerer unknown and dose 3 BNT162b2; INFLAMMATION (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Inflammation"; AXILLARY PAIN (medically significant), LYMPHADENITIS (medically significant), both outcome "unknown" and described as "Very painful armpit / lymphnode inflammation following receipt of vaccine just before menstrual cycle". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) negative, notes: No - Negative COVID-19 test. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029825 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymph node pain, Myalgia, Off label use, Pain, Pyrexia, SARS-CoV-2 test, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101886045

Write-up: fever; For all three vacci es has severe muscle ache; body ache; armpit swelling especially left side and near site of vaccine; Lymph node pain; off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112300840346250-KT7L3 (RA). Other Case identifier(s): GB-MHRA-ADR 26414188 (RA). A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Lot number: FN3543) as dose 3 (booster), single for covid-19 immunisation. Date of last menstrual period: 08Dec2021. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 24Apr2021, for COVID-19 immunisation, reaction(s): "severe muscle ache", "severe body ache", "Fever"; Covid-19 vaccine astrazeneca (Dose 2), administration date: 26Jun2021, for COVID-19 immunisation, reaction(s): "severe muscle ache", "severe body ache", "Fever". 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. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant), outcome "not recovered", described as "fever"; LYMPH NODE PAIN (medically significant) with onset 28Dec2021, outcome "recovering", described as "Lymph node pain"; MYALGIA (medically significant), outcome "unknown", described as "For all three vacci es has severe muscle ache"; PAIN (medically significant), outcome "unknown", described as "body ache"; SWELLING (medically significant), outcome "unknown", described as "armpit swelling especially left side and near site of vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) negative, notes: No - Negative COVID-19 test. For all three vaccines has severe muscle and body acting with fever. Severe lymph nodes pain and armpit swelling especially left side and near site of vaccine. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029839 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary mass, Axillary pain, Erythema, Feeling hot, Immunisation, Lymphadenopathy, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101885911

Write-up: Swelling arm; redness; Rash; warmth; Axillary lump; Axillary pain; Booster; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP) from the regulatory authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112300928105970-I8ZUZ (MHRA). Other Case identifier(s): GB-MHRA-ADR 26414524 (MHRA). A 28-year-old female patient (not pregnant nor breastfeeding) received BNT162b2 (COMIRNATY), on 27Dec2021 (Lot number: FN5254) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included 1st and 2nd dose with BNT162b2, for COVID-19 immunization. The patient had not had symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine, and not enrolled in a clinical trial. A COVID-19 test on 27Jul2021 was positive. It was reported that a day after receiving the booster dose, the armpit began to feel sore. Two days after vaccine the armpit swelled. Three days post vaccine, the armpit was still sore and swollen and a painful lump on the inside of the upper arm had appeared, accompanied by warmth, redness/rash and some swelling. The patient was recovering from redness, and had not recovered from swelling of armpit, axillary lump, rash, and axillary pain, while the outcome of warmth was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029840 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE; VENTOLIN
Current Illness: Asthma; Chest infection; Cold; Depression
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101885937

Write-up: off label use; Interchange of vaccine products; Booster; Asthma/ breathing started to be erratic; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112300932261380-71XZU. Other Case identifier: GB-MHRA-ADR 26414. A 35-year-old male patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (ongoing); "Asthma" (ongoing); "Chest infection", start date: 24Dec2021 (ongoing); "Cold", start date: 24Dec2021 (ongoing). Patient currently had a chest infection and cold since Christmas eve (24Dec2021). Patient had not had symptoms associated with COVID-19. Concomitant medications included: SERTRALINE taken for depression; VENTOLIN (reported as blue VENTOLIN inhaler) taken for asthma. Vaccination history included: COVID-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; ASTHMA (medically significant) with onset 27Dec2021, outcome "recovering", described as "Asthma/ breathing started to be erratic". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2021) negative. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The reporting consumer considered this report not related to possible inflammation of the heart (myocarditis or pericarditis). Clinical course: asthma was fine till he had booster, in evening after the booster his breathing started to be erratic. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029884 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-26
Onset:2021-12-27
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heavy periods
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101885847

Write-up: Menorrhagia (Period following her jab was 3 times heavier than usual); This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112301248109170-UNONN. Other Case identifier(s): GB-MHRA-ADR 26415629. A 32 year-old female patient received bnt162b2 (COMIRNATY), administration date 26Nov2021 (Lot number: fh4751) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Heavy periods" (unspecified if ongoing). The patient''s concomitant medications were not reported. Patient was not enrolled in clinical trial and was unsure if patient has had symptoms associated with COVID-19; had not undergone a COVID-19 test. Patient''s last menstrual period date: 27Dec2021. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Menorrhagia (Period following her jab was 3 times heavier than usual)". Clinical course: Patient was apprehensive of having COVID jab due to concerns about her menstruation. Stated that she gets heavy periods and did not want to make that worse. Period following her jab was 3 times heavier than usual as having to use 3 times amount of pads and was leaking through her clothes which she never before had. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029893 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-27
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Cough, Fatigue, Headache, Immunisation, Interchange of vaccine products, Off label use, Oropharyngeal 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), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive
CDC Split Type: GBPFIZER INC202101885645

Write-up: off label use; booster; Interchange of vaccine products; Chills; Headache; Sore throat; Fever; Cough; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the regulatory authority (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112301304286130-G56N3 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26415901 (MHRA). A 55 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 20Mar2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: 06Jun2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "off label use"; IMMUNISATION (medically significant), outcome "unknown", described as "booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; CHILLS (medically significant) with onset 27Dec2021, outcome "recovering", described as "Chills"; HEADACHE (medically significant) with onset 27Dec2021, outcome "recovered", described as "Headache"; OROPHARYNGEAL PAIN (medically significant) with onset 27Dec2021, outcome "recovering", described as "Sore throat"; PYREXIA (medically significant) with onset 27Dec2021, outcome "recovered", described as "Fever"; COUGH (medically significant) with onset 27Dec2021, outcome "recovering", described as "Cough"; FATIGUE (medically significant) with onset 27Dec2021, outcome "recovered", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) Yes - Positive. Clinical details reported as follows: I have taken LTF and they are all negative. Reaction was quite bad after a few hours with chills it is getting better now. 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029894 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Dizziness, Fatigue, Feeling abnormal, Illness, Immunisation, Maternal exposure during breast feeding, Middle insomnia, Muscle twitching, Off label use, Panic reaction, Paraesthesia, Product use issue, SARS-CoV-2 test, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow), Neonatal exposures via breast milk (narrow), Medication errors (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: HELIUM
Current Illness: Breast feeding
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 INC202101885939

Write-up: vomiting; sleep has been affected as I normally sleep through the night but since having the booster I have woken multiple times; I keep panicking; My head feels like it''s been filled with helium it''s so light; Maternal exposure during breast feeding; Maternal exposure during breast feeding; Maternal exposure during breast feeding; Twitching; Fatigue; Anxiety; Sickness; Booster; Off label use; Spaced out/I feel poorly; Vertigo; Pins and needles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112301312454890-OWTDS. Other Case identifier(s): GB-MHRA-ADR 26415922. A 28 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing). Concomitant medication(s) included: HELIUM. Vaccination history included: Bnt162b2 (Dose-1), administration date: 14Jul2021, for COVID-19 immunisation, reaction(s): "It feels like my skin is really tight over my back and the tops of my arms", "when my skin is touched with clothing or a hand it sends electric zapping shock twitchy feelings all over my body", "pins and needles"; Bnt162b2 (Dose-2), administration date: 17Sep2021, for COVID-19 immunisation, reaction(s): "It feels like my skin is really tight over my back and the tops of my arms", "when my skin is touched with clothing or a hand it sends electric zapping shock twitchy feelings all over my body", "pins and needles", "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Off label use"; FEELING ABNORMAL (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Spaced out/I feel poorly"; VERTIGO (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Vertigo"; PARAESTHESIA (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Pins and needles"; MUSCLE TWITCHING (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Twitching"; FATIGUE (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Fatigue"; ANXIETY (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Anxiety"; VOMITING (medically significant), outcome "unknown", described as "vomiting"; MIDDLE INSOMNIA (medically significant), outcome "unknown", described as "sleep has been affected as I normally sleep through the night but since having the booster I have woken multiple times"; PANIC REACTION (medically significant), outcome "unknown", described as "I keep panicking"; ILLNESS (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Sickness"; DIZZINESS (non-serious), outcome "unknown", described as "My head feels like it''s been filled with helium it''s so light"; MATERNAL EXPOSURE DURING BREAST FEEDING (non-serious), PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "Maternal exposure during breast feeding". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative, notes: No - Negative COVID-19 test. I keep panicking and I don''t know whether it''s because of the vaccine or it''s just my brains reaction to feeling so strange and out of sorts. Patient last menstrual period date:2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200012093 same patient/same product, different dose/events.;GB-PFIZER INC-202200012086 Baby case


VAERS ID: 2029900 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Heart rate abnormal, Immunisation, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885571

Write-up: Booster; Chest pain; Heart rate; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112301335065340-TLOZX (RA). Other Case identifier(s): GB-MHRA-ADR 26415950 (RA). A 37 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Lot number: FK9706) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; CHEST PAIN (medically significant) with onset 27Dec2021, outcome "unknown", described as "Chest pain"; HEART RATE ABNORMAL (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Heart rate". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029908 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling abnormal, Headache, Immunisation, Interchange of vaccine products, Lethargy, Malaise, Nervousness, Off label use, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Medication errors (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 INC202101885685

Write-up: lethargic; shaky; Chronic headaches; Shaky feelings; Feeling sick; Foggy feeling in head; 1st dose and 2nd dose were non-Pfizer vaccine and 3rd dose was BNT162B2; 1st dose and 2nd dose were non-Pfizer vaccine and 3rd dose was BNT162B2; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112301415084320-2RY8P (MHRA). Other Case identifier(s): GB-MHRA-ADR 26416280 (MHRA). A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown, expiration date unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "1st dose and 2nd dose were non-Pfizer vaccine and 3rd dose was BNT162B2"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "booster"; HEADACHE (medically significant) with onset 28Dec2021, outcome "recovered" (29Dec2021) (also reported as resolving), described as "Chronic headaches"; NERVOUSNESS (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Shaky feelings"; MALAISE (medically significant) with onset 28Dec2021, outcome "recovering", described as "Feeling sick"; FEELING ABNORMAL (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Foggy feeling in head"; LETHARGY (non-serious), outcome "unknown", described as "lethargic"; TREMOR (non-serious), outcome "unknown", described as "shaky". Clinical course: Patient had been very shaky, lethargic, and being sick from the booster vaccine. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was 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: 2029912 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Immunisation, Lymphadenopathy, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: 2021; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101885618

Write-up: Glands swollen; Pain around the underarm chest area; BOOSTER; Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; COVID-19 virus test positive; This is a spontaneous report received from a contactable consumer from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112301425000510-ATCZ7. Other Case identifier: GB-MHRA-ADR 26416307. A 48-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1), for COVID-19 IMMUNISATION; Comirnaty (DOSE 2), for COVID-19 IMMUNISATION, reaction: "Pain around the underarm chest area". The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "BOOSTER"; LYMPHADENOPATHY (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Glands swollen"; CHEST PAIN (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Pain around the underarm chest area"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant) with onset 2021, outcome "unknown", described as "Chest pain"; PYREXIA (medically significant) with onset 2021, outcome "unknown", described as "Fever"; DYSPNOEA (medically significant) with onset 2021, outcome "unknown", described as "Shortness of breath"; SARS-COV-2 TEST POSITIVE (medically significant) with onset 2021, outcome "unknown", described as "COVID-19 virus test positive". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: positive. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19. Date of LMP was 23-DEC-2021. Patient was not pregnant. Patient was not currently breastfeeding. Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "Yes". Did the symptoms lead to a hospital stay?: "No". Were any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken?: "No". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029939 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-27
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Fatigue, Heart rate, Heart rate irregular, Immunisation, Interchange of vaccine products, Limb discomfort, Myocarditis, Off label use, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Was tested Covid positive in Feb 2021)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Heart beat; Result Unstructured Data: Test Result:Irregular; Test Date: 20210131; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Test Date: 202102; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101885903

Write-up: Myocarditis; Chest pain/sharp chest pain (left and not constant); Shortness of breath; Heart palpitations/Loud heartbeat; Irregular heartbeat; Discomfort in chest area; Fatigue/unusual tiredness; Discomfort in the whole of the left arm; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112301548487750-WPNXP (RA). Other Case identifier(s): GB-MHRA-ADR 26417001 (RA). A 32 year-old patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 29Jan2021, stop date: 08Feb2021, notes: Was tested Covid positive in Feb 2021. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine moderna (Dose 1), for COVID-19 immunisation; Covid-19 vaccine moderna (Dose 2), for COVID-19 immunisation, reaction(s): "Discomfort in the chest area", "Sharp chest pain (left and not constant)", "Shortness of breath", "Irregular heartbeat", "Discomfort in the whole of the left arm".Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Booster"; MYOCARDITIS (medically significant) with onset 27Dec2021, outcome "recovering", described as "Myocarditis"; CHEST PAIN (medically significant) with onset 2021, outcome "unknown", described as "Chest pain/sharp chest pain (left and not constant)"; DYSPNOEA (medically significant) with onset 2021, outcome "unknown", described as "Shortness of breath"; PALPITATIONS (medically significant) with onset 2021, outcome "unknown", described as "Heart palpitations/Loud heartbeat"; HEART RATE IRREGULAR (medically significant) with onset 2021, outcome "unknown", described as "Irregular heartbeat"; CHEST DISCOMFORT (medically significant) with onset 2021, outcome "unknown", described as "Discomfort in chest area"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue/unusual tiredness"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Discomfort in the whole of the left arm". The patient underwent the following laboratory tests and procedures: heart rate: (2021) irregular; sars-cov-2 test: (31Jan2021) yes - positive covid-19 test; (Feb2021) positive.Clinical course: It was reported that on both the Second dose and Booster shot, the effect happened a couple of days after the shots were administered. The reactions experienced were: sharp chest pain (left and not constant), discomfort in the chest area, discomfort in the whole of the left arm, irregular heartbeat, shortness of breath. The symptoms were especially obvious in the night during sleep, particularly on the irregular and loud heartbeat. During that time, there had not been vigorous exercises nor no exercises/activities performed on a daily basis. On the second dose (Moderna), the effect took around three weeks to fade. This report relates to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to hospital stay. The diagnosis was not made by a medical professional. There had not been any other recent or ongoing illness. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029942 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Joint swelling, Photophobia, Sensitive skin, Swollen tongue
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious meningitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Fibromyalgia; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101885983

Write-up: Joint swelling; Tongue swelling non-specific; Hypersensitive skin; Eyes sensitive to sunlight; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112301554076820-HQTQK (RA). Other Case identifier(s): GB-MHRA-ADR 26416984 (RA). A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodeficiency). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number unknown), for COVID-19 immunisation; Bnt162b2 (Dose 2, Lot number unknown), for COVID-19 immunisation. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant, and she was not currently breastfeeding. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; JOINT SWELLING (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Joint swelling"; SWOLLEN TONGUE (medically significant) with onset 27Dec2021, outcome "recovered" (28Dec2021), described as "Tongue swelling non-specific"; SENSITIVE SKIN (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Hypersensitive skin"; PHOTOPHOBIA (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Eyes sensitive to sunlight". 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: 2030031 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101885929

Write-up: Injection site sore, especially when lifting arm over head; Injection site red; Injection site swollen; Lymph nodes in armpit sore and swollen; Lymph node pain; This is a spontaneous report received from a contactable reporter from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112302224181630-ADSX2. Other Case identifier: GB-MHRA-ADR 26418534. A 15-year-old male patient received bnt162b2, administration date 27Dec2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Vaccination history included: BNT162b2 (Dose 1), for COVID-19 immunization. The following information was reported: lymph node pain, vaccination site pain, vaccination site erythema, vaccination site swelling and lymphadenopathy all with outcome unknown. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. regulatory authorities. The reporting consumer considered this report not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030042 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dental paraesthesia, Fatigue, Hyperaesthesia, Immunisation, Interchange of vaccine products, Migraine, Nausea, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Atopy (I have Atopy which I''m told makes my body prone to overreact to viruses.); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885570

Write-up: Tingling teeth; Fever; Chronic fatigue; Increased skin sensitivity; Nausea; Migraine; off label use; Interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112302250578980-NJSIP (MHRA). Other Case identifier(s): GB-MHRA-ADR 26418593 (MHRA). A 48 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Atopy" (unspecified if ongoing), notes: I have Atopy which I''m told makes my body prone to overreact to viruses.; "Suspected COVID-19", start date: 20Feb2020, stop date: 10Mar2020. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine astrazeneca (Dose 2), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (disability) with onset 27Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 27Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 27Dec2021, outcome "unknown", described as "booster"; MIGRAINE (disability) with onset 28Dec2021, outcome "recovering", described as "Migraine"; DENTAL PARAESTHESIA (disability) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Tingling teeth"; PYREXIA (disability) with onset 28Dec2021, outcome "recovered" (29Dec2021), described as "Fever"; FATIGUE (disability) with onset 28Dec2021, outcome "recovering", described as "Chronic fatigue"; HYPERAESTHESIA (disability) with onset 28Dec2021, outcome "recovering", described as "Increased skin sensitivity"; NAUSEA (disability) with onset 28Dec2021, outcome "recovering", described as "Nausea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report dose not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Clinical course: I have Atopy which I''m told makes my body prone to overreact to viruses. Patient has not tested


VAERS ID: 2030052 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Decreased appetite, Dizziness, Fatigue, Headache, Immunisation, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101885599

Write-up: Dizziness; Fever; General body pain; Booster; Appetite lost; Headache; Shivers; Fatigue; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112310006407890-ZFUUC (RA). Other Case identifier(s): GB-MHRA-ADR 26418721 (RA). A 35-year-old female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st single dose), for COVID-19 immunisation; Bnt162b2 (2nd single dose), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; DECREASED APPETITE (medically significant) with onset 27Dec2021, outcome "recovering", described as "Appetite lost"; HEADACHE (medically significant) with onset 27Dec2021, outcome "recovered" (30Dec2021), described as "Headache"; CHILLS (medically significant) with onset 27Dec2021, outcome "recovered" (29Dec2021), described as "Shivers"; FATIGUE (medically significant) with onset 27Dec2021, outcome "recovering", described as "Fatigue"; DIZZINESS (medically significant) with onset 28Dec2021, outcome "recovering", described as "Dizziness"; PYREXIA (medically significant) with onset 28Dec2021, outcome "recovered" (29Dec2021), described as "Fever"; PAIN (medically significant) with onset 28Dec2021, outcome "recovering", described as "General body pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Additional information: Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy No follow-up attempts are possible. No further information is expected.


VAERS ID: 2030072 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Malaise, Nausea, Pain in extremity, SARS-CoV-2 test, Somnolence
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? 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
CDC Split Type: GBPFIZER INC202101886027

Write-up: Headache; Feeling unwell; Nausea; Sleepy; Shivers; Painful arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112310342323890-5Q3QJ (MHRA). Other Case identifier(s): GB-MHRA-ADR 26418904 (MHRA). A 26 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant,Patient is not currently breastfeeding. Last menstrual period date: 8Dec2021. The following information was reported: HEADACHE (medically significant) with onset 27Dec2021, outcome "recovered" (29Dec2021), described as "Headache"; MALAISE (medically significant) with onset 27Dec2021, outcome "recovering", described as "Feeling unwell"; NAUSEA (medically significant) with onset 27Dec2021, outcome "recovered" (29Dec2021), described as "Nausea"; SOMNOLENCE (medically significant) with onset 27Dec2021, outcome "recovering", described as "Sleepy"; CHILLS (medically significant) with onset 27Dec2021, outcome "recovered" (28Dec2021), described as "Shivers"; PAIN IN EXTREMITY (medically significant) with onset 27Dec2021, outcome "recovered" (29Dec2021), described as "Painful arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No" No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030077 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dizziness, Hangover, Headache, Illness, Immunisation, Interchange of vaccine products, Myalgia, Nausea, Off label use, Pain, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: STELARA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Psoriasis; Psoriatic arthritis; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101885612

Write-up: sickness; Woke up with extreme hangover type symptoms; General aches and pains; Feeling queasy; Vomiting; Diarrhea; Forehead headache; Dizziness; Muscle ache; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112310511182240-I3HVR Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26419213 Regulatory Authority. A 38 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...; "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response and i... Concomitant medication(s) included: STELARA taken for psoriasis, psoriatic arthropathy. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, with mild to no reaction or problems), for Covid-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2, with mild to no reaction or problems), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; VOMITING (medically significant) with onset 28Dec2021, outcome "recovering", described as "Vomiting"; DIARRHOEA (medically significant) with onset 28Dec2021, outcome "recovering", described as "Diarrhea"; HEADACHE (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Forehead headache"; DIZZINESS (medically significant) with onset 28Dec2021, outcome "recovering", described as "Dizziness"; MYALGIA (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Muscle ache"; ILLNESS (medically significant), outcome "unknown", described as "sickness"; HANGOVER (medically significant), outcome "unknown", described as "Woke up with extreme hangover type symptoms"; PAIN (medically significant), outcome "unknown", described as "General aches and pains"; NAUSEA (medically significant), outcome "unknown", described as "Feeling queasy". Therapeutic measures were taken as a result of illness. Clinical details: Patient last menstrual period date was 25Dec2021. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Woke up with extreme hangover type symptoms (without any alcohol) with extreme sickness and awful headache and dizziness. Had to take and continue to take Mild anti sickness tablets to control as still. Feeling queasy 4 days on along with mild headache and general aches and pains. This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030099 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Chest pain, Dyspnoea, Fatigue, Musculoskeletal stiffness, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: VITAMIN B12 [VITAMIN B12 NOS]; YACELLA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No, Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Heart palpitations; Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; Racing heart (tachycardia); Armpit pain; Palpitations; Stiffness; Fever; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26420118) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Armpit pain), the second episode of PYREXIA (Fever), MUSCULOSKELETAL STIFFNESS (Stiffness), PALPITATIONS (Heart palpitations), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), the first episode of PYREXIA (Fever), DYSPNOEA (Shortness of breath), TACHYCARDIA (Racing heart (tachycardia)) and PALPITATIONS (Palpitations) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL (YACELLA) for Contraception, VITAMIN B12 [VITAMIN B12 NOS] for Dietary B12 deficiency, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from an unknown date to 20-Jun-2021 for Vaccination. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant), the first episode of PYREXIA (Fever) (seriousness criterion medically significant) and PALPITATIONS (Palpitations) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant). On an unknown date, the patient experienced the second episode of PYREXIA (Fever) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). On 27-Dec-2021, PALPITATIONS (Palpitations) had resolved. On 29-Dec-2021, MUSCULOSKELETAL STIFFNESS (Stiffness) had resolved. At the time of the report, AXILLARY PAIN (Armpit pain) had not resolved and last episode of PYREXIA (Fever), PALPITATIONS (Heart palpitations), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No, Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Treatment medications were not provided. Palpitations was the first reaction occurred to patient around 6 hours after the vaccination, it had lasted around 3 hours. The armpit pain was still occurring after 4 days. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial The patient''s report was related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms had not caused patient to stay to hospital, diagnosis was not made by a medical professional and No blood tests such as certain proteins( called troponin) that signal muscle damage was taken. COMPANY COMMENT: This is a Regulatory case concerning a 26-old female patient with no clinical history who experienced the unexpected events of AXILLARY PAIN, CHEST PAIN, PYREXIA, DYSPNOEA, PALPITATIONS, TACHYCARDIA, FATIGUE, PYREXIA (2nd episode), MUSCULOSKELETAL STIFFNESS and PALPITATIONS The events occurred 1 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority; Sender''s Comments: COMPANY COMMENT: This is a Regulatory case concerning a 26-old female patient with no clinical history who experienced the unexpected events of AXILLARY PAIN, CHEST PAIN, PYREXIA, DYSPNOEA, PALPITATIONS, TACHYCARDIA, FATIGUE, PYREXIA (2nd episode), MUSCULOSKELETAL STIFFNESS and PALPITATIONS The events occurred 1 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority


VAERS ID: 2030105 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pain, Peripheral swelling, Rash, Rash erythematous, Rash pruritic, 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 (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: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA; LOTRIDERM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally) a steroid cream once every 3 to 4 days for an undiagnosed condition)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: rash; Itchy rash; Shooting pain; Headache; Red rash; Swelling arm; This case was received via Regulatory Authority, MHRA (Reference number: GB-MHRA-ADR 26421055) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), HEADACHE (Headache), PAIN (Shooting pain), RASH (rash) and PERIPHERAL SWELLING (Swelling arm) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally) a steroid cream once every 3 to 4 days for an undiagnosed condition). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 19-Jun-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination, BETAMETHASONE DIPROPIONATE, CLOTRIMAZOLE (LOTRIDERM) for Vulval itching. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant). On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced RASH PRURITIC (Itchy rash) (seriousness criterion medically significant) and PAIN (Shooting pain) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH (rash) (seriousness criterion medically significant). At the time of the report, RASH ERYTHEMATOUS (Red rash), RASH PRURITIC (Itchy rash), HEADACHE (Headache) and PAIN (Shooting pain) had not resolved and RASH (rash) and PERIPHERAL SWELLING (Swelling arm) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had Moderna booster on 27 Dec early morning. By late afternoon, the area of the jab was swelling, red, hot and felt hard to the touch. On 28 Dec, rash and swelling had grown and woke up with a headache. Paracetamol helped with headaches. On 29 Dec, Swelling reducing, rash bigger, headache still, raised itchy bumps along jawline and behind left ear, occasional shooting pain radiating from elbow down to wrist of arm that had jab but only lasts for a few seconds. On 30 Dec, rash same, headache same, raised itchy bumps along jawline, behind ear and under chin and still occasional shooting pain. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Treatment medications included Paracetamol for Headache. Company comment This is a regulatory case concerning a 46-year-old female patient with medical history of Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally) a steroid cream once every 3 to 4 days for an undiagnosed condition), who experienced the serious unexpected, according to CCDS, events of rash erythematous, rash pruritic, headache, pain, rash and peripheral swelling. The events rash erythematous and peripheral swelling occurred on the same day after the third dose of mRNA-1273. The event Headache occurred the day after the third dose of mRNA-1273. Rash pruritic and pain occurred approximately 2 days after the third dose of mRNA-1273. Rash occurred on an unknown date after the third dose of mRNA-1273 vaccine. At the time of the report, the events were resolving. The rechallenge was assessed as unknown according to SD. The medical history of Steroid therapy remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 46-year-old female patient with medical history of Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally) a steroid cream once every 3 to 4 days for an undiagnosed condition), who experienced the serious unexpected, according to CCDS, events of rash erythematous, rash pruritic, headache, pain, rash and peripheral swelling. The events rash erythematous and peripheral swelling occurred on the same day after the third dose of mRNA-1273. The event Headache occurred the day after the third dose of mRNA-1273. Rash pruritic and pain occurred approximately 2 days after the third dose of mRNA-1273. Rash occurred on an unknown date after the third dose of mRNA-1273 vaccine. At the time of the report, the events were resolving. The rechallenge was assessed as unknown according to SD. The medical history of Steroid therapy remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030143 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Oropharyngeal pain, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

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

Write-up: Sore throat; Drowsiness; Headache; Vomiting; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), OROPHARYNGEAL PAIN (Sore throat), SOMNOLENCE (Drowsiness) and VOMITING (Vomiting) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On 28-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and SOMNOLENCE (Drowsiness) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). On 29-Dec-2021, VOMITING (Vomiting) had resolved. At the time of the report, HEADACHE (Headache), OROPHARYNGEAL PAIN (Sore throat) and SOMNOLENCE (Drowsiness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided Patient not had any symptoms associated with COVID-19 and not had a COVID-19 test. Patient not tested positive for COVID-19 since she had the vaccine. Patient was not enrolled in clinical trial. It was reported that the events were not related to possible inflammation of the heart (myocarditis or pericarditis). Company comment: This is a regulatory case concerning a 33-year-old, female patient with no medical history reported who experienced the unexpected serious events of Headache, Oropharyngeal pain, Somnolence and Vomiting. The event of Vomiting occurred on the same date after the third dose of mRNA-1273 vaccine, the events of Headache and Somnolence one day later and the event of Oropharyngeal pain two days later. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event seriousness, rechallenge and action taken with the suspect product were kept as per Agency.; Sender''s Comments: This is a regulatory case concerning a 33-year-old, female patient with no medical history reported who experienced the unexpected serious events of Headache, Oropharyngeal pain, Somnolence and Vomiting. The event of Vomiting occurred on the same date after the third dose of mRNA-1273 vaccine, the events of Headache and Somnolence one day later and the event of Oropharyngeal pain two days later. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event seriousness, rechallenge and action taken with the suspect product were kept as per Agency.


VAERS ID: 2030150 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple sclerosis (Taking medicines for multiple sclerosis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: chronic fatigue; High temperature; Headache; Generalised aching; Nausea; Fatigue; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26422212) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (chronic fatigue), PYREXIA (High temperature), HEADACHE (Headache), PAIN (Generalised aching), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. Concurrent medical conditions included Multiple sclerosis (Taking medicines for multiple sclerosis). Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 27-Sep-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 24-Mar-2021 to an unknown date for an unknown indication. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), PAIN (Generalised aching) (seriousness criterion disability), NAUSEA (Nausea) (seriousness criterion disability) and FATIGUE (Fatigue) (seriousness criterion disability). On an unknown date, the patient experienced FATIGUE (chronic fatigue) (seriousness criterion disability). At the time of the report, FATIGUE (chronic fatigue) outcome was unknown, PYREXIA (High temperature), HEADACHE (Headache), PAIN (Generalised aching) and NAUSEA (Nausea) was resolving and FATIGUE (Fatigue) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had the booster at 8.45am and by 6pm the same day, patient could barely move, she had chronic fatigue, a temperature 39.7. Such a bad headache, patient couldn''t lift her head off the pillow. Patient tried using paracetamol, but it didn''t have any effect. She didn''t eat for about 24 hours but tried to drink as much water as she should. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 51-year-old female patient with relevant medical history of Multiple sclerosis who experienced serious unexpected events of Fatigue, reported as Fatigue and Chronic fatigue, Pyrexia, Headache, Pain and Nausea. The events occurred on the same day after the booster dose of mRNA-1273. It was reported that the patient was treated with paracetamol, but it was not effective. At the time of the report, Pyrexia, highest reported 39.7, Headache, Pain and Nausea were resolving whereas outcome of the event Fatigue was ambiguously reported as still ongoing and unknown. The rechallenge and action taken with the suspect product were reported as unknown as per and kept as such. Event terms, onset dates and outcomes captured per Authority reporting. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. Causality is confounded with patient''s reported medical history. The benefit-risk relationship of mRNA-1273 is not affected by this report. It should be noted that prior to Company product the patient received two doses of COVID-19 VACCINE ASTRAZENECA and one dose of Tozinameran, and, therefore, Interchange of vaccine products should have been considered in this particular case.; Sender''s Comments: This case concerns a 51-year-old female patient with relevant medical history of Multiple sclerosis who experienced serious unexpected events of Fatigue, reported as Fatigue and Chronic fatigue, Pyrexia, Headache, Pain and Nausea. The events occurred on the same day after the booster dose of mRNA-1273. It was reported that the patient was treated with paracetamol, but it was not effective. At the time of the report, Pyrexia, highest reported 39.7, Headache, Pain and Nausea were resolving whereas outcome of the event Fatigue was ambiguously reported as still ongoing and unknown. The rechallenge and action taken with the suspect product were reported as unknown as per and kept as such. Event terms, onset dates and outcomes captured per Authority reporting. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. Causality is confounded with patient''s reported medical history. The benefit-risk relationship of mRNA-1273 is not affected by this report. It should be noted that prior to Company product the patient received two doses of COVID-19 VACCINE ASTRAZENECA and one dose of Tozinameran, and, therefore, Interchange of vaccine products should have been considered in this particular case.


VAERS ID: 2030168 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Feverish; Headache; Foggy feeling in head; This case was received via regulatory authority on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This case was received via regulatory authority on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Feverish), HEADACHE (Headache) and FEELING ABNORMAL (Foggy feeling in head) in a 23-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 06-Aug-2021 to an unknown date for an unknown indication. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FEELING ABNORMAL (Foggy feeling in head) (seriousness criterion medically significant). On 28-Dec-2021, PYREXIA (Feverish), HEADACHE (Headache) and FEELING ABNORMAL (Foggy feeling in head) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was provided. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial The report was related to possible inflammation of the heart myocarditis or pericarditis. Company comment: This regulatory case concerns a 23-year-old female patient, with no medical history reported, who experienced the serious unexpected events of PYREXIA, HEADACHE and FEELING ABNORMAL. The events occurred on the same day of the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable as no information about further dosing has been disclosed. A SARS-CoV-2 test: negative was performed on an unknown date. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.; Sender''s Comments: This regulatory case concerns a 23-year-old female patient, with no medical history reported, who experienced the serious unexpected events of PYREXIA, HEADACHE and FEELING ABNORMAL. The events occurred on the same day of the third dose of the mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable as no information about further dosing has been disclosed. A SARS-CoV-2 test: negative was performed on an unknown date. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.


VAERS ID: 2030185 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-10
Onset:2021-12-27
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Breast pain, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Lipodystrophy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Breast pain; Armpit pain; Throat pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26423274) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of BREAST PAIN (Breast pain), AXILLARY PAIN (Armpit pain) and OROPHARYNGEAL PAIN (Throat pain) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced BREAST PAIN (Breast pain) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant) and OROPHARYNGEAL PAIN (Throat pain) (seriousness criterion medically significant). At the time of the report, BREAST PAIN (Breast pain), AXILLARY PAIN (Armpit pain) and OROPHARYNGEAL PAIN (Throat pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Treatment medication information was not provided by the reporter. Patient not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Company Comment: This is a regulatory case concerning a female patient of an unknown age with no relevant medical history, who experienced the unexpected serious events of Breast pain, Axillary pain and Oropharyngeal pain. The events occurred 17 days after the third dose of mRNA-1273 vaccine. The outcome of the events was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority report due to important medical condition.; Sender''s Comments: This is a regulatory case concerning a female patient of an unknown age with no relevant medical history, who experienced the unexpected serious events of Breast pain, Axillary pain and Oropharyngeal pain. The events occurred 17 days after the third dose of mRNA-1273 vaccine. The outcome of the events was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority report due to important medical condition.


VAERS ID: 2030279 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Headache; This case was received via regulatory authority on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 24-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. The patient developed severe headache that couldn''t improve with over-the-counter painkillers. Doctors prescribed her cocodamol, which helped a bit but not completely and then she started with aspirin. Although it''s less severe, she can feel experience headache and muscle pain on her back, neck, and head. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment: This is a regulatory case concerning a 42-year-old, female patient with no medical history reported who experienced the unexpected serious event of Headache three days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. As reported, the patient also developed muscle pain on her back, neck, and head, however these events were not coded by RA. The event terms, event seriousness, rechallenge and action taken with the suspect product were kept as per SD.; Sender''s Comments: This is a regulatory case concerning a 42-year-old, female patient with no medical history reported who experienced the unexpected serious event of Headache three days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. As reported, the patient also developed muscle pain on her back, neck, and head, however these events were not coded by RA. The event terms, event seriousness, rechallenge and action taken with the suspect product were kept as per SD.


VAERS ID: 2030320 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-27
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: This case was received via regulatory authority RA (Reference number: GB-RA-ADR 26424787) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain) and PAIN IN EXTREMITY (Painful arm) in a 53-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Pain) (seriousness criterion medically significant). At the time of the report, PAIN (Pain) and PAIN IN EXTREMITY (Painful arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical history was reported. It was stated that there was limited use of arm and was very painful. Patient was unable to move her arm out to the side or raise above chest height. Patient was struggled to get dressed without some help and sleep had been affected due to constant pain. It was stated that the reaction did not occur until approximately a week after injection and was still not better 12 days after booster. Patient was taking over the counter painkillers and using heat pad to treat pain so far. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report was not related to possible inflammation of the heart (myocarditis or pericarditis). Company Comment: This case refers to a 53-year-old female patient with no known medical history who experienced the unexpected events of Pain and Pain in extremity. Pain in extremity occurred approximately 6 days after the third dose of mRNA-1273 vaccine while the event of Pain occurred after an unspecified number of days post exposure to the vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case refers to a 53-year-old female patient with no known medical history who experienced the unexpected events of Pain and Pain in extremity. Pain in extremity occurred approximately 6 days after the third dose of mRNA-1273 vaccine while the event of Pain occurred after an unspecified number of days post exposure to the vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030328 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; PFIZER BIONTECH COVID-19 VACCINE; COVID-19 VACCINE ASTRAZENECA
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Palpitations; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424869) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (Batch no. 000022a) for an unknown indication. Concurrent medical conditions included Suspected COVID-19 since 24-Dec-2021. Concomitant products included CITALOPRAM from 01-Oct-2021 to an unknown date for Anxiety, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 09-Jul-2021 to an unknown date and COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) from 21-Feb-2021 to an unknown date for COVID-19 vaccination. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant). On 27-Dec-2021, PALPITATIONS (Palpitations) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. 10 minutes after receiving Moderna Vaccine dose patient got a sudden bout of palpitations which made feel faint, patient had to sit in the floor as patient felt would pass out. Patient also got a sensation of feeling ice cold from head to toes and experienced a strange taste in mouth. Patient was seen by the paramedic at the vaccination site and after 20 minutes of observation patient was allowed to leave. Patient had no further symptoms. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment medications provided by the reporter. Company Comment: This case refers to a 36-year-old female patient with a medical history of anxiety who experienced the unexpected event of Palpitations on the same day after receiving the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case refers to a 36-year-old female patient with a medical history of anxiety who experienced the unexpected event of Palpitations on the same day after receiving the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030334 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-12-27
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005237 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ophthalmic herpes zoster, SARS-CoV-2 test
SMQs:, Ocular infections (narrow), Opportunistic infections (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2; COVID-19 MRNA VACCINE BNT162B2
Current Illness: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response); Type 2 diabetes mellitus (Diabetes Mellitus type 2- insulin dependent)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Ophthalmic zoster; This case was received via RA (Reference number: GB-MHRA-ADR 26424914) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of OPHTHALMIC HERPES ZOSTER (Ophthalmic zoster) in a 68-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005237) for an unknown indication. Concurrent medical conditions included Type 2 diabetes mellitus (Diabetes Mellitus type 2- insulin dependent) and Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response). Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 21-May-2021 to an unknown date and TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for an unknown indication. On 21-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced OPHTHALMIC HERPES ZOSTER (Ophthalmic zoster) (seriousness criterion medically significant). At the time of the report, OPHTHALMIC HERPES ZOSTER (Ophthalmic zoster) 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. Treatment information was not provided. The patient had not tested positive for COVID 19 since vaccine administration, had no symptoms associated with COVID 19 and was not enrolled in clinical trial. The concomitant vaccine was administered on 21 May 2021 and on 29 Nov 2021. Company Comment: This case refers to a 68-year-old male patient with a medical history of immunodeficiency who experienced the unexpected event of Ophthalmic herpes zoster approximately 1 month and 6 days after receiving the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case refers to a 68-year-old male patient with a medical history of immunodeficiency who experienced the unexpected event of Ophthalmic herpes zoster approximately 1 month and 6 days after receiving the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The medical history of immunodeficiency remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030338 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2; GEDAREL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: High temperature; Nausea; Shivers; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424944) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivers), PYREXIA (High temperature) and NAUSEA (Nausea) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 24-Jun-2021 to an unknown date and DESOGESTREL, ETHINYLESTRADIOL (GEDAREL) from 01-Jan-2020 to an unknown date for an unknown indication. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant). On 28-Dec-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 28-Dec-2021, CHILLS (Shivers), PYREXIA (High temperature) and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding Patient is not enrolled in clinical trial. No treatment medication were reported. Company comment: This case concerns a 31-year-old, female patient with no medical history, previously vaccinated with TOZINAMERAN, who experienced the unexpected events of chills, pyrexia and nausea. The events occurred on the same day or 1 day after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 31-year-old, female patient with no medical history, previously vaccinated with TOZINAMERAN, who experienced the unexpected events of chills, pyrexia and nausea. The events occurred on the same day or 1 day after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030362 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Fatigue, Headache, Migraine, Nausea
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE; SERTRALINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Exhaustion; Headache; Migraine; Nausea; Feeling of total lack of energy; This case was received via the RA (Reference number: GB-MHRA-ADR 26425150) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Exhaustion), HEADACHE (Headache), MIGRAINE (Migraine), NAUSEA (Nausea) and ASTHENIA (Feeling of total lack of energy) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. Concomitant products included SERTRALINE from 09-Sep-2019 to an unknown date for Anxiety, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 23-Jun-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced FATIGUE (Exhaustion) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and ASTHENIA (Feeling of total lack of energy) (seriousness criterion medically significant). At the time of the report, FATIGUE (Exhaustion), HEADACHE (Headache), MIGRAINE (Migraine), NAUSEA (Nausea) and ASTHENIA (Feeling of total lack of energy) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Unsured if patient had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. Treatment information was not provided. Patient was not enrolled in clinical trial Date of LMP: 21-DEC-2021; Sender''s Comments: This case concerns a 27-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Fatigue, Headache, Migraine, Nausea, and Asthenia. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2030403 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Immunisation, Interchange of vaccine products, Investigation, Myocarditis, Off label use, Pain in extremity, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: investigations or tests; Result Unstructured Data: Test Result:Unknow results; Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200009400

Write-up: myocarditis; SARS-CoV-2 infection; Suspected COVID-19; Painful arm; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201040027085750-WYNFI (RA). Other Case identifier(s): GB-MHRA-ADR 26430559 (RA). A 49 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose-1 MANUFACTURER UNKNOWN, ), for COVID-19 immunisation; Covid-19 vaccine (Dose-2 MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; MYOCARDITIS (medically significant), outcome "recovering", described as "myocarditis"; COVID-19 (medically significant) with onset 29Dec2021, outcome "not recovered", described as "SARS-CoV-2 infection"; PAIN IN EXTREMITY (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Painful arm"; SUSPECTED COVID-19 (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Suspected COVID-19". The events "myocarditis", "sars-cov-2 infection", "painful arm" and "suspected covid-19" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: (unspecified date) unknow results; sars-cov-2 test: (29Dec2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: Had booster, since then confirmed COVID positive. Pain in left arm since booster, from top all way down to finger tips. Called 111 and since attended A&E. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030612 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Petechiae
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: ITPFIZER INC202101881059

Write-up: After a few hours, the capillaries in her legs started to burst; A few minutes after the administration, she had severe pain (migraine-like) in the right side of the head only; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 47 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: PETECHIAE (medically significant) with onset 27Dec2021, outcome "not recovered", described as "After a few hours, the capillaries in her legs started to burst"; HEADACHE (non-serious) with onset 27Dec2021, outcome "unknown", described as "A few minutes after the administration, she had severe pain (migraine-like) in the right side of the head only". The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2030695 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-12-27
   Days after vaccination:106
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG8643 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220102; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Positive
CDC Split Type: PHPFIZER INC202200001275

Write-up: Tested positive for COVID-19; Tested positive for COVID-19; Experienced fever, cough and cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Sep2021 (Lot number: FG8643) at the age of 43 years as dose 2, single and administration date 20Aug2021 (Lot number: FG8643) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "Tested positive for COVID-19"; NASOPHARYNGITIS (non-serious) with onset 27Dec2021, outcome "unknown", described as "Experienced fever, cough and cold". The patient also experienced fever and cough. The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: (02Jan2022) positive. For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FG8643. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2032657 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-27
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Date: 20220102; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: CHPFIZER INC202200023529

Write-up: Drug ineffective; A family member was infected with the Corona virus on 22/23Dec2021 and tested positive on 27Dec2021.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A male patient received bnt162b2 (COMIRNATY), administration date 06Aug2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 27Dec2021, outcome "recovered" (02Jan2022), described as "Drug ineffective"; COVID-19 (medically significant) with onset 27Dec2021, outcome "recovered" (02Jan2022), described as "A family member was infected with the Corona virus on 22/23Dec2021 and tested positive on 27Dec2021.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive; (02Jan2022) negative. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033000 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-12-27
   Days after vaccination:292
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alopecia areata, Blood test, Diagnostic procedure, SARS-CoV-2 test
SMQs:, Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alopecia
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: Hair follicle test; Result Unstructured Data: Test Result:Unknown results; Test Name: Hair stress test; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210112; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000755

Write-up: Alopecia areata; This is a spontaneous report received from a contactable reporter (Other HCP) from the Agency Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-APPCOVID-202201012249230310-4HPYE Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26424503 Regulatory Authority. A 29 year-old female patient (not pregnant) received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), administration date: 10Mar2021 (Lot number: ER1741) as dose 2, single for COVID-19 immunization. Relevant medical history included: "Alopecia" (unspecified if ongoing). The patient has not had symptoms associated with COVID-19 and was not currently breastfeeding. Her last menstrual period was reported to be on 01Apr2018. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 Unknown manufacturer, Had first vaccination and Covid-19), for COVID-19 Immunization, reaction(s): "Covid-19"; Covid-19 vaccine, for COVID-19 Immunization, reaction(s): "hair started falling out". The following information was reported: ALOPECIA AREATA (medically significant) with onset 27Dec2021, outcome "recovering", described as "Alopecia areata". The patient had first vaccination and Covid-19. She noticed her hair started falling out. Diagnosed with alopecia by a doctor. The patient stated that her steroid cream didn''t work. She was referred to a dermatologist who has been giving her steroid injections in her scalp. The patient was not enrolled in a clinical trial. The patient underwent the following laboratory tests and procedures: blood tests regularly: (unspecified date) unknown results; diagnostic procedure (Hair stress test, Hair follicle test): (unspecified date) unknown results; (unspecified date) unknown results; SARS-CoV-2 test: (12Jan2021) positive, notes: Yes - Positive COVID-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033158 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Headache, Immunisation, Interchange of vaccine products, Nasopharyngitis, Off label use, Oropharyngeal pain, Rhinorrhoea, Sneezing
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000781

Write-up: cold; Sneezing; Runny nose; Earache; Sore throat; off label use; interchange of vaccine products; booster; Headache dull; This is a spontaneous report received from a contactable reporter (Consumer) from a regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112311127064400-0GAWJ. Other Case identifier(s): GB-MHRA-ADR 26421046. A 55 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2 Unknown manufacturer), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "booster"; HEADACHE (medically significant) with onset 27Dec2021 came on within 2 hours of having the vaccine, outcome "recovered with sequelae", described as "Headache dull"; SNEEZING (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Sneezing"; RHINORRHOEA (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Runny nose"; EAR PAIN (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Earache"; OROPHARYNGEAL PAIN (medically significant) with onset 27Dec2021 came on within 2 hours of having the vaccine, outcome "recovered with sequelae", described as "Sore throat"; NASOPHARYNGITIS (medically significant), outcome "unknown", described as "cold". Additional information: Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not currently breastfeeding. 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: 2033230 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Cough, Headache, Hyperhidrosis, Immunisation, Interchange of vaccine products, Myalgia, Off label use, Pain, Photophobia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000422

Write-up: muscle soreness; sweating; chest cough; headache; headache stepped up a gear body ache; hot and cold sweating to the point the bed is soaked by morning; Painful cough; Light sensitivity to eye; Fever; off label use; Interchange of vaccine products; Booster; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Regulatory number: GB-RA-WEBCOVID-202112311800062680-5MB1R (RA). Other Case identifier(s): GB-RA-ADR 26422996 (RA). A 44 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; MYALGIA (medically significant), outcome "recovering", described as "muscle soreness"; HYPERHIDROSIS (medically significant), outcome "recovering", described as "sweating"; COUGH (medically significant), outcome "recovering", described as "chest cough"; HEADACHE (medically significant), outcome "recovering", described as "headache"; MYALGIA (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Muscle pain"; PYREXIA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Fever"; COUGH (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Painful cough"; PHOTOPHOBIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Light sensitivity to eye"; PAIN (medically significant), outcome "unknown", described as "headache stepped up a gear body ache"; COLD SWEAT (medically significant), outcome "unknown", described as "hot and cold sweating to the point the bed is soaked by morning". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: The patient went to gym day of booster and that night to muscles, had worked where exceptionally sore, went to gym next day feeling a little of with muscle soreness and headache starting. Again muscles had worked unbelievably sore. Then headache stepped up a gear body ache all over go hot and cold sweating to the point the bed was soaked by morning. The patient had now developed really chest cough the releases loads of mucous and was very painful. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis).Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033284 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Computerised tomogram, Headache, Lip swelling, Lumbar puncture, Rash, SARS-CoV-2 test, Suspected COVID-19, X-ray
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Ct; Result Unstructured Data: Test Result:Unknown results; Test Name: lumber puncture; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211222; Test Name: COVID-19 virus test; Test Result: Negative ; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202200000751

Write-up: headache; Lips swollen; Abdomen pain; Rash face; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter (Consumer) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112312212240990-OCOPU. Other Case identifier: GB-MHRA-ADR 26423280. A 20 year-old female patient (not pregnant nor breastfeeding) received BNT162B2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. No known previous allergy. The following information was reported: COVID-19 (hospitalization) with onset 27Dec2021, outcome "recovering", described as "SARS-CoV-2 infection"; HEADACHE (hospitalization), outcome "not recovered"; RASH (hospitalization) with onset 27Dec2021, outcome "recovered" (29Dec2021), described as "Rash face"; LIP SWELLING (hospitalization), outcome "unknown", described as "Lips swollen"; and ABDOMINAL PAIN (hospitalization), outcome "unknown". The patient underwent the following laboratory tests and procedures: computerised tomogram (CT): (unspecified date) unknown results; lumbar puncture: (unspecified date) unknown results; COVID-19 virus test: (22Dec2021) negative; x-ray: (unspecified date) unknown results. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : 202200017336 Same patient/reporter/dose but different event


VAERS ID: 2033335 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Decreased appetite, Fatigue, Fear, Immunisation, Interchange of vaccine products, Off label use, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Cardiomyopathy (broad), Arthritis (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000536

Write-up: fright; very fatigue; muscles in my back paining; shoulder paining and soar; lack of appetite; Heart racing; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority . The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201011207561680-OPD4B. Other Case identifier(s): GB-MHRA-ADR 26423979. A 36 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine moderna (DOSE NUMBER UNKNOWN), administration date: 22Aug2021, for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; FEAR (medically significant), outcome "recovering", described as "fright"; FATIGUE (medically significant), outcome "recovering", described as "very fatigue"; PALPITATIONS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Heart racing"; BACK PAIN (medically significant), outcome "unknown", described as "muscles in my back paining"; ARTHRALGIA (medically significant), outcome "unknown", described as "shoulder paining and soar"; DECREASED APPETITE (medically significant), outcome "unknown", described as "lack of appetite". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) negative, notes: No - Negative COVID-19 test. Clinical course: Patient last menstrual period date: 15-DEC-2021. 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 reported her heart started racing at a rapid paste and beating very loudly all quite new to me. Feeling a Great surge of fright. Very Fatigue, muscles in my back and shoulder paining and soar and lack of appetite. Details of any relevant investigations or tests conducted: "Took a bilateral flow test but it was negative." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033433 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000263

Write-up: Heavy periods; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202201012212304960-BXMSY. Other Case identifier(s): GB-MHRA-ADR 26424444. A 28 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose number unknown), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 28Dec2021, outcome "recovering", described as "Heavy periods". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. The patient is not pregnant, not currently breastfeeding. The patient last menstrual period date: 29Dec2021. The patient had no symptoms associated with COVID-19, 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: 2033486 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Chest pain, Computerised tomogram, Depressed level of consciousness, Electrocardiogram, Fatigue, Gait inability, Headache, Hepatomegaly, Hypotension, Incontinence, Kidney enlargement, Limb immobilisation, Lymphoedema, Myocarditis, Palpitations, Pericarditis, SARS-CoV-2 test, Syncope, Tachycardia, Troponin, Ultrasound lymph nodes, Vaginal haemorrhage, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: blood pressure; Result Unstructured Data: Test Result:Low; Test Name: blood tests; Result Unstructured Data: Test Result:Unknown results; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown results; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211226; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: Troponin; Result Unstructured Data: Test Result:Normal; Test Name: Ultrasound of lymph nodes; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202200003534

Write-up: Fatigue/unusual tiredness; Heart palpitations; Racing heart (tachycardia); Myocarditis; Pericarditis; Liver enlargement; Lymphedema; Limb immobilisation; Fainting; Vomiting; Incontinence; Unconscious partial; Chest pain; Unable to walk; Headache; Vaginal bleeding; Low blood pressure; Kidney enlargement; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201021223084680-UK5KL (RA). Other Case identifier(s): GB-MHRA-ADR 26424875 (RA). A 35 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Lot number: FN5254) at the age of 35 years as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19 and was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient last menstrual period date: 03Dec2021. The following information was reported: SYNCOPE (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae", described as "Fainting"; VOMITING (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered with sequelae", described as "Vomiting"; INCONTINENCE (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovering", described as "Incontinence"; DEPRESSED LEVEL OF CONSCIOUSNESS (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovered" (29Dec2021), described as "Unconscious partial"; CHEST PAIN (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "not recovered", described as "Chest pain"; GAIT INABILITY (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovering", described as "Unable to walk"; HEADACHE (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "not recovered", described as "Headache"; VAGINAL HAEMORRHAGE (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "not recovered", described as "Vaginal bleeding"; HYPOTENSION (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "not recovered", described as "Low blood pressure"; KIDNEY ENLARGEMENT (hospitalization, disability, medically significant, life threatening) with onset 27Dec2021, outcome "recovering", described as "Kidney enlargement"; LYMPHOEDEMA (hospitalization, disability, medically significant, life threatening) with onset 28Dec2021, outcome "recovering", described as "Lymphedema"; LIMB IMMOBILISATION (hospitalization, disability, medically significant, life threatening) with onset 28Dec2021, outcome "recovering", described as "Limb immobilisation"; HEPATOMEGALY (hospitalization, disability, medically significant, life threatening) with onset 29Dec2021, outcome "recovering", described as "Liver enlargement"; FATIGUE (hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Fatigue/unusual tiredness"; PALPITATIONS (hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Racing heart (tachycardia)"; MYOCARDITIS (hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Myocarditis"; PERICARDITIS (hospitalization, disability, medically significant, life threatening), outcome "unknown", described as "Pericarditis". The patient was hospitalized for syncope, vomiting, incontinence, depressed level of consciousness, chest pain, gait inability, headache, vaginal haemorrhage, hypotension, kidney enlargement, lymphoedema, limb immobilisation, hepatomegaly, fatigue, palpitations, tachycardia, myocarditis, pericarditis (start date: 27Dec2021, discharge date: 01Jan2022, hospitalization duration: 6 day(s)).The patient underwent the following laboratory tests and procedures: blood pressure measurement: (27Dec2021) low; blood test: (unspecified date) unknown results; computerised tomogram: (unspecified date) unknown results; electrocardiogram: (unspecified date) unknown results; sars-cov-2 test: (26Dec2021) no - negative COVID-19 test; troponin: (unspecified date) normal; ultrasound lymph nodes: (unspecified date) unknown results. Imaging such as (CT, ECG, ultrasound) and blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken were taken and troponin levels were normal. Therapeutic measures were taken as a result of syncope, vomiting, incontinence, depressed level of consciousness, chest pain, gait inability, headache, vaginal haemorrhage, hypotension, kidney enlargement, lymphoedema, limb immobilisation, hepatomegaly, fatigue, palpitations, tachycardia, myocarditis, pericarditis. The diagnosis was made by a medical professional (Registrar). The treatment (Blood thinners) was prescribed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033494 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Interchange of vaccine products, Off label use, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APIXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clot blood; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef..)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003447

Write-up: Swelling under arm out; Armpit pain; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201021405233170-MSZJR Regulatory Authority. A 39 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodeficiency); Clot blood/2 previous clots in spleen" (unspecified if ongoing). Patient had no symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient was not currently breastfeeding. Concomitant medication(s) included: APIXABAN taken for thrombosis. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (medically significant) with onset 28Dec2021, outcome "recovering", described as "Armpit pain"; PERIPHERAL SWELLING (medically significant), outcome "unknown", described as "Swelling under arm out". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The report of the patient was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033528 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Immunisation, Migraine, Myocarditis, Nasal congestion, Nausea, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003491

Write-up: myocarditis; Fever; Nauseous; Booster; Numbness of limbs; Migraine; Sore throat; Nose congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201022042229550-JFMQS Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26425228 Regulatory Authority. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Lot number: FK9706) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started, Unsure when symptoms stopped; "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization; Bnt162b2 (Dose 2, single), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; MYOCARDITIS (medically significant), outcome "not recovered", described as "myocarditis"; HYPOAESTHESIA (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Numbness of limbs"; PYREXIA (medically significant) with onset 27Dec2021, outcome "recovered" (30Dec2021), described as "Fever"; MIGRAINE (medically significant) with onset 27Dec2021, outcome "recovered" (31Dec2021), described as "Migraine"; OROPHARYNGEAL PAIN (medically significant) with onset 27Dec2021, outcome "recovered" (31Dec2021), described as "Sore throat"; NASAL CONGESTION (medically significant) with onset 27Dec2021, outcome "recovered" (31Dec2021), described as "Nose congestion"; NAUSEA (medically significant) with onset 27Dec2021, outcome "recovered" (31Dec2021), described as "Nauseous". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. The patient was not enrolled in clinical trial. Clinical information: It was reported that the patient''s report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033533 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blister, Disturbance in attention, Fatigue, Headache, Herpes zoster, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Severe cutaneous adverse reactions (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Medication errors (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENTOLINE [SALBUTAMOL SULFATE]; METOCLOPRAMIDE; NEXIUM CONTROL; MONTELUKAST; SYMBICORT; ALMOTRIPTAN; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction (use of steroids to calm immune response from allergic reaction.); Asthma chronic (Asthma medication); Esophageal acid reflux; Migraine headache; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Comments: Asthma medication and use of steroids to calm immune response from allergic reaction. 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: GBPFIZER INC202200003469

Write-up: Shingles; Extreme tiredness; Skin blisters on my arms/wrist; Lack of concentration; Pain around back and sides of waist; Off label use; Interchange of vaccine products; Booster; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201022101183200-RLTWA. Other Case identifier(s): GB-MHRA-ADR 26425255. A 42 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergic reaction" (unspecified if ongoing), notes: use of steroids to calm immune response from allergic reaction.; "Asthma/ Asthma chronic" (unspecified if ongoing), notes: Asthma medication; "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "Migraine headache" (unspecified if ongoing); "Esophageal acid reflux/ Acid reflux (esophageal)" (unspecified if ongoing). Date of last menstrual period: 26Dec2021. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test nor tested positive for COVID-19 since having the vaccine was not enrolled in clinical trial. Patient was not currently breastfeeding. Concomitant medication(s) included: VENTOLINE [SALBUTAMOL SULFATE] taken for asthma, start date: 01Apr1993; METOCLOPRAMIDE, start date: 02Mar2002; NEXIUM CONTROL taken for gastrooesophageal reflux disease, start date: 06Jan2010; MONTELUKAST taken for asthma, start date: 10Dec2016; SYMBICORT taken for asthma, start date: 22Sep2016; ALMOTRIPTAN taken for migraine, start date: 10Jun2018; PANTOPRAZOLE taken for gastrooesophageal reflux disease, start date: 01Aug2021. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), administration date: 06May2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 2), administration date: 30Jun2021, for COVID-19 Immunisation; Influenza vaccine (split virion, inactivated), administration date: 27Sep2021, for immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Headache"; HERPES ZOSTER (medically significant), outcome "not recovered", described as "Shingles"; FATIGUE (medically significant), outcome "not recovered", described as "Extreme tiredness "; BLISTER (medically significant), outcome "not recovered", described as "Skin blisters on my arms/wrist"; DISTURBANCE IN ATTENTION (medically significant), outcome "unknown", described as "Lack of concentration"; BACK PAIN (medically significant), outcome "unknown", described as "Pain around back and sides of waist". The reporter did not consider the event related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033622 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Anosmia, Confusional state, Cough, Dyspnoea, Fatigue, Headache, Hyperhidrosis, Insomnia, Myalgia, Palpitations, Parosmia, Pyrexia, SARS-CoV-2 test, Salivary hypersecretion, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: laboured breathing; loss of smell; sweating; breathlessness; Fatigue/unusual tiredness; Fever; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Perversion olfactory; Taste loss; Coughing; Confusion; Labored breathing; Headache; Salivation; Fever; Insomnia; Palpitations; Muscle ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26429461) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (laboured breathing), ANOSMIA (loss of smell), HYPERHIDROSIS (sweating), DYSPNOEA (breathlessness), PAROSMIA (Perversion olfactory), AGEUSIA (Taste loss), COUGH (Coughing), HEADACHE (Headache), CONFUSIONAL STATE (Confusion), DYSPNOEA (Labored breathing), FATIGUE (Fatigue/unusual tiredness), the second episode of PYREXIA (Fever), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)), SALIVARY HYPERSECRETION (Salivation), the first episode of PYREXIA (Fever), INSOMNIA (Insomnia), PALPITATIONS (Palpitations) and MYALGIA (Muscle ache) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 20-Feb-2020 to 27-Feb-2020. On 27-Dec-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criteria disability and medically significant), DYSPNOEA (Labored breathing) (seriousness criteria disability and medically significant), SALIVARY HYPERSECRETION (Salivation) (seriousness criteria disability and medically significant), the first episode of PYREXIA (Fever) (seriousness criteria disability and medically significant), INSOMNIA (Insomnia) (seriousness criteria disability and medically significant), PALPITATIONS (Palpitations) (seriousness criteria disability and medically significant) and MYALGIA (Muscle ache) (seriousness criteria disability and medically significant). On 28-Dec-2021, the patient experienced COUGH (Coughing) (seriousness criteria disability and medically significant) and CONFUSIONAL STATE (Confusion) (seriousness criteria disability and medically significant). On 01-Jan-2022, the patient experienced PAROSMIA (Perversion olfactory) (seriousness criteria disability and medically significant) and AGEUSIA (Taste loss) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced DYSPNOEA (laboured breathing) (seriousness criteria disability and medically significant), ANOSMIA (loss of smell) (seriousness criteria disability and medically significant), HYPERHIDROSIS (sweating) (seriousness criteria disability and medically significant), DYSPNOEA (breathlessness) (seriousness criteria disability and medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criteria disability and medically significant), the second episode of PYREXIA (Fever) (seriousness criteria disability and medically significant), DYSPNOEA (Shortness of breath) (seriousness criteria disability and medically significant), PALPITATIONS (Heart palpitations) (seriousness criteria disability and medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criteria disability and medically significant). On 30-Dec-2021, MYALGIA (Muscle ache) had resolved. At the time of the report, DYSPNOEA (laboured breathing), ANOSMIA (loss of smell), HYPERHIDROSIS (sweating), DYSPNOEA (breathlessness), PAROSMIA (Perversion olfactory), AGEUSIA (Taste loss), COUGH (Coughing), HEADACHE (Headache), CONFUSIONAL STATE (Confusion) and DYSPNOEA (Labored breathing) had not resolved, FATIGUE (Fatigue/unusual tiredness), the last episode of PYREXIA (Fever), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown, SALIVARY HYPERSECRETION (Salivation) and INSOMNIA (Insomnia) was resolving and PALPITATIONS (Palpitations) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient last menstrual period date: 20-DEC-2021 No concomitant medication was reported No treatment information was provided Relevant investigations or tests conducted: "two negative at home test kits" The patient reported the report was related to possible inflammation of the heart. Company comment: This regulatory authority case concerns a 32-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (disability and medically significant) events of Ageusia (AESI), Anosmia (AESI), Parosmia, Dyspnoea, Cough, Hyperhidrosis, Confusion, Palpitations, Tachycardia, Headache, Myalgia, Pyrexia and Fatigue and other serious events after mRNA- 1273 vaccine. The onset of the events occurred within a few hours after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding these events. The patient thought the report was related to possible inflammation of the heart. However, medical assessment and diagnostic work-up was not disclosed. Headache, Myalgia, Pyrexia and Fatigue are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Reporter?s comment: Considerable muscle pain following injection, followed by insomnia due to markedly increased saliva which she kept to spit out of her mouth because it was almost drowning her whilst patient tried to sleep. Other, to be expected symptoms, such as headache. Fever was 37.8 degrees with profuse sweating. Some lingering confusion. Loss of smell and taste as per actual covid. Concerning heart palpitations, breathlessness, labored breathing, difficulty speaking. All in all, a distinctly unpleasant experience when she had not been sick with so much as a cold for 2 years and did not want the vaccine. Patient had the vaccine because she has to travel this year, and ''coincidentally'', if one believes in such a notion, experienced this wide range of extremely uncomfortable symptoms which onset in a few hours following the vaccine. It is disgusting. I am waiting for GP to open again following bank holiday so she can discuss these symptoms further. Patient was not pregnant and was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Re-challenge was reported as unknown.; Sender''s Comments: This regulatory authority case concerns a 32-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (disability and medically significant) events of Ageusia (AESI), Anosmia (AESI), Parosmia, Dyspnoea, Cough, Hyperhidrosis, Confusion, Palpitations, Tachycardia, Headache, Myalgia, Pyrexia and Fatigue and other serious events after mRNA- 1273 vaccine. The onset of the events occurred within a few hours after the first dose of mRNA- 1273 vaccine. Very limited information is available regarding these events. The patient thought the report was related to possible inflammation of the heart. However, medical assessment and diagnostic work-up was not disclosed. Headache, Myalgia, Pyrexia and Fatigue are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2033653 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

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

Write-up: Shortness of breath; Dizzy spells; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26430472) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and DIZZINESS (Dizzy spells) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant) and DIZZINESS (Dizzy spells) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Shortness of breath) and DIZZINESS (Dizzy spells) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Company comment: This regulatory authority case concerns a 31-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Dyspnoea and Dizziness after mRNA- 1273 vaccine. The onset of the events occurred on the day after the third dose of mRNA- 1273 vaccine (reported as 3b dose). Very limited information is available regarding clinical course and diagnostic work-up. Dizziness - according to the database - is consistent with the known safety profile of the vaccine, but since it was reported with a seriousness criterion it is considered unexpected. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test.; Sender''s Comments: This regulatory authority case concerns a 31-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Dyspnoea and Dizziness after mRNA- 1273 vaccine. The onset of the events occurred on the day after the third dose of mRNA- 1273 vaccine (reported as 3b dose). Very limited information is available regarding clinical course and diagnostic work-up. Dizziness - according to the database - is consistent with the known safety profile of the vaccine, but since it was reported with a seriousness criteria it is considered unexpected. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2033886 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-12-27
   Days after vaccination:264
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202200021638

Write-up: vaccination failure; COVID-19 PCR test positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the RA. -WEB. Regulatory number: IT-MINISAL02-826275. A 91 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 07Apr2021 (Lot number: ET7205) as dose 2, 0.3 ml single and intramuscular, administration date 15Mar2021 (Lot number: ET1831) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 27Dec2021, outcome "recovering", described as "vaccination failure"; SARS-COV-2 TEST POSITIVE (medically significant) with onset 27Dec2021, outcome "recovering", described as "COVID-19 PCR test positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) positive. Follow-up (12Jan2022): Follow-up attempts are completed. No further information is expected.


VAERS ID: 2033959 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-14
Onset:2021-12-27
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Head injury, Headache, Road traffic accident, Soft tissue injury
SMQs:, Accidents and injuries (narrow), 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: PHPFIZER INC202200020312

Write-up: Soft tissue injury sec to VA r/o Head Injury; Soft tissue injury sec to VA r/o Head Injury; Soft tissue injury sec to VA r/o Head Injury; Headache; Joint pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300129404. A 28 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 14Dec2021 (Lot number: unknown) at the age of 28 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SOFT TISSUE INJURY (medically significant), ROAD TRAFFIC ACCIDENT (medically significant), HEAD INJURY (medically significant), outcome "unknown" and all described as "Soft tissue injury sec to r/o Head Injury"; HEADACHE (non-serious) with onset 27Dec2021 11:35, outcome "recovered" (27Dec2021 11:40), described as "Headache"; ARTHRALGIA (non-serious) with onset 27Dec2021 11:35, outcome "recovered" (27Dec2021 11:40), described as "Joint pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2036779 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hyperaesthesia, Pain
SMQs:

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

Write-up: Whole body skin sensitivity; Severe headache; Whole body aches; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache), PAIN (Whole body aches) and HYPERAESTHESIA (Whole body skin sensitivity) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for COVID-19 immunisation. Concomitant products included CODEINE PHOSPHATE, PARACETAMOL (CO-CODAMOL) and PREGABALIN (PREGABALIN MYLAN) for an unknown indication. On 27-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 27-Dec-2021, the patient experienced HEADACHE (Severe headache) (seriousness criterion medically significant) and PAIN (Whole body aches) (seriousness criterion medically significant). On 28-Dec-2021, the patient experienced HYPERAESTHESIA (Whole body skin sensitivity) (seriousness criterion medically significant). On 29-Dec-2021, HYPERAESTHESIA (Whole body skin sensitivity) had resolved. On 30-Dec-2021, HEADACHE (Severe headache) was resolving. On 31-Dec-2021, PAIN (Whole body aches) was resolving. No concomitant medication information was provided. No treatment medication was provided. Company comment: This is a regulatory case concerning a 25 year-old, female patient with concomitant use of pregabalin, who experienced the serious (due to medically important condition) unexpected, according to Agency, events of headache, pain and Hyperaesthesia. Events were assessed as serious by the Regulatory Authority. The events occurred the same day to 1 day after the mRNA-1273 vaccine, dose number not provided. The outcome of the event Hyperaesthesia was reported as recovered and the events headache and pain as recovering. The rechallenge was not applicable since dose number was not provided. The concomitant use of pregabalin remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 25 year-old, female patient with concomitant use of pregabalin, who experienced the serious (due to medically important condition) unexpected, according to Agency, events of headache, pain and Hyperaesthesia. Events were assessed as serious by the Regulatory Authority. The events occurred the same day to 1 day after the mRNA-1273 vaccine, dose number not provided. The outcome of the event Hyperaesthesia was reported as recovered and the events headache and pain as recovering. The rechallenge was not applicable since dose number was not provided. The concomitant use of pregabalin remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2036924 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Cough, Immunisation, Increased viscosity of upper respiratory secretion, Influenza like illness, Malaise, Pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: 20211231; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003793

Write-up: cough/persistent cough; nasal discharge; chest pain; feeling sick; thick nasal mucus; ache; booster; fever; flu like symptoms; This is a spontaneous report received from a contactable reporter consumer or other non HCP from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201022238085950-7X4EH. Other Case identifier(s): GB-MHRA-ADR 26425315. A 27 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (batch/lot number: FN5254) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19, not enrolled in clinical trial. Vaccination history included: bnt162b2 (dose 1), administration date: 26Jun2021, for COVID-19 immunisation; Comirnaty (dose 2), administration date: 21Aug2021, for COVID-19 immunisation, reactions: "inappropriate schedule of product administration". The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "booster"; COUGH (medically significant), outcome "not recovered", described as "cough/persistent cough"; RHINORRHOEA (medically significant), outcome "not recovered", described as "nasal discharge"; INFLUENZA LIKE ILLNESS (medically significant), outcome "recovered", described as "flu like symptoms"; PAIN (medically significant) with onset 28Dec2021, outcome "recovered" (30Dec2021), described as "ache"; CHEST PAIN (medically significant) with onset 29Dec2021, outcome "recovered" (01Jan2022), described as "chest pain"; PYREXIA (medically significant) with onset 27Dec2021, outcome "recovered" (31Dec2021), described as "fever"; MALAISE (medically significant) with onset 28Dec2021, outcome "recovered" (31Dec2021), described as "feeling sick"; INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (medically significant) with onset 28Dec2021, outcome "recovering", described as "thick nasal mucus". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (31Dec2021) no - negative covid-19 test. The patient has not tested positive for COVID-19 since having the vaccine. Additional information: the flu like symptoms lasted for about 5 days but cough has persisted for a good 7 days and this appears to be the only main symptom the patient left along with some nasal discharge. The patient did not relate the report to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200024599 same patient, different dose/events


VAERS ID: 2036926 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3545 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood cholesterol, Blood test, Contusion, Decreased appetite, Emotional distress, Eye pain, Fatigue, Headache, Nerve compression, Pain, Pyrexia, Tremor
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Glaucoma (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholesterol; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: cholesterol; Result Unstructured Data: Test Result:light increased; Comments: year ago; Test Name: blood tests; Result Unstructured Data: Test Result:unknown result
CDC Split Type: GBPFIZER INC202200003723

Write-up: fever; tiredness; pain behind the eyes; shakes; Trapped nerve; Headache; High temperature; Fatigue; Decreased appetite; Ache/skin felt very sore to touch all over; Bruising; Mental distress; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201022249471010-KSCQ1. Other Case identifier(s): GB-MHRA-ADR 26425329. A 28-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Lot number: Fn3545) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood cholesterol" (unspecified if ongoing); "Suspected COVID-19", start date: 27Dec2021, stop date: 30Dec2021. The patient''s concomitant medications were not reported. The following information was reported: PYREXIA (medically significant), outcome "unknown", described as "fever"; FATIGUE (medically significant), outcome "unknown", described as "tiredness"; HEADACHE (medically significant) with onset 27Dec2021, outcome "recovering", described as "Headache"; PYREXIA (medically significant) with onset 27Dec2021, outcome "recovered" (29Dec2021), described as "High temperature"; FATIGUE (medically significant) with onset 27Dec2021, outcome "recovering", described as "Fatigue"; DECREASED APPETITE (medically significant) with onset 27Dec2021, outcome "recovered" (30Dec2021), described as "Decreased appetite"; PAIN (medically significant) with onset 27Dec2021, outcome "recovered" (31Dec2021), described as "Ache/skin felt very sore to touch all over"; CONTUSION (medically significant) with onset 27Dec2021, outcome "not recovered", described as "Bruising"; EMOTIONAL DISTRESS (medically significant) with onset 27Dec2021, outcome "recovered with sequelae", described as "Mental distress"; NERVE COMPRESSION (medically significant) with onset 29Dec2021, outcome "recovering", described as "Trapped nerve"; EYE PAIN (medically significant), outcome "unknown", described as "pain behind the eyes"; TREMOR (medically significant), outcome "unknown", described as "shakes". The patient underwent the following laboratory tests and procedures: blood cholesterol: light increased, notes: year ago; blood test: unknown result. Therapeutic measures were taken as a result of pain, eye pain. Clinical course: the patient had fever like symptoms for 2/3 days, skin felt very sore to touch all over, shakes, pain behind the eyes, tiredness and only took paracetamol for the pain. Stop date of 30Dec2021 was also reported for headache and fatigue. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This report does not relate to possible blood clots or low platelet counts, possible myocarditis or pericarditis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2037025 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature increased, Chest discomfort, Chills, Fatigue, Headache, Mental fatigue, Night sweats, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: occasional head aches; Chest tightness; Chills; Fatigue; Mental fatigue; Frequent headaches; Night sweats; Temperature elevation; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26430081) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (occasional head aches), NIGHT SWEATS (Night sweats), BODY TEMPERATURE INCREASED (Temperature elevation), CHILLS (Chills), FATIGUE (Fatigue), MENTAL FATIGUE (Mental fatigue), HEADACHE (Frequent headaches) and CHEST DISCOMFORT (Chest tightness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE ASTRAZENECA. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE ASTRAZENECA. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced NIGHT SWEATS (Night sweats) (seriousness criterion medically significant) and BODY TEMPERATURE INCREASED (Temperature elevation) (seriousness criterion medically significant). On 28-Dec-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), MENTAL FATIGUE (Mental fatigue) (seriousness criterion medically significant) and HEADACHE (Frequent headaches) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced CHEST DISCOMFORT (Chest tightness) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (occasional head aches) (seriousness criterion medically significant). On 28-Dec-2021, NIGHT SWEATS (Night sweats) had resolved. On 30-Dec-2021, HEADACHE (Frequent headaches) had resolved. On 31-Dec-2021, BODY TEMPERATURE INCREASED (Temperature elevation) and CHILLS (Chills) had resolved. At the time of the report, HEADACHE (occasional head aches) outcome was unknown, FATIGUE (Fatigue) and MENTAL FATIGUE (Mental fatigue) was resolving and CHEST DISCOMFORT (Chest tightness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported by patient. patient reported paracetamol as treatment medication. Patient got night sweat on first night after booster vaccine, patient also reported difficulty regulating temperature - hot, cold continued, and physical fatigue, brain fog, occasional head aches. Patient also reacted to 2nd astrazeneca vaccine but that was only for 3 days and this continued a week on. This is a regulatory case concerning a patient of unknown age and gender with no medical history reported, who experienced the events of headache, night sweats, body temperature increased, chills, fatigue, mental fatigue and chest discomfort. A concomitant product in this case is the Covid-19 AstarZeneca vaccine. The events night sweats and body temperature increased occurred on the same day after the third dose of mRNA ? 1273 vaccine, while the other events was experienced within the next couple of days. Events were reported as medically significant and at the time of report the outcome of headache was still unknown while fatigue and mental fatigue was resolving. Only chest discomfort had not resolved, the rest of the events have resolved at the time of report. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a patient of unknown age and gender with no medical history reported, who experienced the events of headache, night sweats, body temperature increased, chills, fatigue, mental fatigue and chest discomfort. A concomitant product in this case is the Covid-19 AstarZeneca vaccine. The events night sweats and body temperature increased occurred on the same day after the third dose of mRNA ? 1273 vaccine, while the other events was experienced within the next couple of days. Events were reported as medically significant and at the time of report the outcome of headache was still unknown while fatigue and mental fatigue was resolving. Only chest discomfort had not resolved, the rest of the events have resolved at the time of report. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 2037104 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000021A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), 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: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Chest pain; Shortness of breath; Heart palpitations; Fatigue/unusual tiredness; Fever; Racing heart (tachycardia); Chest pain; Short of breath; This case was received (Reference number: GB-MHRA-ADR 26433736) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of TACHYCARDIA (Racing heart (tachycardia)), the first episode of CHEST PAIN (Chest pain), DYSPNOEA (Short of breath), the second episode of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), FATIGUE (Fatigue/unusual tiredness) and PYREXIA (Fever) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000021A) for an unknown indication. The patient''s past medical history included Clinical trial participant. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant) and DYSPNOEA (Short of breath) (seriousness criterion medically significant). On an unknown date, the patient experienced TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant), the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, TACHYCARDIA (Racing heart (tachycardia)), the last episode of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), FATIGUE (Fatigue/unusual tiredness) and PYREXIA (Fever) outcome was unknown and DYSPNOEA (Short of breath) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. The patient started to get these side effects about hour after got the booster. The chest pains was so bad and could not breath. never had any medical problems in the past . Patient had not tested positive for COVID-19 since having the vaccine.It was reported that patient''s report was related to possible inflammation of the heart (myocarditis or pericarditis) Company Comment: This case concerns a 22 year-old female patient with a history of clinical trial participation who experienced the unexpected events of chest pain, and dyspnea which occurred the same day after vaccination with mRNA-1273 administered as a booster third dose, and the unexpected serious events of tachycardia, palpitations fatigue and pyrexia which occurred on an unknown date relative to vaccination. The medical history of clinical trial participation remains a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 22 year-old female patient with a history of clinical trial participation who experienced the unexpected events of chest pain, and dyspnea which occurred the same day after vaccination with mRNA-1273 administered as a booster third dose, and the unexpected serious events of tachycardia, palpitations fatigue and pyrexia which occurred on an unknown date relative to vaccination. The medical history of clinical trial participation remains a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2037168 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Coagulopathy, Loss of consciousness, Lymphadenopathy, Peripheral swelling, SARS-CoV-2 test, Swelling, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage laboratory terms (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), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Neck swelling; Clotting disorder; Fainting; Unconsciousness; Swollen arm; Swollen lymph nodes; Chest pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26436207) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), LOSS OF CONSCIOUSNESS (Unconsciousness), CHEST PAIN (Chest pain), PERIPHERAL SWELLING (Swollen arm), LYMPHADENOPATHY (Swollen lymph nodes), SWELLING (Neck swelling) and COAGULOPATHY (Clotting disorder) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening). On 28-Dec-2021, the patient experienced SYNCOPE (Fainting) (seriousness criteria hospitalization, medically significant and life threatening), LOSS OF CONSCIOUSNESS (Unconsciousness) (seriousness criteria hospitalization, medically significant and life threatening), PERIPHERAL SWELLING (Swollen arm) (seriousness criteria hospitalization and life threatening), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criteria hospitalization and life threatening) and COAGULOPATHY (Clotting disorder) (seriousness criteria hospitalization and life threatening). On 29-Dec-2021, the patient experienced SWELLING (Neck swelling) (seriousness criteria hospitalization and life threatening). At the time of the report, SYNCOPE (Fainting), CHEST PAIN (Chest pain), PERIPHERAL SWELLING (Swollen arm), LYMPHADENOPATHY (Swollen lymph nodes) and SWELLING (Neck swelling) was resolving, LOSS OF CONSCIOUSNESS (Unconsciousness) had resolved with sequelae and COAGULOPATHY (Clotting disorder) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical problem before the covid jabs 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 Lab test included, Heart testing, blood clotting testing, ct scans, xray, blood testing, urine testing, results were not provided. No concomitant product was provided. No treatment information was provided. Company Comment: This case concerns a 28 year-old female patient with no reported medical history who experienced the unexpected serious events of syncope, loss of consciousness, chest pain, swelling, peripheral swelling, lymphadenopathy, and coagulopathy which occurred 1 to 3 days after vaccination with mRNA-1273 administered as a booster third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 28 year-old female patient with no reported medical history who experienced the unexpected serious events of syncope, loss of consciousness, chest pain, swelling, peripheral swelling, lymphadenopathy, and coagulopathy which occurred 1 to 3 days after vaccination with mRNA-1273 administered as a booster third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2037236 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-14
Onset:2021-12-27
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FM3802 / 3 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: GBPFIZER INC202200032995

Write-up: drug ineffective; COVID Positive PCR; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient. A 46 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 14Dec2021 10:00 (Lot number: FM3802) as dose 3 (booster), single, administered in arm left, administration date 04Jun2021 10:00 (Lot number: EY5420) as dose 2, single and administered in arm left, administration date 13May2021 10:00 (Lot number: ET1831) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 27Dec2021 19:00, outcome "recovered", described as "drug ineffective"; SARS-COV-2 TEST POSITIVE (medically significant) with onset 27Dec2021 19:00, outcome "recovered", described as "COVID Positive PCR". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (27Dec2021) positive, notes: Nasal Swab.


VAERS ID: 2037353 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 216036 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperpyrexia, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: hyperpyrexia; Result Unstructured Data: Fever: 40.5 to 42 degrees Celcius
CDC Split Type: NLMODERNATX, INC.MOD20224

Write-up: Muscle pain; Response to or around the injection site: redness; Response to or around the injection site: swelling, occurring within a week of vaccination; Inflammatory reaction at the reaction site: redness, heat, pain, swelling, arising within a week of vaccination; Response to or around the injection site: heat; Response to or around the injection site: pain; Don''t feel good; Fever: 40.5 to 42 degrees Celcius; This case was received via Regulatory Authority (Reference number: NL-LRB-00740454) on 12-Jan-2022 and was forwarded to Moderna on 12-Jan-2022. This regulatory authority case was reported by a non-health professional and describes the occurrence of HYPERPYREXIA (Fever: 40.5 to 42 degrees Celcius) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 216036) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Disease risk factor. Previously administered products included for Product used for unknown indication: BioNTech/Pfizer vaccin (Comirnaty) COVID-19 VACCIN PFIZER INJVLST 0,3ML on 22-Jan-2021, COMIRNATY (COVID-19 VACCIN PFIZER INJVLST 0 and3ML) on 12-Feb-2021. Past adverse reactions to the above products included No adverse event with BioNTech/Pfizer vaccin (Comirnaty) COVID-19 VACCIN PFIZER INJVLST 0,3ML and COMIRNATY. Concomitant products included LEVOTHYROXINE for an unknown indication. On 27-Dec-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced HYPERPYREXIA (Fever: 40.5 to 42 degrees Celcius) (seriousness criterion medically significant). On 28-Dec-2021, the patient experienced MALAISE (Don''t feel good). On 29-Dec-2021, the patient experienced INJECTION SITE WARMTH (Response to or around the injection site: heat), INJECTION SITE PAIN (Response to or around the injection site: pain), INJECTION SITE ERYTHEMA (Response to or around the injection site: redness), INJECTION SITE SWELLING (Response to or around the injection site: swelling, occurring within a week of vaccination) and INJECTION SITE INFLAMMATION (Inflammatory reaction at the reaction site: redness, heat, pain, swelling, arising within a week of vaccination). On an unknown date, the patient experienced MYALGIA (Muscle pain). At the time of the report, HYPERPYREXIA (Fever: 40.5 to 42 degrees Celcius), INJECTION SITE WARMTH (Response to or around the injection site: heat), INJECTION SITE PAIN (Response to or around the injection site: pain), INJECTION SITE ERYTHEMA (Response to or around the injection site: redness), INJECTION SITE SWELLING (Response to or around the injection site: swelling, occurring within a week of vaccination) and INJECTION SITE INFLAMMATION (Inflammatory reaction at the reaction site: redness, heat, pain, swelling, arising within a week of vaccination) had not resolved, MALAISE (Don''t feel good) was resolving and MYALGIA (Muscle pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, Hyperpyrexia: 40.5 to 42 (High) Fever: 40.5 to 42 degrees Celcius. Sender''s Diagnosis included Injection site inflammation No treatment medication information was reported; Sender''s Comments: This case concerns a patient, with medical history of (Disease risk factor), who experienced the serious unexpected event(s) of Hyperpyrexia and additional non-serious events. The event(s) started occurring approximately within 1 day(s) after the 1st dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered unknown. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2038762 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; Chest pain; This case was received(Reference number: GB-MHRA-ADR 26440014) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue/unusual tiredness), the second episode of CHEST PAIN (Chest pain), PYREXIA (Fever), DYSPNOEA (Shortness of breath) and the first episode of CHEST PAIN (Chest pain) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Co-suspect product included non-company product IBUPROFEN for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 01-Jun-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started IBUPROFEN (unknown route) at an unspecified dose. On 27-Dec-2021, the patient experienced the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue/unusual tiredness), the last episode of CHEST PAIN (Chest pain), PYREXIA (Fever) and DYSPNOEA (Shortness of breath) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Medical History information was reported. Patient had not symptoms associated with COVID-19, not had a COVID-19 test. Patient had Sharp chest pain on the day of vaccination lasting for around 30 seconds to one minute, then two days fever, and mild occasional chest pain on the left side for the last six days accompanied by mild difficulty in breathing. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. GP examination, A and E visit, cardiogram, X-ray was conducted. The report was related to possible myocarditis or pericarditis. Patient took Ibuprofen for 2-3 days. Cardiac monitoring, chest X-ray were done with no result reported. Patient had not done blood tests and such as for certain proteins (called troponin) that signal heart muscle damage taken. There was no ongoing illness. The treatment medication was not reported. Company Comment: This RA case concerns a male patient with unknown age, with no medical history reported., vaccinated with Tozinameran ( Pfizer Covid 19 vaccine ) as primary series 2 doses, who experienced Serious ( Medically significant ) unexpected event of Chest pain which occurred on the same day post vaccination with the 3rd dose of mRNA-12763 vaccine ( Moderna Covid 19 vaccine ) . On an unknown date after vaccination with the 3rd dose , he experienced other Serious ( medically significant ) , unexpected events of fatigue, chest pain , fever and dyspnea . This case was worked up for possible heart inflammation where the patient underwent Chest x- ray and cardiac monitoring however results were not reported also no blood tests were performed , patient was not also hospitalized. This patient was also prescribed with Ibuprofen to be taken for 2-3 days. The re-challenge was captured as unknown by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender''s Comments: This RA case concerns a male patient with unknown age, with no medical history reported., vaccinated with Tozinameran ( Pfizer Covid 19 vaccine ) as primary series 2 doses, who experienced Serious ( Medically significant ) unexpected event of Chest pain which occurred on the same day post vaccination with the 3rd dose of mRNA-12763 vaccine ( Moderna Covid 19 vaccine ) . On an unknown date after vaccination with the 3rd dose , he experienced other Serious ( medically significant ) , unexpected events of fatigue, chest pain , fever and dyspnea . This case was worked up for possible heart inflammation where the patient underwent Chest x- ray and cardiac monitoring however results were not reported also no blood tests were performed , patient was not also hospitalized. This patient was also prescribed with Ibuprofen to be taken for 2-3 days. The re-challenge was captured as unknown by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 2038770 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-12-27
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthmatic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Swollen lymph nodes; Muscle pain; Chronic pain; Injection site pain; Fatigue; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26440820) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain), FATIGUE (Fatigue), MYALGIA (Muscle pain), PAIN (Chronic pain) and LYMPHADENOPATHY (Swollen lymph nodes) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for an unknown indication. Concurrent medical conditions included Asthmatic. On 23-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Dec-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 28-Dec-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant) and PAIN (Chronic pain) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). On 29-Dec-2021, INJECTION SITE PAIN (Injection site pain) had resolved. At the time of the report, FATIGUE (Fatigue), MYALGIA (Muscle pain) and LYMPHADENOPATHY (Swollen lymph nodes) was resolving and PAIN (Chronic pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported No treatment medication were reported Patient had The injection site pain started within a couple of hours of the vaccine, then patient was felt extremely fatigued, had to leave work and went to bed and slept for 4 hours straight. That night patient was kept up with pains all over the body, everything hurt and patient was struggled to sleep. The pains had mostly subsided after 24-36 hrs but patient was still feeling unusually tired, and if patient was do too much activity patient had feel pain in limbs again. This is a regulatory case concerning a 39-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of injection site pain, fatigue, myalgia, pain and lymphadenopathy. The events occurred within first 3 days after the third dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The events were assessed as serious by the Regulatory Authority. The rechallenge was reported as unknown; however, could be considered as not applicable since the events occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 39-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of injection site pain, fatigue, myalgia, pain and lymphadenopathy. The events occurred within first 3 days after the third dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The events were assessed as serious by the Regulatory Authority. The rechallenge was reported as unknown; however, could be considered as not applicable since the events occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2040494 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5109 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Dysphagia, Goitre, Headache, Immunisation, Postmenopausal haemorrhage, Pyrexia, Rash, SARS-CoV-2 test, Thyroid pain
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypothyroidism (broad), Hyperthyroidism (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy; Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Name: fever; Result Unstructured Data: Test Result:39.2 Centigrade; Comments: 39.2?C fever; Test Date: 20220103; Test Name: Rapid test; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: CAPFIZER INC202200018360

Write-up: 6 days later spotting (3 years post menopausal); 39.2?C fever; chills; rash; very bad headache; 7 days later severe pain/swelling of Thyroid & difficulty swallowing; 7 days later severe pain/swelling of Thyroid & difficulty swallowing; 7 days later severe pain/swelling of Thyroid & difficulty swallowing; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An adult female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 27Dec2021 15:30 (Lot number: FF5109) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "several foods and other products" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Codeine, reaction(s): "Allergy", notes: Codeine, and several foods and other products. Vaccination history included: Pfizer-biontech (Dose Number: 2, Batch/Lot No: FD7204, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 28Jul2021, for COVID-19 IMMUNISATION, reaction(s): "Inappropriate schedule of vaccine administered"; Pfizer-biontech (Dose Number: 1, Batch/Lot No: EW0199, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 13May2021, for COVID-19 IMMUNISATION. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021 15:30, outcome "unknown", described as "booster"; POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 02Jan2022 10:00, outcome "recovering", described as "6 days later spotting (3 years post menopausal)"; PYREXIA (non-serious) with onset 02Jan2022 10:00, outcome "recovering", described as "39.2?C fever"; CHILLS (non-serious) with onset 02Jan2022 10:00, outcome "recovering", described as "chills"; RASH (non-serious) with onset 02Jan2022 10:00, outcome "recovering", described as "rash"; HEADACHE (non-serious) with onset 02Jan2022 10:00, outcome "recovering", described as "very bad headache"; DYSPHAGIA (non-serious), THYROID PAIN (non-serious), GOITRE (non-serious) all with onset 02Jan2022 10:00, outcome "recovering" and all described as "7 days later severe pain/swelling of Thyroid & difficulty swallowing". The events "6 days later spotting (3 years post menopausal)", "39.2?c fever", "chills", "rash", "very bad headache" and "7 days later severe pain/swelling of thyroid & difficulty swallowing" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) 39.2 Centigrade, notes: 39.2?C fever; sars-cov-2 test: (03Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of postmenopausal haemorrhage, pyrexia, chills, rash, headache, dysphagia, thyroid pain, goitre. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.


VAERS ID: 2040731 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCA0002 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test normal, Bradycardia, Burning sensation, Cardiovascular examination, Chills, Coronavirus test, Dizziness, Fatigue, Off label use, Palpitations, Product use issue
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood values ??normal; Result Unstructured Data: Test Result:Normal; Test Name: heart examination normal; Result Unstructured Data: Test Result:Normal; Test Name: several corona tests performed; Result Unstructured Data: Test Result:No result provided
CDC Split Type: DEPFIZER INC202200022934

Write-up: Breastfeeding women developed bradycardia; Breastfeeding women developed fatigue; Breastfeeding women developed chills; burning sensation in the lung; heart palpitation; severe dizziness; breast feeding; breast feeding; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): 112830. A female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Lot number: PCA0002) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE 1, ), administration date: 06Dec2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), PRODUCT USE ISSUE (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "breast feeding"; BRADYCARDIA (medically significant) with onset 30Dec2021, outcome "unknown", described as "Breastfeeding women developed bradycardia"; FATIGUE (non-serious) with onset 30Dec2021, outcome "unknown", described as "Breastfeeding women developed fatigue"; CHILLS (non-serious) with onset 30Dec2021, outcome "unknown", described as "Breastfeeding women developed chills"; BURNING SENSATION (non-serious) with onset 30Dec2021, outcome "unknown", described as "burning sensation in the lung"; PALPITATIONS (non-serious) with onset 30Dec2021, outcome "unknown", described as "heart palpitation"; DIZZINESS (non-serious) with onset 30Dec2021, outcome "unknown", described as "severe dizziness". The patient underwent the following laboratory tests and procedures: blood test normal: normal; cardiovascular examination: normal; coronavirus test: no result provided. bnt162b2 is under agreement with Biontech.; Sender''s Comments: Linked Report(s) : 202200038613 Baby Case


VAERS ID: 2041055 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: Frequent headaches; Nausea; High temperature; Generalised aching; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26431645) on 07-Jan-2022 and was forwarded to Moderna on 07-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Frequent headaches), NAUSEA (Nausea), PYREXIA (High temperature) and PAIN (Generalised aching) in a 56-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Booster. Concomitant products included MONTELUKAST and SERTRALINE for an unknown indication. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 27-Dec-2021, the patient experienced HEADACHE (Frequent headaches) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and PAIN (Generalised aching) (seriousness criterion medically significant). On 01-Jan-2022, HEADACHE (Frequent headaches), NAUSEA (Nausea), PYREXIA (High temperature) and PAIN (Generalised aching) had resolved. No Medical History information was reported. The patient experienced frequent headaches, achy, temperature and nausea. Treatment information was not provided. Company comment: This regulatory case concerns a 56-year-old female patient, with no medical history reported, who experienced the serious unexpected events of HEADACHE, NAUSEA, PYREXIA and PAIN. The events occurred on the same day of the third dose of the mRNA-1273 vaccine. The rechallenge is reported unknown, but it could be considered as not applicable since no information about further dosing has been disclosed. The concomitant MONTELUKAST and SERTRALINE remain as confounders. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.; Sender''s Comments: This regulatory case concerns a 56-year-old female patient, with no medical history reported, who experienced the serious unexpected events of HEADACHE, NAUSEA, PYREXIA and PAIN. The events occurred on the same day of the third dose of the mRNA-1273 vaccine. The rechallenge is reported unknown, but it could be considered as not applicable since no information about further dosing has been disclosed. The concomitant MONTELUKAST and SERTRALINE remain as confounders. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.


VAERS ID: 2041087 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein increased, Condition aggravated, SARS-CoV-2 test, Trismus
SMQs:, Dystonia (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: Complex regional pain syndrome; CRP increased; Ehlers-Danlos syndrome
Allergies:
Diagnostic Lab Data: Test Name: CRP increased; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003666

Write-up: crps; Jaw spasm; the vaccine caused a major flare up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201022012150550-FW4HI (MHRA). Other Case identifier(s): GB-MHRA-ADR 26425207 (MHRA). A 18 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Lot number: FN3543) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "CRP increased" (unspecified if ongoing); "EDS" (unspecified if ongoing); "CRPS" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: C-REACTIVE PROTEIN INCREASED (disability, medically significant), outcome "recovering", described as "crps"; TRISMUS (disability, medically significant) with onset 27Dec2021, outcome "recovered" (27Dec2021), described as "Jaw spasm"; CONDITION AGGRAVATED (disability, medically significant), outcome "unknown", described as "the vaccine caused a major flare up". The patient underwent the following laboratory tests and procedures: c-reactive protein increased: unknown results; sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: The patient was CRPS EDS suspected FND Suspected POTS. She had no symptoms associated with COVID-19. She was neither pregnant nor currently breastfeeding. On 28Dec2021, she had last menstrual period. She had not tested positive for COVID-19 since having the vaccine. She was not enrolled in clinical trial. Her report did not relate to possible inflammation of the heart (myocarditis or pericarditis). She reported that, She already had CRPS in her left knee, foot and ankle, the vaccine caused a major flare up. Also the jaw spasms were powerful enough to sublux my jaw for a few hours. For the question below mild or slightly uncomfortable refers to jaw spasms, the others refer to her CRPS. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2041101 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Dizziness, Electrocardiogram, Immunisation, Interchange of vaccine products, Migraine, Off label use, Palpitations, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Normal; Test Name: ECG; Result Unstructured Data: Test Result:Normal; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009410

Write-up: felt faint; Migraine headache; Palpitations; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the RA. Regulatory number: GB-MHRA-WEBCOVID-202201031035237660-VC8TC. Other Case identifier(s): GB-MHRA-ADR 26426986. A 41 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: May2021, for Covid-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: Aug2021, for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; DIZZINESS (medically significant), outcome "not recovered", described as "felt faint"; MIGRAINE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Migraine headache"; PALPITATIONS (medically significant) with onset 29Dec2021, outcome "recovering", described as "Palpitations". The patient underwent the following laboratory tests and procedures: blood test: normal; electrocardiogram: normal; sars-cov-2 test: no - negative covid-19 test. Clinical course: Patient last menstrual period date was 02Dec2021. Patient has not had symptoms associated with COVID-19 Patient was not pregnant, Patient was not currently breastfeeding. The patient had to visit for ECG and blood tests as the headache was worse when lying down and felt faint just before headache started. This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Patient had not tested positive for COVID-19 since having the vaccine. Patient was 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: 2041171 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Body temperature, Dizziness, Eye pain, Headache, Illness, Immunisation, Nausea, Pain, Pain in extremity, Paraesthesia, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: Body temperature; Result Unstructured Data: Test Result:High; Comments: High temperature; Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009501

Write-up: Leg pain; Sickness; Dizzy spells; High temperature; Pins and needles; Light headedness; Headache; General body pain; Nausea; Eye pain; Armpit pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201032134162640-ULACO. Other Case identifier(s): GB-MHRA-ADR 26430396. A 35 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 27May2021, for COVID-19 immunisation; Bnt162b2 (DOSE 2), administration date: 03Aug2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "General body pain"; NAUSEA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Nausea"; DIZZINESS (medically significant) with onset 30Dec2021, outcome "recovered", described as "Dizzy spells"; DIZZINESS (medically significant) with onset 29Dec2021, outcome "recovered", described as "Light headedness"; HEADACHE (medically significant) with onset 29Dec2021, outcome "recovered", described as "Headache"; PYREXIA (medically significant) with onset 30Dec2021, outcome "recovered", described as "High temperature"; AXILLARY PAIN (medically significant) with onset 28Dec2021, outcome "recovering", described as "Armpit pain"; PARAESTHESIA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Pins and needles"; EYE PAIN (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Eye pain"; PAIN IN EXTREMITY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Leg pain"; ILLNESS (medically significant) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Sickness". The patient underwent the following laboratory tests and procedures: body temperature: (30Dec2021) high, notes: High temperature; sars-cov-2 test: (29Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Patient''s last menstrual period was on 31Dec2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical. This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2041187 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Dyspnoea, Immunisation, Influenza, Nasopharyngitis, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abnormal breathing; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009533

Write-up: Progressively worsened; Breathing is affected; Flu symptoms; Mild cold; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201032354141160-C8S98 (RA). Other Case identifier(s): GB-MHRA-ADR 26430533 (RA). A 61 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 04Dec2021, stop date: 18Dec2021; "underlying breathing problems anyway" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Thyroxine; Atorvastatin; Bisoprolol; Rivaroxabin. Vaccination history included: Bnt162b2 (Dose-1, Manufacturer unknown), for Covid-19 immunisation; Bnt162b2 (Dose-2, Manufacturer unknown), for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; INFLUENZA (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Flu symptoms"; NASOPHARYNGITIS (medically significant) with onset 28Dec2021, outcome "unknown", described as "Mild cold"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "Progressively worsened"; DYSPNOEA (medically significant), outcome "unknown", described as "Breathing is affected". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. ADDITIONAL INFORMATION: I take rivaroxaban, atorvastatin, bisoprolol and thyroxine. Started as a mild cold on the day after the vaccine was given. Progressively worsened and now my breathing is affected. I have underlying breathing problems anyway. I do not know the outcome of this, as I have not yet sought medical attention. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. the report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2041203 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Herpes zoster, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Depression
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200015414

Write-up: Constant headaches; Shingles/ Singles on right eye and head; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201041242511130-DMZUX. Other Case identifier(s): GB-MHRA-ADR 26433266. A 35 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; HERPES ZOSTER (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Shingles/ Singles on right eye and head"; HEADACHE (medically significant), outcome "unknown", described as "Constant headaches". The patient underwent the following laboratory tests and procedures: SARS-COV-2 test: (27Dec2021) no - negative COVID-19 test. Clinical course: Patient had singles on his right eye and head with constant headaches. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2041250 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-18
Onset:2021-12-27
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Prolonged menses; This case was received via RA (Reference number: GB-MHRA-ADR 26440530) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Prolonged menses) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Prolonged menses) (seriousness criterion medically significant). At the time of the report, HEAVY MENSTRUAL BLEEDING (Prolonged menses) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient last menstrual period date reported 27-DEC-2021. There was no concomitant medication reported. There was no treatment medication reported. Company Comment: This regulatory case concerns a 36-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious event of heavy menstrual bleeding. The event occurred 9 days after administration of the third dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. The event had not resolved at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 36-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious event of heavy menstrual bleeding. The event occurred 9 days after administration of the third dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. The event had not resolved at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2041269 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-25
Onset:2021-12-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Multiple sclerosis (Taking medicines for multiple sclerosis. Patient took aubagio for MS.)
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Dizziness on standing up; This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (Dizziness on standing up) in a 60-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Multiple sclerosis (Taking medicines for multiple sclerosis. Patient took aubagio for MS.). Previously administered products included for Multiple sclerosis: AUBAGIO. Past adverse reactions to the above products included No adverse event with AUBAGIO. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 06-Jun-2021 to an unknown date for an unknown indication. On 25-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced DIZZINESS POSTURAL (Dizziness on standing up) (seriousness criterion disability). At the time of the report, DIZZINESS POSTURAL (Dizziness on standing up) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had dizziness, fever, headaches, sneezing, sinus pain, earache, weakness, extreme tiredness. Treatment product was not provided by the reporter. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This is a regulatory authority case concerning a 60-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Dizziness on standing up. The events occurred approximately 2 days after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as not resolved The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 60-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Dizziness on standing up. The events occurred approximately 2 days after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as not resolved The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2041353 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-27
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (broad), 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: COVID-19 VACCINE ASTRAZENECA; DEPO-PROVERA
Current Illness: Ehlers-Danlos syndrome; Postural orthostatic tachycardia syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Tachycardia; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26445770) on 07-Jan-2022 and was forwarded to Moderna on 07-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Postural orthostatic tachycardia syndrome and Ehlers-Danlos syndrome. Concomitant products included MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) for Contraception, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 08-Jun-2021 to an unknown date for an unknown indication. On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced TACHYCARDIA (Tachycardia) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criteria disability and medically significant), CHEST PAIN (Chest pain) (seriousness criteria disability and medically significant), DYSPNOEA (Shortness of breath) (seriousness criteria disability and medically significant), PALPITATIONS (Heart palpitations) (seriousness criteria disability and medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criteria disability and medically significant). At the time of the report, TACHYCARDIA (Tachycardia) had not resolved and FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient suffered with Tachycardia when trying to do anything, Patient had POTS and it was made it totally uncontrollable. Diagnosis not made by HCP. Patient was not hospitalized. Patient was not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Treatment Medication use information was not provided by reporter. Company comment: This is a regulatory authority case concerning a 32-year-old female patient with medical history of postural orthostatic tachycardia syndrome, Ehlers-Danlos syndrome and vaccination with COVID-19 AstraZeneca vaccine; who experienced unexpected events of tachycardia, palpitations, dyspnoea, chest pain and fatigue (seriousness criteria disability and medically significant assessed as per Regulatory Authority reporting). The event tachycardia occurred 6 days after the administration of third dose of mRNA-1273 vaccine. The rest of the events occurred on an unknown date. Treatment details were not provided. Patient''s medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 32-year-old female patient with medical history of postural orthostatic tachycardia syndrome, Ehlers-Danlos syndrome and vaccination with COVID-19 AstraZeneca vaccine; who experienced unexpected events of tachycardia, palpitations, dyspnoea, chest pain and fatigue (seriousness criteria disability and medically significant assessed as per Regulatory Authority reporting). The event tachycardia occurred 6 days after the administration of third dose of mRNA-1273 vaccine. The rest of the events occurred on an unknown date. Treatment details were not provided. Patient''s medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2041419 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-05
Onset:2021-12-27
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Miscarriage of pregnancy; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26452215) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage of pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 05-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 27-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ABORTION SPONTANEOUS (Miscarriage of pregnancy) (seriousness criteria medically significant and congenital anomaly). The delivery occurred on 27-Dec-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion w Cong Anomaly. At the time of the report, ABORTION SPONTANEOUS (Miscarriage of pregnancy) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was provided. company comment This is a regulatory case concerning a female patient of unknown age, with no medical history, who experienced the unexpected, serious (seriousness criteria-medically significant, congenital anomaly) event of Abortion Spontaneous, 22 days after the interchange of vaccine administration with the third dose of mRNA-1273 vaccine for an unknown indication. Concomitant products included tozinameran (pfizer biontech covid-19 vaccine) for an unknown indication and dose number, on an unknown date. The last menstrual period and estimated date of delivery were not provided. No treatment medication was provided. At the time of the report, abortion spontaneous had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious, as per Regulatory Authority report.; Sender''s Comments: This is a regulatory case concerning a female patient of unknown age, with no medical history, who experienced the unexpected, serious (seriousness criteria-medically significant, congenital anomaly) event of Abortion Spontaneous, 22 days after the interchange of vaccine administration with the third dose of mRNA-1273 vaccine for an unknown indication. Concomitant products included tozinameran (pfizer biontech covid-19 vaccine) for an unknown indication and dose number, on an unknown date. The last menstrual period and estimated date of delivery were not provided. No treatment medication was provided. At the time of the report, abortion spontaneous had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious, as per Regulatory Authority report.


VAERS ID: 2041472 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia
Allergies:
Diagnostic Lab Data: Test Name: Uterine biopsy; Result Unstructured Data: Test Result:Unknown; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200056429

Write-up: SARS-CoV-2 infection; Drug Ineffective; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority and product quality group. A 35 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 23Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 28Jul2021 (Lot number: FF3319) as dose 2, single and administration date 01Jun2021 (Lot number: EW3143) as dose 1, single for covid-19 immunisation. Relevant medical history included: "anaemia" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 27Dec2021, outcome "recovered" (03Jan2022), described as "SARS-CoV-2 infection"; DRUG INEFFECTIVE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Drug Ineffective". The patient underwent the following laboratory tests and procedures: biopsy endometrium: unknwon; sars-cov-2 test: no - negative covid-19 test. Clinical course: Patient last menstrual period date 28Jun2021. Patient did not have symptoms associated with COVID-19. Patient was not breastfeeding. Received first dose start of June started bleeding the end of June had not stopped bleeding and losing clots since, had been on tranexamic acid and been for uterine biopsy, uterine biopsy was clear and tranexamic acid didn''t stop the bleeding, still currently bleeding today. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis) and blood clots or low platelet counts. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200035495 Same patient/vaccine, different dose/events (DOSE 3);GB-PFIZER INC-202200056430 Same patient/vaccine, different dose/events (DOSE 1);GB-PFIZER INC-202200056431 Same patient/vaccine, different dose/events (DOSE 2)


VAERS ID: 2044960 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-12-27
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Skin irritation
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Skin irritation; This case was received via regulatory authority on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of SKIN IRRITATION (Skin irritation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced SKIN IRRITATION (Skin irritation) (seriousness criterion medically significant). At the time of the report, SKIN IRRITATION (Skin irritation) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. patient had severe skin irritation 4 weeks. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Company comment: This case concerns a patient of unknown age and indication with no medical history reported, who experienced the unexpected, serious (medically significant) events of skin irritation. The event occurred 1 month and 10 days after the booster dose of mRNA-1273. Information regarding clinical presentation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a patient of unknown age and indication with no medical history reported, who experienced the unexpected, serious (medically significant) events of skin irritation. The event occurred 1 month and 10 days after the booster dose of mRNA-1273. Information regarding clinical presentation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2045008 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000029A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211223; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Chills; Feverish; Headache; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Feverish) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000029A) for an unknown indication. No Medical History information was reported. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 29-Dec-2021, CHILLS (Chills) and HEADACHE (Headache) had resolved. On 01-Jan-2022, PYREXIA (Feverish) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was unsure if patient has had symptoms associated with COVID-19 No Concomitant medication information was reported. No treatment medications were provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Company comment: This case concerns a patient of unknown age and gender with no medical history, who experienced the unexpected events of chills, pyrexia and headache. The events occurred on the same day after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a patient of unknown age and gender with no medical history, who experienced the unexpected events of chills, pyrexia and headache. The events occurred on the same day after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2045014 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unsure if patient has had symptoms associated with COVID-19 Patient is not pregnant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Hives; This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Unsure if patient has had symptoms associated with COVID-19 Patient is not pregnant. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced URTICARIA (Hives) (seriousness criterion medically significant). At the time of the report, URTICARIA (Hives) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication were provided. Batch/lot number : Phizer booster Unsure if patient has had symptoms associated with COVID-19 Patient is not pregnant Patient Reported that First 2 jabs I was given astrazenica as have allergies but my booster was done at a walk in pop up centre which gave me the phizer for my booster jab which I had a immediate reaction to that has just got worse and worse since and has now been diagnosed as severe hives due to reaction Patient is not enrolled in clinical trial This is a regulatory authority case concerning a 40-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Urticaria. The event occurred approximately on the same day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed.The event was reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 40-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Urticaria. The event occurred approximately on the same day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed.The event was reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2045018 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, 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: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Tiredness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26451211) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, FATIGUE (Tiredness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication provided. No treatment information mentioned. Unsure if patient has had symptoms associated with COVID-19. After the booster patient had fatigue, sore and achey arm. Also achey body. Then cold symptoms which made her feel really poorly resulting to have time off work. Takes nearly two weeks to start feeling better. Patient complained that she does not want moderna again. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Adverse reaction did not occur as a result of an exposure during pregnancy Patient was asked to provide details of any relevant investigations or tests conducted: "Negative lateral flow and negative pcr" Company comment This case concerns a 40-year-old female patient, with medical history of Immunodeficiency, who experienced the unexpected serious event of FATIGUE. The event occurred on the same day after the administration of the third dose of mRNA-1273 vaccine. At the time of the report, FATIGUE had not resolved. Patient?s medical history of Immunodeficiency, remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 40-year-old female patient, with medical history of Immunodeficiency, who experienced the unexpected serious event of FATIGUE. The event occurred on the same day after the administration of the third dose of mRNA-1273 vaccine. At the time of the report, FATIGUE had not resolved. Patient?s medical history of Immunodeficiency, remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2045058 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Oral contraceptive
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: nausea; high temperature; Fever; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26452307) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (nausea), PYREXIA (high temperature) and PYREXIA (Fever) in a 20-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). Concurrent medical conditions included Oral contraceptive. On 27-Dec-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (nausea) (seriousness criterion medically significant) and PYREXIA (high temperature) (seriousness criterion medically significant). On 29-Dec-2021, PYREXIA (Fever) had resolved. At the time of the report, NAUSEA (nausea) and PYREXIA (high temperature) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient''s last menstrual period was on 07-Jan-2022. The patient was on contraceptive pill. Patient is not pregnant, Patient is not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company comment: This is a regulatory case concerning a 20 year-old, female patient with a history of suspected COVID-19 and concomitant use of contraceptive pill, who experienced the serious (due to medically important condition) unexpected, events of nausea and pyrexia (reported as fever and high temperature). Events were assessed as serious by the Regulatory Authority. The event pyrexia (reported as fever) occurred the same day after the third dose of mRNA-1273 vaccine and the events nausea and pyrexia (reported as high temperature) on an unknown date. The outcome of the event pyrexia (reported as fever) was reported as recovered; and the events nausea and pyrexia (reported as high temperature) as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the third dose. The medical history, of suspected COVID-19 and concomitant use of contraceptive pill remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 20 year-old, female patient with a history of suspected COVID-19 and concomitant use of contraceptive pill, who experienced the serious (due to medically important condition) unexpected, events of nausea and pyrexia (reported as fever and high temperature). Events were assessed as serious by the Regulatory Authority. The event pyrexia (reported as fever) occurred the same day after the third dose of mRNA-1273 vaccine and the events nausea and pyrexia (reported as high temperature) on an unknown date. The outcome of the event pyrexia (reported as fever) was reported as recovered; and the events nausea and pyrexia (reported as high temperature) as not recovered. The rechallenge was not applicable, as the events were reported exclusively after the third dose. The medical history, of suspected COVID-19 and concomitant use of contraceptive pill remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2045092 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal distension, Headache, Hyperhidrosis, Loss of consciousness, Peripheral swelling, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (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), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211102; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: sweating; Blacked out; Abdomen enlarged; Swelling arm; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26452818) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26452818) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out), ABDOMINAL DISTENSION (Abdomen enlarged), PERIPHERAL SWELLING (Swelling arm), HEADACHE (Headache) and HYPERHIDROSIS (sweating) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 01-Nov-2021 to 11-Nov-2021. Concomitant products included LOSARTAN for Blood pressure, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 28-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant). On 29-Dec-2021, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criterion medically significant) and ABDOMINAL DISTENSION (Abdomen enlarged) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant). On 29-Dec-2021, LOSS OF CONSCIOUSNESS (Blacked out) had resolved. On 31-Dec-2021, PERIPHERAL SWELLING (Swelling arm) had resolved. On 03-Jan-2022, HEADACHE (Headache) had resolved. At the time of the report, ABDOMINAL DISTENSION (Abdomen enlarged) was resolving and HYPERHIDROSIS (sweating) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The treatment medication was not reported. Patient took the vaccine 11 hours later sweating and felt very hot and glued up. Next day that was gone but suffered with a headache which would not go and felt like no energy and arm pit swelled and was painful. Day after Patient''s abdomen started to swell and blacked out at the shops. Patient''s headache lasted for over a week and nothing helped to ease it. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient went to urgent care given short course of antibiotics to help with abdomen swelling, still not properly recovered now but headache gone. This is a regulatory case concerning a 48-year-old female patient with a medical history of suspected of having Covid-19, who experienced the unexpected events of hyperhidrosis, abdominal distension, loss of consciousness, peripheral swelling and the expected event of headache. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The events all occurred within 2 days after the third dose of mRNA ? 1273 vaccine. Event loss of consciousness resolved on the same day of occurrence, peripheral swelling only lasted 3 days, headache resolved after 6 days, while at the time of report abdominal distension was resolving but hyperhidrosis had not resolved. All the events was reported as medically significant. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 48-year-old female patient with a medical history of suspected of having Covid-19, who experienced the unexpected events of hyperhidrosis, abdominal distension, loss of consciousness, peripheral swelling and the expected event of headache. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The events all occurred within 2 days after the third dose of mRNA ? 1273 vaccine. Event loss of consciousness resolved on the same day of occurrence, peripheral swelling only lasted 3 days, headache resolved after 6 days, while at the time of report abdominal distension was resolving but hyperhidrosis had not resolved. All the events was reported as medically significant. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 2045119 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: Diarrhea; Headache; Painful periods; This case was received via a Regulatory Authority (Reference number: GB-MHRA-ADR 26453175) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), HEADACHE (Headache) and DYSMENORRHOEA (Painful periods) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced DYSMENORRHOEA (Painful periods) (seriousness criterion medically significant). On an unknown date, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 29-Dec-2021, DYSMENORRHOEA (Painful periods) had resolved. At the time of the report, DIARRHOEA (Diarrhea) and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had no illness or took any medicines that effect her immune system. She had not symptoms associated with COVID-19 Not had a COVID-19 test. Patient was on periods when had the booster. Suffered from mild period pains for a few hours after first start. Had injection around 12.40pm. However, by 3.30pm, roughly, they were so bad, was doubled over and could not move. Patient had light headed and fainted in doorway. Only for might be a few seconds. When patient came around, was sick and had diarrhea and a nasty headache. When patient tried to move from the bathroom, fainted again and was brought around by patient''s house mate, on the kitchen floor, some time later when she came home from work. She had to help the patient upstairs to bed. Patient was continued to be sick and had diarrhea until gone 5am and spent the next day in bed sleeping. It had pretty much gone by 29th but as a side note, patient was struggled to lift right arm, due to the pain , since had the injection. Hard to put clothes on/ take off. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. No concomitant medications reported. No treatment medications provided. Company comment: This case concerns a 46-year-old female patient with unknown medical history, who experienced serious unexpected DYSMENORRHOEA and DIARRHOEA on the same day after the third dose of mRNA-1273, and HEADACHE with unknown onset date. As per source document the patient fainted on the same day when received the third dose. Outcome of DYSMENORRHOEA had resolved while DIARRHOEA and HEADACHE were resolving at the time of the report. The reporter did not provide causality assessment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 46-year-old female patient with unknown medical history, who experienced serious unexpected DYSMENORRHOEA and DIARRHOEA on the same day after the third dose of mRNA-1273, and HEADACHE with unknown onset date. As per source document the patient fainted on the same day when received the third dose. Outcome of DYSMENORRHOEA had resolved while DIARRHOEA and HEADACHE were resolving at the time of the report. The reporter did not provide causality assessment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2045194 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-27
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, COVID-19, Drug ineffective, Malaise, Palpitations, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocarditis; Pericarditis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:positivw; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200047180

Write-up: Heart racing; Arterial fibrillation; Feeling unwell; Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201102221494840-P5DSU (RA). Other Case identifier(s): GB-MHRA-ADR 26459145 (RA). A 54 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Myocarditis" (unspecified if ongoing); "Pericarditis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot number: unknown, Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (hospitalization) with onset 27Dec2021, outcome "recovered", described as "Drug ineffective"; COVID-19 (hospitalization) with onset 27Dec2021, outcome "recovered", described as "SARS-CoV-2 infection"; PALPITATIONS (hospitalization), outcome "not recovered", described as "Heart racing"; ATRIAL FIBRILLATION (hospitalization, medically significant), outcome "unknown", described as "Arterial fibrillation"; MALAISE (hospitalization), outcome "unknown", described as "Feeling unwell". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positivw, notes: Yes - Positive COVID-19 test. The report of the patient was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200067175 Same patient/different dose/different events


VAERS ID: 2045700 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-01
Onset:2021-12-27
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Multiple injuries, Pain, Road traffic accident, Skin abrasion
SMQs:, Accidents and injuries (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: PHPFIZER INC202200020283

Write-up: MPI 2ND TO VA; MPI 2ND TO VA; ABRASIONS; BODY PAIN; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300129398 (PHFDA). A 26 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 25 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: MULTIPLE INJURIES (medically significant), ROAD TRAFFIC ACCIDENT (medically significant), outcome "unknown" and all described as "MPI 2ND TO VA"; SKIN ABRASION (non-serious) with onset 27Dec2021 11:00, outcome "recovered" (27Dec2021 11:05), described as "ABRASIONS"; PAIN (non-serious) with onset 27Dec2021 11:00, outcome "recovered", described as "BODY PAIN". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2045701 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-01
Onset:2021-12-27
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Hypophosphatasia, Skull malformation
SMQs:, Congenital, familial and genetic disorders (narrow), 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: PHPFIZER INC202200020288

Write-up: Hypophosphatasia; Joint pain; Skull malformation; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. A 38 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Dec2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 01Dec2021 (Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SKULL MALFORMATION (medically significant) with onset 27Dec2021 09:50, outcome "recovered" (28Dec2021 09:55), described as "Skull malformation"; HYPOPHOSPHATASIA (medically significant), outcome "unknown", described as "Hypophosphatasia"; ARTHRALGIA (non-serious) with onset 27Dec2021 09:50, outcome "recovered" (28Dec2021 09:55), described as "Joint pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2045703 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-04
Onset:2021-12-27
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Multiple injuries, Road traffic accident
SMQs:, Accidents and injuries (narrow), 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: PHPFIZER INC202200020298

Write-up: Joint pain; MPI SEC TO VA; MPI SEC TO VA; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300129402. A 30 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 04Nov2021 (Batch/Lot number: unknown) at the age of 30 years as dose 2, single and intramuscular, administration date 11Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: MULTIPLE INJURIES (medically significant), ROAD TRAFFIC ACCIDENT (medically significant) all with onset 2021, outcome "unknown" and all described as "MPI SEC TO VA"; ARTHRALGIA (non-serious) with onset 27Dec2021 11:30, outcome "recovered" (27Dec2021 11:35), described as "Joint pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2045721 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 129001 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: 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? 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: PHPFIZER INC202200020402

Write-up: Blank stares for 10 seconds/Mild seizure; This is a spontaneous report received from a contactable reporter (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300130033 (PHFDA). A 27-year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 27Dec2021 (Lot number: 129001) at the age of 27 years as dose number unknown, single for covid-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (hospitalization, medically significant) with onset 27Dec2021 12:00, outcome "recovering", described as "Blank stares for 10 seconds/Mild seizure". Patient developed mild seizure for 10 seconds after 1 hour post vaccination. No other symptoms noted. No previous episodes of seizure. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2045731 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 12300H / 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: 20211227; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:160/100 mmHg; Comments: 15:20
CDC Split Type: PHPFIZER INC202200020456

Write-up: Elevated BP (160/100); This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300129682. A 32 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 27Dec2021 (Lot number: 12300H) at the age of 32 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 27Dec2021 15:20, outcome "recovered" (27Dec2021 17:00), described as "Elevated BP (160/100)". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (27Dec2021) 160/100 mmHg, notes: 15:20. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2048989 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200015798

Write-up: lymph nodes in the armpit of the arm that patient received her vaccine, which was very painful; sore head; lacked energy; Lymphadenitis; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201041056536190-HAJTK (RA). Other Case identifier(s): GB-MHRA-ADR 26432865 (RA). A 33 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing), notes: Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1; Lot number unknown), for COVID-19 immunisation; Bnt162b2 (Dose: 2; Lot number unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "booster"; LYMPHADENITIS (medically significant) with onset 28Dec2021, outcome "recovered" (31Dec2021), described as "Lymphadenitis"; LYMPHADENOPATHY (medically significant), outcome "unknown", described as "lymph nodes in the armpit of the arm that patient received her vaccine, which was very painful"; HEADACHE (medically significant), outcome "unknown", described as "sore head"; ASTHENIA (medically significant), outcome "unknown", described as "lacked energy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Additional information: These symptoms lasted for 5 days after the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Report does report relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2049024 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Immunisation, Limb discomfort, Monoplegia, Muscular weakness, Pain in extremity, Paraesthesia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (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: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200015553

Write-up: Both legs felt heavy for a few days; Prickly feeling all over body; Strange sensation in left leg and feels very weak; Paralysis leg; 6 sharp shooting pains in left leg; Booster; Face/ neck was numb; Face/ neck was numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201042135341130-1YVZG. Other Case identifier(s): GB-MHRA-ADR 26436045. A 36 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Steroid therapy" (unspecified if ongoing), notes: taking regular steroid treatment (e.g. orally or rectally). The patient took concomitant medications. Date of last menstrual period was 02Dec2021. Patient had not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; MONOPLEGIA (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Paralysis leg"; HYPOAESTHESIA (medically significant), HYPOAESTHESIA (medically significant) all with onset 27Dec2021, outcome "unknown" and all described as "Face/ neck was numb"; PAIN IN EXTREMITY (medically significant) with onset 28Dec2021, outcome "unknown", described as "6 sharp shooting pains in left leg"; LIMB DISCOMFORT (medically significant), outcome "unknown", described as "Both legs felt heavy for a few days"; PARAESTHESIA (medically significant), outcome "unknown", described as "Prickly feeling all over body"; MUSCULAR WEAKNESS (medically significant), outcome "unknown", described as "Strange sensation in left leg and feels very weak". The patient underwent SARS-CoV-2 test and result was no - negative COVID-19 test. Patient''s face/ neck was numb the night she had booster. Then the next day she had 6 sharp shooting pains in left leg. Her both legs felt heavy for a few days with a prickly feeling all over her body. She was now left with a strange sensation in left leg and felt very weak. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2049030 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, SARS-CoV-2 test, Superficial vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211225; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200015585

Write-up: Thrombophlebitis superficial on dorsal section of penis; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201042348201230-TFMIE. Other Case identifier(s): GB-MHRA-ADR 26436210. A 36 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Lot number: FK9706) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 nor tested positive for COVID-19 since having the vaccine ad was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation; Bnt162b2 (Dose 2, single), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; SUPERFICIAL VEIN THROMBOSIS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Thrombophlebitis superficial on dorsal section of penis ". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Dec2021) no - negative COVID-19 test. The reporter did not consider the event related to possible inflammation of the heart (myocarditis or pericarditis). Clinical Course: having masturbated twice since vaccination with no apparent issue, he discovered a raised and hard cord like vein on dorsal section of penis a few days later, which was discomforting to the touch and when erect. Masturbating the following day, the discomfort became painful, and another further day without masturbation, a new larger lateral cord developed near the head. This cord is discomforting while flaccid due to it''s location, and mildly painful while erect. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2049246 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-15
Onset:2021-12-27
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220104; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Dermatographia; This case was received via RA (Reference number: GB-MHRA-ADR 26454195) on 10-Jan-2022 and was forwarded to Moderna on 10-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Dermatographia) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced MECHANICAL URTICARIA (Dermatographia) (seriousness criterion disability). At the time of the report, MECHANICAL URTICARIA (Dermatographia) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No treatment medications were reported. Patient had not had symptoms associated with COVID-19 Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 28-year-old female patient with no medical history provided, who experienced serious unexpected event of Mechanical urticaria (dermatographia). The event occurred 12 days after the patient had received the mRNA-1273 vaccine (as third dose, booster). At the time of this report, the event was still ongoing and no information regarding the clinical course of the event was provided. The rechallenge and action taken with the suspect product were reported as unknown as per RA and kept as such, however, could have been considered as not applicable as the patient experienced the event following the third dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 28-year-old female patient with no medical history provided, who experienced serious unexpected event of Mechanical urticaria (dermatographia). The event occurred 12 days after the patient had received the mRNA-1273 vaccine (as third dose, booster). At the time of this report, the event was still ongoing and no information regarding the clinical course of the event was provided. The rechallenge and action taken with the suspect product were reported as unknown as per RA and kept as such, however, could have been considered as not applicable as the patient experienced the event following the third dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2049301 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-12-27
   Days after vaccination:200
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 2 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9707 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Burning feet syndrome
SMQs:, Peripheral neuropathy (broad)

Life Threatening? No
Birth Defect? No
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.MOD20224

Write-up: Burning feet syndrome; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26458843) on 11-Jan-2022 and was forwarded to Moderna on 11-Jan-2022. This regulatory authority case was reported by a physician and describes the occurrence of BURNING FEET SYNDROME (Burning feet syndrome) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3002332 and 3003608) for an unknown indication. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. No Medical History information was reported. On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced BURNING FEET SYNDROME (Burning feet syndrome) (seriousness criterion medically significant). At the time of the report, BURNING FEET SYNDROME (Burning feet syndrome) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Patient had not symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Within one week of booster patient was not getting burning/heat to feet. Blood tests were going to be carried out. Treatment details were not reported. Patient was not enrolled in clinical trial. Company comment: This regulatory case concerns a 32-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) event of burning feet syndrome. The event occurred after 5 days of receiving a dose of Biontech''s COVID-19 vaccine. The patient received as first and second dose of her COVID-19 vaccination schedule two doses of mRNA-1273 vaccine, with an interval between doses of approximately 58 days. The last mRNA-1273 vaccine dose was administered 4 months and 20 days prior to the event. Regulatory authority captured the rechallenge as unknown. It was reported that blood tests were going to be carried out, however, no results were available by the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria was maintained for the events for consistency with the RA report.; Sender''s Comments: This regulatory case concerns a 32-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) event of burning feet syndrome. The event occurred after 5 days of receiving a dose of Biontech''s COVID-19 vaccine. The patient received as first and second dose of her COVID-19 vaccination schedule two doses of mRNA-1273 vaccine, with an interval between doses of approximately 58 days. The last mRNA-1273 vaccine dose was administered 4 months and 20 days prior to the event. Regulatory authority captured the rechallenge as unknown. It was reported that blood tests were going to be carried out, however, no results were available by the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria was maintained for the events for consistency with the RA report.


VAERS ID: 2049499 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-11
Onset:2021-12-27
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005686 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bacterial infection, Deep vein thrombosis, Duodenal ulcer, Pain, SARS-CoV-2 test, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal ulceration (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211223; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Blood clot; Pain; Duodenal ulcers; Bacterial infection; DVT of calf; This case was received via RA (Reference number: GB-MHRA-ADR 26464137) on 12-Jan-2022 and was forwarded to Moderna on 12-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot), PAIN (Pain), DUODENAL ULCER (Duodenal ulcers), BACTERIAL INFECTION (Bacterial infection) and DEEP VEIN THROMBOSIS (DVT of calf) in a 50-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005686) for an unknown indication. No Medical History information was reported. On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT of calf) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criteria hospitalization and medically significant), PAIN (Pain) (seriousness criteria hospitalization and medically significant), DUODENAL ULCER (Duodenal ulcers) (seriousness criteria hospitalization and medically significant) and BACTERIAL INFECTION (Bacterial infection) (seriousness criteria hospitalization and medically significant). On 11-Jan-2022, DEEP VEIN THROMBOSIS (DVT of calf) was resolving. At the time of the report, THROMBOSIS (Blood clot), PAIN (Pain), DUODENAL ULCER (Duodenal ulcers) and BACTERIAL INFECTION (Bacterial infection) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant products were reported. No treatment information was reported by the reporter. Patient admitted to hospital on 23rd December with 2 duodenal ulcers that were bleeding. This was stopped and 1 unit of blood given and kept in hospital for 6 days on an omeprazole drip. Two days before he left, he had a mild cramp in my calf muscle. He was the most active person on the ward, walking all the way to the hospital entrance twice a day and keeping active. He left hospital and two days later he was re-admitted and kept overnight. On 31st December he had an ultrasound that identified a blood clot in his leg. He was sent home and told to take paracetamol to help with the pain as they could not give him thinners due to impact on stomach recovery. he was fit and healthy and no previous medical conditions. he rarely drink and eat well. The ulcers were caused by a bacterial infection, however he not convinced that his hospital stay was the cause of the blood clot in his leg. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case refers to a 50-year-old male patient with no known medical history who experienced the unexpected events of Thrombosis, Pain, Duodenal ulcer, Bacterial infection and Deep vein thrombosis. Deep vein thrombosis occurred approximately 16 days after the third dose of mRNA-1273 vaccine while the events of Thrombosis, Pain, Duodenal ulcer and Bacterial infection occurred after an unspecified number of days post exposure to the vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case refers to a 50-year-old male patient with no known medical history who experienced the unexpected events of Thrombosis, Pain, Duodenal ulcer, Bacterial infection and Deep vein thrombosis. Deep vein thrombosis occurred approximately 16 days after the third dose of mRNA-1273 vaccine while the events of Thrombosis, Pain, Duodenal ulcer and Bacterial infection occurred after an unspecified number of days post exposure to the vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2049540 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-12-27
   Days after vaccination:234
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes (The lady has diabetes and other diseases as well, for which she has been taking drugs for years.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID test; Test Result: Positive
CDC Split Type: HUPFIZER INC202200033020

Write-up: on 28Dec2021 they went out to test her, her COVID test was positive, so now she is in quarantine; on 28Dec2021 they went out to test her, her COVID test was positive, so now she is in quarantine; On Monday, 27Dec2021 she got sick, she called her GP; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient. A female patient received BNT162B2 (COMIRNATY), administration date 07May2021 (Lot number: FA5829, Expiration Date: 31Aug2021) as dose 2, single and administration date 02Apr2021 (Lot number: EW2239, Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunization. Relevant medical history included: "diabetes" (ongoing), notes: The lady has diabetes and other diseases as well, for which she has been taking drugs for years. The patient''s concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 28Dec2021, outcome "unknown" and all described as "on 28Dec2021 they went out to test her, her COVID test was positive, so now she is in quarantine"; MALAISE (non-serious) with onset 27Dec2021, outcome "unknown", described as "On Monday, 27Dec2021 she got sick, she called her GP". The event "on 28dec2021 they went out to test her, her covid test was positive, so now she is in quarantine" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) positive. Investigation result was received on 12Jan2021 from product quality group which states; Conclusion FA5829: ''For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced regulatory authority ID resulted in the following conclusion: Reference regulatory authority ID 6099425 (see File attachment in this investigation record). The complaint for ''PFIZER-BIONTECH COVID-19 VACCINE'' was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FA5829. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.'' Conclusion EW2239: The complaint for ''PFIZER-BIONTECH COVID-19 VACCINE'' was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EW2239. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.''; Sender''s Comments: Linked Report(s) : HU-PFIZER INC-202200084548 same reporter, patient and suspect product, different dose and events


VAERS ID: 2049606 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ACB8421 / 3 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Electrocardiogram, Electrocardiogram ambulatory, Immunisation, Loss of consciousness, Muscle rigidity, Syncope, Trismus, Ultrasound Doppler
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), Dystonia (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (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: Test Name: Computed Axial Tomography encephalus; Result Unstructured Data: Test Result:results unknown; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:results unknown; Test Name: Holter; Result Unstructured Data: Test Result:results unknown; Test Name: echocolordoppler supra-aortic trunks; Result Unstructured Data: Test Result:results unknown; Comments: examination was performed recently
CDC Split Type: ITPFIZER INC202200043763

Write-up: Approximately 2 days after covid vaccine (3 dose Pfizer) sudden onset of syncopal episode with loss of consciousness. Not sphincteric incontinence.; Approximately 2 days after covid vaccine (3 dose Pfizer) sudden onset of syncopal episode with loss of consciousness. Not sphincteric incontinence.; patient was rigid; contracture of the masseters (trismus); Booster; This is a spontaneous report received from a contactable reporter (Physician) from the regulatory authority-WEB. Regulatory number: IT-MINISAL02-827626. A 73 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right (right shoulder), administration date 27Dec2021 08:00 (Lot number: ACB8421, Expiration Date: 30Jun2022) as dose 3 (booster), 0.3ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for covid-19 immunisation; Covid-19 vaccine (dose 2, manufacturer unknown), for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; SYNCOPE (medically significant), LOSS OF CONSCIOUSNESS (medically significant) all with onset 29Dec2021, outcome "recovered" (29Dec2021) and all described as "Approximately 2 days after covid vaccine (3 dose Pfizer) sudden onset of syncopal episode with loss of consciousness. Not sphincteric incontinence."; MUSCLE RIGIDITY (non-serious) with onset 29Dec2021, outcome "recovered", described as "patient was rigid"; TRISMUS (non-serious) with onset 29Dec2021, outcome "recovered", described as "contracture of the masseters (trismus)". The reporter stated that syncope lasted less than one minute with sphincter continence. The present grandson stated that the patient was rigid with contracture of the masseters (trismus). The patient underwent the following laboratory tests and procedures: computerised tomogram head: results unknown; electrocardiogram: results unknown; electrocardiogram ambulatory: results unknown; ultrasound doppler: results unknown, notes: examination was performed recently. The patient did not prescribe with echocolordoppler supra-aortic trunks and requested for additional information and reports, actions taken (Prescription Computed Axial Tomography encephalus, Electrocardiogram following Holter). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2052131 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Pain in extremity, Sensory loss
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (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: FRPFIZER INC202200032696

Write-up: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 68 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose), for COVID-19 immunisation, reaction(s): "pain in arm"; Comirnaty (2nd dose), for COVID-19 immunisation, reaction(s): "pain in arm". The following information was reported: IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "pain localized in the little finger of the right hand and the palm"; SENSORY LOSS (non-serious), outcome "not recovered", described as "She has lost sensitivity". Patient was unhappy because she is an organist and can no longer play. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender''s Comments: Linked Report(s): FR-PFIZER INC-202200041304 same patient, different doses/ different events.


VAERS ID: 2052202 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Migraine, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200030978

Write-up: Acute migraine; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from contactable reporter (Consumer) from the regulatory authority-WEB. Regulatory number: GB-MHRA-WEBCOVID-202112291254030910-KZAAC. Other Case identifier(s): GB-MHRA-ADR 26408744. A 47 year-old male patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Lot number: fn3543) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19" (unknown if ongoing), notes: Unsure when symptoms started, Unsure when symptoms stopped. Patient had not tested positive for COVID-19 since having the vaccine, was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN), administration date: 06May2021, for COVID-19 immunisation; COVID-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; MIGRAINE (medically significant) with onset 28Dec2021, outcome "not recovered", described as "Acute migraine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2052221 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Immunisation, Interchange of vaccine products, Nausea, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202200030970

Write-up: Fever chills; Headache; Nausea; Off label use; Interchange of vaccine products; Booster; Tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112291535399150-79SUZ. Other Case identifier(s): GB-MHRA-ADR 26410051. A 28 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Lot number: FN3543) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported and patient had no symptoms associated with COVID 19. Patient has not tested positive for COVID-19 since having the vaccine as patient is not enrolled in clinical trial. Vaccination history included: COVID-19 vaccine astrazeneca (Dose Number Unknown), for COVID-19 Immunization; COVID-19 vaccine (Dose Number Unknown, manufacturer unknown), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 27Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 27Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 27Dec2021, outcome "unknown", described as "Booster"; FATIGUE (medically significant) with onset 27Dec2021, outcome "recovered with sequelae", described as "Tiredness"; PYREXIA (medically significant) with onset 28Dec2021, outcome "recovered" (28Dec2021), described as "Fever chills"; HEADACHE (medically significant) with onset 28Dec2021, outcome "recovered with sequelae", described as "Headache"; NAUSEA (medically significant) with onset 28Dec2021, outcome "recovered" (28Dec2021), described as "Nausea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Patient is not enrolled in clinical trial. This report is not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


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