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From the 1/14/2022 release of VAERS data:

Found 1,031,637 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

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VAERS ID: 1926733 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Freezing phenomenon, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; BISOPROLOL; EPLERENONE; LANSOPRAZOLE; RAMIPRIL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646107

Write-up: Off-label use; Interchange of vaccine products; Booster; shivering; Freezing phenomenon; Tiredness; 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-202111220912572380-FHE4C (RA). Other Case identifier(s): GB-MHRA-ADR 26233848 (RA). A 61 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medications included: ASPIRIN, ATORVASTATIN, BISOPROLOL, EPLERENONE, LANSOPRAZOLE and RAMIPRIL. Vaccination history included: Covid-19 vaccine (dose1 and dose 2 Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: CHILLS (medically significant, life threatening) with onset 20Nov2021, outcome "recovering", described as "shivering"; FREEZING PHENOMENON (medically significant, life threatening) with onset 20Nov2021, outcome "recovered with sequelae" (21Nov2021), described as "Freezing phenomenon"; FATIGUE (medically significant, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Tiredness". Clinical course: After having the vaccine everything was fine until he went to bed woke up in the night freezing cold and was unable to get up as unable to get up out of bed. After 3 or 4 hours fell back to sleep and was still really cold and shivering. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) negative covid-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1926752 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH475 2 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Immunisation, Insomnia, Interchange of vaccine products, Neuropathy peripheral, Off label use, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Medication errors (broad), Opportunistic infections (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: BETAHISTINE; BOOTS ALLERGY RELIEF; CODEINE; FELODIPINE; LEVOTHYROXINE; LISINOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diverticulitis; Hypertension; Vertigo
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646183

Write-up: unable to sleep for 2 nights; shingles pain; Neuropathy; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP, patient) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111221036254050-DYTM1. Other Case identifier(s): GB-MHRA-ADR 26234132. A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH475 2) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diverticulitis" (unspecified if ongoing); "Vertigo" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included: BETAHISTINE taken for vertigo, stop date: 12Jul2021; BOOTS ALLERGY RELIEF, start date: 16Jun2010; CODEINE, start date: 06Jun2020; FELODIPINE taken for hypertension, start date: 14Sep2017; LEVOTHYROXINE, start date: 03May2019; LISINOPRIL taken for hypertension, start date: 09Jun2021. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; NEUROPATHY PERIPHERAL (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Neuropathy"; INSOMNIA (medically significant), outcome "unknown", described as "unable to sleep for 2 nights"; HERPES ZOSTER (medically significant), outcome "not recovered", described as "shingles pain". Symptoms were a recurrence of shingles pain, tracking the nerve from under patient arm into chest and shoulder. Very painful. 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 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 needed. No further information is expected.


VAERS ID: 1926759 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Feeling of body temperature change, Headache, Immunisation, Interchange of vaccine products, Myalgia, Nausea, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (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? 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 (Asthma inhalers)
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646482

Write-up: nausea; headache; joint and muscle pain; fever; shivering; cold and hot; Pain joint; 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-202111221116554020-LUE4U (MHRA). Other Case identifier(s): GB-MHRA-ADR 26234247 (MHRA). A 55 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: Not Known) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma inhalers. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1/Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2/Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; NAUSEA (medically significant), outcome "unknown", described as "nausea"; HEADACHE (medically significant), outcome "unknown", described as "headache"; MYALGIA (medically significant), outcome "unknown", described as "joint and muscle pain"; PYREXIA (medically significant), outcome "unknown", described as "fever"; ARTHRALGIA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Pain joint"; CHILLS (medically significant), outcome "unknown", described as "shivering"; FEELING OF BODY TEMPERATURE CHANGE (medically significant), outcome "unknown", described as "cold and hot". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) negative, notes: No - Negative COVID-19 test. 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. No follow-up attempts are possible. No further information expected.


VAERS ID: 1926761 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Feeling hot, Headache, Illness, Immunisation, Loss of consciousness, Spinal pain, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRAMADOL; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646469

Write-up: spinal pain; whole body shaking; feeling hot; Blackout; sick; booster injection; no balance; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the parent. Regulatory number: GB-MHRA-WEBCOVID-202111221136313120-VG939 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26234359 (MHRA). A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 20Nov2021 (Lot number: FH4751) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 21Nov2021, stop date: 22Nov2021. Concomitant medication(s) included: TRAMADOL taken for spinal pain; PARACETAMOL taken for spinal pain. Past drug history included: Tramadol; Paracetamol. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster injection"; LOSS OF CONSCIOUSNESS (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "Blackout"; SPINAL PAIN (medically significant), outcome "not recovered", described as "spinal pain"; TREMOR (medically significant), outcome "not recovered", described as "whole body shaking"; FEELING HOT (medically significant), outcome "not recovered", described as "feeling hot"; BALANCE DISORDER (medically significant), outcome "unknown", described as "no balance"; HEADACHE (medically significant), outcome "unknown", described as "headache"; ILLNESS (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "sick". Additional information: Apart from whole body shaking, the patient had no balance, feeling hot, sick ( only once on the 21st), and headache. The patient was so hot, he got to the window to further open the windows, he done the first one ok, then opened the second and woke with his head on the windowsill, he did not know How long this episode went on as he lived alone. He never had this happen before, he took Tramadol 50mg daily and Paracetamol 500mg daily, for spinal pain control. He had to increase this at times. He had taken 1 tramadol and 1 paracetamol on the 20th, the date of booster injection. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1926765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Feeling abnormal, Immunisation, Insomnia, Interchange of vaccine products, Lymphadenopathy, Off label use, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (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:
CDC Split Type: GBPFIZER INC202101646452

Write-up: Vomiting; sore arm, shoulder and chest on side where jab was done; sore arm, shoulder and chest on side where jab was done; sore arm, shoulder and chest on side where jab was done; difficulty sleeping; couldn''t get comfortable; Swollen lymph nodes/lymph nodes in my armpit on the same side to be very tender and enlarged; 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. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111221147354040-BNWDH (MHRA). Other Case identifier(s): GB-MHRA-ADR 26234349 (MHRA). A female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (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. Past drug history included: Losartan. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer for Dose 1), for COVID-19 Immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer for Dose 2), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; VOMITING (medically significant), outcome "not recovered", described as "Vomiting"; LYMPHADENOPATHY (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Swollen lymph nodes/lymph nodes in my armpit on the same side to be very tender and enlarged"; PAIN IN EXTREMITY (medically significant), outcome "unknown", ARTHRALGIA (medically significant), CHEST PAIN (medically significant), outcome "not recovered" and all described as "sore arm, shoulder and chest on side where jab was done"; INSOMNIA (medically significant), outcome "unknown", described as "difficulty sleeping"; FEELING ABNORMAL (medically significant), outcome "unknown", described as "couldn''t get comfortable". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926773 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye pain, Headache, Heavy menstrual bleeding, Menstruation irregular, Pyrexia, SARS-CoV-2 test, Sciatica
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Fertility disorders (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; Sciatica; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Inconclusive
CDC Split Type: GBPFIZER INC202101646607

Write-up: Heavy periods; My period has come 10 days early rafter taking the Pfizer vaccine; eye pain; sciatica pain; fever; pressure headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from a Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111221232122690-HVVVS. Other Case identifiers: GB-MHRA-ADR 26234407. A 46 year-old female patient received BNT162B2 (COMIRNATY), administration date 20Nov2021 (Lot number: Unknown) at the age of 46 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Sciatica" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Suspected COVID-19", start date: 30Mar2020, stop date: 30Sep2020. Patient was not pregnant, not currently breastfeeding and was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, single, Lot number: Unknown), for COVID-19 immunisation, reaction: "sciatica pain". The following information was reported: HEAVY MENSTRUAL BLEEDING (disability, medically significant) with onset 20Nov2021, outcome "recovered with sequelae", described as "Heavy periods"; MENSTRUATION IRREGULAR (disability, medically significant) with onset 20Nov2021, outcome "recovered with sequelae", described as "My period has come 10 days early rafter taking the Pfizer vaccine"; EYE PAIN (disability, medically significant) with onset 2021, outcome "recovering", described as "eye pain"; SCIATICA (disability, medically significant) with onset 2021, outcome "recovering", described as "sciatica pain"; PYREXIA (disability, medically significant) with onset 2021, outcome "recovering", described as "fever"; HEADACHE (disability, medically significant) with onset 2021, outcome "recovering", described as "pressure headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: inconclusive. 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-202101654865 Same patient/drug, different dose/event


VAERS ID: 1926795 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dysphagia, Immunisation, Interchange of vaccine products, Off label use, Restlessness, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Overweight (otherwise in good health.); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211018; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101646654

Write-up: Vomited every 1-2 hours for 12 hrs or more; Off label use; Interchange of vaccine product; Booster; extremely painful hip joints; unable to sit or lie down for any length of time for about 4-6 hours; unable to drink water or take pain relief or 18 hrs; 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-202111221448406450-A2EDK (RA). Other Case identifiers: GB-MHRA-ADR 26234823 (RA). A female patient received BNT162B2 (COMIRNATY), administration date 20Nov2021 (Lot number: Unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing), notes: otherwise in good health.; "Suspected COVID-19", start date: Oct2021 (unspecified if ongoing). 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. Concomitant medication included: INFLUENZA VIRUS, administration date Nov2021. Vaccination history included: COVID-19 vaccine astrazeneca (Dose 1, single, Lot number: Unknown), administration date: Jan2021, for COVID-19 immunization; COVID-19 vaccine astrazeneca (Dose 2, single, Lot number: Unknown), administration date: 15May2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine product"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; VOMITING (medically significant) with onset 21Nov2021, outcome "recovered" (22Nov2021), described as "Vomited every 1-2 hours for 12 hrs or more"; ARTHRALGIA (medically significant) with onset 2021, outcome "recovered" (2021), described as "extremely painful hip joints"; RESTLESSNESS (medically significant) with onset 2021, outcome "recovered" (2021), described as "unable to sit or lie down for any length of time for about 4-6 hours"; DYSPHAGIA (medically significant) with onset 2021, outcome "recovered" (2021), described as "unable to drink water or take pain relief or 18 hrs". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Oct2021) positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926798 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-09
Onset:2021-11-20
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Costochondritis, Electrocardiogram, Joint swelling, Pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: ECG; Result Unstructured Data: Test Result:Unknown result; Test Date: 20210919; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101646152

Write-up: Costochondritis; swollen and painful joints; painful joints; chest pains; painful breathing and lying down; 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-202111221455516610-K3FAN. Other Case identifier(s): GB-MHRA-ADR 26234990. A 15 year-old female patient received bnt162b2 (COMIRNATY), administration date 09Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 15Sep2021 (not ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. The patient is normally fit and healthy with no underlying Conditions. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The following information was reported: COSTOCHONDRITIS (disability, medically significant) with onset 20Nov2021, outcome "not recovered", described as "Costochondritis"; JOINT SWELLING (disability, medically significant) with onset 2021, outcome "unknown", described as "swollen and painful joints "; ARTHRALGIA (disability, medically significant) with onset 2021, outcome "unknown", described as "painful joints "; CHEST PAIN (disability, medically significant) with onset 2021, outcome "unknown", described as "chest pains"; PAIN (disability, medically significant) with onset 2021, outcome "unknown", described as "painful breathing and lying down". The events "costochondritis", "swollen and painful joints ", "painful joints ", "chest pains" and "painful breathing and lying down" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: (21Nov2021) unknown result; sars-cov-2 test: (19Sep2021) yes - positive covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926806 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Immunisation, Interchange of vaccine products, Myalgia, Nausea, Neck pain, Off label use
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (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: LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646427

Write-up: Neck pain; Nausea; Fatigue; Headache; Muscle ache; 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-202111221518299560-TXPKD (Regulatory Authority). Other Case identifier(s): GB-MHRA-ADR 26234880 (Regulatory Authority). A 58-year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant", notes. Concomitant medication(s) included: influenza vaccine (INFLUENZA VIRUS), administration date 05Nov2021; losartan, start date: Jul2016. Vaccination history included: covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA) (DOSE 1), administration date: 25Mar2021, for COVID-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (DOSE 2), administration date: 13Jun2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Headache"; MYALGIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Muscle ache"; NECK PAIN (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Neck pain"; NAUSEA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Nausea"; FATIGUE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Fatigue". Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926828 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FX9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest pain, Electrocardiogram, Immunisation, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:Unknown results; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown results; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211122; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646299

Write-up: pins and needles; Chest pain; 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-202111221610313620-AN3IM (MHRA). Other Case identifier(s): GB-MHRA-ADR 26235043 (MHRA). A 64 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FX9413) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose-1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose-2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; PARAESTHESIA (medically significant), outcome "unknown", described as "pins and needles"; CHEST PAIN (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Chest pain". The events "pins and needles" and "chest pain" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown results; chest x-ray: (unspecified date) unknown results; electrocardiogram: (unspecified date) unknown results; sars-cov-2 test: (22Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: Chest pain with pins and needles down arm. Attended A&E.. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Suspect Reactions Please provide details of any relevant investigations or tests conducted: "Chest X-ray, blood tests, ECG." Patient has not had symptoms associated with COVID-19


VAERS ID: 1926829 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Breast pain, Chills, Feeling hot, Immunisation, Interchange of vaccine products, Musculoskeletal stiffness, Off label use, Pain of skin, Sleep disorder
SMQs:, Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Lipodystrophy (broad), Arthritis (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 INC202101646534

Write-up: interrupted sleep; stiff bones in hands; Breast pain; Skin pain; Chills; Feeling hot; off label use; Interchange of vaccine products; Booster; Back pain; 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-202111221612133210-SJ25W (MHRA). Other Case identifier(s): GB-MHRA-ADR 26235069 (MHRA). A 51 year-old female patient (not pregnant or breastfeeding) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. It was unsure if patient has had symptoms associated with COVID-19. The patient had no COVID-19 test. Patient is not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine astrazeneca (Dose-2), administration date: 22May2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose-1), administration date: 13Mar2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; BACK PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Back pain"; BREAST PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Breast pain"; PAIN OF SKIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Skin pain"; CHILLS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Chills"; FEELING HOT (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Feeling hot"; SLEEP DISORDER (medically significant), outcome "unknown", described as "interrupted sleep"; MUSCULOSKELETAL STIFFNESS (medically significant), outcome "unknown", described as "stiff bones in hands". Therapeutic measures were taken as a result of back pain, breast pain, pain of skin, chills, feeling hot, sleep disorder, musculoskeletal stiffness included paracetamol. The reporter did not relate the events to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1926832 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Fatigue, Immunisation, Interchange of vaccine products, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular 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: 20211122; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646210

Write-up: Felt faint; Chest pain; Tiredness; Off label use; Interchange of vaccine products; Booster; Feverish; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202111221621597850-XOJDR, Safety Report Unique Identifier GB-MHRA-ADR 26235133. A 73 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 73 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. 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 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Feverish"; DIZZINESS (medically significant), outcome "not recovered", described as "Felt faint"; CHEST PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Chest pain"; FATIGUE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Tiredness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) no - negative covid-19 test. Clinical course: Within 5 minutes of Pfizer booster vax. Symptoms lasted approximately one hour. Symptoms recurred two days later. 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.


VAERS ID: 1926842 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Myocarditis, Off label use, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: inflammation of the heart; Result Unstructured Data: Test Result:UNKNOWN; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646438

Write-up: Headache; Off label use; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202111221735205240-0JIOQ. Other Case identifier(s): GB-MHRA-ADR 26235219. A 57 years old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (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 (First Dose, Single), for COVID-19 immunization; Bnt162b2 (Second Dose, Single), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Headache". The patient underwent the following laboratory tests and procedures: myocarditis: unknown; sars-cov-2 test: negative, notes: No - Negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926844 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Feeling hot, Immunisation, Pain, Pruritus, Rash erythematous, SARS-CoV-2 test, Urticaria
SMQs:, Severe cutaneous adverse reactions (broad), 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: ANTI-D IMMUNOGLOBULIN; VITAMIN B12 [CYANOCOBALAMIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type 2 diabetes mellitus; Vitamin B12 deficiency
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101646327

Write-up: itchy; Sore; Warm; red rash on left forearm and upper arm with tiny fluid filled bubbles; red rash on left forearm and upper arm with tiny fluid filled bubbles; Hives; 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-202111221736517310-CDGLN (RA). Other Case identifier(s): GB-MHRA-ADR 26235245 (RA). A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "B12 deficiency" (unspecified if ongoing); "Type 2 diabetes" (unspecified if ongoing). Concomitant medications included: ANTI-D IMMUNOGLOBULIN; INFLUENZA VIRUS taken for immunisation, administration date 28Oct2021; VITAMIN B12 [CYANOCOBALAMIN], start date: 10Nov2021. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation, reactions: "red rash on left forearm and upper arm with tiny fluid filled bubbles", "warm", "sore", "Itchy". Patient has not had symptoms associated with COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; URTICARIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Hives"; PRURITUS (medically significant), outcome "not recovered", described as "itchy"; PAIN (medically significant), outcome "unknown", described as "Sore"; FEELING HOT (medically significant), outcome "unknown", described as "Warm"; RASH ERYTHEMATOUS (medically significant), BLISTER (medically significant), outcome "unknown" and all described as "red rash on left forearm and upper arm with tiny fluid filled bubbles". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Clinical course included Itchy, sore, warm, red rash on left forearm and upper arm with tiny fluid filled bubbles. (This also happened after the second vaccine dose in a more severe way affecting both arms, shoulders and upper chest , Dr prescribed strong anti histermine though it wasn''t identified as being vaccine related at the time.. ). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926846 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Immunisation, Myalgia, Nausea, Palpitations, Peripheral swelling, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUMETANIDE; CO-CODAMOL; INFLUENZA VIRUS; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure (I have RA and heart failure with three hospital admissions in the past twelve months.); Hospitalization; Immunisation; Pain relief; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646431

Write-up: Muscle ache; Joint ache; Swollen arm; Headache; Booster; Heart pounding; Nausea; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111221749533120-JVCCD (RA). Other Case identifier(s): GB-MHRA-ADR 26235258 (RA). A 67-year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart failure" (unspecified if ongoing), notes: patient has RA and heart failure with three hospital admissions in the past twelve months.; "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...; "hospital admissions" (unspecified if ongoing); "Pain relief" (unspecified if ongoing); "Immunisation" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication(s) included: bumetanide taken for Heart failure; codeine phosphate, paracetamol (CO-CODAMOL) taken for Pain relief; influenza vaccine (INFLUENZA VIRUS) taken for immunisation; ramipril. 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 20Nov2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Swollen arm"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache"; MYALGIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Muscle ache"; ARTHRALGIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Joint ache"; PALPITATIONS (medically significant) with onset 20Nov2021, outcome "recovering", described as "Heart pounding"; NAUSEA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Nausea". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (20Nov2021) negative, notes: No - Negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926848 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Immunisation, Interchange of vaccine products, Off label use, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATENOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hereditary haemochromatosis; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20200528; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646311

Write-up: shaking; chills; fever; tiredness; headaches; Fever chills; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable consumer from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111221756479660-NC7IC (RA). Other Case identifier(s): GB-MHRA-ADR 26235254 (RA). A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hereditary haemochromatosis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient had Hereditary haemochromatosis. Patient has not had symptoms associated with COIVD-19. Concomitant medications included: ATENOLOL taken for hypertension, start date: 04May2019. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; TREMOR (medically significant), outcome "not recovered", described as "shaking"; CHILLS (medically significant), outcome "not recovered", described as "chills"; PYREXIA (medically significant), outcome "not recovered", described as "fever"; FATIGUE (medically significant), outcome "not recovered", described as "tiredness"; PYREXIA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Fever chills"; HEADACHE (medically significant), outcome "unknown", described as "headaches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28May2020) negative, notes: No - Negative COVID-19 test. Detail course was reported as: Severe fever with shaking followed by severe chills. The patient was in bed fully clothed with a fleece on and covered by two extra blankets and the worst bout took two hours to control. Also tiredness and headaches. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial This report not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts possible. No further information expected. Information about batch number has been obtained.


VAERS ID: 1926851 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Diarrhoea, Headache, 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Had Covid 25/09/21)
Allergies:
Diagnostic Lab Data: Test Date: 20210925; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101646124

Write-up: fever; chills; Head pain/headache; diarrhoea; 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-202111221806344120-5YF76 (RA). Other Case identifier(s): GB-MHRA-ADR 26235275 (RA). A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) at the age of 62 years as dose 3 (booster),single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 25Sep2021, stop date: 04Oct2021, notes: Had Covid 25/09/21. Additional information: Had Covid 25/09/21. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca, administration date: Feb2021, for COVID-19 vaccination; Covid-19 vaccine, for COVID-19 vaccination. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant), outcome "not recovered", described as "fever"; CHILLS (medically significant), outcome "not recovered", described as "chills"; HEADACHE (medically significant) with onset 20Nov2021, outcome "recovering", described as "Head pain/headache"; DIARRHOEA (medically significant) with onset 20Nov2021, outcome "recovering", described as "diarrhoea". Case narrative: Chills, severe fever, bad headache, diarrhoea. It felt as bad as when she had Covid three months ago. She won''t have any more of these vaccines! Patient has not tested positive for COVID-19 since having the vaccine. Case reported as medically significant by health authority. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Sep2021) yes - positive covid-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1926857 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Delirium, Headache, Hyperhidrosis, Immunisation, Interchange of vaccine products, Myalgia, Off label use, Poor quality sleep, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), 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: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: temp; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 20210214; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test; Test Name: laterlal flow test; Test Result: Negative ; Comments: Took laterlal flow test- was negative
CDC Split Type: GBPFIZER INC202101646368

Write-up: chills; delirium; muscle aches; could not sleep; sweats; temp 38.5c; Headache; Interchange of vaccine products; off label use; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111221832471750-XAU9O (MHRA). Other Case identifier(s): GB-MHRA-ADR 26235324 (MHRA). A 55-year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 14Feb2021, stop date: 03Mar2021. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer for Dose 1), for COVID-19 Immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer for Dose 2), for COVID-19 Immunization. The following information was reported: CHILLS (disability), outcome "recovering", described as "chills"; DELIRIUM (disability), outcome "recovering", described as "delirium"; HEADACHE (disability) with onset 20Nov2021, outcome "not recovered", described as "Headache"; MYALGIA (disability), outcome "unknown", described as "muscle aches"; POOR QUALITY SLEEP (disability), outcome "unknown", described as "could not sleep"; HYPERHIDROSIS (disability), outcome "unknown", described as "sweats"; PYREXIA (disability), outcome "unknown", described as "temp 38.5c". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (14Feb2021) positive, notes: Yes - Positive COVID-19 test; laterlal flow test (unspecified date) negative, notes: Took laterlal flow test- was negative; body temperature: (unspecified date) 38.5 Centigrade. Therapeutic measures were taken as a result of chills, delirium, headache, poor quality sleep. Clinical course: Woke at approximately midnight 8+ vaccine, severe headache, chills and delirium, could not sleep, during daylight couldn''t have direct light, took paracetamol, night 2 chills and sweats temp 38.5c, still headache and muscle aches and "paon". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Does your report relate to possible inflammation of the heart (myocarditis or pericarditis): "No". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926864 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Headache, Immunisation, Interchange of vaccine products, Off label use, Tonsillar hypertrophy
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: HYDROXOCOBALAMIN; LEVOTHYROXINE; METFORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic; Hypothyroidism; Vitamin B12 decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646638

Write-up: Armpit pain; Swollen tonsils; Headache; patient received third (booster) dose of BNT162b2/previously received two doses of COVID-19 vaccine, at least one is non-Pfizer COVID-19 Vaccine; patient received third (booster) dose of BNT162b2/previously received two doses of COVID-19 vaccine, at least one is non-Pfizer COVID-19 Vaccine; patient received third (booster) dose of BNT162b2/previously received two doses of COVID-19 vaccine, at least one is non-Pfizer COVID-19 Vaccine; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111221849397430-PHYX4. Other Case identifier(s): GB-MHRA-ADR 26235342. A 39 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Diabetic" (unspecified if ongoing); "Vitamin B12 decreased" (unspecified if ongoing). Concomitant medication(s) included: HYDROXOCOBALAMIN taken for vitamin b12 decreased, start date: 04Nov2021, stop date: 17Nov2021; LEVOTHYROXINE taken for hypothyroidism; METFORMIN taken for diabetes mellitus, start date: 01Nov2021. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 2, SINGLE;Lot number: UNKNOWN), administration date: May2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 1, SINGLE;Lot number: UNKNOWN), administration date: Mar2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "patient received third (booster) dose of BNT162b2/previously received two doses of COVID-19 vaccine, at least one is non-Pfizer COVID-19 Vaccine"; AXILLARY PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Armpit pain"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache"; TONSILLAR HYPERTROPHY (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Swollen tonsils". The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. The patient did not have a COVID-19 test. The patient was not pregnant and was not breastfeeding at the time of this report. The patient had not tested positive for COVID-19 since having the vaccine. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926871 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, 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: CERAZETTE [DESOGESTREL]; EPILIM CHRONO; LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Underactive
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646424

Write-up: Nausea; Booster; extreme headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-RA-WEBCOVID-202111221949058860-3TEAM (RA). Other Case identifier(s): GB-RA-ADR 26235404 (RA). A 54 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Underactive" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing). Concomitant medication(s) included: CERAZETTE [DESOGESTREL], start date: 2001; EPILIM CHRONO taken for epilepsy, start date: 1978; LEVOTHYROXINE taken for decreased activity. Vaccination history included: Bnt162b2 (DOSE 2), for COVID-19 immunisation; Bnt162b2 (DOSE 1), for COVID-19 immunisation. The patient did not have symptoms associated with COVID-19. The patient was not enrolled in clinical trial. The patient was not breastfeeding at the time of report. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "extreme headache"; NAUSEA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Nausea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no-negative covid-19 test. The patient had not tested positive for COVID-19 since having the vaccine. Therapeutic measures were taken as a result of headache, the tablets (unspecified drug) were not helping. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926880 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
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: Immunisation; Multiple sclerosis (Taking medicines for multiple sclerosis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646560

Write-up: Off label use; Interchange of vaccine products; Booster; Shivering; fever; vomiting; swollen glands right side of neck; Headache; 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-202111222123158660-LBPLR. Other Case identifier(s): GB-MHRA-ADR 26235669. A 68 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing), notes: Taking medicines for multiple sclerosis; "Immunisation" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date 2021. Vaccination history included: Covid-19 vaccine (dose 1), for COVID-19 immunisation; Covid-19 vaccine (dose 2), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 20Nov2021, outcome "recovering", described as "Headache"; CHILLS (medically significant), outcome "unknown", described as "Shivering"; PYREXIA (medically significant), outcome "unknown", described as "fever"; VOMITING (medically significant), outcome "unknown", described as "vomiting"; LYMPHADENOPATHY (medically significant), outcome "unknown", described as "swollen glands right side of neck". Other details: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient 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: 1926887 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Enuresis, Fatigue, Feeling abnormal, Headache, Hypotension, Immunisation, Interchange of vaccine products, Malaise, Nervousness, Off label use, Palpitations, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL FUMARATE; LOSARTAN POTASSIUM; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Low blood pressure; Mitral valve repair (following mitral valve surgery in 2019)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:Low
CDC Split Type: GBPFIZER INC202101646614

Write-up: Felt faint/felt extremely lightheaded; Faint; Feeling sick/ill/not well; Headache; Feeling bad; low blood pressure; got out of bed for the bathroom; shaky; breathless; conscious of my heartbeat; Felt extremely tired; patient received third dose of BNT162b2 in 2021; patient received third dose of BNT162b2 in 2021; patient received third dose of BNT162b2 in 2021; 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-202111222207526450-JM0LJ. Other Case identifier: GB-MHRA-ADR 26236160. A 63 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "low blood pressure" (unspecified if ongoing); "mitral valve surgery", start date: 2019, stop date: 2019, notes: following mitral valve surgery in 2019. Concomitant medication(s) included: BISOPROLOL FUMARATE, start date: 20Dec2019; LOSARTAN POTASSIUM, start date: 08Feb2020; INFLUENZA VIRUS vaccine taken for immunisation, administration date 20Oct2021; PARACETAMOL. Vaccination history included: COVID-19 vaccine astrazeneca (DOSE 1, SINGLE, Batch/Lot no. - unknown), administration date: 12Feb2021, for COVID-19 Immunisation; COVID-19 vaccine astra zeneca (DOSE 2, SINGLE, Batch/Lot no. - unknown), administration date: 07May2021, for COVID-19 Immunisation. Patient had no symptoms associated with COVID-19 nor had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 2021, outcome "unknown" and all described as "patient received third dose of BNT162b2 in 2021"; DIZZINESS (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Felt faint/felt extremely lightheaded"; SYNCOPE (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Faint"; MALAISE (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Feeling sick/ill/not well"; HEADACHE (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Headache"; FEELING ABNORMAL (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Feeling bad"; HYPOTENSION (medically significant) with onset 2021, outcome "not recovered", described as "low blood pressure"; ENURESIS (medically significant) with onset 2021, outcome "not recovered", described as "got out of bed for the bathroom"; NERVOUSNESS (medically significant) with onset 2021, outcome "unknown", described as "shaky"; DYSPNOEA (medically significant) with onset 2021, outcome "unknown", described as "breathless"; PALPITATIONS (medically significant) with onset 2021, outcome "unknown", described as "conscious of her heartbeat"; FATIGUE (medically significant) with onset 2021, outcome "unknown", described as "Felt extremely tired". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) low. Clinical course: Got out of bed for the bathroom, felt extremely lightheaded and ill, woke her husband who took her to bathroom where she fainted for about 25-30 seconds. Felt sick and shaky and breathless and was conscious of her heartbeat. Felt extremely tired and not well for about 24 hours. Paramedic called and attended and felt that it could be a combination of the Pfizer booster and her low blood pressure, following mitral valve surgery in 2019. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926897 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Epilepsy, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Scan brain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Sleep apnea
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: head scan; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101646586

Write-up: dizziness; The patient received third dose of COMIRNATY on 20Nov2021; The patient received third dose of COMIRNATY on 20Nov2021; The patient received third dose of COMIRNATY on 20Nov2021; Epileptic fit; Collapsed; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111222317581230-UAFRB (RA). Other Case identifier(s): GB-MHRA-ADR 26236180 (RA). A 53 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 08:30 (Lot number: Unknown) at the age of 53 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sleep apnea" (unspecified if ongoing). 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 patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine astrazeneca (Dose 1, single, Lot number: Unknown), for COVID-19 immunisation; COVID-19 vaccine astrazeneca (Dose 2, single, Lot number: Unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization), INTERCHANGE OF VACCINE PRODUCTS (hospitalization), IMMUNISATION (hospitalization) all with onset 20Nov2021 08:30, outcome "unknown" and all described as "The patient received third dose of COMIRNATY on 20Nov2021"; EPILEPSY (hospitalization) with onset 20Nov2021, outcome "recovering", described as "Epileptic fit"; DIZZINESS (hospitalization) with onset 20Nov2021 12:30, outcome "unknown", described as "dizziness"; SYNCOPE (hospitalization) with onset 20Nov2021, outcome "unknown", described as "Collapsed". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test; scan brain: unknown results. The clinical course was: At 12:30 patient complained of dizziness then collapsed and started fitting. Hadn''t had a fit since 19 years old, he''s now 54. The patient was taken to hospital for head scan, further tests pending. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926899 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Contusion, Fatigue, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (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: AMITRIPTYLINE; CITALOPRAM
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: temperature; Result Unstructured Data: Test Result:High; Test Date: 20201228; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101646561

Write-up: Off label use; Interchange of vaccine products; Booster; Headache; Glands swollen; High temperature; Exhaustion; Bruising; 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-202111222359302600-IMZFG (MHRA). Other Case identifier(s): GB-MHRA-ADR 26236199 (MHRA). A 53 year-old patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 27Dec2020 (ongoing). Patient was not enrolled in clinical trial. Concomitant medication(s) included: AMITRIPTYLINE; CITALOPRAM. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 20Nov2021, outcome "recovering", described as "Headache"; LYMPHADENOPATHY (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Glands swollen"; PYREXIA (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "High temperature"; FATIGUE (medically significant) with onset 20Nov2021, outcome "recovering", described as "Exhaustion"; CONTUSION (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Bruising". The patient underwent the following laboratory tests and procedures: body temperature: (20Nov2021) high; sars-cov-2 test: (28Dec2020) yes - positive covid-19 test. Patient had not tested positive for COVID-19 since having the vaccine. 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: 1926905 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
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, Lymphadenopathy, Off label use, SARS-CoV-2 test
SMQs:, Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646182

Write-up: Interchange of vaccine products; Lymphadenopathy; Extreme pain in the arm pit continuing down the breast and down the inner arm of the injected arm; Booster; Off label use; This is a spontaneous report received from a contactable consumer from the Regulatory AUTHORITY. Regulatory number: GB-MHRA-WEBCOVID-202111230235066000-TRZUY. Other Case identifier: GB-MHRA-ADR 26236209. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 36 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. Vaccination history included: COVID-19 vaccine (1ST DOSE, MANUFACTURER UNKNOWN), for COVID-19 Immunisation; COVID-19 vaccine (2ND DOSE, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Lymphadenopathy"; AXILLARY PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Extreme pain in the arm pit continuing down the breast and down the inner arm of the injected arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926908 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Migraine, Off label use, Palpitations, Pulmonary pain, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (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:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Long COVID (Diagnosed with long covid since March 2020)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101646119

Write-up: Migraine; Lung pain; Palpitations; Shaking; 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. Regulatory number: GB-MHRA-WEBCOVID-202111230616347140-SBUTD. Other Case identifier(s): GB-MHRA-ADR 26236357. A 50-year-old patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 01Mar2020 (ongoing); "long covid", start date: Mar2020 (unspecified if ongoing), notes: Diagnosed with long covid since March 2020. Text for relevant medical history and concurrent conditions: Diagnosed with long covid since March 2020. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; MIGRAINE (medically significant) with onset 21Nov2021, outcome "recovering", described as "Migraine"; PULMONARY PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Lung pain"; PALPITATIONS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Palpitations"; TREMOR (medically significant) with onset 21Nov2021, outcome "recovering", described as "Shaking". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: yes - positive covid-19 test. Case narrative: Patient has not tested positive for COVID-19 since having the vaccine. Case reported as medically significant by health authority. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926913 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Hyperhidrosis, Immunisation, Insomnia, Interchange of vaccine products, Myalgia, Off label use, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), 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: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654424

Write-up: Fatigue; Joint ache; Muscle ache; Fever; Sweating; Insomnia; off label use; Interchange of vaccine products; booster; This is a spontaneous report received from a contactable Consumer from the products Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111232254151300-DDGPS (RA). Other Case identifier(s): GB-MHRA-ADR 26240921 (RA). A 51 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 07Apr2020, stop date: 21Apr2020. Patient not had a COVID-19 test. Last menstrual period was on 27Oct2021. Concomitant medication included: influenza vaccine (INFLUENZA VIRUS). 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 20Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; FATIGUE (medically significant) with onset 21Nov2021, outcome "recovering", described as "Fatigue"; ARTHRALGIA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Joint ache"; MYALGIA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Muscle ache"; PYREXIA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Fever"; HYPERHIDROSIS (medically significant) with onset 21Nov2021, outcome "recovering", described as "Sweating"; INSOMNIA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Insomnia". Clinical course: 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 needed. No further information is expected.


VAERS ID: 1926914 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Nausea; This case was received via regulatory authority Reference number: -MHRA-ADR 26241792) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 75-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 20-Nov-2021 to an unknown date for Routine vaccination. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 21-Nov-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This case concerns a 75-year-old male patient with a relevant medical history of Influenza vaccine administration on the same day as mRNA-1273 vaccine, who experienced the serious unexpected events of Headache and Nausea. The events occurred the same day after the third dose of mRNA-1273 vaccine. The medical history of Influenza vaccine administration is a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 75-year-old male patient with a relevant medical history of Influenza vaccine administration on the same day as mRNA-1273 vaccine, who experienced the serious unexpected events of Headache and Nausea. The events occurred the same day after the third dose of mRNA-1273 vaccine. The medical history of Influenza vaccine administration is a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1926924 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Back pain, Chest pain, Depressed mood, Dizziness, Dyspnoea, Erythema, Fatigue, Insomnia, Joint stiffness, Mental fatigue, Nausea, Peripheral swelling, SARS-CoV-2 test, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gilbert''s syndrome (Gilbert''s Syndrome which is to do with bilirubin and the liver); Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: swelling; Depressed mood; Jaw stiffness; Shortness of breath; Redness; Chest pain; Back ache; Abdominal pain; Mental fatigue; Dizziness; Fatigue; Insomnia; Swollen arm; Nausea; This case was received via RA (Reference number: GB-MHRA-ADR 26243658) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (swelling), PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Redness), CHEST PAIN (Chest pain), INSOMNIA (Insomnia), BACK PAIN (Back ache), ABDOMINAL PAIN (Abdominal pain), FATIGUE (Fatigue), MENTAL FATIGUE (Mental fatigue), DEPRESSED MOOD (Depressed mood), JOINT STIFFNESS (Jaw stiffness), DYSPNOEA (Shortness of breath), NAUSEA (Nausea) and DIZZINESS (Dizziness) in a 31-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Gilbert''s syndrome (Gilbert''s Syndrome which is to do with bilirubin and the liver) and Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). Concomitant products included PARACETAMOL for Headache. On 20-Nov-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), INSOMNIA (Insomnia) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced ERYTHEMA (Redness) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), BACK PAIN (Back ache) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant), MENTAL FATIGUE (Mental fatigue) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced DEPRESSED MOOD (Depressed mood) (seriousness criterion medically significant), JOINT STIFFNESS (Jaw stiffness) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING (swelling) (seriousness criterion medically significant). At the time of the report, SWELLING (swelling), PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (Redness), BACK PAIN (Back ache), ABDOMINAL PAIN (Abdominal pain) and DYSPNOEA (Shortness of breath) was resolving, CHEST PAIN (Chest pain) and DIZZINESS (Dizziness) outcome was unknown and INSOMNIA (Insomnia), FATIGUE (Fatigue), MENTAL FATIGUE (Mental fatigue), DEPRESSED MOOD (Depressed mood), JOINT STIFFNESS (Jaw stiffness) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided. A few hours after vaccine the patient felt very fatigued and arm was very painful, swelling began and couldn''t touch it or move it very well. Despite being extremely tired she couldn''t sleep, when she did sleep it was very light/broken. This was continuing. She felt very nauseous (still do) and the morning after had extreme dizziness, to the point she couldn''t stand up. That following day she had strong lower backache and low abdominal cramps. She had chest pains on and off, shortness of breath and recently experiencing pain/numbness in her jaw and cheekbones (feels very rigid and stiff). As the days go on she seem to experience something new. The patient did not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Company comment: This regulatory authority case concerns a 31-year-old female patient with a relevant medical history of Suspected COVID-19, who experienced the unexpected serious (medically significant) events of Swelling, Peripheral swelling, Joint stiffness, Dyspnoea, Chest pain, Back pain, Abdominal pain, Erythema, Fatigue, Mental fatigue, Insomnia, Depressed mood, Nausea and Dizziness after mRNA- 1273 Moderna vaccine. The onset of the events occurred within the first 2 days after the first dose of mRNA- 1273 Moderna vaccine. Vaccination site swelling, Rash, Fatigue, Nausea and Dizziness are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome, they are considered unexpected. SARS-CoV2 test was reported to be positive on an unknown date. This may be in connection with the patient�s history of Suspected COVID-19, given that it was reported that the patient did not tested positive for COVID-19 since having the vaccine. The rechallenge was reported as unknown, only information about the first dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report; Sender''s Comments: This regulatory authority case concerns a 31-year-old female patient with a relevant medical history of Suspected COVID-19, who experienced the unexpected serious (medically significant) events of Swelling, Peripheral swelling, Joint stiffness, Dyspnoea, Chest pain, Back pain, Abdominal pain, Erythema, Fatigue, Mental fatigue, Insomnia, Depressed mood, Nausea and Dizziness after mRNA- 1273 Moderna vaccine. The onset of the events occurred within the first 2 days after the first dose of mRNA- 1273 Moderna vaccine. Vaccination site swelling, Rash, Fatigue, Nausea and Dizziness are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome, they are considered unexpected. SARS-CoV2 test was reported to be positive on an unknown date. This may be in connection with the patient�s history of Suspected COVID-19, given that it was reported that the patient did not tested positive for COVID-19 since having the vaccine. The rechallenge was reported as unknown, only information about the first dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report


VAERS ID: 1926927 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 4675 / 2 - / OT

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

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

Write-up: Sciatica; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26243968) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SCIATICA (Sciatica) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 4675) for COVID-19 vaccination. The patient''s past medical history included Viral syndrome and Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef). Concomitant products included ELASOMERAN (COVID-19 VACCINE MODERNA) from 25-Sep-2021 to an unknown date for an unknown indication. On 20-Nov-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced SCIATICA (Sciatica) (seriousness criterion disability). At the time of the report, SCIATICA (Sciatica) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment provided. This regulatory authority case concerns a 50-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious event of sciatica. The event occurred on the same day after the second dose of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, the outcome of the event is not recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This regulatory authority case concerns a 50-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious event of sciatica. The event occurred on the same day after the second dose of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, the outcome of the event is not recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1926937 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Eyelid ptosis, Groin pain, Headache, Lymphadenopathy, Musculoskeletal stiffness, Pain in extremity, Rash, Renal pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Periorbital and eyelid disorders (narrow), Osteonecrosis (broad), Ocular motility disorders (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Rash; Neck stiffness; Swollen glands; Ptosis; Kidney pain; Groin pain; Hand pain; Leg pain; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26247560) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands), EYELID PTOSIS (Ptosis), MUSCULOSKELETAL STIFFNESS (Neck stiffness), HEADACHE (Headache), RENAL PAIN (Kidney pain), GROIN PAIN (Groin pain), PAIN IN EXTREMITY (Hand pain), PAIN IN EXTREMITY (Leg pain) and RASH (Rash) in a 51-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No medical history was provided. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 20-Nov-2021 to an unknown date for Vaccination. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion disability), PAIN IN EXTREMITY (Hand pain) (seriousness criterion disability) and PAIN IN EXTREMITY (Leg pain) (seriousness criterion disability). On 21-Nov-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion disability), EYELID PTOSIS (Ptosis) (seriousness criterion disability), RENAL PAIN (Kidney pain) (seriousness criterion disability) and GROIN PAIN (Groin pain) (seriousness criterion disability). On 22-Nov-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck stiffness) (seriousness criterion disability). On 23-Nov-2021, the patient experienced RASH (Rash) (seriousness criterion disability). On 21-Nov-2021, EYELID PTOSIS (Ptosis) had resolved. On 23-Nov-2021, RENAL PAIN (Kidney pain), GROIN PAIN (Groin pain), PAIN IN EXTREMITY (Hand pain) and PAIN IN EXTREMITY (Leg pain) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen glands), MUSCULOSKELETAL STIFFNESS (Neck stiffness) and RASH (Rash) was resolving and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient last menstruation period was 01-Mar-2021. Day of vaccination patient had immediately after receiving both vaccines fever of 38.8 (continued to day 4) and pain that did not lessen with paracetamol, severe stabbing headache on one side, painful to lie down, pain and stiffness in hand (same side as vaccination), nausea (continuing), Day 1 following vaccine was drooping eyelid (temporary), swollen painful glands, severe neck stiffness, leg pain - pain bearing weight or trying to walk, severe pain in kidney area (both sides), groin pain and day 3 Red rash across front of neck Patient has not tested positive for covid-19 since having the vaccine Patient was not enrolled in clinical trial This case concerns a 51-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of lymphadenopathy, eyelid ptosis, musculoskeletal stiffness, headache, renal pain, groin pain, pain in extremity and rash. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 51-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of lymphadenopathy, eyelid ptosis, musculoskeletal stiffness, headache, renal pain, groin pain, pain in extremity and rash. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1927532 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (narrow)

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

Write-up: Ringing in ears; This case was received via RA (Reference number: GB-MHRA-ADR 26236159) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears) in a 61-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. No reported medical history. Concomitant products included DOLUTEGRAVIR SODIUM, LAMIVUDINE (DOVATO) and BISOPROLOL for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) 1 dosage form. On 20-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced TINNITUS (Ringing in ears) (seriousness criterion medically significant). At the time of the report, TINNITUS (Ringing in ears) had not resolved. It was reported that, patient was taking Spijevax for COVID booster. Treatment details were not reported. Company Comment: This regulatory authority case concerns a 61-year-old male patient undergoing treatment with Bisoprolol and Dolutegravir/Lamivudine, who experienced the unexpected serious (medically significant) event of Tinnitus after mRNA- 1273 Moderna vaccine. The event occurred approximately on the day after the booster dose of mRNA- 1273 vaccine. At the time of the report, the event had not resolved. Very limited information is available regarding clinical course and diagnostic work-up. The rechallenge was reported as unknown, only information about the booster dose is available. Concomitant medication Bisoprolol may have contributed to the event. Moreover, treatment with Dolutegravir/Lamivudine suggests the patient has chronic human immunodeficiency virus infection, which might be a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report; Sender''s Comments: This regulatory authority case concerns a 61-year-old male patient undergoing treatment with Bisoprolol and Dolutegravir/Lamivudine, who experienced the unexpected serious (medically significant) event of Tinnitus after mRNA- 1273 Moderna vaccine. The event occurred approximately on the day after the booster dose of mRNA- 1273 vaccine. At the time of the report, the event had not resolved. Very limited information is available regarding clinical course and diagnostic work-up. The rechallenge was reported as unknown, only information about the booster dose is available. Concomitant medication Bisoprolol may have contributed to the event. Moreover, treatment with Dolutegravir/Lamivudine suggests the patient has chronic human immunodeficiency virus infection, which might be a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report


VAERS ID: 1927541 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Test Date: 20211121; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Light-headed; Fever chills; Headache; Tired all the time; Muscle ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26245428) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), DIZZINESS (Light-headed), PYREXIA (Fever chills), HEADACHE (Headache), FATIGUE (Tired all the time) and MYALGIA (Muscle ache) in a 62-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 12-Nov-2021 to an unknown date for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), DIZZINESS (Light-headed) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Tired all the time) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On 21-Nov-2021, PYREXIA (Fever chills) had resolved. On 22-Nov-2021, HEADACHE (Headache) had resolved. On 23-Nov-2021, NAUSEA (Nausea), DIZZINESS (Light-headed), FATIGUE (Tired all the time) and MYALGIA (Muscle ache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Paracetamol was taken by the patient. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. Company Comment: This case concerns a 62-year-old female subject, with no medical history reported, who experienced the unexpected and serious events of Nausea, Dizziness, Pyrexia, Headache, Fatigue, and Myalgia. The events of Nausea, Pyrexia, Headache, Fatigue, and Myalgia, are unexpected as they are retained as serious per the source document Authority reporting. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge is not applicable, as no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 62-year-old female subject, with no medical history reported, who experienced the unexpected and serious events of Nausea, Dizziness, Pyrexia, Headache, Fatigue, and Myalgia. The events of Nausea, Pyrexia, Headache, Fatigue, and Myalgia, are unexpected as they are retained as serious per the source document Authority reporting. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge is not applicable, as no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1928211 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-20
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE389 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pneumonia, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20211213746

Write-up: DEEP VEIN THROMBOSIS LEG; PNEUMONIA FOLLOWING PULMONARY INFARCTION; PULMONARY EMBOLISM; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, DE-PEI-202100261171 ] concerned a 23 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE389 expiry: UNKNOWN) dose was not reported, 1 total administered on 12-NOV-2021 for prophylactic vaccination (Dose number in series :1). No concomitant medications were reported. On 20-NOV-2021, the patient experienced pneumonia following pulmonary infarction and pulmonary embolism and on 23-NOV-2021, the patient experienced deep vein thrombosis leg. On an unspecified date the patient was hospitalized. No of days hospitalized was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pneumonia following pulmonary infarction, pulmonary embolism, and deep vein thrombosis leg. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).


VAERS ID: 1928233 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Headache, Nausea, Pyrexia, SARS-CoV-2 test, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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: 20211117; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Dizziness; Vertigo; Nausea; Headache; Fever; Chills; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26237037) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VERTIGO (Vertigo), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 50-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for COVID-19 immunisation. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant) and VERTIGO (Vertigo) (seriousness criterion medically significant). On 21-Nov-2021, NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, DIZZINESS (Dizziness) and VERTIGO (Vertigo) had not resolved and HEADACHE (Headache) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test. Patient Started to feel unwell in the morning after the vaccine, this started with nausea, then headache, chills and fever that got worse as the day went on. Then she woke the following day and felt better. The following day, On Monday 22nd November she woke with really bad vertigo and dizziness, the vertigo is not as bad, but she still felt dizzy. This is a regulatory case concerning a 50 year-old, female patient with no relevant medical history, who experienced the serious (due to medically important condition) unexpected, according CCDS, events of Dizziness, vertigo, nausea, Headache, Pyrexia and chills. The events Dizziness and vertigo occurred approximately 3 days after the booster dose of mRNA-1273 vaccine, the events nausea, Headache, Pyrexia and Chills 1 day after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Report was related to possible inflammation of the heart (myocarditis or pericarditis). Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.; Sender''s Comments: This is a regulatory case concerning a 50 year-old, female patient with no relevant medical history, who experienced the serious (due to medically important condition) unexpected, according CCDS, events of Dizziness, vertigo, nausea, Headache, Pyrexia and chills. The events Dizziness and vertigo occurred approximately 3 days after the booster dose of mRNA-1273 vaccine, the events nausea, Headache, Pyrexia and Chills 1 day after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1928235 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Asthma exercise induced, Chest discomfort, Dyspnoea, Headache
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

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

Write-up: Headache; Asthma; Tight chest; Shortness of breath; Exertional asthma; This case was received via the Regulatory Authority (Reference number GB-MHRA-ADR 26242613) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA, ASTHMA EXERCISE INDUCED, HEADACHE, ASTHMA, and CHEST DISCOMFORT in a 32-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concomitant products included CLENIL COMPOSITUM HFA from 16-Apr-2021 to an unknown date and VENTOLIN HFA for Asthma, INFLUENZA VACCINE for Asthmatic. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced DYSPNOEA (seriousness criterion medically significant), ASTHMA EXERCISE INDUCED (seriousness criterion medically significant) and CHEST DISCOMFORT (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (seriousness criterion medically significant) and ASTHMA (seriousness criterion medically significant). At the time of the report, DYSPNOEA, ASTHMA EXERCISE INDUCED, and CHEST DISCOMFORT had not resolved and HEADACHE and ASTHMA had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was unknown. It was reported that he took inhalers as normal with increased used in Ventolin. He now on steroid tablets to try and controlled the asthma episode. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient not had symptoms associated with COVID-19 and not had a COVID-19 test. This case concerns a 32-year-old male subject, with no medical history reported, who experienced the unexpected and serious events of Dyspnoea, Asthma exercise induced, Headache, Asthma, and Chest discomfort. The events of Dyspnoea, Asthma exercise induced, and Chest discomfort occurred the same day after the third dose of mRNA-1273 vaccine. The events of Headache and Asthma occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge is not applicable, as no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. No medical history information was reported. Treatment medication information was not provided by the reporter.


VAERS ID: 1928238 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Joint swelling, Lymphadenopathy, Nausea, Pain in extremity, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high (taking amlodipine (11-NOV-2021)); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Gallbladder operation (developed Sepsis/Pneumonia after but recovered); Glands swollen; Pneumonia; Rash; Sepsis; Tiredness
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Tiredness; the first i had a very swollen; chills; Aches & pains in legs; Swollen glands; Vomited; Shivering; Painful arm; Nauseous; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26243655) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), JOINT SWELLING (the first I had a very swollen), CHILLS (chills), HEADACHE (Headache), PAIN IN EXTREMITY (Aches & pains in legs), NAUSEA (Nauseous), LYMPHADENOPATHY (Swollen glands), PAIN IN EXTREMITY (Painful arm), VOMITING (Vomited) and CHILLS (Shivering) in a 56-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Glands swollen, Tiredness, Pneumonia, Rash, Sepsis and Gallbladder operation (developed Sepsis/Pneumonia after but recovered) in 2016. Previously administered products included for Product used for unknown indication: Vit B complex (Advised by ENT) in June 2021, Vit D (Advised by ENT) in June 2021, Septron, LANSOPRAZOLE (for reflex (before covid)), OXYTETRACYCLINE (for skin), AMOXICILLIN, antihistamine (advised by GP) and mometasone fuorate (ADVISED BY GP). Past adverse reactions to the above products included No adverse event with LANSOPRAZOLE, OXYTETRACYCLINE, Vit B complex, Vit D, antihistamine and mometasone fuorate; and Reaction allergic (NOS) with AMOXICILLIN and Septron. Concurrent medical conditions included Suspected COVID-19 since 03-Feb-2021, Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)) and Blood pressure high (taking amlodipine (11-NOV-2021)). On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nauseous) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant), VOMITING (Vomited) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant), JOINT SWELLING (the first i had a very swollen) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant). On 21-Nov-2021, VOMITING (Vomited) and CHILLS (Shivering) had resolved. At the time of the report, FATIGUE (Tiredness) had not resolved and JOINT SWELLING (the first i had a very swollen), CHILLS (chills), HEADACHE (Headache), PAIN IN EXTREMITY (Aches & pains in legs), NAUSEA (Nauseous), LYMPHADENOPATHY (Swollen glands) and PAIN IN EXTREMITY (Painful arm) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Tested positive in Feb 2021 and have had long Covid since. Had cardiology tests done due to discovering in June that her blood pressure was high, is taking Amlodipine and something showed on ECG-awaiting results. Has had ENT issues since Covid and swollen glands. Astra zenica vaccines 01-APR-2021 and 20-JUN-21 with reactions. Awaiting results of an Echo, treadmill ECG and 24hr trace. She did not have heart symptoms prior Feb 21. This regulatory case concerns a 56-year-old, female patient with medical history of long COVID-19, who experienced the unexpected, serious (IME) events of joint swelling, chills, headache, pain in extremity, nausea, vomiting, lymphadenopathy and fatigue. The events occurred after one dose of mRNA-1273 vaccine, considered as the third dose of her COVID-19 vaccine schedule. Tested positive in February 2021 for COVID-19 and has had long COVID-19 since. Discovered in June that her blood pressure was high and was treated with Amlodipine, also reported a non-specified finding on ECG. On November 11, as she has had ENT issues since COVID-19 and swollen glands, had a throat/neck ultrasound, all normal.Has been on antihistamine and mometasone spray. She received two previous doses of AstraZeneca''s COVID-19 vaccine and had reactions to both doses. After first one, very swollen, hot, red and hard lump around jab entry point, that lasted months and still does not feel totally back to normal. Had headache and flu symptoms with temperature and chills after both doses and felt tired and off her food with sore joints, however she did not report these symptoms. Regulatory authority captured the rechallenge as unknown, however, no information about further dosing is disclosed. Medical history of long COVID-19 and previous AstraZeneca''s COVID-19 vaccines, remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of IME was maintained for the events for consistency with the RA report.; Sender''s Comments: This regulatory case concerns a 56-year-old, female patient with medical history of long COVID-19, who experienced the unexpected, serious (IME) events of joint swelling, chills, headache, pain in extremity, nausea, vomiting, lymphadenopathy and fatigue. The events occurred after one dose of mRNA-1273 vaccine, considered as the third dose of her COVID-19 vaccine schedule. Tested positive in February 2021 for COVID-19 and has had long COVID-19 since. Discovered in June that her blood pressure was high and was treated with Amlodipine, also reported a non-specified finding on ECG. On November 11, as she has had ENT issues since COVID-19 and swollen glands, had a throat/neck ultrasound, all normal.Has been on antihistamine and mometasone spray. She received two previous doses of AstraZeneca''s COVID-19 vaccine and had reactions to both doses. After first one, very swollen, hot, red and hard lump around jab entry point, that lasted months and still does not feel totally back to normal. Had headache and flu symptoms with temperature and chills after both doses and felt tired and off her food with sore joints, however she did not report these symptoms. Regulatory authority captured the rechallenge as unknown, however, no information about further dosing is disclosed. Medical history of long COVID-19 and previous AstraZeneca''s COVID-19 vaccines, remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of IME was maintained for the events for consistency with the RA report.


VAERS ID: 1930352 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Chest pain, Dyspepsia, Fatigue
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101683597

Write-up: Fatigue/unusual tiredness; Cardiac pain; Heartburn; Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory number: GB-MHRA-WEBCOVID-202111211840552550-QBGHS (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232791 (MHRA). A 47-year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), for Covid-19 immunisation. The following information was reported: ANGINA PECTORIS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Cardiac pain"; DYSPEPSIA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Heartburn"; CHEST PAIN (non-serious) with onset 20Nov2021, outcome "not recovered", described as "Chest pain"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue/unusual tiredness". Additional information: The patient have like a short stabbing pin in the heart that comes and goes maybe every 10-15 minutes. Sometimes its just like a single stab other times its like 2-3 stabbing pains one after the other. It only lasts a few seconds and then dies down. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report not related to possible inflammation of the heart (myocarditis or pericarditis). It was Unknown if the symptoms lead to a hospital stay. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930358 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH 3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, Chills, Dysaesthesia, Fatigue, Feeling cold, Headache, Hyperhidrosis, Immunisation, Interchange of vaccine products, Myalgia, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute depression; Blood cholesterol abnormal
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646208

Write-up: Extreme tiredness; My nerves felt like they were all firing simultaneously - all over body but especially in my lower back; Off label use; Interchange of vaccine products; Booster; sweating; chills/ shivering; Fever; Headache; Muscle ache; bone ache; felt very cold; This is a spontaneous report received from a contactable reporter (Consumer) from The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111220912107870-NZEC4 (MHRA). Other Case identifier: GB-MHRA-ADR 26233868 (MHRA). A 66 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH 3220) at the age of 66 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing); "Acute depression" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol abnormal, start date: 2017; CITALOPRAM taken for depression, start date: 2015; and INFLUENZA VIRUS taken for immunisation, administration date Oct2021. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 27Feb2021 and Covid-19 vaccine astrazeneca (Dose 2), administration date: 01May2021, both for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; HYPERHIDROSIS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "sweating"; CHILLS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "chills/ shivering"; PYREXIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Fever"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache"; MYALGIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Muscle ache"; BONE PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "bone ache"; FEELING COLD (medically significant) with onset 20Nov2021, outcome "unknown", described as "felt very cold"; FATIGUE (medically significant), outcome "unknown", described as "Extreme tiredness"; DYSAESTHESIA (medically significant), outcome "unknown", described as "My nerves felt like they were all firing simultaneously - all over body but especially in my lower back". The patient underwent the following laboratory test: COVID-19 virus test: no - negative covid-19 test. Clinical course: Initially felt very cold, shivering, followed by fevers and sweating. Muscle and bone aches. Extreme tiredness. My nerves felt like they were all firing simultaneously - all over body but especially in my lower back. Continuous headache. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow up attempts are needed. No further information is expected.


VAERS ID: 1930364 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dizziness postural, Head discomfort, Headache, Illness, Immunisation, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic; Dizzy; Endometriosis; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646249

Write-up: dizziness; Sickness; Dizzy on standing; Booster; Rash; Headache; feels heavy in head; 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-202111221015370240-7J471. Other Case identifier(s): GB-MHRA-ADR 26233989. A 37 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Dizziness" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response and i...; "Type 1 diabetic" (unspecified if ongoing); "Asthmatic" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing). Patient last menstrual period date was on 06Nov2021. Patient has not had symptoms associated with COVID-19. Patient is not pregnant at time of vaccination. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer, ), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; DIZZINESS (medically significant), outcome "recovering", described as "dizziness"; ILLNESS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Sickness"; RASH (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Rash"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache"; HEAD DISCOMFORT (medically significant) with onset 20Nov2021, outcome "not recovered", described as "feels heavy in head"; DIZZINESS POSTURAL (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Dizzy on standing". The headache started yesterday afternoon, its very painful and feels heavy in patient''s head. Patient noticed the rash on her arm around the injection site when getting ready for bed last night. She had woke up this morning and the rash is still there but also swollen. The sickness also started this morning along with the dizziness when standing up. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) negative, notes: No - Negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930385 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac flutter, Dyspnoea, Immunisation, Malaise, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tachyarrhythmia terms, nonspecific (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646350

Write-up: Nausea; Feeling unwell; Loss of energy; Shortness of breath; Heart fluttering; Booster; Muscle soreness; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111221615476310-WIGST. Other Case identifier(s): GB-MHRA-ADR 26235172. A 63-year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response and i...; "Asthmatic" (unspecified if ongoing). Unsure if patient has had symptoms associated with COVID-19. Concomitant medication included: INFLUENZA VIRUS taken for influenza, administration date 05Nov2021. 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 20Nov2021, outcome "unknown", described as "Booster"; MYALGIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Muscle soreness"; NAUSEA (medically significant) with onset 21Nov2021, outcome "recovered" (22Nov2021), described as "Nausea"; MALAISE (medically significant) with onset 21Nov2021, outcome "recovering", described as "Feeling unwell"; ASTHENIA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Loss of energy"; DYSPNOEA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Shortness of breath"; CARDIAC FLUTTER (medically significant) with onset 21Nov2021, outcome "recovering", described as "Heart fluttering". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of myalgia, nausea, malaise, asthenia, dyspnea, and cardiac flutter. Clinical course: she hadn''t received any treatment at the moment. She had been trying to deal with it herself with rest and paracetamol. She had no problem with the first 2 covid jabs just the Booster. She was planning on giving it another day to see how she goes. 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: 1930416 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Blood pressure high
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: home test which tested positive
CDC Split Type: GBPFIZER INC202101654449

Write-up: Interchange of vaccine products; headache; shivers; body aches; feeling nauseous; SARS-CoV-2 infection; High temperature; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-MHRA-WEBCOVID-202111230708125130-XSYYP (MHRA). Other Case identifier(s): GB-MHRA-ADR 26236824 (MHRA). A 53 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) as dose 2 (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Had Pfizer booster as my second vaccine as could not get AstraZeneca fir my second vaccine), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; HEADACHE (medically significant), outcome "not recovered", described as "headache"; CHILLS (medically significant), outcome "not recovered", described as "shivers"; COVID-19 (medically significant) with onset 22Nov2021, outcome "not recovered", described as "SARS-CoV-2 infection"; PYREXIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "High temperature"; PAIN (medically significant), outcome "unknown", described as "body aches"; NAUSEA (medically significant), outcome "unknown", described as "feeling nauseous". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Nov2021) positive, notes: home test which tested positive. Clinical course: Patient was not enrolled in clinical trial. Patient had Pfizer booster as the second vaccine as could not get AstraZeneca for her second vaccine. She was given Pfizer booster batch number FK9413 as her second dose on 20Nov2021. On 21Nov2021 she had shivers, headache, high temperature, body aches, feeling nauseous. On 22Nov2021, patient did a home test which tested positive. Patient booked PCR test 23Nov2021 awaiting results. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1930417 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BN3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101646621

Write-up: previously received the first and second dose of COVID-19 vaccine (Primary Immunization series complete but unknown manufacturer); previously received the first and second dose of COVID-19 vaccine (Primary Immunization series complete but unknown manufacturer); received third (booster) dose of BNT162b2; Bilious vomiting; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202111230737301500-VN8QW, Safety Report Unique Identifier GB-MHRA-ADR 26236672. A 68-year-old female patient received third (booster) dose of BNT162b2 (COMIRNATY; Lot Number: BN3220), via an unspecified route of administration on 20Nov2021 (at the age of 68-years) as a single dose for COVID-19 immunisation. Medical history included suspected COVID-19 started on 15Dec2020 and no longer ongoing (unsure when symptoms stopped). The patient was not enrolled in clinical trial. Concomitant medications were not reported. The patient previously received the first and second dose of COVID-19 vaccine (Primary Immunization series complete but unknown manufacturer), both on unspecified date for COVID-19 immunisation. On 20Nov2021, the patient experienced bilious vomiting, reported as serious for being medically significant. The GP (general physician) prescribed prochlorperazine to the patient. The outcome of bilious vomiting was recovering. The patient had negative COVID-19 virus test on unspecified date. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930423 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Immunisation, Interchange of vaccine products, Myalgia, Off label use
SMQs:, Rhabdomyolysis/myopathy (broad), 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: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654667

Write-up: Fatigue; Muscle ache; Headache; Patient received third dose on 20Nov2021; Patient received third dose on 20Nov2021; Patient received third dose on 20Nov2021; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202111230837025750-KZESX (RA). Other Case identifier(s): GB-MHRA-ADR 26236997 (RA). A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Patient had not tested positive for COVID-19 since having the vaccine, was not enrolled in clinical trial, had no symptoms associated with COVID-19 , not had a COVID-19 test. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date 20Nov2021. Vaccination history included: COVID-19 vaccine (DOSE 1, SINGLE, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; COVID-19 vaccine (DOSE 2, SINGLE, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Patient received third dose on 20Nov2021"; FATIGUE (medically significant) with onset 20Nov2021 16:00, outcome "recovering", described as "Fatigue"; MYALGIA (medically significant) with onset 20Nov2021 16:00, outcome "recovering", described as "Muscle ache"; HEADACHE (medically significant) with onset 20Nov2021 16:00, outcome "recovering", described as "Headache". Clinical course: booster and flu jab received in the morning, symptoms started appearing at around 4pm. The report did not relate to possible inflammation of the heart (myocarditis, pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930428 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Immunisation, Interchange of vaccine products, Off label use, Pyrexia, Rash, Rash erythematous, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), 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 Date: 20211120; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7; Test Date: 20211122; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101654546

Write-up: Off label use; Interchange of vaccine products; Booster; Started rash skin turned very pink like sunburn, approx 4 hrs after booster jab of Pfizer; Rash began with chest and ended up being full torso; temperature of 37.7; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111230914037350-5ODWP (MHRA). Other Case identifier: GB-MHRA-ADR 26237154 (MHRA). A 59 year-old female patient received BNT162B2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) at the age of 59 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 was not enrolled in clinical trial. Vaccination history included: COVID-19 vaccine AstraZeneca (Dose number unknown, single, Lot number: unknown, Primary Immunization series complete), administration date: 27Feb2021, for COVID-19 Immunization; COVID-19 vaccine AstraZeneca (Dose number unknown, single, Lot number: unknown, Primary Immunization series complete), for COVID-19 Immunization. Patient reported that she did not have any of these effects when having the Astra Zeneca Jab. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; RASH ERYTHEMATOUS (medically significant) with onset 20Nov2021, outcome "recovering", described as "Started rash skin turned very pink like sunburn, approx 4 hrs after booster jab of Pfizer"; RASH (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Rash began with chest and ended up being full torso"; PYREXIA (medically significant) with onset 20Nov2021, outcome "unknown", described as "temperature of 37.7". The patient underwent the following laboratory tests and procedures: body temperature: (20Nov2021) 37.7; sars-cov-2 test: (22Nov2021) negative. No follow up attempts are possible. No further information is expected.


VAERS ID: 1930431 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Insomnia, Interchange of vaccine products, Musculoskeletal chest pain, Off label use, Pain, Product use issue, 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: INFLUENZA VACCINE
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 INC202101654658

Write-up: Rib pain; Armpit pain; difficulty sleeping; Pain dull; Off label use; Interchange of vaccine product; Booster; Product use for unapproved combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111230937449000-VO8MR (MHRA). Other Case identifier(s): GB-MHRA-ADR 26237368 (MHRA). A 62 year-old patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 20Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE, administration date 20Nov2021. Patient has 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. Vaccination history included: COVID-19 vaccine (Dose 1, Single, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; COVID-19 vaccine (Dose 2, Single, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine product"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Pain dull"; INSOMNIA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "difficulty sleeping"; MUSCULOSKELETAL CHEST PAIN (medically significant) with onset 23Nov2021, outcome "unknown", described as "Rib pain"; PRODUCT USE ISSUE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Product use for unapproved combination"; AXILLARY PAIN (medically significant) with onset 23Nov2021, outcome "unknown", described as "Armpit pain". Clinical course: It was reported that patient had pain in left arm on 2nd day after booster which became worse on 3rd day and caused difficulty sleeping. By 4th day pain had spread into arm pit and in morning it has moved into top of ribs on the same side. Also patient did not know if this is relevant or not but had flu jab on the same day, in right arm but have no effects on that side. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: no - negative COVID-19 test. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930434 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
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, Lymphadenopathy, Off label use, Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Vaccination site erythema, Vaccination site warmth
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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 INC202101654398

Write-up: Underarm very swollen and painful; Injection site red and upper arm swollen and warm.; Injection site red and upper arm swollen and warm.; Underarm very swollen; Swollen glands; 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-202111230945145310-TWEYS. Other Case identifier(s): GB-MHRA-ADR 26237395. A 51 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 51 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 astrazeneca (Dose 1), administration date: 10Mar2021, for COVID-19 immunization; Covid-19 vaccine astrazeneca (Dose 2), administration date: 21May2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Underarm very swollen"; LYMPHADENOPATHY (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Swollen glands"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "Underarm very swollen and painful"; VACCINATION SITE ERYTHEMA (medically significant), VACCINATION SITE WARMTH (medically significant), outcome "unknown" and all described as "Injection site red and upper arm swollen and warm.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. It was reported that the patient had underarm very swollen and painful. Injection site red and upper arm swollen and warm. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. 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; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930442 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Decreased appetite, Diarrhoea, Fatigue, Headache, Immunisation, Injection site pain, Interchange of vaccine products, Myalgia, Nausea, Night sweats, Off label use, Pyrexia, SARS-CoV-2 test, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210925; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654454

Write-up: tiredness; muscle pain; sleepy; headache; fever; diarrhea; nausea; chills; decreased appetite; night sweats; feeling weak/lack of energy; Off label use; Interchange of vaccine products; Booster; Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory number: GB-MHRA-WEBCOVID-202111231035479070-YU0MK (MHRA). Other Case identifier(s): GB-MHRA-ADR 26237749 (MHRA). A 62 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 07Dec2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Past drug history included: Losartan; Sinvistating; Amplode. Vaccination history included: Covid-19 vaccine astrazeneca (Dose unknwon, Lot number Unknown), administration date: 23Feb2021, for Covid-19 immunisation; Covid-19 vaccine (Manufacturer unknown ), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; FATIGUE (medically significant), outcome "unknown", described as "tiredness"; MYALGIA (medically significant), outcome "unknown", described as "muscle pain"; SOMNOLENCE (medically significant), outcome "unknown", described as "sleepy"; HEADACHE (medically significant), outcome "unknown", described as "headache"; PYREXIA (medically significant), outcome "unknown", described as "fever"; DIARRHOEA (medically significant), outcome "unknown", described as "diarrhea"; NAUSEA (medically significant), outcome "unknown", described as "nausea"; CHILLS (medically significant), outcome "unknown", described as "chills"; INJECTION SITE PAIN (medically significant) with onset 20Nov2021, outcome "recovered" (23Nov2021), described as "Injection site pain"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decreased appetite"; NIGHT SWEATS (non-serious), outcome "unknown", described as "night sweats"; ASTHENIA (non-serious), outcome "unknown", described as "feeling weak/lack of energy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Sep2021) negative, notes: No - Negative COVID-19 test. Clinical course: Patient experienced tiredness, headache, muscle pain, chills, diarrhoea, fever, nausea, arm pain, feeling weak, lack of energy/sleepy, decreased appetite, and night sweats Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930451 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disorientation, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Medication errors (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654455

Write-up: Disorientated; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111231152315330-ZIP7R (RA). Other Case identifier(s): GB-MHRA-ADR 26238144 (RA). A 79 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Under active Thyroid" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Thyroxine, notes: 100mg thyroxine for under active thyroid. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Lot number: Not known), for COVID-19; Covid-19 vaccine astrazeneca (Dose 2, Lot number: Not known), for COVID-19. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; DISORIENTATION (medically significant) with onset 21Nov2021, outcome "recovering", described as "Disorientated". Clinical course: It was reported that patient was disorientated four times since having the vaccine. Patient was not enrolled in clinical trial, not had symptoms associated with COVID-19 and not had a COVID-19 test. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930454 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3320 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Immunisation, Interchange of vaccine products, Magnetic resonance imaging, Myalgia, Off label use, Pollakiuria, Pruritus, Renal pain, SARS-CoV-2 test, Vaccination site pain, Vaccination site pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: MRI
Allergies:
Diagnostic Lab Data: Test Name: MRI scan; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654650

Write-up: Itchy; Urination frequency of; Kidney pain; Shivering; Muscle pain; painful muscle/injection site pain; injection site was itchy; The patient received third dose of COMIRNATY on 20Nov2021; The patient received third dose of COMIRNATY on 20Nov2021; The patient received third dose of COMIRNATY on 20Nov2021; 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-202111231205177050-O8ALO (MHRA). Other Case identifier(s): GB-MHRA-ADR 26238613 (MHRA). A 69 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 20Nov2021 (Lot number: FH3320) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Magnetic resonance imaging" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Concomitant medication(s) included: INFLUENZA VIRUS, administration date 17Sep2021.Vaccination history included: COVID-19 vaccine astrazeneca (DOSE 1, SINGLE, Lot number: AB0006), administration date: 12Feb2021, for COVID-19 Immunisation, reaction(s): "Painful arm/Painful L arm", "Muscle pain", "unable to use arm and lift it above head", "Trapped nerves"; COVID-19 vaccine astrazeneca (DOSE 2, SINGLE, Lot number: PV46678), administration date: 28Apr2021, for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "The patient received third dose of COMIRNATY on 20Nov2021"; POLLAKIURIA (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "Urination frequency of"; RENAL PAIN (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "Kidney pain"; CHILLS (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "Shivering"; MYALGIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Muscle pain"; VACCINATION SITE PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "painful muscle/injection site pain"; VACCINATION SITE PRURITUS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "injection site was itchy"; PRURITUS (medically significant) with onset 22Nov2021, outcome "recovered" (23Nov2021), described as "Itchy". The events "urination frequency of", "kidney pain", "shivering", "muscle pain", "painful muscle/injection site pain" and "injection site was itchy" were evaluated at the physician office visit. Clinical course was : In the February patient had really painful muscle after the 1st injection. She is unable to use her arm and lift it above her head because of the pain in the muscles. She had reported it to her doctor and he said it was not down to the Covid injection. She went to an osteopath but he couldn''t help her. She have since been diagnosed with trapped nerves and am waiting for results of an MRI scan before having operations either to the neck or arms. She have since had the booster the day after she started urinating often and had a pain in my kidneys and shivering. She drunk fluids to flush the kidneys. The next day the injection site was itchy and painful which it still is. She have taken antihistamine. The patient decided to have the injection in her painful left arm because she couldn''t afford to lose the use of her right arm if it is the COVID injection that has caused this. Her muscles are really painful and she haven''t had full use of it since February. She have reported the reaction to her doctor this morning and they want to test a sample of her urine. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: unknown results; sars-cov-2 test: no - negative COVID-19 test. Therapeutic measures (antihistamine) were taken as a result of vaccination site pruritus, pruritus. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1930459 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Eye swelling, Fatigue, Immunisation, Interchange of vaccine products, Neck pain, Off label use, SARS-CoV-2 test, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congenital heart disease NOS; Ischaemic heart disease
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654502

Write-up: Neck pain; Diarrhoea; Swollen of face feeling; Tiredness; Swollen eyes; 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-202111231225056990-6OHYE (MHRA). Other Case identifier(s): GB-MHRA-ADR 26238271 (MHRA). A 44 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ischaemic heart disease" (unspecified if ongoing); "Congenital heart disease" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; NECK PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Neck pain"; EYE SWELLING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Swollen eyes"; DIARRHOEA (medically significant) with onset 21Nov2021, outcome "recovered" (2021), described as "Diarrhoea"; SWELLING FACE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Swollen of face feeling"; FATIGUE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Tiredness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: It was reported that the patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. 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: 1930463 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Nausea, Off label use
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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 INC202101654215

Write-up: Nausea; Primary immunisation: Astrazeneca; Booster: COMIRNATY; Primary immunisation: Astrazeneca; Booster: COMIRNATY; Primary immunisation: Astrazeneca; Booster: COMIRNATY; 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-202111231246456390-4YH22. Other Case identifier(s): GB-MHRA-ADR 26238471. A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596) 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 06Nov2021. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 2), administration date: 22May2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 1), administration date: 06Mar2021, for COVID-19 immunisation. The patient did not have symptoms associated with COVID-19. The patient not had a COVID-19 test and was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Primary immunisation: Astrazeneca; Booster: COMIRNATY"; NAUSEA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Nausea". The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930471 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? Yes
Died? No
Permanent Disability? Yes
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: 20211120; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101654673

Write-up: Patient received third dose of Comirnaty; Suspected COVID-19; Vaccination; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111231330487100-KS1S7 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26238715 (MHRA). A 40 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: Unknown) as dose 3 (booster), single for COVID-19 immunisation. Patient had not had symptoms associated with COVID-19. 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 (Dose 2, Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, congenital anomaly, disability, medically significant, life threatening) with onset 20Nov2021, outcome "unknown", described as "Patient received third dose of Comirnaty"; SUSPECTED COVID-19 (hospitalization, congenital anomaly, disability, medically significant, life threatening) with onset 20Nov2021, outcome "unknown", described as "Suspected COVID-19"; IMMUNISATION (hospitalization, congenital anomaly, disability, medically significant, life threatening) with onset 20Nov2021, outcome "not recovered", described as "Vaccination". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930472 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Nasal congestion, Off label use, SARS-CoV-2 test, Sinus headache
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: SOLIFENACIN; TAMSULOSIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101654674

Write-up: Nose congestion; Headache sinus; Patient received third dose of Comirnaty; Patient received third dose of Comirnaty; Patient received third dose of Comirnaty; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111231330508520-UXSSG (MHRA). Other Case identifier(s): GB-MHRA-ADR 26238716 (MHRA). A 46 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH3220) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: SOLIFENACIN, start date: 01Jan2010; TAMSULOSIN, start date: 01Jan2010. Vaccination history included: COVID-19 vaccine astrazeneca (Dose 1, single, lot number: unknown), administration date: 24Mar2021, for COVID-19 immunisation; COVID-19 vaccine astrazeneca (Dose 2, single, lot number: unknown), administration date: 23May2021, for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Patient received third dose of Comirnaty"; NASAL CONGESTION (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Nose congestion"; SINUS HEADACHE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Headache sinus". The patient underwent the following laboratory tests and procedures: SARS-COV-2 test: (21Jan2021) negative. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1930477 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Fatigue, Immunisation, Influenza, Pyrexia
SMQs:, 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)

Life Threatening? No
Birth Defect? No
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: Asthmatic
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: temperature; Result Unstructured Data: Test Result:High
CDC Split Type: GBPFIZER INC202101654338

Write-up: Flu; Weakness; Tiredness; Patient received booster dose of COMIRNATY; High temperature; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111231447424130-M2SD5. Other Case identifier(s): GB-MHRA-ADR 26239186. A 12 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596) at the age of 12 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthmatic" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot Number: UNKNOWN ), for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE; Lot Number: UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; PYREXIA (medically significant) with onset 20Nov2021, outcome "recovering", described as "High temperature"; INFLUENZA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Flu"; ASTHENIA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Weakness"; FATIGUE (medically significant) with onset 21Nov2021, outcome "recovering", described as "Tiredness". The patient underwent the following laboratory tests and procedures: body temperature: (20Nov2021) high. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930482 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chest pain, Erythema, Immunisation, Influenza, Interchange of vaccine products, Malaise, Nasopharyngitis, Off label use, Pain in extremity, Rash, Rash erythematous, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654511

Write-up: Red rash; Flu symptoms; Off label Use; Interchange of vaccine products; Booster; feeling very unwell; Red hot arm; aching in arms; aching in arms, chest and back; Like flu; cold; Rash on chest; chest with constant burning feeling; 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-202111231522351880-OQBEJ (MHRA). Other Case identifier(s): GB-MHRA-ADR 26239504 (MHRA). A 53 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 53 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 (First dose, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Second dose, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label Use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; MALAISE (medically significant) with onset 2021, outcome "not recovered", described as "feeling very unwell"; RASH ERYTHEMATOUS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Red rash"; INFLUENZA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Flu symptoms"; ERYTHEMA (medically significant) with onset 2021, outcome "unknown", described as "Red hot arm"; PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "unknown", described as "aching in arms"; BACK PAIN (medically significant) with onset 2021, outcome "unknown", described as "aching in arms, chest and back"; INFLUENZA (medically significant) with onset 2021, outcome "unknown", described as "Like flu"; NASOPHARYNGITIS (medically significant) with onset 2021, outcome "unknown", described as "cold"; RASH (medically significant) with onset 2021, outcome "unknown", described as "Rash on chest"; CHEST PAIN (medically significant) with onset 2021, outcome "unknown", described as "chest with constant burning feeling". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) no - negative covid-19 test and GP said anti histamines and cream for rash. It was unsure if patient has had symptoms associated with COVID-19 and patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial and the report dose not relate to possible inflammation of the heart. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930502 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Chest X-ray, Chest pain, Immunisation, Influenza, Interchange of vaccine products, Irregular breathing, Malaise, Myalgia, Off label use, Product use issue, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: Test Result:Unknown result; Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown result; Test Date: 2021; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Unknown result; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654619

Write-up: Chest pain; Irregular breathing; High temperature; Muscle pain; From the day following the booster and flu vaccines I felt not well; 3rd dose was administered, and the patient has previously received the full primary immunization series of an unknown manufacturer; 3rd dose was administered, and the patient has previously received the full primary immunization series of an unknown manufacturer; 3rd dose was administered, and the patient has previously received the full primary immunization series of an unknown manufacturer; Comirnaty dose on 20Nov2021, Influenza vaccine on 20Nov2021; Flu; This is a spontaneous report received from a contactable consumer from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111231726341240-BMIGA (MHRA). Other Case identifier(s): GB-MHRA-ADR 26239985 (MHRA). A 56-year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (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 20Nov2021. Vaccination history included: COVID-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; COVID-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization, medically significant), INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant), IMMUNISATION (hospitalization, medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "3rd dose was administered, and the patient has previously received the full primary immunization series of an unknown manufacturer"; PRODUCT USE ISSUE (hospitalization, medically significant) with onset 20Nov2021, outcome "unknown", described as "Comirnaty dose on 20Nov2021, Influenza vaccine on 20Nov2021"; MALAISE (hospitalization, medically significant) with onset 21Nov2021, outcome "unknown", described as "From the day following the booster and flu vaccines I felt not well"; CHEST PAIN (hospitalization, medically significant) with onset 22Nov2021 (around 5 pm), outcome "recovering", described as "Chest pain"; IRREGULAR BREATHING (hospitalization, medically significant) with onset 22Nov2021, outcome "recovering", described as "Irregular breathing"; PYREXIA (hospitalization, medically significant) with onset 22Nov2021 (around 5 pm), outcome "recovering", described as "High temperature"; MYALGIA (hospitalization, medically significant) with onset 22Nov2021, outcome "recovering", described as "Muscle pain"; INFLUENZA (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Flu". The patient was hospitalized for off label use, interchange of vaccine products, immunisation, malaise, chest pain, irregular breathing, pyrexia, myalgia, influenza (start date: 2021); the patient was hospitalized for product use issue (start date: 2021). The events "chest pain", "irregular breathing", "high temperature" and "muscle pain" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (2021) unknown result; blood test: (2021) unknown result; chest x-ray: (2021) unknown result; sars-cov-2 test: (unspecified date) no - negative COVID-19 test. Clinical course reported as: From the day following the booster and flu vaccines the patient felt not well. But around 5pm on 22nd. He felt severe chest pain and had a really high temperature. He called nhs 24 who got him in to see how he was. They told him to go to A&E after seeing how bad he was. As they thought he was having a heart attack or had pneumonia. After 4 hours at A&E they told him there was nothing they could see wrong but it was probably a severe reaction to having both vaccines at the same time and they do not think both should be together as the research was done in a small proportion of the population and only for that proportions second dose not 3rd. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930518 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast swelling, Immunisation, Interchange of vaccine products, Limb discomfort, Off label use, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654468

Write-up: swelling under my left arm. Very painful and uncomfortable; swelling under my left arm. Very painful and uncomfortable; Large fluid build up under my arm pit round to my breast; swelling under my left arm. Very painful and uncomfortable; Booster; Off label use; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority number: GB-MHRA-WEBCOVID-202111231952346670-OGCNL (MHRA). Other Case identifier(s): GB-MHRA-ADR 26240220 (MHRA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 2), for COVID-19 immunization; Covid-19 vaccine astrazeneca (Dose 1), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; PERIPHERAL SWELLING (medically significant) with onset 22Nov2021, outcome "not recovered", PAIN IN EXTREMITY (medically significant), LIMB DISCOMFORT (medically significant), outcome "unknown" and all described as "swelling under my left arm. Very painful and uncomfortable"; BREAST SWELLING (medically significant), outcome "unknown", described as "Large fluid build up under my arm pit round to my breast". Clinical course: Usually fit and healthy not on any medication. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Large fluid build up under my arm pit round to my breast phoned my GP who advised me to wait a week. this is my booster I had no side effects from my first 2 astreazenica this was Pfizer I was told it was fine to mix. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report 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: 1930519 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Immunisation, Interchange of vaccine products, Nausea, Off label use, Oropharyngeal pain, Pruritus, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (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: Medical History/Concurrent Conditions: COVID-19 (Covid hospitalised Jan2021); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210102; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101654234

Write-up: Sore throat; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; The patient received booster dose; Chills; Fever; Headache; Itching; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111232000000830-HMCQM (RA). Other Case identifier(s): GB-MHRA-ADR 26240321 (RA). A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH3220) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 02Jan2021 (unspecified if ongoing), notes: Covid hospitalised Jan2021; "Suspected COVID-19", start date: 22Dec2020 (unknown if ongoing), notes: Unsure when symptoms stopped. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 2, SINGLE; Lot no.: Unknown), for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 1, SINGLE; Lot no.: Unknown), for COVID-19 immunisation. Previous vaccines were AZ. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "The patient received booster dose"; CHILLS (medically significant) with onset 20Nov2021, outcome "recovering", described as "Chills"; PYREXIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Fever"; HEADACHE (medically significant) with onset 20Nov2021, outcome "recovering", described as "Headache"; PRURITUS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Itching"; NAUSEA (medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Nausea"; OROPHARYNGEAL PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Jan2021) yes - positive covid-19 test. Patient did not test positive for COVID-19 since having the vaccine. Therapeutic measures were taken as a result of chills, pyrexia, headache, pruritus, nausea, oropharyngeal pain. Paracetamol was taken four hourly with plenty of water based drinks. Minimal effect. Clinical course: The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930527 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654458

Write-up: Swollen lymph nodes; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202111232029463870-6GSX9. Other Case identifier(s): GB-MHRA-ADR 26240344. A 53 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 18Apr2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 01), administration date: 24Feb2021, for COVID-19 immunization; Covid-19 vaccine astrazeneca (Dose 02), administration date: 12May2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 21Nov2021, outcome "recovering", described as "Swollen lymph nodes". Clinical course: Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. Report was not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1930536 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Cold-stimulus headache, Dyspnoea, Eye swelling, Flushing, Hypoaesthesia, Hypotonia, Liver injury, Muscle spasms, Pain in jaw, Pyrexia, Swelling face
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101654412

Write-up: injury pain; swelling to the left hadn''t side of the face; frozen; woke; numb arm and hand; Chest pain; Numbness; Eye swelling; Breathlessness; Muscle cramp; Jaw pain; flushed cheeks; fever; 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-202111232148074880-JUPFX (MHRA). Other Case identifier(s): GB-MHRA-ADR 26240595 (MHRA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER: 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: LIVER INJURY (medically significant), outcome "unknown", described as "injury pain"; SWELLING FACE (medically significant), outcome "unknown", described as "swelling to the left hadn''t side of the face"; COLD-STIMULUS HEADACHE (medically significant), outcome "unknown", described as "frozen"; HYPOTONIA (medically significant), outcome "unknown", described as "woke"; FLUSHING (medically significant) with onset 20Nov2021, outcome "unknown", described as "flushed cheeks"; PYREXIA (medically significant) with onset 20Nov2021, outcome "unknown", described as "fever"; CHEST PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Chest pain"; HYPOAESTHESIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Numbness"; EYE SWELLING (medically significant) with onset 21Nov2021, outcome "recovering", described as "Eye swelling"; DYSPNOEA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Breathlessness"; MUSCLE SPASMS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Muscle cramp"; PAIN IN JAW (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Jaw pain"; HYPOAESTHESIA (medically significant), outcome "unknown", described as "numb arm and hand"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "injury pain has worsened". Clinical course: Patient was had symptoms associated with COVID-19 did not have a COVID-19 test. Fever and flushed cheeks on the evening of vaccine. Woke with frozen shoulder, numb arm and hand and swelling to the left hadn''t side of the face. Chest pain went breathing with sharp chest pain under the shoulder blade and left breast. Breathless on exertion. Patient was also had permanent cramp in left calve and existing injury pain has worsened. 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: 1930540 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5475 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Immunisation, Interchange of vaccine products, Lymphadenopathy, Myalgia, Off label use, Oropharyngeal pain, Pain in extremity, Status epilepticus, Throat irritation
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654416

Write-up: 3 days after the vaccine; Swollen lymph nodes; aching muscles and joints; my throat felt really itchy; my arm started to ache; Off label use; Interchange of vaccine products; Booster; Sore throat; Muscle ache; Tiredness; 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-202111232247131880-ABEXG. Other Case identifier(s): GB-MHRA-ADR 26240918. A 28 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK5475) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; STATUS EPILEPTICUS (medically significant), outcome "recovering", described as "3 days after the vaccine"; OROPHARYNGEAL PAIN (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Sore throat"; MYALGIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Muscle ache"; FATIGUE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Tiredness"; LYMPHADENOPATHY (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Swollen lymph nodes"; THROAT IRRITATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "my throat felt really itchy"; PAIN IN EXTREMITY (medically significant) with onset 20Nov2021, outcome "unknown", described as "my arm started to ache"; ARTHRALGIA (medically significant) with onset 21Nov2021, outcome "unknown", described as "aching muscles and joints". Clinical Information: In the evening on the day of the vaccination, her throat felt really itchy and her arm started to ache. The following morning she woke up with aching muscles and joints. 3 days after the vaccine, the lymph nodes in her armpits are swollen. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Patient last menstrual period date (22-NOV-2021). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report did not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930542 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Immunisation, Influenza, Interchange of vaccine products, Off label use, Pain in extremity, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: CO-CODAMOL; IBUPROFEN; VENTOLIN [SALBUTAMOL SULFATE]
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Head pain; Pain joint
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101654487

Write-up: 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-202111232259356730-8ELDY (MHRA). Other Case identifier(s): GB-MHRA-ADR 26240931 (MHRA). A 45 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Patient was not currently breastfeeding. Relevant medical history included: "Suspected COVID-19", start date: 29Jun2021 (ongoing); "Head pain" (unspecified if ongoing); "Pain joint" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: CO-CODAMOL taken for headache; IBUPROFEN taken for arthralgia; INFLUENZA VIRUS taken for immunisation, administration date Oct2021; VENTOLIN [SALBUTAMOL SULFATE] taken for asthma. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Batch/lot number: Not known), administration date: 27Feb2021, for Covid-19 immunization; Covid-19 vaccine astrazeneca (Dose 2, Batch/lot number: Not known), administration date: 07May2021, for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache"; CHILLS (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Chills"; INFLUENZA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Flu symptoms"; PAIN IN EXTREMITY (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Painful arm"; VISION BLURRED (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Blurry vision". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jul2021) positive, notes: Yes - Positive COVID-19 test. Therapeutic measures were taken as a result of headache, chills, influenza, pain in extremity, vision blurred. Clinical course: Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1930550 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Amenorrhoea, Aura, Blood test, Chest pain, Dyspnoea, Ear inflammation, Fatigue, Lymphadenitis, Magnetic resonance imaging, Menstruation irregular, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia, Troponin, X-ray
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Fertility disorders (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Normal; Test Name: MRI; Result Unstructured Data: all normal; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: Troponin; Result Unstructured Data: Normal; Test Name: X-ray; Result Unstructured Data: all normal
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Irregular periods; Ear inflammation; aura; inflammation; Amenorrhea; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26240956) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of AURA (aura), LYMPHADENITIS (inflammation), AMENORRHOEA (Amenorrhea), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), PYREXIA (Fever), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)), MENSTRUATION IRREGULAR (Irregular periods) and EAR INFLAMMATION (Ear inflammation) in a 25-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 20-Jan-2020 to 01-Mar-2020 and Clinical trial participant. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 13-Sep-2021 to an unknown date for Asthma. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient received second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On an unknown date, received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced AMENORRHOEA (Amenorrhea) (seriousness criteria hospitalization, disability and medically significant). On an unknown date, the patient experienced AURA (aura) (seriousness criteria hospitalization, disability and medically significant), LYMPHADENITIS (inflammation) (seriousness criteria hospitalization, disability and medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criteria hospitalization, disability and medically significant), CHEST PAIN (Chest pain) (seriousness criteria hospitalization, disability and medically significant), PYREXIA (Fever) (seriousness criteria hospitalization, disability and medically significant), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization, disability and medically significant), PALPITATIONS (Heart palpitations) (seriousness criteria hospitalization, disability and medically significant), TACHYCARDIA (Racing heart (tachycardia)) (seriousness criteria hospitalization, disability and medically significant), MENSTRUATION IRREGULAR (Irregular periods) (seriousness criteria hospitalization, disability and medically significant) and EAR INFLAMMATION (Ear inflammation) (seriousness criteria hospitalization, disability and medically significant). At the time of the report, AURA (aura), LYMPHADENITIS (inflammation), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), PYREXIA (Fever), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)), MENSTRUATION IRREGULAR (Irregular periods) and EAR INFLAMMATION (Ear inflammation) outcome was unknown and AMENORRHOEA (Amenorrhea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Magnetic resonance imaging: normal (normal) all normal. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Troponin: normal (normal) Normal. On an unknown date, X-ray: normal (normal) all normal. The patient had amenorrhea, chest pain, fever, heart palpitations, shortness of breath and racing heart (tachycardia). There was a lymph node inflammation. There was no pregnancy but missed periods. The patient had extreme fatigue. The patient had Astra Zeneca as first two doses 6 months ago. Patient also had chronic ear inflammation with an unknown cause since AstraZeneca vaccine. Saw an ear nose and throat (ENT) who found inflammation but no cause known. These issues started straight after first dose of Astra Zeneca (in left ear which was the same side patient was vaccinated on). Patient also had an aura in left eye with unknown cause. Patient neurologist did not know why this was happening either. Patient believed that the patient was injured by the AstraZeneca Vaccine. No doctors in the patient''s country would help or even admit to the possibility patient had been injured by the AstraZeneca vaccine. Patient was 25 and might not had it in the first place. Patient had not tested positive for COVID-19 since having the vaccine. Study details: NHS antibody study. Last tested a few months ago and was positive for antibodies. The patient had magnetic resonance imaging (MRI), blood tests and X-rays all were normal, showed that this was from the AstraZeneca vaccine. No treatment information was provided. Company Comment This case concerns a 25-year-old, female patient with relevant medical history of suspected COVID-19 and clinical trial participant, who experienced the unexpected events of aura, lymphadenitis, amenorrhoea, fatigue, chest pain, pyrexia, dyspnoea, palpitations, tachycardia, menstruation irregular and ear inflammation. The events occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. 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 25-year-old, female patient with relevant medical history of suspected COVID-19 and clinical trial participant, who experienced the unexpected events of aura, lymphadenitis, amenorrhoea, fatigue, chest pain, pyrexia, dyspnoea, palpitations, tachycardia, menstruation irregular and ear inflammation. The events occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1930553 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Cognitive disorder, Eye pain, Fatigue, Headache, Mental fatigue, Muscular weakness, Musculoskeletal pain, Pain in extremity, Paraesthesia, Pruritus, Skin burning sensation, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history that is relevant. Issues have not resolved yet Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654540

Write-up: itchy skin arm, feet, legs, knees and in hands,; burning skin in arm, on feet, in hands.; Mental fatigue; I am extremely tired/fatigue; Pins and needles; I have intermittent sharp pain in head above right eye.; Hand pain; I have pains behind right knee, right leg gives in suddenly; i cannot think; I have sudden muscle weakness in right leg where the leg suddenly gives way/muscle weakness/Weakness in extremity/Localised muscle weakness; Pain back; Pain behind eyes; I have pains in wrist in both arms left arm where I was injected is worse than right arm; pain at injection site left arm; I have intermittent pain behind left shoulder blade.; 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-202111240059074780-XFOXV (MHRA). Other Case identifiers: GB-MHRA-ADR 26240968 (MHRA). A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 20Nov2021 (Lot number: Unknown) at the age of 47 years as dose 1, single for COVID-19 immunisation. Patient last menstrual period date 08Nov2021. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 nor had a COVID-19 test and was not currently pregnant/breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The following information was reported: MUSCULAR WEAKNESS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "I have sudden muscle weakness in right leg where the leg suddenly gives way/muscle weakness/Weakness in extremity/Localised muscle weakness"; BACK PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Pain back"; MENTAL FATIGUE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Mental fatigue"; FATIGUE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "I am extremely tired/fatigue"; PARAESTHESIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Pins and needles"; HEADACHE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "I have intermittent sharp pain in head above right eye."; PAIN IN EXTREMITY (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Hand pain"; PAIN IN EXTREMITY (medically significant) with onset 21Nov2021, outcome "not recovered", described as "I have pains behind right knee, right leg gives in suddenly"; COGNITIVE DISORDER (medically significant) with onset 21Nov2021, outcome "not recovered", described as "i cannot think"; PRURITUS (medically significant) with onset 22Nov2021, outcome "not recovered", described as "itchy skin arm, feet, legs, knees and in hands,"; SKIN BURNING SENSATION (medically significant) with onset 22Nov2021, outcome "not recovered", described as "burning skin in arm, on feet, in hands."; EYE PAIN (medically significant) with onset 2021, outcome "unknown", described as "Pain behind eyes"; ARTHRALGIA (medically significant) with onset 2021, outcome "unknown", described as "I have pains in wrist in both arms left arm where I was injected is worse than right arm"; VACCINATION SITE PAIN (medically significant) with onset 2021, outcome "unknown", described as "pain at injection site left arm"; MUSCULOSKELETAL PAIN (medically significant) with onset 2021, outcome "unknown", described as "I have intermittent pain behind left shoulder blade.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1930555 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hallucination, visual, Headache, Heart rate, Heart rate increased, Immunisation, Interchange of vaccine products, Nightmare, Off label use, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Medication errors (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: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:elevated; Test Date: 20211119; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101654560

Write-up: headache; off label use; Interchange of vaccine products; Booster; nightmares; Visual hallucinations; elevated heart rate; 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-202111240337383500-0W3NB (RA). Other Case identifier(s): GB-MHRA-ADR 26240985 (RA). A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 62 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 20Mar2020, stop date: 18Aug2020. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1, Single, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; COVID-19 vaccine (DOSE 2, Single, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; NIGHTMARE (disability) with onset 20Nov2021, outcome "not recovered", described as "nightmares"; HALLUCINATION, VISUAL (disability) with onset 20Nov2021, outcome "not recovered", described as "Visual hallucinations"; HEART RATE INCREASED (disability) with onset 20Nov2021, outcome "unknown", described as "elevated heart rate"; HEADACHE (disability), outcome "not recovered", described as "headache". The patient underwent the following laboratory tests and procedures: heart rate: (unspecified date) elevated; SARS-CoV-2 test: (19Nov2021) no - negative COVID-19 test. Clinical Course: The system would not allow patient to state vivid, hallucinatory nightmares 2-3 hours after falling asleep. Extremely disturbing dreams which mean patient woke up with an elevated heart rate. This had gone in for 3 nights now and made it hard to function in the day. The patient had a low grade, permanent headache too. 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: 1930637 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA LOT 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Goitre, Headache, Malaise, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypothyroidism (broad), Hyperthyroidism (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: fever; i awoke with a stabbing pain in the chest and severe trembling / shivering at 3am ( 21-11- 2021 ); generally unwell; headache; High temperature; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26253582) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (fever), GOITRE (i awoke with a stabbing pain in the chest and severe trembling / shivering at 3am ( 21-11- 2021 )), MALAISE (generally unwell), HEADACHE (headache) and PYREXIA (High temperature) in a 56-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. LOT 3004675) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion hospitalization). On an unknown date, the patient experienced PYREXIA (fever) (seriousness criterion hospitalization), GOITRE (i awoke with a stabbing pain in the chest and severe trembling / shivering at 3am ( 21-11- 2021 )) (seriousness criterion hospitalization), MALAISE (generally unwell) (seriousness criterion hospitalization) and HEADACHE (headache) (seriousness criterion hospitalization). On 25-Nov-2021, PYREXIA (High temperature) was resolving. At the time of the report, PYREXIA (fever), GOITRE (i awoke with a stabbing pain in the chest and severe trembling / shivering at 3am ( 21-11- 2021 )), MALAISE (generally unwell) and HEADACHE (headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. All started about 10 hours after the booster vaccination (20-11-2021), the patient had a headache and felt like a fever was coming on, took 1gm paracetamol and went to bed at 10pm. He woke with a stabbing pain in the chest and severe trembling/shivering,took more paracetamol and after around 30 minutes manages to sleep further until 9am.All that day he felt disoriented, light headed, sore chest and generally unwell, took paracetamol again at 2pm but this gave very little relief. In the evening started again trembling, sore chest and found temperature was up to 42 cg, his wife called on 111 who upgraded the situation to 999 to send an ambulance after the symptoms had worsened.The patient went to hospital however after many hours and several checks nothing serious was found.was running such high temperatures then leading to the trembling and no point was he perspiring during this ordeal, however on 25-11-2021, he still had a mildly high temperature but he was feeling much better but not completely gone yet.No con med was reported nor treat inf. CC This case concerns a 56-year-old male, with no relevant history reported in this case, who experienced the serious unexpected events of Pyrexia (Reported as Fever and Reported as High Temperature), Goitre, Malaise and Headache. The event Pyrexia (Reported as High Temperature) occurred the same day of the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Recovering/Resolving. The events Pyrexia (Reported as Fever), Goitre, Malaise and Headache occurred on an unknown date and the outcome at the time of the report was Recovering/Resolving. The rechallenge is not applicable since the events occurred after the 3rd dose of the of the mRNA-1273 vaccine and another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 56-year-old male, with no relevant history reported in this case, who experienced the serious unexpected events of Pyrexia (Reported as Fever and Reported as High Temperature), Goitre, Malaise and Headache. The event Pyrexia (Reported as High Temperature) occurred the same day of the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Recovering/Resolving. The events Pyrexia (Reported as Fever), Goitre, Malaise and Headache occurred on an unknown date and the outcome at the time of the report was Recovering/Resolving. The rechallenge is not applicable since the events occurred after the 3rd dose of the of the mRNA-1273 vaccine and another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1930648 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-11-20
   Days after vaccination:261
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 - / OT

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

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

Write-up: pain; itch; rash; Neck pain; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26253721) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), PAIN (pain), PRURITUS (itch) and RASH (rash) in a 51-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. Concurrent medical conditions included Coeliac disease. On 04-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 22-May-2021, received second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant), PRURITUS (itch) (seriousness criterion medically significant) and RASH (rash) (seriousness criterion medically significant). At the time of the report, NECK PAIN (Neck pain) had not resolved and PAIN (pain), PRURITUS (itch) and RASH (rash) 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient had 2 courses of steroids and 5 antihistamines per day for 6 weeks for rash. She still feel the itch frequently. Sought private chiropractor and physiotherapist treatment and she was in severe pain. Company comment. This case concerns a 51-year-old female patient, with medical history of Coeliac disease, and having received first and second dose of COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected serious events of NECK PAIN, PAIN, PRURITUS and RASH. The events occurred on the following day of the administration of the third dose of mRNA- 1273 vaccine. The rechallenge was unknown. Patient�s medical history of Coeliac disease, remains as a confounder. Patient having received first and second dose of COVID-19 VACCINE ASTRAZENECA, makes this vaccine a co-suspect drug. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. No concomitant medication was reported. No treatment information was reported.; Sender''s Comments: This case concerns a 51-year-old female patient, with medical history of Coeliac disease, and having received first and second dose of COVID-19 VACCINE ASTRAZENECA, who experienced the unexpected serious events of NECK PAIN, PAIN, PRURITUS and RASH. The events occurred on the following day of the administration of the third dose of mRNA- 1273 vaccine. The rechallenge was unknown. Patient�s medical history of Coeliac disease, remains as a confounder. Patient having received first and second dose of COVID-19 VACCINE ASTRAZENECA, makes this vaccine a co-suspect drug. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 1930649 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-11-20
   Days after vaccination:304
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Mouth ulceration, Pain in extremity, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthmatic; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Mouth ulcer; Painful arm; This case was received via regulatory authority. (Reference number: GB-MHRA-ADR 26253714) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) and MOUTH ULCERATION (Mouth ulcer) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concurrent medical conditions included Asthmatic and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). On 20-Jan-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced MOUTH ULCERATION (Mouth ulcer) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm) was resolving and MOUTH ULCERATION (Mouth ulcer) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had painful arm for 2 days and mouth sores. Patient was asthmatic and took servitude inhaler. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Company comment This case concerns a patient of an unknown age and gender, with medical history of Asthmatic and Taking regular steroid treatment, who experienced the unexpected serious events of PAIN IN EXTREMITY and MOUTH ULCERATION. The events occurred after the administration of the third dose of mRNA- 1273 vaccine. The rechallenge was unknown. Patient�s medical history of regular steroid treatment remains as a confounder for event MOUTH ULCERATION. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a patient of an unknown age and gender, with medical history of Asthmatic and Taking regular steroid treatment, who experienced the unexpected serious events of PAIN IN EXTREMITY and MOUTH ULCERATION. The events occurred after the administration of the third dose of mRNA- 1273 vaccine. The rechallenge was unknown. Patient�s medical history of regular steroid treatment remains as a confounder for event MOUTH ULCERATION. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 1930651 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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: INFLUENZA VIRUS
Current Illness: Coeliac disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Neck pain; This case was received via RA (Reference number: GB-MHRA-ADR 26253739) on 26-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain) in a 51-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concurrent medical conditions included Coeliac disease. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 04-Nov-2021 to an unknown date for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-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. 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. It was reported that patient had severe neck pain so bad that the patient had to make an at work a chiropractor and a physiotherapist. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial No concomitant medication details provided. No treatment medication details provided. Company Comment: This case concerns a 51-year-old female subject, with no relevant medical history, who experienced the unexpected and serious event of Neck pain. The event occurred one day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 51-year-old female subject, with no relevant medical history, who experienced the unexpected and serious event of Neck pain. The event occurred one day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1930668 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dyspnoea, Headache, Localised infection, Myalgia, SARS-CoV-2 test, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Bipolar II disorder; Blood pressure high; Fibromyalgia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Shortness of breath; Arm infection; Muscle pain; Swelling; Chills; Headache; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26256312) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Swelling), DYSPNOEA (Shortness of breath), LOCALISED INFECTION (Arm infection), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Muscle pain) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Fibromyalgia, Blood pressure high and Bipolar II disorder. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced LOCALISED INFECTION (Arm infection) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). On 22-Nov-2021, HEADACHE (Headache) had resolved. On 23-Nov-2021, CHILLS (Chills) had resolved. On 24-Nov-2021, MYALGIA (Muscle pain) had resolved. At the time of the report, SWELLING (Swelling), DYSPNOEA (Shortness of breath) and LOCALISED INFECTION (Arm infection) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-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. Relevant concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding It was reported that patient took antibiotics for seven days.Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Re-challenge was reported as unknown. Company comment: This case concerns a 36-year-old female patient with medical history of high blood pressure, fibromyalgia and Bipolar type 2, who experienced the serious unexpected events of swelling, dyspnoea, localized infection, headache and chills. The events swelling, headache and chills occurred on the same day after the third dose of mRNA-1273. The events myalgia and localized infection occurred the day after the third dose of mRNA-1273. The event dypnoea occurred approximately 2 days after the third dose of mRNA-1273. The outcome of the events were either recovering or recovered. The rechallenge is unknown, according to SD. 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 36-year-old female patient with medical history of high blood pressure, fibromyalgia and Bipolar type 2, who experienced the serious unexpected events of swelling, dyspnoea, localized infection, headache and chills. The events swelling, headache and chills occurred on the same day after the third dose of mRNA-1273. The events myalgia and localized infection occurred the day after the third dose of mRNA-1273. The event dypnoea occurred approximately 2 days after the third dose of mRNA-1273. The outcome of the events were either recovering or recovered. The rechallenge is unknown, according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1930679 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fall, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow)

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

Write-up: Weakness muscle; Fall; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26256667) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness muscle) and FALL (Fall) in a 73-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced MUSCULAR WEAKNESS (Weakness muscle) (seriousness criterion medically significant) and FALL (Fall) (seriousness criterion medically significant). At the time of the report, MUSCULAR WEAKNESS (Weakness muscle) and FALL (Fall) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient did not had symptoms associated with COVID-19 and not had a COVID-19 test. Treatment information was not provided. Company Comment This case concerns a 73-year-old, male patient with no relevant medical history reported, who experienced the unexpected serious events of muscular weakness and fall. The events occurred approximately on the same day after the third dose of mRNA-1273 vaccine. No information was disclosed on the first two doses administered. The rechallenge was unknown as per reporter�s assessment. 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 event.; Sender''s Comments: This case concerns a 73-year-old, male patient with no relevant medical history reported, who experienced the unexpected serious events of muscular weakness and fall. The events occurred approximately on the same day after the third dose of mRNA-1273 vaccine. No information was disclosed on the first two doses administered. The rechallenge was unknown as per reporter�s assessment. 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 event.


VAERS ID: 1930684 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-06
Onset:2021-11-20
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222-L951 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy, Dysarthria, Facial paralysis, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: slurred speech; facial paralysis; Bell''s palsy; This case was received via RA (Reference number: GB-MHRA-ADR 26257372) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSARTHRIA (slurred speech), FACIAL PARALYSIS (facial paralysis) and BELL''S PALSY (Bell''s palsy) in an 82-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. The patient''s past medical history included Clinical trial participant. Previously administered products included for Product used for unknown indication: LANSOPRAZOLE (15mg), CLOPIDOGREL (75MG), ADCAL-D3 (1500 Mg 4AU), Hyabak 0.15% eye drops, Amlodipine (5mg), Atenolol (25 mg), Ramipril (10 mg) and ISOSORBIDE MONONITRATE. Past adverse reactions to the above products included No adverse event with ADCAL-D3, Amlodipine, Atenolol, CLOPIDOGREL, Hyabak 0.15% eye drops, ISOSORBIDE MONONITRATE, LANSOPRAZOLE and Ramipril. Concurrent medical conditions included Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...). On 06-Oct-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced BELL''S PALSY (Bell''s palsy) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced DYSARTHRIA (slurred speech) (seriousness criterion hospitalization prolonged) and FACIAL PARALYSIS (facial paralysis) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, DYSARTHRIA (slurred speech), FACIAL PARALYSIS (facial paralysis) and BELL''S PALSY (Bell''s palsy) 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. Concomitant medications were not reported The patient had facial paralysis on right side, head aches on the right hand side, flu symptoms and slurred speech Patient has not tested positive for covid-19 since having the vaccine. Patient was clinical trial participant and study details included Covid 19 vaccine trials No treatment information was provided. Company comment: This case concerns a 82-year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of dysarthria, serious expected AESI events of facial paralysis and Bell''s palsy. The event Bell''s palsy occurred approximately 45 days after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) and the same day after the third dose of Pfizer COVID-19 Vaccine. The events facial paralysis and dysarthria occurred on an unknown date after the third dose of mRNA-1273. The rechallenge is unknown, according to SD. The concomitant medications of atenolol, ramipirl, isosorbide mononitrate, clopidogrel may suggest a cardiovascular disorder and hypertension, that could be a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 82-year-old female patient with no relevant medical history reported, who experienced the serious unexpected events of dysarthria, serious expected AESI events of facial paralysis and Bell''s palsy. The event Bell''s palsy occurred approximately 45 days after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) and the same day after the third dose of Pfizer COVID-19 Vaccine. The events facial paralysis and dysarthria occurred on an unknown date after the third dose of mRNA-1273. The rechallenge is unknown, according to SD. The concomitant medications of atenolol, ramipirl, isosorbide mononitrate, clopidogrel may suggest a cardiovascular disorder and hypertension, that could be a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1930695 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

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

Write-up: Nausea; Joint ache; Tired out; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26258640) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), ARTHRALGIA (Joint ache) and FATIGUE (Tired out) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant) and FATIGUE (Tired out) (seriousness criterion medically significant). On 21-Nov-2021, NAUSEA (Nausea), ARTHRALGIA (Joint ache) and FATIGUE (Tired out) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Treatment medication was not reported. Relevant concomitant medications were not provided by the reporter. Company Comment: This case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of nausea, arthralgia and fatigue. The events occurred one day after the booster dose of mRNA-1273. The rechallenge was not applicable since information about the previous doses have not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. Nausea, arthralgia and fatigue are expected events but considered unexpected due to seriousness assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a female patient of unknown age with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of nausea, arthralgia and fatigue. The events occurred one day after the booster dose of mRNA-1273. The rechallenge was not applicable since information about the previous doses have not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. Nausea, arthralgia and fatigue are expected events but considered unexpected due to seriousness assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1930699 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA ELO141 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Delirium, Dizziness, Fatigue, Headache, Vertigo positional
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Vestibular disorders (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENDROFLUAZIDE; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: BPPV (Not medicated); Chronic fatigue (Not medicated)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: bppv; Fatigue; Light-headed; Appetite lost; Headache; Delirium; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26258911) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VERTIGO POSITIONAL (bppv), FATIGUE (Fatigue), DIZZINESS (Light-headed), DECREASED APPETITE (Appetite lost), HEADACHE (Headache) and DELIRIUM (Delirium) in a 64-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. ELO141) for an unknown indication. The patient''s past medical history included BPPV (Not medicated) and Chronic fatigue (Not medicated). Concomitant products included BENDROFLUMETHIAZIDE (BENDROFLUAZIDE) from 01-Aug-2004 to an unknown date for Hypertension, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 06-Mar-2021 to an unknown date for Vaccination. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) at an unspecified dose. On 20-Nov-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant), DIZZINESS (Light-headed) (seriousness criterion medically significant), DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and DELIRIUM (Delirium) (seriousness criterion medically significant). On an unknown date, the patient experienced VERTIGO POSITIONAL (bppv) (seriousness criterion medically significant). On 22-Nov-2021, DELIRIUM (Delirium) had resolved. At the time of the report, VERTIGO POSITIONAL (bppv), FATIGUE (Fatigue) and DIZZINESS (Light-headed) had not resolved and DECREASED APPETITE (Appetite lost) and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown Route) and mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment information was not provided by the reporter. The patient was not tested positive for COVID-19 since having the vaccine Company Comment: This regulatory case concerns a 64-year-old female patient, with history of benign paroxysmal positional vertigo chronic fatigue syndrome, who experienced the serious (medically significant) unexpected events of VERTIGO POSITIONAL, FATIGUE, DIZZINESS, DECREASED APPETITE, HEADACHE and DELIRIUM. All events except for vertigo positional, occurred 1 day after receiving a dose of mRNA-1273, which was the third dose of a vaccination schedule that included 2 prior doses of CHADOX 1 NCoV-19 vaccine. The rechallenge is captured as unknown as provided by the Regulatory Authority assessment. Patient''s history of benign paroxysmal vertigo and chronig fatigue syndrome remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. The patient was not enrolled in clinical trial; Sender''s Comments: This regulatory case concerns a 64-year-old female patient, with history of benign paroxysmal positional vertigo chronic fatigue syndrome, who experienced the serious (medically significant) unexpected events of VERTIGO POSITIONAL, FATIGUE, DIZZINESS, DECREASED APPETITE, HEADACHE and DELIRIUM. All events except for vertigo positional, occurred 1 day after receiving a dose of mRNA-1273, which was the third dose of a vaccination schedule that included 2 prior doses of CHADOX 1 NCoV-19 vaccine. The rechallenge is captured as unknown as provided by the Regulatory Authority assessment. Patient''s history of benign paroxysmal vertigo and chronig fatigue syndrome remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1930747 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vertigo
SMQs:, Vestibular disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Vertigo; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26262508) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 62-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 05-Mar-2021 to an unknown date for COVID-19 vaccination. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VERTIGO (Vertigo) (seriousness criterion medically significant). At the time of the report, VERTIGO (Vertigo) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment medications were reported. Patient has not had symptoms associated with COVID-19. After patient started with vertigo started next day doctor prescribed prochlorperazine. Patient had not been tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. 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" Company Comment This case concerns a 62-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious event of vertigo. The event occurred approximately on the next day after the third dose of mRNA-1273 vaccine. The first two doses administered were CHADOX1 NCOV-19 (COVID-19 VACCINE ASTRAZENECA). The rechallenge was unknown as per reporter�s assessment. The history of CHADOX1 NCOV-19 (COVID-19 VACCINE ASTRAZENECA) administration remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to important medical event.; Sender''s Comments: This case concerns a 62-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious event of vertigo. The event occurred approximately on the next day after the third dose of mRNA-1273 vaccine. The first two doses administered were CHADOX1 NCOV-19 (COVID-19 VACCINE ASTRAZENECA). The rechallenge was unknown as per reporter�s assessment. The history of CHADOX1 NCOV-19 (COVID-19 VACCINE ASTRAZENECA) administration remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority�s report due to important medical event.


VAERS ID: 1930761 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinsonism (Patient at present taking Sinemet+ medication for parkinsons)
Allergies:
Diagnostic Lab Data: Test Date: 20211003; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Stomach ache; Feverish; Vomiting; Diarrhea; Fever; Joint pain; Nausea; This case was received via RA (Reference number: GB-MHRA-ADR 26265598) on 30-Nov-2021 and was forwarded to Moderna on 30-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), PYREXIA (Feverish), VOMITING (Vomiting), DIARRHOEA (Diarrhea), PYREXIA (Fever), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. The patient''s past medical history included Parkinsonism (Patient at present taking Sinemet+ medication for parkinsons). On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On 25-Nov-2021, VOMITING (Vomiting), DIARRHOEA (Diarrhea), PYREXIA (Fever), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache) and PYREXIA (Feverish) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Oct-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications were reported It was reported that the day after being vaccinated patient felt totally drained and feverish, this quickly developed into a nauseous feeling and stomach ache, patient later suffered a vomiting attack. After 2 days she was feeling no better, but no longer nauseous, this feeling was replaced by aches in all her joints and swelling of the glands in her armpits and continuing feeling feverish and chilled. These symptoms continued for the following 6 days from being vaccinated This case concerns a 63-year-old female patient with a history of Parkinsonism, at present taking Sinemet and not specified medication for parkinsons, who experienced the serious unexpected events of Abdominal pain upper, Pyrexia, Vomiting, Diarrhoea, Arthralgia and Nausea. The events occurred the next day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The concomitant medication for parkinsons could remain as confounders for the events of nausea, abdominal pain, vomitting and diarrhoea. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. The events doesn''t seem to be serious by medical judgement and from a clinical or regulatory standpoint, but they were assessed as serious as per regulatory authority report and retained for consistency.; Sender''s Comments: This case concerns a 63-year-old female patient with a history of Parkinsonism, at present taking Sinemet and not specified medication for parkinsons, who experienced the serious unexpected events of Abdominal pain upper, Pyrexia, Vomiting, Diarrhoea, Arthralgia and Nausea. The events occurred the next day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The concomitant medication for parkinsons could remain as confounders for the events of nausea, abdominal pain, vomitting and diarrhoea. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. The events doesn''t seem to be serious by medical judgement and from a clinical or regulatory standpoint, but they were assessed as serious as per regulatory authority report and retained for consistency.


VAERS ID: 1930901 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK6302 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anti-platelet antibody, Pulmonary infarction, Thrombosis, Thrombosis with thrombocytopenia syndrome
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Name: anti-platelet antibody; Result Unstructured Data: Test Result:Detection for anti-platelet antibody (PF4) was; Comments: ongoing
CDC Split Type: JPPFIZER INC202101647882

Write-up: Thrombosis with thrombocytopenia syndrome; widespread Pulmonary infarction; Thrombosis of the left leg; This is a spontaneous report received from a contactable reporter (physician) from Regulatory Authority. Regulatory number: v21131567 (RA). A 14 year-old male patient (also reported as 14-year and 5-month-old male) received BNT162b2 (COMIRNATY), administration date 19Nov2021 at 16:45 (Lot number: FK6302, Expiration Date: 30Apr2022) at the age of 14 years as dose 2, single for COVID-19 immunisation. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Vaccination history included: BNT162b2 (first dose, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (medically significant) with onset 20Nov2021 12:49, outcome "recovering", described as "Thrombosis with thrombocytopenia syndrome"; PULMONARY INFARCTION (medically significant) with onset 20Nov2021 12:49, outcome "recovering", described as "widespread Pulmonary infarction"; THROMBOSIS (medically significant) with onset 20Nov2021 12:49, outcome "recovering", described as "Thrombosis of the left leg". The patient underwent the following laboratory tests and procedures: anti-platelet antibody: detection for anti-platelet antibody (PF4) was ongoing. Therapeutic measures were taken as a result of thrombosis with thrombocytopenia syndrome, pulmonary infarction, thrombosis. On 20Nov2021 at 12:49 (1 day after the vaccination), the patient experienced Thrombosis with thrombocytopenia syndrome. On 23Nov2021 (4 days after the vaccination), the outcome of the event was recovering. The course of the event was as follows: Thrombosis of the left leg and widespread Pulmonary infarction were noted. Detection for anti-platelet antibody (PF4) was ongoing. Heparin therapy was ongoing for the patient, and the general condition was favorable. The reporter classified the event as non-serious and assessed that the event was related to BNT162b2. Other possible cause(s) of the event such as any other diseases was reported as "Investigation is ongoing". The reporter commented as follows: The reporter suspected that thrombosis was an adverse reaction due to the vaccination. This case would be considered significant for encouraging the COVID-19 vaccine for children in the future. However, the reporter requested the case to be announced without causing overreaction, such as refraining from HPV vaccination. Follow-up attempts are completed. No further information is expected.; Reporter''s Comments: The reporter suspected that thrombosis was an adverse reaction due to the vaccination. This case would be considered significant for encouraging the COVID-19 vaccine for children in the future. However, the reporter requested the case to be announced without causing overreaction, such as refraining from HPV vaccination.


VAERS ID: 1930926 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Body temperature, Contusion, Electrocardiogram ambulatory, Electroencephalogram, Epilepsy, Fall, Lack of spontaneous speech, Loss of consciousness, Magnetic resonance imaging head, Orthostatic intolerance, Postictal paralysis, Pyrexia, Quadriplegia, Schellong test, Syncope, Visual impairment, Vital signs measurement
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Pyrexia of 38 degrees Centigrade/fever declined; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20211121; Test Name: Pyrexia of 38 degrees Centigrade/fever declined; Result Unstructured Data: Test Result:fever declined Centigrade; Test Date: 202111; Test Name: Holter electrocardiography; Result Unstructured Data: Test Result:not provided; Test Date: 202111; Test Name: brain waves/EEG follow; Result Unstructured Data: Test Result:not provided; Test Date: 20211121; Test Name: brain waves/EEG follow; Result Unstructured Data: Test Result:no special abnormality; Comments: there was no special abnormality in brain waves; Test Date: 202111; Test Name: Head MRI; Result Unstructured Data: Test Result:not provided; Test Date: 202111; Test Name: standing load test; Result Unstructured Data: Test Result:not provided; Test Date: 20211120; Test Name: vital signs; Result Unstructured Data: Test Result:no abnormalities; Comments: There were no abnormalities in vital signs
CDC Split Type: JPPFIZER INC202101655420

Write-up: Loss of consciousness; the patient could not speak or get hands and feet work/speech and Quadriplegia improved; It was considered as Syncope vasovagal caused by continuous standing up; symptoms that can be considered as Todd''s paralysis after the recovery of consciousness persisted for 50 minutes; the possibility of Epilepsy and Arrhythmia cannot be denied; the possibility of Epilepsy and Arrhythmia cannot be denied; the patient got vision darkend; fell down; got head bruise; the patient could not speak; Pyrexia of 38 degrees Centigrade; the factors of Orthostatic dysregulation were carefully investigated; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) received via COVID-19 Regulatory Authority (RA). A 12-year-old female patient (not pregnant) received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: FE8162, Expiration Date: 28Feb2022), via an unspecified route of administration, on 19Nov2021 (the day of the second vaccination, at the age of 12-year-old), as DOSE 2, SINGLE for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: FE8162, Expiration date:28Feb2022), for COVID-19 immunisation. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 20Nov2021, outcome "recovering", described as "Loss of consciousness"; QUADRIPLEGIA (medically significant) with onset 20Nov2021, outcome "recovering", described as "the patient could not speak or get hands and feet work/speech and Quadriplegia improved"; SYNCOPE (medically significant) with onset 20Nov2021, outcome "recovering", described as "It was considered as Syncope vasovagal caused by continuous standing up"; POSTICTAL PARALYSIS (medically significant) with onset 20Nov2021, outcome "recovering", described as "symptoms that can be considered as Todd''s paralysis after the recovery of consciousness persisted for 50 minutes"; EPILEPSY (medically significant), ARRHYTHMIA (medically significant) all with onset 20Nov2021, outcome "recovering" and all described as "the possibility of Epilepsy and Arrhythmia cannot be denied"; VISUAL IMPAIRMENT (non-serious) with onset 20Nov2021, outcome "recovering", described as "the patient got vision darkend"; FALL (non-serious) with onset 20Nov2021, outcome "recovering", described as "fell down"; CONTUSION (non-serious) with onset 20Nov2021, outcome "recovering", described as "got head bruise"; LACK OF SPONTANEOUS SPEECH (non-serious) with onset 20Nov2021, outcome "recovering", described as "the patient could not speak"; PYREXIA (non-serious) with onset 20Nov2021, outcome "recovering", described as "Pyrexia of 38 degrees Centigrade"; ORTHOSTATIC INTOLERANCE (non-serious) with onset 20Nov2021, outcome "recovering", described as "the factors of Orthostatic dysregulation were carefully investigated". The events "loss of consciousness", "the patient could not speak or get hands and feet work/speech and quadriplegia improved", "it was considered as syncope vasovagal caused by continuous standing up", "symptoms that can be considered as todd''s paralysis after the recovery of consciousness persisted for 50 minutes", "the possibility of epilepsy and arrhythmia cannot be denied", "the possibility of epilepsy and arrhythmia cannot be denied", "the patient got vision darkend", "fell down", "got head bruise", "the patient could not speak", "pyrexia of 38 degrees centigrade" and "the factors of orthostatic dysregulation were carefully investigated" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: body temperature: (20Nov2021) 38 Centigrade; (21Nov2021) fever declined; electrocardiogram ambulatory: (Nov2021) not provided; electroencephalogram: (Nov2021) not provided; (21Nov2021) no special abnormality, notes: there was no special abnormality in brain waves; magnetic resonance imaging head: (Nov2021) not provided; schellong test: (Nov2021) not provided; vital signs measurement: (20Nov2021) no abnormalities, notes: There were no abnormalities in vital signs. Therapeutic measures were taken as a result of loss of consciousness, quadriplegia, syncope, postictal paralysis, epilepsy, arrhythmia, visual impairment, fall, contusion, lack of spontaneous speech, pyrexia, orthostatic intolerance including treatment with fluid replacement. The course of the events was as follows: On the next day of the second vaccination(19Nov2021), when practised basketball, the patient got vision darkend, Loss of consciousness, fell down and got head bruise. A few minutes later, consciousness improved, but the patient could not speak or get hands and feet work, so the patient was sent to the medical emergency centre in hospital. By the time of arrival (50 minutes after the symptoms developed), speech and Quadriplegia improved. There were no abnormalities in vital signs except Pyrexia of 38 degrees Centigrade. After observation, the patient was transported to pediatrics. From the next day, consciousness was clear, fever declined, and there was no special abnormality in brain waves. It was considered as Syncope vasovagal caused by continuous standing up, but because symptoms that can be considered as Todd''s paralysis after the recovery of consciousness persisted for 50 minutes, it was considered to be atypical of Syncope vasovagal. Because the possibility of Epilepsy and Arrhythmia cannot be denied, the following measures was taken. Head MRI, Holter electrocardiography and EEG follow were performed in outpatient department. The standing load test was carried out, and the factors of Orthostatic dysregulation were carefully investigated. It was considered that there was no direct causal relationship with corona vaccine, but Pyrexia after vaccination may be related to the occurrence of this episode, so this report was submitted. The reporter did not provide the event onset date. No follow-up attempts are possible. No further information is expected. ; Sender''s Comments: Based on available information of the vaccine BNT162B2, a temporal relation between the event Loss of consciousness, Quadriplegia, Syncope vasovagal, Todd''s paralysis, Epilepsy, Arrhythmia and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1930927 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Body temperature, Dyspraxia, Electrocardiogram ambulatory, Electroencephalogram, Epilepsy, Fall, Head injury, Investigation, Loss of consciousness, Magnetic resonance imaging head, Movement disorder, Orthostatic intolerance, Postictal paralysis, Pyrexia, Quadriplegia, Syncope, Vital signs measurement
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Pyrexia; Result Unstructured Data: Test Result:38 Centigrade; Test Name: Holter ECG; Result Unstructured Data: Test Result:unknown results; Test Name: brain wave / follow-up brain waves; Result Unstructured Data: Test Result:unknown results; Test Date: 20211121; Test Name: brain wave / follow-up brain waves; Result Unstructured Data: Test Result:no particular abnormality in the brain waves; Test Name: standing load test; Result Unstructured Data: Test Result:unknown results; Test Name: Head MRI; Result Unstructured Data: Test Result:unknown results; Test Date: 20211120; Test Name: vital signs; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC202101655939

Write-up: syncope vasovagal due to continued standing / atypical for vasovagal syncope; Todd''s paralysis developed; epilepsy; arrhythmia; Orthostatic dysregulation; Loss of consciousness / blackout; quadriplegia; fell; hit in the head; could not have conversations; could not move hands and feet; Pyrexia of 38 degrees centigrade was noted; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from Regulatory Authority. Regulatory number: v21131626 (RA). A 12-year and 7-month-old female patient received bnt162b2 (COMIRNATY solution for injection, Lot number: FE8162, Expiration Date: 28Feb2022), administration date 19Nov2021 10:00 (the day of the vaccination), via an unspecified route of administration as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient relevant medical history and concomitant medications were not reported. Family history of the patient was unknown. Vaccination history included: Covid-19 vaccine (1st single dose, MANUFACTURER UNKNOWN), for COVID-19 immunisation. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 20Nov2021 at 11:00 (1 day after the vaccination), the patient experienced loss of consciousness. On 20Nov2021 (1 day after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On the following day (20Nov2021) of the second dose vaccination (19Nov2021), during basketball practice, the patient experienced a blackout, lost of consciousness, and fell, resulting in a hit in the head. The patient regained consciousness in a few minutes but could not have conversations and move hands and feet. The patient was transferred to the emergency center at the reporting hospital. On arrival (50 minutes after the onset), difficulty in speech and quadriplegia were improved. Pyrexia of 38 degrees centigrade was noted, but there were no abnormalities in vital signs. The patient was moved to the pediatrics department for follow-up observation. On the following day, the patient had clear consciousness and Pyrexia was abated. There was no particular abnormality in the brain wave. It was considered there was a possibility of the patient might have Syncope vasovagal due to continued standing. However, the symptom appeared to be Todd''s paralysis developed after recovery from loss of consciousness which continued for 50 minutes, was atypical for Syncope vasovagal. The following treatment strategies were planned as possibilities of epilepsy and arrhythmia could not be ruled out. Head MRI, Holter ECG, and follow-up brain waves were conducted on an outpatient basis. A standing load test was conducted for examined the predisposition to Orthostatic dysregulation.On 23Nov2021 (4 days after the vaccination), the outcome of the event was recovering. The reporter reported this case because this episode might be involved by pyrexia after the vaccination, although the reporter considered there was no direct causal relationship with corona vaccine. The reporting pharmacist classified the event as serious (hospitalization from 20Nov2021 to 23Nov2021) and the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1931019 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Eye swelling, Headache, Malaise, Pain, SARS-CoV-2 test, Vaccination site erythema
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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: around; eyes; pain; feeling sick; Headache; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 26258368) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (around), EYE SWELLING (eyes), PAIN (pain), MALAISE (feeling sick) and HEADACHE (Headache) in a 29-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion disability). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (around) (seriousness criterion disability), EYE SWELLING (eyes) (seriousness criterion disability), PAIN (pain) (seriousness criterion disability) and MALAISE (feeling sick) (seriousness criterion disability). At the time of the report, VACCINATION SITE ERYTHEMA (around), EYE SWELLING (eyes), PAIN (pain), MALAISE (feeling sick) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medication was not given. No treatment medication was given. It was reported that patient had pain around the eyes and felt very tired and sleeping most of time. Company Comment: This regulatory case concerns a 29-year-old, female patient with no medical history reported, who experienced the unexpected, serious events of vaccination site erythema, eye swelling, pain, malaise and headache. The event headache occurred on the same day after administration of the third dose of the Moderna mRNA-1273 vaccine. The start dates of the events vaccination site erythema, eye swelling, pain and malaise were not provided. The patient felt sick with accompanying headache and pain around the eyes. She also felt very tired and was sleeping most of time. Treatment information was not provided. The events had not resolved at time of the report. The rechallenge was unknown as per Regulatory Authority report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 29-year-old, female patient with no medical history reported, who experienced the unexpected, serious events of vaccination site erythema, eye swelling, pain, malaise and headache. The event headache occurred on the same day after administration of the third dose of the Moderna mRNA-1273 vaccine. The start dates of the events vaccination site erythema, eye swelling, pain and malaise were not provided. The patient felt sick with accompanying headache and pain around the eyes. She also felt very tired and was sleeping most of time. Treatment information was not provided. The events had not resolved at time of the report. The rechallenge was unknown as per Regulatory Authority report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1931029 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Muscular weakness, Oedema peripheral, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS; LISINOPRIL; OMEPRAZOLE; PARACETAMOL; SERTRALINE; THYROXINE
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Lower leg edema; Upper limb edema; Weakness muscle; Weakness of arms; This case was received via Regulatory authority-RA (Reference number: GB-MHRA-ADR 26262443) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness of arms), MUSCULAR WEAKNESS (Weakness muscle), OEDEMA PERIPHERAL (Lower leg edema) and OEDEMA PERIPHERAL (Upper limb edema) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. No medical history was reported. Concomitant products included PARACETAMOL from 12-Nov-2021 to an unknown date for Fall, LISINOPRIL for Hypertension, LEVOTHYROXINE SODIUM (THYROXINE) for Hypothyroidism, ATORVASTATIN, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 12-Mar-2021 to an unknown date, INFLUENZA VACCINE (INFLUENZA VIRUS) from 19-Nov-2021 to an unknown date, OMEPRAZOLE and SERTRALINE for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced MUSCULAR WEAKNESS (Weakness of arms) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced MUSCULAR WEAKNESS (Weakness muscle) (seriousness criterion medically significant). On 24-Nov-2021, the patient experienced OEDEMA PERIPHERAL (Lower leg edema) (seriousness criterion medically significant) and OEDEMA PERIPHERAL (Upper limb edema) (seriousness criterion medically significant). At the time of the report, MUSCULAR WEAKNESS (Weakness of arms), MUSCULAR WEAKNESS (Weakness muscle), OEDEMA PERIPHERAL (Lower leg edema) and OEDEMA PERIPHERAL (Upper limb edema) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment drug was provided by reporter. Patient has not had symptoms associated with COVID-19. Patient had COVID-19 booster and flu vaccine on 19th November, upper arms sore on 20th and 21st and very cold hands, over the next few days edema developed during the day in lower limbs reducing overnight. Struggling with movement, getting up and down from sitting position. 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 female patient of unknown age, with a history of hypertension, who experienced the unexpected, serious (medically significant) events of muscular weakness and oedema peripheral. The events started the next day after the booster dose of mRNA-1273. The rechallenge was not applicable since patient received the first two doses with CHADOX1 NCOV-19. The medical history of hypertension, as well as concomitant influenza vaccine (which was applied on the same date as the mRNA-1273 booster) are confounding factors. Diagnostic tests and treatment information has not been provided at the time of this report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a female patient of unknown age, with a history of hypertension, who experienced the unexpected, serious (medically significant) events of muscular weakness and oedema peripheral. The events started the next day after the booster dose of mRNA-1273. The rechallenge was not applicable since patient received the first two doses with CHADOX1 NCOV-19. The medical history of hypertension, as well as concomitant influenza vaccine (which was applied on the same date as the mRNA-1273 booster) are confounding factors. Diagnostic tests and treatment information has not been provided at the time of this report. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1931734 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysgeusia, Fatigue, Influenza like illness, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Taste sour; Flu-like aching; Fatigue; Nausea; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26256320) on 28-Nov-2021 and was forwarded to Moderna on 28-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSGEUSIA (Taste sour), INFLUENZA LIKE ILLNESS (Flu-like aching), NAUSEA (Nausea) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced DYSGEUSIA (Taste sour) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 21-Nov-2021, NAUSEA (Nausea) had resolved. On 22-Nov-2021, DYSGEUSIA (Taste sour) and INFLUENZA LIKE ILLNESS (Flu-like aching) had resolved. On 23-Nov-2021, FATIGUE (Fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negetive No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient report is not related to myocarditis or pericarditis. Company Comment: This regulatory case concerns a female patient, of unknown age, with no relevant medical history, who experienced the unexpected, serious events of dysgeusia, influenza like illness, nausea and fatigue. The event nausea occurred on the same day after administration of the third dose of the Moderna mRNA-1273 vaccine. The events dysgeusia, influenza like illness and fatigue occurred 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 rechallenge was unknown as per Regulatory Authority report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a female patient, of unknown age, with no relevant medical history, who experienced the unexpected, serious events of dysgeusia, influenza like illness, nausea and fatigue. The event nausea occurred on the same day after administration of the third dose of the Moderna mRNA-1273 vaccine. The events dysgeusia, influenza like illness and fatigue occurred 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 rechallenge was unknown as per Regulatory Authority report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1933983 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, 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? 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: Chest ache (no need for hospitalization); Chills (no need for hospitalization); COVID-19 (Unsure when symptoms stopped); Tiredness (no need for hospitalization)
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101654170

Write-up: Tiredness; Primary Immunisation: ASTRAZENECA; Booster: COMIRNATY; Primary Immunisation: ASTRAZENECA; Booster: COMIRNATY; COMIRNATY was administered as a third booster dose; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111231035405620-LUXVN. Other Case identifier: GB-MHRA-ADR 26237657. A 60-year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 10Jul2021 (unspecified if ongoing), notes: Unsure when symptoms stopped; "Chills" (not ongoing), notes: no need for hospitalization; "Tiredness" (not ongoing), notes: no need for hospitalization; "Chest ache" (not ongoing), notes: no need for hospitalization. The patient was not enrolled in clinical trial. Concomitant medication(s) included: FLUCELVAX TETRA [INFLUENZA VACCINE INACT SAG 4V], administration date 08Nov2021. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, Primary Immunization series complete but unknown manufacturer), 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), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Primary Immunisation: ASTRAZENECA; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "COMIRNATY was administered as a third booster dose"; FATIGUE (medically significant) with onset 21Nov2021, outcome "recovered" (22Nov2021), described as "Tiredness". The report was not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jul2021) positive. The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1933995 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Feeling cold, Immunisation, Interchange of vaccine products, Off label use, Palpitations, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), 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: LATANOPROST
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ocular hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654320

Write-up: Vomiting; Chilliness; Dizziness; Palpitations; The patient previously received two doses of COVID-19 vaccine (at least one is non-Pfizer COVID-19 Vaccine) and then third (booster) dose of BNT162B2; The patient previously received two doses of COVID-19 vaccine (at least one is non-Pfizer COVID-19 Vaccine) and then third (booster) dose of BNT162B2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111231252024080-AS7V0 (RA). Other Case identifier: GB-MHRA-ADR 26238499 (RA). A 61-year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ocular hypertension" (unspecified if ongoing). The patient did not had symptoms associated with COVID-19 and was not enrolled in clinical trial. Concomitant medication included: LATANOPROST taken for ocular hypertension. Vaccination history included: Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "The patient previously received two doses of COVID-19 vaccine (at least one is non-Pfizer COVID-19 Vaccine) and then third (booster) dose of BNT162B2"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "The patient received the third/booster dose of BNT162b2"; VOMITING (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "Vomiting"; FEELING COLD (medically significant) with onset 21Nov2021, outcome "recovered" (22Nov2021), described as "Chilliness"; DIZZINESS (medically significant) with onset 21Nov2021, outcome "recovering", described as "Dizziness"; PALPITATIONS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Palpitations". The report was not related to possible inflammation of the heart (myocarditis or pericarditis). The patient did not have a COVID-19 test. The patient had not been 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: 1934020 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101654312

Write-up: Glands swollen; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111232202024550-RWIML (MHRA). Other Case identifier(s): GB-MHRA-ADR 26240619 (MHRA). A female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Additional information: 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 2, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Glands swollen". Additional information: Patient has not tested positive for COVID-19 since having the vaccine. Case reported as medically significant by health authority. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1934113 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
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, Myocarditis, Off label use, Pain in extremity, Pruritus, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 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 INC202101689521

Write-up: myocarditis; Itching; Pain in arm; booster; off label use; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The Regulatory Authority number GB-MHRA-WEBCOVID-202111281203172200-KX0DI, other case identifier(s) GB-MHRA-ADR 26262875. A male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (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, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported MYOCARDITIS (medically significant), outcome not recovered; OFF LABEL USE (medically significant) with onset 20Nov2021, outcome unknown; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome unknown; IMMUNISATION (non-serious) with onset 20Nov2021, outcome unknown; PRURITUS (non-serious) with onset 26Nov2021, outcome recovering; PAIN IN EXTREMITY (non-serious) with onset 21Nov2021, outcome recovering. The patient underwent the following laboratory tests and procedures SARS-COV-2 test negative, No - Negative COVID-19 test. Additional information included the patient was not enrolled in a clinical trial. Additional information included itching, pain in the arm. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). The 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: 1934141 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Erythema, Haemorrhage, Immunisation, Lymphadenopathy, Pain in extremity, Vaccination site pain, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; THYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure; Thyroid disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101651558

Write-up: arm bleed; injection site pain; injection site swelling/where the patient had the needle put in the swelling; arm aches; arm aches down to elbow and all shoulder; swollen with a large lump; redness; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "under active thyroid" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; THYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 1 , Anatomical Location: Arm Left), for COVID-19 Immunisation; Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; HAEMORRHAGE (medically significant) with onset 22Nov2021 18:00, outcome "not recovered", described as "arm bleed"; VACCINATION SITE PAIN (non-serious) with onset 22Nov2021 18:00, outcome "not recovered", described as "injection site pain"; VACCINATION SITE SWELLING (non-serious) with onset 22Nov2021 18:00, outcome "not recovered", described as "injection site swelling/where the patient had the needle put in the swelling"; PAIN IN EXTREMITY (non-serious) with onset 22Nov2021 18:00, outcome "not recovered", described as "arm aches"; ARTHRALGIA (non-serious) with onset 22Nov2021 18:00, outcome "not recovered", described as "arm aches down to elbow and all shoulder"; LYMPHADENOPATHY (non-serious) with onset 22Nov2021 18:00, outcome "not recovered", described as "swollen with a large lump"; ERYTHEMA (non-serious) with onset 22Nov2021 18:00, outcome "not recovered", described as "redness". The events "arm bleed", "injection site pain", "injection site swelling/where the patient had the needle put in the swelling", "arm aches", "arm aches down to elbow and all shoulder", "swollen with a large lump" and "redness" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of vaccination site pain. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient''s arm bleed when she had it done and the just ached for 2 days, Monday teatime she noticed it was very red and swollen with a large lump where the patient had the needle put in the swelling as got worse and the redness is much worse and her arm aches down to elbow and all shoulder. The patient had taken pictures from Monday to this morning.


VAERS ID: 1934164 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-11-20
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 20211122; Test Name: body temperature; Result Unstructured Data: Test Result: up to 37.9; Test Date: 20211121; Test Name: SARS Cov-2 test; Test Result: Negative; Test Date: 20211122; Test Name: SARS Cov-2 test; Test Result: Positive; Test Date: 20211122; Test Name: SARS Cov-2 test; Test Result: Positive; Test Date: 20211123; Test Name: SARS Cov-2 test; Test Result: Positive.
CDC Split Type: GRPFIZER INC202101655260

Write-up: Covid-19 infection, Covid-19 test positive with symptoms; Covid-19 infection, Covid-19 test positive with symptoms; This is a spontaneous report received from a contactable Consumer from product quality group. A 52 year-old female patient received bnt162b2 (COMIRNATY), administration date 02Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date 12May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Nov2021, outcome unknown. Symptoms included sore throat 20Nov2021, low fever 37.9 degrees C on 22Nov2021. The fever lasted until 23Nov2021. She did not have any other symptoms. SARS Cov-2 rapid test on 21Nov2021 was negative. She took 2 SARS Cov-2 self tests on 22nov2021 that were both positive. SARS Cov-2 PCR test on 23Nov2021 was positive. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1934248 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK6302 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyskinesia, Hypoaesthesia, Injury, Mobility decreased, Movement disorder, Muscular weakness, Neuropathy peripheral, Tremor, Vaccination site irritation
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Akathisia (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RISPERIDONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coxalgia; Schizophrenia
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade
CDC Split Type: JPPFIZER INC202101630585

Write-up: was still losing some kind of ability to move; Movements involuntary like a small wave of the left arm from side to side/Movements involuntary like Convulsion/Movements involuntary on left hand/involuntary movement in which upper arms trembled; Numbness in hand/it was hard to use strength in left arm, it was not completely, but it was numb/numbness on left hand; Movement disorder; upper arms trembled slightly; Radial nerve disorder; mild direct injury; irritation by chemicals/the drug might irritate the nerves; it was hrad to use strength in left arm/muscular weakness; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 23Nov2021, this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from a contactable physician via medical information team and received from the Regulatory Agency (RA). Regulatory authority report number is v21131378. The patient was a 14-year and 3-month-old female. Body temperature before vaccination was 36.6 degrees centigrade. The patient had coxalgia (Left). The patient was taking RISPERIDONE from another hospital (Schizophrenia). On 09Oct2021, the patient previously received the first dose of BNT162b2 (Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 17Oct2021 (after the first dose), the patient experienced herpes zoster. The outcome of the event was recovering with taking Aciclovir orally. On 20Nov2021 at 15:00 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FK6302, Expiration date: 30Apr2022) intramuscular in the arm left for COVID-19 immunization. On 20Nov2021 at 15:03 (the day of the vaccination), the patient experienced Radial nerve disorder. The detail of the reaction was reported as follows: On 20Nov2021 (Saturday) afternoon, the patient received the second dose of Comirnaty at left upper arm. To prevent the Vagus N reflex (as reported), the patient was put on the bed and received intramuscular injection from side. The patient was made to sleep for 5 minutes right after that. But 2-3 minutes after intramuscular injection, the patient experienced movements involuntary like upper arms trembled slightly from side to side/Movements involuntary like Convulsion, numbness, and movement disorder. Consciousness was clear, general condition was good. After about 30 minutes, since the movements involuntary disappeared, the patient was told to go home. Since the patient didn''t receive vaccination on a chair but on a bed and when receive intramuscular injection, and the patient''s upper arm was a little pronated, the patient was injected a little further back than planned. When the phone call was made today in daytime, Movements involuntary repeated the process of occurring and disappearing. There was Numbness in hand, the patient could hold a plastic bottle with left hand, but it was unstable. It was hard to use strength in left arm, it was not completely, but it was numb. It might touch the radial nerve. The reporter confirmed that there was no chattering pain when intramuscular injection, so the patient received the vaccination. The patient was still losing some kind of ability to move, so the reporter considered it might be mild direct injury or irritation by chemicals. Depending on the situation, the reporter was considering to request a neurologist to examine the patient. The 14-year-old girl who experienced Movements involuntary, numbness and Movement disorder on left hand was examined again on 22Nov2021, 24Nov2021, 26Nov2021 and watched progress. The patient revisited clinic on 22Nov2021. The patient could move the left hand slightly; however, muscular weakness was noted. The patient had numbness. The patient had involuntary movement occasionally. It was discussed about the vaccination site again calmly. Although it felt like the site was a little backward, it was found that the site was almost in the right place. Movements involuntary reduced day by day, it was hard to notice that anymore. Numbness was getting better for the most part. Movement of muscle (muscle strength) compared to right improved to 10%~20% at first, on 24Nov2021 to 30%~40%, on 26Nov2021 it improved to about 60%~70%. It was felt that the patient would get better without leaving any disorder. It was not sure what was the reason, there was no direct damage by needle. But it was felt that the drug might irritate the nerves from a little distance. On 22Nov2021 (2 days after the vaccination), the outcome of the events Radial nerve disorder, "Movements involuntary like a small wave of the left arm from side to side/Movements involuntary like Convulsion/Movements involuntary on left hand/involuntary movement in which upper arms trembled", "Numbness in hand/it was hard to use strength in left arm, it was not completely, but it was numb/numbness on left hand", "it was hard to use strength in left arm/muscular weakness", upper arms trembled slightly, and "was still losing some kind of ability to move" was recovering; "irritation by chemicals/the drug might irritate the nerves" was not recovered; and mild direct injury was unknown. The reporter classified the event as non-serious (didn''t know until they see how it goes) and assessed that the events was related to BNT162b2. There were other possible cause(s) of the event such as any other diseases, but not specified. The reporter commented as follows: On 22Nov2021, the vaccination site was examined and judged that the vaccine was injected to the appropriate site (the intersection between the anteroposterior axillary line and perpendicular line from the acromion [illegible writing]).; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101699896 same reporter/patient, different dose/AE


VAERS ID: 1937248 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Confusional state, Diarrhoea, Headache, Immunisation, Interchange of vaccine products, Off label use, Product use issue, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VACCINE
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101670806

Write-up: Diahorrea; Product use for unapproved combination; Headache; Vomiting; Off label use; Interchange of vaccine products; Booster; Confused; Shivers; 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-APPCOVID-20211125140029 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26252766 (MHRA). A 55 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no medical problems. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 20Nov2021. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test. Patient was not enrolled in clinical trial. Past drug history included: Sertraline for Depression; Lansoprazole for hiatus hernia. Vaccination history included: COVID-19 vaccine astrazeneca (Dose 1, Single), for COVID-19 immunisation; COVID-19 vaccine astrazeneca (Dose 2, Single), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; CONFUSIONAL STATE (medically significant) with onset 2021, outcome "not recovered", described as "Confused"; HEADACHE (medically significant) with onset 20Nov2021, outcome "recovering", described as "Headache"; VOMITING (medically significant) with onset 20Nov2021, outcome "recovering", described as "Vomiting"; CHILLS (medically significant) with onset 2021, outcome "recovered" (2021), described as "Shivers"; DIARRHOEA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Diahorrea"; PRODUCT USE ISSUE (non-serious) with onset 20Nov2021, outcome "unknown", described as "Product use for unapproved combination". Clinical Course: It was reported by the patient that this started on the evening of her vaccine booster and flu injection as she was not told which one she was receiving in each arm. She was not sure which injection caused the reaction but her left arm was still very hot and she was still very confused as to why she was given the Pfizer injection as her booster when both her previous injections were AstraZeneca. She also thought the nurse who administered this, should answer this if taken the time to explain. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1937250 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse drug reaction, Asthenia, Fatigue, Hyperhidrosis, Pain in extremity
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Bad sweats; Sores in mouth; Weakness; Pain in arm; Pains all over; Fatigue; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26263068) on 29-Nov-2021 and was forwarded to Moderna on 29-Nov-2021. This regulatory authority case was reported by a non-health professional and describes the occurrence of HYPERHIDROSIS (Bad sweats), ADVERSE DRUG REACTION (Sores in mouth), ASTHENIA (Weakness), PAIN IN EXTREMITY (Pain in arm), ADVERSE DRUG REACTION (Pains all over) and FATIGUE (Fatigue) in a 69-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 09-Mar-2020 to 21-Mar-2020. On 20-Nov-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced ADVERSE DRUG REACTION (Sores in mouth) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), ADVERSE DRUG REACTION (Pains all over) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (Bad sweats) (seriousness criterion medically significant). On 25-Nov-2021, ASTHENIA (Weakness), ADVERSE DRUG REACTION (Pains all over) and FATIGUE (Fatigue) had resolved. At the time of the report, HYPERHIDROSIS (Bad sweats) outcome was unknown, ADVERSE DRUG REACTION (Sores in mouth) was resolving and PAIN IN EXTREMITY (Pain in arm) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication were provided. Patient not had a COVID-19 test. Patient''s history included other conditions, not mentioned in the report, known to lower immune response. Company Comment: This regulatory case concerns a 69-year-old, female patient with no relevant medical history, who experienced the unexpected, serious events of hyperhidrosis, adverse drug reaction (sores in mouth), asthenia, pain in extremity, adverse drug reaction (pains all over) and fatigue. The events adverse drug reaction (sores in mouth), asthenia, pain in extremity, adverse drug reaction (pains all over) and fatigue occurred on the same day after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The start date of the event hyperhidrosis was not provided. The patient experienced excruciating joint pains and muscle pains, associated with movements. She was too weak to make drinks or food for 48 hours. She slept on-and-off for 48 hours as she was also too weak to move. The patient also experienced bad sweats, sores in the mouth, headaches, and was physically sick at one point and unable to eat. Treatment information was not provided. However, the events asthenia, adverse drug reaction (pains all over) and fatigue had resolved at the time of the report. The event adverse drug reaction (sores in mouth) was resolving but the event pain in extremity had not resolved at the time of the report. The outcome of the event hyperhidrosis was unknown. The rechallenge was unknown as the dose number was not provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Patient is not enrolled in clinical trial; Sender''s Comments: This regulatory case concerns a 69-year-old, female patient with no relevant medical history, who experienced the unexpected, serious events of hyperhidrosis, adverse drug reaction (sores in mouth), asthenia, pain in extremity, adverse drug reaction (pains all over) and fatigue. The events adverse drug reaction (sores in mouth), asthenia, pain in extremity, adverse drug reaction (pains all over) and fatigue occurred on the same day after administration of an unspecified dose of the Moderna mRNA-1273 vaccine. The start date of the event hyperhidrosis was not provided. The patient experienced excruciating joint pains and muscle pains, associated with movements. She was too weak to make drinks or food for 48 hours. She slept on-and-off for 48 hours as she was also too weak to move. The patient also experienced bad sweats, sores in the mouth, headaches, and was physically sick at one point and unable to eat. Treatment information was not provided. However, the events asthenia, adverse drug reaction (pains all over) and fatigue had resolved at the time of the report. The event adverse drug reaction (sores in mouth) was resolving but the event pain in extremity had not resolved at the time of the report. The outcome of the event hyperhidrosis was unknown. The rechallenge was unknown as the dose number was not provided. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1937342 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Immunisation, Interchange of vaccine products, Off label use, Peripheral swelling, Pruritus, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: APIXABAN; ATORVASTATIN; INDAPAMIDA; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pH abnormal; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101662066

Write-up: itching; swollen legs and arms; Hives giant; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111240738530310-MUU6U (RA). Other Case identifier(s): GB-MHRA-ADR 26241586 (RA). A 85 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 03Jan2020, stop date: 20Jan2020; "Blood pH" (unspecified if ongoing). Concomitant medication(s) included: APIXABAN taken for blood ph abnormal; ATORVASTATIN; INDAPAMIDA; RAMIPRIL. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 1), for covid-19 immunisation; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 2), for covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; ANGIOEDEMA (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Hives giant"; PRURITUS (non-serious), outcome "unknown", described as "itching"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swollen legs and arms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Day 5, the patient woke in night with itching swollen legs and arms, not in the face. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1937347 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Nasal congestion, Off label use, Rash erythematous, Rash pruritic, Rhinorrhoea, SARS-CoV-2 test, Skin disorder, Sneezing
SMQs:, Anaphylactic reaction (narrow), 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: Medical History/Concurrent Conditions: Clinical trial participant; Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101661605

Write-up: Red rash; off label use; Interchange of vaccine products; booster; sneezing; runny nose; sudden onset of stuffy; small bumps on skin; itchy pink rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the. Regulatory number: GB-MHRA-WEBCOVID-202111240812473790-QK8RS (RA). Other Case identifier(s): GB-MHRA-ADR 26241842 (RA). A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; SNEEZING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "sneezing"; RHINORRHOEA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "runny nose"; NASAL CONGESTION (medically significant) with onset 20Nov2021, outcome "not recovered", described as "sudden onset of stuffy"; RASH ERYTHEMATOUS (medically significant) with onset 23Nov2021, outcome "not recovered", described as "Red rash"; SKIN DISORDER (medically significant) with onset 2021, outcome "unknown", described as "small bumps on skin"; RASH PRURITIC (medically significant) with onset 2021, outcome "not recovered", described as "itchy pink rash". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of skin disorder, rash pruritic. Clinical course: Patient had not had symptoms associated with COVID-19. Sudden onset of stuffy, runny nose and sneezing during the night. Extremely itchy pink rash and small bumps on skin of thighs and knees. Laratidine taken and itchiness reduced but not resolved - continued into next day, mainly on knees and elbows. Patient had not tested positive for COVID-19 since having the vaccine. The 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: 1937350 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Depression, Immunisation, SARS-CoV-2 test
SMQs:, Depression (excl suicide and self injury) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety state
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101661620

Write-up: Depression/ depressive episode; booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111240828153570-NYWER (RA). Other Case identifier(s): GB-MHRA-ADR 26241834 (RA). A 30 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Anxiety state" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included: SERTRALINE taken for anxiety state. 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 20Nov2021, outcome "unknown", described as "booster"; DEPRESSION (medically significant) with onset 22Nov2021, outcome "recovered with sequelae", described as "Depression". It''s also reported depressive episode (medically significant) on an unspecified date with outcome of not recovered. Depressive episode was brief but intense which is unusual for patient. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: no - negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. "Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: No". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1937356 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
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, Neuropathy peripheral, Off label use, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Medication errors (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101661603

Write-up: tingling; Peripheral neuropathy; 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-202111240852121120-NTP6E (MHRA). Other Case identifier(s): GB-MHRA-ADR 26242077 (MHRA). A 51 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 51 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. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN, SINGLE), administration date: 18Mar2021, for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; NEUROPATHY PERIPHERAL (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Peripheral neuropathy"; PARAESTHESIA (non-serious), outcome "not recovered", described as "tingling". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: The patient woke up with tingling in his right hand at the finger tips. This has spread up my fingers to cover 2/3 of the finger. 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: 1937365 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PZ FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Clavicle fracture, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Pain, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101662009

Write-up: general unwell; lumps on collar bone; general unwell aching feeling throughout my body.; Lymph nodes enlarged; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202111240954447030-S2LR3. Other Case identifier(s): GB-MHRA-ADR 26242460. A 52 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: PZ FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally). The patient''s concomitant medications were not reported. Past drug history included: Flixonase. Vaccination history included: Covid-19 vaccine (Dose 1 Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2 Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; VOMITING (medically significant), outcome "not recovered", described as "general unwell"; CLAVICLE FRACTURE (medically significant), outcome "not recovered", described as "lumps on collar bone"; LYMPHADENOPATHY (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Lymph nodes enlarged"; PAIN (medically significant), outcome "unknown", described as "general unwell aching feeling throughout my body.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: The patient had lumps on collar bone, swollen under armpit, general unwell aching feeling throughout my body. Unsure if patient had symptoms associated with COVID-19. Patient was not breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. 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 needed. No further information is expected.


VAERS ID: 1937378 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
Submitted: 0000-00-00
Entered: 2021-12-10
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, Nausea, Off label use, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vomiting
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: HERCEPTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101661643

Write-up: The patient previously received two doses of COVID-19 VACCINE ASTRAZENECA and then third (booster) dose of BNT162B2; The patient previously received two doses of COVID-19 VACCINE ASTRAZENECA and then third (booster) dose of BNT162B2; The patient previously received two doses of COVID-19 VACCINE ASTRAZENECA and then third (booster) dose of BNT162B2; Fever chills; Vomiting; Painful arm; Nausea; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111241114137160-BF2RW (RA). Other Case identifier(s): GB-MHRA-ADR 26243008 (RA). A 58 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Neoplasm" (unspecified if ongoing), notes: Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy); "Breast cancer" (unspecified if ongoing). Concomitant medications included: HERCEPTIN taken for breast cancer, start date: 21Jan2021; INFLUENZA VIRUS taken for immunisation, administration date 06Oct2021. Vaccination history included: Covid-19 vaccine astrazeneca (Second dose), administration date: 04May2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (First dose), administration date: 06Feb2021, for COVID-19 immunisation. Patient had not had symptoms associated with COVID-19. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant), outcome "unknown" and all described as "The patient previously received two doses of COVID-19 VACCINE ASTRAZENECA and then third (booster) dose of BNT162B2"; NAUSEA (medically significant) with onset 20Nov2021, outcome "recovering", described as "Nausea"; PYREXIA (medically significant) with onset 21Nov2021, outcome "recovered" (23Nov2021), described as "Fever chills"; VOMITING (medically significant) with onset 21Nov2021, outcome "recovered" (22Nov2021), described as "Vomiting"; PAIN IN EXTREMITY (medically significant) with onset 21Nov2021, outcome "recovering", described as "Painful arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Reaction. Did her report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, they would ask her some additional questions at the end of this report: "No". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1937383 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchiectasis; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101661875

Write-up: Head pain; Vomiting; Fever chills; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202111241147263730-PCUUT. Other Case identifier(s): GB-MHRA-ADR 26243209. A 69-year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 02Feb2021 (unspecified if ongoing), notes: Unsure when symptoms stopped; "bronchiectasis" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Levothyroxine; Symbicort. Vaccination history included: Covid-19 vaccine astrazeneca (unknown dose number), administration date: 14Mar2021, for Covid-19 immunisation; Covid-19 vaccine (unknown dose number), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 21Nov2021, outcome "recovering", described as "Head pain"; VOMITING (medically significant) with onset 21Nov2021, outcome "recovered with sequelae" (Nov2021), described as "Vomiting"; PYREXIA (medically significant) with onset 21Nov2021, outcome "recovered" (24Nov2021), described as "Fever chills". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (02Feb2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: The patient has not tested positive for COVID-19 since having the vaccine. The 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 needed. No further information is expected.


VAERS ID: 1937403 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Immunisation, Interchange of vaccine products, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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: AMLODIPINE; ATORVASTATIN; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholesterol; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101661739

Write-up: Diarrhea; Feverish; Abdominal 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-202111241337063980-VAPHA (MHRA). Other Case identifier(s): GB-MHRA-ADR 26243983 (MHRA). A 65-year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension, start date: 01Jan2010; ATORVASTATIN taken for blood cholesterol, start date: 01Jan2015; INFLUENZA VIRUS, administration date 28Oct2021; RAMIPRIL taken for hypertension, start date: 01Jan2010. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Batch/lot number: Not known), administration date: 01Mar2021, for Covid-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2, Batch/lot number: Not known), administration date: 23May2021, for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 21Nov2021, outcome "recovered" (24Nov2021), described as "Feverish"; ABDOMINAL PAIN (medically significant) with onset 21Nov2021, outcome "recovering", described as "Abdominal pain"; DIARRHOEA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Diarrhoea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient did not had symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report does not relate to possible inflammation of the heart (myocarditis or pericarditis) No follow up attempts are possible. No further information is expected.


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