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From the 11/12/2021 release of VAERS data:

Found 875,292 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 238 out of 8,753

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VAERS ID: 1840875 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dermatitis allergic, Fatigue, Inappropriate schedule of product administration, Myalgia, Nasopharyngitis, Pneumonia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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 INC202101403471

Write-up: Pneumonia; Dermatitis allergic; Fatigue; Myalgia; Nasopharyngitis; dose 1 on 25Aug2021/ dose 2 on 07Oct2021; This is a spontaneous report from a contactable healthcare professional via the Agency Regulatory Authority. Regulatory authority report number is 645385. A 43-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 07Oct2021 (Batch/Lot number was not reported) (at the age of 43-years-old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was previously administered with first dose of BNT162B2 (COMIRNATY) on 25Aug2021 for COVID-19 immunisation. On 14Oct2021, 7 days after vaccination, the patient experienced pneumonia, dermatitis allergic, fatigue, myalgia and nasopharyngitis. Outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1840907 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-06
Onset:2021-10-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7204 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Cardiac discomfort
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? 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:
CDC Split Type: CAPFIZER INC202101450384

Write-up: Inside pressure with moments of pain at the heart region. The pain is stronger when I do physical effort or sit on the bended on the chair.; Inside pressure with moments of pain at the heart region. The pain is stronger when I do physical effort or sit on the bended on the chair.; This is a spontaneous report from a contactable consumer or other non hcp. A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection via an unspecified route of administration, administered in Left Arm on 06Oct2021 12:00 (Batch/Lot Number: FD7204) as Dose 1, Single (age at vaccination: 55-years-old) for COVID19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not diagnosed with covid-19 before and tested post vaccination. On 07Oct2021 02:00 the patient experienced Inside pressure with moments of pain at the heart region. The pain is stronger when he was doing physical effort or sit on the bended chair. The events resulted in emergency room visit.The outcome of the events was not recovered No follow-up attempts possible. No further information is expected.


VAERS ID: 1841446 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-10-07
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Depression, Hyperventilation, Post-acute COVID-19 syndrome, Sleep apnoea syndrome
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (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:
CDC Split Type: FRPFIZER INC202101450199

Write-up: Possible sleep apnea to be explored; Diagnosis of long COVID; Hyperventilation syndrome; anxiety; depression; This is a spontaneous report from a contactable physician. This is the second of two reports. The first report is a report downloaded from the Regulatory Agency-WEB, regulatory authority number is FR-AFSSAPS-BX20219692. A 47-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date in May2021 (Lot number and expiration date was not reported) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY), via intramuscular on an unspecified date in Apr2021 (Lot number and expiration date was not reported) as DOSE 1, SINGLE for COVID-19 immunization and experienced vaccination failure, COVID-19, flu-like symptoms, headache, asthenia, sleep disturbance, mood disorder, respiratory disorder, anosmia, ageusia, tinnitus, diarrhea. The patient experienced diagnosis of long COVID, hyperventilation syndrome, anxiety, depression on 07Oct2021. Therapeutic measures were taken as a result of diagnosis of long COVID, hyperventilation syndrome, anxiety, depression. It was reported that possible sleep apnea was to be explored. The patient was also scheduled for thoracic computed tomography scan and consultation in pneumology department. The patient continued physiotherapy (including respiratory therapy). The outcome of sleep apnea was unknown and the outcome of other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101414830 Same patient, different product (dose), different adverse events


VAERS ID: 1841479 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Immunisation, Interchange of vaccine products, Off label use, Product use issue, Pruritus, Rash erythematous, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN; DOXAZOSIN; EVOREL CONTI
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HRT; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101418103

Write-up: Rash erythematous; Giant hives; Itching both hands; Off label use; Booster; Interchange of vaccine products; Product use for unapproved combination; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110141355015530-4BW4Z, Safety Report Unique Identifier GB-MHRA-ADR 26079165. A 74-year-old female patient received COMIRNATY (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Oct2021 (Lot Number: FF8222) as (at the age of 74-year-old) DOSE NUMBER UNKNOWN (BOOSTER), SINGLE for COVID-19 immunisation. Hisotrical vaccine included Covid-19 Vaccine (Primary Immunization series complete but unknown manufacturer). Medical history included hypertension, hormone replacement therapy. Concomitant medication(s) included CANDESARTAN taken for hypertension, start and stop date were not reported; DOXAZOSIN taken for hypertension, start and stop date were not reported; EVOREL CONTI taken for hormone replacement therapy, start and stop date were not reported; INFLUENZA VIRUS taken for an unspecified indication on 07Oct2021. The patient experienced itching both hands on 07Oct2021 with outcome of recovering, giant hives on 11Oct2021 with outcome of recovering, rash erythematous on an unspecified date with outcome of unknown. The clinical course was reported as generalized itching. Itching both hands. Itching hands started within day or two of having the vaccine and continues on and off still. It''s not there all the time. Itching head within day or two of the vaccine and is intermittent to date. Red itchy rash appearing in different parts of the body mainly over the torso and this is there most of the time. Large hives with smaller hives mid front torso. Although these symptoms haven''t completely gone away they respond to antihistamine. The outcome of the other events was unknown. Case reported as non serious. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 20Jul2021 No - Negative COVID-19 test. Patient has not had symptoms associated with COVID-19.Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1841490 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Muscular weakness, Off label use, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101401125

Write-up: pain in upper thighs; off label use; Booster; Muscle weakness; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110171625369690-FAOKL, Safety Report Unique Identifier GB-MHRA-ADR 26085536. A 96-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Oct2021 (Batch/Lot Number: FF8222) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) taken for an unspecified indication, start and stop date were not reported. The patient experienced muscle weakness on 07Oct2021 with outcome of not recovered, pain in upper thighs on an unspecified date with outcome of unknown. The events were reported as serious caused disability. The patient also experienced off label use and booster on an unspecified date with outcome of unknown. The clinical course was reported as follows: pain in upper thighs and general weakness in both legs. Patient has not tested positive for COVID-19 since having the vaccine. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1841571 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-06
Onset:2021-10-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101417816

Write-up: Migraine; This is a spontaneous report from a contactable consumer (patient) or other non HCP received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110201057581360-TAXLK, Safety Report Unique Identifier GB-MHRA-ADR 26097468. A 42-years-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/ Lot number: not reported) via an unspecified route of administration on 06Oct2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. No medications and no illnesses. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 07Oct2021 (after 1 day of vaccination), patient experienced migraine (medically significant). it was reported that Migraine was full blown by the morning after the vaccine (which she had at around 14.30 in the afternoon the day before). It was awful, and do not usually get migraines, and it lasted for 2 weeks. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on an unspecified date. The outcome of event was recovered with sequelae on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1841686 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal movement disorder, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (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: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101379951

Write-up: Significantly reduced baby movements and kicks; Maternal exposure during pregnancy (Second-trimester (13-28 weeks); This is 1 of 2 spontaneous report from a contactable consumer received from a Regulatory Authority. This consumer reported information for both mother and fetus/baby. This is a fetus/baby report. A Fetus patient of unspecified gender received bnt162b2 (COMIRNATY), dose 1 Transplacental on 07Oct2021 as DOSE 1, SINGLE for covid-19 immunization. The mother had not had symptoms associated with COVID-19 Not had a COVID-19 test. The mother had not tested positive for COVID-19 since having the vaccine. The mother was not enrolled in clinical trial. The mother''s medical history included: One previous miscarriage at 10 weeks; Pregnancy. The mother''s previously took influenza virus for immunisation on 21Sep2021. Concomitant medications included folic acid taken for vitamin supplementation. The patient experienced significantly reduced baby movements and kicks on 08Oct2021. Movements returned to normal from on 12Oct2021. The mother was exposed to the medicine Second-trimester (13-28 weeks). The outcome of events was recovered on 12Oct2021. Seriousness criteria reported as medical significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101367518 Mother case


VAERS ID: 1841765 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6270 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Body temperature, Chest pain, Cough, Diarrhoea, Dizziness, Oropharyngeal pain, Pulmonary pain, Pyrexia, SARS-CoV-2 test, Vertigo
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asymptomatic COVID-19; Headache (Headache, mild cortical osteosclerosis hands); Osteosclerosis (Headache, mild cortical osteosclerosis hands)
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 202103; Test Name: sars-cov-2 test; Test Result: Positive ; Comments: Positive asymptomatic on March 38, negative on April 8; Test Date: 20210408; Test Name: sars-cov-2 test; Test Result: Negative ; Comments: Positive asymptomatic on March 38, negative on April 8
CDC Split Type: ITPFIZER INC202101420568

Write-up: lot of cough; diarrhea; stomach ache; dizziness; sore throat; chest and lungs Pfizer full doses; After the vaccine I had a fever 39; chest and lungs Pfizer full doses; Head revolving around; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-799971. A 33-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FG6270), via an unspecified route of administration, administered in arm left on 07Oct2021 (at the age of 33-year-old) as dose 1, single for covid-19 immunization. Patient relevant medical history includes headache and mild cortical osteosclerosis hands and Positive asymptomatic COVID-19 in March 2021 to 08Apr2021. The patient concomitant medications were not reported. It was reported that, single dose because positive for Covid in March 2021 - Actions taken (Tachipirina without results and ferments) - Impact on quality of life (10/10). Positive asymptomatic on March 38, negative on April 8. After the vaccine the patient had a fever 39, dizziness, stomach-ache, diarrhoea and a lot of coughs, sore throat, head revolving around, chest and lungs Pfizer full doses. The patient underwent lab tests: body temperature: 39 Centigrade on an unspecified date, sars-cov-2 test on unspecified date in Mar2021: positive (Positive asymptomatic on March 38, negative on April 8) and negative (Positive asymptomatic on March 38, negative on April 8) on 08Apr2021. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Headache, mild cortical osteosclerosis hands


VAERS ID: 1841807 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Oxygen saturation, Oxygen saturation decreased, Throat irritation
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
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: Anaphylaxis
Allergies:
Diagnostic Lab Data: Test Date: 20211007; Test Name: BP; Result Unstructured Data: Test Result:118/90; Comments: 16:20; Test Date: 20211007; Test Name: pulse; Result Unstructured Data: Test Result:75; Comments: 16:20; Test Date: 20211007; Test Name: pulse; Result Unstructured Data: Test Result:71; Comments: 17:15; Test Date: 20211007; Test Name: Sat; Result Unstructured Data: Test Result:93-95 %; Comments: 16:20; Test Date: 20211007; Test Name: Sat; Test Result: 96 %; Comments: 16:50; Test Date: 20211007; Test Name: Sat; Test Result: 96 %; Comments: 17:15
CDC Split Type: JPPFIZER INC202101409535

Write-up: Oxygen saturation (Sat) 93-95%; itchy throat; This is a spontaneous report from a contactable pharmacist received from the- regulatory authority report number is v21129593. A 56-year and 4-month-old male patient received first dose of bnt162b2 (COMIRNATY; Lot Number: FF2782; Expiration Date: 30Nov2021) intramuscular on 07Oct2021 at 16:00 (at 56-year and 4-month-old) as single dose for covid-19 immunisation. Medical history included anaphylaxis diagnosed in 2019. The patient''s concomitant medications were not reported. Clinical course was as follows: on 07Oct2021 at 16:00, the patient received the first dose of bnt162b2 Intramuscular Injection. At 16:15, the patient experienced itchy throat. At 16:20, Blood pressure (BP) was 118/90, pulse (P) 75, Oxygen saturation (Sat) 93-95%. At 16:30, No aggravation of the symptoms. At 16:35, drip infusion and injection were instructed. SOLU-CORTEF 100 mg + saline 100mL (DIV), STRONGER NEO-MINOPHAGEN C (IV). At 16:50, Sat 96%. At 17:15, Sat 96%, P 71. The symptoms improved. As of 07Oct2021 (after the vaccination), the outcome of the event was recovering.The reporting pharmacist classified the event as non-serious and assessed the causality between the event and bnt162b2 as related. The reporting pharmacist commented as follows: The patient has been diagnosed with anaphylaxis in 2019. On examination, it was not anaphylaxis.; Reporter''s Comments: The patient has been diagnosed with anaphylaxis in 2019. On examination, it was not anaphylaxis.


VAERS ID: 1842425 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, Fall, Traumatic haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

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

Write-up: Head bruise and injury due to fall; Head bruise and injury due to fall; Head bleeding due to bruise and injury; This case was received via the RA (Reference number: JP-TAKEDA-2021TJP112586) on 26-Oct-2021 and was forwarded to Moderna on 01-Nov-2021. This case was reported by a prefectural staff via a medical representative. On an unknown date, the patient received the 1st dose of this vaccine. On 07-Oct-2021, the patient received the 2nd dose of this vaccine. After 30 minutes of follow-up after the vaccination, the patient fell when standing up from a chair. The patient had head bruise and bleeding due to injury at that time. The patient was raced to a hospital just in case. The patient returned home as there was no problem after examinations. The outcome of head bruise and injury due to fall and head bleeding due to bruise and injury was reported as resolved. Follow-up investigation will be made. Company Comment: Fall developed after the administration of the COVID-19 vaccine mRNA (mRNA 1273) and is temporally related to the COVID-19 vaccine mRNA (mRNA 1273). Contusion and traumatic haemorrhage developed after the administration of the COVID-19 vaccine mRNA (mRNA 1273), but the effects of concurrent events are also considered.; Sender''s Comments: This case concerns a male patient in the fourth decade of age with no reported medical history who experienced the unexpected serious events of fall, contusion and traumatic hemorrhage. The events occurred the same day after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1842537 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Myalgia, Neurological examination, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history as per SD
Allergies:
Diagnostic Lab Data: Test Date: 202110; Test Name: GCS; Result Unstructured Data: GCS:E4V5M6
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Asthenia; Pain; Systemic soreness; This regulatory authority case was reported by an other health care professional and describes the occurrence of ASTHENIA (Asthenia), PAIN (Pain) and MYALGIA (Systemic soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history as per SD. On 05-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced ASTHENIA (Asthenia) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant) and MYALGIA (Systemic soreness) (seriousness criterion medically significant). At the time of the report, ASTHENIA (Asthenia), PAIN (Pain) and MYALGIA (Systemic soreness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Neurological examination: e4v5m6 GCS:E4V5M6. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter Treatment product was not provided by the reporter It was reported that the patient age was 69 years 4 months. Patient blood type was A. patient experienced systemic soreness, pain and weakness till now after the second dose of Moderna''s vaccine, so the patient was sent to emergency room. He had smooth breathing. Company Comment: This case concerns a 69-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Asthenia, Pain, Myalgia. The events occurred approximately 2 days after the second dose of Moderna Covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna Covid -19 vaccine, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a permanent incapacity.; Sender''s Comments: This case concerns a 69-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Asthenia, Pain, Myalgia. The events occurred approximately 2 days after the second dose of Moderna Covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna Covid -19 vaccine, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a permanent incapacity.


VAERS ID: 1844459 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7387 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm, Arteriosclerosis, Atrial fibrillation, Brain natriuretic peptide, C-reactive protein, Electrocardiogram, Fall, Immunisation, Investigation, Ischaemic stroke, Magnetic resonance imaging head, Speech disorder, Troponin I increased, Ultrasound Doppler, Vomiting
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVOTHYROX; AMLODIPINE; COAPROVEL; XARELTO; NOVALDEX; TROSPIUM; CACIT D3; ESOMEPRAZOLE
Current Illness: AFib; Carcinoma in situ of breast ductal; Heart valve incompetence; Hypertension arterial; Hypothyroidism; Vascular atheroma
Preexisting Conditions: Medical History/Concurrent Conditions: Blind right eye; Breast carcinoma; Mastectomy
Allergies:
Diagnostic Lab Data: Test Date: 20211007; Test Name: brain natriuretic peptide; Result Unstructured Data: Test Result:273 pg/mL; Test Date: 20211007; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Cold; Test Date: 20211007; Test Name: Electrocardiography; Result Unstructured Data: Test Result:atrial fibrillation in ST segment at V5-6; Test Date: 20211007; Test Name: anti Xa XARELTO; Result Unstructured Data: Test Result:274 ng/ml; Test Date: 20211007; Test Name: Ion disorder; Result Unstructured Data: Test Result:no disorder; Test Date: 20211007; Test Name: Brain magnetic resonance imaging; Result Unstructured Data: Test Result:acute left frontal and temporoparietal ischaemic; Comments: acute left frontal and temporoparietal ischaemic lesions of different ages in the superficial left sylvian territory; Test Date: 20211007; Test Name: cardiac troponin I; Result Unstructured Data: Test Result:0.046 ug/L; Test Date: 20211007; Test Name: Doppler ultrasound of the supra-aortic trunks; Result Unstructured Data: Test Result:atheromatous infiltration; Comments: atheromatous infiltration of the common carotid arteries and carotid bifurcations without significant lesion, patency of the vertebra subclavian axis.
CDC Split Type: FRPFIZER INC202101414934

Write-up: Received third dose of COMIRNATY on 07Oct2021; Ischemic stroke; Fall; vomiting; difficulty in speaking; atrial fibrillation; cardiac troponin I 0.046 ug/l (0.000 - 0.016); brain natriuretic peptide; ascending aorta; atheromatous infiltration of the common carotid arteries; This is a spontaneous report from a contactable physician. This is the first of two reports. The first report is a report downloaded from the regulatory authority number FR-AFSSAPS-BS20211891. An 88-years-old female patient received bnt162b2 (COMIRNATY), dose 3 intramuscular, administered in Arm Left on 07Oct2021 (Batch/Lot Number: FE7387) as third dose (booster) (at the age of 88-years-old) for covid-19 immunisation. Medical history included ongoing arteriosclerosis , ongoing atrial fibrillation , ongoing hypothyroidism , breast cancer from 1991 to 1997, intraductal proliferative breast lesion from 2019 and ongoing , ongoing heart valve incompetence , ongoing hypertension , blindness unilateral, mastectomy from 2019 to an unknown date. Concomitant medications included levothyroxine sodium (LEVOTHYROX) taken for an unspecified indication, start and stop date were not reported; amlodipine taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, irbesartan (COAPROVEL) taken for an unspecified indication, start and stop date were not reported; rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported; tamoxifen citrate (NOVALDEX) taken for an unspecified indication, start and stop date were not reported; trospium taken for an unspecified indication, start and stop date were not reported; calcium carbonate, colecalciferol (CACIT D3) taken for an unspecified indication, start and stop date were not reported; esomeprazole taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of COMIRNATY Lot # EJ6788 intramuscular in left arm on 20Jan2021. The patient previously received second dose of COMIRNATY Lot # EP9598 intramuscular in left arm on 19Feb2021 and experienced atrial fibrillation, systolic murmur abnormal, ventricular hypertrophy and Stable hypertensive heart disease. On 07Oct2021, the patient was referred to the emergency room due to a fall of undetermined origin with vomiting and difficulty in speaking. Electrocardiography: atrial fibrillation in ST segment at V5 V6. Blood test: Cold C-reactive protein, no ion disorder, cardiac troponin I 0.046 ug/l (0.000 - 0.016), brain natriuretic peptide 273 pg/ml (0 -100), anti Xa XARELTO 274 ng/ml. Brain magnetic resonance imaging: acute left frontal and temporoparietal ischaemic lesions of different ages in the superficial left sylvian territory. Doppler ultrasound of the supra aortic trunks: atheromatous infiltration of the common carotid arteries and carotid bifurcations without significant lesion, patency of the vertebra subclavian axis. In conclusion, left sylvian ischemic stroke at Day 0 of a Dose 3 COMIRNATY in a female patient with breast cancer, persistent atrial fibrillation, ascending aorta and atheromatous carotids. The outcome of all events was resolving. All events were serious with hospitalization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1844609 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood immunoglobulin A, Blood pressure measurement, Chest discomfort, Coagulation time, Interchange of vaccine products, Off label use, Pruritus, Rash papular, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CYCLIZINE; IBUPROFEN; LORATADINE; PARACETAMOL; PROPRANOLOL
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Anxiety; Clinical trial participant; Clot blood; Dust allergy; Headache; Nausea; Postural orthostatic tachycardia syndrome; Raised blood pressure
Allergies:
Diagnostic Lab Data: Test Name: IgA; Result Unstructured Data: Test Result:Low; Comments: Low IgA of 0.4-0.5; Test Name: blood pressure; Result Unstructured Data: Test Result:slightly raised; Test Name: blood clotting time; Result Unstructured Data: Test Result:Slightly prolonged; Test Date: 20210409; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101417740

Write-up: heavy chest; hives; itchy; Raised rash; Itchy skin; Tight chest; off label use; interchange of vaccine products; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202110190019163000-ONURA, Safety Report Unique Identifier GB-MHRA-ADR 26090348. A 30-year-old male patient received the third dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FJ5782), via an unspecified route of administration on 07Oct2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Medical history included clot blood from an unknown date and unknown if ongoing, postural orthostatic tachycardia syndrome from an unknown date and unknown if ongoing, dust allergy from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, suspected covid-19 from 23Mar2020 and ongoing, clinical trial participant from an unknown date and unknown if ongoing, raised blood pressure from an unknown date and unknown if ongoing, headache from an unknown date and unknown if ongoing , nausea from an unknown date and unknown if ongoing , Allergy from an unknown date and unknown if ongoing. Concomitant medication(s) included influenza vaccine (INFLUENZA VIRUS) taken for immunisation on 02Oct2021; cyclizine (MANUFACTURER UNKNOWN) taken for nausea, start and stop date were not reported; ibuprofen (MANUFACTURER UNKNOWN) taken for headache, start and stop date were not reported; loratadine (MANUFACTURER UNKNOWN) taken for allergy , start and stop date were not reported; paracetamol (MANUFACTURER UNKNOWN) taken for headache, start and stop date were not reported; propranolol (MANUFACTURER UNKNOWN) taken for postural orthostatic tachycardia syndrome, start and stop date were not reported. The patient previously received first dose of COVID-19 VACCINE ASTRAZENECA (COVID-19 VACCINE ASTRAZENECA, Batch/Lot Number: unknown) via an unspecified route of administration on 21Jan2021 for COVID-19 immunization and second dose of COVID-19 VACCINE ASTRAZENECA (COVID-19 VACCINE ASTRAZENECA, Batch/Lot Number: unknown) via an unspecified route of administration on 27Mar2021 for COVID-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. On an unspecified date in 2021, the patient experienced heavy chest, hives, itchy and on 12Oct2021, the patient had raised rash, itchy skin, tight chest. Patient had raised red lumps started on chest around 4 days after booster. Over several days more formed on legs, under his arms, back, testicles and in my hair. Very itchy, occasionally warm and red. Look and feel like bites but doesn''t appear to be bites. Doesn''t look like typical Hives. Occasionally have a heavy chest especially when laying down. Antihistamines seem to take the edge off. Symptoms come and go. Still finding new lumps 11 days after booster but the number is declining. Seriousness criteria was reported as other medically important condition. The patient underwent lab tests and procedures which included blood immunoglobulin A: Low IgA of 0.4-0.5, blood clotting time: slightly prolonged, blood pressure: slightly raised; all three on an unspecified date, sars-cov-2 test: yes - positive covid-19 test on 09Apr2021. General Practitioner advised antihistamine. Study details were reported as Office for National Statistics monthly swab and blood test. The report does not relate to possible inflammation of the heart. The outcome of heavy chest, hives, itchy, tight chest was resolving, raised rash, itchy skin was not resolved. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1844628 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF822 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Immunisation, Off label use, SARS-CoV-2 test
SMQs:, Hearing impairment (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Date: 20211019; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101418078

Write-up: Palsy Bells; Off label use; Booster; This is a spontaneous report from a contactable Other HCP. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202110191142343450-SSSPE, Safety Report Unique Identifier GB-MHRA-ADR 26091606. A 51-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number FF822), via an unspecified route of administration at single dose on 07Oct2021 (at the age of 51-years-old) for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration, dose 1, single on 15Jan2021 as single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: was not reported) via an unspecified route of administration on 29Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history included steroid therapy from an unknown date and unknown if ongoing Taking regular steroid treatment (e.g. orally or rectally). The patient concomitant medications were not reported. The patient experienced palsy bells on 08Oct2021, off label use on 07Oct2021, booster on 07Oct2021. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 19Oct2021 (No - Negative COVID-19 test). No causality assessment was provided. The patient not had symptoms associated with COVID-19. Date of LMP: 10Oct2021. On steroids patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The events was reported as eventually disability and non-serious. The outcome of the events was recovering for Palsy Bells. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1844703 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pain in extremity, Sweating fever
SMQs:, Tendinopathies and ligament disorders (broad), 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: FLUOXETIN; OESTROGEL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Perimenopausal symptoms; Perimenopause; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101417993

Write-up: Aching in limb; Sweating fever; Painful arm; BNT162B2 (Comirnaty) on 07Oct2021 as third booster dose; BNT162B2 (Comirnaty) on 07Oct2021 as third booster dose; BNT162B2 (Comirnaty) on 07Oct2021 as third booster dose; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110201312369330-BXNWQ, Safety Report Unique Identifier GB-MHRA-ADR 26098750. A 48-year-old female patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 07Oct2021 (Lot Number: Fg3712) at the age of 48 years old, as third booster dose, single for COVID-19 immunisation. Medical history included non-ongoing suspected COVID-19 from 16Mar2020 to 27Mar2020, clinical trial participant, perimenopausal symptoms, and perimenopause. The patient has not had a COVID-19 test. Patient is not pregnant and not currently breastfeeding. Concomitant medications included FLUOXETIN for perimenopausal symptoms from 01Sep2021; and OESTROGEL for perimenopause from 01Aug2021. The patient previously took COVID-19 Vaccine for covid-19 immunization (Primary Immunization series complete but unknown manufacturer). On 07Oct2021, the patient experienced painful arm. On 08Oct2021, the patient experienced aching in limb and sweating fever. Outcome of the event aching in limb was recovered on 09Oct2021, event painful arm was recovered on 14Oct2021, and event sweating fever was recovered on 10Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1845071 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood test, Chills, Dyspnoea, Inappropriate schedule of product administration, Malaise, Nausea, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; IBUPROFEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test for pulmonary embolism; Result Unstructured Data: Test Result:Result was good; Test Date: 20210809; Test Name: corona, bevconfirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC202101413725

Write-up: Syncope/I passed out twice; Weakness/I feel very weak every day and I passed out twice because of this; not feeling well; Cold shivers; Dyspnoea/I am short of breath every day these days. I can no longer walk without being short of breath.; Nausea; inappropriate schedule of vaccine administered: second dose on 07Oct2021 and first dose on 30Jul2021; This is a spontaneous report from a contactable consumer (patient). This is the 1st of 2 reports, for the second dose. The report downloaded from the regulatory authority number NL-LRB-00700075. A 24-year-old female patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 07Oct2021 (Lot Number: FF2834) as DOSE 2, SINGLE for covid-19 immunisation. Medical history was not provided. Concomitant medications included paracetamol and ibuprofen. Historical Vaccine included the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 30Jul2021 as DOSE 1, SINGLE for covid-19 immunisation, and patient experience Myalgia/Muscle pain and fever (onset on 30Jul2021) and Covid-19 from 09Aug2021 to an unknown date under dose 1. The patient experienced syncope/I passed out twice; weakness/I feel very weak every day and I passed out twice because of this; not feeling well; cold shivers; dyspnoea/I am short of breath every day these days and I can no longer walk without being short of breath; nausea, above events all occurred on 08Oct2021. And patient experienced inappropriate schedule of vaccine administered: second dose on 07Oct2021 and first dose on 30Jul2021 on an unspecified date. The patient underwent lab tests and procedures which included Blood test for pulmonary embolism: result was good; "corona, bevconfirmed with test": positive on 09Aug2021. The outcome of events syncope and nausea was recovering; of events weakness, not feeling well, cold shivers and dyspnoea was not recovered. Sender''s comment: Since the nature of the reported reaction does not imply seriousness according to one of the CIOMS critera, the report was considered as non-serious by No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101436859 the same reporter/patient, different event/dose


VAERS ID: 1845685 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-10-07
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 055E21A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Carbuncle, Cellulitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Cellulitis; Fever, Cellulitis, Carbuncle; Fever; This regulatory authority case was reported by an other health care professional and describes the occurrence of CELLULITIS (Cellulitis), CARBUNCLE (Fever, Cellulitis, Carbuncle) and PYREXIA (Fever) in a 54-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 055E21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Sep-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criteria hospitalization and medically significant), CARBUNCLE (Fever, Cellulitis, Carbuncle) (seriousness criterion hospitalization) and PYREXIA (Fever) (seriousness criterion hospitalization). At the time of the report, CELLULITIS (Cellulitis), CARBUNCLE (Fever, Cellulitis, Carbuncle) and PYREXIA (Fever) was resolving. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication was provided. No Treatment medication was provided. Company comment- This case concerns a 54-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of cellulitis, carbuncle, and pyrexia. The event pyrexia is unexpected as it is retained as serious per the source document Authority reporting. The events occurred 22 days after the dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since no dose number was reported. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. Events term, onset date, outcome and seriousness captured per source document from Regulatory Authority reporting.; Sender''s Comments: This case concerns a 54-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of cellulitis, carbuncle, and pyrexia. The event pyrexia is unexpected as it is retained as serious per the source document Authority reporting. The events occurred 22 days after the dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since no dose number was reported. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. Events term, onset date, outcome and seriousness captured per source document from Regulatory Authority reporting.


VAERS ID: 1847133 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-06
Onset:2021-10-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Coronary artery disease, Eosinophilia, General physical health deterioration, Goitre, Immunisation, Pneumonia
SMQs:, Eosinophilic pneumonia (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: DEPFIZER INC202101454089

Write-up: Community acquired pneumonia of the right lower lobe; passive eosinophilia; coronary artery disease; euthyroid goiter nodosa; Booster dose; Chills; progressive deterioration of general condition; This is a spontaneous report from a contactable physician (patient) based on information received by Pfizer from Biontech [manufacturer control number: 93994, license party for Comirnaty]. A 55-year-old male patient received the third dose of BNT162b2 (COMIRNATY; solution for injection; Lot Number: Unknown) via an unspecified route of administration on 06Oct2021 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first and second doses of COVID-19 vaccine (MANUFACTURER UNKNOWN), both via an unspecified route of administration on unspecified dates as single doses for COVID-19 immunization. On 07Oct2021, the patient experienced chills and progressive deterioration of general condition and on an unspecified date the patient experienced, community acquired pneumonia of the right lower lobe, passive eosinophilia, coronary artery disease and euthyroid goiter nodosa. The events were serious for hospitalization on 12Oct2021. The course of the events was reported as follows: chills on the day after vaccination, progressive deterioration of general condition. Inpatient admission to the hospital 5 days later. Diagnosis: Community acquired pneumonia of the right lower lobe, passive eosinophilia after COVID 19 vaccination, coronary artery disease, euthyroid goiter nodosa. The clinical outcomes of the events chills, progressive deterioration of general condition, community acquired pneumonia of the right lower lobe, passive eosinophilia, coronary artery disease and euthyroid goiter nodosa were not recovered/not resolved (still experiencing side effect). The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the available information, a possible contributory role of vaccination with third dose of BNT162B2 to the reported events chills, progressive deterioration of general condition, community acquired pneumonia of the right lower lobe and passive eosinophilia cannot be excluded considering the plausible drug-event temporal association. The reported coronary artery disease and euthyroid goiter nodose are more likely intercurrent conditions and unrelated to vaccination with BNT162B2. 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: 1847678 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF82222 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101428772

Write-up: Fatigue extreme; Booster; This is a solicited report from a Regulatory Authority from a contactable consumer. This is a report received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-YCVM-202110231813264500-CWHHA. Safety Report Unique Identifier GB-MHRA-ADR 26114012. An 80-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Oct2021 (at the age of 80 years) (Batch/Lot Number: FF82222) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced fatigue extreme on 07Oct2021. The outcome of the event was recovered on 09Oct2021. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the available information, plausible temporal association and known drug safety profile, the event fatigue is assessed as related to the suspect drug. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 1847682 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hallucination, Headache, Immunisation, Off label use
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101439348

Write-up: booster; booster; Headache; Dizziness; Hallucinations; This is a spontaneous report from a non-contactable healthcare professional (patient). A 33-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in arm right on 07Oct2021 at 14:45 (Lot Number: Ff8288) as dose 3 (booster), single (at the age of 33 years old) for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 12Jan2021 (Batch/Lot No: Bnt16262, as reported) as dose 1 administered arm right, then on 06Apr2021 as dose 2 (Batch/Lot No: Em4965) administered in arm right for COVID-19 immunisation. The patient experienced headache, dizziness, hallucinations on 07Oct2021 at 15:30 (events assessed as medically significant). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information in the case report, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1847905 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysarthria, Hemiparesis, Lacunar infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: BEZAFIBRAT; GLICLAZIDE; GLUCIENT; PERINDOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (allergy: calcium antagonists)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101437818

Write-up: Lacunar infarction; right hemiparesis; Dysarthria; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00697028. A 63-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 07Oct2021 (at the age of 63-year-old) (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included for nifedipin and calciumantagonists. Concomitant medication(s) included bezafibrate (BEZAFIBRAT, tablet mga 400mg); gliclazide (GLICLAZIDE, tablet mga 30mg); metformin hydrochloride (GLUCIENT, tablet mga 500mg); perindopril (PERINDOPRIL, tablet 4mg), all taken for an unspecified indication, start and stop date were not reported. No previous COVID-19 infection. The patient experienced lacunar infarction in the left a. cerebri media (ACM) (hospitalization) on 07Oct2021 (within 1 day from vaccination) with outcome of recovering, right hemiparesis (medically significant) on an unspecified date with outcome of unknown, dysarthria (non-serious) on an unspecified date with outcome of unknown. Hospitalization information: for lacunar infarction in the left a. cerebri media Recording of 24 hours before observation. The clinical course of events was as follows: lacunar infarction in a. cerebri media (caused or prolonged hospitalization) following his first administration of COVID-19 vaccine Pfizer injection fluid (action taken: not applicable) for COVID 19 immunisation. The patient was treated with double therapy with thrombocyte aggregation inhibitors. The patient was recovering from lacunar infarction. Confounding factors, allergy: nifedipine, calcium channel blockers. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1848020 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-04
Onset:2021-10-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine, Blood glucose, Blood pressure abnormal, Body temperature, Carotid artery disease, Cerebral haemorrhage, Coma scale, Computerised tomogram head, Epilepsy, Heart rate, Hyperglycaemia, Infection, Intracranial pressure increased, Ischaemic stroke, Nystagmus, Perfusion brain scan, Pyrexia, Seizure, Syncope, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211007; Test Name: creatinine; Result Unstructured Data: 0.6-1.3 mg/dL; Test Date: 20211007; Test Name: Random glucose; Result Unstructured Data: Random glucose 163 mg/dL, mild hyperglycemia; Test Date: 20211007; Test Name: Body Temperature; Result Unstructured Data: 35.9 degree celsius; Test Date: 20211007; Test Name: GCS; Result Unstructured Data: E4V5M6; Test Date: 20211007; Test Name: Brain CT; Result Unstructured Data: Showed no bleeding; Test Date: 20211008; Test Name: Brain CT; Result Unstructured Data: Showed multiple acute hemorrhages (acute ischemic change with hemorrhage); Test Date: 20211009; Test Name: Brain CT; Result Unstructured Data: Showed no expansion of bleeding; Test Date: 20211007; Test Name: Heart Rate; Result Unstructured Data: 56 beats per minute; Test Date: 20211007; Test Name: brain perfusion; Result Unstructured Data: Well brain perfusion; Test Date: 20211007; Test Name: white blood cells; Result Unstructured Data: Blood test results showed mild increase in white blood cells (10640/?L)
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Convulsion; Brain CT and MTI showed multiple acute hemorrhages (acute ischemic change with hemorrhage); Mild hyperglycemia; Symptoms of nystagmus; Maintaining blood pressure 120-160mmHg; Fever; Developed weak carotid artery after drinking alcohol and was admitted to the emergency department; Infection; Lowering cerebral pressure; Symptoms of epilepsy; Ischemic stroke; Developed syncope; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of ISCHAEMIC STROKE (Ischemic stroke), SYNCOPE (Developed syncope), SEIZURE (Convulsion), CAROTID ARTERY DISEASE (Developed weak carotid artery after drinking alcohol and was admitted to the emergency department), INFECTION (Infection), INTRACRANIAL PRESSURE INCREASED (Lowering cerebral pressure), EPILEPSY (Symptoms of epilepsy), CEREBRAL HAEMORRHAGE (Brain CT and MTI showed multiple acute hemorrhages (acute ischemic change with hemorrhage)), HYPERGLYCAEMIA (Mild hyperglycemia), NYSTAGMUS (Symptoms of nystagmus), BLOOD PRESSURE ABNORMAL (Maintaining blood pressure 120-160mmHg) and PYREXIA (Fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced ISCHAEMIC STROKE (Ischemic stroke) (seriousness criteria hospitalization prolonged and medically significant), SYNCOPE (Developed syncope) (seriousness criteria hospitalization and medically significant), CAROTID ARTERY DISEASE (Developed weak carotid artery after drinking alcohol and was admitted to the emergency department) (seriousness criteria hospitalization and medically significant), INFECTION (Infection) (seriousness criterion hospitalization), INTRACRANIAL PRESSURE INCREASED (Lowering cerebral pressure) (seriousness criteria hospitalization and medically significant), EPILEPSY (Symptoms of epilepsy) (seriousness criteria hospitalization and medically significant), HYPERGLYCAEMIA (Mild hyperglycemia) (seriousness criterion hospitalization), NYSTAGMUS (Symptoms of nystagmus) (seriousness criterion hospitalization), BLOOD PRESSURE ABNORMAL (Maintaining blood pressure 120-160mmHg) (seriousness criterion hospitalization) and PYREXIA (Fever) (seriousness criterion hospitalization). On 08-Oct-2021, the patient experienced CEREBRAL HAEMORRHAGE (Brain CT and MTI showed multiple acute hemorrhages (acute ischemic change with hemorrhage)) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced SEIZURE (Convulsion) (seriousness criteria hospitalization and medically significant). The patient was treated with DIAZEPAM for Convulsions, at an unspecified dose and frequency; LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for Nystagmus, at an unspecified dose and frequency; AMPICILLIN SODIUM, SULBACTAM SODIUM (UNASYN [AMPICILLIN SODIUM;SULBACTAM SODIUM]) for Fever and Infection, at a dose of UNK UNK, q8h; PIRACETAM (ROFEW) for Perfusion brain scan, at a dose of UNK UNK, bid; LABETALOL HYDROCHLORIDE (TRANDATE) for Hypertension, at a dose of 12.5 milligram as required; NICARDIPINE HYDROCHLORIDE (HOLDIPINE) for Hypertension, at a dose of UNK UNK, prn; MANNITOL for Intracranial pressure increase, at a dose of 100 ml every eight hours; Surgery (intra-arterial thrombectomy procedure) for Seizure and Surgery (Intra-arterial thrombectomy) for Nystagmus. At the time of the report, ISCHAEMIC STROKE (Ischemic stroke), SYNCOPE (Developed syncope), SEIZURE (Convulsion), CAROTID ARTERY DISEASE (Developed weak carotid artery after drinking alcohol and was admitted to the emergency department), INFECTION (Infection), INTRACRANIAL PRESSURE INCREASED (Lowering cerebral pressure), EPILEPSY (Symptoms of epilepsy), CEREBRAL HAEMORRHAGE (Brain CT and MTI showed multiple acute hemorrhages (acute ischemic change with hemorrhage)), HYPERGLYCAEMIA (Mild hyperglycemia), NYSTAGMUS (Symptoms of nystagmus), BLOOD PRESSURE ABNORMAL (Maintaining blood pressure 120-160mmHg) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2021, Blood creatinine: increased (High) 0.6-1.3 mg/dL. On 07-Oct-2021, Blood glucose: 163 mg/dl (High) Random glucose 163 mg/dL, mild hyperglycemia. On 07-Oct-2021, Body temperature: 35.9 degree celsius (abnormal) 35.9 degree celsius. On 07-Oct-2021, Coma scale: e4v5m6 (abnormal) E4V5M6. On 07-Oct-2021, Computerised tomogram head: normal (normal) Showed no bleeding. On 07-Oct-2021, Heart rate: 56 (abnormal) 56 beats per minute. On 07-Oct-2021, Perfusion brain scan: normal (normal) Well brain perfusion. On 07-Oct-2021, White blood cell count: 10640/?l (High) Blood test results showed mild increase in white blood cells (10640/?L). On 08-Oct-2021, Computerised tomogram head: abnormal (abnormal) Showed multiple acute hemorrhages (acute ischemic change with hemorrhage). On 09-Oct-2021, Computerised tomogram head: normal (normal) Showed no expansion of bleeding. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. On 08-Oct-2021, based on the consultation of neurosurgery, patient was recommended to monitor GCS and controlled blood pressure/cerebral pressure and continued without necessity of surgical treatment. On 11-Oct-2021, the patient''s vital signs were stable under the control of the drug, and the further rehabilitation exercise was expected to conduct. Company comment: This case concerns a 71 year-old male patient with no reported medical history who experienced the unexpected serious adverse events of special interest ischemic stroke, cerebral hemorrhage, epilepsy as well as syncope, increased intracranial pressure, hyperglycemia, nystagmus, hyperglycemia, abnormal blood pressure, infection and pyrexia. The events occurred approximately 4 to 5 days after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 71 year-old male patient with no reported medical history who experienced the unexpected serious adverse events of special interest ischemic stroke, cerebral hemorrhage, epilepsy as well as syncope, increased intracranial pressure, hyperglycemia, nystagmus, hyperglycemia, abnormal blood pressure, infection and pyrexia. The events occurred approximately 4 to 5 days after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1851857 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-10-07
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 2 - / 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: FAMOSAN; TREXAN (METHOTREXATE); MELOXICAM MYLAN; SORTIS; CALCICHEW; ZALDIAR; FORTRANS [MACROGOL 4000;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE;SODIUM SULFATE ANHYDRO; FORTILIP; MILURIT; GODASAL; GLUCOPHAGE XR; ACIDUM FOLICUM; DI
Current Illness: Arterial hypertension (compensated on medication); Atherogenic dyslipidemia; Coxarthrosis; Genu valgum; Gonarthrosis; Hyperglyceridaemia (3,5 mmol/l); Hyperuricemia; Seropositive RA; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Carpal tunnel syndrome (after surgery of both wrists); Fracture Colles''; Hysterectomy; Ischemic cerebral infarction; Salpingo-oophorectomy; Scapholunate dissociation; Sigmoid diverticulosis
Allergies:
Diagnostic Lab Data: Test Date: 20211007; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20211008; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: CZPFIZER INC202101437314

Write-up: Drug ineffective; COVID-19 disease; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number CZ-CZSUKL-21011230. This case was split to capture at risk event after 2nd dose. This is first of two report - for both doses (LOE scenario). Second report (for the 2nd dose) AER: 202101480350. A 67-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FC2473), via intramuscular route administered on 01Jun2021 as dose 2, single and first dose via intramuscular route administered on 20Apr2021 (Lot Number: EW4815) as dose 1, single for COVID-19 immunization. Medical history included ischaemic cerebral infarction from 15May2019, diverticulum intestinal from 14Jul2016, ongoing type 2 diabetes mellitus, ongoing hyperuricaemia, scapholunate dissociation, hysterectomy from 2007, ongoing Gonarthrosis, radius fracture, carpal tunnel syndrome (after surgery of both wrists), ongoing Coxarthrosis, ongoing Atherogenic dyslipidemia, ongoing Genu valgum, Salpingo-oophorectomy from 2007, ongoing Hyperglyceridaemia: 3,5 mmol/l, ongoing Seropositive RA and ongoing Arterial hypertension: compensated on medication. Concomitant medications included famotidine (FAMOSAN), methotrexate (TREXAN (METHOTREXATE)), meloxicam (MELOXICAM MYLAN), atorvastatin calcium (SORTIS), calcium carbonate (CALCICHEW), paracetamol, tramadol hydrochloride (ZALDIAR), macrogol 4000, potassium chloride, sodium bicarbonate, sodium chloride, sodium sulfate anhydrous (FORTRANS [MACROGOL 4000;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE;SODIUM SULFATE ANHYDROUS]), fenofibrate (FORTILIP), allopurinol (MILURIT), acetylsalicylic acid, glycine (GODASAL), metformin hydrochloride (GLUCOPHAGE XR), acidum folicum (ACIDUM FOLICUM), gliclazide (DIAPREL), indapamide, perindopril arginine (PRESTARIUM NEO COMBI), empagliflozin (JARDIANCE) and methylprednisolone (MEDROL [METHYLPREDNISOLONE]) taken for an unspecified indication, start and stop date were not reported.On 07Oct2021, the patient experienced Drug ineffective and Covid-19 disease. The patient underwent lab tests which included SARS-Cov-2 test positive on 07Oct2021 and SARS-Cov-2 test positive on 08Oct2021. The outcome of event Covid-19 disease was recovering. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : CZ-PFIZER INC-202101480350 same patient, different vaccine doses


VAERS ID: 1852131 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH9951 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood creatine phosphokinase increased, Body temperature, Chills, Feeling abnormal, Gait disturbance, Immunisation, Muscle spasms, Pyrexia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211007; Test Name: Creatine kinase; Result Unstructured Data: Test Result:almost 6000; Test Date: 20211007; Test Name: body temperature; Result Unstructured Data: Test Result:38.8 Centigrade
CDC Split Type: FIPFIZER INC202101437391

Write-up: booster; Blood creatine phosphokinase increased; Tremor; Feeling abnormal; Pyrexia / 38.8c; Walking difficulty; Cramps calf; Chills; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority, company number FI-FIMEA-20215671. A 29-years-old female patient received third (booster) dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Oct2021 (Batch/Lot Number: FH9951) (at the age of 29-years-old ) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Oct2021 the patient experienced blood creatine phosphokinase increased, tremor, feeling abnormal, pyrexia 38.8C, walking difficulty, cramps calf and chills. It was reported that symptoms started the same evening of vaccine on 07Oct2021 with fever (38.8C), ague, shaking. On Friday, the fever continued. On Saturday, cramping of the calves. On Sunday, the patient could no longer walk with the legs. The calves felt like they were going to explode, bubbling. On Sunday she went to the emergency room, lab tests showed Creatine kinase of almost 6000. Under hydration overnight in hospital. Heavy physical strain on 05Oct2021 preceding the vaccine. But before on Saturday, walking was possible normally. The symptoms began after the vaccine. The events were considered serious as hospitalization. The outcome of the events was recovering. No follow-up attempts are needed. No further information expected.


VAERS ID: 1852329 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-06
Onset:2021-10-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, C-reactive protein, Chest pain, Echocardiogram, Electrocardiogram, Fibrin D dimer, Pericarditis, Platelet count, Troponin
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: Creatine phosphokinase; Result Unstructured Data: Test Result:97 IU/l; Test Date: 20211015; Test Name: Protein C-reactive; Result Unstructured Data: Test Result:0.6 mg/l; Test Date: 20211016; Test Name: Echocardiography; Result Unstructured Data: Test Result:hyperechoic inferior-posterior pericardium; Comments: Normal left ventricular ejection fraction, non-dilated left ventricle, no valvulopathy, normal Systolic Pulmonary Artery Pressure, hyperechoic inferior-posterior pericardium consistent with acute post-vaccination pericarditis sicca; Test Date: 20211016; Test Name: ECG; Result Unstructured Data: Test Result:Regular sinus rhythm concave aspect diffuse ST ele; Comments: Regular sinus rhythm concave aspect diffuse ST elevation; Test Date: 20211015; Test Name: D-dimer; Result Unstructured Data: Test Result:270 ng/ml; Test Date: 20211016; Test Name: D-dimer; Result Unstructured Data: Test Result:300 ng/ml; Test Date: 20211015; Test Name: platelet count; Result Unstructured Data: Test Result:254000 /mm3; Test Date: 20211016; Test Name: platelet count; Result Unstructured Data: Test Result:263000 /mm3; Test Date: 20211016; Test Name: troponin; Result Unstructured Data: Test Result:<0.002 ng/ml; Test Date: 20211015; Test Name: troponin; Result Unstructured Data: Test Result:<3 ng/L
CDC Split Type: FRPFIZER INC202101437743

Write-up: chest pain; Pericarditis/pericarditis sicca; This is a spontaneous report from a contactable physician downloaded from the RA, regulatory authority number FR-AFSSAPS-NY20214789. A 31-years-old male patient received the first dose of bnt162b2 (COMIRNATY) intramuscular on 06Oct2021 (Lot Number: FG7387) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis on 07Oct2021, chest pain on 16Oct2021. Emergency room visit on 16Oct2021 for chest pain. Diagnosis of pericarditis sicca, ongoing medical care with medication. Discharged. The events resulted in visit to emergency room and ongoing medical care with medication. Therapeutic measures were taken as a result of pericarditis and chest pain. The patient underwent lab tests and procedures which included Creatine phosphokinase (normal high 190): 97 IU/L on 15Oct2021, Protein C-reactive (normal high 5): 0.6 mg/l on 15Oct2021, Echocardiography: Normal left ventricular ejection fraction, non-dilated left ventricle, no valvulopathy, normal Systolic Pulmonary Artery Pressure, hyperechoic inferior-posterior pericardium consistent with acute post-vaccination pericarditis sicca on 16Oct2021, ECG: Regular sinus rhythm concave aspect diffuse ST elevation on 16Oct2021, D-dimer: 270 ng/ml on 15Oct2021, D-dimer: 300 ng/ml on 16Oct2021, platelet count: 254000 /mm3 on 15Oct2021, platelet count: 263000 /mm3 on 16Oct2021, troponin: <0.002 ng/ml on 16Oct2021, troponin (normal high15): <3 ng/l on 15Oct2021. Outcome of the events pericarditis and chest pain was unknown. This is serious report. No follow-up attempts are needed. No further information expected.


VAERS ID: 1852710 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Immunisation, Muscular weakness, Off label use, Transient ischaemic attack
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life 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: BURINEX; CLOPIDOGREL; ELIQUIS; MIRTAZAPINE; MONTELUKAST; COMBODART; INSPRA; ESOMEPRAZOLE; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Flu prophylaxis
Allergies:
Diagnostic Lab Data: Test Name: Brain CT; Result Unstructured Data: Test Result:Results not provided
CDC Split Type: IEPFIZER INC202101435732

Write-up: weakness in arms and legs; TIA; vaccinated with the booster dose of COMIRNATY; vaccinated with the booster dose of COMIRNATY; This is a spontaneous report from a contactable other health professional downloaded from the regulatory authority number IE-HPRA-2021-085435, Safety Report Unique Identifier IE-HPRA-2021-085435. An 85-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 07Oct2021 (Batch/Lot number was not reported) (at the age of 85-year-old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included flu prophylaxis. Concomitant medications included bumetanide (BURINEX), clopidogrel, apixaban (ELIQUIS), mirtazapine, montelukast, dutasteride, tamsulosin hydrochloride (COMBODART), eplerenone (INSPRA), esomeprazole, and atorvastatin, all taken for unspecified indications, start and stop date were not reported; and INFLUENZA VACCINE (brand unspecified) on 07Oct2021 for flu prophylaxis. Historical vaccine included COVID-19 Vaccine (Unknown Manufacturer), dose 1 and dose 2, both on unspecified dates for COVID-19 immunisation. On 07Oct2021, the patient was vaccinated with the booster dose of COMIRNATY. The patient received COVID booster and flu vaccination on same day. On 08Oct2021, 1 day later, the patient experienced weakness in arms and legs and transient ischaemic attack (TIA). The reported seriousness for both events was serious: hospitalization and medically significant. The patient was treated with aspirin (brand unspecified). The patient underwent a Brain CT (unknown date), but the results not provided. At the time of reporting, the outcome of the events weakness in arms and legs and TIA was not recovered (symptoms were persisting). No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1852760 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 2701995 / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER 2701995 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood culture, Chills, Computerised tomogram head, Computerised tomogram thorax, Conjunctival hyperaemia, Culture urine, Dyspnoea, Electrocardiogram, Hypotension, Investigation, Medical counselling, Miosis, Presyncope, Respiratory failure, Skin discolouration, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Conjunctival disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DEPAKIN; CARBOLITHIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Delusional disorder, unspecified type; Obesity (third degree obesity); Venous insufficiency (Bilateral venous insufficiency of the lower limbs)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood culture; Result Unstructured Data: Test Result:Unknown; Test Date: 2021; Test Name: Brain computerised tomography; Result Unstructured Data: Test Result:Unknown; Test Date: 2021; Test Name: Computerised tomogram thorax; Result Unstructured Data: Test Result:Unknown; Test Date: 2021; Test Name: Culture urine; Result Unstructured Data: Test Result:Unknown; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:Unknown; Test Date: 2021; Test Name: Resuscitation-specialist, internal medicine and cardiology consultations; Result Unstructured Data: Test Result:Unknown; Test Date: 2021; Test Name: Medical counselling; Result Unstructured Data: Test Result:Unknown
CDC Split Type: ITPFIZER INC202101436894

Write-up: Dyspnoea; Pre-syncope; Hypotension; Asthenia; Respiratory failure; Chills; Conjunctival hyperaemia; Skin discolouration; Miosis; lipothymic episode; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-800480. A 58-years-old male patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection) intramuscular on 05Oct2021 (Batch/Lot Number: 2701995) as dose 2, 0.3 ml single for covid-19 immunisation, and received aripiprazole (ABILIFY), intramuscular from 07Oct2021 (Batch/Lot Number: 2701995) to 07Oct2021, at 400 mg 2 vials intramuscular injection for delusion. Medical history included obesity, unknown if ongoing third degree obesity, Venous insufficiency unknown if ongoing Bilateral venous insufficiency of the lower limbs, delusional ideation, unknown if ongoing. Concomitant medications included valproate sodium (DEPAKIN) taken for peripheral venous disease from 26Sep2021 to 07Oct2021, lithium carbonate (CARBOLITHIUM) taken for peripheral venous disease from 30Sep2021 to 07Oct2021. The patient received first dose of Comirnaty on an unknown date in 2021 for covid-19 immunisation. On 07Oct2021 the patient experienced dyspnoea, pre-syncope, hypotension, asthenia, respiratory failure, chills, conjunctival hyperaemia, skin discolouration, miosis and lipothymic episode. The events were captures as serious (hospitalisation). It was reported that Approximately 10 min after administration of Abilify Maintena 400 mg 2 vials intramuscular injection, the patient presented with a lipotimic episode with reported dyspnea and sudden asthenia. They presented fixed miosis, conjunctival hyperemia, hypotension, and respiratory failure. Shortly thereafter they manifested appearance of marbling on abdomen and limbs and shaking chills. On 05Oct2021 administered 2nd dose of Comirnaty Sars-Cov2 vaccine. Resuscitation-specialist, internal medicine and cardiology consultations required, blood culture and urine culture performed, chest computerised tomography scan with contrast medium, brain computed tomography with contrast medium, Electrocardiography. Administered oxygen therapy, antibiotic therapy i., clexane. The condition regressed completely on 09Oct2021. Request for resuscitation, internal medicine and cardiology consultations. Therapeutic measures were taken as a result of all the events. The patient underwent lab tests and procedures which included blood culture: unknown on 2021, computerised tomogram head: unknown on 2021, computerised tomogram thorax: unknown on 2021, culture urine: unknown on 2021, electrocardiogram: unknown on 2021, investigation: unknown on 2021, medical counselling: unknown on 2021. The action taken in response to the events for aripiprazole was permanently withdrawn on 07Oct2021. The outcome of all the events was resolved on 09Oct2021. No follow up attempts are possible. No further information is expected.


VAERS ID: 1852829 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-10-07
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROCORALAN; PREGABALIN MYLAN; EZEQUA; FLEXIBAN; SAMYR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to NSAIDs; Arthritis rheumatoid; Ovarian neoplasm; Psoriatic arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20211011; Test Name: sars-cov-2 test; Test Result: Positive.
CDC Split Type: ITPFIZER INC202101480280

Write-up: positive sars-cov 2 test on 11Oct2021; positive sars-cov 2 test on 11Oct2021; Anosmia; Cough; Fever; Ageusia; This is a spontaneous report from a contactable pharmacist from the Regulatory Authority IT-MINISAL02-802902. A 45-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: FA4597), via intramuscular route, administered on 15May2021 at 22:23 as DOSE 2, SINGLE and first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EX0893), via intramuscular route, administered in deltoid left on 17Apr2021 at 10:23 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included ovarian neoplasm, psoriatic arthritis, arthritis rheumatoid, and NSAID allergy. Concomitant medications included PROCORALAN 5 mg for palpitations, PREGABALIN MYLAN, EZEQUA, FLEXIBAN, and SAMYR. On 07Oct2021, the patient experienced anosmia, cough, fever, and ageusia. On 11Oct2021, the patient was tested positive for SARS-COV-2. The patient underwent lab tests and procedures which included SARS-CoV-2 test Positive on 11Oct2021. The outcome of the events was recovered on 15Oct2021. No follow-up attempts are possible. No further information is expected. It was considered appropriate to codify the suspected ADR with the term ineffective vaccination since the time elapsed between the second dose and positivity is reasonable.


VAERS ID: 1852958 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4092 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Immunisation
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Frailty; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101437691

Write-up: Increased tendency to fall down; DOSE 3; This is a spontaneous report from a contactable physician downloaded from the regulatory authority NO-NOMAADVRE-FHI-2021-U9nn8q. A 75-years-old male patient received bnt162b2 (COMIRNATY), dose 3 intramuscular on 07Oct2021 (Lot Number: FH4092) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included parkinson''s disease, Frailty. The patient''s concomitant medications were not reported. The patient previously received COVID-19 Vaccine dose 1 and dose 2 for COVID-19 immunisation (Primary Immunization series complete but unknown manufacturer). The patient experienced increased tendency to fall down (hospitalization) on 08Oct2021. The patient was hospitalized for increased tendency to fall down from 08Oct2021 to an unknown date. A 75-year-old man received the third dose of the covid-19 vaccine Comirnaty. The day after vaccination, he was admitted to the geriatric ward in hospital due to an increased tendency to fall. Previously known Parkinson''s disease and severe frailty. The outcome of the event was recovered with sequelae on an unspecified date. The RA assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1853023 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4632 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Anaphylactic reaction, Blood pressure measurement, Dyspnoea, Erythema, Heart rate, Heart rate increased
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211007; Test Name: blood pressure; Result Unstructured Data: Test Result:130/80 mmHg; Test Date: 20211007; Test Name: Heart rate; Result Unstructured Data: Test Result:118; Comments: Units:/min
CDC Split Type: ROPFIZER INC202101439614

Write-up: Anaphylactic reaction; Breathing difficult; Heart rate increased; Agitation; Moderate cervico-thoracic eritem; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number RO-NMA-2021-SPCOV13257. Safety Report Unique Identifier RO-NMA-2021-SPCOV13257. A 30-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: FA4632), via an unspecified route of administration on 07Oct2021 (age at vaccination 30-year-old) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 07Oct2021, on the same day, at the vaccination centre, the patient experienced breathing difficult, heart rate increased, agitation, anaphylactic reaction, moderate cervico-thoracic eritem. The case was considered serious (Other medically important). Therapeutic measures were taken as a result of breathing difficult, heart rate increased, agitation, anaphylactic reaction, moderate cervico-thoracic eritem. As a corrective therapy the patient received 1/2 vial of adrenaline, hydrocortisone hemisuccinate 200 mg intravenously, loratadine 10 mg, 1 tablet. In the reporter''s opinion the events were related to Comirnaty, lot FA4632. The patient underwent lab tests and procedures which included heart rate was 118 /min on 07Oct2021, blood pressure measurement was 130/80 mmhg on 07Oct2021. The outcome of the events was unknown. Sender Comment: This case was reported by a physician in the Registry of Vaccination and received by RA from the Centre for Communicable Diseases. The case was considered serious (Other medically important) by the Sender based on RA List.


VAERS ID: 1855155 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-07
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Headache
SMQs:, 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)

Life Threatening? No
Birth Defect? No
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 INC202101452439

Write-up: Cerebrovascular accident; Headache; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 646464. A 36-year-old male patient received bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 07Oct2021, the patient experienced Cerebrovascular accident and headache. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1855212 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-07
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Nausea, Pain in extremity, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101458329

Write-up: Ventricular fibrillation; Headache; Nausea; Pain in extremity; This is a spontaneous report from a contactable health professional via the Agency Regulatory Authority . Regulatory authority report number is 648999. A 48-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ventricular fibrillation, headache, nausea, and pain in extremity on 07Oct2021. Outcome of the events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1855246 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-10-07
   Days after vaccination:246
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211007; Test Name: COVID-19 PCR; Test Result: Positive.
CDC Split Type: BEPFIZER INC202101444088

Write-up: Drug ineffective; COVID-19 infection after vaccination; This is a spontaneous report from a contactable pharmacist from the Regulatory Authority. The regulatory authority number BE-FAMHP-DHH-N2021-108028. An 84-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Feb2021 (Batch/Lot Number: EJ6136; Expiration Date: 30Apr2021) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced covid-19 infection after vaccination and drug ineffective on 07Oct2021. Test positive PCR on 07Oct2021. The patient underwent lab tests and procedures which included COVID-19 PCR positive on 07Oct2021. The outcome of the events was unknown. Investigation result received on 27Oct2021 from Product Complaint Team. 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 EJ6136. 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. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. Treatment -, Evolution of the ADR -, and positive PCR test 07Oct2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1855453 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-10-07
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCJU6 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood lactate dehydrogenase, Electrocardiogram, Myocarditis, N-terminal prohormone brain natriuretic peptide, Troponin T
SMQs:, Cardiomyopathy (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? 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: Allergy to grains (Barley); Bronchial asthma; Grass allergy; Pollen allergy
Allergies:
Diagnostic Lab Data: Test Name: GPT; Result Unstructured Data: Test Result:52 IU/l; Comments: increased; Test Name: GOT; Result Unstructured Data: Test Result:170 IU/l; Comments: increased; Test Name: CK; Result Unstructured Data: Test Result:633 IU/l; Comments: increased; Test Name: CKMB; Result Unstructured Data: Test Result:45 IU/l; Comments: increased; Test Name: LDH; Result Unstructured Data: Test Result:557 IU/l; Test Name: ECG; Result Unstructured Data: Test Result:changes; Test Name: NT-proBNP; Result Unstructured Data: Test Result:1350 pg/mL; Comments: increased; Test Name: Troponin T; Result Unstructured Data: Test Result:34600 ng/L; Comments: increased
CDC Split Type: DEPFIZER INC202101490445

Write-up: Myocarditis; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100214514. An adolescent male patient received second dose of BNT162b2 (COMIRNATY), intramuscular on 28Sep2021 (Lot Number: SCJU6) as single dose for COVID-19 immunisation. Medical history included bronchial asthma and allergies (grasses, pollen, barley), all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously received first dose of COVID-19 vaccine (MANUFACTURER UNKNOWN) for COVID-19 immunization. The patient experienced myocarditis on 07Oct2021. The event was serious, hospitalization/life threatening. On an unspecified date, the patient underwent lab tests and procedures which included alanine aminotransferase (GPT): 52 IU/l (increased), aspartate aminotransferase (GOT): 170 IU/l (increased), blood creatine phosphokinase (CK): 633 IU/l (increased), blood creatine phosphokinase mb (CKMB): 45 IU/l (increased), blood lactate dehydrogenase (LDH): 557 IU/l, electrocardiogram (ECG): changes, n-terminal prohormone brain natriuretic peptide (NT-proBNP): 1350 pg/ml (increased), troponin T: 34600 ng/l (increased). The patient outcome of the event was not recovered. Relatedness of drug to reaction was assessed by Regulatory Authority as indeterminate. No follow-up attempts possible. No further information expected.


VAERS ID: 1855876 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / UNK LA / SYR
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Product administered at inappropriate site, Shoulder injury related to vaccine administration
SMQs:, Drug abuse and dependence (broad), 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: Medical History/Concurrent Conditions: Breast cancer; Lymph node excision (lymph node removal from breast cancer 9 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBGLAXOSMITHKLINEGB202122

Write-up: Shoulder injury related to vaccine administration; Vaccine administered at inappropriate site; Case received by GSK via Regulatory Authority on 3rd November 2021. This case was reported by a consumer via regulatory authority and described the occurrence of shoulder injury related to vaccine administration in a 73-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis. Co-suspect products included TOZINAMERAN (BIONTECH COVID-19 MRNA VACCINE) (batch number FF8222, expiry date unknown) for prophylaxis. The patient''s past medical history included lymph node excision (lymph node removal from breast cancer 9 years ago) and breast cancer. On 7th October 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season (parenteral) and BIONTECH COVID-19 MRNA VACCINE (parenteral). On 7th October 2021, unknown after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced vaccine administered at inappropriate site. On 8th October 2021, 1 day after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced shoulder injury related to vaccine administration (serious criteria other: serious as per reporter). On an unknown date, the outcome of the shoulder injury related to vaccine administration was not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the shoulder injury related to vaccine administration to be related to Influenza vaccine Quadrivalent 2021-2022 season. Additional details was reported as follows: The age at vaccination was unknown. The patient received Influenza vaccine Quadrivalent 2021-2022 season and BIONTECH COVID-19 MRNA VACCINE on left arm. The time to onset for shoulder injury related to vaccine administration was 1 day with respect to BIONTECH COVID-19 MRNA VACCINE. It was unknown if the reporter considered the shoulder injury related to vaccine administration to be related to BIONTECH COVID-19 MRNA VACCINE. The batch number for Influenza vaccine Quadrivalent 2021-2022 season was reported as Flu, however was captured as unknown. As per case narrative patient received both Influenza vaccine and Covid-19 MRNA vaccine on the same arm, hence additional event of medication error of " vaccine administered at inappropriate site" was captured. Initial information was received from consumer via regulatory authority on 3rd November 2021 Shoulder injury related to vaccine administration Case narrative SIRVA - pain and immobility of left shoulder. After covid and flu vaccines in left arm, experienced some expected soreness and discomfort though no other side effects. Several days later, left arm pain increased somewhat and has since developed further restrictive movement such as changing gear, general house hold duties and simple manoeuvres. Shoulder injury related to vaccine administration (SIRVA?) Although double jabs are generally given one in each arm, because of lymph node removal from breast cancer 9 years ago, it was considered advisable to receive both vaccines in same arm. So don'' know which one has caused the problem but it is the vaccination itself, not the contents of vaccine. Medication Error Details: I think possibly under the circumstances it would have been important for me to have received jabs separately so that it might have been easier to locate a safer margin for area to be given in its best place? I didn''t know this, but have since realised the location site for vaccinations is crucial. I do need help with this problem as if it continues my daily living will indeed be compromised. Seek Advice Details: Needs advice but as yet unable to access appropriate guidance and information. Affecting daily living inasmuch that left arm has restricted movement and pain. Received two vaccines in same arm.


VAERS ID: 1858961 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-10-07
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D01AA / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211007; Test Name: SARS COVID test PCR; Test Result: Positive
CDC Split Type: DEPFIZER INC202101455183

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100211470. A 62-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 01Jun2021 (Batch/Lot Number: 1D01aA) at 61 years of age as dose 2, single, and intramuscular on 11May2021 (Batch/Lot Number: FX8680) at 61 years of age as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient''s weight was not reported, and height was not reported. On 07Oct2021, the patient experienced vaccination failure and COVID-19. The patient underwent lab tests and procedures which included SARS COVID test PCR: positive on 07Oct2021. Outcome of the events was unknown. This report is serious (hospitalization). Relatedness of drug to reaction(s)/event(s) by Regulatory Authority (source of assessment) was reported as B. Indeterminate. No follow-up attempts possible. No further information expected.


VAERS ID: 1763694 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (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? No
Previous Vaccinations: 2nd dose, heart racing, increase bp, onset of GAD
Other Medications: Losartan, setraline, crestor, garlique
Current Illness: Elevated blood pressure, headache
Preexisting Conditions: High blood pressure, high cholesterol
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Racing heartbeat at 12 hours post vaccine


VAERS ID: 1764301 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram abnormal, Anticoagulant therapy, Chest pain, Computerised tomogram thorax abnormal, Dyspnoea, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Loryna, venlafaxine
Current Illness: COVID in August
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: CT angiogram chest 10/6/21
CDC Split Type:

Write-up: Dyspnea and Chest pain, Pulmonary Emboli, Apixaban, admitted to hospital for further workup


VAERS ID: 1764533 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-09-30
Onset:2021-10-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC-3184 / 2 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Erythema, Neck pain, Pain of skin, Pruritus, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lamictal 150mg BID, tri-sprentec tablet daily, zolfot 50mg daily
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Woke up on morning of 10/6/2021 at 0645 with redness and swelling of neck, primarily left sided. Itchy and painful feeling like blistering sunburn. No new products were used, no new exposures, no history of allergic reactions. Temperature 97.3, neck warm to touch.


VAERS ID: 1764562 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-09-30
Onset:2021-10-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (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: Humalog Vitamin D Toprol XL atorvastatin
Current Illness: Newly diagnosis of SVT July 2021
Preexisting Conditions: Type 1 diabetic
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Heart rate 163 beats per min. at 01:00 am on 10/6/2021.


VAERS ID: 1764576 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / SYR

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

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

Write-up: Fever, headache body aches


VAERS ID: 1764594 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA FE3592 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bupropion Buspirone Dulera Janumet Levothyroxine Montelukast Ventolin Allegra Biotin Nasalcrom Vitamin C Vitamin D
Current Illness:
Preexisting Conditions:
Allergies: Penicillin Benadryl Darvocet
Diagnostic Lab Data:
CDC Split Type:

Write-up: ipsilateral supraclavicular lymphadenopathy


VAERS ID: 1764611 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 LA / -

Administered by: Public       Purchased by: ?
Symptoms: Wrong product administered
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
CDC Split Type:

Write-up: Patient had wanted Janssen vaccine and was given Pfizer in error. No treatment, but explained she would now need to get a 2nd dose of Pfizer in 21 days.


VAERS ID: 1764623 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, Lymphadenopathy, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (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: similar lymphadenopathy with Pfizer covid vaccine #2 - forgot to report to VAERS. Resolved in approx one week. no further issu
Other Medications: daily multivitamin only
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: swollen, tender supraclavicular and infraclavicular lymphadenopathy


VAERS ID: 1764678 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered
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: Patient received two of the same vaccine - Pfizer dose 3 (booster). Patient intended to receive one COVID booster and one influenza vaccine, but after getting the first vaccine he sat down at another COVID vaccine table instead of the influenza table.


VAERS ID: 1764733 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: North Dakota  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 3 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Interchange of vaccine products
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: Developmental Disabled
Allergies: Amoxicillin, Pedizole
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received Moderna as primary series. Received Pfizer vaccine as a booster. Did not have vaccine card present.


VAERS ID: 1764780 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: New York  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

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

Write-up: Patient started feeling dizzy after receiving the second dose. He was given water and asked to sit for a while. He felt somewhat better and went home.


VAERS ID: 1764797 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-11
Onset:2021-10-06
   Days after vaccination:209
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802068 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram ambulatory, 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: vit c iron
Current Illness: none
Preexisting Conditions: epstein-barr
Allergies: elderberry penicillin codeine demerol Benadryl morphine
Diagnostic Lab Data: blood work chest xray echocardiogram Holter monitor
CDC Split Type:

Write-up: chest pain BP 250/195 pulse rate 40''s blacking out


VAERS ID: 1764823 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-10-04
Onset:2021-10-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8839 / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Losartan, Lo Loesterin, Famitodine, Mucinex, methotrexate, ashwagandha, probiotic, collagen, multivitamin, vit. D, zinc, magnesium, fish oil, ginko
Current Illness: None
Preexisting Conditions: Granulomatosis with polyangiitis (Wegener''s Granulamatosis), hypertension.
Allergies: none
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Swollen area near clavicle (lymph node maybe). Appx the size of a pingpong ball but flattened and not fully round. Sore, tender to the touch in area on and around the swelling.


VAERS ID: 1764825 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0716C21A / 2 - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Nasal congestion, Nausea, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Massive headache, everything hurts, nausea, throwing up, stuffed up head


VAERS ID: 1764867 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-03-04
Onset:2021-10-06
   Days after vaccination:216
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       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:
CDC Split Type:

Write-up: Admitted to Hospital on Date of Adverse Event [recorded in VAERS] for treatment of Covid-19 Positive following completion of Covid Vaccine Series


VAERS ID: 1764868 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 3 LA / IM

Administered by: Military       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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt received 3rd dose of covid 19 vaccine. Pt lost consciousness in chair and was placed on floor by 2 corpsmen. Feet were elevated. Pt woke up about 10 seconds later, A&O x4. Pt stated this has happened before with venipuncture but never a vaccine. VSS. RRT arrived and transported patient to ED in stable condition.


VAERS ID: 1764870 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Montana  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Chills, Fatigue, Muscular weakness, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: FATIGUE, FEVER OF GREATER THAN 101.5 FOR APPROX 9 HOURS, CHILLS, MUSCLE WEAKNESS


VAERS ID: 1764908 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822809 / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: SULFA
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Pt felt nauseated and dizzy after the Janssen vaccination; pt was sitting in the observation area and confronted by RN; pt placed on gurney to be evaluated; vitals taken q5 mins; pt relieved of nausea and dizziness after consuming nutrients and fluids (240ml of apple juice, 240 ml of water); Vitals: 10/06/21 0823 10/06/21 0830 10/06/21 0835 BP: 124/77 100/60 115/74 BP Patient Position: SITTING SITTING STANDING BP Location: RA-RIGHT ARM RA-RIGHT ARM RA-RIGHT ARM Pulse: 84 85 89 Resp: 18 18 18 Temp: 97.2 ?F (36.2 ?C) 97.2 ?F (36.2 ?C) SpO2: 98% 97% 99% Height: 5'' 3" (1.6 m) 5'' 3" (1.6 m)


VAERS ID: 1764953 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301458A / 3 LA / -

Administered by: Military       Purchased by: ?
Symptoms: Extra dose administered, Rash, Rash erythematous, Swelling, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Medication errors (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: VITAMINE D3
Current Illness: DENIES
Preexisting Conditions: HTN
Allergies: NKDA
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: PATIENT REPORTS RASH BILATERAL ARMS AND LEGS THAT STARTED AT 0400 AFTER HER THRID DOSE. RASH HAS SLIGHT REDNESS WITH SWELLING, BUT PATIENT DENIES ITCHING. SHE REPORTED SAME RASH AFTER HER FIRST AND SECOND DOSE. DENIES SHORTNESS OF BREATH OR CHEST PAIN. EDUCATATED PATIENT THAT RASH MAY OCCUR AFTER THE VACCINE. ADVISED PATIENT TO TAKE OTC BENADRYL FOR RASH AND ACETAMINOPHEN FOR PAIN. PATIENT DENIES EMERGENCY AND WILL CONTINUE TO MONITOR.


VAERS ID: 1764956 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Incorrect dose administered
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: not applicable
Current Illness: not applicable
Preexisting Conditions: not applicable
Allergies: not applicable
Diagnostic Lab Data: not applicable
CDC Split Type:

Write-up: Vaccine was reconstituted with less than the required amount of sterile dilutant. Patient was given the vaccine at a higher concentration than recommended.


VAERS ID: 1764976 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0809 / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products
SMQs:, Medication errors (narrow)

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: Unknown
Current Illness: Unknown
Preexisting Conditions: Lung issues
Allergies: Unknown
Diagnostic Lab Data: None
CDC Split Type:

Write-up: The patient received Moderna for the first two doses of the COVID-19 vaccine series and presented to the pharmacy to receive a booster dose of Pfizer BioNTech COVID-19 vaccine. Patient received the Pfizer BioNTech COVID-19 vaccine for the 3rd dose, so this form is being submitted due to the error of not receiving the primary series of the Pfizer BioNTech COVID-19 vaccine prior to receiving the Pfizer BioNTech COVID-19 booster.


VAERS ID: 1764994 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysgeusia, Nausea, Tinnitus
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow)

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

Write-up: Within 24 hours felt nauseous, tinnitus in both ears, metal taste in my mouth


VAERS ID: 1765001 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Feeling jittery, Headache, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Vestibular disorders (broad), Dehydration (broad)

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

Write-up: Patient started feeling lightheaded, reported feeling fast heart rate, jittery, headache.


VAERS ID: 1765006 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039D21A / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Flank pain, Migraine, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Retroperitoneal fibrosis (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: Naltrexone 4.5 mg, Nystatin 1,000,000 iu BID TERBINAFINE 250 mg q d Melatonin 120 mg q Hs Amphotericin B 200 mg BID FISH OIL VIT C
Current Illness: NONE
Preexisting Conditions: CVID Mold biotoxin illness Hashimotos Thuroiditis
Allergies: Diflucan?$g hives
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Hives on chin Moderate bilateral flank pain Migraine headache


VAERS ID: 1765007 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-05-07
Onset:2021-10-06
   Days after vaccination:152
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / -

Administered by: Unknown       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:
CDC Split Type:

Write-up: Admitted to Hospital on Date of Adverse Event [recorded in VAERS] for treatment of Covid-19 Positive following completion of Covid Vaccine Series


VAERS ID: 1765025 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: New York  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 3 LA / SC
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 3 LA / SC

Administered by: Private       Purchased by: ?
Symptoms: Dysgeusia, Paraesthesia oral
SMQs:, Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre 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? Yes
Hospitalized? No
Previous Vaccinations: FLU VACCINE - SAME ADVERSE RESPONSE AS TODAY
Other Medications: LIPITOR, ZOLOFT
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: XYVOX
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: METALLIC TASTW, TINGLING OF LIPS


VAERS ID: 1765039 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Dyspnoea, Rales
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (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: flu
Other Medications: Keppra - weaning off
Current Illness: none noted
Preexisting Conditions: history of seizures
Allergies: flu vaccine, eggs, peanut, almond, Propofol, fentanyl
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was given the Pfizer Covid vaccine at 0938 and was placed to be observed. She started showing signs of SOB at 0950 and was placed in an Exam room. O2 was applied at 0953 at 2 L 911 was called at 0953 Patient was communicating and never lose conscious. HR 147, O2 stat was 97 Epi 0.3 ml given at 0955 RN and NP were in the room with me assisting. EMS arrived at 1002. O2 was increased and Nebulizer applied due to reported Rails in lungs Additional Epi was given by EMS 1010 patient said her brother was outside in the car. She produced her phone and found his number and Her Brother was called who was waiting outside the building and instructed that she was going to be taken to Medical Center and directions were given.


VAERS ID: 1765057 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-10-04
Onset:2021-10-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3590 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D3 125mcg Omeprazole Dr 40 mg Escitalopram 20mg Carisoprodol 350mg Oxycodone-Acetaminophen 5-325mg Gabapentin 400mg Melatonin 10mg Methylprednisolonb 4mg dose pack
Current Illness: no
Preexisting Conditions: Asthma Microscopic colitis
Allergies: all melons sulpha Dilaudid Demerol Dicloxacillin
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient report that after speaking with the cdc this morning she was adv that by her being on steroids she should not have been given the vaccine...She stated that after the vaccine she gets rapid increase of heart beat


VAERS ID: 1765078 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204B21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dysphagia, Dyspnoea, Pharyngeal swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: anaphylaxis
Other Medications: Wellbutrin, Claritin, Ibuprofen as needed, possibly Q-Symvia
Current Illness: None
Preexisting Conditions: Anxiety
Allergies: Moderna Vaccine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient planned to wait for 60 minutes post vaccination due to prior allergic reaction to Moderna. At 45 min, she began having throat swelling, difficulty swallowing, and labored breathing. Epi pen given, albuterol started, and 6 L of 02 placed. EMS arrived within 5 min and transported to the ED.


VAERS ID: 1765117 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-10-04
Onset:2021-10-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid, 1000mg Methotrexate (suspended for vaccination a week before vaccination) Stelara (suspended for vaccination and have not had a shot for 10 weeks)
Current Illness: Psoriatic arthritis
Preexisting Conditions: Psoriatic arthritis
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swollen lymph nodes, ipsilateral to vaccination site. Pain around lymph nodes.


VAERS ID: 1765144 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-10-04
Onset:2021-10-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30145BA / 3 LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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: N/a
Current Illness: N/a
Preexisting Conditions: N/a
Allergies: N/a
Diagnostic Lab Data: None provided
CDC Split Type:

Write-up: Fatigue , nausea, skin pale, headache, dizziness


VAERS ID: 1765150 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039D21A / 1 LA / IM

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

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

Write-up: Fever, Fatigue, nausea


VAERS ID: 1765181 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-26
Onset:2021-10-06
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 2 UN / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Fall, Rhabdomyolysis, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad), Accidents and injuries (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitamin D, Vitamin C, Zinc, B12, Metoprolol, Aspirin, donepezil, rosuvastatin
Current Illness: None
Preexisting Conditions: Dementia, arthritis, HTN, HLD, AAA s/p stent repair
Allergies: Penicillin
Diagnostic Lab Data: COVID PCR test +
CDC Split Type:

Write-up: Breakthrough COVID-19 infection on 10/06/2021 found on admission to the hospital s/p unwitnessed fall and rhabdomyolysis


VAERS ID: 1765192 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8839 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Consciousness fluctuating, Fall, Syncope, Urinary incontinence
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Patient received his first dose of Pfizer Covid-19 vaccine. He seemed fine other than being a little nervous and reluctant to receive the shot. The screening questionnaire we conduct with all patients looking to receive vaccination checked out fine - no abnormalities, no prior reactions to any vaccines, no allergies, etc. A few minutes after administering the vaccine, the patient came up to the pharmacy counter and was leaning on it, then proceeded to faint and fall to the floor. He went in and out of consciousness for about a minute before he was able to sit himself up. He also involuntarily urinated. Once he regained consciousness, I gave him a bottle of orange juice and another team member activated EMS. EMS arrived within about 5 to 10 minutes, and checked his vitals. Everything checked out fine. The patient refused to leave with EMS to be admitted to the hospital. After EMS left, he stayed in the pharmacy waiting room and waited for his girlfriend to come picked him up. He was here about 45 minutes total, and seemed fine when he left with her.


VAERS ID: 1765236 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301558A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Incorrect product formulation administered
SMQs:, Medication errors (narrow)

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

Write-up: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-


VAERS ID: 1765249 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / -

Administered by: Public       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fever, chills, headache,fatigue, joints ache


VAERS ID: 1765275 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Dizziness, Lethargy
SMQs:, Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: dizziness, lethargic


VAERS ID: 1765296 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-03-27
Onset:2021-10-06
   Days after vaccination:193
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6995 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Fatigue, Feeling abnormal, Oxygen saturation decreased, Pyrexia, Respiratory tract congestion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: hospitalized 10/6 - fully vaccinated for COVID19, has yet to get booster, with PMH of HTN, HLD who presented to the ED with complaints of SOA. Pt reports that he started feeling poorly 4 days PTA on 10/2/21 with congestion, dry cough, low grade fever and fatigue. He went to the pharmacy for a rapid COVID test and was diagnosed on 10/3/21. He reports that he has since been monitoring his O2 and his O2 was 88% today, so he came in for evaluation.


VAERS ID: 1765300 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-03-30
Onset:2021-10-06
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Polymerase chain reaction
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: Fasenra
Current Illness:
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data: Cycle threshold of 40.9 on 10/6
CDC Split Type:

Write-up: Hospitalization due to COVID-19 Reported per Janssen COVID-19 Vaccine EUA


VAERS ID: 1765307 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Expired product administered
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: Patient received expired vaccination.


VAERS ID: 1765351 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-27
Onset:2021-10-06
   Days after vaccination:193
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       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:
CDC Split Type:

Write-up: Admitted to Hospital on Date of Adverse Event [recorded in VAERS] for treatment of Covid-19 Positive following completion of Covid Vaccine Series


VAERS ID: 1765353 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-10-01
Onset:2021-10-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048F21A / 3 AR / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Fever-Mild


VAERS ID: 1765361 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PFIZER FF2587 / 3 LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Injection site pain, Injection site swelling, Pain, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Took 2 Tylenol PM last night.
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain and swelling at arm injection site. Pain and swelling under arm on right arm where received injection. Burning pain sensation.


VAERS ID: 1765373 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8020 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Fatigue, Feeding disorder, Nausea, Pallor, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Patient reported this morning; pale, fever (99.9 - 100.8), chills, fatigue, and nausea. Patient reports throwing up a couple of times. Patient not able to eat. Patient currently napping, wife making broth and electrolyte drink (Gatorade-like drink).


VAERS ID: 1765374 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3590 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered
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: Error: Wrong Dose of Vaccine - Too High-


VAERS ID: 1765380 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF 8839 / 1 LA / SYR

Administered by: Military       Purchased by: ?
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Anthrax Series 3
Other Medications: Zinc, Vitamin C and D
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: After receiving the Pfizer Covid 19 shot my Left Hand completely numb. Left Arm Moderately Numb. Numbness began approximately 2200 hours after the shot.


VAERS ID: 1765400 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
SMQs:, Medication errors (narrow)

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 Received booster vaccine 11 days early


VAERS ID: 1765401 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-02-23
Onset:2021-10-06
   Days after vaccination:225
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 010M20A / 2 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026L20A / 1 LA / IM

Administered by: Unknown       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:
CDC Split Type:

Write-up: Pt received Moderna x2. Pt tested COVID + on 10/6/21 and admitted to hospital for COVID on 10/6/2021. Pt receiving dexamethasone.


VAERS ID: 1765405 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: New York  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Extra dose administered
SMQs:, Medication errors (narrow)

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

Write-up: None stated.


VAERS ID: 1765419 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: South Dakota  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA COVID / 3 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Dysarthria, Headache, Hypoaesthesia, Nausea
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Neurontin, Tegretol XR, Kesimpta, Nexium, levothyroxine, Potassium chloride, Allegra
Current Illness: none that I am aware of.
Preexisting Conditions: Multiple sclerosis, Asthma, depression and anxiety, hypokalemia
Allergies: Penicillin, Gadolinium Derivatives, Morphine, Shellfish, Biaxin, Codeine, Dilaudid, Hydrocodone, Lortab, Nsaids, Sulfa Drugs
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient noted to be having some reaction symptoms shortly after getting the COVID vaccine. Vaccine given at 1327 - spouse noted to have given her Benadryl 25 mg at 1338 when she first reported HA and numbness starting on the R side of her body. Patient was assessed by Dr. Slurred speech was then noted, as well as patient noting the weakness was now all over. Dr. recommended patient be evaluated in the ED due to these symptoms - patient agrees, with the agreement that an ambulance would be called to transfer patient also. Patient then noted that the HA was a constant ache and she continued to c/o nausea. Ambulance transfer at 1402.


VAERS ID: 1765445 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050E21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050E21A / 2 LA / IM

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

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

Write-up: On 10/06/2021 the client presented to the clinic for her 2nd dose of Covid vaccine. Upon assessment of the patient''s record the nurse realized the patient was under the age of 18 when she received her 1st dose of Moderna vaccine on 09/08/2021. Patient reports a sore arm at the injection site, but no other side effects. Nursing manager advised that the patient and her parent be made aware of the situation. The patient and parent verbalized understanding that under the EUA for Moderna the patient should not have received Moderna vaccine due to her being under 18. The patient and her parent were given the information necessary to make a decision regarding the 2nd dose of the vaccine. The patient and her parent voiced their concerns of the risk of Covid versus the risk of receiving a 2nd dose of vaccine. A 2nd dose of vaccine was administered in the LA, the patient was observed for the 15 minutes per guidelines and no adverse effects were noted.


VAERS ID: 1765449 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30145BA / 1 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Dizziness, Dysphagia, Dyspnoea, Migraine, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

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

Write-up: Patient was experincing diffeuclty breathing, diffucult swallowing, migraine, dizziness, sob and nausea. Pt vitals were stable and was rapidly transported to the ER


VAERS ID: 1765469 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-10-05
Onset:2021-10-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

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: Trileptal, Lipitor, Lyrica, synthroid, citracal, metropolol, aspy81, B12, valtrex
Current Illness: None
Preexisting Conditions: CAD Osteoporosis Arthritis Transgeminal Neuralgia Lumbar issues Vertigo
Allergies: Nine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Red rash on thigh


VAERS ID: 1765480 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 2 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Underdose
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: 1 mL Flashpoint needle syringe containing 0.3 Pfizer COVID vaccine was inserted into patient''s right deltoid. As syringe was plunged, the vaccine fluid was forced out of faulty syringe onto patient''s arm. An additional dose/needle/syringe of the vaccine was required to properly vaccinate patient.


VAERS ID: 1765486 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 1 RA / IM

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

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

Write-up: Patient reported discomfort- chest pain. Was brought to the emergency room


VAERS ID: 1765500 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822809 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Condition aggravated, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Pro Air albuterol inhaler
Current Illness: asthma
Preexisting Conditions: asthma
Allergies: Allergic reaction to allergy shot
Diagnostic Lab Data: none to report
CDC Split Type:

Write-up: Adverse effects to report after 5 minutes of observation, Pt started having shortness of breath/asthma symptoms 5 minutes after vaccine. Nurse checked pt''s O2 at 93%, BP 183/159, Pulse 108. Offered Epi-Pen Pt Declined and said they had their own but only felt asthma symptoms, . Pt used albuterol inhaler. Offered to call EMS Pt declined Wife drove to ER. When we opted to call 911 but Pt declined several times and had partner take them right up the street to ER


VAERS ID: 1765504 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003C21A / UNK RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered
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: Asthma, Prostate Cancer, HTN. Memory impaired
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received an additional dose one month after completing vaccine series. Did not have vaccine record at time, verification completed was inaccurate


VAERS ID: 1765511 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: South Dakota  
Vaccinated:2021-02-17
Onset:2021-10-06
   Days after vaccination:231
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022M20A / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood pressure increased, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: numerous
Current Illness: cva, chf, diabetes
Preexisting Conditions: cva, chf , diabetes
Allergies: pcn, keflex, aspirin
Diagnostic Lab Data: hospital admission same day
CDC Split Type:

Write-up: blood pressure went up. felt like couldn''t move legs, got admitted to hospital


VAERS ID: 1765516 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 3 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Blood pressure increased, Dysarthria, Facial paralysis
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (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: N/A
Current Illness: ATHEROSCLEROSIS OF AORTA, BILATERAL MASTECTOMY DEFORMITY, CHRONIC PAIN, DERANGEMENT OF LEFT KNEE, DIVERTICULOSIS, DM TYPW 2, EPILEPSY, HTN, ASTHMA, OSTEOARTHRITIS OF BILATERAL KNEES, RIGHT OPEN ANGLE GLAUCOMA, SEVERE OBESITY
Preexisting Conditions: HX OF BREAST CANCER, FATTY LIVER, COLONIC POLYPS
Allergies: BACLOFEN, NABUMETONE, SHRIMP AGENT, BENZONATATE, LISINOPRIL, LOSARTAN POTASSIUM, AMPICILLIN, ERTHROMYCIN BASE, INDOMETHACIN, ULTRAM, GABAPENTIN, SULFA, WELLBUTRIN, LIDOCAINE, CAFFEINE, FLUOXETINE HYDROCHLORIDE, IVP DYE, IODINE CONTAINING, KETOROLAC TROMETHAMINE, LACTOSE, LEXAPRO, PROCARDIA, PROPOXYPHENE HCL
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Pt appeared with moderate facial drooping; pt remained A&O x4 with slurred speech; pt informed nurse of seizures with vaccine administration (this being her third seizure with three vaccinations); vs taken, pt informed of severity of bp elevation, pt tolerated education; pt informed of concern and possible hospital admission to monitor bp elevation, pt declined education, stated "I''ll be fine once the medication kicks in." pt reassessed 5mins after initial assessment and vs, pt A&O x4, clear speech, and no facial drooping; pt informed nurse of willingness to go home after gaining back full consciousness and no hospital admission was needed; pt ambulatory with front wheel walker independently, left the unit @1200 Vitals: 10/06/21 1147 10/06/21 1155 BP: (!) 194/77 (!) 177/56 BP Patient Position: SITTING SITTING BP Location: RL-RIGHT LEG RA-RIGHT ARM Pulse: 73 75 Resp: 20 18 SpO2: 99% 99%


VAERS ID: 1765531 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: New York  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040D21A / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Loss of consciousness, Respiratory arrest, Resuscitation, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: UNKNOWN
Preexisting Conditions: NONE REPORTED
Allergies: NO KNOWN ALLERGIES
Diagnostic Lab Data:
CDC Split Type:

Write-up: 5 minutes after administering Moderna Civid-19 vaccine , patient complained of feeling dizzy, lost composure, responsive to questions for a few seconds and lost consciousness with in next minute and became unresponsive and stopped breathing. Administered CPR and called 911. 1 dose of Epipen 0.3mg administered before arrival of EMS. continued administering CPR until ems arrived and by then she gained back her consciousness became responsive. EMS took her to ER


VAERS ID: 1765536 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30135BA / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Erythema, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: patient''s parent began to notice redness on patient''s face and neck about 30 minutes after receiving vaccine. Patient was brought to registered nurse. Blood pressure and pulse were normal. patient was able to breathe normal. After about 10 minutes, patient began to get redness on upper chest and chest felt hot. Benadryl was offered but patient has a hard time swallowing pills because of swollen tonsils (swollen tonsils before vaccine). Paramedics were called. when they arrived they decided to take patient to Hospital to due further tests, including a blood test. Patient was able to walk out on her own. Parent noticed that redness had spread to legs.


VAERS ID: 1765559 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC 3183 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Immediate post-injection reaction, Neck pain, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Oral polio. I explained in the earlier section.
Other Medications: Iron, Vitamin C, Zinc/Copper, Silica, Omega-3
Current Illness: None. I have genetically confirmed Hereditary Hemorrhagic Telangiectasia, Type 1.
Preexisting Conditions: HHT- Type 1
Allergies: With Zythromax I experienced Guillain Barre on the third day. I also experienced Guillain Barre with the polio vaccine as a child.
Diagnostic Lab Data: None that I remember. The first time I experienced GB, I was a child and it was with the oral polio vaccine. I was in a lot of pain, could not walk or get up, and I could not feel my legs. It went away several days later. I do not remember if there was any treatment and/or medications, but I do remember having immunoglobulin shots a few times in my childhood. The second time, it was the day that the third dose of Zythromax was due. I woke up and could not feel my legs. It went away later that day after I stopped taking the medication.
CDC Split Type:

Write-up: At the time of the injection, I immediately felt a lot of pain on the arm that extended to the elbow and up to the neck (under the jaw). I figured that was normal and simply waited about 25 minutes there. I got home and at about 3 pm, I began to feel tingling on the left leg, mostly on the front (toes and padded area) of the foot. I began to get nervous due to my past GB experience. About an hour later, I began to feel the same on the right foot, same area. Right now it is 5:07 pm and I feel the same.


VAERS ID: 1765589 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Nevada  
Vaccinated:2021-09-28
Onset:2021-10-06
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204B21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Dizziness, Feeling abnormal
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (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: None
Current Illness: None
Preexisting Conditions: Hep C
Allergies: None
Diagnostic Lab Data: None- sent to hospital
CDC Split Type:

Write-up: While working on the ranch, the patient stated he felt dizzy, experienced chest pain and shoulder pain. Stated "I feel like I''m going to die..."


VAERS ID: 1765603 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-10-06
Onset:2021-10-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2590 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Loss of consciousness, Syncope, Urinary incontinence
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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Within 1 minute of receiving the vaccine, the patient lost consciousness & urinated herself. Within 1 minute she regained consciousness. Her vitals signs were normal after fainting & 30 min after vaccination.


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