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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: 2003221 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-01
Onset:2021-11-24
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Hypertension, Pain in extremity, Skin discolouration, Vaccination site movement impairment
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hepatic insufficiency (Post infection.); Low blood pressure
Preexisting Conditions: Medical History/Concurrent Conditions: CMV infection (weaker liver after infections (mononucleosis and Cytomegalovirus)); COVID-19; Mononucleosis infectious (weaker liver after infections (mononucleosis and Cytomegalovirus))
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101830877

Write-up: Yellowing of a nail and toe; high heart arrhythmia - very high blood pressure; Heart arrhythmia - high blood pressure; Pain of the vaccinated arm/ Pain and restricted movement of left arm; Restricted movement of the vaccinated arm/Pain and restricted movement of left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: CZ-CZSUKL-21013408. Other Case identifier(s): CZ-CZSUKL-21012880. A 43 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "CMV infection", start date: 2005, stop date: 2005, notes: weaker liver after infections (mononucleosis and Cytomegalovirus); "Mononucleosis infectious", start date: 1996, stop date: 1996, notes: weaker liver after infections (mononucleosis and Cytomegalovirus); "Low blood pressure" (ongoing); "Hepatic insufficiency" (ongoing), notes: Post infection.; "COVID-19", start date: Mar2021, stop date: Mar2021. The patient''s concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant) with onset 24Nov2021, outcome "unknown", described as "high heart arrhythmia - very high blood pressure"; HYPERTENSION (medically significant) with onset 24Nov2021, outcome "recovered" (27Nov2021), described as "Heart arrhythmia - high blood pressure"; PAIN IN EXTREMITY (non-serious) with onset 24Nov2021, outcome "recovered" (26Nov2021), described as "Pain of the vaccinated arm/ Pain and restricted movement of left arm "; VACCINATION SITE MOVEMENT IMPAIRMENT (non-serious) with onset 24Nov2021, outcome "recovered" (26Nov2021), described as "Restricted movement of the vaccinated arm/Pain and restricted movement of left arm "; SKIN DISCOLOURATION (non-serious) with onset 27Nov2021, outcome "recovered" (29Nov2021), described as "Yellowing of a nail and toe". Clinical course: The reporter stated although patient''s blood pressure was normally low, on the day of vaccination and the following three days, he often woke up during the night and felt high heart arrhythmia - very high blood pressure. What was interesting was that it always was during the night, during a calm part of his sleep. During the day he had his usual low blood pressure. He never had problems with his heart, never experienced arrhythmias. He was not sure whether to call himself an ambulance during those three nights. He was a healthy person, was not going through any stress when the reaction happened. Pain and restricted movement of left arm started on November 24th, 2021, lasted for 2 days. Yellowing of a nail and finger on his foot started on November 27th, lasted for 2 days. His left arm, where the vaccine was applied, was painful for two days and his movement was restricted, especially when he tried to move it upwards. Three days after the vaccination his finger and nail on his foot changed colour to yellow, almost orange, it was the finger next to his big toe. The patient did not have this on any other toe.It took two days for the original colour of the nail and toe to come back. The toe was not previously strained physically or pushed against, same as other toes. The reporter does not wish to contact the attending physician. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2003563 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness postural, Incorrect route of product administration, Seizure, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Drug abuse and dependence (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101817505

Write-up: Dizziness on standing up; Epileptic seizures after 1st corona vaccination Biontech. Approx. 10 minutes after vaccination; Chest pain; fainting; incorrect route of vaccine administered; Visual disturbance; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: DE-PEI-CADR2021205767. Other Case identifier(s): DE-CADRPEI-2021205767, DE-PEI-202100232316. A 15 year-old female patient received bnt162b2 (COMIRNATY), intravenous, administration date 24Nov2021 (Batch/Lot number: unknown) at the age of 15 years as dose 1,single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS POSTURAL (hospitalization) with onset 24Nov2021, outcome "not recovered", described as "Dizziness on standing up"; SEIZURE (hospitalization) with onset 24Nov2021, outcome "not recovered", described as "Epileptic seizures after 1st corona vaccination Biontech. Approx. 10 minutes after vaccination"; CHEST PAIN (hospitalization) with onset 24Nov2021, outcome "unknown", described as "Chest pain"; SYNCOPE (medically significant) with onset 24Nov2021, outcome "not recovered", described as "fainting"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "incorrect route of vaccine administered"; VISUAL IMPAIRMENT (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Visual disturbance" . Sender Comment: Are you or the person concerned known of any allergies? If yes, which? no Information on risk factors or previous illnesses None/ fainted approx. 10 minutes after vaccination. Since then Seizures every 5-10 minutes. Duration approx 1 minute No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2003572 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCUE1 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, Hypothyroidism
SMQs:, Angioedema (broad), Hypothyroidism (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to metals; Dust allergy; Reaction to preservatives
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101816999

Write-up: allergic reaction immediately after vaccination, severe redness on the neck and face; Hypothyroidism; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the WEB. Regulatory number: DE-PEI-CADR2021206347. Other Case identifier(s): DE-CADRPEI-2021206347, DE-PEI-202100232390. A 41 year-old female patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: SCUE1) at the age of 41 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "allergy to House dust" (unspecified if ongoing); "allergy to nickel" (unspecified if ongoing); "allergy to methyldibromo glutaronitrile dibromodicyanobutane" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (hospitalization) with onset 24Nov2021, outcome "recovered", described as "allergic reaction immediately after vaccination, severe redness on the neck and face"; HYPOTHYROIDISM (medically significant), outcome "unknown", described as "Hypothyroidism". The events "allergic reaction immediately after vaccination, severe redness on the neck and face" and "hypothyroidism" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of hypersensitivity, hypothyroidism. Hypothyroidism: treatment by an on-site emergency physician and observation in the emergency room for total 4 hours. Medications are given for allergic reactions. Relatedness of drug to event: Allergic reaction. A. Consistent causal association to immunization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2003594 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1022A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Deafness, Dizziness, Tinnitus
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hearing impairment (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pollen allergy (allergic to early bloomers)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101833066

Write-up: Deafness can no longer hear anything; Tinnitus; Balance disorder and dizziness due to ear; Balance disorder and dizziness due to ear; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: DE-PEI-CADR2021209380 . Other Case identifier(s): DE-CADRPEI-2021209380 (Webportal), DE-PEI-202100260466. A 32 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: 1F1022A) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Pollen allergy" (ongoing), notes: allergic to early bloomers. The patient''s concomitant medications were not reported. Past drug history included: Paracetamol, reaction(s): "allergy", notes: allergic to paracetamol. The following information was reported: DEAFNESS (medically significant) with onset 24Nov2021, outcome "unknown", described as "Deafness can no longer hear anything"; TINNITUS (non-serious) with onset 24Nov2021, outcome "unknown", described as "Tinnitus"; BALANCE DISORDER (non-serious), DIZZINESS (non-serious) all with onset 24Nov2021, outcome "unknown" and all described as "Balance disorder and dizziness due to ear". Event assessment: Deafness, Tinnitus, Balance difficulty/: A. Consistent causal association to immunization Sender''s comment: Do you or the person concerned have any known allergies? If yes, which ones? Paracetamol and early bloomers / continuing No follow-up attempts are possible. No further information is expected.


VAERS ID: 2003906 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-11-24
   Days after vaccination:274
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211127; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101832298

Write-up: COVID-19; fever; cough; rhinitis; asthenia; Vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Physician) from the RA and product quality group. Regulatory number: FR-AFSSAPS-AN20214700 (RA). A 57 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 23Feb2021 (Lot number: EJ6789, Expiration Date: 31May2021) as dose 2, single and intramuscular, administered in arm left, administration date 26Jan2021 (Lot number: EJ6788) 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) with onset 24Nov2021, outcome "not recovered", described as "Vaccination failure"; COVID-19 (medically significant) with onset 27Nov2021, outcome "not recovered", described as "COVID-19"; PYREXIA (medically significant) with onset 24Nov2021, outcome "not recovered", described as "fever"; COUGH (medically significant) with onset 24Nov2021, outcome "not recovered", described as "cough"; RHINITIS (medically significant) with onset 24Nov2021, outcome "not recovered", described as "rhinitis"; ASTHENIA (medically significant) with onset 24Nov2021, outcome "not recovered", described as "asthenia". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Nov2021) positive. Additional Information: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6789.A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. RA concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2003942 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-21
Onset:2021-11-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Blood test, Dyspnoea, Echocardiogram, Electrocardiogram, Myocarditis, Pericardial effusion, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; NEOMERCAZOLE; METFORMIN HYDROCHLORIDE; LANTUS; NOVORAPID; BIPRETERAX N; DUOPLAVIN; BISOPROLOL ABACUS MEDICINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardioverter placement; Hypertension arterial; Hyperthyroidism; Insulin-requiring type 2 diabetes mellitus; Ischaemic heart disease; Thyroid nodule (toxic)
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:T4L are slightly increased to 23.8 pmol / L; Test Date: 20211125; Test Name: Blood test; Result Unstructured Data: Test Result:thyroid stimulating hormone was low (0.320 mIU/L); Test Date: 20211130; Test Name: Blood test; Result Unstructured Data: Test Result:collapsed on (0.050 mIU/L); Test Name: echocardiography; Result Unstructured Data: Test Result:pericardial effusion; Test Name: electrocardiography; Result Unstructured Data: Test Result:sinus rhythm; Comments: but the defibrillator check shows a passage in AF (paroxysmal) with 3 episodes of ventricular tachycardia
CDC Split Type: FRPFIZER INC202101831070

Write-up: Myopericarditis; increasingly progressive grade III dyspnoea; 3 episodes of ventricular tachycardia; pericardial effusion; Atrial fibrillation; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: FR-AFSSAPS-GR20215065 (RA). Other Case identifier(s): FR-AFSSAPS-2021169593 (RA). A 84 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 21Nov2021 (Batch/Lot number: unknown) as dose 1, 0.3ml single for covid-19 immunisation. Relevant medical history included: "Thyroid nodule (toxic)" (unspecified if ongoing); "Insulin-requiring type 2 diabetes mellitus" (unspecified if ongoing); "Ischaemic heart disease" (unspecified if ongoing); "Cardioverter placement" (unspecified if ongoing); "Hypertension arterial" (unspecified if ongoing); "Hyperthyroidism" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; NEOMERCAZOLE; METFORMIN HYDROCHLORIDE; LANTUS; NOVORAPID; BIPRETERAX N; DUOPLAVIN; BISOPROLOL ABACUS MEDICINE. The following information was reported: MYOCARDITIS (hospitalization, medically significant) with onset 25Nov2021, outcome "recovering", described as "Myopericarditis"; DYSPNOEA (hospitalization) with onset 25Nov2021, outcome "recovering", described as "increasingly progressive grade III dyspnoea"; VENTRICULAR TACHYCARDIA (hospitalization, medically significant) with onset 24Nov2021, outcome "recovering", described as "3 episodes of ventricular tachycardia"; PERICARDIAL EFFUSION (hospitalization, medically significant) with onset 24Nov2021, outcome "recovering", described as "pericardial effusion"; ATRIAL FIBRILLATION (hospitalization, medically significant) with onset 24Nov2021, outcome "recovering", described as "Atrial fibrillation". The patient was hospitalized for myocarditis, dyspnoea, ventricular tachycardia, pericardial effusion, atrial fibrillation (start date: 25Nov2021, discharge date: 03Dec2021, hospitalization duration: 8 day(s)). The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) t4l are slightly increased to 23.8 pmol / l; (25Nov2021) thyroid stimulating hormone was low (0.320 miu/l); (30Nov2021) collapsed on (0.050 miu/l); echocardiogram: (unspecified date) pericardial effusion; electrocardiogram: (unspecified date) sinus rhythm, notes: but the defibrillator check shows a passage in AF (paroxysmal) with 3 episodes of ventricular tachycardia. Clinical course: As it stands, at least 3 hypotheses may remain: decompensation of hyperthyroidism, whether or not caused by the vaccine (some reports indicate decompensation of chronic autoimmune pathology post-vaccination by stimulation of the immune system), worsening of arrhythmia in a severe cardiopathic patient (the signals of post-vaccination cardiac arrhythmias are numerous and under surveillance) or a purely iatrogenic vaccine origin. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2003953 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-11-24
   Days after vaccination:115
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Hyperthermia, Lower respiratory tract congestion, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test, Vaccination failure
SMQs:, Cardiac failure (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Accidents and injuries (broad), Respiratory failure (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: INNOVAIR; CLOZAPINE; LASILIX FAIBLE; IPRATROPIUM MERCK; IRBESARTAN; IMPORTAL; MELATONIN; MIANSERIN; SERESTA; PARACETAMOL; RIVASTIGMINE; VENTOLINE [SALBUTAMOL]; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic conjunctivitis; Asthma; Cognitive disorder (with suspicion of Levy body dementia); Complete rupture of rotator cuff; COVID-19 pneumonitis; Disease Parkinson''s; Embolism pulmonary; Failure respiratory (severe, obstructive); Hip fracture (left hip); Hip replacement; Hypertension arterial; Knee total replacement; Obstructive ventilatory defect
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: oxygen saturation; Result Unstructured Data: Test Result:90-91 %; Test Date: 20211126; Test Name: sars-cov-2 PCR test; Test Result: Positive ; Comments: Indian variant
CDC Split Type: FRPFIZER INC202101828361

Write-up: appearance of bronchial congestion; hyperthermia; 90-91% limit saturation at home; Appearance of asthenia/sars-cov-2 PCR test: positive; infection on day 2 of symptoms and on day 1 of PCR/sars-cov-2 PCR test: positive; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the regulatory authority. Regulatory number: FR-AFSSAPS-LL20218174. A 84 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19 pneumonitis" (unspecified if ongoing); "Hypertension arterial" (unspecified if ongoing); "Cognitive disorder" (unspecified if ongoing), notes: with suspicion of Levy body dementia; "Embolism pulmonary" (unspecified if ongoing); "Disease Parkinson''s" (unspecified if ongoing); "Failure respiratory" (unspecified if ongoing), notes: severe, obstructive; "Asthma" (unspecified if ongoing); "Complete rupture of rotator cuff" (unspecified if ongoing); "Obstructive ventilatory defect" (unspecified if ongoing); "total knee prothesis" (unspecified if ongoing); "total hip prothesis" (unspecified if ongoing); "periprosthetic hip fracture" (unspecified if ongoing), notes: left hip; "acute allergic conjunctivitis" (unspecified if ongoing). Concomitant medication(s) included: INNOVAIR; CLOZAPINE; LASILIX FAIBLE; IPRATROPIUM MERCK; IRBESARTAN; IMPORTAL; MELATONIN; MIANSERIN; SERESTA; PARACETAMOL; RIVASTIGMINE; VENTOLINE [SALBUTAMOL]; TAMSULOSIN. The following information was reported: VACCINATION FAILURE (hospitalization, medically significant) with onset 24Nov2021, outcome "not recovered", described as "Appearance of asthenia/sars-cov-2 PCR test: positive"; COVID-19 (hospitalization, medically significant) with onset 24Nov2021, outcome "not recovered", described as "infection on day 2 of symptoms and on day 1 of PCR/sars-cov-2 PCR test: positive"; LOWER RESPIRATORY TRACT CONGESTION (hospitalization) with onset 25Nov2021, outcome "unknown", described as "appearance of bronchial congestion"; HYPERTHERMIA (hospitalization) with onset 25Nov2021, outcome "unknown", described as "hyperthermia"; OXYGEN SATURATION DECREASED (hospitalization) with onset 25Nov2021, outcome "unknown", described as "90-91% limit saturation at home". Appearance of asthenia since 24Nov2021. On 25Nov2021 appearance of bronchial congestion, hyperthermia and 90-91% limit saturation at home. Treatment: by O2 and aerosols. The patient underwent the following laboratory tests and procedures: oxygen saturation: (25Nov2021) 90-91 %; sars-cov-2 test: (26Nov2021) positive, notes: Indian variant. Therapeutic measures were taken as a result of vaccination failure, covid-19, lower respiratory tract congestion, hyperthermia, oxygen saturation decreased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2004017 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-05
Onset:2021-11-24
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Antiphospholipid antibodies, Blood test, C-reactive protein, Computerised tomogram, Deep vein thrombosis, Platelet count, Prostatic specific antigen, Stool analysis, Thrombophlebitis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: RINVOQ
Current Illness: Arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Blood parathyroid hormone; Cervical neuralgia; Coxarthrosis; Finger osteoarthritis; Sciatica; Spinal canal stenosis
Allergies:
Diagnostic Lab Data: Test Name: Antiphospholipid Syndrome; Test Result: Negative ; Comments: Etiological assessment of Venous Thromboembolic Disease (VTE): Negative Antiphospholipid Syndrome balance sheet; Test Date: 20211123; Test Name: Biology; Result Unstructured Data: Test Result:Biological inflammatory syndrome; Comments: Biological inflammatory syndrome with a CRP at 113g / dL without hyperleukocytosis; no thrombocytopenia with platelets: 275G / L.; Test Date: 20211125; Test Name: Computed Tomography; Result Unstructured Data: Test Result:effusion; Comments: Right pleural effusion blade. Partial left pleural effusion of low abundance. Subcapsular hypodensic range of non-specific hepatic segment IV, to be rechecked or supplemented by MRI. Doubt about a thrombosis of the superficial and common femoral veins left, to be compared with an ultrasound. No other suspicious lesions detectable.; Test Date: 20211123; Test Name: CRP; Result Unstructured Data: Test Result:113 g/dl; Test Date: 20211123; Test Name: platelets; Result Unstructured Data: Test Result:275 x10 9/l; Test Date: 20211126; Test Name: PSA; Result Unstructured Data: Test Result:0.43; Comments: Normal; Test Date: 20211126; Test Name: Blood in the stool; Test Result: Negative
CDC Split Type: FRPFIZER INC202101818287

Write-up: Thrombophlebitis; left femoral deep vein thrombosis; This is a spontaneous report received from a contactable reporter (Physician) from the Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-NC20216238. A 75 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 05Nov2021 (Lot number: FG3739) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Narrow lumbar canal" (unspecified if ongoing); "Bilateral L5 sciatica" (unspecified if ongoing); "Distal interphalangeal osteoarthritis" (unspecified if ongoing); "Bilateral C5 cervicobrachial neuralgia" (unspecified if ongoing); "Coxarthrosis" (unspecified if ongoing); "PTH" (unspecified if ongoing); "Immunonegative arthritis", start date: 2012 (ongoing). Concomitant medication(s) included: RINVOQ taken for arthritis. Vaccination history included: Covid-19 vaccine (1st dose, manufacturer unknown), for covid-19 immunisation. He was admitted to hospital on 23Nov2021 for treatment of an unlabeled immunonegative polyarthritis, evolving since 2012, worsening, and currently in the 15th line of treatment under Rinvoq, for additional assessment and in particular search for AA amyloidosis against the background of persistent inflammatory syndrome. On his entrance examination, he found a painful left lower limb, edematous with loss of calf sway. Paraclinical investigations confirm the presence of a left femoral deep vein thrombosis, diagnosed on 24Nov2021, on day 19 of the 2nd injection of Comirnaty. After questioning, no more recent bed rest (but patient not very active due to the painful context). The following information was reported: THROMBOPHLEBITIS (medically significant) with onset 24Nov2021, outcome "recovering", described as "Thrombophlebitis"; DEEP VEIN THROMBOSIS (medically significant) with onset 24Nov2021, outcome "recovering", described as "left femoral deep vein thrombosis". The patient underwent the following laboratory tests and procedures: antiphospholipid antibodies: (unspecified date) negative, notes: Etiological assessment of Venous Thromboembolic Disease (VTE): Negative Antiphospholipid Syndrome balance sheet; blood test: (23Nov2021) biological inflammatory syndrome, notes: Biological inflammatory syndrome with a CRP at 113g / dL without hyperleukocytosis; no thrombocytopenia with platelets: 275G / L; computerised tomogram: (25Nov2021) effusion, notes: Right pleural effusion blade. Partial left pleural effusion of low abundance. Subcapsular hypodensic range of non-specific hepatic segment IV, to be rechecked or supplemented by MRI. Doubt about a thrombosis of the superficial and common femoral veins left, to be compared with an ultrasound. No other suspicious lesions detectable; c-reactive protein: (23Nov2021) 113 g/dl; platelet count: (23Nov2021) 275 x10 9/l; prostatic specific antigen: (26Nov2021) 0.43, notes: Normal; stool analysis: (26Nov2021) negative. Therapeutic measures were taken as a result of thrombophlebitis, deep vein thrombosis. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2004560 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Dizziness, Immunisation, Insomnia, Interchange of vaccine products, Malaise, Myalgia, Nausea, Off label use, Product use issue, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN CILEXETIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101823208

Write-up: Muscle pain; Fever; Generalised joint pain; Nausea/thought "I" would vomit; Insomnia; Feeling unwell; Weakness; Primary immunisation series: Any one dose AstraZeneca and another dose unknown manufacturer; Booster: COMIRNATY/COMIRNATY was administered on same day when INFLUENZA vaccine was administered; Primary immunisation series: Any one dose AstraZeneca and another dose unknown manufacturer; Booster: COMIRNATY; dose number 3; Fever chills; Injection site pain; INFLUENZA vaccine was administered on same day when COMIRNATY was administered; Dizzy; 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-202112171624461870-RIXNH. Other Case identifier(s): GB-MHRA-ADR 26353222. A female patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Batch/Lot number: unknown, expiration date unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: CANDESARTAN CILEXETIL taken for hypertension; INFLUENZA VIRUS taken for immunisation, administration date 24Nov2021. Vaccination history included: Covid 19 vaccine (DOSE NUMBER UNKNOWN, SINGLE; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine AstraZeneca (DOSE NUMBER UNKNOWN, SINGLE; Lot number: UNKNOWN; Route of administration: Unspecified.), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 24Nov2021, outcome "unknown", described as "Primary immunisation series: Any one dose AstraZeneca and another dose unknown manufacturer; Booster: COMIRNATY/COMIRNATY was administered on same day when INFLUENZA vaccine was administered"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Nov2021, outcome "unknown", described as "Primary immunisation series: Any one dose AstraZeneca and another dose unknown manufacturer; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "dose number 3"; PYREXIA (medically significant) with onset 24Nov2021, outcome "recovered" (26Nov2021), described as "Fever chills"; VACCINATION SITE PAIN (medically significant) with onset 24Nov2021, outcome "recovered" (27Nov2021), described as "Injection site pain"; MYALGIA (medically significant) with onset 25Nov2021, outcome "recovered" (27Nov2021), described as "Muscle pain"; PYREXIA (medically significant) with onset 25Nov2021, outcome "recovered" (26Nov2021), described as "Fever"; ARTHRALGIA (medically significant) with onset 25Nov2021, outcome "recovered" (27Nov2021), described as "Generalised joint pain"; NAUSEA (medically significant) with onset 25Nov2021, outcome "recovered" (26Nov2021), described as "Nausea/thought "I" would vomit"; INSOMNIA (medically significant) with onset 25Nov2021, outcome "recovered" (25Nov2021), described as "Insomnia"; MALAISE (medically significant) with onset 25Nov2021, outcome "recovered" (26Nov2021), described as "Feeling unwell"; ASTHENIA (medically significant) with onset 25Nov2021, outcome "recovered" (25Nov2021), described as "Weakness"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizzy"; PRODUCT USE ISSUE (non-serious) with onset 24Nov2021, outcome "unknown", described as "INFLUENZA vaccine was administered on same day when COMIRNATY was administered". Clinical course: Injection site pain came on within hours. Later that evening the chills set in. The patient was so cold that they had great difficulty in getting to sleep. The chills continued all of the next day. All of the above symptoms set in late afternoon and early evening and continued until the individual dates listed. The insomnia on the second night was sever. It took hours to get to sleep and then only in very short 40-to-60-minute periods. At 05:00 the patient had to rise as she thought she would vomit. The patient became very dizzy and had to lie of the floor until it passed. The patient did not get any more sleep. She felt so unwell and moving was such an effort. She lived alone; it was frightening for the patient. The patient had not been tested positive for COVID-19 since having the vaccine. Patient had no symptoms associated with COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: 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: 2004783 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-24
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Lymphadenopathy, Nasal congestion, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (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 INC202101821649

Write-up: Overactive sinus and overactive nose; Overactive sinus, resulting in cough and overactive nose; Gland in neck; 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-202112181133164930-HQPBQ (RA). Other Case identifier(s): GB-MHRA-ADR 26357462 (RA). A 62 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VIRUS, administration date 12Oct2021. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The following information was reported: LYMPHADENOPATHY (medically significant) with onset 24Nov2021, outcome "recovering", described as "Gland in neck"; NASAL CONGESTION (medically significant), outcome "unknown", described as "Overactive sinus and overactive nose"; COUGH (medically significant), outcome "unknown", described as "Overactive sinus, resulting in cough and overactive nose". The patient underwent the following laboratory tests and procedures: COVID-19 virus 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: 2006932 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-30
Onset:2021-11-24
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2022-01-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Dry mouth, Sleep disorder, Type 1 diabetes mellitus
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101835870

Write-up: Type 1 diabetes mellitus; Abdominal pain; Dry mouth; Sleep disorder; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: 681145 (TGA). A 12 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 30Oct2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: TYPE 1 DIABETES MELLITUS (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Type 1 diabetes mellitus"; ABDOMINAL PAIN (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Abdominal pain"; DRY MOUTH (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Dry mouth"; SLEEP DISORDER (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Sleep disorder". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2007471 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G044A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: FIPFIZER INC202101845376

Write-up: Menstruation prolonged; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Agency Regulatory Authority-WEB. Regulatory number: FI-FIMEA-20217939. A 16 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: 1G044A) 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 1, manufacturer unknown), for COVID-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (medically significant) with onset 24Nov2021 (reported also as 3 weeks after 2nd dose, for clarification), outcome "not recovered", described as "Menstruation prolonged". Prolonged vaginal bleeding starting 3 weeks after the 2nd dose is similar to normal menstruation. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2008159 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004730 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20214

Write-up: fatigue; Rillingen; headache; Injection site response; Koorts; Muscle pain; Feeling unwell; This case was received via Regulatory Authority (Reference number: BE-FAMHP-DHH-N2021-110053) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), CHILLS (Rillingen), HEADACHE (headache), INJECTION SITE REACTION (Injection site response), PYREXIA (Koorts), MYALGIA (Muscle pain) and MALAISE (Feeling unwell) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004730) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Comirnaty on 17-Feb-2021 and Comirnaty on 11-Mar-2021. Past adverse reactions to the above products included No adverse event with Comirnaty and Comirnaty. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced FATIGUE (fatigue) (seriousness criterion disability), CHILLS (Rillingen) (seriousness criterion disability), HEADACHE (headache) (seriousness criterion disability), INJECTION SITE REACTION (Injection site response) (seriousness criterion disability), PYREXIA (Koorts) (seriousness criterion disability), MYALGIA (Muscle pain) (seriousness criterion disability) and MALAISE (Feeling unwell) (seriousness criterion disability). On 26-Nov-2021, FATIGUE (fatigue), CHILLS (Rillingen), HEADACHE (headache), INJECTION SITE REACTION (Injection site response), PYREXIA (Koorts), MYALGIA (Muscle pain) and MALAISE (Feeling unwell) was resolving. Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter. The evolution of the ADR - Restorative. Company comment. This regulatory authority case concerns a 35 � year � old, female patient, with no reported relevant medical history, who experienced the unexpected serious events of myalgia, chills, fatigue, pyrexia, malaise, headache, and injection site reaction. The events myalgia, chills, fatigue, pyrexia, and headache are unexpected as they are retained as serious per the source document Authority reporting. The events occurred on the same day after the administration of one dose (unknown dosage) of mRNA-1273 vaccine, considered as third dose of COVID-19 vaccine schedule. The patient received previously two doses of Comirnaty COVID-19 vaccine. At the time of the report the outcome of the events was recovering. No medical assessment or treatment has been informed. The case was assessed as serious as per Regulatory Authority�s report due to disability, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reporter''s Comments: Treatment - No Evolution of the ADR - Restorative ADR description - Check the observed side effect (s). You can describe this update (s) in detail in the Description field of the update (s).; Sender''s Comments: This regulatory authority case concerns a 35 � year � old, female patient, with no reported relevant medical history, who experienced the unexpected serious events of myalgia, chills, fatigue, pyrexia, malaise, headache, and injection site reaction. The events myalgia, chills, fatigue, pyrexia, and headache are unexpected as they are retained as serious per the source document Authority reporting. The events occurred on the same day after the administration of one dose (unknown dosage) of mRNA-1273 vaccine, considered as third dose of COVID-19 vaccine schedule. The patient received previously two doses of Comirnaty COVID-19 vaccine. At the time of the report the outcome of the events was recovering. No medical assessment or treatment has been informed. The case was assessed as serious as per Regulatory Authority�s report due to disability, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2008254 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Chest discomfort, Erythema, Pruritus, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (narrow), 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? Yes
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: Clinical trial participant; Erythema; Skin disorder; Urticarial rash; Vasculitic rash; Comments: None of the above. No significant illnesses. Had Covid in March 2020 with persisting antibodies till December 2020 at least. Developed trunk vasculitic rash when sero converted at day 13-14 with original Covid infection. Persisting skin changes ever since. The urticarial rash was different, just red erythema on trunk and chest. Inconclusive test
Allergies:
Diagnostic Lab Data: Test Date: 2020; Test Name: antibodies; Result Unstructured Data: Test Result:persisting antibodies; Comments: till December 2020 at least; Test Date: 20200311; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive test
CDC Split Type: GBPFIZER INC202101837960

Write-up: Urticarial rash; red erythema; itch; tight chest feeling; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202112201908039410-8GK6D (MHRA). Other Case identifier(s): GB-MHRA-ADR 26366405 (MHRA). A 63 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: Fk0596) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Urticarial rash" (unspecified if ongoing); "Erythema" (unspecified if ongoing); "Suspected COVID-19", start date: 10Mar2020 (ongoing); "Clinical trial participant" (unspecified if ongoing); "trunk vasculitic rash " (unspecified if ongoing); "skin changes " (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: URTICARIA (medically significant) with onset 24Nov2021, outcome "recovered" (25Nov2021), described as "Urticarial rash"; ERYTHEMA (medically significant) with onset 24Nov2021, outcome "recovered" (25Nov2021), described as "red erythema"; PRURITUS (medically significant) with onset 24Nov2021, outcome "recovered" (25Nov2021), described as "itch"; CHEST DISCOMFORT (medically significant) with onset 24Nov2021, outcome "recovered" (25Nov2021), described as "tight chest feeling". The patient underwent the following laboratory tests and procedures: antibody test: (2020) persisting antibodies, notes: till December 2020 at least; sars-cov-2 test: (11Mar2020) inconclusive test. Additional information: No significant illnesses. Had Covid in March 2020 with persisting antibodies till December 2020 at least. Developed trunk vasculitic rash when sero converted at day 13-14 with original Covid infection. Persisting skin changes ever since. The urticarial rash was different, just red erythema on trunk and chest. Inconclusive test. Case narrative: The rash developed about 8 hours after the vaccination with extensive red erythema and itch and a tight chest feeling. Slept overnight and there was improvement the next day. Relevant investigations or tests conducted: no tests performed. Patient has not tested positive for COVID-19 since having the vaccine. Case reported as serious by health authority (other medically important condition). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2008591 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-24
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate increased, Palpitations, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; FEXOFENADINE
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.MOD20214

Write-up: heart racing; Heartbeats increased; Palpitations; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26372400) on 22-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing), PALPITATIONS (Palpitations) and HEART RATE INCREASED (Heartbeats increased) in a 58-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concomitant products included FEXOFENADINE for Hives, AMITRIPTYLINE from 20-Aug-2021 to an unknown date for Nerve pain. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criteria hospitalization and medically significant). On 27-Nov-2021, the patient experienced HEART RATE INCREASED (Heartbeats increased) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PALPITATIONS (heart racing) (seriousness criteria hospitalization and medically significant). At the time of the report, PALPITATIONS (heart racing), PALPITATIONS (Palpitations) and HEART RATE INCREASED (Heartbeats increased) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Lab data provided Heart rate between 150 and 165. Lab data Heart ultra sound scan, 48 hours ECG was performed on 27 Nov with unknown results. Palpitation for a few days then heart racing for over 12 hours and advised to go to A&E. Treatment medication were provided Digoxin to slow heart rate and still taking digoxin tablets although and heart has stayed at normal rate. Company comment: This is a regulatory case concerning a 58 year-old, female patient with concomitant use of amitriptyline, who experienced the serious (due to medically important condition and hospitalization) unexpected, according RA, events of palpitations (reported as Heart racing and Palpitations) and heart rate increased. The events palpitations (reported as Palpitations) and heart rate increased occurred approximately 9 to 12 days after the booster dose of mRNA-1273 vaccine and the event palpitations (reported as Heart racing) on an unknown date. The outcome of the events was reported as not recovered. The patient was prescribed digoxin and several studies were performed while in the emergency room but results were not provided. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The concomitant use of amitriptyline remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 58 year-old, female patient with concomitant use of amitriptyline, who experienced the serious (due to medically important condition and hospitalization) unexpected, according RA, events of palpitations (reported as Heart racing and Palpitations) and heart rate increased. The events palpitations (reported as Palpitations) and heart rate increased occurred approximately 9 to 12 days after the booster dose of mRNA-1273 vaccine and the event palpitations (reported as Heart racing) on an unknown date. The outcome of the events was reported as not recovered. The patient was prescribed digoxin and several studies were performed while in the emergency room but results were not provided. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The concomitant use of amitriptyline remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2008599 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; ASTRAZENECA COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Red rash; Hand rash; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26372984) on 22-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) and RASH (Hand rash) in a 60-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) for an unknown indication. On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced RASH (Hand rash) (seriousness criterion medically significant). On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant). At the time of the report, RASH ERYTHEMATOUS (Red rash) and RASH (Hand rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Unsure if patient has had symptoms associated with COVID-19. It was reported that, the red rash on both hands extended upto her forearms and the skin was red, cracked, peeling and very sore. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Patient showed her hands to a pharmacist, who suggested hydrocortisone cream, which helped a bit but not much. Compant comment:This RA case concerns a female patient of 60 years with medical history of Interchange of vaccine products (was with TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) on unknown dates before current vaccination), who experienced the unexpected serious events of Rash and Rash Erythematous. The event Rash occurred one day after the third dose of the mRNA-1273 vaccine and event Rash Erythematous occurred on unknown date after the third dose of the mRNA-1273 vaccine. The outcome of events was not recovered. The Interchange of vaccine products remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority �s report due to important medical condition.; Sender''s Comments: This RA case concerns a female patient of 60 years with medical history of Interchange of vaccine products (was with TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) on unknown dates before current vaccination), who experienced the unexpected serious events of Rash and Rash Erythematous. The event Rash occurred one day after the third dose of the mRNA-1273 vaccine and event Rash Erythematous occurred on unknown date after the third dose of the mRNA-1273 vaccine. The outcome of events was not recovered. The Interchange of vaccine products remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority �s report due to important medical condition.


VAERS ID: 2008958 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cough, Headache, Liver function test, Pyrexia, Respiratory disorder, SARS-CoV-2 test, Viral infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: Body temperature; Result Unstructured Data: Test Result:High; Test Date: 2021; Test Name: LFT; Test Result: Negative ; Test Date: 20211127; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: PCR
CDC Split Type: GBPFIZER INC202101852098

Write-up: High temperature; Viral infection; continuous cough; headaches; was prescribed steroids to help with my breathing during this illness; This is a spontaneous report received from a contactable consumer (patient) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112221143208290-06Q3P. Other Case identifier(s): GB-MHRA-ADR 26377668. A 49-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The following information was reported: VIRAL INFECTION (medically significant) with onset 24Nov2021, outcome "unknown", described as "Viral infection"; COUGH (medically significant) with onset 2021, outcome "not recovered", described as "continuous cough"; PYREXIA (medically significant) with onset 25Nov2021, outcome "not recovered", described as "High temperature"; HEADACHE (medically significant) with onset 2021, outcome "unknown", described as "headaches"; RESPIRATORY DISORDER (medically significant) with onset 2021, outcome "unknown", described as "was prescribed steroids to help with my breathing during this illness". The events "viral infection", "continuous cough", "high temperature", "headaches" and "was prescribed steroids to help with my breathing during this illness" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: (25Nov2021) high; liver function test (LFT): (2021) negative; COVID-19 virus test: (27Nov2021) no - negative covid-19 test, notes: PCR. Therapeutic measures were taken as a result of respiratory disorder, treatment included steroids. Clinical course: After 6 days she came down with an illness that resembled Covid. Continuous cough, headaches and temperature. Have tested negative PCR and LFT but was very ill for two weeks. She''s normally very healthy and haven''t been ill in 10 years. Doctor concluded viral infection. Patient was prescribed steroids to help with her breathing during this illness. Patient has not tested positive for COVID-19 since having the vaccine. Tested negative for Covid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2009172 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Back pain, Gait disturbance, Heavy menstrual bleeding, Immunisation, Interchange of vaccine products, Menstrual disorder, Off label use, Pain
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ENALAPRIL; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101852417

Write-up: backache; tummy cramps; pain; could hardly walk; dark red blood & lots of clots; Heavy periods; 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-202112222131210820-RUUXT. Other Case identifier(s): GB-MHRA-ADR 26381794. A 45 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: FL1939) as dose 3 (booster), single for covid-19 immunisation. Patient was not currently breastfeeding. Relevant medical history included: "Asthma" (unspecified if ongoing); "high BP" (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL taken for hypertension; SALBUTAMOL taken for asthma. Past drug history included: Salbutamol for asthma . Vaccination history included: Covid-19 vaccine (DOSE NUMBER 1, UNKNOWN MANUFACTURER), for COVID-19 immunization; Covid-19 vaccine (DOSE NUMBER 2, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 24Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "Booster"; BACK PAIN (medically significant), outcome "recovered", described as "backache"; ABDOMINAL PAIN UPPER (medically significant), outcome "recovered", described as "tummy cramps"; PAIN (medically significant), outcome "recovered", described as "pain"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 03Dec2021, outcome "recovered" (17Dec2021), described as "Heavy periods"; GAIT DISTURBANCE (medically significant), outcome "unknown", described as "could hardly walk"; MENSTRUAL DISORDER (medically significant), outcome "unknown", described as "dark red blood & lots of clots". Therapeutic measures were taken as a result of back pain, abdominal pain upper, pain, gait disturbance. The patient last menstrual period was on 08Dec2021. 5 days before her period was due, she had constant painful tummy cramps and backache which was not usual for her. It was so bad she could hardly walk and painkillers didn''t help with the pain. When her period came it was very, very heavy, dark red blood and lots of clots which again was unusual for her. The flow was so heavy she had to change tampons every 30 minutes and her period lasted 9 days (her period was 4 days). She was bedridden and she couldn''t go out as her flow was so very heavy. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2009739 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood gases, Brain natriuretic peptide, Computerised tomogram thorax, Echocardiogram, Fibrin D dimer, Immunisation, Oxygen saturation, PCO2, PO2, Pulmonary embolism, Troponin I, pH body fluid
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NORVASC; LIPIDIL; ATACAND PLUS; ATROVITA
Current Illness: Arterial hypertension; Dyslipidaemia; Non-smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: HCO3; Result Unstructured Data: Test Result:30; Test Name: ABGS flo2; Test Result: 21 %; Test Name: Pro BNP; Result Unstructured Data: Test Result:90; Test Date: 20211207; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:it showed pulmonary embolism bilaterally; Comments: on the subsectional branches of the lower lobes; Test Date: 20211124; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:PASP 25 and no other pathological finding; Test Date: 20211206; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:PASP 60; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:2243; Test Name: Saturation; Test Result: 96 %; Test Name: pCO2; Result Unstructured Data: Test Result:40; Test Name: pH; Result Unstructured Data: Test Result:7.47; Test Name: pO; Result Unstructured Data: Test Result:70; Test Name: Troponin I; Result Unstructured Data: Test Result:9.7
CDC Split Type: GRPFIZER INC202101828406

Write-up: Pulmonary embolism; Booster; This is a spontaneous report received from a contactable reporter (Physician) from the Regulatory Authority. Regulatory number: GR-GREOF-202109968 (Agency). A 80 year-old female patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Dyslipidaemia" (ongoing); "Arterial hypertension" (ongoing); "Non-smoker" (ongoing). Concomitant medications included: NORVASC taken for dyslipidaemia, hypertension; LIPIDIL taken for dyslipidaemia, hypertension; ATACAND PLUS taken for dyslipidaemia, hypertension; ATROVITA taken for dyslipidaemia, hypertension all at 1x1. 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, life threatening) with onset 24Nov2021, outcome "unknown", described as "Booster"; PULMONARY EMBOLISM (hospitalization, life threatening) with onset 04Dec2021, outcome "not recovered", described as "Pulmonary embolism". The patient was hospitalized for immunisation, pulmonary embolism (start date: Dec2021). The event "pulmonary embolism" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: echocardiogram: (24Nov2021) pulmonary arterial systolic pressure (PASP) 25 and no other pathological finding; (06Dec2021) PASP 60; computerised tomogram thorax: (07Dec2021) it showed pulmonary embolism bilaterally, notes: on the subsectional branches of the lower lobes; fibrin d dimer: (unspecified date) 2243; troponin i: (unspecified date) 9.7; brain natriuretic peptide: (unspecified date) 90; blood gases: (unspecified date) 21 %; po2: (unspecified date) 70; pco2: (unspecified date) 40; ph body fluid: (unspecified date) 7.47; blood bicarbonate: (unspecified date) 30; oxygen saturation: (unspecified date) 96 %. Clinical course: It was reported that the patient had a feeling of weight retrocisternally since 6 months ago. The symptom was evaluated by the treating internist and a cardiologist without findings. Because she reported this symtptom at the vaccination centre for the 3rd dose she was advised to see a cardiologist for confirmation. On 24Nov2021 she had a cardiac ultrasound with PASP 25 and without any other pathological finding. The third dose was approved and was given on the same day. 10 days later, on 04Dec2021 and 05Dec2021 the patient presented with dyspnoea and a feeling of weight and a cardiologist was called. In the new cardiac ultrasound on 06Dec2021 PASP 60 was found and in agreement with a pneumonologist CTPA (CT pulmonary angiogram) was performed on 07Dec2021 at a private health center. Pulmonary embolism was found bilaterally on the subsectional branches of the lower lobes and she was admitted at a hospital. She did not have other symptoms the last month. Without risk factors for pulmonary embolism except the age. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2009810 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-01
Onset:2021-11-24
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood pressure diastolic, Blood pressure increased, Blood pressure systolic, Heart rate increased, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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:
Current Illness: Exercise adequate (I play sports recreationally)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:90 mmHg; Test Date: 202111; Test Name: Blood pressure diastolic; Result Unstructured Data: Test Result:95 mmHg; Test Date: 202111; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:160 mmHg; Test Date: 202111; Test Name: Blood pressure systolic; Result Unstructured Data: Test Result:150 mmHg
CDC Split Type: HRPFIZER INC202101817339

Write-up: Arrhythmia; increased heart rate; increased pressure; increased pulse in rest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the RA. The reporter is the patient. Regulatory number: HR-HALMEDAPP-202111302023315650-59TAB (RA). Other Case identifier(s): HR-HALMED-300052740 (RA). A 32 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date Nov2021 (Lot number: FE6208) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Exercise adequate" (ongoing), notes: I play sports recreationally. The patient''s concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant) with onset 24Nov2021, outcome "unknown", described as "Arrhythmia"; PALPITATIONS (non-serious) with onset 24Nov2021, outcome "unknown", described as "increased heart rate"; BLOOD PRESSURE INCREASED (non-serious) with onset 24Nov2021, outcome "unknown", described as "increased pressure"; HEART RATE INCREASED (non-serious) with onset 24Nov2021, outcome "unknown", described as "increased pulse in rest". The patient underwent the following laboratory tests and procedures: blood pressure diastolic (60-89): (Nov2021) 90 mmHg; (Nov2021) 95 mmHg; blood pressure systolic (90-139): (Nov2021) 160 mmHg; (Nov2021) 150 mmHg. Clinical Course: Patient was discovered the reaction abot 10 days after the first dose of comirnaty vaccine. RA/Method was used for assessment and the result was possible. Patient reported that he had been without disease. He was healthy same was confirm by confirmed by Doctor. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2010934 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fall, Fibrin D dimer, Fibrin D dimer increased, Headache, Interchange of vaccine products, Malaise, Off label use, Type III immune complex mediated reaction, Vibratory sense increased, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Medication errors (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Dizziness; Falling; Feeling unwell; Headache; Monoclonal gammopathy; Product dose omission; Vibratory sense increased; Vomiting; Comments: The patient has suffered from COVID-19 in October 2020.
Allergies:
Diagnostic Lab Data: Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:abnormal
CDC Split Type: CZPFIZER INC202101875876

Write-up: VOMITTING; INNER VIBRATION; HEADACHE; ILL VALUES OF D DIMERS; FAULTY IMMUNITY REACTION; DIZZINESS; FALLING; PATIENT HAS RECEIVED COMIRNATY (PFIZER) INSTEAD OF VAXZEVRIA AS A SECOND DOSE (OFF LABEL USE); PATIENT HAS RECEIVED COMIRNATY (PFIZER) INSTEAD OF VAXZEVRIA AS A SECOND DOSE (INTERCHANGE OF VACCINE PRODUCTS); PATIENT HAS SPENT 1 MONTH IN BED/GENERALLY FEELING UNWELL; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Other Case identifier(s): CZ-AstraZeneca-2021A879205 (AstraZeneca). A 74 year-old female patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Batch/Lot number: unknown) as dose 2 (initial pfizer dose), single for covid-19 immunisation. Relevant medical history included: "Monoclonal gammopathy" (unspecified if ongoing); "COVID-19", start date: Oct2021 (unspecified if ongoing); "Vomiting", start date: Mar2021 (unspecified if ongoing); "Vibratory sense increased", start date: Mar2021 (unspecified if ongoing); "Headache", start date: Mar2021 (unspecified if ongoing); "Feeling unwell", start date: Mar2021, stop date: Mar2021; "Product dose omission", start date: 27May2021 (unspecified if ongoing); "Dizziness", start date: Mar2021 (unspecified if ongoing); "Falling", start date: Mar2021 (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Vaxzevria (Dose 1, Batch/lot number: ABV 5811, Route of Administration: Intramuscular), administration date: 04Mar2021. The following information was reported: TYPE III IMMUNE COMPLEX MEDIATED REACTION (medically significant), outcome "unknown", described as "FAULTY IMMUNITY REACTION"; OFF LABEL USE (non-serious) with onset 24Nov2021, outcome "unknown", described as "PATIENT HAS RECEIVED COMIRNATY (PFIZER) INSTEAD OF VAXZEVRIA AS A SECOND DOSE (OFF LABEL USE)"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 24Nov2021, outcome "unknown", described as "PATIENT HAS RECEIVED COMIRNATY (PFIZER) INSTEAD OF VAXZEVRIA AS A SECOND DOSE (INTERCHANGE OF VACCINE PRODUCTS)"; VOMITING (non-serious), outcome "unknown", described as "VOMITTING"; VIBRATORY SENSE INCREASED (non-serious), outcome "not recovered", described as "INNER VIBRATION"; HEADACHE (non-serious), outcome "not recovered", described as "HEADACHE"; FIBRIN D DIMER INCREASED (non-serious), outcome "unknown", described as "ILL VALUES OF D DIMERS"; MALAISE (non-serious), outcome "recovered" (Mar2021), described as "PATIENT HAS SPENT 1 MONTH IN BED/GENERALLY FEELING UNWELL"; DIZZINESS (non-serious), outcome "unknown", described as "DIZZINESS"; FALL (non-serious), outcome "unknown", described as "FALLING". The patient underwent the following laboratory tests and procedures: fibrin d dimer: abnormal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2011847 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Gait disturbance, Off label use, Pain, Product use issue, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101847349

Write-up: painful on waist; walking up the stairs was excruciating; Back pain; Off label use; Drug use in unapproved population; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP) from the Regulatory Authority (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112220707030620-SXQOH (MHRA). Other Case identifier: GB-MHRA-ADR 26375970 (MHRA). A 38-year-old female patient (not pregnant) received BNT162B2 (COMIRNATY), administration date 24Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing). Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The following information was reported: BACK PAIN (medically significant) with onset 02Dec2021, outcome "not recovered", described as "Back pain"; PAIN (medically significant), outcome "unknown", described as "painful on waist"; GAIT DISTURBANCE (medically significant), outcome "unknown", described as "walking up the stairs was excruciating"; OFF LABEL USE (non-serious) with onset 24Nov2021, outcome "unknown", described as "Off label use"; PRODUCT USE ISSUE (non-serious) with onset 24Nov2021, outcome "unknown", described as "Drug use in unapproved population". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of back pain, pain included massage. Clinical course: patient had severe back pain, which she had never experienced; walking up the stairs was excruciating. Sitting to drive can be difficult. Patient now found it hard to drive manual cars. Just rotating left to right on the bed can be painful on waist, but when she touched to massage, she was unable to isolate, but it''s deeply rooted the pain. 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: 2011888 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Immunisation, Interchange of vaccine products, Loss of personal independence in daily activities, Magnetic resonance imaging, Off label use, SARS-CoV-2 test, Suicidal ideation, Tremor
SMQs:, Suicide/self-injury (narrow), Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Full bloods; Result Unstructured Data: Test Result:Unknown result; Test Name: MRI; Result Unstructured Data: Test Result:Unknown result; Test Date: 20211220; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101851776

Write-up: It is LIFE CHANGING and has made me feel suicidal; Tremor/Severe Chronic debilitating internal and external tremors of whole body; Leave me unable to work, hold items, write, type adequately, function other than very basic tasks; 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-202112221103400580-SKTXL. Other Case identifier(s): GB-MHRA-ADR 26377351. A 51 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 24Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 24Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 24Nov2021, outcome "unknown", described as "Booster"; TREMOR (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 26Nov2021, outcome "not recovered", described as "Tremor/Severe Chronic debilitating internal and external tremors of whole body"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (caused and prolonged hospitalization, disability, medically significant, life threatening) with onset 26Nov2021, outcome "unknown", described as "Leave me unable to work, hold items, write, type adequately, function other than very basic tasks"; SUICIDAL IDEATION (hospitalization, medically significant, life threatening) with onset 2021, outcome "unknown", described as "It is LIFE CHANGING and has made me feel suicidal". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) unknown result; magnetic resonance imaging: (unspecified date) unknown result; sars-cov-2 test: (20Dec2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of tremor, loss of personal independence in daily activities included benzodiazepines treatment. Additional Information: Patient has not had symptoms associated with COVID-19. Severe Chronic debilitating internal and external tremors of whole body (akin to Parkinson''s) Leave me unable to work, hold items, write, type adequately, function other than very basic tasks. Have been prescribed Benzodiazepines by Consultant Neurologist at [hospital name] following confirmation diagnosis this HAS been caused by the Pfizer booster, no one knows if this is temporary or permanent. It is LIFE CHANGING and has made me feel suicidal. It is destroying my life. If I had known this I would not have taken the vaccine. We are not as a family ever taking another vaccine again. The seriousness of this booster MUST be considered. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2012702 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-11-24
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest discomfort, Fatigue, Gait disturbance, Headache, Hypoaesthesia, Hypoaesthesia oral, Limb discomfort, Muscle spasms, Musculoskeletal stiffness, Myalgia, Palpitations, Paraesthesia, Skin burning sensation, Somnolence, Vascular rupture
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202101857257

Write-up: skin burning; pins at legs; muscle pain; feeling of heaviness; inability to walk; pain in head; weight on chest; feeling palpitations; cramps; feeling of weakness; fatigue; sleepiness; feeling of stifness; numbness of lips; broken veins in leg; Numbness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 38 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 22Jun2021 20:00 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VASCULAR RUPTURE (medically significant) with onset 25Nov2021, outcome "recovered" (2022), described as "broken veins in leg"; HYPOAESTHESIA (non-serious) with onset 24Nov2021, outcome "recovered" (2022), described as "Numbness"; SKIN BURNING SENSATION (non-serious) with onset 25Nov2021, outcome "recovered" (2022), described as "skin burning"; PARAESTHESIA (non-serious) with onset 25Nov2021, outcome "recovered" (2022), described as "pins at legs"; MYALGIA (non-serious) with onset 25Nov2021, outcome "recovered" (2022), described as "muscle pain"; LIMB DISCOMFORT (non-serious) with onset 25Nov2021, outcome "recovered" (2022), described as "feeling of heaviness"; GAIT DISTURBANCE (non-serious) with onset 25Nov2021, outcome "recovered" (2022), described as "inability to walk"; HEADACHE (non-serious) with onset 25Nov2021, outcome "recovered" (2022), described as "pain in head"; CHEST DISCOMFORT (non-serious) with onset 25Nov2021, outcome "recovered" (2022), described as "weight on chest"; PALPITATIONS (non-serious) with onset 25Nov2021, outcome "recovered" (2022), described as "feeling palpitations"; MUSCLE SPASMS (non-serious) with onset 25Nov2021, outcome "recovered" (2022), described as "cramps"; ASTHENIA (non-serious) with onset 25Nov2021, outcome "recovered" (2022), described as "feeling of weakness"; FATIGUE (non-serious) with onset 25Nov2021, outcome "recovered" (2022), described as "fatigue"; SOMNOLENCE (non-serious) with onset 25Nov2021, outcome "recovered" (2022), described as "sleepiness"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 25Nov2021, outcome "recovered" (2022), described as "feeling of stifness"; HYPOAESTHESIA ORAL (non-serious) with onset 25Nov2021, outcome "recovered" (2022), described as "numbness of lips". The events "broken veins in leg", "numbness", "skin burning", "pins at legs", "muscle pain", "feeling of heaviness", "inability to walk", "pain in head", "weight on chest", "feeling palpitations", "cramps", "feeling of weakness", "fatigue", "sleepiness", "feeling of stifness" and "numbness of lips" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of vascular rupture, hypoaesthesia, skin burning sensation, paraesthesia, myalgia, limb discomfort, gait disturbance, headache, chest discomfort, palpitations, muscle spasms, asthenia, fatigue, somnolence, musculoskeletal stiffness, hypoaesthesia oral. Clinical information: Patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No other medications was received within 2 weeks of vaccination. patient was not diagnosed with COVID-19 and patient was not tested for covid-19. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event vascular rupture cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 2012703 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-24
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Pulmonary thrombosis, Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GTPFIZER INC202101718358

Write-up: thrombosis on my right leg and both lungs; thrombosis on my right leg and both lungs; 3rd shoot of the vaccine; This case has been considered Invalid as ICH-Unspecified Product. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient. A 55 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (2nd dose, MANUFACTURER UNKNOWN), for Covid-19 immunisation; Covid-19 vaccine (1st dose, MANUFACTURER UNKNOWN), for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "3rd shoot of the vaccine"; PULMONARY THROMBOSIS (hospitalization, medically significant), VENOUS THROMBOSIS LIMB (hospitalization, medically significant) all with onset 24Nov2021, outcome "not recovered" and all described as "thrombosis on my right leg and both lungs". The event "thrombosis on my right leg and both lungs" and "thrombosis on my right leg and both lungs" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of pulmonary thrombosis, venous thrombosis limb. Follow-up (28Dec2021): This is a spontaneous follow-up report received from the same contactable consumer. Updated information included: information of patient, suspect product, historical vaccines, event details (outcome, treatment) clinical course, causality assessment, new event of Booster The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2012796 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Dizziness, Hypertension, Immunisation, Interchange of vaccine products, Off label use, Pallor, Tachycardia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101845746

Write-up: off label use; Interchange of vaccine products; booster; PALE; CLAMMY; TACHYCARDIA; HYPERTENSION; VOMITTING; DIZZY; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority. Regulatory number: IE-HPRA-2021-088401 (Regulatory Authority). Other Case identifier(s): IE-HPRA-CVARR2021121523292 (Regulatory Authority). A 54 year-old female patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: FH0114) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1: MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2: MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability) with onset 24Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 24Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 24Nov2021, outcome "unknown", described as "booster"; PALLOR (disability) with onset 24Nov2021, outcome "recovered" (2021), described as "PALE"; COLD SWEAT (disability) with onset 24Nov2021, outcome "recovered" (2021), described as "CLAMMY"; TACHYCARDIA (disability) with onset 24Nov2021, outcome "recovered" (2021), described as "TACHYCARDIA"; HYPERTENSION (disability) with onset 24Nov2021, outcome "recovered" (2021), described as "HYPERTENSION"; VOMITING (disability) with onset 24Nov2021, outcome "recovered" (2021), described as "VOMITTING"; DIZZINESS (disability) with onset 24Nov2021, outcome "recovered" (2021), described as "DIZZY". Time interval between beginning of drug administration and start of events Tachycardia and Hypertension was reported as 15 min. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2012939 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Facial pain, Fatigue, Hypoaesthesia, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine; Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine; Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine; Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine; Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine; Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine; Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-818253) on 22-Dec-2021 and was forwarded to Moderna on 22-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine), FATIGUE (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine), ARTHRALGIA (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine), PARAESTHESIA (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine), FACIAL PAIN (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine), PAIN IN EXTREMITY (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine) and ASTHENIA (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 vaccination. No Medical History information was reported. On 22-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Nov-2021, the patient experienced HYPOAESTHESIA (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine) (seriousness criterion disability), FATIGUE (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine) (seriousness criterion disability), ARTHRALGIA (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine) (seriousness criterion disability), PARAESTHESIA (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine) (seriousness criterion disability), FACIAL PAIN (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine) (seriousness criterion disability), PAIN IN EXTREMITY (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine) (seriousness criterion disability) and ASTHENIA (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine) (seriousness criterion disability). At the time of the report, HYPOAESTHESIA (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine), FATIGUE (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine), ARTHRALGIA (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine), PARAESTHESIA (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine), FACIAL PAIN (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine), PAIN IN EXTREMITY (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine) and ASTHENIA (Tingling, numbness, and pain in the face and shoulder and arm, with fatigue and loss of arm strength appeared three days after administration anticovid moderna vaccine) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Patient was allergic to Augmentin and some foods. No concomitant medications were provided by reporter. No treatment medications were provided. Company comment. This regulatory authority case concerns a 48 � year � old, female patient, with no reported relevant medical history, who experienced the unexpected serious events of hypoaesthesia, fatigue, arthralgia, paraesthesia, facial pain, pain in extremity, and asthenia. The events fatigue and arthralgia are unexpected as they are retained as serious per the source document Authority reporting. The events occurred two days after a dose of mRNA-1273. At the time of the report the outcome of the events was not recovered. No medical assessment or treatment has been informed. The case was assessed as serious as per Regulatory Authority�s report due to disability, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity and the reporter states it is more appropriate to enter ''other clinically relevant condition as serious criteria. The benefit-risk relationship of mRNA-1273 is not affected by this report. Allergies to Augmentin and Some Foods; Reporter''s Comments: The referrer has entered as a severity criterion ''serious or permanent disability'' but after assessment of the case and comparison with the detector it is more appropriate to enter ''other clinically relevant condition'' than we will update after transition to RNF; Sender''s Comments: This regulatory authority case concerns a 48 � year � old, female patient, with no reported relevant medical history, who experienced the unexpected serious events of hypoaesthesia, fatigue, arthralgia, paraesthesia, facial pain, pain in extremity, and asthenia. The events fatigue and arthralgia are unexpected as they are retained as serious per the source document Authority reporting. The events occurred two days after a dose of mRNA-1273. At the time of the report the outcome of the events was not recovered. No medical assessment or treatment has been informed. The case was assessed as serious as per Regulatory Authority�s report due to disability, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity and the reporter states it is more appropriate to enter ''other clinically relevant condition as serious criteria. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2012952 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 349283017 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dyspnoea, Nausea, Pyrexia, Tachycardia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Ageusia, Anosmia, Extreme Asthenia, Fever, Breathing Difficulty with slight crackles at the bottom of the lung); Neutralising antibodies (Quantitative Dosage Total Antibodies Anti-Sars Cov2 (IgG+ IgM + IgA) Anti - RBD Protein Spike S1); Neutralizing antibodies (Quantitative Dosage Total Antibodies Anti-Sars Cov2 (IgG+ IgM + IgA) Anti - RBD Protein Spike S1)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.; Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.; Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.; Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.; Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-819436) on 24-Dec-2021 and was forwarded to Moderna on 24-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of TACHYCARDIA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.), DYSPNOEA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.), ASTHENIA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.), NAUSEA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.) and PYREXIA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.) in a 60-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 349283017) for COVID-19 vaccination. The patient''s past medical history included Neutralising antibodies (Quantitative Dosage Total Antibodies Anti-Sars Cov2 (IgG+ IgM + IgA) Anti - RBD Protein Spike S1) on 28-Apr-2021, Neutralizing antibodies (Quantitative Dosage Total Antibodies Anti-Sars Cov2 (IgG+ IgM + IgA) Anti - RBD Protein Spike S1) on 06-Oct-2021 and COVID-19 (Ageusia, Anosmia, Extreme Asthenia, Fever, Breathing Difficulty with slight crackles at the bottom of the lung) on 18-Mar-2021. On 24-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 24-Nov-2021, the patient experienced TACHYCARDIA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.) (seriousness criterion hospitalization), DYSPNOEA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.) (seriousness criterion hospitalization), ASTHENIA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.) (seriousness criterion hospitalization), NAUSEA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.) (seriousness criterion hospitalization) and PYREXIA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.) (seriousness criterion hospitalization). At the time of the report, TACHYCARDIA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.), DYSPNOEA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.), ASTHENIA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.), NAUSEA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.) and PYREXIA (Nausea, tachycardia, dyspnoea, fever and asthenia after first dose administration of anticovid vaccine in person previously infected with covid and still with high antibody titre.) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported . Treatment information was not provided. Company Comment: This case concerns a 60 year-old female patient with a history of COVID-19 in March 2021 and anti-SARS CoV2 neutralizing antibodies in April and October 2021 who experienced the unexpected serious events of tachycardia, dyspnea, asthenia, nausea, and pyrexia which occurred on the same day after vaccination with mRNA-1273 vaccine. The medical history of COVID-19 and the use of concomitant medication anti-SARS CoV2 neutralizing antibodies remain confounders for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2021: Follow up information received on 27-DEC-2021. Medical History was added.; Sender''s Comments: This case concerns a 60 year-old female patient with a history of COVID-19 in March 2021 and anti-SARS CoV2 neutralizing antibodies in April and October 2021 who experienced the unexpected serious events of tachycardia, dyspnea, asthenia, nausea, and pyrexia which occurred on the same day after vaccination with mRNA-1273 vaccine. The medical history of COVID-19 and the use of concomitant medication anti-SARS CoV2 neutralizing antibodies remain confounders for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2013000 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-20
Onset:2021-11-24
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006322 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Gait inability, Myocarditis, Rash macular
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: Red spots on hands and feet, inability to walk and move his right hand due to pain, the analysis did not result in any virus, but touched the heart creating myocarditis; Red spots on hands and feet, inability to walk and move his right hand due to pain, the analysis did not result in any virus, but touched the heart creating myocarditis; Red spots on hands and feet, inability to walk and move his right hand due to pain, the analysis did not result in any virus, but touched the heart creating myocarditis; This case was received via Regulatory authority. This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS (Red spots on hands and feet, inability to walk and move his right hand due to pain, the analysis did not result in any virus, but touched the heart creating myocarditis) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3006322) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Oct-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Nov-2021, the patient experienced MYOCARDITIS (Red spots on hands and feet, inability to walk and move his right hand due to pain, the analysis did not result in any virus, but touched the heart creating myocarditis) (seriousness criterion medically significant), RASH MACULAR (Red spots on hands and feet, inability to walk and move his right hand due to pain, the analysis did not result in any virus, but touched the heart creating myocarditis) and GAIT INABILITY (Red spots on hands and feet, inability to walk and move his right hand due to pain, the analysis did not result in any virus, but touched the heart creating myocarditis). At the time of the report, MYOCARDITIS (Red spots on hands and feet, inability to walk and move his right hand due to pain, the analysis did not result in any virus, but touched the heart creating myocarditis), RASH MACULAR (Red spots on hands and feet, inability to walk and move his right hand due to pain, the analysis did not result in any virus, but touched the heart creating myocarditis) and GAIT INABILITY (Red spots on hands and feet, inability to walk and move his right hand due to pain, the analysis did not result in any virus, but touched the heart creating myocarditis) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant products were not provided. Treatment medication were not reported.; Reporter''s Comments: Psoriasis; Sender''s Comments: This is a regulatory case concerning a 29-year-old male patient with no medical history reported, who experienced the expected serious event of Myocarditis, with the unexpected events of Rash macular and Gait inability(seriousness criterion medically significant). These events occurred approximately 1 month after the patient received dose of mRNA-1273 (Spikevax). The rechallenge was unknown since there''s only information about one dose.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2013023 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214014 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Burning sensation, Pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrodesis (Spine arthrodesis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain; Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain; Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain; Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain; This case was received via regulatory authority (Reference number: MOC20211227000182) on 27-Dec-2021 and was forwarded to Moderna on 27-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BURNING SENSATION (Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain), BACK PAIN (Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain), PAIN (Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain) and PRURITUS (Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214014) for COVID-19 vaccination. The patient''s past medical history included Arthrodesis (Spine arthrodesis). Previously administered products included for COVID-19 vaccination: SPIKEVAX (EX COVID-19 VACCINE MODERNA) (MODERNA BIOTECH SPAIN and S.L.) (J07BX03) on 23-Oct-2021. Past adverse reactions to the above products included No adverse event with SPIKEVAX (EX COVID-19 VACCINE MODERNA) (MODERNA BIOTECH SPAIN and S.L.) (J07BX03). On 24-Nov-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 ml. On 24-Nov-2021, the patient experienced BURNING SENSATION (Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain) (seriousness criterion congenital anomaly), BACK PAIN (Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain) (seriousness criterion congenital anomaly), PAIN (Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain) (seriousness criterion congenital anomaly) and PRURITUS (Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain) (seriousness criterion congenital anomaly). At the time of the report, BURNING SENSATION (Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain), BACK PAIN (Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain), PAIN (Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain) and PRURITUS (Even with 2 Moderna vaccine great shoulder pain in the middle back as burning as I had pins like the first time do not pass. Itching, very strong pain) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No Concomitant medications were reported Patient reported that it was already happened with the dose 1 and dose 2 same sharp pains that radiate to the shoulder blade and middle back do not pass by saying that he the bearer of bar to the spine for scoliosis surgery, and of not having done any movement after the dose but rather stayed at rest, as if he had a great burning of the pins at each movement of arms, unable to perform normal activities anymore and with great fear of feeling pain. Patient visited neurosurgery. Patient received diazepan at night to sleep. Company Comment: This case concerns a 51-year-old female patient with previous relevant medical history of Spine arthrodesis, who experienced the serious unexpected events of Burning sensation, Back pain, Pain and Pruritus. The events occurred on the same day after a dose of COVID-19 Vaccine Moderna (mRNA-1273). Medical history of Spine arthrodesis could remain a confounder for back pain. Events seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Dec-2021: Follow up added Events and historical vaccine updated. On 29-Dec-2021: Follow up received on 29-Dec-2021 and conatins medical history Updated.; Reporter''s Comments: The signaling was referred to as Severe - congenital anomalies by the signaller, as it seemed to be the most suitable choice as a criterion of severity, considered to be a SERIOUS reaction for him. It could be referred to as a serious- other clinically relevant condition.; Sender''s Comments: .This case concerns a 51-year-old female patient with previous relevant medical history of Spine arthrodesis, who experienced the serious unexpected events of Burning sensation, Back pain, Pain and Pruritus. The events occurred on the same day after a dose of COVID-19 Vaccine Moderna (mRNA-1273). Medical history of Spine arthrodesis could remain a confounder for back pain. Events seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 2013306 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-05
Onset:2021-11-24
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anti-thyroid antibody, Basedow's disease, Blood thyroid stimulating hormone, Body temperature, Hyperhidrosis, Hyperthyroidism, Thyroxine free, Tremor, Tri-iodothyronine free, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Hypothyroidism (broad), Hyperthyroidism (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211129; Test Name: TSH receptor antibody (reported as TRAb); Result Unstructured Data: Test Result:9.8 IU/l; Test Date: 20211124; Test Name: thyroid stimulating hormone (reported as TSH); Result Unstructured Data: Test Result:below 0.005; Test Date: 20211129; Test Name: thyroid stimulating hormone (reported as TSH); Result Unstructured Data: Test Result:below 0.01; Test Date: 20211105; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20211124; Test Name: Free thyroxine (reported as FT4); Result Unstructured Data: Test Result:over 7.77; Test Date: 20211129; Test Name: Free thyroxine (reported as FT4); Result Unstructured Data: Test Result:3.33; Test Date: 20211129; Test Name: free triiodothyronine (reported as FT3); Result Unstructured Data: Test Result:over 20
CDC Split Type: JPPFIZER INC202101864377

Write-up: Basedow''s disease / TSH below 0.01, free triiodothyronine (reported as FT3) over 20, FT4 3.33, TSH receptor antibody (reported as TRAb) 9.8 IU/L; Hyperthyroidism / Free thyroxine (reported as FT4) over 7.77, thyroid stimulating hormone (reported as TSH) below 0.005; Weight decreased; Excess sweating; Shaking of hands; This is a spontaneous report received from a contactable reporter(s) (Physician) from The Regulatory Authority . Regulatory number: v21132445 (PMDA). A 27 year-8-month-old female patient received bnt162b2 (COMIRNATY), administration date 05Nov2021 (Batch/Lot number: unknown) (the day of vaccination) at the age of 27 year-8-month-old as dose 1, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The 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) was unclear. Body temperature before vaccination was 36.6 degrees Centigrade on 05Nov2021. The following information was reported: BASEDOW''S DISEASE (medically significant) with onset 24Nov2021, outcome "recovering", described as "Basedow''s disease / TSH below 0.01, free triiodothyronine (reported as FT3) over 20, FT4 3.33, TSH receptor antibody (reported as TRAb) 9.8 IU/L"; HYPERTHYROIDISM (medically significant) with onset 24Nov2021, outcome "recovering", described as "Hyperthyroidism / Free thyroxine (reported as FT4) over 7.77, thyroid stimulating hormone (reported as TSH) below 0.005"; WEIGHT DECREASED (non-serious) with onset 24Nov2021, outcome "recovering", described as "Weight decreased"; HYPERHIDROSIS (non-serious) with onset 24Nov2021, outcome "recovering", described as "Excess sweating"; TREMOR (non-serious) with onset 24Nov2021, outcome "recovering", described as "Shaking of hands". The events "basedow''s disease / tsh below 0.01, free triiodothyronine (reported as ft3) over 20, ft4 3.33, tsh receptor antibody (reported as trab) 9.8 iu/l", "hyperthyroidism / free thyroxine (reported as ft4) over 7.77, thyroid stimulating hormone (reported as tsh) below 0.005", "weight decreased", "excess sweating" and "shaking of hands" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: anti-thyroid antibody: (29Nov2021) 9.8 IU/l; blood thyroid stimulating hormone: (24Nov2021) below 0.005; (29Nov2021) below 0.01; body temperature: (05Nov2021) 36.6 Centigrade, notes: before vaccination; thyroxine free: (24Nov2021) over 7.77; (29Nov2021) 3.33; tri-iodothyronine free: (29Nov2021) over 20. On 24Nov2021 (19 days after the vaccination), the patient experienced Hyperthyroidism (Basedow''s disease)(as reported). The course of the event was as follows: On 05Nov2021, the patient received the vaccine. Due to the Weight decreased, Excess sweating, Shaking of hands, on 24Nov2021, the patient went to consult. The patient was considered as Hyperthyroidism based on Free thyroxine (reported as FT4) over 7.77, thyroid stimulating hormone (reported as TSH) below 0.005, and was referral consultation to the same hospital. On29Nov2021, the patient was diagnosed as Basedow''s disease based on TSH below 0.01, free triiodothyronine (reported as FT3) over 20, FT4 3.33, TSH receptor antibody (reported as TRAb) 9.8 IU/L. On 27Dec2021 (1month and 3 days after the vaccination), the outcome of the event was recovering. The reporting physician classified the event as non-serious and assessed the causality between the event and BNT162b2 as unassessable. The reporting physician commented as follows: the causality between the event and BNT162b2 was unknown, but it could not be denied. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.


VAERS ID: 2013538 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4219 / 3 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Decreased appetite, Dizziness, Dysphonia, Gait disturbance, Guillain-Barre syndrome, Headache, Immunisation, Magnetic resonance imaging head, Musculoskeletal stiffness, Myalgia, Neurological examination, Pain in extremity, Pyrexia, Vaccination site pain, Visual impairment, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Demyelination (narrow), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: MRI brain; Result Unstructured Data: Test Result:No signs of new pathology; Comments: MRI of brain and column; Test Date: 2021; Test Name: Neurological examination; Result Unstructured Data: Test Result:Extinguished reflexes in his legs; Comments: and increased sensibility to needle-prick distal for Th10-11 on the truncus. As the patient was in spontaneous recovery it was decided that spinal puncture and neurography should not be done.
CDC Split Type: NOPFIZER INC202101845623

Write-up: headache; possibly some hoarseness; weakness in the legs; Thoracic pain; dizziness; GUILLAIN BARRE SYNDROME (SUSPICION OF A MILD GBS-RESEMBLING CONDITION, BUT THIS IS NOT OBJECTIVELY VERIFIED); MUSCLE STIFFNESS; Vomiting; VISUAL DISTURBANCE (OBSCURATION WHEN TRYING TO STAND UP); APPETITE IMPAIRED/he ate and drank minimally; PAIN IN LEG; Booster; VACCINATION SITE PAIN; GENERALIZED MUSCLE ACHES; FEVER; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency WEB. Regulatory number: NO-NOMAADVRE-FHI-2021-Uwzjnm (RA). Other Case identifier(s): NO-NOMAADVRE-E2B_00065265 (RA). A 75 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 24Nov2021 12:00 (Lot number: FH4219) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose; batch/lot number: EW8904), administration date: 06Apr2021, for COVID-19 immunisation; Comirnaty (2nd dose; batch/lot number: EX6564), administration date: 18May2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 24Nov2021, outcome "unknown", described as "Booster"; HEADACHE (hospitalization) with onset 27Nov2021, outcome "recovering", described as "headache"; DYSPHONIA (hospitalization) with onset 27Nov2021, outcome "recovering", described as "possibly some hoarseness"; GAIT DISTURBANCE (hospitalization) with onset 27Nov2021, outcome "recovering", described as "weakness in the legs"; CHEST PAIN (hospitalization) with onset 27Nov2021, outcome "recovering", described as "Thoracic pain"; DIZZINESS (hospitalization) with onset 27Nov2021, outcome "recovering", described as "dizziness"; GUILLAIN-BARRE SYNDROME (hospitalization) with onset 27Nov2021, outcome "recovering", described as "GUILLAIN BARRE SYNDROME (SUSPICION OF A MILD GBS-RESEMBLING CONDITION, BUT THIS IS NOT OBJECTIVELY VERIFIED)"; MUSCULOSKELETAL STIFFNESS (hospitalization) with onset 27Nov2021, outcome "recovering", described as "MUSCLE STIFFNESS"; VOMITING (hospitalization) with onset 27Nov2021, outcome "recovered" (27Nov2021), described as "Vomiting"; VISUAL IMPAIRMENT (hospitalization) with onset 27Nov2021, outcome "recovering", described as "VISUAL DISTURBANCE (OBSCURATION WHEN TRYING TO STAND UP)"; DECREASED APPETITE (hospitalization) with onset 27Nov2021, outcome "recovering", described as "APPETITE IMPAIRED/he ate and drank minimally"; PAIN IN EXTREMITY (hospitalization) with onset 27Nov2021, outcome "recovering", described as "PAIN IN LEG"; VACCINATION SITE PAIN (non-serious) with onset 25Nov2021, outcome "recovered" (2021), described as "VACCINATION SITE PAIN"; MYALGIA (non-serious) with onset 25Nov2021, outcome "recovering", described as "GENERALIZED MUSCLE ACHES"; PYREXIA (non-serious) with onset 25Nov2021, outcome "recovered" (2021), described as "FEVER". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging head: (2021) no signs of new pathology, notes: MRI of brain and column; neurological examination: (2021) extinguished reflexes in his legs, notes: and increased sensibility to needle-prick distal for Th10-11 on the truncus. As the patient was in spontaneous recovery it was decided that spinal puncture and neurography should not be done. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : NO-PFIZER INC-202101884968 same patient and vaccine, different doses and events


VAERS ID: 2015187 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101874696

Write-up: Facial palsy; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Party.Other Case identifier(s):111783(Biontech) A male patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1 (batch unknown)), for COVID-19 immunisation; Comirnaty (dose 2 (batch unknown)), for COVID-19 immunisation. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 16Dec2021, outcome "not recovered", described as "Facial palsy"; IMMUNISATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "Booster". The event "facial palsy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of facial paralysis. On 24Nov2021 patient received the 3rd corona vaccination from Biontech at the PRIVACY. On 16Dec2021 Patient suffered left facial palsy which severely restricted him.Since 18Dec2021 Patient have been receiving treatment in neurology, eye clinics and ENT of the PRIVACY, so far without improvement. The lot number for bnt162b2 was not provided and will be requested during follow up. [Comirnaty] is under agreement with [Biontech]


VAERS ID: 2015247 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRP9 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Immunisation, Palpitations, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101865487

Write-up: Lung embolism; Dyspnoea; Palpitations; Booster; This is a spontaneous report received from a non-contactable reporter (Physician) from the Regulatory Authority-WEB. Regulatory number: DE-DCGMA-21195424 (RA). Other Case identifier: DE-PEI-202100284279 (RA). An 84-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 24Nov2021 (Lot number: SCRP9) at the age of 84 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: COMIRNATY (DOSE 1), administration date: 25Mar2021, when the patient was 84 years old, for COVID-19 immunisation; COMIRNATY (DOSE 2), administration date: 15Apr2021, when the patient was 84 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant, life threatening) with onset 24Nov2021, outcome "unknown", described as "Booster"; PULMONARY EMBOLISM (medically significant, life threatening) with onset 03Dec2021, outcome "not recovered", described as "Lung embolism"; DYSPNOEA (life threatening) with onset 03Dec2021, outcome "not recovered", described as "Dyspnoea"; PALPITATIONS (life threatening) with onset 03Dec2021, outcome "not recovered", described as "Palpitations". Clinical course: The causal relationship of COMIRNATY and all events assessed as D. Unclassifiable by the RA. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015673 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G047A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Echocardiogram, Electrocardiogram
SMQs:, Supraventricular tachyarrhythmias (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APROVEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral vascular disturbance; Hypertension arterial (High blood pressure); Ischaemic heart disease; Non-insulin-dependent diabetes mellitus; Overweight; Penicillin allergy; Tabaquism (Severe 10 years ago)
Allergies:
Diagnostic Lab Data: Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:Left ventricular ejection fraction: 60% in biplane; Comments: minimal mitral insufficiency, low left ventricle filling pressures, the rest without abnormalities.; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Atrial fibrillation bursts under inputs; Comments: Sinus rhythm, PRS 156 milliseconds, narrow QRS, normal repolarisation, QT 430 milliseconds.
CDC Split Type: FRPFIZER INC202101859390

Write-up: Atrial fibrillation paroxysmal; This is a spontaneous report received from a contactable reporter(s) (Physician). Regulatory number: FR-AFSSAPS-PB20217339 (AFSSAPS). A 67 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 24Nov2021 (Lot number: 1G047A) at the age of 67 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Hypertension arterial" (unspecified if ongoing), notes: High blood pressure; "Non-insulin-dependent diabetes mellitus" (unspecified if ongoing); "Tabaquism" (unspecified if ongoing), notes: Severe 10 years ago; "Overweight" (unspecified if ongoing); "Allergy to penicillin " (unspecified if ongoing). Family history included: "Cerebral vascular accident" (unspecified if ongoing); "Ischaemic heart disease" (unspecified if ongoing). Concomitant medication(s) included: APROVEL. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 24Nov2021, outcome "not recovered", described as "Atrial fibrillation paroxysmal". The event "atrial fibrillation paroxysmal" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: echocardiogram: left ventricular ejection fraction: 60% in biplane, notes: minimal mitral insufficiency, low left ventricle filling pressures, the rest without abnormalities; electrocardiogram: atrial fibrillation bursts under inputs, notes: Sinus rhythm, PRS 156 milliseconds, narrow QRS, normal repolarisation, QT 430 milliseconds. Therapeutic measures were taken as a result of atrial fibrillation which included treatment with ELIQUIS 5 mg X 2 and SATOLOL 40 mg X 2 was proposed by the cardiologist. Clinical course: The patient presented on the day of her vaccination with COMIRNATY (injection in question not specified) with a sensation of arrhythmia which required a consultation and a cardiological assessment. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015680 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G047A / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Immunisation, Interchange of vaccine products, Off label use, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101859336

Write-up: This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: FR-AFSSAPS-PC20215398 (RA). A 68-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 24Nov2021 (Lot number: 1G047A) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Vaxzevria (Dose 1, Lot number: ABV5045, route of administration: Intramuscular), administration date: 08Mar2021, for COVID-19 immunisation; Vaxzevria (Dose 2, Lot number: ABW3645, Route of Administration: Intramuscular), administration date: 14May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 24Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Moderate pain in the anterior aspect of the right arm and forearm"; PARAESTHESIA (medically significant) with onset Dec2021, outcome "not recovered", described as "Paresthesia in the right hand"; DISCOMFORT (medically significant) with onset Dec2021, outcome "not recovered", described as "Sensation of heaviness in the right upper limb". Clinical course: Moderate pain in the anterior aspect of the right arm and forearm, which appeared the day after vaccination and lasted 48 hours. Then disappeared and reappeared 12 days later, as a sensation of heaviness in the right upper limb with occasional paraesthesia in the right hand. Perfect and painless cervical mobility, no other symptoms. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2015904 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-24
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest scan, Chills, Cough, Dizziness, Fatigue, Food craving, Headache, Immunisation, Interchange of vaccine products, Investigation, Malaise, Myalgia, Nausea, Off label use, Oxygen saturation, Pyrexia, SARS-CoV-2 test, Thirst, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (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), 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? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: listened to chest; Result Unstructured Data: Test Result:all clear; Test Name: Tested for diabetes; Result Unstructured Data: Test Result:all clear; Test Name: Oxygen Sats; Result Unstructured Data: Test Result:all clear; Test Date: 20211122; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101857951

Write-up: Nausea; craving sugar; muscle aches; OFF LABEL USE; INTERCHANGE OF VACCINE PRODUCTS; BOOSTER; fatigue; vomiting; headache; feeling unwell; shivering; coughing; fever; dizziness; excessive thirst; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112241032133100-SK4ZU. Other Case identifier(s): GB-MHRA-ADR 26391218. A 65-year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medications included: INFLUENZA VIRUS taken for immunisation, start date: 24Nov2021, stop date: 24Nov2021; PARACETAMOL, start date: 2021, stop date: 2021. 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 2021, outcome "unknown", described as "OFF LABEL USE"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 2021, outcome "unknown", described as "INTERCHANGE OF VACCINE PRODUCTS"; IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "BOOSTER"; FATIGUE (medically significant) with onset 2021, outcome "not recovered", described as "fatigue"; VOMITING (medically significant) with onset 2021, outcome "not recovered", described as "vomiting"; HEADACHE (medically significant) with onset 2021, outcome "not recovered", described as "headache"; MALAISE (medically significant) with onset 2021, outcome "not recovered", described as "feeling unwell"; CHILLS (medically significant) with onset 2021, outcome "not recovered", described as "shivering"; COUGH (medically significant) with onset 2021, outcome "not recovered", described as "coughing"; PYREXIA (medically significant) with onset 2021, outcome "not recovered", described as "fever"; DIZZINESS (medically significant) with onset 2021, outcome "not recovered", described as "dizziness"; THIRST (medically significant) with onset 2021, outcome "not recovered", described as "excessive thirst"; NAUSEA (medically significant) with onset 24Nov2021, outcome "recovered" (30Nov2021), described as "Nausea"; FOOD CRAVING (medically significant) with onset 2021, outcome "unknown", described as "craving sugar"; MYALGIA (medically significant) with onset 2021, outcome "unknown", described as "muscle aches". The events "fatigue", "vomiting", "headache", "feeling unwell", "shivering", "coughing", "fever", "dizziness", "excessive thirst", "nausea", "craving sugar" and "muscle aches" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: listened to chest: (unspecified date) all clear; tested for diabetes: (unspecified date) all clear; Oxygen Sats: (unspecified date) all clear; COVID-19 virus test: (22Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Week one: dizziness, fatigue, vomiting, muscles aches, shivering, fever, excessive thirst, craving sugar. Week two: headache on waking for two hours, feeling unwell, fatigue. Week three: feeling unwell, coughing. Relevant investigations or tests conducted: saw GP on 12Jul2021: tested for diabetes, checked oxygen sats, listened to chest. All clear. Reaction report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016018 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
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 INC202101857562

Write-up: Shoulder pain (due joint disorder); Off label use; Interchange of vaccine products; Booster; Shoulder pain (due joint disorder); 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-202112242224504030-ILQPV. Other Case identifier(s): GB-MHRA-ADR 26393937. A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 21Nov2021 (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 24Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "Booster"; ARTHRALGIA (medically significant) with onset 24Nov2021, outcome "not recovered", ARTHROPATHY (medically significant), outcome "unknown" and all described as "Shoulder pain (due joint disorder)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Her shoulder was aching since she got her Pfizer booster. It went worth during driving, cooking especially chopping or picking up loads. 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; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2016356 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Heart rate, Heart rate increased, Investigation, Myocarditis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: Heart rate; Result Unstructured Data: Test Result:High; Test Date: 202112; Test Name: Heart rate; Result Unstructured Data: Test Result:Elevated; Comments: Elevated heartbeat; Test Date: 20211124; Test Name: Examination; Result Unstructured Data: Test Result:myocarditis; Comments: patient went to an Accident and Emergency department for examination and reported ''''they said myocarditis''''.
CDC Split Type: IEPFIZER INC202101859170

Write-up: Chest pains, sharp pain / sharp pain in front chest and back; Breathlessness; Discomfort in the chest area / discomfort in my chest; Myocarditis; High heart rate when relaxed / elevated heartbeat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. The reporter is the patient. Regulatory number: IE-HPRA-2021-088347 (HPRA). Other Case identifier(s): IE-HPRA-CVARR2021121623337 (HPRA). A 29 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 12:00 (Lot number: FH8469) at the age of 29 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CHEST PAIN (medically significant) with onset 24Nov2021 18:00, outcome "not recovered", described as "Chest pains, sharp pain / sharp pain in front chest and back"; DYSPNOEA (medically significant) with onset 24Nov2021 18:00, outcome "not recovered", described as "Breathlessness"; CHEST DISCOMFORT (medically significant) with onset 24Nov2021 18:00, outcome "not recovered", described as "Discomfort in the chest area / discomfort in my chest"; MYOCARDITIS (medically significant) with onset 24Nov2021 18:00, outcome "not recovered", described as "Myocarditis"; HEART RATE INCREASED (medically significant) with onset 24Nov2021 18:00, outcome "not recovered", described as "High heart rate when relaxed / elevated heartbeat". The events "chest pains, sharp pain / sharp pain in front chest and back", "breathlessness", "discomfort in the chess area / discomfort in my chest", "myocarditis" and "high heart rate when relaxed / elevated heartbeat" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: heart rate: (24Nov2021) high; (Dec2021) elevated, notes: Elevated heartbeat; investigation: (24Nov2021) myocarditis. Clinical course: At around 6pm on 24Nov2021, the patient experienced chest pains, sharp pains, breathlessness, discomfort in the chest area and a high heart rate when relaxed. The duration was reported as 2-4 minutes. It was reported the first occasion this happened, the patient had an episode of chest pain. The second time it happened was on 12Dec2021. The patient had a sharp pain in the front chest and back, which lasted about 3-4 minutes, then it settled. Ever since then, the patient had a discomfort in the chest and an elevated heartbeat. The patient went to an Accident and Emergency department for examination and reported ''''they said myocarditis''''. Therapeutic measures included (Colchicine Tiofarma) as a result of chest pain, dyspnoea, chest discomfort, myocarditis, heart rate increased. The patient stated it didn''t work, as he got an allergic reaction and had to stop. At the time of reporting, the patient had not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016604 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-11-24
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Cough, Dyspnoea, Weight decreased
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101851191

Write-up: DOB; WEIGHT LOSS; Cough; LOW BACK PAIN; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300127517 (PHFDA). A 19 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 24Sep2021 (Batch/Lot number: unknown) at the age of 18 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DYSPNOEA (hospitalization) with onset 24Nov2021, outcome "recovering", described as "DOB"; WEIGHT DECREASED (hospitalization) with onset 24Nov2021, outcome "recovering", described as "WEIGHT LOSS"; COUGH (hospitalization) with onset 24Nov2021, outcome "recovering", described as "Cough"; BACK PAIN (hospitalization) with onset 24Nov2021, outcome "recovering", described as "LOW BACK PAIN". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2016895 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-11-24
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8142 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101867833

Write-up: Vaccination failure; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-536 (INFARMED). A 59 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 28May2021 (Lot number: FA8142) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 24Nov2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 24Nov2021, outcome "unknown", described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) positive. Clinical course: The reporter''s assessment of the casual relationship of all the events with the suspect product was "possible" (Method of assessment: unknown). Case is not serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016897 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-11-24
   Days after vaccination:193
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101867851

Write-up: Vaccine failure; covid-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-542 (INFARMED). A 64 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15May2021 (Lot number: EW9127) as dose 1, 0.3ml,single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 24Nov2021, outcome "unknown", described as "Vaccine failure"; COVID-19 (medically significant) with onset 24Nov2021, outcome "unknown", described as "covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) positive.The reporter''s assessment of the causal relationship of the [Drug ineffective, COVID-19] with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Possible. Case not serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-11-24
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: international unit(s)
CDC Split Type: PTPFIZER INC202101868238

Write-up: Vaccine failure; Vaccine failure; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-546 (INFARMED). A 27 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 10Jun2021 (Lot number: EX8680) as dose 1 0.3 ml, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Nov2021, outcome "unknown" and all described as "Vaccine failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) positive, notes: international unit(s). The reporter''s assessment of the causal relationship of the event (Drug Ineffective) with the suspect product was Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Possible. Case non serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016900 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-11-24
   Days after vaccination:193
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: PTPFIZER INC202101868070

Write-up: Vaccination failure; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-547 (INFARMED). A 40 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15May2021 (Lot number: EW9127) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 24Nov2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 24Nov2021, outcome "unknown", described as "Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) positive. The action taken for bnt162b2 was unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19. The reporter''s assessment of the causal relationship of the event Drug Ineffective with the suspect product was: Source of assessment: Reporter, Method of assessment: Unknown, Result of Assessment: Possible. Clinical Course: Adverse event after dose 1. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2016910 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-11-24
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7083 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Iu international unit(s)
CDC Split Type: PTPFIZER INC202101874908

Write-up: Vaccination failure; Vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Agency Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-790 (INFARMED). A 59 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 16Jun2021 (Lot number: FA7083) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Nov2021, outcome "unknown" and all described as "Vaccination failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) positive, notes: Iu international unit(s). The reporter assessed the causal relationship of Drug ineffective with the suspect product was possible. The physician reported the case as non-serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2017033 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 023F21A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (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: SEMODERNATX, INC.MOD20214

Write-up: Massive bilateral pulmonary embolisms with right ventricular influence; This case was received via Regulatory Authority (Reference number: SE-MPA-2021-096284) on 23-Dec-2021 and was forwarded to Moderna on 23-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Massive bilateral pulmonary embolisms with right ventricular influence) in a 77-year-old male patient who received mRNA-1273 (COVID19 MODERNA) (batch no. 023F21A) for an unknown indication. No Medical History information was reported. On 23-Nov-2021, the patient received third dose of mRNA-1273 (COVID19 MODERNA) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced PULMONARY EMBOLISM (Massive bilateral pulmonary embolisms with right ventricular influence) (seriousness criteria hospitalization and life threatening). At the time of the report, PULMONARY EMBOLISM (Massive bilateral pulmonary embolisms with right ventricular influence) was resolving. For mRNA-1273 (COVID19 MODERNA) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This is a regulatory authority case concerning a 77-year-old male patient, with no medical history, who experienced the serious and unexpected AESI of pulmonary embolism. The event occurred the following day a third dose of mRNA-1273 vaccine was administered. Patient required hospitalization. No further details were provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 77-year-old male patient, with no medical history, who experienced the serious and unexpected AESI of pulmonary embolism. The event occurred the following day a third dose of mRNA-1273 vaccine was administered. Patient required hospitalization. No further details were provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2017213 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7898 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC202101817643

Write-up: Loss of consciousness; This is a spontaneous report received from a contactable reporter(s) (Physician) from The Regulatory Authority WEB. Regulatory number: SI-JAZMP-NCPHV-2021SI2003_2003 (JAZMP). Other Case identifier(s): JAZMP-300019348 (JAZMP). A 26 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 24Nov2021 (Lot number: FG7898, Expiration Date: 31Mar2022) at the age of 26 years 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 1, manufacture unknown), for COVID-19 immunisation. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 24Nov2021, outcome "recovered" (24Nov2021), described as "Loss of consciousness". A casual relationship between Comirnaty and event Loss of consciousness was assessing being possible according to Source of assessment: JAZMP, Method of assessment: No follow-up attempts are possible. No further information is expected.


VAERS ID: 2020118 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS; LEVOTHYROXINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211226; 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: pain in hands; aching; Aching pain in hands, forearms, elbows; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26397416) on 28-Dec-2021 and was forwarded to Moderna on 28-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain in hands), PAIN (aching) and PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows) in a 61-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Concomitant products included LEVOTHYROXINE for Hyperthyroidism, INFLUENZA VACCINE (INFLUENZA VIRUS) from 25-Nov-2021 to an unknown date for an unknown indication. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (pain in hands) (seriousness criterion medically significant) and PAIN (aching) (seriousness criterion medically significant). On 25-Nov-2021, PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows) had resolved. At the time of the report, ARTHRALGIA (pain in hands) and PAIN (aching) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Approximately 8 hours after receiving the Moderna booster in her right arm, her right hand, wrist, and lower arm felt excruciatingly painfully heavy, like she had a metal or lead weight to carry. She had hardly any use in her fingers, could only lift light things, could hardly move her arm without the aid of her right hand, found it difficult to put on her clothes and was extremely uncomfortable. If she had not been vaccinated, she would have thought she had a stroke. This condition lasted about 12 hours, but she was thankful to have received the jab and would be happy to have another, now that she knew what side effects she may have. Hearing about other people''s reactions, she considered herself to have been lucky. Patient had not tested positive for COVID-19 since having the vaccine. She was not enrolled in clinical trial. It was reported that, her reaction was not related to possible inflammation of the heart (myocarditis or pericarditis). No treatment drugs were reported. The medical history was not provided by the reporter. Company comment: This case concerns a 61-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of pain in extremity. The event occurred approximately 12 hours after the booster dose of mRNA-1273. Concomitant influenza vaccine administration is a confounding factor. The event was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 61-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of pain in extremity. The event occurred approximately 12 hours after the booster dose of mRNA-1273. Concomitant influenza vaccine administration is a confounding factor. The event was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2020277 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Oropharyngeal pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THMODERNATX, INC.MOD20214

Write-up: Pain in throat and chest pain; Pain in throat and chest pain; This case was received via Zuellig Pharma (Reference number: MOD-2021-292) on 28-Dec-2021 and was forwarded to Moderna on 29-Dec-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of OROPHARYNGEAL PAIN (Pain in throat and chest pain) and CHEST PAIN (Pain in throat and chest pain) in a 31-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (Pain in throat and chest pain) (seriousness criterion hospitalization) and CHEST PAIN (Pain in throat and chest pain) (seriousness criterion hospitalization). At the time of the report, OROPHARYNGEAL PAIN (Pain in throat and chest pain) and CHEST PAIN (Pain in throat and chest pain) had resolved. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment medication was given. It was reported that 7 days after injection, the vaccine recipient had rash that appeared on the left forearm. She had difficulty in breathing, treated at the hospital, found a slight irregular heartbeat.; Sender''s Comments: This case concerns a patient, with medical history (not reported), who experienced the serious unexpected events(s) of Oropharyngeal pain and chest pain. The event(s) started occurring approximately within 8 day(s) after the 1st dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered unknown. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2023066 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5475 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Hypoaesthesia, Hypokinesia, Immunisation, Interchange of vaccine products, Musculoskeletal stiffness, Myalgia, Off label use, Paraesthesia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101870048

Write-up: restriction of upper arm and shoulder movement; mild muscle ache in left upper arm; Left upper arm feels numb and dead and sometimes tingly; Shoulder pain; Shoulder muscle stiffness; Numbness of upper arm; Off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112271748318540-HUHX9 (RA). Other Case identifier(s): GB-MHRA-ADR 26400057 (RA). A 51 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: FK5475) 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, lot number unknown), administration date: 18Mar2021, for COVID-19 immunization; Covid-19 vaccine AstraZeneca (Dose: 2, lot number unknown), administration date: 25May2021, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 24Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "Booster"; HYPOKINESIA (medically significant), outcome "unknown", described as "restriction of upper arm and shoulder movement"; ARTHRALGIA (medically significant) with onset 07Dec2021, outcome "not recovered", described as "Shoulder pain"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 07Dec2021, outcome "not recovered", described as "Shoulder muscle stiffness"; HYPOAESTHESIA (medically significant) with onset 07Dec2021, outcome "not recovered", described as "Numbness of upper arm"; MYALGIA (non-serious), outcome "unknown", described as "mild muscle ache in left upper arm"; PARAESTHESIA (non-serious), outcome "unknown", described as " Left upper arm feels numb and dead and sometimes tingly". Clinical course: Left upper arm feels numb and dead and sometimes tingly. Restriction of upper arm and shoulder movement, her left arm feels heavy. Constant mild muscle ache in left upper arm and shoulder. Pain in left shoulder and arm when trying to take clothes off over her head. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Dec2021) negative, notes: No - Negative COVID-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2023098 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Immunisation, Interchange of vaccine products, Menstruation irregular, Off label use, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; BUSCOPAN; GABAPENTIN; METFORMIN; OMEPRAZOLE; PROGESTERONE; VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control; Blood cholesterol abnormal; Clinical trial participant (Study details: Office of national statistics testing study); Depression; Diabetes; Esophageal reflux; Fibromyalgia; Irritable bowel syndrome
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101869999

Write-up: Irregular menstrual cycle; Unexpected bleeding started about half way through my cycle, and continued for approximately 23 days; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112272045365340-5X7OD. Other Case identifier(s):GB-MHRA-ADR 26400846. A 25 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing), notes: Study details: Office of national statistics testing study; "Depression" (unspecified if ongoing); "Birth control" (unspecified if ongoing); "Esophageal reflux" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Irritable bowel syndrome" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. Patient last menstrual period date was 24Dec2021. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol abnormal; BUSCOPAN taken for irritable bowel syndrome; GABAPENTIN taken for fibromyalgia; INFLUENZA VIRUS taken for immunisation, administration date 06Oct2021; METFORMIN taken for diabetes mellitus; OMEPRAZOLE taken for gastrooesophageal reflux disease; PROGESTERONE taken for oral contraception; VENLAFAXINE taken for depression. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN), administration date: 27Feb2021, for COVID-19 IMMUNISATION, reaction(s): "menstrual issues"; Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 24Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "Booster"; MENSTRUATION IRREGULAR (medically significant) with onset 03Dec2021, outcome "unknown", described as "Irregular menstrual cycle"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 03Dec2021, outcome "unknown", described as "Unexpected bleeding started about half way through my cycle, and continued for approximately 23 days". Clinical course: Unexpected bleeding started about half way through my cycle, and continued for approximately 23 days. About half way through this time, there seemed to be a slight improvement that I would expect towards the end of a period, before the bleeding then increased and became much more uncomfortable again. Therefore I''m unsure if this was one event of unexpected bleeding, or 2 very short menstrual cycles that overlapped. I experienced menstrual issues with my original vaccines, though they were AstraZeneca, which is what led me to believe that this was a reaction to my Pfizer booster and not a separate medical issue. Unknown if this issue will continue. Patient has not tested positive for COVID-19 since having the vaccine. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). 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. No further information is expected.


VAERS ID: 2023393 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-11-24
   Days after vaccination:221
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004737 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PV46674 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Headache, Hot flush, Nasopharyngitis, Poor quality sleep, SARS-CoV-2 test
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Stomach upset; Hot flush; Headache; Cold; Sleep unwell; This case was received via RA (Reference number: GB-MHRA-ADR 26415061) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NASOPHARYNGITIS (Cold), ABDOMINAL DISCOMFORT (Stomach upset), HOT FLUSH (Hot flush) and POOR QUALITY SLEEP (Sleep unwell) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004737) 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. No Medical History information was reported. On 17-Apr-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 24-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced POOR QUALITY SLEEP (Sleep unwell) (seriousness criterion medically significant). On 24-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), NASOPHARYNGITIS (Cold) (seriousness criterion medically significant) and HOT FLUSH (Hot flush) (seriousness criterion medically significant). On 25-Dec-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset) (seriousness criterion medically significant). On 26-Dec-2021, ABDOMINAL DISCOMFORT (Stomach upset) had resolved. On 30-Dec-2021, POOR QUALITY SLEEP (Sleep unwell) was resolving. At the time of the report, HEADACHE (Headache), NASOPHARYNGITIS (Cold) and HOT FLUSH (Hot flush) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was reported. No treatment medication information was reported. Company comment: This case concerns a 45-year-old female patient with no medical history provided who experienced serious unexpected events of Poor quality sleep, Headache, Nasopharyngitis, Hot flush and Abdominal discomfort. The event Poor quality sleep occurred prior to vaccination with the mRNA-1273, however, as it was reported that six days after the vaccination the event was still resolving causal relationship cannot be excluded. The events Headache, Nasopharyngitis and Hot flush occurred on the same day after the third dose of mRNA-1273 and were resolving at the time of the report. The event Abdominal discomfort occurred one day after the vaccine and resolved the following day. No further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per RA and kept as such. Event terms, onset dates and outcomes captured per Regulatory Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient received COVID-19 VACCINE ASTRAZENECA prior to Company product, Interchange of vaccine products should have been considered in this particular case.; Sender''s Comments: This case concerns a 45-year-old female patient with no medical history provided who experienced serious unexpected events of Poor quality sleep, Headache, Nasopharyngitis, Hot flush and Abdominal discomfort. The event Poor quality sleep occurred prior to vaccination with the mRNA-1273, however, as it was reported that six days after the vaccination the event was still resolving causal relationship cannot be excluded. The events Headache, Nasopharyngitis and Hot flush occurred on the same day after the third dose of mRNA-1273 and were resolving at the time of the report. The event Abdominal discomfort occurred one day after the vaccine and resolved the following day. No further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per RA and kept as such. Event terms, onset dates and outcomes captured per Regulatory Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient received COVID-19 VACCINE ASTRAZENECA prior to Company product, Interchange of vaccine products should have been considered in this particular case.


VAERS ID: 2023620 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Stillbirth
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC202101859299

Write-up: The patient went to a check-up due to less movement for the child. On the same day, it was confirmed that the fetus was lifeless. Stillbirth was induced; Booster; This is a spontaneous report received from a contactable reporter(s) (Physician) from the regulatory authority. Regulatory number: IS-IMA-7540 (IMA). A 30 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient was 28 weeks pregnant at the time of exposure to bnt162b2 and at the event onset. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose number unknown), for COVID-19 immunisation; COVID-19 vaccine (Dose number unknown, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "Booster"; STILLBIRTH (medically significant) with onset 01Dec2021, outcome "unknown", described as "The patient went to a check-up due to less movement for the child. On the same day, it was confirmed that the fetus was lifeless. Stillbirth was induced". The event "the patient went to a check-up due to less movement for the child. on the same day, it was confirmed that the fetus was lifeless. stillbirth was induced" was evaluated at the physician office visit. The patient was reported to have no underlying diseases. The pregnancy resulted in still birth. The fetal outcome is intrauterine death. Patient received both doses of the vaccine/is fully vaccinated. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2023812 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deafness, Disturbance in attention, Eustachian tube dysfunction, Fatigue, Hunger, Vaccination site pain
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINUPRET [ASCORBIC ACID;GENTIANA LUTEA ROOT;PRIMULA SPP. FLOWER;RUMEX ACETOSA;SAMBUCUS NIGRA FLOWER;
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHMODERNATX, INC.MOD20214

Write-up: Fatigue; Eustachian tube dysfunction; Hearing loss; Hungry; Sore arm in my injected area; Unable to focus or concentrate; This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), EUSTACHIAN TUBE DYSFUNCTION (Eustachian tube dysfunction), DEAFNESS (Hearing loss), HUNGER (Hungry), VACCINATION SITE PAIN (Sore arm in my injected area) and DISTURBANCE IN ATTENTION (Unable to focus or concentrate) in a 31-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for Eustachian tube dysfunction. Concomitant products included SINUPRET [ASCORBIC ACID;GENTIANA LUTEA ROOT;PRIMULA SPP. FLOWER;RUMEX ACETOSA;SAMBUCUS NIGRA FLOWER;VERBENA OFFICINALIS HERB] from 23-Nov-2021 to an unknown date for an unknown indication. On 24-Nov-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant), EUSTACHIAN TUBE DYSFUNCTION (Eustachian tube dysfunction) (seriousness criterion medically significant), DEAFNESS (Hearing loss) (seriousness criterion medically significant), HUNGER (Hungry) (seriousness criterion medically significant), VACCINATION SITE PAIN (Sore arm in my injected area) (seriousness criterion medically significant) and DISTURBANCE IN ATTENTION (Unable to focus or concentrate) (seriousness criterion medically significant). On 22-Dec-2021, FATIGUE (Fatigue), EUSTACHIAN TUBE DYSFUNCTION (Eustachian tube dysfunction), DEAFNESS (Hearing loss), HUNGER (Hungry), VACCINATION SITE PAIN (Sore arm in my injected area) and DISTURBANCE IN ATTENTION (Unable to focus or concentrate) outcome was unknown. mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) dosing remained unchanged. End date of product administration was given as 30-NOV-2021. Company comment This Regulatory Authority case concerns a 31-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) events of fatigue, Eustachian tube dysfunction, deafness, hunger, vaccination site pain and disturbance in attention. The events fatigue, hunger and vaccination site pain occurred on the same day after receiving an unknown dose number of mRNA-1273 vaccine. Evolved the next day with disturbance in attention. 2 days after vaccination developed hearing loss in her left ear, she went to emergency department and diagnosed with eustachian tube dysfunction for what she received a non-reported treatment. It was reported that she received her second dose of vaccination while having on-off hearing loss in her left ear. She went to ENT and was prescribed with a steroid for 5 days. The rechallenge was not applicable. 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 no reported medical history, who experienced the unexpected, serious (Medically significant) events of fatigue, Eustachian tube dysfunction, deafness, hunger, vaccination site pain and disturbance in attention. The events fatigue, hunger and vaccination site pain occurred on the same day after receiving an unknown dose number of mRNA-1273 vaccine. Evolved the next day with disturbance in attention. 2 days after vaccination developed hearing loss in her left ear, she went to emergency department and diagnosed with eustachian tube dysfunction for what she received a non-reported treatment. It was reported that she received her second dose of vaccination while having on-off hearing loss in her left ear. She went to ENT and was prescribed with a steroid for 5 days. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023925 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCB0003 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cholecystitis
SMQs:, Infectious biliary disorders (narrow), Gallbladder related disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC202101869352

Write-up: Cholecystitis; This is a spontaneous report received from a contactable reporter (Physician) from the regulatory authority-WEB. Regulatory number: SI-JAZMP-NCPHV-2021SI1772_1772 (regulatory authority). Other Case identifier(s): JAZMP-300019659 (regulatory authority). A 82 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Nov2021 (Lot number: PCB0003, Expiration Date: 28Feb2022) as dose 1, 30 ug single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: CHOLECYSTITIS (hospitalization) with onset 24Nov2021, outcome "unknown", described as "Cholecystitis". Therapeutic measures were taken as a result of cholecystitis and included treatment as operated. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2024315 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-14
Onset:2021-11-24
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Insomnia
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Insomnia disorder; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26411133) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia disorder) in a 58-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Concurrent medical conditions included Asthma. On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced INSOMNIA (Insomnia disorder) (seriousness criterion medically significant). At the time of the report, INSOMNIA (Insomnia disorder) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not had symptoms associated with COVID-19 and was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment:This regulatory authority case concerns a 58-year-old male patient with medical history of Asthma, who experienced the unexpected serious events of Insomnia, which occurred 10 days after receiving the third dose of mRNA-1273 Vaccine. The outcome was reported as not resolved. Patients underlying medical history and steroid therapy remains confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority''s report due to important medical condition.; Sender''s Comments: This regulatory authority case concerns a 58-year-old male patient with medical history of Asthma, who experienced the unexpected serious events of Insomnia, which occurred 10 days after receiving the third dose of mRNA-1273 Vaccine. The outcome was reported as not resolved. Patients underlying medical history and steroid therapy remains confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority''s report due to important medical condition.


VAERS ID: 2025791 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 3089ITB / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Magnetic resonance imaging heart, Myocarditis, Off label use
SMQs:, Cardiomyopathy (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: MRI heart; Result Unstructured Data: Test Result:excluded: coronary heart disease; Comments: cardiac catheter differential diagnosis excluded: coronary heart disease.
CDC Split Type: DEPFIZER INC202101865323

Write-up: Myocarditis; Off-label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a non-contactable consumer from the Regulatory Authority. Regulatory number: DE-202100284723 (RA). A 69-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 24Nov2021 (Lot number: 3089ITB) at the age of 69 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: Vaxzevria (dose 1, lot number: 210072), administration date: 30Jun2021, when the patient was 69 years old, for COVID-19 immunisation; Comirnaty (DOSE 2 (INITIAL PFIZER DOSE), SINGLE, lot number: FE9174), administration date: 28Jul2021, when the patient was 69 years old, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization, life threatening) with onset 24Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, life threatening) with onset 24Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (hospitalization, life threatening) with onset 24Nov2021, outcome "unknown", described as "Booster"; MYOCARDITIS (hospitalization, life threatening), outcome "recovered", described as "Myocarditis". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging heart: excluded: coronary heart disease, notes: cardiac catheter differential diagnosis excluded: coronary heart disease. No follow-up attempts are possible. No further information is expected. Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202200038079 same reporter/patient/product, different dose/event


VAERS ID: 2025883 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-24
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Immunisation, Influenza like illness, Palpitations, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Fragrance sensitivity; Nickel sensitivity; Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101874031

Write-up: After the second vaccination I had chills, a fever for 3 days and a palpitations of the heart after the booster the same symptoms again, fever lowering medicine did not help.; Booster; Palpitations of the heart; Chills; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The Regulatory Authority number DE-PEI-CADR2021206112, other case identifier(s) DE-CADRPEI-2021206112, DE-PEI-202100232444. A 56 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 24Nov2021 (Lot number: Unknown) as dose 3 (booster), single, intramuscular (Lot number: Unknown) as dose 2, single, and (Batch/Lot number: unknown) for covid-19 immunisation. Relevant medical history included Nickel sensitivity (unspecified if ongoing); Fragrance sensitivity (unspecified if ongoing); Type 1 diabetes mellitus (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunisation. The following information was reported IMMUNISATION (hospitalization) with onset 24Nov2021, outcome unknown; INFLUENZA LIKE ILLNESS (hospitalization), outcome recovering; PALPITATIONS (non-serious), outcome unknown; CHILLS (non-serious), outcome unknown; PYREXIA (non-serious), outcome unknown. Health authority comment included allergies to Nickel, fragrance mix. Information on risk factors or previous illnesses Diabetes 1, After 3 days the fever and other symptoms have subsided. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2025886 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-23
Onset:2021-11-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVY8 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101874313

Write-up: Syncope; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. -WEB. Regulatory number: DE-PEI-CADR2021206252. Other Case identifier(s): DE-CADRPEI-2021206252, DE-PEI-202100232303. A 31 year-old male patient received bnt162b2 (COMIRNATY), administration date 23Nov2021 (Lot number: SCVY8) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (hospitalization) with onset 24Nov2021, outcome "recovering", described as "Syncope". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2025888 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-08
Onset:2021-11-24
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SDEH4 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Transient ischaemic attack
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Drug allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101874104

Write-up: Transient ischaemic attack; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority-WEB. Regulatory number: DE-PEI-CADR2021206370 Regulatory Authority. Other Case identifier(s): DE-CADRPEI-2021206370 Regulatory Authority, DE-PEI-202100232746 Regulatory Authority. A 70 year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3ML), via unspecified route of administration, administration date 08Nov2021 (Lot number: SDEH4) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Allergy to Novaminsulfon" (unspecified if ongoing); "Apoplexy" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (hospitalization) with onset 24Nov2021, outcome "recovered" (25Nov2021), described as "Transient ischaemic attack". Health Authority Comment: Do you or the person concerned have any known allergies? If yes, which ones? Novaminsulfon. Information on risk factors or previous illnesses Condition after Apoplexy Inpatient hospitalisation, complete recovery of the symptoms No follow-up attempts are possible. No further information is expected.


VAERS ID: 2025949 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Inappropriate schedule of product administration, Influenza like illness, Pyrexia, SARS-CoV-2 test, Tinnitus
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hearing impairment (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Sars-Cov-2 PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC202101874129

Write-up: Hearing loss on the right, up to 45dB in the low frequency range, 4 days after second booster vaccination; Inappropriate schedule of vaccine administered; Flu-like symptoms; headache; fever; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from the regulatory authority-WEB. Regulatory number: DE-PEI-CADR2021207144 (RA). Other Case identifier(s): DE-CADRPEI-2021207144 (RA Webportal), DE-PEI-202100233050 (RA). A 55-year-old female patient received BNT162B2 (COMIRNATY), administration date 24Nov2021 (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: Comirnaty (dose 1), administration date: Jun2021, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (hospitalization) with onset 24Nov2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; TINNITUS (hospitalization) with onset 27Nov2021, outcome "not recovered", described as "Hearing loss on the right, up to 45dB in the low frequency range, 4 days after second booster vaccination"; INFLUENZA LIKE ILLNESS (non-serious) with onset 25Nov2021, outcome "unknown", described as "Flu-like symptoms"; HEADACHE (non-serious) with onset 25Nov2021, outcome "unknown", described as "headache"; PYREXIA (non-serious) with onset 25Nov2021, outcome "unknown", described as "fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2021) positive. Therapeutic measures were taken as a result of tinnitus which includes intravenous therapy with prednisolone (Stennert regimen) for hearing loss on the right. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? No. Information on risk factors or previous illnesses None / Initially flu-like symptoms (headache + fever) 25Nov2021 + 26Nov2021. Since this morning, hearing loss on the right with ototonus and tinnitus on the right. Now in-patient at PRIVACY for intravenous therapy with prednisolone (Stennert regimen) for hearing loss on the right. The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 2025986 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1023A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure measurement, Cardiovascular disorder, Chills, Dizziness, Heart rate increased, Hypertension, Influenza, Nausea, Pain, Palpitations
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Infective pneumonia (broad), Dehydration (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction to wasp sting; Chronic fatigue syndrome; Drug intolerance; Fibromyalgia; Mast cell activation syndrome; Paradoxical drug reaction
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:high; Test Name: pulse; Result Unstructured Data: Test Result:fast
CDC Split Type: DEPFIZER INC202101873757

Write-up: Flu symptoms; Dizziness; pain; burning pain; nausea; chills; circulatory problems; palpitations; high blood pressure; fast pulse; allergic shock; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-CADR2021215474 (RA). Other Case identifier(s): DE-CADRPEI-2021215474 (RA Webportal), DE-PEI-202100268025 (RA). A 69 year-old female patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: 1F1023A) at the age of 69 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Allergic to wasp stings" (unspecified if ongoing); "drug intolerance" (unspecified if ongoing); "mast cell activation syndrome" (unspecified if ongoing); "Chronic fatigue syndrome" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "paradoxical reaction to drugs" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Histamine, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 Immunization. The following information was reported: INFLUENZA (hospitalization) with onset 24Nov2021, outcome "not recovered", described as "Flu symptoms"; DIZZINESS (hospitalization) with onset 24Nov2021, outcome "not recovered", described as "Dizziness"; ANAPHYLACTIC SHOCK (medically significant) with onset 24Nov2021, outcome "unknown", described as "allergic shock"; PAIN (non-serious) with onset 25Nov2021, outcome "unknown", described as "burning pain"; NAUSEA (non-serious) with onset 25Nov2021, outcome "unknown", described as "nausea"; CHILLS (non-serious) with onset 25Nov2021, outcome "unknown", described as "chills"; CARDIOVASCULAR DISORDER (non-serious) with onset 25Nov2021, outcome "unknown", described as "circulatory problems"; PALPITATIONS (non-serious) with onset 25Nov2021, outcome "unknown", described as "palpitations"; HYPERTENSION (non-serious) with onset 25Nov2021, outcome "unknown", described as "high blood pressure"; HEART RATE INCREASED (non-serious) with onset 25Nov2021, outcome "unknown", described as "fast pulse"; PAIN (non-serious) with onset 05Dec2021, outcome "unknown", described as "pain". The patient underwent the following laboratory tests and procedures: blood pressure measurement: high; heart rate increased: fast. Therapeutic measures were taken as a result of anaphylactic shock which included treatment with cortisone, famotidine. Sender''s comment: Do you or the person concerned have any known allergies? If so, what are they? Allergic to wasp stings, drug intolerance, mast cell activation syndrome, histamine. Details of risk factors or previous illnesses: Chronic fatigue syndrome, fibromyalgia, mast cell activation syndrome, paradoxical reaction to drugs. I was informed thoroughly before the vaccination, Charite and allergy portals only give recommendations for vaccinate, but I very much regret my decision to get vaccinated. I feel very, very bad and nobody knows about it. Everyone can say that after a long time. After the first vaccination, it took 3 months before I felt a little better. On 24Nov2021, I suffered from an allergic shock (treated with cortisone, famotidine), treatment was unsuccessful. On 25Nov2021, I suffered from an onset of dizziness, burning pain, nausea, chills, circulatory problems, palpitations, high blood pressure and a fast pulse. On 26Nov2021, I informed my doctor, she couldn''t help me. (There was no need for treatment). Terrible days followed with the above-mentioned symptoms. On 05Dec2021, the pain and other problems were so severe that I had to go to the hospital. At my request, I was given an infusion (prednisolone/Histakut). Unfortunately, this was also unsuccessful. On 12Dec2021, I got homeopathic treatment on my own accord, as I could not tolerate much. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026041 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCTN4 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Eye pain, Fatigue, Headache, Hot flush, Lymphadenopathy, Malaise, Myalgia, Nausea, Palpitations, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: DEPFIZER INC202101879813

Write-up: Headache; Fatigue; Dizziness; Nausea; Arthralgia; Malaise; Flush hot; Myalgia; Heart racing; Myalgia; Arthralgia; Dizziness; Malaise; Vaccination site pain; Fatigue; Vaccination site pain; Painful eye movement; Swollen lymph nodes; Vaccination site pain; This is a non-interventional study report from the Regulatory Authority-WEB. Regulatory number: DE-SVPEI-202100935872 (RA). A 46 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 24Nov2021 17:03 (Lot number: SCTN4) at the age of 46 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (hospitalization) with onset 04Dec2021, outcome "recovering", described as "Headache"; FATIGUE (hospitalization) with onset 04Dec2021, outcome "recovering", DIZZINESS (hospitalization) with onset 04Dec2021, outcome "recovering" and all described as "Dizziness"; NAUSEA (hospitalization) with onset 04Dec2021, outcome "recovering", described as "Nausea"; ARTHRALGIA (hospitalization) with onset 04Dec2021, outcome "recovering", MALAISE (hospitalization) with onset 04Dec2021, outcome "recovering" and all described as "Malaise"; HOT FLUSH (hospitalization) with onset 04Dec2021, outcome "recovering", described as "Flush hot"; MYALGIA (hospitalization) with onset 04Dec2021, outcome "recovering", PALPITATIONS (hospitalization) with onset 04Dec2021, outcome "recovering" and all described as "Heart racing"; MYALGIA (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Myalgia"; ARTHRALGIA (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Arthralgia"; LYMPHADENOPATHY (non-serious) with onset 25Nov2021 19:47, outcome "not recovered", described as "Swollen lymph nodes"; DIZZINESS (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Dizziness"; MALAISE (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Malaise"; EYE PAIN (non-serious) with onset 25Nov2021 19:47, outcome "not recovered", described as "Painful eye movement"; VACCINATION SITE PAIN (non-serious) with onset 30Nov2021, outcome "not recovered", VACCINATION SITE PAIN (non-serious) with onset 25Nov2021 19:47, outcome "not recovered" and all described as "Vaccination site pain"; VACCINATION SITE PAIN (non-serious) with onset 24Nov2021, outcome "not recovered", described as "Vaccination site pain"; FATIGUE (non-serious) with onset 30Nov2021, outcome "not recovered", described as "Fatigue". The reporter''s assessment of the causal relationship of the "headache", "fatigue", "dizziness", "nausea", "arthralgia", "malaise", "flush hot", "myalgia", "heart racing", "swollen lymph nodes", "painful eye movement" and "vaccination site pain" with the suspect product(s) bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Considering the plausible drug-event temporal association and/or known safety profile, there is a reasonable possibility that reported events were related to BNT162B2 vaccine administration. Case will be reassessed upon receipt of additional information. 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: 2026089 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-22
Onset:2021-11-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dyspnoea, Immunisation, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101874215

Write-up: Booster; Respiration labored; Diarrhea; Fever; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority. Regulatory number: FR-AFSSAPS-BR20214266. A 81 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 22Nov2021 (Lot number: Unknown) as dose 3 (booster), singer for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1, Batch /lot: ER9470), administration date: 22Mar2021, for COVID-19 Immunisation; Comirnaty (Dose 2, Batch /lot:EW4815), administration date: 19Apr2021, for COVID-19 Immunisation. The following information was reported: IMMUNISATION (hospitalization), outcome "unknown", described as "Booster"; DYSPNOEA (hospitalization) with onset 24Nov2021, outcome "recovering", described as "Respiration labored"; DIARRHOEA (hospitalization) with onset 24Nov2021, outcome "recovering", described as "Diarrhea"; PYREXIA (hospitalization) with onset 24Nov2021, outcome "recovering", described as "Fever". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026122 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7911 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Overweight; Renal failure NOS (severe renal failure)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101879830

Write-up: an oxygen-dependent pulmonary embolism on DVT lower right limb; Booster; This is a spontaneous report received from a contactable reporter, Physician, from the Agency Regulatory Authority-WEB. Regulatory number: FR-AFSSAPS-BX202111388 Regulatory Authority. A 70-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 24Nov2021 (Lot number: FG7911) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Renal failure NOS" (unspecified if ongoing), notes: severe renal failure; "Diabetes mellitus" (unspecified if ongoing); "Overweight" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Comirnaty (1st dose, Left arm, Intramuscular injection, Lot number: EW2239), administration date: 07Apr2021, for COVID-19 immunisation; Comirnaty (2nd dose, Left arm, Injection intramuscular, Lot number: EX6537), administration date: 03May2021, for COVID-19 immunisation. The following information was reported: immunisation (hospitalization) with onset 24Nov2021, outcome unknown; pulmonary embolism (hospitalization) with onset 26Nov2021, outcome recovering, described as "an oxygen-dependent pulmonary embolism on DVT lower right limb". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026501 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Interchange of vaccine products, Muscle spasms, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Dystonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882523

Write-up: This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112290846293860-Z3OO0 (RA). Other Case identifier(s): GB-MHRA-ADR 26407314 (RA). A 63 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (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, Manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 24Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Headache"; MUSCLE SPASMS (medically significant) with onset 26Nov2021, outcome "recovered" (05Dec2021), described as "Cramp"; PAIN IN EXTREMITY (medically significant) with onset 26Nov2021, outcome "recovered" (05Dec2021), described as "Pain in left calf". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Therapeutic measures (half aspirin) were taken as a result of headache, muscle spasms, pain in extremity.Clinical course: it was reported that the patient had headaches especially in the morning everyday, also some pain in left calf, like a cramp, forcing him to stand up and walk around try ease the pain. Had since taken half a aspirin which seems stopped the pain in calf ,not the headaches. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026509 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bedridden, Dry skin, Eczema, Immunisation, Interchange of vaccine products, Nasopharyngitis, Off label use, SARS-CoV-2 test, Skin exfoliation, Skin fissures, Skin weeping, Sunburn, Ulcer
SMQs:, Severe cutaneous adverse reactions (broad), Gastrointestinal ulceration (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Eczema
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882527

Write-up: Eczema acute; Off label use; Interchange of vaccine products; Booster; Dry skin/Dry skin on my hands has lead to cracking at the knuckles and open sores; Sunburn/I was confined to bed with symptoms similar to extreme sunburn across my face, neck, chest, stomach and arms; Winter; Skin loss/Skin loss on my neck has resulted in weeping skin; Dry skin on my hands has lead to cracking at the knuckles and open sores; Skin loss on my neck has resulted in weeping skin; My eczema symptoms were accelerating; Confined to bed; Open sore; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112291052497200-SBNVZ. Other Case identifier(s): GB-MHRA-ADR 26408270. A 54 year-old male patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "I have had eczema for approximately 15 years now" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Fexofenadine , notes: Taking fexofenadine 18mg antihistamine Hydrocortisone cream application. Vaccination history included: COVID-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; COVID-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 24Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "Booster"; ECZEMA (medically significant) with onset 10Dec2021, outcome "not recovered", described as "Eczema acute"; DRY SKIN (medically significant) with onset 2021, outcome "recovered", described as "Dry skin/Dry skin on my hands has lead to cracking at the knuckles and open sores"; SUNBURN (medically significant) with onset 2021, outcome "recovered", described as "Sunburn/I was confined to bed with symptoms similar to extreme sunburn across my face, neck, chest, stomach and arms"; NASOPHARYNGITIS (medically significant) with onset 2021, outcome "recovered", described as "Winter"; SKIN EXFOLIATION (medically significant) with onset 2021, outcome "recovered", described as "Skin loss/Skin loss on my neck has resulted in weeping skin"; SKIN FISSURES (medically significant) with onset 2021, outcome "unknown", described as "Dry skin on my hands has lead to cracking at the knuckles and open sores"; SKIN WEEPING (medically significant) with onset 2021, outcome "unknown", described as "Skin loss on my neck has resulted in weeping skin"; ECZEMA (medically significant) with onset 2021, outcome "unknown", described as "My eczema symptoms were accelerating"; BEDRIDDEN (medically significant) with onset 2021, outcome "unknown", described as "Confined to bed"; ULCER (medically significant) with onset 2021, outcome "unknown", described as "Open sore". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Therapeutic measures were taken as a result of eczema, dry skin, sunburn, skin exfoliation, skin fissures, skin weeping, eczema, bedridden, ulcer. Clinical course: it was reported that patient had eczema for approximately 15 years now. In recent years the effects had been minimal and was manageable with only slight worsening through winter months. This year he had seen no significant change through the autumn. However, after his booster vaccination at the end of November,he noticed a steady increase of symptoms through December. He controlled his diet and stopped alcohol intake from 17Dec2021 and this held his eczema symptoms to a manageable level. On Christmas eve and Christmas Day he indulged in a festive diet but with reduced alcohol intake. On Boxing Day evening he realised his eczema symptoms were accelerating and the following day he was confined to bed with symptoms similar to extreme sunburn across his face, neck, chest, stomach and arms. Dry skin on his hands has lead to cracking at the knuckles and open sores. Skin loss on his neck had resulted in weeping skin. He is now on a short course of steroids which has improved his current condition but he was worried as to how severe the eczema returns once the steroids are finished. He attributed this flare up to the booster vaccination because he had only experienced this level of eczema when he initially contracted the condition. Since then he had experienced a slow and steady improvement with no relapses outside of expected seasonal downturns. He had also reported that there had been no changes in his diet. 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: 2026669 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Epistaxis, Immunisation, Interchange of vaccine products, Joint swelling, Lower respiratory tract infection, Off label use, SARS-CoV-2 test, Sinus disorder, Swelling, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200019332

Write-up: Swelling of the joints mostly knees; Bad chest infection; Coughing; Nose bleeding; Hives; Sinus problems; Swelling; Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine (ASTRAZENECA); Booster: COMIRNATY; Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine (ASTRAZENECA); Booster: COMIRNATY; Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine (ASTRAZENECA); Booster: COMIRNATY; This is a spontaneous report received from a contactable reporter (Consumer, patient) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201051427402480-K3MOJ (RA). Other Case identifier(s): GB-MHRA-ADR 26439472 (RA). A 62 year-old female patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: fh4751) 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 NUMBER UNKNOWN, SINGLE), administration date: 15Mar2021, for COVID-19 immunisation, reaction(s): "cold like symptoms", "Blood pressure high", "Feeling unwell"; Covid-19 vaccine (DOSE NUMBER UNKNOWN, manufacturer unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability, medically significant), INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant), IMMUNISATION (disability, medically significant) all with onset 24Nov2021, outcome "unknown" and all described as "Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine (ASTRAZENECA); Booster: COMIRNATY"; SWELLING (disability, medically significant) with onset 26Nov2021, outcome "not recovered", described as "Swelling"; JOINT SWELLING (disability, medically significant), outcome "unknown", described as "Swelling of the joints mostly knees", and patient never had the problem; LOWER RESPIRATORY TRACT INFECTION (disability, medically significant), outcome "unknown", described as "Bad chest infection"; COUGH (disability, medically significant), outcome "unknown", described as "Coughing"; EPISTAXIS (disability, medically significant), outcome "unknown", described as "Nose bleeding"; URTICARIA (disability, medically significant), outcome "unknown", described as "Hives"; SINUS DISORDER (disability, medically significant), outcome "unknown", described as "Sinus problems". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Therapeutic measures were taken as a result of swelling, joint swelling, lower respiratory tract infection, cough, epistaxis, urticaria, sinus disorder. Clinical course: Doctor gave patient antibiotic for one week, which she had to go back and see her for another week of antibiotic. She had three weeks of work which was very upsetting. The first astrazeneca jab, gave her high blood pressure, made her feel very unwell with cold like symptoms. At that time, she had 2 weeks off work. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026975 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-11-24
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4721 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positive
CDC Split Type: PTPFIZER INC202200001311

Write-up: Vaccination failure; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority-WEB and product quality group. Regulatory number: PT-INFARMED-T202112-1390. A 18 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 31Aug2021 (Lot number: FE4721) as dose 2, 0.3 ml single and intramuscular, administration date 10Aug2021 (Lot number: FG4442) as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 24Nov2021, outcome "recovered" (03Dec2021), described as "Vaccination failure"; COVID-19 (medically significant) with onset 24Nov2021, outcome "recovered" (03Dec2021), described as "Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) positive, notes: Positive. Clinical course: The reporters assessment of the casual relationship of the (All events) with the suspect product was: Source of assessment: reporter, Method of assessment: Unknown, Result of Assessment: Possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026976 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-11-24
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Neck discomfort; Overweight
Allergies:
Diagnostic Lab Data: Test Date: 20211124; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202200001321

Write-up: Vaccination failure; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority and product quality group. Regulatory number: PT-INFARMED-T202112-1392 (INFARMED). A 51 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 07Jul2021 (Lot number: FE1573) as dose 2, 0.3 ml single and intramuscular, administration date 09Jun2021 (Lot number: FD1921) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Neck discomfort", start date: 02Jun2011 (unknown if ongoing); "Overweight", start date: 13Aug2018 (unknown if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 24Nov2021, outcome "recovered" (03Dec2021), described as "Vaccination failure"; COVID-19 (medically significant) with onset 24Nov2021, outcome "recovered" (03Dec2021), described as "Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (24Nov2021) positive, notes: Positive Iu international unit(s). The reporters assessment of the casual relationship of the (vaccination failure) with the suspect product was: Source of assessment: reporter, Method of assessment: Unknown, Result of Assessment: Possible Reporter Comment: Other information-"A77.01 COVID-19 INFECTION 07Dec2021 T83 OVERWEIGHT 13Aug2018 L01 SYMPTOM / NECK COMPLAINT 02Jun2011" No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-"A77.01 COVID-19 INFECTION 07Dec2021 T83 OVERWEIGHT 13Aug2018 L01 SYMPTOM / NECK COMPLAINT 02Jun2011"


VAERS ID: 2027026 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Dizziness, Hemiplegia, Immunisation
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101873979

Write-up: Clot in the brain (stroke); Reduced ability on the right side; Dizziness; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer) Regulatory number: SE-MPA-2021-099222. A 53-year-old female patient received BNT162B2 (COMIRNATY), administration date 24Nov2021 (Lot number: Unknown) as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Hypertension" (ongoing); "Diabetes" (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (1st dose, manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (2nd dose, manufacturer unknown), for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 24Nov2021, outcome "unknown", described as "Booster"; CEREBROVASCULAR ACCIDENT (hospitalization) with onset 18Dec2021, outcome "recovering", described as "Clot in the brain (stroke)"; DIZZINESS (hospitalization) with onset 18Dec2021, outcome "recovering", described as "Dizziness"; HEMIPLEGIA (hospitalization) with onset 18Dec2021, outcome "recovering", described as "Reduced ability on the right side". Additional information: The reporter stated that the patient had dizziness, reduced ability on the right side and has been on sick leave. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029257 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1H049A / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Duplexsonographie; Result Unstructured Data: Test Result:unknown result
CDC Split Type: DEPFIZER INC202200002340

Write-up: Deep vein thrombosis leg; booster; This is a spontaneous report received from a non-contactable reporter (Physician) from the Regulatory Authority-WEB. Regulatory number: DE-PEI-202100286293 (RA). An 81-year-old female patient received bnt162b2 (COMIRNATY), administration date 24Nov2021 (Lot number: 1H049A) at the age of 81 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 24Nov2021, outcome "unknown", described as "booster"; DEEP VEIN THROMBOSIS (medically significant) with onset 25Nov2021, outcome "not recovered", described as "Deep vein thrombosis leg". The patient underwent the following laboratory tests and procedures: ultrasound doppler: unknown result. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029786 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea exertional, Erectile dysfunction, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Pulmonary hypertension (broad), Medication errors (broad), Sexual dysfunction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101882953

Write-up: Off label use; interchange of vaccine products; Booster; Inability to maintain erection; Breathlessness/quickly out of breath when doing physical activity; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the RA. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112292302322270-RAYT4. Other Case identifier: GB-MHRA-ADR 26412744. A 53 year-old male patient received BNT162B2 (COMIRNATY), administration date 24Nov2021 (Lot number: FK0596) as dose 3 (booster), single for COVID-19 immunization. The patient had no relevant medical history. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: Off label use, interchange of vaccine products and booster, all medically significant with onset 24Nov2021 and outcome of unknown; "Inability to maintain erection" (medically significant) and "Breathlessness/quickly out of breath when doing physical activity" (non-serious), both with onset 2021 and outcome of not recovered. It was reported that after having taken the booster, the patient have seemed to be quickly out of breath when doing physical activity and this was not the case before the Pfizer booster COVID vaccine. It has also been observed that the erection cannot be maintained. 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 is expected.


VAERS ID: 2030181 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-24
Onset:2021-11-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Anosmia, Back pain, Diarrhoea, Headache, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

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

Write-up: Watery diarrhoea; Nausea; Chronic headaches; Loss of taste; Loss of smell; Back ache; Painful arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26423253) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Chronic headaches), BACK PAIN (Back ache), DIARRHOEA (Watery diarrhoea), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and PAIN IN EXTREMITY (Painful arm) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 13-Mar-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 25-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced BACK PAIN (Back ache) (seriousness criterion medically significant). On 26-Nov-2021, the patient experienced AGEUSIA (Loss of taste) (seriousness criterion medically significant) and ANOSMIA (Loss of smell) (seriousness criterion medically significant). On 27-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Chronic headaches) (seriousness criterion medically significant) and DIARRHOEA (Watery diarrhoea) (seriousness criterion medically significant). On 26-Nov-2021, PAIN IN EXTREMITY (Painful arm) had resolved. On 01-Dec-2021, HEADACHE (Chronic headaches), BACK PAIN (Back ache), DIARRHOEA (Watery diarrhoea) and ANOSMIA (Loss of smell) had resolved. On 07-Dec-2021, NAUSEA (Nausea) had resolved. On 08-Dec-2021, AGEUSIA (Loss of taste) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medications were not reported. Right after having the booster dose, patient had arm pain straight away and was painful for a few days and could hardly move it. Her back aches for several days at the same time then her headache started along with constantly feeling nauseous. She was sick and had diarrhea for a few days. Loss of appetite, taste, smell,feeling nauseous went on for the best part of two weeks. With the actual sickness, patient also had a banging head for 5 days in a row. Her partner who had the booster at the same time as she, was exactly had the same except instead of being sick, he had shivering badly for a few days. The symptoms were getting worse day by day with addition of more side effects. Patient performed LFT and PCR in thought of COVID-19 infection, however it came negative. Almost 3 weeks later patient felt normal and was able to eat without feeling nauseous. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient last menstrual period date was 19-Nov-2019. Company comment: This is a regulatory case concerning a 51-year-old, female patient with no medical history reported, with an Interchange of vaccine products (two doses were with COVID-19 VACCINE ASTRAZENECA, 7 months before current vaccination), who experienced the serious unexpected, according CCDS, AESI and the serious unexpected, according CCDS, events of Back pain, Pain in extremity, Nausea, Headache and Diarrhoea. The event pain in the extremity occurred approximately the same day after the booster dose of mRNA-1273 vaccine. The event back pain occurred approximately one day after the booster dose of mRNA-1273 vaccine. The events ageusia and anosmia occurred approximately two days after the booster dose of mRNA-1273 vaccine. The events nausea headache and diarrhoea occurred approximately three days after the booster dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. At; Sender''s Comments: This is a regulatory case concerning a 51-year-old, female patient with no medical history reported, with an Interchange of vaccine products (two doses were with COVID-19 VACCINE ASTRAZENECA, 7 months before current vaccination), who experienced the serious unexpected, according CCDS, AESI and the serious unexpected, according CCDS, events of Back pain, Pain in extremity, Nausea, Headache and Diarrhoea. The event pain in the extremity occurred approximately the same day after the booster dose of mRNA-1273 vaccine. The event back pain occurred approximately one day after the booster dose of mRNA-1273 vaccine. The events ageusia and anosmia occurred approximately two days after the booster dose of mRNA-1273 vaccine. The events nausea headache and diarrhoea occurred approximately three days after the booster dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. At the time of the report, the outcome of the events was recovered/resolved, no treatment was provided for reported events. The case was assessed as serious as per Regulatory Authority�s report due to important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1889927 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-10-12
Onset:2021-11-23
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN J822811 / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Heart rate increased, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: 10mg of Rouvistan
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data:
CDC Split Type:

Write-up: My heart heart was elevated to twice my normal rate for 8 hours. I had body aches, headache and fever.


VAERS ID: 1893432 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Injection site pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
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; Amlidopine
Current Illness: None
Preexisting Conditions: Hypertension
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Injection site pain, fatigue, body aches,


VAERS ID: 1893435 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-11-19
Onset:2021-11-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033F21A / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Pain, Urinary tract infection
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None yet
CDC Split Type:

Write-up: I woke up in the night with a raging urinary tract infection. Pain level was 7 or 8 out of 10. The shot I got was a booster.


VAERS ID: 1893644 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Vermont  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8027 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, 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:

Write-up: The vial was reconstituted incorrectly. Rather than adding 1.8 ml of diluent, 0.8 ml of diluent was added.


VAERS ID: 1893655 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Maine  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: No adverse event, Product preparation issue
SMQs:, Medication errors (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:

Write-up: Pfizer was administered undiluted to patient. No harm to patient.


VAERS ID: 1893678 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM9809 / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood test normal, Fatigue, Hepatic enzyme increased, Liver function test, Transaminases increased, Ultrasound liver normal
SMQs:, Liver related investigations, signs and symptoms (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: vitamin D3. multivitamin tablet
Current Illness: no
Preexisting Conditions: celiac
Allergies: Gluten hydrocodone hydromorphone
Diagnostic Lab Data: LFT 3/11, 3/17, 5/3, 6/2, and 8/10. gradually improving. negative blood work up for identifiable causes. normal liver US 5/18/21
CDC Split Type:

Write-up: Transaminitis (elevated liver enzymes), fatigue. ALT 110. AST 52. symptoms lasted around 6 months and resolved with time.


VAERS ID: 1893707 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Sunscreen
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swollen Face


VAERS ID: 1893716 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chills, Headache, Neck pain, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: Lexapro
Current Illness: N/a
Preexisting Conditions: Leukoplakia/ dysplasia of tongue
Allergies: N/a
Diagnostic Lab Data: N/a
CDC Split Type:

Write-up: Felt mild soreness in arm within few hours after but no other symptoms occurred until about 2am the following morning. Fever, chills, entire body was achy and sore, headache and neck pain.


VAERS ID: 1893903 (history)  
Form: Version 2.0  
Age: 9.0  
Sex: Male  
Location: Puerto Rico  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1620 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: 11/22/21 vaccine Pfizer lot FJ1620 was administered (adult vaccine) to pediatric patient. 11/23/21 Mother of the child was notified. Mother reports child not presenting any symptoms after vaccination


VAERS ID: 1893911 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8030 / 2 - / -

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

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

Write-up: rash on right side of face


VAERS ID: 1893919 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-11-08
Onset:2021-11-23
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5127 / 1 LA / SYR

Administered by: School       Purchased by: ?
Symptoms: Menstruation normal
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none known
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Started her period for the first time on 11/23/2021 at 10 years old. (Probably coincidence, but wanted to report it)


VAERS ID: 1893940 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-15
Onset:2021-11-23
   Days after vaccination:222
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 2 - / -

Administered by: Public       Purchased by: ?
Symptoms: Body temperature increased, COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Alzheimer''s dementia, depression, HTN, hyperlipidemia, ASHD, BPH
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: developed temp of 101.3 and tested positive for COVID 11/23/2021- has known exposure from wife who visited


VAERS ID: 1893964 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Pfizer first dose. Chest pain and fatigue
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Nausea, chest pain, headache, fatigue, fever, shortness of breath


VAERS ID: 1893972 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031H21A / N/A LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Hypoaesthesia, Injection site pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (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: Typical reaction to first two Pfizer shots (headache, lethargy, eyes sensitive to light) but cleared up after about 6 hours in b
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Walnuts and pecans
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Woke up about 12 hours after vaccination with the ball of my left foot mostly numb. Never had this symptom before and can''t attribute it to anything else directly. 6 hours later the numbness is reduced but still present. Have a slight headache and sore at site of injection. No other complaints.


VAERS ID: 1894006 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH LH8027 / 3 LA / IM
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 54C23 / N/A RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Agonal respiration, Dizziness, Loss of consciousness, Seizure
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), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Duloxetine 60 mg capsule daily
Current Illness: none
Preexisting Conditions: h/o spinal fusion 8-10 years ago knee surgery 14 years ago
Allergies: nkda
Diagnostic Lab Data: Vitals as above no testing or lab work done in clinic. To be assessed in ED.
CDC Split Type:

Write-up: 8:50 am given injections. 8:52 reported feeling dizzy and lightheaded. Passed out and helped to floor. unconscious for about 20 seconds with agonal breathing and seizure like movement of upper extremities while out. vital signs: 8:52 am 135/85 alert P 65 O2 sat 100% Blood sugar 98 sweaty and pale 9:03 131/95 P-64 Resp 20 Alert and orientated. REported feeling better Evaluated by provider and transported to Regions ED for further evaluation as patient and wife felt more monitoring needed.


VAERS ID: 1894029 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939906 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Swelling face, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: skin welts and facial swelling


VAERS ID: 1894048 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8030 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Product preparation issue, Underdose
SMQs:, Medication errors (broad)

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

Write-up: The Pfizer vaccine was mixed incorrectly (too much diluent used), so the patient received an invalid dose.


VAERS ID: 1894056 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-11-18
Onset:2021-11-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012H21B / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Injection site reaction, Pain, Pruritus, Rash erythematous, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flonase inhaler for allergy, MgOx 400 mg daily.
Current Illness: None
Preexisting Conditions: CAD, degenerative arthritis, degenerative disk disease lumbar, depression, Diabetes type 2, dyslipidemia, flank pain, hypothyroidism, urinary incontinence, hx of TB, HFpEF
Allergies: Atorvastatin - Codeine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt has localized rash that is red and warm to touch on her left arm where she received her Moderna Covid 19 booster shot on Thursday, 11/18/21 . Rash is itching with mild pain. Ppt is reporting that rash came up on Saturday morning. Size of rash is 14 X 8 cm. Pt had Pfizer 2 shot COVID 19 series and did not have this kind of reaction when she took that vaccine.


VAERS ID: 1894126 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH 8030 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Thirst
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (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: COVID?19 Pfizer
Other Medications: Co Q-10, 200 mg; calcium 650 mg w/ 1000 IU Vitamin D3; Acidophilus ProBiotic-4, 500 Million; Aspirin 81; Rosuvastatin Calcium, 20 mg; B-Complex 100; PepogestOmeprazole DR, 20 mg; Lisinopril, 40 mg; Amlodipine best late, 5 mg, D 3 2,000 IU
Current Illness: None
Preexisting Conditions: Chronic heart disease
Allergies: Morphine Seafood
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Headache, sore arm, chills, fatigue, very thirsty


VAERS ID: 1894128 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-11-15
Onset:2021-11-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 651-483-5461 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccine breakthrough infection
SMQs:

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

Write-up: Fully vaccinated with breakthrough infection. Inpatient stay


VAERS ID: 1894139 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Idaho  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Nausea, Pain, Restlessness, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

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

Write-up: Patient reports she received the booster vaccine yesterday evening. She had some mild aches/pains and some restlessness last night. A few hours ago, she developed nausea/vomiting, and her aches/pains intensified. She presented to the office for a Zofran injection which greatly resolved her nausea/vomiting. Her PCP advising she also takes 1000mg Tylenol TID for the next couple days to help with aches/pains. She understood.


VAERS ID: 1894152 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-11-22
Onset:2021-11-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211D21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DETAILED INFO NOT AVAILABLE AS PATIENT IS NOT A REGULAR CLIENT WITH THE PHARMACY, NO CHRONIC CONDITIONS AS PER CONSENT FORM
Current Illness: DETAILED INFO NOT AVAILABLE AS PATIENT IS NOT A REGULAR CLIENT WITH THE PHARMACY, NO CHRONIC CONDITIONS AS PER CONSENT FORM
Preexisting Conditions: DETAILED INFO NOT AVAILABLE AS PATIENT IS NOT A REGULAR CLIENT WITH THE PHARMACY, NO CHRONIC CONDITIONS AS PER CONSENT FORM
Allergies: NONE AS PER CONSENT FORM
Diagnostic Lab Data: information not available
CDC Split Type:

Write-up: UNCERTAIN


VAERS ID: 1894156 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-11-19
Onset:2021-11-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1620 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Blood test abnormal, Chest X-ray, Computerised tomogram normal, Electrocardiogram, Fibrin D dimer increased, Hypertension, Influenza like illness, Musculoskeletal chest pain
SMQs:, Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Epilepsy, Asthma, Depression, Bipolar
Allergies: Shellfish allergy, dust mite allergy, cockroach allergy
Diagnostic Lab Data: EKG, CT Scan, Chest Xray, Blood work - 11/22/21 D-Dimer in bloodwork appeared elevated which was the cause of the CT scan which the CT scan came back negative. They could not find the probable cause of the elevated D-Dimer and advised me to go home, take Tylenol/Ibuprofen and rest.
CDC Split Type:

Write-up: Took my second dosage on 11/19/21, experienced some flu like symptoms and a low grade temp of 99 on 11/20/21, felt fine 11/21/21 and woke up at 3:30 AM on 11/22/21 with severe pain in by rib cage, chest, and upper abdomen. Went to the emergency room that morning, got tired of waiting to be seen after waiting three hours and went home. Went to Urgent care where they checked by vitals and advised my blood pressure is high, recommended I go back to the emergency room. Went back around 10-11 AM in which they did an EKG, Blood work, CT Scan, and Chest X-ray on me. Blood work indicated that my D-Dimer was elevated and they did a CT Scan to check for bloodclots, but the CT scan came back negative.


VAERS ID: 1894158 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Electrocardiogram, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DOXYCYCLINE
Current Illness:
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data: EKG 11-23-21
CDC Split Type:

Write-up: VASOVAGAL SYNCOPE FAINTNESS FOLLOWING 30 MINUTES AFTER VACCINATION


VAERS ID: 1894167 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-11-23
Onset:2021-11-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033F21A / UNK - / SYR

Administered by: Public       Purchased by: ?
Symptoms: Dizziness, Seizure
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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

Write-up: Patient started to feel lightheaded and convulsed. He eventually slid down his chair and was caught by his parent. Our medical presiding Doctor tended to him and he felt better after some time with water and a snack bar. The ambulance came and he felt better at the moment and refused to go with them. Parents were with him and will be driving him to get his bloodwork done for further screening.


VAERS ID: 1894173 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-02-19
Onset:2021-11-23
   Days after vaccination:277
Submitted: 0000-00-00
Entered: 2021-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA N/A NOT GIVEN A / 1 - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA N/A NOT GIVEN A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Positive COVID-19 PCR test on 11/23/2021
CDC Split Type:

Write-up: Patient received two Moderna COVID-19 vaccines on 2/19/2021 and 3/16/2021, respectively, and was admitted to our hospital on 11/23/2021 and was tested positive with COVID-19 on 11/23/2021


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