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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 115 out of 10,493

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VAERS ID: 2033438 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Diarrhoea, Hyperhidrosis, Immunisation, Nausea, Night sweats, Off label use, Pain in extremity, Product use issue, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000851

Write-up: Night sweats; woke up soaked in sweat; feverish; Aching in limb; Off label use; Drug use in unapproved population/ Maternal exposure during breast feeding; Booster; Diarrhea; Nausea; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional) from the Regulatory Authority. The Regulatory number is GB-MHRA-WEBCOVID-202201012223356730-1IELQ (Agency) and the Other Case identifier is GB-MHRA-ADR 26424456 (Agency). The reporter is the patient. A 34-year-old female patient (not pregnant) received the third dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 30Dec2021 (batch/lot number: unknown) at the age of 34 years old, as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Relevant medical history included: "Breast feeding" (ongoing). Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose (batch/lot number: unknown) as DOSE 1, SINGLE) for COVID-19 immunization; Bnt162b2 (second dose (batch/lot number: unknown) as DOSE 2, SINGLE) for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown" described as "Booster"; DIARRHOEA (medically significant) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "Diarrhea"; NAUSEA (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "Nausea"; NIGHT SWEATS (medically significant) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Night sweats"; HYPERHIDROSIS (medically significant) with onset 31Dec2021, outcome "unknown" described as "woke up soaked in sweat"; PYREXIA (medically significant) with onset 31Dec2021, outcome "not recovered" described as "feverish"; PAIN IN EXTREMITY (medically significant) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Aching in limb"; OFF LABEL USE (non-serious) with onset 30Dec2021, outcome "unknown" described as "Off label use"; PRODUCT USE ISSUE (non-serious) with onset 30Dec2021, outcome "unknown" described as "Drug use in unapproved population/ Maternal exposure during breast feeding." The clinical course was reported as follows: Around 8 hours after the vaccination, I had diarrhea and nausea. Around 16 hours after the vaccination, I woke up soaked in sweat and feeling feverish with aching limbs. 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; information about the batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200017181 Baby case


VAERS ID: 2033444 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FL9994 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Lymph node pain, Lymphadenopathy, Movement disorder, Neuralgia, Pain in extremity, Skin warm, Somnolence
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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:
CDC Split Type: GBPFIZER INC202200000275

Write-up: lymph nodes in same armpit swelled up; Lymph nodes in same armpit swelled up, extremely painful; Fatigue/exhausted; Keep napping; Nerve pain; Booster; Painful arm; arm unable to lift it; Skin warm/Arm got quite hot; 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-202201012318092560-WMOMD. Other Case identifier(s): GB-MHRA-ADR 26424525. A 32 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FL9994) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. Date of last menstrual period: 11Dec2021. The patient''s relevant medical history and concomitant medications were not reported. 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 (disability) with onset 30Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (disability) with onset 30Dec2021, outcome "recovering", described as "Painful arm"; MOVEMENT DISORDER (disability) with onset 30Dec2021, outcome "unknown", described as "arm unable to lift it"; SKIN WARM (disability) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "Skin warm/Arm got quite hot"; NEURALGIA (disability) with onset 31Dec2021, outcome "not recovered", described as "Nerve pain"; LYMPHADENOPATHY (disability), outcome "recovering", described as "lymph nodes in same armpit swelled up"; LYMPH NODE PAIN (disability), outcome "unknown", described as "Lymph nodes in same armpit swelled up, extremely painful"; FATIGUE (disability) with onset 31Dec2021, outcome "not recovered", described as "Fatigue/exhausted"; SOMNOLENCE (disability) with onset 31Dec2021, outcome "not recovered", described as "Keep napping". Clinical course: Patient has not had symptoms associated with COVID-19 and has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient was not currently breastfeeding. Patient experienced very sore arm, was unable to lift it. her arm got quite hot, lasted a day or so. Also triggered an existing nerve pain in my arm. The Lymph nodes in same armpit got swelled up and was extremely painful. Currently, on day 2 of this. They''re were visibly swollen. She was absolutely exhausted and had been in bed for 2 days so far. It was also reported that, she was keep napping which she rarely does. This reaction does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033447 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Feeling abnormal, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, SARS-CoV-2 test, Swelling, Vaccination site swelling, Vaccination site warmth
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Dementia (broad), Haemodynamic oedema, effusions and fluid overload (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: EVOREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HRT
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200000807

Write-up: swelling is on left side of neck; Heat and slight raised skin from injection site; Heat and slight raised skin from injection site; foggy headache; foggy headache; Supraclavicular lymph nodes enlarged/Lymph node and clavicle are sore; 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. Regulatory number: GB-MHRA-WEBCOVID-202201012344127130-MJG58. Other Case identifier: GB-MHRA-ADR 26424550. A 50-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administration date 30Dec2021 (Lot number: FN5254) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "HRT (Hormone replacement therapy)" (unspecified if ongoing). Concomitant medication included: EVOREL taken for HRT. Vaccination history included: COVID-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunisation; COVID-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; SWELLING (medically significant), outcome "unknown", described as "swelling is on left side of neck"; LYMPHADENOPATHY (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Supraclavicular lymph nodes enlarged/Lymph node and clavicle are sore"; VACCINATION SITE WARMTH (medically significant), VACCINATION SITE SWELLING (medically significant), outcome "unknown" and all described as "Heat and slight raised skin from injection site"; FEELING ABNORMAL (medically significant), HEADACHE (medically significant), outcome "unknown" and all described as "foggy headache". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative. Therapeutic measures were taken as a result of swelling, lymphadenopathy, vaccination site warmth, vaccination site swelling, feeling abnormal, headache. Clinical course details: Patient had taken antihistamine and paracetamol, no problem with swallowing, swelling is on left side of neck, same side as injection. Patient also reported heat and slight raised skin from injection site, but no sign of spread; lymph node and clavicle were sore, foggy headache. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033451 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Immunisation, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200000790

Write-up: swollen lymph nodes; Swollen glands; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201020004565630-ELVM3 (RA). Other Case identifier: GB-MHRA-ADR 26424556 (RA). A 35 year-old female patient (not pregnant nor breastfeeding) received BNT162B2 (COMIRNATY), administration date 30Dec2021 (Lot number: FK9706) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: dose 1 & 2 of BNT162B2 for COVID-19 Immunisation. The following information was reported: LYMPHADENOPATHY (medically significant), outcome "not recovered", described as "swollen lymph nodes"; LYMPHADENOPATHY (medically significant), outcome "recovering", described as "Swollen glands". Additional information: swollen lymph nodes under both armpits (more swollen on the armpit of the arm the vaccine was given). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033452 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Body temperature increased, Confusional state, Fatigue, Feeling hot, Immunisation, Increased appetite, Influenza, Memory impairment, Oropharyngeal pain, SARS-CoV-2 test, Sinonasal obstruction, Sinus headache, Sinusitis, Somnolence, Tearfulness, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Sinusitis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000778

Write-up: confused; sleepy; i feel hot all the time; blocked nose; Flu symptoms; Headache sinus; Sore throat; Tiredness; Body temperature increased; Sinusitis; Tearfulness; Loss of weight; Increased appetite; Mental confusion; Forgetfulness; 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-202201020007341600-LPUBR (RA). Other Case identifier(s): GB-MHRA-ADR 26424566 (RA). A 33 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: Not known), for COVID-19 immunisation; Bnt162b2 (Dose 2, Lot number: Not known), for COVID-19 immunisation. Patient last menstrual period date Jun2021. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; CONFUSIONAL STATE (medically significant), outcome "recovering", described as "confused"; SOMNOLENCE (medically significant), outcome "recovering", described as "sleepy"; FEELING HOT (medically significant), outcome "recovering", described as "i feel hot all the time"; SINONASAL OBSTRUCTION (medically significant), outcome "recovering", described as "blocked nose"; INFLUENZA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Flu symptoms"; SINUS HEADACHE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Headache sinus"; OROPHARYNGEAL PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Sore throat"; FATIGUE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Tiredness"; BODY TEMPERATURE INCREASED (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Body temperature increased"; SINUSITIS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Sinusitis"; TEARFULNESS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Tearfulness"; WEIGHT DECREASED (medically significant) with onset 31Dec2021, outcome "unknown", described as "Loss of weight"; INCREASED APPETITE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Increased appetite"; CONFUSIONAL STATE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Mental confusion"; MEMORY IMPAIRMENT (medically significant) with onset 31Dec2021, outcome "unknown", described as "Forgetfulness". Clinical course details: The patient have a history of sinusitis but haven''t had a bout of it since the pandemic, until her booster jab. She have become confused and forgetful. She feel hot all the time, even with the windows open. She was sleepy throughout the day and still sleep through at night. Blocked nose, sore throat. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. 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 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: 2033463 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Diarrhoea, Erythema, Feeling hot, Immunisation, Lymphadenopathy, Peripheral swelling, Vaccination site mass
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000852

Write-up: Swollen arm; a pea sized lump at the injection site; very red; hot to touch; Diarrhea; Swollen lymph nodes; 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-202201020210074560-FJPKY (RA). Other Case identifier(s): GB-MHRA-ADR 26424593 (RA). A 38-year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (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 has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (DOSE 1.), for COVID-19 immunization; Bnt162b2 (DOSE 2.), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; DIARRHOEA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Diarrhea"; PERIPHERAL SWELLING (medically significant), outcome "unknown", described as "Swollen arm"; VACCINATION SITE MASS (medically significant), outcome "unknown", described as "a pea sized lump at the injection site"; ERYTHEMA (medically significant), outcome "unknown", described as "very red"; FEELING HOT (medically significant), outcome "unknown", described as "hot to touch". Additional information: Patient has not tested positive for COVID-19 since having the vaccine. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033466 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 NOT KNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Immunisation
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000823

Write-up: Period pains; 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-202201020450419880-MYROL (RA). Other Case identifier: GB-MHRA-ADR 26424606 (RA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: Not known) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. 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 30Dec2021, outcome "unknown", described as "Booster"; DYSMENORRHOEA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Period pains". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033468 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Dizziness postural, Fatigue, Headache, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vaccination site pain
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: Flu; Headache; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: PCR test; Test Result: Positive
CDC Split Type: GBPFIZER INC202200000245

Write-up: Positional dizziness; Appetite lost; Fatigue; Injection site pain; Off label use; interchange of vaccine products; Booster; Headache; This is a spontaneous report received from a contactable consumer from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201020633136860-5VINJ (RA). A 49-year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN3543) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Headache" (unspecified if ongoing); "Flu" (unspecified if ongoing); "Suspected COVID-19", start date: 22Nov2021, stop date: 15Dec2021. The patient had strong flu like reactions to both AstraZeneca vaccines that took several days to clear. The patient had PCR confirmed COVID in Nov2021 that had him bedbound for 5 days and off work for 3 weeks with headaches. The patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (dose 1, lot number: not known), for COVID-19 immunisation, reaction(s): "strong flu like reactions"; Covid-19 vaccine astrazeneca (dose 2, lot number: not known), for COVID-19 immunisation, reaction(s): "strong flu like reactions". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Nov2021) positive. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Headache"; DECREASED APPETITE (medically significant) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Appetite lost"; FATIGUE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Fatigue"; VACCINATION SITE PAIN (medically significant) with onset 30Dec2021, outcome "recovered" (02Jan2022), described as "Injection site pain"; DIZZINESS POSTURAL (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Positional dizziness". The patient started with dizziness on 30Dec2021. The patient was okay when sitting or standing but started when moving around or leaning. Headache mostly on one side of head. Bad enough to stay off work. The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033501 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, COVID-19, Chills, Nausea, Ocular hyperaemia, Pain in extremity, Pyrexia, SARS-CoV-2 test, Salivary hypersecretion, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANUSOL [BISMUTH OXIDE;MYROXYLON BALSAMUM BALSAM;ZINC OXIDE]; CERELLE; GARDASIL; GARDASIL; HYDROCORTISONE; PROPRANOLOL; VOLTAROL [DICLOFENAC SODIUM]
Current Illness: Palpitations (has anxiety related palpitations)
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data: Test Date: 20220101; 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: Vomiting; SARS-CoV-2 infection; Eye blood shot; Salivary hypersecretion; Abdominal pain; Nausea; Chills; Feverish; Painful arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26425000) 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 COVID-19 (SARS-CoV-2 infection), ABDOMINAL PAIN (Abdominal pain), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), PYREXIA (Feverish), PAIN IN EXTREMITY (Painful arm), OCULAR HYPERAEMIA (Eye blood shot) and SALIVARY HYPERSECRETION (Salivary hypersecretion) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: COVID-19 MRNA VACCINE BNT162B2 on 12-Jun-2021 and COVID-19 MRNA VACCINE BNT162B2 on 29-Aug-2021. Past adverse reactions to the above products included No adverse event with COVID-19 MRNA VACCINE BNT162B2 and COVID-19 MRNA VACCINE BNT162B2. Concurrent medical conditions included Palpitations (has anxiety related palpitations) since November 2021 and Anxiety. Concomitant products included HYDROCORTISONE from 15-Oct-2014 to an unknown date for Eczema, BISMUTH OXIDE, MYROXYLON BALSAMUM BALSAM, ZINC OXIDE (ANUSOL [BISMUTH OXIDE;MYROXYLON BALSAMUM BALSAM;ZINC OXIDE]) for Hemorrhoids, PROPRANOLOL from 10-Mar-2016 to an unknown date for Panic attacks, DESOGESTREL (CERELLE) from 26-Jun-2014 to an unknown date for Period pains, HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Vaccination, DICLOFENAC SODIUM (VOLTAROL [DICLOFENAC SODIUM]) for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant) and SALIVARY HYPERSECRETION (Salivary hypersecretion) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and OCULAR HYPERAEMIA (Eye blood shot) (seriousness criterion medically significant). On 01-Jan-2022, NAUSEA (Nausea) and VOMITING (Vomiting) had resolved. At the time of the report, COVID-19 (SARS-CoV-2 infection) and OCULAR HYPERAEMIA (Eye blood shot) had not resolved, ABDOMINAL PAIN (Abdominal pain), CHILLS (Chills), PYREXIA (Feverish) and PAIN IN EXTREMITY (Painful arm) was resolving and SALIVARY HYPERSECRETION (Salivary hypersecretion) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2022, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. Before patient take the booster dose on the 30th, she had a negative result in the rapid COVID test. The next day she did not take the rapid test and started with slight nausea and feverish at work. Fitness watch shows a higher heart rate than usual but she didn''t feel any heart issues, also not related to her palpitations history. At night, patient refers abdominal pains, increased salivation along with a significant alcohol intake. On 01Jan2022, in the early morning patient started vomiting (2 episodes) and having intense stomach pains throughout the day, both symptoms resolved. On the same morning patient tested positive for COVID, and in the afternoon patient noticed a blood spot on the inner side of her right eye that was ongoing until the time of this report. Despite describing the abdominal pains as really strong, patient was able to sleep, eat, and did not mention taking any medication. She did call EMS and was told to report as an adverse event of the vaccine, but no other treatment or intervention was mentioned. Although patient had tested positive for COVID, she did not mention any specific care taken, or other symptoms related to it. Company comment: This is an RA case concerning a 24-year-old, female patient with no relevant medical history reported who experienced abdominal pain asssociated with vomiting and fever. The events started on the same day she received the booster dose and lasted for 1 day, improving without any treatment. Patient also reports testing positive for COVID-19 on a rapid test on 01Jan2021. From the report it seems to be an auto-test that patient takes routinely every morning. No treatment or follow-up for COVID-19 was mentioned. Primary vaccination completed with Pfizer vaccine. Event seriousness was captured as provided by the Regulatory Authority. The benefit-risk relationship of mRNA-1273 in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Significant Follow up contains removal of Events- Stomach Pains, Myocarditis. Addition of an Event Saliva increased. Vaccine BIONTECH from concomitant to past drug history updated. Addition of Medical History Anxiety.; Sender''s Comments: This is an RA case concerning a 24-year-old, female patient with no relevant medical history reported who experienced abdominal pain asssociated with vomiting and fever. The events started on the same day she received the booster dose and lasted for 1 day, improving without any treatment. Patient also reports testing positive for COVID-19 on a rapid test on 01Jan2021. From the report it seems to be an auto-test that patient takes routinely every morning. No treatment or follow-up for COVID-19 was mentioned. Primary vaccination completed with Pfizer vaccine. Event seriousness was captured as provided by the Regulatory Authority. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 2033503 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Abdominal pain, Chills, Delayed recovery from anaesthesia, Fatigue, Headache, Immunisation, Interchange of vaccine products, Malaise, Myalgia, Off label use
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200003565

Write-up: Off label use; Interchange of vaccine products; Booster; Abdominal pain; Drowsiness prolonged postoperative; Feeling sick; Muscle ache; Headache; Tiredness; Chills; 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-202201021458188510-WSHLM. Other Case identifier(s): GB-MHRA-ADR 26424995. A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for COVID-19 immunisation. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not breastfeeding at the time of report and the patient was not enrolled in clinical trial. 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 AstraZeneca (Dose 2), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; ABDOMINAL PAIN (medically significant) with onset 30Dec2021, outcome "recovering", described as "Abdominal pain"; DELAYED RECOVERY FROM ANAESTHESIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Drowsiness prolonged postoperative"; MALAISE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Feeling sick"; MYALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Muscle ache"; HEADACHE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Headache"; FATIGUE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Tiredness"; CHILLS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Chills". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033523 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9707 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with 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 INC202200003642

Write-up: Migraine aura; Fatigue; Migraine; Nausea; 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-202201021840372980-NXSAB. Other Case identifier(s): GB-MHRA-ADR 26425139. A female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Lot number: FK9707) 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: MIGRAINE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Migraine"; MIGRAINE WITH AURA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Migraine aura"; NAUSEA (non-serious) with onset 30Dec2021, outcome "not recovered", described as "Nausea"; FATIGUE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report is not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033560 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 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? 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: COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211126; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202200003501

Write-up: 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) Regulatory number: GB-MHRA-WEBCOVID-202201030645211870-KXZI3. Other Case identifier(s): GB-MHRA-ADR 26425927. A 51 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN3543) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 23Nov2021 (unspecified if ongoing), notes: Unsure when symptoms stopped. Date of last menstrual period: 28Nov2021. Patient has not tested positive for COVID-19 since having the vaccine was not enrolled in clinical trial. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccin astrazeneca (Dose 1), administration date: 22Feb2021, for COVID-19 immunisation; Covid-19 vaccin astrazeneca (Dose 2), administration date: 17May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; MIGRAINE (medically significant) with onset 31Dec2021, outcome "recovered" (02Jan2022), described as "Migraine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) positive. The reporter did not consider the event related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033575 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Chills, Diarrhoea, Fatigue, Headache, Influenza like illness, Migraine, Night sweats, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
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: chills; feel ill with flu like illness; headache; Night sweats; Fatigue; Diarrhea; Migraine; This case was received via RA (Reference number: GB-MHRA-ADR 26426749) 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 CHILLS (chills), INFLUENZA LIKE ILLNESS (feel ill with flu like illness), HEADACHE (headache), MIGRAINE (Migraine), NIGHT SWEATS (Night sweats), FATIGUE (Fatigue) and DIARRHOEA (Diarrhea) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant) and DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced NIGHT SWEATS (Night sweats) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (feel ill with flu like illness) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). At the time of the report, CHILLS (chills), INFLUENZA LIKE ILLNESS (feel ill with flu like illness), HEADACHE (headache) and DIARRHOEA (Diarrhea) was resolving and MIGRAINE (Migraine), NIGHT SWEATS (Night sweats) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) 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 drugs 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. Patient felt ill with flu like illness, headache constant like migraine accompanied by sweats and chills. Company comment: This regulatory case concerns a 41-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of INFLUENZA LIKE ILNESS, MIGRAINE and DIARRHOEA amongst others. The events occurred within the first 2 days after receiving a third dose of mRNA-1273. No information about previous vaccination schedule was provided. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory case concerns a 41-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of INFLUENZA LIKE ILNESS, MIGRAINE and DIARRHOEA amongst others. The events occurred within the first 2 days after receiving a third dose of mRNA-1273. No information about previous vaccination schedule was provided. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2033577 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspepsia
SMQs:, Gastrointestinal nonspecific dysfunction (narrow)

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

Write-up: Heartburn; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26426792) 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 DYSPEPSIA (Heartburn) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 04-Oct-2021 to an unknown date for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced DYSPEPSIA (Heartburn) (seriousness criterion disability). On 31-Dec-2021, DYSPEPSIA (Heartburn) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not had symptoms associated with COVID-19 and did not had a COVID-19 test. Patient did not previously suffer from heartburn. The heartburn came on suddenly in the evening of the first day after patient received the COVID vaccine and was severed for over three hours and did not had recovery until the afternoon of the second day. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No treatment information was provided. Company comment: This regulatory authority concerns a 42-year-old patient of an unknown gender with no medical history reported, who experienced the unexpected serious (disability) events of Dyspepsia after mRNA- 1273 vaccine. The onset of the event occurred on the day after the third dose of mRNA- 1273 vaccine (reported as 3b dose) and had a duration of approximately 1 day. The seriousness criterion of the event was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority concerns a 42-year-old patient of an unknown gender with no medical history reported, who experienced the unexpected serious (disability) events of Dyspepsia after mRNA- 1273 vaccine. The onset of the event occurred on the day after the third dose of mRNA- 1273 vaccine (reported as 3b dose) and had a duration of approximately 1 day. The seriousness criterion of the event was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2033608 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000029A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, Hypertension, Pain, Palpitations, Pyrexia, SARS-CoV-2 test, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), 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), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2; COVID-19 MRNA VACCINE BNT162B2
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Chest pain; Heart palpitations; Fever; Fatigue/unusual tiredness; Shortness of breath; Racing heart (tachycardia); Fainting; Blood pressure high; Heart racing; Chest pain; Fever; Ache; Headache; Fatigue; This case was received via RA (Reference number: GB-MHRA-ADR 26428156) 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 PAIN (Ache), HEADACHE (Headache), FATIGUE (Fatigue), FATIGUE (Fatigue/unusual tiredness), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)), the second episode of CHEST PAIN (Chest pain), the second episode of PYREXIA (Fever), HYPERTENSION (Blood pressure high), the first episode of CHEST PAIN (Chest pain), PALPITATIONS (Heart racing), the first episode of PYREXIA (Fever) and SYNCOPE (Fainting) in a 22-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000029A) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 30-Dec-2021 to 03-Jan-2022. Concomitant products included (COVID-19 MRNA VACCINE BNT162B2) from 28-Jun-2021 to an unknown date for Vaccination, (COVID-19 MRNA VACCINE BNT162B2) for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), HYPERTENSION (Blood pressure high) (seriousness criterion medically significant), the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), PALPITATIONS (Heart racing) (seriousness criterion medically significant) and the first episode of PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant), TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant), the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), the second episode of PYREXIA (Fever) (seriousness criterion medically significant) and SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, PAIN (Ache), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved, FATIGUE (Fatigue/unusual tiredness), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)), the last episode of CHEST PAIN (Chest pain), the last episode of PYREXIA (Fever) and SYNCOPE (Fainting) outcome was unknown and HYPERTENSION (Blood pressure high) and PALPITATIONS (Heart racing) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that, patient spent a night in A+E with all the symptoms which was still not fully recovered but was feeling better as time went. Patient was taking paracetamol. Patient did not tested positive for COVID-19 after he had received the vaccine. The patient''s reaction was related to possible inflammation of the heart (myocarditis or pericarditis). Relevant investigations or tests such as blood tests, ECG and heart monitoring were conducted. Symptoms lead to a hospital stay which was for 1 night long and diagnosis was made by a medical professional (cardiologist, GP etc.), specific details of the diagnosis was given by doctor. No treatment medication details was prescribed because of the symptoms. No other imaging carried out such as but not limited to, chest X-ray, echocardiogram, cardiac MRI, chest computerized tomography (CT). Blood tests such as for certain proteins (called troponin) that signal heart muscle damage was taken. There were no other recent or ongoing illness.; Sender''s Comments: This is an RA case concerning a 22-year-old, male patient with no relevant medical history reported, who experienced the events of hypertension, chest pain, tachycardia, palpitations, pyrexia, headache, fatigue, dyspnea and syncope. The events occurred 1 day after receiving the third dose of mRNA 1273. Primary vaccination completed with Pfizer product. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 2033629 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Vomiting projectile
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Shivers; Vomiting projectile; This case was received via Regulatory Authority, MHRA (Reference number: GB-MHRA-ADR 26429945) 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 VOMITING PROJECTILE (Vomiting projectile) and CHILLS (Shivers) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). Concomitant products included LEVOTHYROXINE for Underactive. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced VOMITING PROJECTILE (Vomiting projectile) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant). On 31-Dec-2021, CHILLS (Shivers) had resolved. On 02-Jan-2022, VOMITING PROJECTILE (Vomiting projectile) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient had jab at 3pm on 30/12. Early hours started to shake and felt very cold. She took paracetamol. She vomited several times over the next couple of days. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This is a regulatory case concerning a female patient of an unknown age with medical history of an unspecified immunodeficiency who experienced the unexpected serious events of Vomiting projectile and Chills. The event of Vomiting projectile occurred on the same day after the third dose of mRNA-1273 vaccine and the event of Chills one day 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 SD.; Sender''s Comments: This is a regulatory case concerning a female patient of an unknown age with medical history of an unspecified immunodeficiency who experienced the unexpected serious events of Vomiting projectile and Chills. The event of Vomiting projectile occurred on the same day after the third dose of mRNA-1273 vaccine and the event of Chills one day 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 SD.


VAERS ID: 2033631 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005287 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2; CITALOPRAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211221; 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; Neck pain; Fatigue; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 26430074) 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 NECK PAIN (Neck pain), FATIGUE (Fatigue) and HEADACHE (Headache) in a 33-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005287) for an unknown indication. Concomitant products included CITALOPRAM from 01-Jan-2014 to an unknown date for Anxiety, (COVID-19 MRNA VACCINE BNT162B2) for COVID-19 vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, NECK PAIN (Neck pain) had not resolved and FATIGUE (Fatigue) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was provided.; Sender''s Comments: This is an RA case concerning a 33-year-old, male patient with no relevant medical history reported who experienced the events of headache, neck pain and fatigue. The events occurred 1 day after th booster dose of mRNA1273; Case seriousness was captured as provided by the Regulatory Authority. Primary vaccination completed with Pfizer vaccine. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 2033649 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Lymphadenopathy, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Supraclavicular lymph nodes enlarged; Tiredness; Muscle ache; High temperature; This case was received (Reference number: GB-MHRA-ADR 26430426) 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 LYMPHADENOPATHY (Supraclavicular lymph nodes enlarged), FATIGUE (Tiredness), MYALGIA (Muscle ache) and PYREXIA (High temperature) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). On 31-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced LYMPHADENOPATHY (Supraclavicular lymph nodes enlarged) (seriousness criterion medically significant). On 31-Dec-2021, FATIGUE (Tiredness), MYALGIA (Muscle ache) and PYREXIA (High temperature) had resolved. At the time of the report, LYMPHADENOPATHY (Supraclavicular lymph nodes enlarged) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient did not had symptoms associated with COVID-19. Patient was not currently breastfeeding No concomitant medications were reported It was reported that patient experienced tiredness, high temperature , full body ache which resolved after a days rest. The supraclavicular lymphadenopathy continued. Patient had not tested positive for COVID-19 since she had received the vaccine. No treatment information was provided. Company comment: This case concerns a 37-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of lymphadenopathy, fatigue, myalgia and pyrexia. The events started the same day after the booster dose of mRNA-1273. Events of fatigue, myalgia, and pyrexia resolved after a day of rest. Lymphadenopathy (described as enlarged supraclavicular lymph nodes), was ongoing at the time of the report. 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 37-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of lymphadenopathy, fatigue, myalgia and pyrexia. The events started the same day after the booster dose of mRNA-1273. Events of fatigue, myalgia, and pyrexia resolved after a day of rest. Lymphadenopathy (described as enlarged supraclavicular lymph nodes), was ongoing at the time of the report. 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: 2033650 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Palpitations, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Heart palpitations; Fatigue/unusual tiredness; Fever; high temperature; joint pain; shivering; Palpitation; Headache recurrent; Fatigue; Fever; This case was received via Regulatory Agency (Reference number: GB-MHRA-ADR 26430446) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations), FATIGUE (Fatigue/unusual tiredness), the second episode of PYREXIA (Fever), PYREXIA (high temperature), ARTHRALGIA (joint pain), CHILLS (shivering), HEADACHE (Headache recurrent), FATIGUE (Fatigue), PALPITATIONS (Palpitation) and the first episode of PYREXIA (Fever) in a 49-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 02-May-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and the first episode of PYREXIA (Fever) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced HEADACHE (Headache recurrent) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced PALPITATIONS (Palpitation) (seriousness criterion medically significant). On an unknown date, the patient experienced PALPITATIONS (Heart palpitations) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), the second episode of PYREXIA (Fever) (seriousness criterion medically significant), PYREXIA (high temperature) (seriousness criterion medically significant), ARTHRALGIA (joint pain) (seriousness criterion medically significant) and CHILLS (shivering) (seriousness criterion medically significant). On 01-Jan-2022, PALPITATIONS (Palpitation) had resolved. At the time of the report, PALPITATIONS (Heart palpitations), FATIGUE (Fatigue/unusual tiredness) and the last episode of PYREXIA (Fever) outcome was unknown and PYREXIA (high temperature), ARTHRALGIA (joint pain), CHILLS (shivering), HEADACHE (Headache recurrent) and FATIGUE (Fatigue) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. 12 hours post vaccine patient was experienced flu like symptoms (joint pain, shivering, high temperature). Lasted 24 hours. 2 days post vaccine patient was experienced 2 suspected palpitations while resting. Patient had experienced feeling fatigued (4 days post vaccine). 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. This report does not relate to possible inflammation of the heart (myocarditis or pericarditis). The diagnosis was not made by a medical professional. The symptoms didn''t lead to a hospital stay. There were no historical conditions reported. Patient had not had symptoms associated with COVID-19 Not had a COVID-19 test Patient was not pregnant, Patient not currently breastfeeding. Company comment: Company comment: This case concerns a 49-year-old, female patient with no medical history, previously vaccinated with COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected events of fatigue(two events), pyrexia(three events), headache, palpitations(two events), arthralgia and chills. The events of fatigue and pyrexia (first episodes) occurred on the same day after the third dose of mRNA-1273, headache occurred 1 day later, palpitations (first episode 2 days later, while the rest of the events occurred on an unknown date. As reported, 12 hours post vaccine patient experienced flu like symptoms (joint pain, shivering, high temperature) which lasted 24 hours. 2 days post vaccine patient experienced 2 suspected palpitations while resting, while patient had experienced feeling fatigued 4 days post vaccine. 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 49-year-old, female patient with no medical history, previously vaccinated with COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected events of fatigue(two events), pyrexia(three events), headache, palpitations(two events), arthralgia and chills. The events of fatigue and pyrexia (first episodes) occurred on the same day after the third dose of mRNA-1273, headache occurred 1 day later, palpitations (first episode 2 days later, while the rest of the events occurred on an unknown date. As reported, 12 hours post vaccine patient experienced flu like symptoms (joint pain, shivering, high temperature) which lasted 24 hours. 2 days post vaccine patient experienced 2 suspected palpitations while resting, while patient had experienced feeling fatigued 4 days post vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2033660 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
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: Migraine, 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220103; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: heart racing; Migraine headache; This case was received (Reference number: GB-MHRA-ADR 26431041) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing) and MIGRAINE (Migraine headache) in a 47-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced MIGRAINE (Migraine headache) (seriousness criterion medically significant). On an unknown date, the patient experienced PALPITATIONS (heart racing) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (heart racing) and MIGRAINE (Migraine headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, 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 had symptoms associated with COVID-19. No treatment drug information provided. Patient experienced Constant headache, did not have sleep, Heart racing, Constantly felt sick, Exhausted from all the side affects. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment: This case concerns a 47-year-old, female patient with no medical history, previously vaccinated with COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected events of migraine and palpitations. The event of migraine occurred approximately 1 day after the third dose of mRNA-1273, while palpitations occurred on unknown date. As reported, the patient experienced constant headache, did not have sleep, heart racing, constantly felt sick and was exhausted from all the side affects. 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 47-year-old, female patient with no medical history, previously vaccinated with COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected events of migraine and palpitations. The event of migraine occurred approximately 1 day after the third dose of mRNA-1273, while palpitations occurred on unknown date. As reported, the patient experienced constant headache, did not have sleep, heart racing, constantly felt sick and was exhausted from all the side affects. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2033707 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-20
Onset:2021-12-30
   Days after vaccination:10
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: Chest pain, Dizziness, Dyspnoea, Fatigue, Irregular breathing, Myocarditis, Palpitations, SARS-CoV-2 test, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), 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), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (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? 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
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: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Fainting; dizziness; irregular breathing; Myocarditis; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26443597) 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 DIZZINESS (dizziness), IRREGULAR BREATHING (irregular breathing), MYOCARDITIS (Myocarditis), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)) and SYNCOPE (Fainting) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005287) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 10-Jul-2021 to 18-Jul-2021. On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (dizziness) (seriousness criterion medically significant), IRREGULAR BREATHING (irregular breathing) (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), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant), TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant) and SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, DIZZINESS (dizziness) and IRREGULAR BREATHING (irregular breathing) was resolving, MYOCARDITIS (Myocarditis) had not resolved and FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)) and SYNCOPE (Fainting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had some heart palpitations, chest pains, dizziness, irregular breathing and heart beating. At the moment patient still have some minor chest stings. report reported myocarditis or pericarditis relate to possible inflammation of the heart No concomitant product was provided. No treatment information was provided. Company Comment: This regulatory authority case concerns a 37-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of Dizziness, Irregular breathing, Fatigue, Chest pain, Dyspnoea, Palpitations and Tachycardia, expected serious AESI event of Myocarditis and expected serious event of Syncope. The event Myocarditis occurred 10 days after and the events Dizziness, Irregular breathing, Fatigue, Chest pain, Dyspnoea, Palpitations, Tachycardia and Syncope on an unknown date after the third mRNA- 1273 vaccine. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. The seriousness criteria of the events were assessed as per regulatory authority report.; Sender''s Comments: This regulatory authority case concerns a 37-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of Dizziness, Irregular breathing, Fatigue, Chest pain, Dyspnoea, Palpitations and Tachycardia, expected serious AESI event of Myocarditis and expected serious event of Syncope. The event Myocarditis occurred 10 days after and the events Dizziness, Irregular breathing, Fatigue, Chest pain, Dyspnoea, Palpitations, Tachycardia and Syncope on an unknown date after the third mRNA- 1273 vaccine. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. The seriousness criteria of the events were assessed as per regulatory authority report.


VAERS ID: 2033770 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-12-30
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Failed in vitro fertilisation; Miscarriage; Stillbirth
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200055600

Write-up: SARS-CoV-2 infection; 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 Authority and Healthcare products Regulatory Agency. The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single and administration date 13May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Abortion spontaneous" (unspecified if ongoing); "Suspected COVID-19", start date: 29Dec2021 (ongoing); "Failed in vitro fertilisation" (unspecified if ongoing); "Stillbirth" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 30Dec2021, outcome "recovering", described as "SARS-CoV-2 infection"; DRUG INEFFECTIVE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Drug ineffective/SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: Yes - Positive COVID-19 test. 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-202200055601 same patient/product, different dose and event;GB-PFIZER INC-202200000622 same patient/product, different dose and event


VAERS ID: 2033794 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-11
Onset:2021-12-30
   Days after vaccination:49
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: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202112; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202200037377

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y + T478K; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y + T478K; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2022FOS000020 (Fosun). This is a spontaneous report received from a non-contactable HCP received via Department of Health (DH). The regulatory authority report number is not applicable. As of 0:00 am, 31-Dec-2021, DH announced that thirteen additional confirmed cases of COVID-19 after Comirnaty vaccination. This report was split for 1 of 13 patients that confirmed COVID-19 after Comirnaty vaccination. A 65-year-old female patient started to receive three doses of Tozinameran (COMIRNATY) (lot number: unknown) on 15-Mar-2021, 09-Apr-2021 and 11-Nov-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 30-Dec-2021, she arrived via flight. On the same day, the patient had symptoms. In Dec-2021, the patient tested positive. She was confirmed as COVID-19 with mutant strain of N501Y and T478K. The adverse event ''confirmed case of COVID-19/imported case with mutant strain of N501Y + T478K'' was considered as Important Medical Event. At the time of the report, the outcome of the event was unknown. Initial report was received on 01-Jan-2022. This case was split from AER 2021FOS007602 due to same reporter/product, different event/patient. This source also attached to AER 2022FOS000774 since same patient, different dosage of vaccination and different event. Follow-up closed, no further information is possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200037375 same reporter/patient and different dose;HK-PFIZER INC-202200020676 same reporter/suspect drug and different patients


VAERS ID: 2033796 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-12-30
   Days after vaccination:227
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202112; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: COVID-19 with mutant strain of N501Y and T478K
CDC Split Type: HKPFIZER INC202200037382

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y + T478K; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y + T478K; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party (BioNTech) and Regulatory Authority. Other Case identifier(s): HK-Fosun-2022FOS000022. This is a spontaneous report received from a non-contactable HCP received via the regulatory authority. The regulatory authority report number is not applicable. As of 0:00 am, 31-Dec-2021, RA announced that thirteen additional confirmed cases of COVID-19 after Comirnaty vaccination. This report was split for 1 of 13 patients that confirmed COVID-19 after Comirnaty vaccination. A 61-year-old male patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 22-Apr-2021 and 17-May-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 30-Dec-2021, he arrived via flight. On the same day, the patient had symptoms. In Dec-2021, the patient tested positive. He was confirmed as COVID-19 with mutant strain of N501Y and T478K. The adverse event ''confirmed case of COVID-19/imported case with mutant strain of N501Y+T478K'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 01-Jan-2022. This case was split from AER 2021FOS007602 due to same reporter/product, different event/patient. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Drugs: COMIRNATY Causality Assessments: COVID-19, Vaccination failure Per Reporter= Possible Per Company (BioNTech) = Possible Follow-up closed, no further information is possible.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200020676 Same reporter/drug/event, different patients


VAERS ID: 2033800 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-12-30
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: COVID-19 with mutant strain of N501Y+T478K.
CDC Split Type: HKPFIZER INC202200048943

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y+T478K; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y+T478K; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2022FOS000028. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. As of 0:00 am, 01-Jan-2022, RA announced that two additional confirmed cases of COVID-19 and six additional asymptomatic cases of COVID-19 after Comirnaty vaccination. This case was split for 1 of 2 confirmed cases of COVID-19 after Comirnaty vaccination. A 54-year-old male patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 09-Jun-2021 and 30-Jun-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 30-Dec-2021, the patient arrived at by flight. The patient developed symptoms on the same day. On an unknown date, the patient tested positive. The patient was confirmed as COVID-19 with mutant strain of N501Y+T478K. The adverse event ''confirmed case of COVID-19/imported case with mutant strain of N501Y+T478K'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 02-Jan-2022. This case was split from AER 2021FOS007569 due to same reporter/product, different event/patient. Follow-up closed, no further information is possible. Drug: Comirnaty Causality Assessments: COVID-19;Vaccination failure Per Reporter= Possible Per Company (BioNTech) = Possible Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200027217 same reporter/product, different event/patient


VAERS ID: 2034792 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 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: INFLUENZA VIRUS
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: Fatigue; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26433268) 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 FATIGUE (Fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 09-Nov-2021 to an unknown date for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Reaction began 7 to 8 hours after vaccination. Fatigue, mental fatigue, shivers, general malaise. Six days so far. Treatment information was not provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 50-year-old male patient, with no medical history provided, who experienced serious unexpected event of Fatigue. As per provided dates in the source document, the event occurred the day after the patient had received the mRNA-1273 vaccine (as third dose, booster). As per case description, the event began 7 to 8 hours after vaccination. It was stated that the patient had fatigue, mental fatigue, shivers and general malaise. At the time of this report, the event of Fatigue was still ongoing. No additional 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 50-year-old male patient, with no medical history provided, who experienced serious unexpected event of Fatigue. As per provided dates in the source document, the event occurred the day after the patient had received the mRNA-1273 vaccine (as third dose, booster). As per case description, the event began 7 to 8 hours after vaccination. It was stated that the patient had fatigue, mental fatigue, shivers and general malaise. At the time of this report, the event of Fatigue was still ongoing. No additional 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: 2036838 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Headache, Immunisation, Interchange of vaccine products, Off label use, Oropharyngeal pain, Pyrexia
SMQs:, 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)

Life Threatening? No
Birth Defect? No
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 INC202200000310

Write-up: Off-label use; Interchange of vaccine products; Booster; Fever; Headache; Sore throat; This is a spontaneous report received from a contactable consumer from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112310938518060-NYAIQ (RA). Other Case identifier(s): GB-MHRA-ADR 26420369 (RA). A 48-year-old female patient received BNT162B2 (COMIRNATY; lot number and expiration date were not reported), via an unspecified route of administration on 30Dec2021 (at the age of 48-years-old) 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 (first dose, MANUFACTURER UNKNOWN), for COVID-19 immunization; COVID-19 vaccine (second dose; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fever"; HEADACHE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Headache"; OROPHARYNGEAL PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Sore throat". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2036844 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Dizziness, Headache, Immunisation, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), 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: CITALOPRAM; QUETIAPINE; RIGEVIDON (28)
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dysmenorrhoea; Mood swings; Suspected COVID-19 (Unsure when symptoms started. Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211017; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200003716

Write-up: Headache/pounding headache like someone was punching the top of my head; High temperature/high temperature throughout the day and this subsided in the evening; Nausea; Dizziness/Dizzy; Painful arm/arm pain in the evening; 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-202201011421021360-RMMAN (RA). Other Case identifier(s): GB-MHRA-ADR 26424093 (RA). A 25 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. Patient last menstrual period date was 30-DEC-2021. Patient was not currently breastfeeding. Relevant medical history included: "Suspected COVID-19" (unknown if ongoing), notes: Unsure when symptoms started. Unsure when symptoms stopped; "Mood swings" (unspecified if ongoing); "Dysmenorrhoea" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM, start date: 2014; QUETIAPINE taken for mood swings, start date: 2018; RIGEVIDON (28) taken for dysmenorrhoea, start date: 2015. Vaccination history included: Comirnaty (Dose 1), for COVID-19 immunization; Comirnaty (Dose 2), for COVID-19 immunization. Patient was not enrolled in clinical trial. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Headache/pounding headache like someone was punching the top of my head"; PAIN IN EXTREMITY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Painful arm/arm pain in the evening"; PYREXIA (medically significant) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "High temperature/high temperature throughout the day and this subsided in the evening"; NAUSEA (medically significant) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Nausea"; DIZZINESS (medically significant) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Dizziness/Dizzy". Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Oct2021) positive, notes: Yes - Positive COVID-19 test. Clinical Course: It was reported that 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: 2036848 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Abdominal pain upper, Arthralgia, Back pain, Bone pain, Crying, Dissociation, Dizziness, Emotional disorder, Feeling abnormal, Hallucination, Hangover, Immunisation, Influenza like illness, Interchange of vaccine products, Limb immobilisation, Mental fatigue, Muscle fatigue, Myalgia, Off label use, Pain, Pain in extremity, Paranoia, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Osteonecrosis (broad), Arthritis (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (taking brown and blue inhaler); Chronic fatigue syndrome; Endometriosis; Fibromyalgia; Heavy periods; Immunodeficiency (illness or condition which reduces the immune response.)
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000250

Write-up: crying; Feverish; Joint ache; bone hurts; Generalised muscle aches; stomach aches; feel like I have mild flu or hangover; feel like I have mild flu or hangover; Pain/just sore; Muscle fatigue; Mental fatigue; Limb immobilization/lost the ability to move completely (apart from fingers and face); back felt heavy and ached a lot; Swollen arm/arm had swollen up and was in pain; arm had swollen up and was in pain/arm is hurting; off label use; interchange of vaccine products; Booster; feeling really hazy; Dizzy; Dissociation; Hallucinations (weird colours, seeing bugs); extremely paranoid; getting very emotional (crying but was not sure why); This is a spontaneous report received from a contactable consumer from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201011637080100-4S8RL. A 25-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic fatigue syndrome" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "suspected fibromyalgia" (unspecified if ongoing); "Asthma" (unspecified if ongoing), notes: taking brown and blue inhaler; "Immunodeficiency" (unspecified if ongoing), notes: illness or condition which reduces the immune response.; "heavy on my period" (unspecified if ongoing). The patient not had symptoms associated with COVID-19. The patient was not pregnant and was not currently breastfeeding. The patient''s last menstrual period date was on 29Dec2021. The patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Past drug history included: Citalopram for mental health disorders, notes: 30mg. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability, medically significant) with onset 30Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 30Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (disability, medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; FEELING ABNORMAL (disability, medically significant) with onset 30Dec2021, outcome "recovering", described as "feeling really hazy"; DIZZINESS (disability, medically significant) with onset 30Dec2021, outcome "recovering", described as "Dizzy"; DISSOCIATION (disability, medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "Dissociation"; HALLUCINATION (disability, medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "Hallucinations (weird colours, seeing bugs)"; PARANOIA (disability, medically significant) with onset 30Dec2021, outcome "unknown", described as "extremely paranoid"; EMOTIONAL DISORDER (disability, medically significant) with onset 30Dec2021, outcome "recovering", described as "getting very emotional (crying but was not sure why)"; CRYING (disability, medically significant), outcome "recovering", described as "crying"; LIMB IMMOBILISATION (disability, medically significant) with onset 30Dec2021, outcome "recovered with sequelae" (30Dec2021), described as "Limb immobilization/lost the ability to move completely (apart from fingers and face)"; BACK PAIN (disability, medically significant) with onset 30Dec2021, outcome "recovering", described as "back felt heavy and ached a lot"; PERIPHERAL SWELLING (disability, medically significant) with onset 30Dec2021, outcome "recovering", described as "Swollen arm/arm had swollen up and was in pain"; PAIN IN EXTREMITY (disability, medically significant) with onset 30Dec2021, outcome "recovering", described as "arm had swollen up and was in pain/arm is hurting"; PAIN (disability, medically significant) with onset 31Dec2021, outcome "not recovered", described as "Pain/just sore"; MUSCLE FATIGUE (disability, medically significant) with onset 30Dec2021, outcome "not recovered", described as "Muscle fatigue"; MENTAL FATIGUE (disability, medically significant) with onset 30Dec2021, outcome "not recovered", described as "Mental fatigue"; PYREXIA (disability, medically significant) with onset 01Jan2022, outcome "not recovered", described as "Feverish"; ARTHRALGIA (disability, medically significant) with onset 01Jan2022, outcome "not recovered", described as "Joint ache"; BONE PAIN (disability, medically significant) with onset 01Jan2022, outcome "not recovered", described as "bone hurts"; MYALGIA (disability, medically significant) with onset 01Jan2022, outcome "not recovered", described as "Generalised muscle aches"; ABDOMINAL PAIN UPPER (disability, medically significant) with onset 01Jan2022, outcome "unknown", described as "stomach aches"; INFLUENZA LIKE ILLNESS (disability, medically significant), HANGOVER (disability, medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "feel like I have mild flu or hangover". The patient had not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) no - negative covid-19 test. Therapeutic measures were taken as a result of arthralgia, bone pain. Clinical course: 30 minutes after booster vaccine, the patient started feeling really hazy and dizzy. It got worse and she started experiencing dissociation, started hallucinating (weird colors, seeing bugs), was extremely paranoid and getting very emotional (crying but was not sure why) and lost the ability to move completely (apart from fingers and face) for 30 minutes, and was slowly recovering mobilization for 2 hours. The patient''s partner called emergency as the patient was extremely panicked as she did not know what was happening to her, but by the time she got through to someone (almost 2 hours later), the effects had lessened. A few hours later her back felt heavy and ached a lot, and her arm had swollen up and was in pain and called emergency again. The day after, she started feeling a bit more normal again, just sore and very out of it with some swelling in arm. 2 days after vaccine, and she was experiencing muscle fatigue, mental fatigue, she had a fever, her arm was still hurting and swollen, her back still hurts, she still feel slightly out of it, her joints and bone hurts even with paracetamol, feel a bit out of it and getting stomach aches. The patient was feeling like I have mild flu or hangover. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2036855 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Eye swelling, Facial paralysis, Immunisation, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211223; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000280

Write-up: Facial droop; Swollen eyes; 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-202201012317418190-53AMJ (RA). Other Case identifier(s): GB-MHRA-ADR 26424523 (RA). A 33 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19" (ongoing), notes: Unsure when symptoms started. Date of last menstrual period was reported as 25Nov2021. Patient is not currently breastfeeding and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. 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 30Dec2021, outcome "unknown", described as "Booster"; FACIAL PARALYSIS (medically significant) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Facial droop"; EYE SWELLING (medically significant) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Swollen eyes". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. These events 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: 2036866 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Immunisation, Menstruation irregular, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200003833

Write-up: during menstruation; Period pains; 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-202201020932137020-9QPY3 (RA). Other Case identifier(s): GB-MHRA-ADR 26424722 (RA). A 28 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN3543) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization, reaction(s): "No adverse event"; Bnt162b2 (DOSE 2), for COVID-19 Immunization, reaction(s): "No adverse event". The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; MENSTRUATION IRREGULAR (medically significant), outcome "not recovered", described as "during menstruation"; DYSMENORRHOEA (medically significant) with onset 01Jan2022, outcome "recovering", described as "Period pains". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) negative. Clinical course: Patient last menstrual period date was 01Jan2022. Patient had no symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Patient diagnosed with endometriosis previously. For 2 of 3 COVID vaccinations which were administered after day 20 of cycle patient has experienced severe period pains. The vaccine which did not cause severe period pain was administered on day 4 of cycle, i.e. during menstruation. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No relevant investigations or tests conducted. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2036870 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Dizziness, Dizziness postural, Immunisation, Interchange of vaccine products, Malaise, Nausea, Off label use, SARS-CoV-2 test, Vertigo
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003802

Write-up: I couldn''t stand on my own without falling; I couldn''t lay down without the room spinning; feeling very sick; still get dizzy now when I get up quickly and if I move my head quicker than a slow movement; Off label use; Interchange of vaccine products; Booster; Nausea; Dizzy; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional) from the Agency Regulatory Authority. The Regulatory number is GB-MHRA-WEBCOVID-202201021013089500-1OCFT Regulatory Authority and the Other Case identifier is GB-MHRA-ADR 26424752 Regulatory Authority. The reporter is the patient. A 49-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY) via an unspecified route of administration on 30Dec2021 (batch/lot number: unknown) at the age of 49 years old, as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Relevant medical history included: "Suspected COVID-19" (start date: 07Jul2021, stop date: 15Jul2021. Patient is not enrolled in clinical trial. Patient is not pregnant and is not currently breastfeeding. Patient last menstrual period date is 04Dec2021. Concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (first dose, unknown manufacturer (batch/lot number: unknown) as DOSE 1, SINGLE) for COVID-19 immunization; Covid-19 vaccine (second dose, unknown manufacturer (batch/lot number: unknown) as DOSE 2, SINGLE) for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown" described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown" described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown" described as "Booster"; NAUSEA (medically significant) with onset 30Dec2021, outcome "recovered" (01Jan2022), described as "Nausea"; DIZZINESS (medically significant) with onset 30Dec2021, outcome "recovering" described as "Dizzy"; BALANCE DISORDER (medically significant), outcome "unknown" described as "I couldn''t stand on my own without falling"; VERTIGO (medically significant), outcome "unknown" described as "I couldn''t lay down without the room spinning"; MALAISE (medically significant), outcome "unknown" described as "feeling very sick"; and DIZZINESS POSTURAL (medically significant) with onset 02Jan2022, outcome "unknown" described as "still get dizzy now when I get up quickly and if I move my head quicker than a slow movement." The patient underwent the following laboratory tests and procedures: COVID-19 virus test (SARS-CoV-2 test): (26Dec2021) negative, notes: No - Negative COVID-19 test. The clinical course was reported as follows: About 6 hours after having the booster, I started to feel dizzy this got gradually worse over the next couple of hours. I couldn''t stand on my own without falling and I couldn''t lay down without the room spinning and feeling very sick. After about 36 hours the dizziness started to lessen. I still get dizzy now (3days later) when I get up quickly and if I move my head quicker than a slow movement. 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; information about the batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 2036879 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, SARS-CoV-2 test, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200003660

Write-up: Partial sight; 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-202201021154232810-FMZQ6. Other Case identifier(s): GB-MHRA-ADR 26424850. A 32 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 11Jul2021, stop date: 11Jul2021. The patient''s 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 (disability, medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; VISUAL IMPAIRMENT (disability, medically significant) with onset 01Jan2022, outcome "not recovered", described as "Partial sight". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jul2021) positive, notes: Yes - Positive COVID-19 test. Clinical information: Lost partial sight in right eye that is acting like a blindspot. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. report does not relate 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: 2036881 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Fatigue, Immunisation, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202200003653

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202201021158580080-IAL96 (RA). Other Case identifier(s): GB-MHRA-ADR 26424853 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (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 not had symptoms associated with COVID-19. 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 30Dec2021, outcome "unknown", described as "booster"; NAUSEA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Nausea"; FATIGUE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Fatigue"; PYREXIA (medically significant) with onset 31Dec2021, outcome "recovering", described as "Fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test no - negative covid-19 test. Clinical course: Patient was not tested positive for COVID-19 since the vaccination. Patient was not enrolled in clinical trial. This report did not 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: 2036882 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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, Dizziness, Immunisation, Interchange of vaccine products, Off label use, Pain, Tinnitus
SMQs:, Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Vestibular 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200003838

Write-up: Intermittent pain; Dizziness; Ringing in ears; Chest pain on the left side under rib cage; 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-202201021246326610-LY30I. Other Case identifier(s): GB-MHRA-ADR 26424887. A 45 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN5254) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (DOSE X; MANUFACTUERER UNKNOWN (where X=1, 2, or number unknown) ), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization, medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (hospitalization, medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; CHEST PAIN (hospitalization, medically significant) with onset 31Dec2021, outcome "not recovered", described as "Chest pain on the left side under rib cage"; PAIN (hospitalization, medically significant), outcome "unknown", described as "Intermittent pain"; DIZZINESS (hospitalization, medically significant), outcome "unknown", described as "Dizziness"; TINNITUS (hospitalization, medically significant), outcome "unknown", described as "Ringing in ears". Chest pain on the left side under rib cage. Intermittent pain. Dizziness and ringing in the ears. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2036891 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Asthenia, Condition aggravated, Diarrhoea, Gastrointestinal pain, Immunisation, Interchange of vaccine products, Malaise, Nausea, Off label use, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (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: AMLODIPINE; CODEINE PHOSPHATE; FUROSEMIDE; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Miscarriage
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 INC202200003605

Write-up: cramps getting worse; Felt ill; Nausea; Suspected COVID-19; Weakness; Diarrhoea; Bowel cramps/very bad bowel cramps; 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. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201021429458410-YQVY0 (Agency). Other Case identifier(s): GB-MHRA-ADR 26424982 (Agency). A 36 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN5254) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Miscarriage" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension, start date: 2016; CODEINE PHOSPHATE taken for abortion spontaneous, start date: 06Nov2021, stop date: 20Nov2021; FUROSEMIDE taken for hypertension, start date: 2020; RAMIPRIL taken for hypertension, start date: 2016, stop date: Oct2021. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), administration date: 28Feb2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 2), administration date: 31Jul2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; SUSPECTED COVID-19 (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Suspected COVID-19"; ASTHENIA (medically significant) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Weakness"; DIARRHOEA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Diarrhoea"; GASTROINTESTINAL PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Bowel cramps/very bad bowel cramps"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "cramps getting worse"; MALAISE (medically significant) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Felt ill"; NAUSEA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Nausea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) negative, notes: No - Negative COVID-19 test. Since received booster jab, I m having very bad bowel cramps, whatever or whenever i eat cramps getting worse and have diarrhoea straight after eat. Sometimes I have nausea all sudden. 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. Report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2036892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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, Contusion, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (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: 20211230; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003739

Write-up: Very painful and swollen armpit; Very painful and swollen armpit/swelling spread to chest area; Hurts to touch and feels like bruising; Swollen lymph nodes; 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. Regulatory number: GB-MHRA-WEBCOVID-202201021536296900-JDHRQ (MHRA). Other Case identifier: GB-MHRA-ADR 26425002 (MHRA). A 28 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (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. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: Off label use, interchange of vaccine products and booster, all with onset 30Dec2021; and swollen lymph nodes with onset 31Dec2021. It was also reported that on an unspecified date, patient experienced very painful and swollen armpit. The swelling spread to chest area. Hurts to touch and feels like bruising. The arm itself was fine. All events were reported as serious per other medically important condition. The outcome of the event swollen lymph nodes was not recovered, while outcome of the remaining events was unknown. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (30Dec2021) no - negative covid-19 test. 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: 2036895 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FK971L / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Neck pain, Off label use, Peripheral swelling, SARS-CoV-2 test, Vaccination site swelling, Vaccination site vesicles
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211111; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200003787

Write-up: Severe swelling and blistering of injection site; Severe swelling and blistering of injection site; Swollen glands; Neck pain; Swollen arm; Off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201021614342640-ANETX. Other Case identifier: GB-MHRA-ADR 26425038. A 38 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FK971L) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 09Nov2021 (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN, SINGLE), administration date: 13Mar2021, for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; VACCINATION SITE VESICLES (medically significant), VACCINATION SITE SWELLING (medically significant) all with onset 31Dec2021, outcome "not recovered" and all described as "Severe swelling and blistering of injection site"; LYMPHADENOPATHY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen glands"; NECK PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Neck pain"; PERIPHERAL SWELLING (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen arm ". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Nov2021) positive, notes: Yes - Positive COVID-19 test. Additional information: Patient is not pregnant. Patient is not currently breastfeeding. The patient had severe swelling and blistering of injection site; it was worsening, affected area now was 6cm x 8cm. The patient has swollen glands in neck. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2036900 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Carditis, Chest pain, Chills, Dyspnoea, Immunisation, Lymphadenopathy, Night sweats, Pain, Palpitations, Pyrexia, Tachycardia, Tenderness
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 (narrow), Dehydration (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:
CDC Split Type: GBPFIZER INC202200003801

Write-up: Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); achey pain; tenderness; heart inflammation/inflammation of the heart (myocarditis or pericarditis); shivers; Feverish/Fever; Swollen lymph nodes/lymph nodes in the armpit have swollen; Booster; sweats during the night starting; 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-202201021738054630-25WG2 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26425109 (MHRA). A 19-year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (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 2), administration date: 09Aug2021, for COVID-19 vaccination, reaction(s): "Pericarditis", "fever", "shivers", "sweats during the night", "heart inflammation"; Bnt162b2 (DOSE 1), administration date: 15Jun2021, for COVID-19 vaccination. The following information was reported: IMMUNISATION (disability) with onset 30Dec2021, described as "Booster"; PYREXIA (disability) with onset 31Dec2021, outcome "recovered" (02Jan2022), described as "Feverish/Fever"; LYMPHADENOPATHY (disability) with onset 31Dec2021, outcome "recovering", described as "Swollen lymph nodes/lymph nodes in the armpit have swollen"; CHEST PAIN (disability), outcome "unknown", described as "Chest pain"; DYSPNOEA (disability), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (disability), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (disability), outcome "unknown", described as "Racing heart (tachycardia)"; PAIN (disability), outcome "unknown", described as "achey pain"; TENDERNESS (disability), outcome "unknown", described as "tenderness"; CARDITIS (disability), outcome "unknown", described as "heart inflammation/inflammation of the heart (myocarditis or pericarditis)"; CHILLS (disability), outcome "unknown", described as "shivers"; NIGHT SWEATS (disability), outcome "unknown", described as "sweats during the night starting". Clinical course: After booster, the patient had experienced fever shivers and sweats during the night starting 12 hours after receiving the jab, lasting 48 hours. After booster, the lymph nodes in the armpit have swollen causing an achy pain and tenderness. After the second dose, the patient experienced heart inflammation, and had done ever since, and now after the booster it seemed to have come back again, after it had seemingly started to get better from the second dose. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report relates to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. A diagnosis was not made by a medical professional. No blood tests, such as for certain proteins (called troponin) that signal heart muscle damage was taken. 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-202200024656 Same patient/vaccine, different dose/event


VAERS ID: 2036907 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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, Headache, Immunisation, Interchange of vaccine products, Nausea, Off label use, Pain of skin, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003734

Write-up: Headache; nausea; Vomiting; Aching joints; Skin 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 United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202201021754314510-MZWRN (MHRA). Other Case identifier(s): GB-MHRA-ADR 26425120 (MHRA). A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 18Oct2021, stop date: 27Oct2021. Concomitant medication(s) included: INFLUENZA VIRUS taken for influenza immunisation, start date: 13Dec2021, stop date: 13Dec2021. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 29Apr2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: 01Jul2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; NAUSEA (medically significant) with onset 31Dec2021, outcome "unknown", described as "nausea"; VOMITING (medically significant) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Vomiting"; ARTHRALGIA (medically significant) with onset 31Dec2021, outcome "recovered" (02Jan2022), described as "Aching joints"; PAIN OF SKIN (medically significant) with onset 31Dec2021, outcome "recovered" (02Jan2022), described as "Skin pain"; HEADACHE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) no - negative covid-19 test. Therapeutic measures were taken as a result of headache which includes Paracetamol and ibuprofen taken every 4-5 hours but are not helping. Additional information: Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Last menstrual period on 23Dec2021. 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: 2036940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Diarrhoea, Immunisation, Interchange of vaccine products, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: CERELLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (yes - positive covid-19 test); Sickle cell trait
Allergies:
Diagnostic Lab Data: Test Date: 20211101; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200003781

Write-up: Diarrhea; Fever chills; 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 authority. Regulatory number: GB-MHRA-WEBCOVID-202201030125346200-OJFBE. Other Case identifier: GB-MHRA-ADR 26425510 . A 35 year-old female patient (not pregnant) received BNT162B2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Sickle cell trait" (unspecified if ongoing); "COVID-19", start date: 01Nov2021 (unspecified if ongoing). The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (01Nov2021) yes - positive covid-19 test. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Concomitant medication included: CERELLE. Vaccination history included: COVID-19 VACCINE ASTRAZENECA (Dose 2), administration date: 01Jun2021, for COVID-19 Immunization; COVID-19 VACCINE ASTRAZENECA (Dose 1), administration date: 01Mar2021, for COVID-19 Immunization. The following information was reported: Off label use, interchange of vaccine products and booster, all with onset 30Dec2021 and outcome of unknown; diarrhea with onset 31Dec2021, outcome "recovering"; and fever chills with onset 31Dec2021, outcome "recovered" (01Jan2022). The events were considered as serious per other medically important condition. 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). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2036984 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary mass, Axillary pain, Immunisation, Interchange of vaccine products, 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:
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009315

Write-up: Feeling of having small lump under armpit; Severe armpit pain; Off-label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer) from a Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201030939543170-Q8BGV. Other Case identifier(s): GB-MHRA-ADR 26426590. A 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (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 had no 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: 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 30Dec2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Severe armpit pain"; AXILLARY MASS (medically significant), outcome "unknown", described as "Feeling of having small lump under armpit". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) no - negative COVID-19 test. Therapeutic measures were taken as a result of axillary pain, axillary mass which included pain killers that did not take pain away. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2036985 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Dyspepsia, Headache, Immunisation, Interchange of vaccine products, Off label use, Paraesthesia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
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 INC202200009282

Write-up: Indigestion; Vomiting; Stomach cramps; Tingling skin; 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. Regulatory number: GB-MHRA-WEBCOVID-202201031005533860-7AISL. Other Case identifier(s): GB-MHRA-ADR 26426775. A 61 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN3543) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 nor tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Headache"; VOMITING (medically significant) with onset 31Dec2021, outcome "recovering", described as "Vomiting"; ABDOMINAL PAIN UPPER (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Stomach cramps"; PARAESTHESIA (medically significant) with onset 31Dec2021, outcome "recovered", described as "Tingling skin"; DYSPEPSIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Indigestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: No - Negative COVID-19 test. The reporter did not consider the event related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2037004 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Ear discomfort, Ear pain, Immunisation, Maternal exposure during pregnancy, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Negative later flows for 2 weeks before vaccine and after
CDC Split Type: GBPFIZER INC202200009632

Write-up: Coughing; Earache/Sore ears; blocked ears that evening; Maternal exposure during pregnancy; Booster; Sore throat; 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-202201031406330240-L3VG8. Other Case identifier(s): GB-MHRA-ADR 26428271. A 34 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pregnancy" (ongoing). The patient is expected to deliver a baby(s). Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication(s) included: FOLIC ACID taken for vitamin supplementation; INFLUENZA VIRUS, administration date 02Dec2021. 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 30Dec2021, outcome "unknown", described as "Booster"; OROPHARYNGEAL PAIN (medically significant) with onset 30Dec2021, outcome "recovering", described as "Sore throat"; COUGH (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Coughing"; EAR PAIN (medically significant) with onset 30Dec2021, outcome "recovering", described as "Earache/Sore ears"; EAR DISCOMFORT (medically significant) with onset 30Dec2021, outcome "recovering", described as "blocked ears that evening "; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 30Dec2021, outcome "unknown", described as "Maternal exposure during pregnancy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Negative later flows for 2 weeks before vaccine and after. Additional information: patient has not tested positive for COVID-19 since having the vaccine. Patient was exposed to the medicine before pregnancy. 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: 2037043 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Decreased appetite, Diarrhoea, Dizziness postural, Dry throat, Fatigue, Hypersensitivity, Immunisation, Interchange of vaccine products, Malaise, Migraine with aura, Nausea, Off label use, Pain, Palpitations, Pruritus, Pyrexia, Rash, SARS-CoV-2 test, Visual impairment
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (has an illness or condition, which reduces the immune response); Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20220103; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009612

Write-up: pain; allergic reaction; diarrhea; appetite absent; palpitations; throat dry; felt unwell; chills; itching; feverish; migraine aura; nausea; skin rash; fatigue; joint pain; vision abnormal; dizziness postural; 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. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201032023522280-NRHVW. Other Case identifiers: GB-MHRA-ADR 26430291. A 53 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (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, which reduces the immune response. The patient has not had symptoms associated with COVID-19, 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 (disability, medically significant) with onset 30Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 30Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (disability, medically significant) with onset 30Dec2021, outcome "unknown", described as "booster"; PAIN (disability, medically significant), outcome "recovering", described as "pain"; HYPERSENSITIVITY (disability, medically significant), outcome "recovering", described as "allergic reaction"; CHILLS (disability, medically significant) with onset 31Dec2021, outcome "recovering", described as "chills"; PRURITUS (disability, medically significant) with onset 31Dec2021, outcome "not recovered", described as "itching"; PYREXIA (disability, medically significant) with onset 31Dec2021, outcome "not recovered", described as "feverish"; MIGRAINE WITH AURA (disability, medically significant) with onset 31Dec2021, outcome "recovering", described as "migraine aura"; NAUSEA (disability, medically significant) with onset 31Dec2021, outcome "not recovered", described as "nausea"; RASH (disability, medically significant) with onset 31Dec2021, outcome "recovering", described as "skin rash"; FATIGUE (disability, medically significant) with onset 31Dec2021, outcome "not recovered", described as "fatigue"; ARTHRALGIA (disability, medically significant) with onset 31Dec2021, outcome "not recovered", described as "joint pain"; VISUAL IMPAIRMENT (disability, medically significant) with onset 31Dec2021, outcome "recovering", described as "vision abnormal"; DIZZINESS POSTURAL (disability, medically significant) with onset 31Dec2021, outcome "not recovered", described as "dizziness postural"; DIARRHOEA (disability, medically significant) with onset 01Jan2022, outcome "not recovered", described as "diarrhea"; DECREASED APPETITE (disability, medically significant) with onset 01Jan2022, outcome "not recovered", described as "appetite absent"; PALPITATIONS (disability, medically significant) with onset 01Jan2022, outcome "recovered with sequelae", described as "palpitations"; DRY THROAT (disability, medically significant) with onset 31Dec2021, outcome "not recovered", described as "throat dry"; MALAISE (disability, medically significant) with onset 31Dec2021, outcome "not recovered", described as "felt unwell". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (03Jan2022) no - negative covid-19 test. The patient has not tested positive for COVID-19 since having the vaccine. Therapeutic measures were taken as a result of malaise. Additional information: the patient received the booster on 30Dec2021 at "GP" then by Friday (31Dec2021) night, the patient felt unwell and this continued currently. The patient has been taking regular paracetamol and lemsip to help and has resulted in severe pain, discomfort, allergic reaction limited her ability and days in still unwell. The patient 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: 2037127 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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: 20211226; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Chest pain; Shortness of breath; Chest pain; This case was received via RA (Reference number: GB-MHRA-ADR 26434943) 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 the first episode of CHEST PAIN (Chest pain), the second episode of CHEST PAIN (Chest pain) and DYSPNOEA (Shortness of breath) in a 34-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). At the time of the report, last episode of CHEST PAIN (Chest pain) and DYSPNOEA (Shortness of breath) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications were provided. Patient had no illnesses and had no medications. Patient was eating a healthy plant-based diet. It was stated that the patient experienced tightness of the chest from the day of vaccination, not terribly uncomfortable and it came and went, sometimes with a pain other times it was just uncomfortable. It was like indigestion, but it was not that. Lab data included brief ECG (was only a few seconds in triage) at hospital. It was stated that the symptoms led to hospital stay which was 1 hour, diagnosis was not made by a medical professional. Company comment: This regulatory authority case concerns a 34-year-old male patient, with no medical history, who experienced the serious (medically significant) unexpected events of CHEST PAIN and DYSPNOEA. The event of chest pain occurred on the same day after receiving a first dose of mRNA-1273. Onset date was not reported for dyspnoea. No information about further dosing was provided at the time of the report. According to source document narrative, patient has experienced chest tightness from the day of the vaccination. He has consulted to the emergency department and an ECG in triage was performed, but no result was provided at the time of the report. No further imaging nor blood tests were performed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory authority case concerns a 34-year-old male patient, with no medical history, who experienced the serious (medically significant) unexpected events of CHEST PAIN and DYSPNOEA. The event of chest pain occurred on the same day after receiving a first dose of mRNA-1273. Onset date was not reported for dyspnoea. No information about further dosing was provided at the time of the report. According to source document narrative, patient has experienced chest tightness from the day of the vaccination. He has consulted to the emergency department and an ECG in triage was performed, but no result was provided at the time of the report. No further imaging nor blood tests were performed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2037158 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000050A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, SARS-CoV-2 test, Swelling, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular 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 Date: 20220102; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Dizzy spells; Blurred vision; Swelling; Headache; Tired out; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26436076) 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 HEADACHE (Headache), FATIGUE (Tired out), DIZZINESS (Dizzy spells), SWELLING (Swelling) and VISION BLURRED (Blurred vision) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000050A) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Tired out) (seriousness criterion medically significant) and SWELLING (Swelling) (seriousness criterion medically significant). On 02-Jan-2022, the patient experienced DIZZINESS (Dizzy spells) (seriousness criterion medically significant) and VISION BLURRED (Blurred vision) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), FATIGUE (Tired out) and DIZZINESS (Dizzy spells) had not resolved and SWELLING (Swelling) and VISION BLURRED (Blurred vision) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2022, 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 medications were reported. No Treatment medication was provided. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Company comment This is a regulatory case concerning a 18-year-old male patient with no medical history reported, who experienced the serious unexpected, according clinical data, events of headache, fatigue, dizziness, swelling and vision blurred. The events headache, fatigue and swelling occurred the day after the third dose of mRNA-1273 vaccine. The events dizziness and blurred vision occurred approximately 3 days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 18-year-old male patient with no medical history reported, who experienced the serious unexpected, according clinical data, events of headache, fatigue, dizziness, swelling and vision blurred. The events headache, fatigue and swelling occurred the day after the third dose of mRNA-1273 vaccine. The events dizziness and blurred vision occurred approximately 3 days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2037170 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-12-30
   Days after vaccination:197
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 00059A / 3 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 1 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / 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: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20220105; 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 (Reference number: GB-MHRA-ADR 26436247) 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 HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 00059A) for an unknown indication. Co-suspect products included non-company products TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for an unknown indication and TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for an unknown indication. Patient has not had symptoms associated with COVID-19. On 16-Jun-2021, the patient received first dose of TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) (unknown route) 1 dosage form. On 12-Aug-2021, the patient received second dose of TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) (unknown route) 1 dosage form. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not 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 report Company Comment: This RA case concerns a patient with unknown age and gender, vaccinated primary series using Tozinameran (COVID-19 MRNA VACCINE BNT162B2f for two doses , who experienced Serious ( medically significant ) , unexpected event of Headache which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case was captured as unknown by this RA report. The reported co suspect drug of Tozinameran may be considered as a confounder for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender''s Comments: This RA case concerns a patient with unknown age and gender, vaccinated primary series using Tozinameran (COVID-19 MRNA VACCINE BNT162B2f for two doses , who experienced Serious ( medically significant ) , unexpected event of Headache which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case was captured as unknown by this RA report. The reported co suspect drug of Tozinameran may be considered as a confounder for this case. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 2037224 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Scan; Result Unstructured Data: Test Result:Unknow results
CDC Split Type: GBPFIZER INC202200022571

Write-up: Lymph nodes enlarged/After the booster its huge again; uncomfortable; 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. A 32 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (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, Lot number-EY5456), administration date: 04Jun2021, for COVID-19 immunisation, reaction(s): "Lymph nodes enlarged"; Bnt162b2 (Dose-2), administration date: 27Aug2021, for COVID-19 immunisation, reaction(s): "Lymph nodes enlarged", "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant), outcome "unknown", described as "Lymph nodes enlarged/After the booster its huge again"; FEELING ABNORMAL (medically significant), outcome "unknown", described as "uncomfortable". The patient underwent the following laboratory tests and procedures: scan: unknow results. Additional information: 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. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient reported that, Enlarged lymph nodes just under my armpit on the vaccinated arm. Started off marble sized ended up quite big. Was seen by GP and referred to (name) for it to be checked. Was advised it was my body reacting to the vaccine and to keep an eye. It never went only shrunk in size. After 2nd vaccine it was still there but no worse. After the booster its huge again and uncomfortable. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "Scan and check at (name) " 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-202200003777 same patient/same product, different dose/events.;GB-PFIZER INC-202200022570 same patient/same product, different dose/events.


VAERS ID: 2037252 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-12-30
   Days after vaccination:186
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202200048291

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K; This is a spontaneous report received from a non-contactable healthcare professional from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2022FOS000037. This is a spontaneous report received from a non-contactable HCP received via Department of Health (DH). The regulatory authority report number is not applicable. As of 0:00 am, 02-Jan-2022, DH announced that seven additional confirmed cases of COVID-19 and nine additional asymptomatic cases of COVID-19 after Comirnaty vaccination. This report was split for 1 of 16 patients. A 24-year-old male patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 06-Jun-2021 and 27-Jun-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization while traveling. Medical history, concomitant medication(s) and past product were not reported. On 30-Dec-2021, the patient developed symptoms. On 31-Dec-2021, the patient arrived while traveling. On 30Dec2021, the patient tested positive. The patient was confirmed as COVID-19 with mutant strains of N501Y and T478K. The adverse event ''confirmed case of COVID-19/imported case with mutant strains of N501Y and T478K'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 03-Jan-2022. This case was split from AER 2021FOS007647 due to same reporter/product, different event/patient. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessment: COVID-19, Vaccination failure Per Reporter = Possible Per Company (BioNTech SE) = Possible No follow-up attempts are possible. No further information is expected. Information on the lot number cannot be obtained.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200030977 same reporter/product, different event/patient


VAERS ID: 2037257 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-12-30
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive.
CDC Split Type: HKPFIZER INC202200058593

Write-up: This is a spontaneous report received from non-contactable reporter (Other HCP) from Regulatory Authority and Regulatory Authority. Other Case identifier: HK-Fosun-2022FOS000045 (RA). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority (RA) The regulatory authority report number is not applicable. As of 0:00 am, 02-Jan-2022, RA announced that seven additional confirmed cases of COVID-19 and nine additional asymptomatic cases of COVID-19 after Comirnaty vaccination. This case was split for 1 of 16 cases. A 60-year-old female patient started to receive two doses of Tozinameran (COMIRNATY) (as reported) (lot number: unknown) on 03-Aug-2021 and 24-Aug-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 29-Dec-2021, the patient arrived by flight on 30-Dec-2021, the patient developed symptoms. On an unknown date, the patient tested positive. The patient was confirmed as COVID-19 with mutant strains of N501Y and T478K. Another case who was a close contact of the patient was also confirmed as COVID-19. The adverse event ''confirmed case of COVID-19/imported case with mutant strains of N501Y and T478K'' was considered as important medical event. The action taken for Tozinameran (COMIRNATY) (as reported) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 03-Jan-2022 and 04-Jan-2022. This case was split from AER 2021FOS007582 due to same reporter/product, different event/patient. Follow-up closed; no further information is possible. The reporter''s and company (RA) assessment of the causal relationship of events with suspect product COMIRNATY was reported as possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200010529 same reporter/drug/event, different patient.


VAERS ID: 2038710 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Neck pain, SARS-CoV-2 test
SMQs:, Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; 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: Neck pain; Shoulder pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26433478) 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 NECK PAIN (Neck pain) and ARTHRALGIA (Shoulder pain) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 13-Mar-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion medically significant). At the time of the report, NECK PAIN (Neck pain) had not resolved and ARTHRALGIA (Shoulder pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. No medical history was provided by the reporter. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19 Report was not relate to possible inflammation of the heart (myocarditis or pericarditis). Company Comment - This regulatory authority case concerns a 30 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of arthralgia and neck pain. The event arthralgia occurred 1 day after the third dose of mRNA-1273 vaccine, the event neck pain occurred 2 days after the dose of mRNA-1273 vaccine. Additional details of clinical presentation and clinical course were not provided. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 30 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of arthralgia and neck pain. The event arthralgia occurred 1 day after the third dose of mRNA-1273 vaccine, the event neck pain occurred 2 days after the dose of mRNA-1273 vaccine. Additional details of clinical presentation and clinical course were not provided. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2038720 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: GBMODERNATX, INC.MOD20224

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm) in a 21-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant). On 02-Jan-2022, PERIPHERAL SWELLING (Swelling arm) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details were provided. No treatment medication details were provided. It was reported that patient experienced severe swelling to the armpit / gland area of the arm where jab given and general unwell. Patient was 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 and not had a COVID-19 test. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). This is a regulatory authority case concerning a 21-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of arm swelling. The events occurred approximately 1 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 events were reported as 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 21-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of arm swelling. The events occurred approximately 1 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 events were reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2038730 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-30
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-17
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: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Heavy periods; This case was received via the Regulatory Authority (Reference number GB-MHRA-ADR 26437401) 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 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 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (seriousness criterion medically significant). At the time of the report, HEAVY MENSTRUAL BLEEDING was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, SARS-CoV-2 test No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by reporter. It was reported that period early by about a week. Very heavy (usually light) Large Clots for a day, similar to after patient had my baby 4 years ago. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No treatment medications provided by the reporter. This case concerns a female patient of an unknown age with no medical history, who experienced the unexpected serious event Heavy Menstrual Bleeding, the event was medically significant as reported by the regulatory authority. The events occurred 8 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was reported as unknown by the regulatory authority. No clinical or treatment details were given. It was reported that the outcome of the event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2038996 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-30
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Decreased appetite, Drug ineffective, Fatigue, Immunisation, Lymphadenopathy, Malaise, Pyrexia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: LFT; Test Result: Positive
CDC Split Type: GBPFIZER INC202200003596

Write-up: fever; weakness; felt unwell; loss of appetite; tired; SARS-CoV-2 infection; Drug Ineffective; Swollen glands; 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-202201022150425730-F8NIL (RA). Other Case identifier(s): GB-MHRA-ADR 26425274 (RA). A 22 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; COVID-19 (medically significant) with onset 01Jan2022, outcome "not recovered", described as "SARS-CoV-2 infection"; DRUG INEFFECTIVE (medically significant) with onset 01Jan2022, outcome "unknown", described as "Drug Ineffective"; PYREXIA (medically significant), outcome "not recovered", described as "fever"; ASTHENIA (medically significant), outcome "not recovered", described as "weakness"; LYMPHADENOPATHY (medically significant) with onset 30Dec2021, outcome "recovering", described as "Swollen glands"; MALAISE (non-serious), outcome "unknown", described as "felt unwell"; DECREASED APPETITE (non-serious), outcome "unknown", described as "loss of appetite"; FATIGUE (non-serious), outcome "unknown", described as "tired". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test; positive. Clinical Course: Patient has not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. Patient had two positive LFT less that 48hrs after booster. 12 hrs after booster felt unwell, temperature, fever, weakness, tired, loss of appetite. Patient was not enrolled in clinical trial. 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.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200027129 same patient/reporter/different dose/event (LOE)


VAERS ID: 2039012 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-30
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Heavy menstrual bleeding, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

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

Write-up: Stomach cramps; Heavy periods; This case was received via MHRA (Reference number: GB-MHRA-ADR 26452678) 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 ABDOMINAL PAIN UPPER (Stomach cramps) and HEAVY MENSTRUAL BLEEDING (Heavy periods) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. No Medical History information was reported. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) (seriousness criterion medically significant). On 02-Jan-2022, HEAVY MENSTRUAL BLEEDING (Heavy periods) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had very heavy, painful period. Stomach cramps and doubled in pain, diarrhea. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. No concomitant medications were provided by reporter No treatment medications were provided by reporter company comment This is a regulatory concerns a 44-year-old female patient, with no medical history, who experienced the unexpected, serious (medically significant) events of abdominal pain upper and heavy menstrual bleeding . The event heavy menstrual bleeding occurred 08 days after the administration of the third dose of mRNA-1273 vaccine for an unknown indication. , abdominal pain occurred unknown days after the third dose. On an unknown date, SARS-CoV-2 test was negative. Patient had very heavy painful period, stomach cramps and pain had doubled with diarrhea. Patient has not had symptoms associated with COVID-19, Patient is not pregnant, Patient is not currently breastfeeding. The event Heavy menstrual bleeding had resolved, abdominal pain upper had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious per Regulatory Authority?s report.; Sender''s Comments: This is a regulatory concerns a 44-year-old female patient, with no medical history, who experienced the unexpected, serious (medically significant) events of abdominal pain upper and heavy menstrual bleeding . The event heavy menstrual bleeding occurred 08 days after the administration of the third dose of mRNA-1273 vaccine for an unknown indication. , abdominal pain occurred unknown days after the third dose. On an unknown date, SARS-CoV-2 test was negative. Patient had very heavy painful period, stomach cramps and pain had doubled with diarrhea. Patient has not had symptoms associated with COVID-19, Patient is not pregnant, Patient is not currently breastfeeding. The event Heavy menstrual bleeding had resolved, abdominal pain upper had not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious per Regulatory Authority?s report.


VAERS ID: 2040487 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Immunisation, Polymerase chain reaction, Pulmonary embolism, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GLUCOSAMINE
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20220103; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: CAPFIZER INC202200013145

Write-up: Massive bilateral PE; Massive bilateral PE (syncopal episode precipitating hospitalization on 03Jan2022); Found to also have L lower limb DVT, asymptomatic (duration of DVT not known); booster; This is a spontaneous report received from a contactable reporter(s) (Physician). A 77 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history. Concomitant medication(s) included: GLUCOSAMINE. The medications that patient received within 2 weeks of vaccination included Cayenne pepper, Glucosamine. Vaccination history included: Bnt162b2 (Dose 2), administration date: 15Jun2021, when the patient was 76 years old, for covid-19 immunisation; Bnt162b2 (Dose 1), administration date: 03Apr2021, when the patient was 76 years old, for covid-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 30Dec2021, outcome "unknown", described as "booster"; PULMONARY EMBOLISM (hospitalization, medically significant) with onset 03Jan2022, outcome "unknown", described as "Massive bilateral PE"; SYNCOPE (hospitalization, medically significant) with onset 03Jan2022, outcome "recovering", described as "Massive bilateral PE (syncopal episode precipitating hospitalization on 03Jan2022)"; DEEP VEIN THROMBOSIS (hospitalization, medically significant) with onset 03Jan2022, outcome "recovering", described as "Found to also have L lower limb DVT, asymptomatic (duration of DVT not known)". The patient was hospitalized for immunisation, pulmonary embolism, syncope, deep vein thrombosis (start date: 03Jan2022). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had COVID-19 test. The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (03Jan2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of pulmonary embolism, syncope, deep vein thrombosis. Treatment received for the adverse events included anticoagulation. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 2041084 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Immunisation, Interchange of vaccine products, Malaise, Off label use, Pain in extremity, Product use issue, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: 20211222; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003713

Write-up: generally unwell; shivering; sore arm; Fever; Shivers; off label use; Interchange of vaccine products; Booster; Drug use in unapproved population; 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-202201020920487900-54JVK (RA). Other Case identifier(s): GB-MHRA-ADR 26424716 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FK9706) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), for Covid-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PRODUCT USE ISSUE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Drug use in unapproved population"; MALAISE (medically significant), outcome "not recovered", described as "generally unwell"; CHILLS (medically significant), outcome "not recovered", described as "shivering"; PYREXIA (medically significant) with onset 31Dec2021, outcome "recovering", described as "Fever"; CHILLS (medically significant) with onset 31Dec2021, outcome "recovered" (02Jan2022), described as "Shivers"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Adverse reaction did not occur as a result of an exposure during pregnancy. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) no - negative covid-19 test. Clinical course: Patient was generally fit and well. It was reported that the report does not relate 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-202200034879 Baby case


VAERS ID: 2041115 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FK9707 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Hot flush, Illness, Immunisation, Pallor, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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: Herpes simplex type II; Vitiligo
Allergies:
Diagnostic Lab Data: Test Date: 20220102; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009464

Write-up: Sickness; Dizzy spells; Hot flushes; Pale skin; Booster; Exhaustion; 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-202201031137078820-RREEM (MHRA). Other Case identifier(s): GB-MHRA-ADR 26427459 (MHRA). A 36 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FK9707) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Non segmental vitiligo" (unspecified if ongoing); "herpesvirus type 2" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "allergic to penicillin", notes: allergic to penicillin. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. Patient last menstrual period date:24Dec2021. Patient has not had symptoms associated with COVID-19. 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. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; ILLNESS (medically significant) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Sickness"; DIZZINESS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Dizzy spells"; HOT FLUSH (medically significant) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Hot flushes"; FATIGUE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Exhaustion"; PALLOR (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Pale skin". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2022) negative, notes: No - Negative COVID-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2041119 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Arthralgia, Diarrhoea, Dyspnoea, Immunisation, Interchange of vaccine products, Myalgia, Off label use, Pain in extremity, Palpitations, Paraesthesia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament 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: Medical History/Concurrent Conditions: Asthma (Mild asthma that does not require steroids)
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 INC202200009481

Write-up: very painful arm; Wrist pain; Shoulder pain; Breathlessness; Palpitations; Off label use; Interchange of vaccine products; Booster; upset stomach; Muscle pain; Pins and needles; Diarrhea; 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-202201031251569730-8P3MR (MHRA). Other Case identifier(s): GB-MHRA-ADR 26427880 (MHRA). A female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN5254) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Mild asthma that does not require steroids. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN (where X=1, 2, or number unknown)), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "very painful arm"; ARTHRALGIA (medically significant), outcome "unknown", described as "Wrist pain"; ARTHRALGIA (medically significant), outcome "unknown", described as "Shoulder pain"; ABDOMINAL DISCOMFORT (medically significant) with onset 30Dec2021, outcome "not recovered", described as "upset stomach"; MYALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Muscle pain"; PARAESTHESIA (medically significant) with onset 30Dec2021, outcome "recovered" (02Jan2022), described as "Pins and needles"; DIARRHOEA (medically significant) with onset 30Dec2021, outcome "recovered" (01Jan2022), described as "Diarrhea"; DYSPNOEA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Breathlessness"; PALPITATIONS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Palpitations". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) negative, notes: No - Negative COVID-19 test. Clinical course: Very painful arm, pain ran from shoulder to wrist including pins and needles. Upset stomach within a few hours of vaccination including diarrhoea. Breathlessness and muscle aches started a few days after vaccination. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2041136 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Immunisation, Pruritus, 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:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009556

Write-up: Booster; Itchy / itchy skin; hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202201031523536070-HVLPG (RA). Other Case identifier(s): GB-MHRA-ADR 26429201 (RA). A 33 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 33 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 30Dec2021, outcome "unknown", described as "Booster"; PRURITUS (medically significant) with onset 30Dec2021, outcome "recovering", described as "Itchy / itchy skin "; URTICARIA (medically significant) with onset 30Dec2021, outcome "recovering", described as "hives". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2041156 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Interchange of vaccine products, Nausea, Off label use, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009544

Write-up: Fatigue; Fever; Nauseous; Off Label use; interchange of vaccine products; Booster; Painful arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201032018454630-GUKMT. Other Case identifier(s): GB-MHRA-ADR 26430253. A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN5254) at the age of 60 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; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off Label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 30Dec2021, outcome "recovering", described as "Painful arm"; FATIGUE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Fatigue"; NAUSEA (medically significant) with onset 30Dec2021, outcome "recovered" (02Jan2022), described as "Nauseous"; PYREXIA (medically significant) with onset 31Dec2021, outcome "recovering", described as "Fever". Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: sars-cov-2 test negative, notes: No - Negative COVID-19 test. Clinical Course: It was reported that the report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2041165 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FK9712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Headache, Immunisation, Interchange of vaccine products, Night sweats, Off label use, Pruritus, Vaccination site pain, Vaccination site rash
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), 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: CERAZETTE [DESOGESTREL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200009601

Write-up: Diarrhoea; Itching; Headache; Injection site pain; Injection site rash; Night sweats; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201032100521810-IA6M8. Other Case identifier(s): GB-MHRA-ADR 26430336. A 38-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FK9712) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication included: desogestrel (CERAZETTE) taken for contraception, start date: 01Oct2009. Vaccination history included: Covid-19 vaccine ASTRAZENECA (1st single dose), administration date: 07Mar2021, for COVID-19 immunisation; Covid-19 vaccine ASTRAZENECA (2nd single dose), administration date: 18May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; DIARRHOEA (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Diarrhoea"; PRURITUS (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Itching"; HEADACHE (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Headache"; VACCINATION SITE PAIN (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Injection site pain"; VACCINATION SITE RASH (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Injection site rash"; NIGHT SWEATS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Night sweats". Additional information: 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 No follow-up attempts are possible. No further information is expected.


VAERS ID: 2041192 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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, Immunisation, Interchange of vaccine products, Off label use, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200009535

Write-up: Painful swelling under armpit; Armpit pain; Off label use; Booster; Interchange of vaccine products; 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-202201040540046570-OM01S. A 48 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3(booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE-1 MANUFACTURE UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE-2 MANUFACTURE UNKNOWN), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; SWELLING (medically significant), outcome "unknown", described as "Painful swelling under armpit"; AXILLARY PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Armpit pain". Clinical course: Onset latency for the events was 01 day. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. 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-MHRA-ADR 26431042


VAERS ID: 2041195 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Dizziness postural, Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response.); Multiple allergies (Take daily antihistamines for multiple allergies)
Allergies:
Diagnostic Lab Data: Test Date: 20220104; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009434

Write-up: Increased shortness of breath; Dizziness upon standing; Armpit pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201040622256210-6YVXN. Other Case identifier(s): GB-MHRA-ADR 26431238. A 17 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 17 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple allergies" (unspecified if ongoing), notes: Take daily antihistamines for multiple allergies -( nothing within vaccine-) no allergic reaction to vaccine.; "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response. The patient''s concomitant medications were not reported. Past drug history included: Beclomethasone. The following information was reported: AXILLARY PAIN (medically significant) with onset 30Dec2021, outcome "recovered with sequelae", described as "Armpit pain"; DIZZINESS POSTURAL (medically significant) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Dizziness upon standing"; DYSPNOEA (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Increased shortness of breath". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) negative, notes: No - Negative COVID-19 test. Clinical course: 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.


VAERS ID: 2041245 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, COVID-19, Erythema, Fatigue, Hypersensitivity, Lip swelling, Palpitations, Pruritus, SARS-CoV-2 test, Swollen tongue, Tachycardia, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; FEXOFENADINE HYDROCHLORIDE; TRANEXAMIC ACID
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction (Unknown. Was given Epi-Pen originally then attended Allergy clinic with food chart*); Angioedema; Family history of cardiovascular disorder (History of heart attacks in family both immediate and wider uncles/aunties/grandad on mothers side); Premature baby (Born 8 week premature); Testicular cancer (12+ years had N-stage 4 testicular cancer); Vitamin D deficiency (Was borderline Vitamin D deficiency so take supplements)
Allergies:
Diagnostic Lab Data: Test Date: 20220104; 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: Fatigue/unusual tiredness; Heart palpitations; Racing heart (tachycardia); SARS-CoV-2 infection; Itchy skin; Face red; Burning sensation; Hives; Swollen lips; Swollen tongue; Allergic reaction; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26440295) 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 BURNING SENSATION (Burning sensation), COVID-19 (SARS-CoV-2 infection), URTICARIA (Hives), LIP SWELLING (Swollen lips), SWOLLEN TONGUE (Swollen tongue), PRURITUS (Itchy skin), ERYTHEMA (Face red), FATIGUE (Fatigue/unusual tiredness), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)) and HYPERSENSITIVITY (Allergic reaction) in a 43-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. The patient''s past medical history included Vitamin D deficiency (Was borderline Vitamin D deficiency so take supplements), Allergic reaction (Unknown. Was given Epi-Pen originally then attended Allergy clinic with food chart*), Testicular cancer (12+ years had N-stage 4 testicular cancer), Premature baby (Born 8 week premature) and Angioedema. Family history included Family history of cardiovascular disorder (History of heart attacks in family both immediate and wider uncles/aunties/grandad on mothers side). Concurrent medical conditions included Suspected COVID-19 since 04-Jan-2022. Concomitant products included FEXOFENADINE HYDROCHLORIDE from 01-Jul-2018 to an unknown date and TRANEXAMIC ACID from 01-Jul-2018 to an unknown date for Allergy multiple, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 15-Jun-2021 to 15-Jun-2021 for COVID-19. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced BURNING SENSATION (Burning sensation) (seriousness criteria medically significant and life threatening). 30-Dec-2021, the patient experienced URTICARIA (Hives) (seriousness criteria medically significant and life threatening), LIP SWELLING (Swollen lips) (seriousness criteria medically significant and life threatening), SWOLLEN TONGUE (Swollen tongue) (seriousness criteria medically significant and life threatening), ERYTHEMA (Face red) (seriousness criteria medically significant and life threatening) and HYPERSENSITIVITY (Allergic reaction) (seriousness criteria medically significant and life threatening). On 31-Dec-2021, the patient experienced PRURITUS (Itchy skin) (seriousness criteria medically significant and life threatening). On 04-Jan-2022, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criteria medically significant and life threatening), PALPITATIONS (Heart palpitations) (seriousness criteria medically significant and life threatening) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criteria medically significant and life threatening). On 31-Dec-2021, BURNING SENSATION (Burning sensation), URTICARIA (Hives), LIP SWELLING (Swollen lips), SWOLLEN TONGUE (Swollen tongue), PRURITUS (Itchy skin), ERYTHEMA (Face red) and HYPERSENSITIVITY (Allergic reaction) had resolved. At the time of the report, COVID-19 (SARS-CoV-2 infection) was resolving and FATIGUE (Fatigue/unusual tiredness), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. Patient suffered with angiodemia and unknown allergic reactions. Within the first night he started to experience fast heart beat which showed average resting heart beat whilst laying down in bed was around 90-100bpm (instead of around 50bpm) the following night was 80-90bpm resting and 3rd night returned to normal. Patient could feel his heart beating excessively causing him issues sleeping. He had forgotten to take precautionary dose of fexofenadine as worried about affecting efficiency. He did notify the team at the time of getting the vaccine he could suffer with a reaction. He got hives on back of neck and throat, red rash on face, burning sensation on fingers and feet; all of this was within 15mins of starting reaction, then started experiencing some swelling on lips and tongue after about 30mins Patient took his fexofenadine and tranexamic acid tablets and this held back the reaction. It took about 24 hours to recover fully. He was borderline asking to be taken to A+E if the drugs had not held back and symptoms got any worse. If it wasnt for pressure on health system with COVID then patient would have attended hospital. It was reported that the report was related to possible inflammation of heart (myocarditis or pericarditis). Patient was not enrolled in clinical trial. Patient had done PCR test and was waiting for results but was a positive LFD. Company Comment: This case concerns a 43-year-old male patient, with relevant medical history of Allergic reaction, Angioedema and vaccination with COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected serious events of Burning sensation, Urticaria, Hypersensitivity, Lip swelling, Swollen tongue, Erythema, Pruritus, Palpitations and COVID-19 (AESI). The events occurred approximately 1-2 days after receiving the third dose of mRNA-1273 Vaccine which resulted in a life threatening condition. The event COVID-19 occurred 6 days after the third dose of the vaccine. At the time of the report the outcome of the events was resolving. The rechallenge is unknown as per SD. The patient''s medical history of Allergic reaction, Angioedema and vaccination with COVID-19 VACCINE ASTRAZENECA, remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 43-year-old male patient, with relevant medical history of Allergic reaction, Angioedema and vaccination with COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected serious events of Burning sensation, Urticaria, Hypersensitivity, Lip swelling, Swollen tongue, Erythema, Pruritus, Palpitations and COVID-19 (AESI). The events occurred approximately 1-2 days after receiving the third dose of mRNA-1273 Vaccine which resulted in a life threatening condition. The event COVID-19 occurred 6 days after the third dose of the vaccine. At the time of the report the outcome of the events was resolved for all events, except COVID-19 which was resolving. The rechallenge is unknown as per SD. The patient''s medical history of Allergic reaction, Angioedema and vaccination with COVID-19 VACCINE ASTRAZENECA, remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2041252 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, Heart rate, Heart rate increased, Migraine without aura, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211230; Test Name: Body temperature; Result Unstructured Data: Test Result:High; Test Date: 20211231; Test Name: Heart rate; Result Unstructured Data: Test Result:Increased/racing; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200019150

Write-up: Headache; Vomiting; Racing heart beat; Common migraine; High temperature; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202201051821028470-I5USU (RA). Other Case identifier(s): GB-MHRA-ADR 26440590 (RA). A 15 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 10:30 (Batch/Lot number: unknown) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient had her last menstruation on 29Dec2021. Patient did not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The following information was reported: HEART RATE INCREASED (medically significant) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Racing heart beat"; MIGRAINE WITHOUT AURA (medically significant) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Common migraine"; HEADACHE (medically significant) with onset 31Dec2021 05:30, outcome "recovered", described as "Headache"; VOMITING (medically significant) with onset 31Dec2021 05:30, outcome "recovered" (31Dec2021), described as "Vomiting"; PYREXIA (medically significant) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "High temperature". 19 hours after receiving vaccine, at 5:30am vomiting and bad headache. Temperature and racing heart beat. This continued throughout the day of the 31Dec2021 vomiting stopped mid morning, other symptoms reduced by early evening of the 31Dec2021. The patient underwent the following laboratory tests and procedures: body temperature: (30Dec2021) high; heart rate: (31Dec2021) increased/racing; sars-cov-2 test: (unspecified date) no - negative covid-19 test. Patient did not test 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: 2041257 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Arthralgia, Fatigue, Headache, Musculoskeletal stiffness, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19 (Unsure when symptoms started.)
Preexisting Conditions: Medical History/Concurrent Conditions: Clotting disorder (Blood clotting disorder.)
Allergies:
Diagnostic Lab Data: Test Date: 20220104; 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; Stiffness; Tiredness; Joint ache; Chronic headaches; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26440985) 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 NAUSEA (Nausea), FATIGUE (Tiredness), ARTHRALGIA (Joint ache), MUSCULOSKELETAL STIFFNESS (Stiffness) and HEADACHE (Chronic headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Clotting disorder (Blood clotting disorder). Concurrent medical conditions included Suspected COVID-19 (Unsure when symptoms started). Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 09-Jan-2021 to 22-Mar-2021 for an unknown indication.On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced ARTHRALGIA (Joint ache) (seriousness criterion medically significant) and HEADACHE (Chronic headaches) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea), FATIGUE (Tiredness), ARTHRALGIA (Joint ache) and MUSCULOSKELETAL STIFFNESS (Stiffness) had not resolved and HEADACHE (Chronic headaches) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial Concomitant product was not provided by the reporter. Treatment information was not provided Company Comment: This RA case concerns a female patient, with unknown age, with history of clotting disorder, vaccinated initially with primary series using TOZINAMERAN ( Covid 19 vaccine Pfizer ) for two doses, who experienced Serious ( medically significant ) , unexpected events of arthralgia and headache which occurred on the same day post vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . One day post vaccination with the 3rd dose she experienced Serious ( Medically significant ) , unexpected event of fatigue while two days post vaccination with the 3rd dose she experienced serious ( Medically significant ) , unexpected events of nausea and musculoskeletal stiffness . 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 female patient, with unknown age, with history of clotting disorder, vaccinated initially with primary series using TOZINAMERAN ( Covid 19 vaccine Pfizer ) for two doses, who experienced Serious ( medically significant ) , unexpected events of arthralgia and headache which occurred on the same day post vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . One day post vaccination with the 3rd dose she experienced Serious ( Medically significant ) , unexpected event of fatigue while two days post vaccination with the 3rd dose she experienced serious ( Medically significant ) , unexpected events of nausea and musculoskeletal stiffness . 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: 2041265 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000050A / 3 - / OT

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

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

Write-up: Fever; Muscle ache; Fatigue; This case was received via RA (Reference number: GB-MHRA-ADR 26441447) 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 PYREXIA (Fever), MYALGIA (Muscle ache) and FATIGUE (Fatigue) in a 25-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000050A) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 12-May-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On 01-Jan-2022, PYREXIA (Fever), MYALGIA (Muscle ache) and FATIGUE (Fatigue) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were provided. It was reported that patient had no symptoms associated with COVID-19. Patient had not tested for covid-19. Post vaccination patient had not tested positive for COVID-19. 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 regulatory case concerns a 25-year-old, male patient with history of concomitant administration of the Pfizer/BioNTech COVID-19 mRNA vaccines, who experienced the unexpected, serious events of pyrexia, myalgia and fatigue. The events occurred beginning on the same day and up to 1 day after administration of the third dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the events had resolved at the time of the report. The history of concomitant administration of the Pfizer/BioNTech COVID-19 mRNA vaccines remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 25-year-old, male patient with history of concomitant administration of the Pfizer/BioNTech COVID-19 mRNA vaccines, who experienced the unexpected, serious events of pyrexia, myalgia and fatigue. The events occurred beginning on the same day and up to 1 day after administration of the third dose of the Moderna mRNA-1273 vaccine. Treatment information was not provided. However, the events had resolved at the time of the report. The history of concomitant administration of the Pfizer/BioNTech COVID-19 mRNA vaccines remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2041287 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-13
Onset:2021-12-30
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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: Shingles; This case was received (Reference number: GB-MHRA-ADR 26442527) 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 HERPES ZOSTER (Shingles) in a 44-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. No Medical History information was reported. On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced HERPES ZOSTER (Shingles) (seriousness criterion medically significant). At the time of the report, HERPES ZOSTER (Shingles) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 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. Relevant concomitant medications were not provided. Treatment information was not provided. Patient has not had symptoms associated with COVID-19 Company comment: This regulatory case concerns a 44-year-old male patient, with medical history reported, who experienced the serious unexpected event of HERPES ZOSTER. The event occurred thirteen days after 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. A SARS-CoV-2 was performed with a negative result 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 44-year-old male patient, with medical history reported, who experienced the serious unexpected event of HERPES ZOSTER. The event occurred thirteen days after 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. A SARS-CoV-2 was performed with a negative result 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: 2041321 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
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: Abdominal pain upper, Chest pain, Fatigue, Feeling abnormal, Hypoaesthesia, Mental fatigue, Myalgia, Nausea, Paraesthesia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breathing difficult; Chest infection (Have been treated for breathing problems and a painful chest/ chesy infection.); Chest pain; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally). Patient had Fostair inhaler.)
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: Pins and needles; Stomach pain; Nausea; Numbness; Fuzzy head; Muscle pain; Fatigue; Mental fatigue; Fever chills; Chest pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26444377) 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 PARAESTHESIA (Pins and needles), HYPOAESTHESIA (Numbness), FEELING ABNORMAL (Fuzzy head), MYALGIA (Muscle pain), ABDOMINAL PAIN UPPER (Stomach pain), NAUSEA (Nausea), FATIGUE (Fatigue), MENTAL FATIGUE (Mental fatigue), PYREXIA (Fever chills) and CHEST PAIN (Chest pain) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Breathing difficult, Chest infection (Have been treated for breathing problems and a painful chest/ chesy infection.), Chest pain and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally). Patient had Fostair inhaler.). Previously administered products included for Drug use for unknown indication: Doxycycline (Took 2 courses of doxycycline in November) and Amoxicillin (Took 1 course of amoxicillin in October). Past adverse reactions to the above products included No adverse event with Amoxicillin and Doxycycline. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced FEELING ABNORMAL (Fuzzy head) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), MENTAL FATIGUE (Mental fatigue) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and CHEST PAIN (Chest pain) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced HYPOAESTHESIA (Numbness) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 03-Jan-2022, the patient experienced PARAESTHESIA (Pins and needles) (seriousness criterion medically significant). On 05-Jan-2022, ABDOMINAL PAIN UPPER (Stomach pain) had resolved. On 06-Jan-2022, NAUSEA (Nausea) and PYREXIA (Fever chills) had resolved. At the time of the report, PARAESTHESIA (Pins and needles), HYPOAESTHESIA (Numbness), FEELING ABNORMAL (Fuzzy head), MYALGIA (Muscle pain), FATIGUE (Fatigue), MENTAL FATIGUE (Mental fatigue) and CHEST PAIN (Chest pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Medical History: Patient has been treated for breathing problems and a painful chest/ chest infection. She was treated with 1 course of amoxicillin in October and 2 courses of doxycycline in November. Concomitant Medications: Taking regular steroid treatment (e.g. orally or rectally) and Fostair inhaler; Sender''s Comments: This is an RA case concerning a 40-year-old, female patient with a history of recent respiratory infection associated with breathing problems and chest pain. One day after taking the third dose patient experienced hypoesthesia, fever and chest pain. Four days later she started with paresthesia. The prolonged course of the infection, requiring 3 cycles of 2 different antibiotics in a 2-month period can be a confounder, since it was associated with chest pain. Also the long-term steroid use should be considered as a confounder due to its risk of Myopathy/Neuropathy Steroid-induced. Event seriousness was captured as provided by the Regulatory Authority. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 2041357 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-17
Onset:2021-12-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005686 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Limb discomfort, 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), 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; COVID-19 VACCINE ASTRAZENECA
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: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Arm discomfort; Heart racing; Shortness of breath; This case was received (Reference number: GB-MHRA-ADR 26445909) 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 LIMB DISCOMFORT (Arm discomfort), PALPITATIONS (Heart racing), the first episode of DYSPNOEA (Shortness of breath), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), the second episode of DYSPNOEA (Shortness of breath) and PALPITATIONS (Heart palpitations) in a 65-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005686) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 10-Jul-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 05-Mar-2021 to an unknown date for Vaccination. On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced LIMB DISCOMFORT (Arm discomfort) (seriousness criterion medically significant), PALPITATIONS (Heart racing) (seriousness criterion medically significant) and the first episode of DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), the second episode of DYSPNOEA (Shortness of breath) (seriousness criterion medically significant) and PALPITATIONS (Heart palpitations) (seriousness criterion medically significant). At the time of the report, LIMB DISCOMFORT (Arm discomfort) and PALPITATIONS (Heart racing) had not resolved and FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), the last episode of DYSPNOEA (Shortness of breath) and PALPITATIONS (Heart palpitations) 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. No Medical History information was reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient report was related to possible inflammation of the heart (myocarditis or pericarditis). Patient was waiting to book appointment with GP. Patient was not enrolled in clinical trial. Treatment medication was not provided by the reporter. Company comment: This is a regulatory case concerning a 65-year-old male patient with no medical history reported, who experienced the serious unexpected, according CCDS, events of limb discomfort, palpitations, the first episode of dyspnoea, fatigue, chest pain, the second episode of dyspnoea and palpitations. The events limb discomfort and the first episode of dyspnoea occurred approximately 13 days after the third dose of mRNA-1273 vaccine. The events fatigue, chest pain, the second episode of dyspnoea and palpitations occurred an unknown date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. The patient stated in narrative "waiting to book appointment with GP".; Sender''s Comments: This is a regulatory case concerning a 65-year-old male patient with no medical history reported, who experienced the serious unexpected, according CCDS, events of limb discomfort, palpitations, the first episode of dyspnoea, fatigue, chest pain, the second episode of dyspnoea and palpitations. The events limb discomfort and the first episode of dyspnoea occurred approximately 13 days after the third dose of mRNA-1273 vaccine. The events fatigue, chest pain, the second episode of dyspnoea and palpitations occurred an unknown date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. The patient stated in narrative "waiting to book appointment with GP".


VAERS ID: 2041362 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
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: 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: COVID-19 MRNA VACCINE BNT162B2
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Hand pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26445969) 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 PAIN IN EXTREMITY (Hand pain) in a 39-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 02-Jul-2021 to an unknown date for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PAIN IN EXTREMITY (Hand pain) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Hand pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient was having pain, swelling and weakness in my right hand since having the booster. 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 39-year-old, female patient with no medical history reported, with Interchange of vaccine products (TOZINAMERAN administration), who experienced the unexpected serious event of pain in extremity, approximately one day after the third (booster) dose of mRNA-1273 vaccine. The patient referred pain, swelling and weakness in her right hand since having the vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.; Sender''s Comments: This is a regulatory case concerning a 39-year-old, female patient with no medical history reported, with Interchange of vaccine products (TOZINAMERAN administration), who experienced the unexpected serious event of pain in extremity, approximately one day after the third (booster) dose of mRNA-1273 vaccine. The patient referred pain, swelling and weakness in her right hand since having the vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.


VAERS ID: 2041468 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FK9706 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abnormal faeces, Body temperature, Chills, Exposure via breast milk, Immunisation, Interchange of vaccine products, Off label use, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal exposures via breast milk (narrow), Noninfectious diarrhoea (broad), 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: Test Name: Body temperature; Result Unstructured Data: Test Result:39.3; Comments: fever of 39.3 for 2 days
CDC Split Type: GBPFIZER INC202200034879

Write-up: Fever/ fever of 39.3; shivering; affected his stools; Vaccine exposure via breastmilk; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional) from the Regulatory Authority. The reporter is the parent. An infant male patient received bnt162b2 (COMIRNATY) via transmammary route of administration on 30Dec2021 (batch/lot number: FK9706) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The breast-feeding mother was generally fit and well, is not enrolled in clinical trial, and has not had symptoms associated with COVID-19. The mother''s vaccination history included: Covid-19 vaccine Astrazeneca (first dose (batch/lot number: unknown) as DOSE 1, SINGLE) for COVID-19 immunization; Covid-19 vaccine Astrazeneca (second dose (batch/lot number: unknown) as DOSE 2, SINGLE) for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown" described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown" described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown" described as "Booster"; PYREXIA (medically significant), outcome "unknown" described as "Fever/ fever of 39.3"; CHILLS (medically significant), outcome "unknown" described as "shivering"; ABNORMAL FAECES (medically significant), outcome "unknown" described as "affected his stools"; EXPOSURE VIA BREAST MILK (non-serious) with onset 30Dec2021, outcome "unknown" described as "Vaccine exposure via breastmilk." The patient underwent the following laboratory tests and procedures: body temperature: 39.3, notes: fever of 39.3 for 2 days. The clinical course was reported as follows: I am breastfeeding my 17-month-old several times a day and I had a sore arm and generally unwell from the vaccine as an adverse reaction. My first 2 jabs were AstraZeneca, third booster Pfizer. This time my son also had a reaction I believe via the breast milk, he had a fever of 39.3 for 2 days and shivering and affected his stools. I thought I would report and feedback to help with research. The mother has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200003713 Maternal case


VAERS ID: 2041498 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Immunisation, Lymphadenopathy, Maternal exposure during pregnancy, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: GRPFIZER INC202200026074

Write-up: she is taking antithrombotic injection; swelling and pain on the neck over the clavicle / swollen lymph nodes; third dose; she is pregnant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 29 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "third dose"; MATERNAL EXPOSURE DURING PREGNANCY (medically significant) with onset 30Dec2021, outcome "unknown", described as "she is pregnant"; THROMBOSIS (medically significant), outcome "unknown", described as "she is taking antithrombotic injection"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swelling and pain on the neck over the clavicle / swollen lymph nodes". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2041505 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-12-30
   Days after vaccination:163
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202201; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202200058718

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y AND T478K; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y AND T478K; This is a spontaneous report received from non-contactable reporter (Other HCP) from License Party(BioNTech) and Regulatory Authority. Other Case identifier(s): HK-Fosun-2022FOS000051. This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is not applicable. As of 0:00 am, 03Jan2022, DH announced that 8 additional confirmed cases and 3 additional asymptomatic cases after Comirnaty vaccination. This report was split for 1 of 11 patients. A 29-year-old female patient receive two doses of (COMIRNATY) (lot number: unknown) on 29Jun2021 and 20Jul2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 30Dec2021, the patient had symptoms. On 01Jan2022, the patient arrived via flight. In Jan2022, the patient test positive. The patient was confirmed COVID-19 with mutant strain of N501Y and T478K. The adverse event ''confirmed case of COVID-19/imported case with mutant strain of N501Y and T478K'' was considered as Important Medical Event. The action taken for (COMIRNATY) regarding the events was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 04Jan2022. This case was split from AER 2021FOS007582 due to same reporter/product, different event/patient. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessments: COVID-19,Vaccination failure were possible per reporter and per company (BioNTech). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200010529 same reporter/drug, different patient/events


VAERS ID: 2041512 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-12-30
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: in country; Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: upon arrival in the Temporary Specimen Collection Centre(TSCC); Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: in country; Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: in another country
CDC Split Type: HKPFIZER INC202200059305

Write-up: OVERSEAS CASE OF COVID-19; OVERSEAS CASE OF COVID-19; This is a spontaneous report received from a non-contactable reporter(Other HCP) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2022FOS000059. This is a spontaneous report received from a non-contactable HCP received via Department of Health (DH). The regulatory authority report number is not applicable. As of 0:00 am, 03-Jan-2022, DH announced that 8 additional confirmed cases, 3 additional asymptomatic cases after Comirnaty vaccination and 1 overseas case of COVID-19 after Comirnaty vaccination. This case was created for one overseas case of COVID-19 after Comirnaty vaccination. A 31-year-old male patient received two dose of Tozinameran (COMIRNATY) (lot number: unknown) on 01-Jul-2021 and 22-Jul-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization in (country). Medical history, concomitant medication(s) and past product were not reported. On 24-Dec-2021, he tested negative in (country). On 25-Dec-2021, he travelled to another country. On 26-Dec-2021, the patient arrived in (country) from another country by flight and his specimen collected upon arrival, tested negative. On 28-Dec-2021, he tested negative in (country). On 30-Dec-2021, he travelled to another country. The patient developed cough and fever from 30-Dec-2021. On 31-Dec-2021, his specimen collected in another country tested positive and confirmed as COVID-19. The adverse event ''overseas case of COVID-19'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 04-Jan-2022. This case was split from AER 2021FOS007582 due to same reporter/product, different event/patient. Follow-up closed, no further information is possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech Causality Assessments: Drug: Comirnaty COVID-19, Vaccination failure Per Reporter= Possible Per Company = Possible; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200010529 same reporter/product, different event/patient


VAERS ID: 2041706 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-12-30
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: Covid-19 test; Test Result: Positive; Test Date: 20220111; Test Name: Covid-19 test; Test Result: Positive.
CDC Split Type: ITPFIZER INC202200068543

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Jul2021 (Lot number: FF4213) at the age of 51 years as dose 2, single and intramuscular, administration date 11Jun2021 (Lot number: FC5435) as dose 1, single for Covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "The patient tested positive for a COVID-19 swab on 30Dec2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2021) positive; (11Jan2022) positive. The patient reported the following symptoms: headache, sore throat, cough and physical fatigue.


VAERS ID: 2041859 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-12-30
   Days after vaccination:189
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin; Mexazolam
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Diabetes.
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: Covid-19 PCR test; Test Result: Positive
CDC Split Type: PTPFIZER INC202200008245

Write-up: This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 46-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 24Jun2021 (Lot number: Unknown) at the age of 45 years as dose 1 single for Covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; MEXAZOLAM. The patient has no known history of allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "Tested positive to Covid-19". Tested positive for Covid-19 and already had a dose of vaccine (only had one dose of vaccine because had Covid-19 before vaccination. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. Therapeutic measures were not taken as a result of drug ineffective, Covid-19. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2042192 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-19
Onset:2021-12-30
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Meningitis viral, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220103; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Viral meningitis; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26450750) 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 MENINGITIS VIRAL (Viral meningitis) 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 19-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced MENINGITIS VIRAL (Viral meningitis) (seriousness criterion hospitalization). At the time of the report, MENINGITIS VIRAL (Viral meningitis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, 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 medications were provided. No treatment medications were provided. Patient had viral meningitis secondary to HSV activation due to vaccine. She was normally fit and well. She did not had symptoms associated with COVID-19. She was not pregnant nor was breastfeeding at the time of report. She was not enrolled in clinical trial. Company comment: This case concerns a 36-year-old female patient, with no reported medical history, who experienced the serious, unexpected event of viral meningitis. The event occurred 11 days after the patient received unspecified dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The patient had viral meningitis secondary to HSV activation due to vaccine. No further information was provided. At the time of report, event was resolving. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 36-year-old female patient, with no reported medical history, who experienced the serious, unexpected event of viral meningitis. The event occurred 11 days after the patient received unspecified dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The patient had viral meningitis secondary to HSV activation due to vaccine. No further information was provided. At the time of report, event was resolving. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 2044570 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-27
Onset:2021-12-30
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0810 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Bursitis, Hypoaesthesia, Immunisation, Influenza like illness, Neuralgia, Off label use, Pain in extremity, Polymerase chain reaction, Product administered at inappropriate site, Suspected COVID-19, Ultrasound scan, Vaccination failure, Vaccination site inflammation, Vaccination site pain, X-ray
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (narrow), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer (NOS); Diabetes.
Preexisting Conditions: Medical History/Concurrent Conditions: Immunocompromised.
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: PCR; Result Unstructured Data: Test Result:Unknown; Comments: she never got the result of that PCR test; Test Name: ultrasound; Result Unstructured Data: Test Result:Normal; Test Name: X-ray; Result Unstructured Data: Test Result: Normal.
CDC Split Type: CAPFIZER INC202101564198

Write-up: She just assumed that she has Covid; She just assumed that she has Covid; she received her booster dose 2 weeks ago; she received her booster dose 2 weeks ago; 48 hours later started to feel pain at the site.; pain and numbness in my entire left arm; pain and numbness in my entire left arm; pain at the site. / quite inflamed; I think I have SIRVA / diagnosed with bursitis; possibly given incorrectly; Nerve pain; Flu like symptoms; This is a spontaneous report from a contactable pharmacist (patient) received via medical information. A 61-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in arm left (not the deltoid, much above deltoid area) on 27Oct2021 (Lot number: FD0810) as dose 3 (booster), single for COVID-19 immunisation. The patient''s medical history included cancer patient (ongoing) and severely immunocompromised (ongoing), Diabetes (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer, Updated Information: Administration date:02Mar2021, Time:14h, Anatomical site: Left deltoid, Route of Administration: Intramuscular, Batch/Lot No.EP6017), administration date: 02Mar2021, for Covid-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer, Updated Information: Administration date:22May2021, Time:13h, Anatomical site: Left deltoid, Route of Administration: Intramuscular, Batch/Lot No.EW0199), administration date: 22May2021, for Covid-19 immunization; Flu vaccine (Manufacturer Unknown and Batch/Lot No. Unknown, Flu /12 days pre, 3rd dose). The patient stated that She just assumed that she has Covid (vaccination failure and suspected COVID-19) (medically significant), she received her booster dose 2 weeks ago (off label use, immunization) on an unspecified date, and 48 hours later started to feel pain at the site. These symptoms have advanced to pain and numbness in her entire left arm that has been going on for two weeks plus and was quite inflamed, pain at the site/quite inflamed. The patient also noted that she think she had shoulder injury related to vaccine administration (SIRVA), the dose was given high on her arm, only noticing due to the placement of the band-aid being quite high up, not 3 fingers down. She has been seen by her Healthcare Professional (HCP) yesterday and been diagnosed with bursitis. She wants to know how effective this dose would be, since it was possibly given incorrectly (ie: into the joint). Patient also had Nerve pain on an unspecified date. On 30Dec2021, patient experienced Flu like symptoms. The events resulted in Physician Office visit. The events "48 hours later started to feel pain at the site.", "pain and numbness in my entire left arm", "pain and numbness in my entire left arm", "pain at the site. / quite inflamed", "i think i have sirva / diagnosed with bursitis" and "nerve pain" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (30Dec2021) unknown, notes: she never got the result of that PCR test; ultrasound scan: (unspecified date) normal; x-ray: (unspecified date) normal. Therapeutic measures were taken as a result of pain in extremity (Anti-inflammatory), bursitis (Anti-inflammatory), neuralgia (Lyrica). Therapeutic measures were not taken as a result of influenza like illness. The outcome of the events pain and numbness in her entire left arm (pain in extremity), bursitis was recovered on an unspecified date in 2021. Flu like symptoms was recovering, Nerve pain was not recovered and for rest all the events it was unknown.The lot number for BNT162B2, was not provided and will be requested during follow up.Follow-up (05Jan2022): This is a follow-up spontaneous report from a contactable pharmacist (patient) received via medical information included: Relevant medical History updated, Historical Vaccine was captured, Lab Data captured (X-Ray, Ultrasound and PCR). Event added (Vaccination failure, Suspected COVID-19, Nerve Pain, Flu like symptoms). Treatment details updated. Outcome was updated for Bursitis and Pain in arm as Recovered. Dose details updated for DOSE 3 (BOOSTER) SINGLE (Lot No.FD0810, Administration date), Dose 1 and Dose 2 details and clinical information updated.; Sender''s Comments: Based on the available reported information, the causal association between the events vaccination failure suspected covid-19, off label use, immunisation and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 2044789 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Amnesia, Dizziness, Illness, Lethargy, Pain, Scleral disorder
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Scleral disorders (narrow), Hypoglycaemia (broad)

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

Write-up: Dizziness; Lethargy; Memory loss; Pain; Sickness; Scleral disorder; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26439603) 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 DIZZINESS (Dizziness), LETHARGY (Lethargy), AMNESIA (Memory loss), PAIN (Pain), ILLNESS (Sickness) and SCLERAL DISORDER (Scleral disorder) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), LETHARGY (Lethargy) (seriousness criterion medically significant), AMNESIA (Memory loss) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant) and SCLERAL DISORDER (Scleral disorder) (seriousness criterion medically significant). On 02-Jan-2022, DIZZINESS (Dizziness), LETHARGY (Lethargy), AMNESIA (Memory loss), PAIN (Pain), ILLNESS (Sickness) and SCLERAL DISORDER (Scleral disorder) had resolved. Patient reported that she was dizzy, had memory loss, pain throughout. She was in total pain, whites of her eyes were visible. She was lethargic sick, almost all of these symptoms lasted 60 hours with effect hours from booster. Concomitant medication was not provided. Treatment information was not provided.; Sender''s Comments: This case concerns a female patient (Age unknown) with no relevant medical history, who experienced the unexpected serious events of Dizziness, Lethargy, Amnesia, Pain, Illness, and Scleral Disorder. The events occurred approximately 1 day after the booster dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after the booster dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 2044811 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITHROMYCIN; ESTRADIOL; FEXOFENADINE; OTOMIZE; UTROGESTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute respiratory tract infection; Otitis externa; Otitis media acute (Left); Vitreous floaters
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Erythematous florid universal rash; Fatigue extreme; This case was received via RA. (Reference number: GB-MHRA-ADR 26449537) 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 RASH ERYTHEMATOUS (Erythematous florid universal rash) and FATIGUE (Fatigue extreme) in a 57-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Vitreous floaters, Otitis externa, Acute respiratory tract infection and Otitis media acute (Left). Concomitant products included FEXOFENADINE from 30-Dec-2021 to an unknown date for Itching, CLARITHROMYCIN from 18-Oct-2021 to 25-Oct-2021, ESTRADIOL from 14-Dec-2020 to an unknown date, DEXAMETHASONE, NEOMYCIN SULFATE (OTOMIZE) from 18-Oct-2021 to 25-Oct-2021 and PROGESTERONE (UTROGESTAN) from 14-Dec-2020 to an unknown date for an unknown indication. On 30-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced RASH ERYTHEMATOUS (Erythematous florid universal rash) (seriousness criterion medically significant) and FATIGUE (Fatigue extreme) (seriousness criterion medically significant). At the time of the report, RASH ERYTHEMATOUS (Erythematous florid universal rash) had not resolved and FATIGUE (Fatigue extreme) was resolving. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. After vaccination patient were experienced with Erythematous florid universal rash,rash and also suffered with fatigue. No treatment medication information was reported Company Comment : This regulatory case concerns a 57-year old female patient with no medical history, who experienced the unexpected serious events of Rash Erythematous and Fatigue on the same day after receiving the mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report. The case was assessed as Serious as per Regulatory Authority?s report.; Sender''s Comments: This regulatory case concerns a 57-year old female patient with no medical history, who experienced the unexpected serious events of Rash Erythematous and Fatigue on the same day after receiving the mRNA-1273 Vaccine. The benefit-risk relationship of mRNA-1273 Vaccine in not affected by this report. The case was assessed as Serious as per Regulatory Authority?s report.


VAERS ID: 2044832 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FK9712 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200015715

Write-up: Severe headache; Migraine; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201040849315770-CGDZH (RA). Other Case identifier(s): GB-MHRA-ADR 26431858 (RA). A 26 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FK9712) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19 . Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; MIGRAINE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Migraine"; HEADACHE (medically significant), outcome "unknown", described as "Severe headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Severe headaches that were causing patient to lay down in a dark room to subside. They''re getting ridiculously painful. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis).No follow-up attempts are needed. No further information is expected.


VAERS ID: 2044846 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FK9707 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (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 INC202200015712

Write-up: Paresthesia/ Tingling in vaccinated arm and hand and face; Off-label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from a Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201041034284510-GSXPI. Other Case identifier: GB-MHRA-ADR 26432826. A 36-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm, administration date 30Dec2021 (Lot number: FK9707) as dose 3 (booster), 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. She had not had a COVID-19 test. Patient was not pregnant, and she was not currently breastfeeding. 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) with onset 30Dec2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PARAESTHESIA (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Paresthesia/ Tingling in vaccinated arm and hand and face". 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. No further information is expected.


VAERS ID: 2044849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Heart rate, Heart rate increased, Immunisation, Palpitations, SARS-CoV-2 test, Tracheitis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (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? 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: Heart rate; Result Unstructured Data: Test Result:Raised; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200015497

Write-up: Chest pain/Intense chest pain lying on back or side, but worsened on right hand side; It felt like something was standing on rib cage and stopping my lungs from expanding; Heart racing/Palpitations; Tracheitis; Raised Heart rate; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201041116425350-NX4BU. Other Case identifier(s): GB-MHRA-ADR 26432929. A 43 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date 24Sep2021. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; CHEST PAIN (medically significant) with onset 02Jan2022 02:00, outcome "recovering", described as "Chest pain/Intense chest pain lying on back or side, but worsened on right hand side"; CHEST DISCOMFORT (medically significant) with onset 02Jan2022 02:00, outcome "unknown", described as "It felt like something was standing on rib cage and stopping my lungs from expanding"; PALPITATIONS (medically significant) with onset 02Jan2022, outcome "recovering", described as "Heart racing/Palpitations"; TRACHEITIS (medically significant) with onset 02Jan2022, outcome "recovering", described as "Tracheitis"; HEART RATE INCREASED (medically significant) with onset 02Jan2022, outcome "unknown", described as "Raised Heart rate". The patient underwent the following laboratory tests and procedures: heart rate: (02Jan2022) raised; sars-cov-2 test: (unspecified date) no - negative COVID-19 test. Therapeutic measures (antihistamines, paracetamol and ibuprofen) were taken as a result of chest pain, chest discomfort, palpitations, tracheitis, heart rate increased. Clinical course: It was reported that On 02Jan at approximately 02:00am patient had an intense chest pain lying on back or side, which worsened on right hand side. It felt like something was standing on her rib cage and stopping her lungs from expanding. Also, raised heart rate and palpitations. She took antihistamines, paracetamol and ibuprofen regularly for 24 hours until the pain subsided a little and then reduced dose of ibuprofen and paracetamol. 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: 2044866 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Guillain-Barre syndrome, Hypoaesthesia, Immunisation, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200015711

Write-up: fatigue; Numb feeling across entire body; Guillain Barre syndrome; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from The Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202201041300157760-7IC41 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26433402 (MHRA). A 29 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (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: 04Jul2021, for COVID-19 immunization; Comirnaty (DOSE 2), administration date: 30Aug2021, for COVID-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "booster"; GUILLAIN-BARRE SYNDROME (medically significant) with onset 31Dec2021, outcome "recovering", described as "Guillain Barre syndrome"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numb feeling across entire body". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) no - negative covid-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Mild fatigue starting approximately 20 hours after vaccine booster was administered. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reporter did not consider the 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.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200028929 same patient, diffrent dose/diffrent event


VAERS ID: 2044906 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FK9712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Body temperature, Erythema, Fatigue, Immunisation, Interchange of vaccine products, Lymph node pain, Lymphadenopathy, Off label use, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:slight temperature; Test Date: 20220101; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200015680

Write-up: Fatigue; Achy arm; armpit swelling; developing pea sized lump, redness in the area; armpit gland still painfull; Swollen glands; Armpit pain; Off label use; Interchange of vaccine products; Booster; Slight temperature; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202201041858255420-7KAO9 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26435624 (MHRA). A 47 year-old patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FK9712) at the age of 47 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, PRIMARY IMMUNIZATION), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, PRIMARY IMMUNIZATION), for COVID-19 Immunization. Patient has not tested positive for COVID-19 since having the vaccine, was not enrolled in clinical trial and has not had symptoms associated with COVID-19. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 30Dec2021, outcome "recovered" (01Jan2022), described as "Slight temperature"; LYMPHADENOPATHY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen glands"; AXILLARY PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Armpit pain"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue"; PAIN (medically significant), outcome "unknown", described as "Achy arm"; LYMPHADENOPATHY (medically significant), outcome "unknown", described as "armpit swelling"; ERYTHEMA (medically significant), outcome "unknown", described as "developing pea sized lump, redness in the area"; LYMPH NODE PAIN (medically significant), outcome "not recovered", described as "armpit gland still painfull". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) slight temperature; sars-cov-2 test: (01Jan2022) negative, notes: No - Negative COVID-19 test. Clinical course: Fatigued with slight temperature. Achy arm, armpit swelling, developing pea sized lump, redness in the area. Six days later armpit gland still painfull. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2044912 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 - / 3 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary mass, Axillary pain, Gait disturbance, Immunisation, Interchange of vaccine products, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), 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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data: Test Date: 20211008; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive test
CDC Split Type: GBPFIZER INC202200015529

Write-up: Struggled to walk for over 24 hours; Lump in right armpit; Pain in thigh; Off label use; Interchange of vaccine products; Booster; Armpit pain; Painful arm; 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-202201042034197120-B7KK1 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26435925 (MHRA). A 37 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE taken for depression, start date: 01Aug2021. 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. Last menstrual period date was 25Dec2021. Vaccination history included: COVID-19 vaccine astrazeneca (DOSE 1), administration date: 01May2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 2), administration date: 01Oct2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (medically significant) with onset 30Dec2021, outcome "recovered with sequelae", described as "Armpit pain"; PAIN IN EXTREMITY (medically significant) with onset 30Dec2021, outcome "recovering", described as "Painful arm"; PAIN IN EXTREMITY (medically significant) with onset 31Dec2021, outcome "recovered" (04Jan2022), described as "Pain in thigh"; GAIT DISTURBANCE (medically significant), outcome "unknown", described as "Struggled to walk for over 24 hours"; AXILLARY MASS (medically significant), outcome "recovering", described as "Lump in right armpit". The patient underwent SARS-CoV-2 test: (08Oct2021) inconclusive test. Reportedly, the patient had pain in armpits and also had a lump in right armpit although this seemed to be decreasing. Pain in thigh was so bad that she struggled to walk for over 24 hours. 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: 2044914 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210929; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200015796

Write-up: Chest pain; pain also in right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201042104423020-88KKO. Other Case identifier(s): GB-MHRA-ADR 26435984. A 56 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: Fn3543) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: 29Sep2021 (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: CHEST PAIN (medically significant) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "Chest pain"; PAIN IN EXTREMITY (medically significant) with onset 30Dec2021, outcome "unknown", described as "pain also in right arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Sep2021) yes - positive covid-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Started when patient went to bed, chest centre to right side and also in right arm. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reporter did not consider the report relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2044920 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200015635

Write-up: Sleep loss; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201050401003520-X4E2H. Other Case identifier: GB-MHRA-ADR 26436290. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (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 had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (Dose 1, Lot number: unknown), for covid-19 immunization; Bnt162b2 (Dose 2, Lot number: unknown), for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; INSOMNIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Sleep loss". 4 days no sleep. End date of sleep loss was 04Jan2022. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). Patient had 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: 2045006 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-15
Onset:2021-12-30
   Days after vaccination:15
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: Back pain, Compression fracture, Injury, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211031; 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: Compression fracture; Injury; Back pain; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26450317) 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 COMPRESSION FRACTURE (Compression fracture), INJURY (Injury) and BACK PAIN (Back pain) in a 47-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 23-Apr-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced BACK PAIN (Back pain) (seriousness criterion medically significant). On an unknown date, the patient experienced COMPRESSION FRACTURE (Compression fracture) (seriousness criterion medically significant) and INJURY (Injury) (seriousness criterion medically significant). On 07-Jan-2022, BACK PAIN (Back pain) had not resolved. At the time of the report, COMPRESSION FRACTURE (Compression fracture) and INJURY (Injury) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2021, SARS-CoV-2 test: positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Approx. 2 weeks Followed by Covid booster (Moderna), Patient had very debillitating pain/aching in the back at the exact site of a previous compression fracture. Previous injury occurred 12 years ago and has caused no problems previously. Pain was not relieved by ice/heat/rest/otc painkillers or stretching. Patient had Constant ache in the bone and not surrounding tissue/muscle. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No relevant investigations or tests were conducted. Company comment: This is a regulatory case concerning a 47-year-old female patient with past medical history of back injury/ compression fracture, who experienced unexpected serious events of Compression fracture, Injury and Back pain approximately two weeks after the third dose of mRNA-1273 vaccine. Reportedly, the first two doses of vaccine were of another manufacturer, which suggests Interchange of vaccine products. The patient''s medical history remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The event coding, seriousness of the events, rechallenge and action taken with the suspect product were kept as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 47-year-old female patient with past medical history of back injury/ compression fracture, who experienced unexpected serious events of Compression fracture, Injury and Back pain approximately two weeks after the third dose of mRNA-1273 vaccine. Reportedly, the first two doses of vaccine were of another manufacturer, which suggests Interchange of vaccine products. The patient''s medical history remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The event coding, seriousness of the events, rechallenge and action taken with the suspect product were kept as per Regulatory Authority reporting.


VAERS ID: 2045054 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Cough; Head cold; Fever; Chills; Headache; General body pain; This case was received via RA (Reference number: GB-MHRA-ADR 26452198) 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 PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), PAIN (General body pain), NASOPHARYNGITIS (Head cold) and COUGH (Cough) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. No Medical History information was reported. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 27-Apr-2021 to an unknown date for Vaccination, INFLUENZA VACCINE (INFLUENZA VIRUS) from 08-Dec-2021 to an unknown date for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PAIN (General body pain) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced NASOPHARYNGITIS (Head cold) (seriousness criterion medically significant). On 02-Jan-2022, the patient experienced COUGH (Cough) (seriousness criterion medically significant). On 31-Dec-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. On 01-Jan-2022, PAIN (General body pain) had resolved. At the time of the report, HEADACHE (Headache) and COUGH (Cough) had not resolved and NASOPHARYNGITIS (Head cold) had resolved with sequelae. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment drug was provided by reporter. Patient had Initial fever, chills and severe body pain all over together with headache. Most resolved within 48 hours. Nasal mucus build up over the first 2 days and non productive cough. These cold like symptoms are persisting. Report made on 10th day post vaccine. Company comment: This is a regulatory case concerning a 45-year-old female patient with no medical history reported, who experienced the serious unexpected, according RA, events of pyrexia, chills, headache, pain, nasopharyngitis and cough. The events pyrexia, chills, headache, pain occurred the same day after the third dose of mRNA-1273 vaccine. The event nasopharyngitis occurred the day after the third dose of mRNA-1273 vaccine. Cough occurred approximately 3 days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 45-year-old female patient with no medical history reported, who experienced the serious unexpected, according RA, events of pyrexia, chills, headache, pain, nasopharyngitis and cough. The events pyrexia, chills, headache, pain occurred the same day after the third dose of mRNA-1273 vaccine. The event nasopharyngitis occurred the day after the third dose of mRNA-1273 vaccine. Cough occurred approximately 3 days after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2045274 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-12-30
   Days after vaccination:180
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: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202201; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202200069999

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y AND T478K; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y AND T478K; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2022FOS000067. As of 0:00 am, 04-Jan-2022, DH announced that 10 additional confirmed cases of COVID-19 and 15 additional asymptomatic cases of COVID-19 after Comirnaty vaccination. This report was split for 1 of 10 patients that confirmed COVID-19 after Comirnaty vaccination. A 13-year-old female patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 12-Jun-2021 and 03-Jul-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 30-Dec-2021, the patient had symptoms. On 02-Jan-2022, the patient arrived from traveling. In Jan-2022, the patient tested positive. The patient was confirmed as COVID-19 with mutant strain of N501Y and T478K. The adverse event ''confirmed case of COVID-19/imported case with mutant strain of N501Y and T478K'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 05-Jan-2022. This case was split from AER 2021FOS007627 due to same reporter/product, different event/patient. Follow-up closed, no further information is possible. Drug: Comirnaty Causality Assessments: Vaccination failure, COVID-19 Per Reporter= Possible Per Company (BioNTech SE) = Possible BNT162B2 (COMIRNATY) is under agreement with BioNTech SE; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200027220 same reporter/product, different event/patient.


VAERS ID: 2045303 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-12-30
   Days after vaccination:241
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: COVID-19, Gene sequencing, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202201; Test Name: Gene sequencing; Result Unstructured Data: Test Result:carried the Variant of Concern Omicron; Test Date: 20220104; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202200071778

Write-up: CONFIRMED CASE OF COVID-19/EPIDEMIOLOGICALLY LINKED WITH IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K/CARRIED THE VARIANT OF CONCERN OMICRON; CONFIRMED CASE OF COVID-19/EPIDEMIOLOGICALLY LINKED WITH IMPORTED CASE WITH MUTANT STRAINS OF N501Y AND T478K/CARRIED THE VARIANT OF CONCERN OMICRON; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from Regulatory Authority. Other Case identifier(s): HK-Fosun-2022FOS000727. This is a spontaneous report received from a non-contactable HCP received via Regulatory authority. The regulatory authority report number is not applicable. A 62-year-old female patient started to receive two doses of BNT162B2 (COMIRNATY) (lot number: unknown) on 12Apr2021 and 03May2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient was retired and had no recent travel history. On 27Dec2021, the patient had a meal from around 12:30 pm to 1:45 pm when the earlier cases tested positive visited the restaurant. On 30Dec2021, the patient developed headache. The patient was arranged to conduct quarantine at the centre in the small hours on 04Jan2022 and her specimen collected on the same day tested positive with a Ct value larger than 20. The patient was an epidemiologically linked with imported case and was confirmed as COVID-19 with mutant strains of N501Y and T478K. In Jan2022, whole genome sequencing analysis conducted by the regulatory authority confirmed that the patient carried the Variant of Concern Omicron. The adverse event ''confirmed case of COVID-19/epidemiologically linked with imported case with mutant strains of N501Y and T478K/carried the Variant of Concern Omicron'' was considered as Important Medical Event. The action taken for BNT162B2 (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 06Jan2022, 07Jan2022 and 09Jan2022. This case was split from AER 2021FOS007611 due to same reporter/product, different event/patient. Follow-up closed, no further information is possible. Causality assessment COVID-19; Vaccination failure Per Reporter=Possible Per Company=Possible; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200023006 same reporter/product, different event/patient


VAERS ID: 2045827 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Gastrointestinal pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Autoimmune disorder; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia (Fibromyalgia which is now being considered an autoimmune disorder)
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: Bowel cramps; This regulatory authority case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (Bowel cramps) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Fibromyalgia (Fibromyalgia which is now being considered an autoimmune disorder). Concurrent medical conditions included Autoimmune disorder and Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced GASTROINTESTINAL PAIN (Bowel cramps) (seriousness criteria disability and medically significant). At the time of the report, GASTROINTESTINAL PAIN (Bowel cramps) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Concomitant medications were provided. Patient had frequent painful bowel cramps and loose bowels. Patient had to take immodium to reduce this which was dangerous for her, but she has no choice and she sought medical advice. Patient had IBS which had been self-treated for approximately 15 years, but the booster seems to have triggered a relapse. This also happened after her 2nd COVID booster in July 2021 and the effects lasted for 5 months which was very unpleasant and uncomfortable. Patient stomach was also very distended. 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 50-year-old, female patient with medical history of fibromyalgia, who experienced the unexpected serious events of Gastrointestinal pain. The events occurred approximately 3 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 event was reported as not resolved. The medical history, of medical history of fibromyalgia remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 50-year-old, female patient with medical history of fibromyalgia, who experienced the unexpected serious events of Gastrointestinal pain. The events occurred approximately 3 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 event was reported as not resolved. The medical history, of medical history of fibromyalgia remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2045954 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 - / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Immunisation, Pharyngitis
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pharyngitis (had symptoms of pharyngitis for 2 days before she received 3rd dose)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC202200001785

Write-up: 3rd dose; Patient''s pharyngitis symptoms aggravated after vaccination; Patient''s pharyngitis symptoms aggravated after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 43 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pharyngitis", start date: 28Dec2021 (unspecified if ongoing), notes: had symptoms of pharyngitis for 2 days before she received 3rd dose. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: 21Apr2021, for COVID-19 immunisation; Bnt162b2 (Dose 2), administration date: 06Jun2021, for COVID-19 immunisation, reaction(s): "1st dose: 21Apr2021, 2nd dose: 06Jun2021". The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "3rd dose"; PHARYNGITIS (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 30Dec2021, outcome "recovered" and all described as "Patient''s pharyngitis symptoms aggravated after vaccination". The event "patient''s pharyngitis symptoms aggravated after vaccination" and "patient''s pharyngitis symptoms aggravated after vaccination" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of pharyngitis, condition aggravated which included oral Azitron and A-ferin treatment and given C-vitamin serum in the hospital on 30Dec2021. The event occurred after product use. The patient had no other vaccinations prior to 4 weeks of 3rd dose. The event pharyngitis did not require admission to intensive care and there were no laboratory findings/imaging results related to event. The patient stated that she started to experience pharyngitis symptoms 2 days before she received 3rd dose but was diagnosed the evening of vaccination due to the aggravation of symptoms. She stated that she did not know the exact recovery date, only that pharyngitis lasted approximately a week. The patient stated that she had been examined by the physician in the emergency room for pharyngitis and stated that she did not know the physician''s name or contact information. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2049003 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FK9712 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200015594

Write-up: Rash is in both armpits; Armpit pain; Itchy rash; Red rash; Itch burning; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202201041719324320-LPSMS (MHRA). Other Case identifier(s): GB-MHRA-ADR 26435367 (MHRA). A 33 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm, administration date 30Dec2021 (Lot number: FK9712) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine, was not enrolled in clinical trial, not had symptoms associated with COVID-19, was not breastfeeding. Patient''s last menstrual period was on 23Dec2021. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 05Jun2021, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), administration date: 31Jul2021, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered ". The following information was reported: IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Armpit pain"; RASH PRURITIC (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Itchy rash"; RASH ERYTHEMATOUS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Red rash"; PRURITUS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Itch burning"; RASH (medically significant), outcome "not recovered", described as "Rash is in both armpits". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. Therapeutic measures were taken as a result of axillary pain, rash pruritic, rash erythematous, pruritus, rash with antihistamine, anti fungal cream, use of ice packs and recommended not using any fragranced body wash, deo etc. Clinical course: Pharmacist also confirmed they have had multiple people report to them the same issue. The side effects were checked with pharmacist. The rash was in both armpits, not just the vaccine injection site arm. Equal in terms of pain/burning/rash. 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.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200030153 Same patient, same product, different event (DOSE 2)


VAERS ID: 2049005 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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: Immunisation, Interchange of vaccine products, Off label use, Pain in extremity, Peripheral swelling, Rash, 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), 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 Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200015498

Write-up: Severe COVID arm; Swollen arm/ Swelling, hot lumpy; Very sore 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). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201041739360160-UVRHX (RA). Other Case identifier(s): GB-MHRA-ADR 26435378 (RA). A 33 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm, administration date 30Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Last menstrual period: 03Dec2021. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. Patient was not currently breastfeeding. Vaccination history included: COVID-19 vaccine astrazeneca (Dose number Unknown), administration date: 11Mar2021, for COVID-19 immunisation; COVID-19 vaccine astrazeneca (Dose number unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen arm/ Swelling, hot lumpy"; PAIN IN EXTREMITY (medically significant) with onset 31Dec2021, outcome "unknown", described as "Very sore arm"; RASH (medically significant), outcome "unknown", described as "Severe COVID arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. Clinical Course: Severe COVID arm. Swelling, hot lumpy and very sore. Worse than her second Astra injection. She reported having COVID arm. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2049026 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-30
   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 FK9707 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye swelling, Immunisation, Interchange of vaccine products, Off label use, Pain, Pyrexia, SARS-CoV-2 test, Skin disorder
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200015812

Write-up: Swollen eyes; bumps appeared on my head and forehead; constant aches and pains; fever; 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-202201042217257200-TLS9F (RA). Other Case identifier(s): GB-MHRA-ADR 26436079 (RA). A 55-year-old male patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FK9707) 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. Unsure if patient has had symptoms associated with COVID-19. The following information was reported: OFF LABEL USE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 30Dec2021, outcome "unknown", described as "Booster"; EYE SWELLING (medically significant), outcome "not recovered", described as "Swollen eyes"; SKIN DISORDER (medically significant), outcome "unknown", described as "bumps appeared on my head and forehead"; PAIN (medically significant), outcome "unknown", described as "constant aches and pains"; PYREXIA (medically significant), outcome "unknown", described as "fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The patient reported that since his booster jab on 30Dec2021, his eyes have swollen, bumps appeared on his head and forehead, and he had constant aches and pains with a fever. He seriously regretted getting the booster. The patient has not tested positive for COVID-19 since having the vaccine. The patient is not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


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