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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 180 out of 8,753

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VAERS ID: 1841628 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Illness, Immunisation, Lethargy, Pain in extremity, SARS-CoV-2 test
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211018; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101426414

Write-up: Aching back arms shoulders legs; Aching back arms shoulders legs; I feel tired; Sick; lethargic; Painful arm; Booster; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient) received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110211740016680-N7ULB. Safety Report Unique Identifier GB-MHRA-ADR-26105021. A 75-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FF8288), via an unspecified route of administration on 14Oct2021 as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient previously received first dose and second dose of historical vaccine bnt162b2 for COVID-19 immunisation. Patient has not tested positive for COVID-19 since having the vaccine; Patient was not enrolled in clinical trial. Details of any relevant investigations or tests conducted reported as none. On 14Oct2021 the patient had booster, On 15Oct2021 patient experienced Painful arm, on an unspecified date she experienced aching back arms shoulders legs, I feel tired, sick and lethargic. The events Painful arm, lethargic were medically significant. It was reported that, patient had aching back arms shoulders legs I feel tired lethargic. She has been sick, she had no reaction to two previous jabs. It was reported that, her arm was so painful for about 20 hours then the pain lessened. She could it remove her bras it was so painful. It was now one week since jab, and she have no energy. On 18Oct2021 the patient underwent lab tests and procedures which included sars-COV-2 test: negative (no - negative covid-19 test). The outcome of the event painful arm was recovered on 17Oct2021, while event lethargic was not recovered, while for all other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841636 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-11
Onset:2021-10-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blindness, Blood test, Cerebrovascular accident, Computerised tomogram, Headache, Magnetic resonance imaging, Migraine, SARS-CoV-2 test
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), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE; VITAMIN B-12
Current Illness: Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: Angiogram; Result Unstructured Data: Test Result:Unknown; Test Name: bloodwork; Result Unstructured Data: Test Result:Unknown; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown; Test Name: MRI; Result Unstructured Data: Test Result:Unknown; Test Date: 20211014; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101428888

Write-up: migraine; headache; sight loss; Stroke; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is -MHRA-WEBCOVID-202110221411531870-7VVPX, Safety Report Unique Identifier -MHRA-ADR 26109885. A 38-years-old non-pregnant female patient received bnt16b2 (COMIRNATY, solution for injection, Lot Number: FF8288) via an unspecified route of administration on 11Oct2021 as dose 1, single for COVID-19 immunization. Patient was usually fit and healthy. Medical history included suspected COVID-19 from 14Feb2020 to an unknown date (Unsure when symptoms stopped), depression, ongoing smoker. The patient last menstrual period date 15Oct2021. Concomitant medication(s) included sertraline (SERTRALINE) taken for depression; cyanocobalamin (VITAMIN B-12) taken for hypovitaminosis from 24Aug2021 to Oct2021. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced migraine, headache, sight loss. On 14Oct2021, the patient experienced stroke. The vaccine was given on Monday 11/10. No undesirable effects noted. Patient had a stressful and emotionally draining day on Wednesday due to supporting a relative through a mental health crisis. Did not sleep until 6 am. Awoke late Thursday morning with a headache which progressed from slight to extreme (felt like extreme pressure inside head). At about 2.30 in the afternoon, patient experienced sudden visual loss in both eyes to one side. A friend advised patient it was probably a migraine so she decided to rest and took paracetamol 4 hourly and ibuprofen 8 hourly. The headaches resolved on Saturday. The loss of vision continued. She presented to hospital on Monday as she suspected some unknown debris was causing her sight loss. She was told that her eyes were healthy and was advised to present to A and E for an urgent CT scan. Patient had blood work and a series of scans including CT, MRI and Angiogram. Tests confirmed that patient had suffered a stroke. The only recognized risk factor is her current smoker status. She has been advised that there is a 50/50 chance of her sight improving. However, it was unlikely to return to its original state. Patient has been prescribed anti platelet medication and statins which she will have to take long term. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis. The patient underwent lab tests and procedures which included angiogram: unknown, blood test: unknown, computerized tomogram: unknown, magnetic resonance imaging: unknown on, sars-cov-2 test: negative on 14Oct2021 (No- Negative COVID-19 test). The outcome of the headache was recovered, stroke was recovering while for the other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1841658 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FF8288 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Blood test, Chest X-ray, Dizziness, Dyspnoea, Electrocardiogram, Emotional distress, Epilepsy, Heart rate increased, Malaise, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:Unknown Result; Test Name: Chest Xray; Result Unstructured Data: Test Result:Unknown Result; Test Name: ECG; Result Unstructured Data: Test Result:Unknown Result; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101457344

Write-up: i do not feel i made an informed choice; heart distress; will not consider a second vaccine; Quick pulse; dizzy; pain extended from left shoulder into the entire upper back; out of breadth; pain in shoulder; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (RA). The regulatory authority report number is [GB-MHRA-WEBCOVID-202110261041170890-DWBVG], Safety Report Unique Identifier [GB-MHRA-ADR 26122423]. A female patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, lot# FF8288), via an unspecified route of administration on 14Oct2021 16:30 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced i do not feel i made an informed choice (malaise), heart distress, will not consider a second vaccine (epilepsy), quick pulse on 15Oct2021, pain in shoulder on 14Oct2021, dizzy on 15Oct2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on an unspecified date No - Negative COVID-19 test. Clinical course reported as: VACCINE administered Thur 14Oct2021 at 4:30pm. Same evening - pain in shoulder close to the administration point. Next day - pain extended from left shoulder into the entire upper back, alongside racing pulse episodes, leaving me out of breadth and dizzy. Symptoms continues into Saturday. Slow recovery from Sunday 17th which is still ongoing with some pressure in the left shoulder and breast still ongoing and episodes of heart distress. Will not consider a second vaccine, not sure my heart can take it. I DO NOT FEEL I made an informed choice, no one said I could have life-lasting impact on my heart. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Chest Xray, ECG, Blood tests done in A&E when I presented for check-up after being out of breadth and with racing pulse. Outcome of quick pulse was recovering, outcome of pain in shoulder, dizzy, out of breadth, pain extended from left shoulder into the entire upper back was unknown, other events was not recovered. Case was reported as serious medically significant, life threatening. No follow up attempts are needed. No further information is expected


VAERS ID: 1841785 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-10-14
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EUTIROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20211017; Test Name: SARC-COV 2 TEST; Test Result: Positive
CDC Split Type: ITPFIZER INC202101481292

Write-up: Drug ineffective; Covid-19; Cough; Fever; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority (RA) -WEB, regulatory authority number IT-MINISAL02-802737. A 52-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: FF0680), intramuscular on 17Jul2021as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (EUTIROX) taken for hypothyroidism, start and stop date were not reported. On 14Oct2021, the patient experienced drug ineffective and covid-19 (medically significant), cough and fever. On 17Oct2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the events was recovering. Reporter Commented that on 25Oct2021 the patient, heard by phone, declared that the ADR was improving even if the cough persists. Not yet negativized. Sender Commented that patient initial inversion after verification in PRIVACY.; Reporter''s Comments: On 25Oct2021 the patient, heard by phone, declared that the ADR is improving even if the cough persists. Not yet negativized.


VAERS ID: 1841872 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-30
Onset:2021-10-14
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Leiomyoma, Myalgia, Pregnancy test, Vaccination site swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (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: Test Name: pregnancy test; Test Result: Positive ; Comments: She had a positive pregnancy test.
CDC Split Type: NLPFIZER INC202101437875

Write-up: Miscarriage; I estimate I was 2 weeks late. it looked like a tidal wave was coming out and I started to leak heavily. According to the doctor I found a fibroid in my underpants.; Reaction at or around the injection site: swelling, occurring within a week of vaccination; Myalgia; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Agency (RA)-WEB and received via Regulatory Authority NL-LRB-00700609. This is first of two reports regarding 2nd dose of Comirnaty lot# FF2834. A 41-years-old pregnant female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number: FF2834) via an unspecified route of administration on 31Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 26Aug2021 as DOSE 1, SINGLE for covid-19 immunisation and had vaccine exposure during pregnancy week: 2. It was reported that the patient''s period was two weeks over time when she had a large bleeding with myoma, which was confirmed by her GP. The patient also reported a miscarriage at this time 14 days after the vaccine, which occurred at an estimated pregnancy duration of about 6 weeks. It was reported it took a while before patient period was due. It was estimated as 2 weeks late. When picking up her youngest at the facility, it looked like a tidal wave was coming out and patient started to leak heavily. According to the doctor, found a fibroid in patient underpants. A positive pregnancy test confirmed this. It was reported that this was the second Covid vaccination, which took place at a pregnancy duration of about 4 weeks and also had myalgia 1 hours after vaccine, injection site swelling 1 day after vaccine and myoma 14 days after the vaccine following administration. It was also reported that it was unclear whether the patient had a myoma as well as a miscarriage. The patient did not have Previous COVID-19 infection. The outcome of the events injection site swelling, and myalgia were recovered, myoma was recovering and other was unknown. Health Authority comments: BioNTech/Pfizer vaccine (Comirnaty): Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: no Date: 26Aug2021. Redness or Swelling: Extensive swelling of vaccinated limb: no; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101447553 same patient , drug different dose


VAERS ID: 1841903 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 F11060 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101418769

Write-up: Fainting; This is a spontaneous report received from a contactable health care professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300111643. A 28-year-old male patient received bnt162b2 (COMIRNATY, lot number F11060), intramuscular on 14Oct2021 (at the age of 28-year-old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fainting on 14Oct2021 12:20 reported as serious with medically significant criterion. The outcome of the event was resolved on 14Oct2021 at 14:30 (reported as 02:30). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841904 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 31060BD / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:180/100 mmHg
CDC Split Type: PHPFIZER INC202101418796

Write-up: Elevated BP/ 180/100 mmHg; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300111941. A 27-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: 31060BD), intramuscular on 14Oct2021 (at the age of 27-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Oct2021 13:30, the patient experienced elevated BP with outcome of recovered on 14Oct2021 14:20. The patient underwent lab tests and procedures which included blood pressure measurement: 180/100 mmHg on 14Oct2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841907 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FH2528 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:160/100 mmHg; Comments: Pre vaccination; Test Date: 20211014; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:220/125 mmHg; Comments: 11:58 AM
CDC Split Type: PHPFIZER INC202101418802

Write-up: Elevated BP (220/125 mmHg); This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300111809. A 62-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: FH2528), intramuscular on 14Oct2021 (at the age of 62-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. It was unknown if the patient was pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated BP (220/125 mmHg) on 14Oct2021 11:58 with outcome of recovered. The patient underwent lab tests and procedures which included blood pressure measurement: 160/100 mmHg on 14Oct2021 (Pre vaccination); and then blood pressure measurement: 220/125 mmHg on 14Oct2021 at 11:58 AM. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841910 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 31060BD / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:160/100; Comments: 09:55
CDC Split Type: PHPFIZER INC202101418822

Write-up: Elevated BP (160/100); This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300111937. A 54-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: 31060BD), intramuscular on 14Oct2021 (at the age of 54-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. It was unknown if the patient was pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated BP on 14Oct2021 09:55 with outcome of recovered on 14Oct2021 10:10. The patient underwent lab tests and procedures which included blood pressure measurement: 160/100 on 14Oct2021 09:55. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842484 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004498 / 2 - / OT

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

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

Write-up: Very severe vomiting; Fever; Nausea; Headache; Fatigue; Shivering; This case was received via the Regulatory Authority (Reference number: BE-FAMHP-DHH-N2021-107906) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Very severe vomiting), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Shivering) in a 39-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004498) for COVID-19 vaccination. No Medical History information was reported. On 13-Oct-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced VOMITING (Very severe vomiting) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability), NAUSEA (Nausea) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), FATIGUE (Fatigue) (seriousness criterion disability) and CHILLS (Shivering) (seriousness criterion disability). On 16-Oct-2021, VOMITING (Very severe vomiting), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Shivering) had resolved. No concomitant medications were provided. No treatment medications were provided. Patient had very severe vomiting for 24 hours the day after the injection, very severe headaches for 60 hours that started the day after the injection and severe fatigue for four days later. Company Comment: This case concerns a 39-year-old, male patient with no relevant medical history, who experienced the unexpected events of vomiting, pyrexia, nausea, headache, fatigue, and chills. The events occurred the following day of the second dose of Spikevax. The rechallenge was not applicable as no information about additional dosing was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Document received on 29 Oct 2021. Reported verbatim for events and narrative updated.; Sender''s Comments: This case concerns a 39-year-old, male patient with no relevant medical history, who experienced the unexpected events of vomiting, pyrexia, nausea, headache, fatigue, and chills. The events occurred the following day of the second dose of Spikevax. The rechallenge was not applicable as no information about additional dosing was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1843959 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Balance disorder, Chest discomfort, Chills, Diarrhoea, Dizziness, Fatigue, Feeling hot, Myalgia, Nausea, Rhinorrhoea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101403492

Write-up: Syncope; Abdominal pain; Balance disorder; Chest discomfort; Chills; Diarrhoea; Dizziness; Fatigue; Feeling hot; Myalgia; Nausea; Rhinorrhoea; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 645289. As per source verbatim: A 57-year-old female patient received BNT162B2 (COMIRNATY; solution for injection, Lot Number: Unknown), via unspecified route of administration, on an unspecified date as a dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On 14Oct2021 the patient experienced syncope, abdominal pain, balance disorder, chest discomfort, chills, diarrhoea, dizziness, fatigue, feeling hot, myalgia, nausea and rhinorrhoea. The outcome for all the reported events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1844584 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Fatigue, Nausea, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (immunodeficiency)); Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Tiredness; Runny nose; Increased shortness of breath; Dizzy spells; This case was received via the RA (Reference number: GB-MHRA-ADR 26082623) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Increased shortness of breath), DIZZINESS (Dizzy spells), NAUSEA (Nausea), FATIGUE (Tiredness) and RHINORRHOEA (Runny nose) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The patient''s past medical history included Asthma, Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)) and Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (immunodeficiency)). On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced DYSPNOEA (Increased shortness of breath) (seriousness criterion medically significant), DIZZINESS (Dizzy spells) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and RHINORRHOEA (Runny nose) (seriousness criterion medically significant). On 15-Oct-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Increased shortness of breath), DIZZINESS (Dizzy spells), NAUSEA (Nausea), FATIGUE (Tiredness) and RHINORRHOEA (Runny nose) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported No treatment information was provided. Patient had eczema, diverticulitis Patient has not had symptoms associated with COVID-19 . Company Comment : This case concerns a male patient of unknown age with relevant medical history of Asthma, Inflammatory bowel disease and Immunodeficiency, who experienced the serious unexpected events of Dyspnea, Dizziness, Nausea, Fatigue and Rhinorrhea. The events of Nausea and Fatigue are unexpected as they are retained as serious per the RA source document. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The patient''s medical history of Asthma, Inflammatory bowel disease and Immunodeficiency remain as confounders for the occurrence of the events. 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 persistent or permanent incapacity.; Sender''s Comments: This case concerns a male patient of unknown age with relevant medical history of Asthma, Inflammatory bowel disease and Immunodeficiency, who experienced the serious unexpected events of Dyspnea, Dizziness, Nausea, Fatigue and Rhinorrhea. The events of Nausea and Fatigue are unexpected as they are retained as serious per the RA source document. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The patient''s medical history of Asthma, Inflammatory bowel disease and Immunodeficiency remain as confounders for the occurrence of the events. 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 persistent or permanent incapacity.


VAERS ID: 1844590 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Myalgia, Syncope, Vaccination site pain, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: No energy; Sore muscles all over body; Vomiting; Sore at injection site; Fainted; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26084344) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted), ASTHENIA (No energy), VACCINATION SITE PAIN (Sore at injection site), MYALGIA (Sore muscles all over body) and VOMITING (Vomiting) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included FLUOXETINE and ETHINYLESTRADIOL, GESTODENE (FEMODENE) for an unknown indication. On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 14-Oct-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), VACCINATION SITE PAIN (Sore at injection site) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On 15-Oct-2021, the patient experienced ASTHENIA (No energy) (seriousness criterion medically significant) and MYALGIA (Sore muscles all over body) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainted) and VOMITING (Vomiting) had resolved and ASTHENIA (No energy), VACCINATION SITE PAIN (Sore at injection site) and MYALGIA (Sore muscles all over body) was resolving. Treatment information was not provided Company comment: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced the unexpected and serious events of asthenia, vomiting, vaccination site pain, syncope and myalgia. The events vomiting, vaccination site pain and syncope occurred the following day a dose of mRNA-1273 (Moderna COVID-19 Vaccine) was administered and the events asthenia and myalgia occurred 2 days after vaccine administration. The rechallenge was not applicable since only information of one dose is disclosed. The benefit-risk relationship of mRNA-1273 (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 event was medically significant.; Sender''s Comments: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced the unexpected and serious events of asthenia, vomiting, vaccination site pain, syncope and myalgia. The events vomiting, vaccination site pain and syncope occurred the following day a dose of mRNA-1273 (Moderna COVID-19 Vaccine) was administered and the events asthenia and myalgia occurred 2 days after vaccine administration. The rechallenge was not applicable since only information of one dose is disclosed. The benefit-risk relationship of mRNA-1273 (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 event was medically significant.


VAERS ID: 1844604 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FF8288 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400548

Write-up: Nosebleed; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110171154267080-D7CR6. Safety report unique identifier is GB-MHRA-ADR 26085388. A 73-years-old female patient received third dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: ff8288), via an unspecified route of administration on 14Oct2021 (Age at time of vaccination 73-years-old) as dose 3 (booster), single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took COVID-19 VACCINE ASTRAZENECA (Batch/Lot number: unknown) dose 1, via an unspecified route of administration on 02Feb2021 as dose 1, single and dose 2 via an unspecified route of administration on 13Apr2021 as dose 2, single for covid-19 immunisation. After second dose of COVID-19 VACCINE ASTRAZENECA, patient experienced weakness of arms, joint pain, facial pain, dry nose, dry throat and increased urinary frequency on 14Jun2021. Patient has not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced nosebleed on 16Oct2021 for over one hour. The case was assessed as serious (medically significant) by the health authority. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative COVID-19 test on an unspecified date. The outcome of event was recovered on 16Oct2021. No follow-up attempts are needed. No further information is expected. Follow-up (22Oct2021): New information from a contactable consumer via regulatory authority included: Case is upgraded to serious (medically significant). Added reaction to historical vaccine (weakness of arms, joint pain, facial pain, dry nose, dry throat and increased urinary frequency), stop date of event nosebleed (16Oct2021) and updated outcome of event nosebleed (from unknown to recovered/ resolved). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1844622 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FB3712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Hypoaesthesia, Immunisation, Vaccination site pain
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:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101417937

Write-up: Numbness in hand; Injection site burning; Burning finger; Booster; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110191025249300-YMWFU, Safety Report Unique Identifier GB-MHRA-ADR 26091370. A 40-year-old male patient received third dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: Fb3712), via an unspecified route of administration on 14Oct2021 (age at vaccination: Unknown) 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. The patient''s concomitant medications were not reported. Patient was not enrolled in clinical trial. Patient previously received doses 1 and dose 2 of BNT162b2 on unspecified dates for COVID-19 immunisation. Patient received the booster on 14Oct2021 and on 15Oct2021, the patient experienced numbness in hand, Injection site burning, burning finger. Patient has not tested positive for COVID-19 since having the vaccine. Report not related to possible inflammation of the heart (myocarditis or pericarditis). The events were reported as serious (Seriousness criteria-Other medically important condition). Outcome of event numbness in hand, vaccination site burning, burning finger was reported as not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1844627 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101417818

Write-up: Booster; Fever; Ache; Off label use; Interchange of vaccine products; 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-202110191122439080-SHNYP, Safety Report Unique Identification Number: GB-MHRA-ADR 26091500. A 26-year-old female patient received third dose of BNT162B2 (COMIRNATY) via an unspecified route of administration as single dose on 14Oct2021 (at the age of 26 years) for COVID-19 immunization. The patient''s 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 pregnant. Patient is not currently breastfeeding. The patient previously took COVID-19 VACCINE ASTRAZENECA on 21Jan2021 for COVID-19 immunization and COVID-19 vaccine on an unknown date. The patient experienced off label use, interchange of vaccine products, booster, fever and ache all on 14Oct2021. The events fever and ache were both reported as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient recovered from fever and ache both on 15Oct2021. It was reported that the report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1844634 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Immunisation, Off label use, SARS-CoV-2 test, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LAMOTRIGIN; LEVOTHYROXINE SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bipolar disorder; Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20211008; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101418075

Write-up: blood clots; Nosebleed; Off label use; Booster; This is a spontaneous report from a contactable consumer (Patient). This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110191234269990-YGN3J, regulatory authority Identifier GB-MHRA-ADR 26091943. A 42-year-old female patient received third dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported), via an unspecified route of administration on 14Oct2021 (at the age of 42-years-old) as Dose 3 (Booster), Single for COVID-19 immunization. Medical history included bipolar disorder and hypothyroidism. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included lamotrigin taken for bipolar disorder from 20Dec2020 to an unspecified stop date; levothyroxine sodium taken for hypothyroidism, start and stop date were not reported, Historical Vaccine was added for first dose of COVID-19 vaccine astrazeneca (COVID-19 VACCINE ASTRAZENECA, Batch/lot number: AB0005), via an unspecified route of administration on 26Jan2021, second dose of COVID-19 vaccine astrazeneca (COVID-19 VACCINE ASTRAZENECA, Batch/lot number: PV46673), via an unspecified route of administration on 29Mar2021 for COVID-19 immunization. The patient had off label use (booster use). On 17Oct2021, the patient''s nose started bleeding for no reason (not caused by an injury) and there were also 2 blood clots, which has never happened before. The patient don''t normally get nose bleeds, hence it was very unexpected. It took approximately 15 minutes for the nose to stop bleeding. The outcome of blood clots was not recovered while nose bleeds recovered on 17Oct2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included negative COVID-19 test on 08Oct2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1844695 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0112 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Pyrexia, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:high; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101418053

Write-up: exhaustion; high temperature; Hives; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110201104561890-N2MEU, and Safety Report Unique Identifier is GB-MHRA-ADR 26097483. A 13-year-old male patient received BNT162B2 (COMIRNATY) (Batch/Lot Number: FK0112), dose 1 via an unspecified route of administration on 12Oct2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) taken for immunization. The patient experienced exhaustion and high temperature on an unspecified date with outcome of not recovered, and hives on 14Oct2021 with outcome of not recovered. The events were reported serious, other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab test which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1844751 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Fatigue, Immunisation, Palpitations, Pericarditis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pericarditis; Suspected COVID-19 (Unsure when symptoms and stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101426584

Write-up: Breathlessness; Chest discomfort; Pericarditis NOS; Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Booster; This is a spontaneous report from a contactable consumer (Patient). This report is received from The regulatory authority report number is GB-MHRA-WEBCOVID-202110201857185740-EZYJH, Safety Report Unique Identifier GB-MHRA-ADR 26100131. A 54-years-old non-pregnant female patient received third dose of BNT162B2 (COMIRNATY Covid-19 vaccine, Formulation: Solution for injection, Lot Number: FF8222), via an unspecified route of administration on 14Oct2021 as dose 3 (booster), single for covid-19 immunisation. Medical history included suspected covid-19 (unsure when symptoms and stopped) from an unknown date and unknown if ongoing, pericarditis from Mar2020 to an unknown date. The patient''s concomitant medications were not reported. Historical vaccine included that patient received first and second dose of BNT162B2 (COMIRNATY Covid-19 vaccine, Formulation: Solution for injection, Lot Number: FF8222), via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for covid-19 immunisation. On an unspecified date, the patient experienced breathlessness, chest discomfort, pericarditis NOS, fatigue/unusual tiredness, chest pain, shortness of breath, heart palpitations. The reporter considered the events as serious (medically significant). She had Pericarditis in April 2020 and GP believed due to a virus. The second vaccine brought it back, and now the booster has brought it back. Chest discomfort/heavy feeling slightly better when leaning forward. Slight breathlessness. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report relates to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay. The outcome of events breathlessness, chest discomfort was resolving, pericarditis NOS was not recovered, and other events was unknown. No follow up attempts are needed. No further information is expected.


VAERS ID: 1844759 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS; LOSARTAN; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pulmonary edema; Pulmonary embolus
Allergies:
Diagnostic Lab Data: Test Name: biopsy; Result Unstructured Data: Test Result:all clear; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: smear; Result Unstructured Data: Test Result:all clear; Test Name: ultrasound; Result Unstructured Data: Test Result:all clear
CDC Split Type: GBPFIZER INC202101417623

Write-up: Heavy periods; off label use; Booster; Interchange of vaccine products; 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-202110202052416740-WCSUB, safety report unique identifier GB-MHRA-ADR 26100754. A 50-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration on 14Oct2021 (at age of 50-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was pulmonary embolus and pulmonary edema. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Concomitant medications included influenza vaccine (INFLUENZA VIRUS) taken for immunisation on 23Sep2021; losartan taken for pulmonary oedema from 22Sep2018 to an unspecified stop date; warfarin taken for pulmonary embolism from 22Jan2019 to an unspecified stop date. Patient previously had dose 1 of COVID-19 VACCINE ASTRAZENECA on 04Mar2021 and dose 2 of COVID-19 VACCINE ASTRAZENECA on 10Apr2021 for covid-19 immunisation. On 15Oct2021, the patient experienced heavy periods. On 14Oct2021, off label use, interchange of vaccine products and booster. Covid vaccine: No reaction to 1st vaccine 2nd covid vaccine. 1 month later very heavy period 40 days- referred to gyny, nothing found Flu vaccine 23Sep2021. No reaction. Covid booster - period started day before booster, and is still very heavy, up 3 times each night, going through approx. 10 period products each day. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test). Previously had smear, biopsy and ultrasound: all clear. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report not related to possible inflammation of the heart (myocarditis or pericarditis). Outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1844937 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood fibrinogen, Chest pain, Diarrhoea, Fibrin D dimer increased, Headache, Myalgia, Pyrexia, Visual field defect, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer; Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer; Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer; Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer; Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer; Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer; Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer; Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer; Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer; Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-800074) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), VISUAL FIELD DEFECT (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), DIARRHOEA (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), ASTHENIA (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), MYALGIA (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), HEADACHE (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), PYREXIA (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), VOMITING (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), FIBRIN D DIMER INCREASED (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer) and BLOOD FIBRINOGEN (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer) in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. Concomitant products included LEVOTHYROXINE SODIUM (EUTIROX) for an unknown indication. On 12-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 14-Oct-2021, the patient experienced CHEST PAIN (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer) (seriousness criterion hospitalization), VISUAL FIELD DEFECT (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer) (seriousness criterion hospitalization), DIARRHOEA (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer) (seriousness criterion hospitalization), ASTHENIA (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer) (seriousness criterion hospitalization), MYALGIA (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer) (seriousness criterion hospitalization), HEADACHE (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer) (seriousness criterion hospitalization), PYREXIA (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer) (seriousness criterion hospitalization), VOMITING (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer) (seriousness criterion hospitalization), FIBRIN D DIMER INCREASED (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer) (seriousness criterion hospitalization) and BLOOD FIBRINOGEN (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer) (seriousness criterion hospitalization). At the time of the report, CHEST PAIN (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), VISUAL FIELD DEFECT (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), DIARRHOEA (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), ASTHENIA (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), MYALGIA (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), HEADACHE (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), PYREXIA (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), VOMITING (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer), FIBRIN D DIMER INCREASED (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer) and BLOOD FIBRINOGEN (Widespread muscle pain asthenia chest pain fever headache scotomas in the right eye vomiting diarrhea increased fibrinogen d-dimer) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided by the reporter. Lab data: Fibrinogen and Fibrin D dimer were tested on 14-OCT-2021 with no results. The vaccine lot was not found. Patient was discharged on 15-OCT-2021. Company Comment: This case concerns a 57-year-old, female patient with no relevant medical history, who experienced the unexpected events of Chest pain, Visual field defect, Diarrhea, Asthenia, Myalgia, Headache, Pyrexia, Vomiting, Fibrin d-dimer increased, and Blood fibrogen. The events occurred approximately 3 days after the first dose of Spikevax . The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Translation received on 29-OCT-2021 includes translated event verbatim and reporter''s comment.; Sender''s Comments: This case concerns a 57-year-old, female patient with no relevant medical history, who experienced the unexpected events of Chest pain, Visual field defect, Diarrhea, Asthenia, Myalgia, Headache, Pyrexia, Vomiting, Fibrin d-dimer increased, and Blood fibrogen. The events occurred approximately 3 days after the first dose of Spikevax . The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1844972 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FG6270 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hyperpyrexia, Lymphadenopathy
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: Body temperature; Result Unstructured Data: Test Result:$g39 Centigrade; Comments: from 14 to 16Oct2021
CDC Split Type: ITPFIZER INC202101445519

Write-up: Enlargement of lymph nodes; Hyperpyrexia; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB, authority number IT-MINISAL02-802435. A 49-years-old female received third dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: FG6270, Expiry: 01Dec2021) via an intramuscular route of administration in left arm/left shoulder on 14Oct2021 (at 11:30) (age at the time of vaccination was 49-year-old) as a DOSE 3, 0.3ml SINGLE dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 14Oct2021, the patient experienced hyperpyrexia and on 16Oct2021, the patient experienced enlargement of lymph nodes. The patient underwent lab tests and procedures which included hyperpyrexia: $g 39 degrees on 14Oct2021. The clinical outcome of events was not recovered. Health Authority Comment: From 14 to 16 high fever ($g 39 degrees) on 16 lymph adenomegaly (supraclavicular left). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1844973 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FH9951 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Back pain, Blood pressure decreased, Blood pressure measurement, Breast pain, Decreased appetite, Discomfort, Dry mouth, Feeling cold, Gait disturbance, Gingival pain, Headache, Hyperhidrosis, Insomnia, Lymphadenopathy, Muscle spasms, Pain, Paraesthesia, Pelvic pain, Syncope, Thirst, Tremor, Vaccination site pain, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Gingival disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Lipodystrophy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? Yes
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:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy multiple; Hypertension; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: blood pressure; Result Unstructured Data: Test Result:80/50
CDC Split Type: ITPFIZER INC202101461823

Write-up: Mastodynia; discomfort was added to the neck, armpits and groin bilaterally as from an inflammatory state; loss of appetite; excruciating pain in the left arm, injection site; visual disturbances such as fog; Headache fullness; pain throughout the body; widespread weakness and asthenia; difficulty standing/Difficulty in walking; pelvic pain; lumbar pain; burning and pain in joints (shoulders, elbows, knees, ankles, sternum, sacroiliac joint); dry mouth; sore gums; need to drink plenty of water; sensation of cold; widespread tremors; cramps all over my body especially abdominal muscles, thighs, buttocks, arms; profuse and cold sweating; drop in blood pressure; collapsed; insomnia; swollen and painful lymph nodes in the neck and groin; tingling in the calf and left ankle; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB IT-MINISAL02-802556. A 55-years-old female patient received bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: FH9951) via an unspecified route of administration, administered in Arm Left on 14Oct2021 (age at vaccination 55-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension, rheumatoid arthritis, allergies. The patient concomitant medications were not reported. On 14Oct2021, the patient experienced immediately after the administration vaccine excruciating pain in the left arm, injection site. 30 minutes after administration widespread weakness and asthenia with difficulty standing and visual disturbances such as fog. After an hour and a half from the administration, associated with the previous symptomatology there was mastodynia, pelvic and lumbar pain and at the height of the kidneys. Two hours after administration, discomfort was added to the neck, armpits, and groin bilaterally as from an inflammatory state. About three hours after administration, there was added burning and pain in the joints (shoulders, elbows, knees, ankles, sternum, sacroiliac joint). Headache, loss of appetite and dry mouth, sore gums such as to avoid lunch and dinner and the need to drink plenty of water. In the evening (12 hours after administration), despite having taken a 1000mg tachipirina, the symptoms worsen with a sensation of cold, widespread tremors, pain throughout the body. Symptoms are not reduced; they are not relieved, but they get worse. The patient felt cramps all over my body, especially abdominal muscles, thighs, buttocks, arms. She took another 1000mg tachipirina but to the symptoms described above is added profuse and cold sweating and drop in blood pressure (80 systolic / 50 diastolic) and collapsed. At this point the doctor was called who suggested immediate venous access and administration of fluids (saline and physiological solution and glutathione) with a combination of oral ibuprofen and intramuscular plasil. After 40 minutes from the administration of the drugs begins a slow, gradual but progressive recovery without being able to get out of bed for 24 hours with asthenia and insomnia. The next day another 1000ml physiological solution is administered and there is almost complete remission of symptoms 48 hours after the administration of the vaccine. To date (10 days from the administration of the vaccine) there is still tingling in the calf and left ankle, swollen and painful lymph nodes in the neck and groin. Treatment was received for the adverse events. The patient underwent lab tests and procedures which included blood pressure measurement and result was 80/50 on 14Oct2021. Outcome of the events was Recovered/Resolved with Sequel.


VAERS ID: 1844975 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-10-14
   Days after vaccination:146
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Investigation, Renal ischaemia
SMQs:, Renovascular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus (The patient is a fragile patient, diabetes mellitus and other endocrinopathies)
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: investigation; Result Unstructured Data: Test Result:ischemic or infectious kidney injury
CDC Split Type: ITPFIZER INC202101463419

Write-up: ischemic or infectious kidney injury under investigation; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number IT-MINISAL02-802938. A 68-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: FA8016; Expiration Date: 30Sep2021), via intramuscular route of administration, administered at the left arm on 21May2021 as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. The patient''s medical history included diabetes mellitus (the patient was fragile patient and with other endocrinopathies) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: ex7389; Expiration Date: 31Jul2021) via an unspecified route of administration on 28Apr2021 as Dose 1, Single for COVID-19 immunization. On 14Oct2021, the patient experienced ischemic or infectious kidney injury under investigation. On an unspecified date, the patient was hospitalized for the event. Outcome of the event was unknown. Reporters comment: The patient is a fragile patient, diabetes mellitus and other endocrinopathies, has done the first dose of Pfizer vaccine on 28Apr2021 lot: ex7389 expiry date 31Jul2021. No follow up attempts needed, no further information is expected


VAERS ID: 1845127 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:150/100
CDC Split Type: PHPFIZER INC202101418771

Write-up: Elevated BP 150/100; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300111653. A 30-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 14Oct2021 (Batch/Lot Number: FD0350) at 30 years of age as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated BP 150/100 on 14Oct2021 12:03 with outcome of recovered on 14Oct2021 (unknown time). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1845128 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FD0350 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20211014; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:160/110 mmHg
CDC Split Type: PHPFIZER INC202101418772

Write-up: Elevated blood pressure 160/110; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300111657. A 41-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 14Oct2021 (lot number: FD0350; expiry date: unknown) at the age of 41-years-old, as dose number unknown, single, for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Oct2021 at 11:30, the patient experienced elevated blood pressure 160/110. Outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1845130 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FH2528 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:150/80 mmHg; Comments: 10:30 AM; Test Date: 20211014; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:180/90 mmHg; Comments: 10:55 AM; Test Date: 20211014; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:194/100 mmHg; Comments: 11:22 AM
CDC Split Type: PHPFIZER INC202101418777

Write-up: Elevated BP 150/80 mmHg, 180/90 mmHg, 194/100 mmHg; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. The regulatory authority report number is PH-PHFDA-300111681. A 55-year-old male patient received BNT162b2 (COMIRNATY, solution for injection, lot number FH2528), intramuscular on 14Oct2021 as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated BP on 14Oct2021 10:30. The patient had the following blood pressure measurement on 14Oct2021: 150/80 mmHg 10:30 AM, 180/90 mmHg 10:55 AM and, 194/100 mmHg 11:22 AM. The outcome of the event was recovered on 14Oct2021 11:45. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1845131 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 31060BD / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:160/90 mmHg
CDC Split Type: PHPFIZER INC202101418793

Write-up: elevated BP with blood pressure measurement of 160/90 mmhg; This is a spontaneous report from a contactable health care professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300111933. A 45-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 14Oct2021 (Lot Number: 31060BD) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced elevated bp with blood pressure measurement of 160/90 mmhg on 14Oct2021 09:26. The event recovered on 14Oct2021 at 09:41. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1845193 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   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 FG7898 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haematemesis, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (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: ACETYLSALICYLSYRA TEVA; ALVEDON; CANDESARTAN SANDOZ; ESCITALOPRAM/SANDOZ; ISONOVA; SPIRONOLAKTON PFIZER
Current Illness: Angina pectoris; Chronic ischemic heart disease, unspecified; Frontotemporal dementia; Hypertension; Mitral insufficiency; Prostate cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101414942

Write-up: Coffee ground vomiting; Vomiting; This is a spontaneous report from a contactable other healthcare professional (nurse) downloaded from the Regulatory Authority-WEB; the Regulatory Authority report number is SE-MPA-2021-090020. A 71-year-old male patient received the third dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 13Oct2021 (batch/lot number: FG7898) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient''s medical history included mitral insufficiency from 2009 and ongoing; hypertension and angina pectoris, both from 2012 and ongoing; prostate cancer from 2017 and ongoing; frontotemporal dementia from 2018 and ongoing; and Chronic ischemic heart disease, unspecified from 2019 and ongoing. Concomitant medications included acetylsalicylic acid (ACETYLSALICYLSYRA TEVA) taken for an unspecified indication from 24Mar2020 to an unspecified stop date; paracetamol (ALVEDON) taken for an unspecified indication from 15Jul2021 to an unspecified stop date; candesartan cilexetil (CANDESARTAN SANDOZ) taken for an unspecified indication from 24Mar2020 to an unspecified stop date; escitalopram oxalate (ESCITALOPRAM/SANDOZ) taken for an unspecified indication from 13Apr2021 to an unspecified stop date; isosorbide mononitrate (ISONOVA) taken for an unspecified indication from 11Jun2020 to an unspecified stop date; and spironolactone (SPIRONOLAKTON PFIZER) taken for an unspecified indication from 24Mar2020 to an unspecified stop date. The patient previously received the first and second dose of COVID-19 Vaccine (manufacturer unknown) via an unspecified route of administration on unknown dates (batch/lot numbers: unknown) as DOSE 1, SINGLE and DOSE 2, SINGLE for COVID-19 immunization. On 14Oct2021, reported as "18 hours after the third dose," the patient started vomiting. The patient also experienced coffee ground vomiting during the night after the vaccination, (on 15Oct2021) which resulted in seeking emergency care. The outcome of the events was not recovered. This case report was assessed as serious since the events required hospitalization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1845621 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-11
Onset:2021-10-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005696 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Myocarditis; This case was received via regulatory authority (Reference number: FI-FIMEA-20215719) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) in a 14-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005696) for COVID-19 vaccination. No Medical History information was reported. On 11-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Oct-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. Company Comment: This is a regulatory authority case concerning a 14 year-old female patient with no relevant medical history reported, who experienced serious, expected event of Myocarditis. The event occurred 4 days after the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 14 year-old female patient with no relevant medical history reported, who experienced serious, expected event of Myocarditis. The event occurred 4 days after the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1845732 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-30
Onset:2021-10-14
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Serious allergic reaction; skin itching; Skin Rash; This regulatory authority case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (Serious allergic reaction), PRURITUS (skin itching) and RASH (Skin Rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 14-Oct-2021, the patient experienced HYPERSENSITIVITY (Serious allergic reaction) (seriousness criterion medically significant), PRURITUS (skin itching) (seriousness criterion medically significant) and RASH (Skin Rash) (seriousness criterion medically significant). At the time of the report, HYPERSENSITIVITY (Serious allergic reaction) and PRURITUS (skin itching) outcome was unknown and RASH (Skin Rash) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. the patient had skin rashes on the whole body started from 4-10-2021 but no such symptoms after receiving the first dose. the patient stated that the skin rash improved after administering the medications and ointment. The concomitant medications were not provided. Company Comment: This case concerns a 72-year-old, male patient with no relevant medical history, who experienced the serious unexpected events of Hypersensitivity, Pruritus and Rash. The events of Hypersensitivity and Rash are unexpected as they are retained as serious per the RA source document. The events occurred approximately 4-14 days after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of 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 persistent or permanent incapacity.; Sender''s Comments: This case concerns a 72-year-old, male patient with no relevant medical history, who experienced the serious unexpected events of Hypersensitivity, Pruritus and Rash. The events of Hypersensitivity and Rash are unexpected as they are retained as serious per the RA source document. The events occurred approximately 4-14 days after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of 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 persistent or permanent incapacity.


VAERS ID: 1845885 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-10-14
   Days after vaccination:246
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: PCR (COVID-19); Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: BEPFIZER INC202101510320

Write-up: Tested positive on 14Oct2021; vaccination failure; This is a spontaneous report from a contactable consumer (patient and Pfizer colleague) via Regulatory Authority. This 40-year-old non-pregnant female patient received BNT162b2 (COMIRNATY) dose 1 on 20Jan2021, lot number EM0477, Expiry: 30Apr2021 and dose 2 of BNT162b2 (COMIRNATY) on 10Feb2021 (Batch/Lot Number: EK9788, Expiry: 31May2021), both as single doses, intramuscularly, in the right arm, for COVID-19 immunization at the age of 39-years-old. Medical history included allergy. Concomitant medications were not reported. The patient tested positive on 14Oct2021 and experienced vaccination failure on 14Oct2021. There was no treatment received for tested positive. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR): positive on 14Oct2021 (Nasal Swab). The outcome of the events was recovered on unspecified date. Investigation results were received from the Regulatory Authority. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lots of the reported lot EM0477 and EK9788. 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. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable.The Investigative process determined that a regulatory notification was required.The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.


VAERS ID: 1846691 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   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 FF2595 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Asthenia, Palpitations, Panic attack
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to chemicals; COPD; Depression; Environmental allergy; Fragrance sensitivity; Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101427489

Write-up: panic attack; racing heart briefly; I felt very weak; nervousness, feeling on edge, jittery; This is a spontaneous case received from a contactable consumer (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2595) Dose 1 via an unspecified route of administration in the left arm on 13Oct2021 at 13:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, penicillin allergy, depression, sensitivity to artificial fragrances dermatitis contact, allergy to chemicals, and sensitivity to pollution; all from an unknown date and unknown if ongoing. The patients concomitant medications were not reported. The patient previously took codeine and experienced hypersensitivity. The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 14Oct2021 at 08:00, the patient experienced panic attacks (medically significant), racing heart briefly, felt very weak, and nervousness,feeling on edge, jittery. The patient reported, "When I woke up (in the morning) on following day after vaccination (14Oct2021) I had a panic attack and a racing heart briefly, and I felt very weak. During the past 9 days (since 14Oct2021) I have had general nervousness, feeling on edge, jittery, and panic attacks. I have not yet visited a health-care professional about these symptoms but I''m planning to see one soon. Because of these symptoms I don''t intend to ever receive a 2nd dose of any Covid vaccine. The patient recovered from racing heart briefly on 14Oct2021. The patient had not recovered from the other events.


VAERS ID: 1847350 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101417592

Write-up: vomiting; body aches and shivers; nausea; fever; Headache; Off label use; 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-202110191916517420-DODKV.Safety Report Unique Identifier is GB-MHRA-ADR 26094246. A 56-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Oct2021 (at the age of 56 years old) (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunisation. The patient received historical vaccine of COVID-19 VACCINE ASTRAZENECA for COVID-19 immunization on an unknown date. Medical history was not reported. Patient has not had symptoms associated with COVID-19. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) taken for immunisation on 14Oct2021. The patient experienced off label use with interchange of vaccine products and product use for unapproved combination on 14Oct2021, vomiting, body aches and shivers, nausea, fever, and headache on an unspecified date. The events were reported as medically significant. The patient underwent lab tests and procedures which included covid-19 virus test: negative on an unknown date (No - Negative COVID-19 test). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of headache was recovered on an unknown date while the other events was not recovered. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1847356 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 - / 3 - / -
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Decreased appetite, Headache, Interchange of vaccine products, Nausea, Off label use
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUDROCORTISONE; HYDROCORTISONE; HYDROXOCOBALAMIN; LERCANIDIPINE; LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Addison''s disease; Blood pressure high; Hypothyroidism; Immunisation; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101417754

Write-up: Shivering; Weakness; Nausea; Appetite lost; Off label use; Interchange of vaccine products; Headache; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202110201139247930-662GU. Safety Report Unique Identifier is GB-MHRA-ADR 26098185. An 86-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Oct2021 (at the age of 86-years-old) (Batch/Lot number and expiry date were not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included steroid therapy (taking regular steroid treatment (e.g. orally or rectally)), hypothyroidism, hypertension (blood pressure high), immunisation, and Addison''s disease. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Concomitant medications included influenza vaccine (INFLUENZA VIRUS) taken for immunisation from 14Oct2021 to an unspecified stop date; fludrocortisone taken for Addison''s disease, start and stop date were not reported; hydrocortisone taken for Addison''s disease, start and stop date were not reported; hydroxocobalamin taken for an unspecified indication, start and stop date were not reported; lercanidipine taken for hypertension, start and stop date were not reported; and levothyroxine taken for hypothyroidism, start and stop date were not reported. Historical vaccine included first and second doses of COVID-19 VACCINE ASTRAZENECA on 23Jan2021 as Dose 1 and on 17Apr2021 as Dose 2 for COVID-19 immunisation. The patient experienced off label use and interchange of vaccine products on 14Oct2021 with outcome of unknown; headache on 14Oct2021 with outcome of recovered on an unspecified date, shivering on 15Oct2021 with outcome of recovered on an unspecified date, weakness on 15Oct2021 with outcome of recovered on 19Oct2021, nausea on 15Oct2021 with outcome of recovered on 19Oct2021, and appetite lost on 15Oct2021 with outcome of recovering. Case narrative: Doubled up on hydrocortisone due to symptoms. Takes this for addisons disease normally. Was advised to take extra to help. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1847419 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101426337

Write-up: Nerve pain in shoulder and arm; Lymph nodes under left arm became very painful; lymph nodes under my left arm became very painful and raised; Patient received first & second dose of ASTRAZENECA and booster dose of COMIRNATY; Patient received first & second dose of ASTRAZENECA and booster dose of COMIRNATY; booster; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202110211527574500-NR9EH, Safety Report Unique Identifier GB-MHRA-ADR 26104286. A 44-year-old female patient received third (booster) dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on 14Oct2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis (not medicated for RA yet) and immunodeficiency (patient had an illness or condition which reduces the immune response (e.g., immunodeficiency)). Concomitant medications were not reported. The patient was not pregnant and was not breastfeeding at the time of report. The patient''s last menstrual period was on 14Oct2021. The patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not enrolled in clinical trial. On 15Oct2021, the patient experienced nerve pain in shoulder and arm and lymph nodes under left arm became very painful; the event nerve pain in shoulder and arm was reported as serious for being medically significant. The clinical course was reported as follows: after her second dose (vaccine) of ASTRAZENECA in Apr2021, the patient had nerve pain in her shoulder down the arm into her hand that was very painful and which was lasted for 6 weeks and had to take medication. The patient had her booster on 14Oct2021 of Pfizer and the day after, lymph nodes in her left arm became very painful and raised, then her nerve pain had returned in shoulder and arm and was very painful again, she had been prescribed medication (unspecified) for this. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of nerve pain in shoulder and arm was recovered on unknown date in Oct2021; while of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1847525 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hallucination, Headache, Immunisation, Off label use, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101429056

Write-up: Hallucination; Headache; Dizziness; received third dose of BNT162B2 (COMIRNATY); received third dose of BNT162B2 (COMIRNATY); This is a spontaneous report from a contactable other HCP received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110230918009750-QLOWH, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 26113152. A female patient of an unspecified age received third dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 14Oct2021 (Lot Number: Ff8288) as dose 3 (booster), single for COVID-19 immunisation. The patient previously received the first and second dose of BNT162B2 on unknown date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient experienced hallucination, headache, dizziness all on an unspecified date with outcome of recovered on an unspecified date. it was reported that Headachey, dizziness followed by hallucinations. The patient underwent lab tests and procedures which included COVID-19 virus test negative on an unspecified date.The report was considered as non-serious by HA. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1847532 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 - / 3 - / -

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

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Chronic kidney disease stage 3 (Kidney disease stage 5 (as reported) on haemodialysis 3 x a week at hospital); Depression; Fistula; Haemodialysis (Kidney disease stage 5 (as reported) on haemodialysis 3 x a week at hospital); Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Low blood pressure; Scoliosis
Allergies:
Diagnostic Lab Data: Test Date: 20211021; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101428902

Write-up: Itchy from head to toe fro vaccine; Widespread non-itchy dull red patchy rash; off label use; Booster; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110231011157250-QJ1P6. Safety Report Unique Identifier GB-MHRA-ADR 26113271. A 44-year-old female patient received BNT162B2 (COMIRNATY), the third dose via an unspecified route of administration on 14Oct2021 (Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included chronic kidney disease stage 3 (Kidney disease stage 5 (as reported) on haemodialysis 3 x a week at hospital), haemodialysis (Kidney disease stage 5 (as reported) on haemodialysis 3 x a week at hospital), depression, asthma, immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...), scoliosis, fistula, low blood pressure. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient last menstrual period was reported as 19Mar2021. The patient''s concomitant medications were not reported. The patient previously received the first dose and the second dose of COVID-19 Vaccine, both on an unspecified date for COVID-19 immunisation (Primary Immunization series complete but unknown manufacturer). The patient experienced widespread non-itchy dull red patchy rash on 16Oct2021. Additional Information: Itchy from head to toe fro vaccine. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The event was reported as serious due to medically significant and congenital anomaly. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 21Oct2021 (No - Negative COVID-19 test). Therapeutic measures were taken as a result of the event widespread non-itchy dull red patchy rash. The outcome of the event widespread non-itchy dull red patchy rash was not recovered, while the other events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1847559 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal pain, Blood test, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN; METRONIDAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Dental care; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); RA
Allergies:
Diagnostic Lab Data: Test Date: 20211022; Test Name: Bloods taken; Result Unstructured Data: Test Result:Unknown Results; Comments: Unknown Results; Test Date: 20211021; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101428835

Write-up: Abdominal pain; Abdominal discomfort; Off label use; Interchange of vaccine products; This is a spontaneous report from a contactable consumer received from The regulatory authority report number is GB-MHRA-WEBCOVID-202110231440012760-GKAJJ, safety report unique identifier is GB-MHRA-ADR 26113690. A 63-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 14Oct2021 (at the age of 63-years old) (Lot Number: FF8288) as dose 3 (booster), single for COVID-19 immunisation. Medical history included appendicectomy from Feb2021 and unknown if ongoing, immunodeficiency from an unknown date and unknown if ongoing Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef), rheumatoid arthritis from 1988 and unknown if ongoing , and dental care from an unknown date and unknown if ongoing. Diagnosed treatment for RA since 1998. Received no medication since 2018. Acute appendectomy in February 2021 three weeks following Astra Zeneca vaccine. Patient has not had symptoms associated with COVID-19. Patient previously received COVID-19 VACCINE ASTRAZENECA, dose 1 via an unspecified route of administration on 30Jan2021 and dose on 09Apr2021 for COVID-19 immunisation. Concomitant medications included amoxicillin taken for dental care from 13Oct2021 to 19Oct2021; influenza vaccine inact sag 4v (FLUCELVAX TETRA) taken for an unspecified indication from 05Oct2021 to an unspecified stop date; metronidazole taken for dental care from 22Sep2021 to 03Oct2021. The patient experienced abdominal pain and abdominal discomfort on 20Oct2021, off label use with interchange of vaccine products on 14Oct2021. Abdominal pain and discomfort. 5 days after booster shot. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Attended GP on 22Oct2021. Bloods taken. No results yet. The events was reported as medically significant. The patient underwent lab tests and procedures which included covid-19 virus test: negative on 21Oct2021 (No - Negative COVID-19 test), blood test: unknown results on 22Oct2021. The outcome of abdominal pain was not recovered, while the rest of the events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1847780 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FG3739 / 1 RA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to molds; Allergy to plants; Cerebral palsy; Disability (60% disability due to spastic diparesis from cerebral palsy with strabismus); Flour sensitivity; Herbal allergy; House dust mite allergy; Strabismus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101495443

Write-up: sternum heat and burning following injection into the right arm COMIRNATY covid19 vaccine lasted more than 20 minutes and manifested about ten minutes after injection. to 23Oct still symptoms.; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the regulatory authority-WEB:IT-MINISAL02-803280. A 32-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 14Oct2021 (Lot Number: FG3739) at age of 32 years old as dose 1, single for covid-19 immunisation. Medical history included allergy to solanaceae, asparagus, chamomile, dust mites and flour, mold, 60% disability due to spastic diparesis from cerebral palsy with strabismus. The patient''s concomitant medications were not reported. The patient previously took Bactrim, panacef, oki, augmentin and streptomycin and experienced allergy. The patient experienced sternum heat and burning following injection into the right arm comirnaty covid19 vaccine lasted more than 20 minutes and manifested about ten minutes after injection. to 23oct still symptoms. (life threatening) on 14Oct2021 with outcome of not recovered. Treatment included communicated the symptoms to the general practitioner. First done three-day therapy with tachipirina 1000 without result. Then 3/4 days of fenextra 400. Reporter comments: allergy to solanaceae, asparagus, chamomile, dust mites and flour, mold. allergy to bactrim, panacef, oki, augmentin and streptomycin. 60% disability due to spastic diparesis from cerebral palsy with strabismus. born preterm. I have not used homeopathic products. sometimes used tormentilla but not in this period No follow-up attempts possible. No further information expected.; Reporter''s Comments: allergy to solanaceae, asparagus, chamomile, dust mites and flour, mold. allergy to bactrim, panacef, oki, augmentin and streptomycin. 60% disability due to spastic diparesis from cerebral palsy with strabismus. born preterm. I have not used homeopathic products. sometimes used tormentilla but not in this period


VAERS ID: 1847781 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Dyspnoea, Tongue spasm
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mite allergy; Pollen allergy (GRAMINACEE)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101493219

Write-up: shortness of breath; Episode of sleep apnea; retroversion of the tongue towards the palate; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-803372. A 20-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number Unknown) via intramuscular on 13Oct2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included mite allergy and pollen allergy (GRAMINACEE) from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 14Oct2021, the patient experienced episode of sleep apnea and retroversion of the tongue towards the palate. On an unspecified date, the patient experienced shortness of breath. The outcome of the events sleep apnea and retroversion of the tongue towards the palate was recovered on an unspecified date while outcome of the event shortness of breath was unknown. Senders comments: lot requested. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1847827 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FH0151 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Nodule, Papule, Toxic skin eruption
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Convulsion
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101430769

Write-up: Toxicoderma; red papule; red Nodule; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21129821. A 25-year and 11-month-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FH0151, Expiration date 31Dec2021), via an unspecified route of administration on 14Oct2021 16:00 at the age of 25-year as dose 1, single for covid-19 immunisation. Body temperature before vaccination was 36.5 degrees Centigrade. Medical history included a history of convulsion in childhood. The patient''s concomitant medications were not reported. On 14Oct2021 at around 18:00 (2 hours after the vaccination), the patient experienced Toxic derma, red papule, red nodule. The course of the event was as follows: on 14Oct2021, 2 hours after receiving the first vaccination of COMIRNATY intramuscular injection, many red papules and red nodules appeared around the back and thighs. On 15Oct2021, the next day, the patient visited the hospital as an outpatient. Even after taking anti-allergic drugs and applying topical medication, symptoms exacerbated. On 18Oct2021, the patient visited the hospital again. Toxicoderma was strongly suspected, so it was determined that the patient needed to be examined and treated in a specialized department. The patient was referred to the nearby dermatology clinic. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The outcome of the event was not recovered. The reporter comment: The symptoms appeared after the vaccination. Therefore, the causality with the vaccine was strongly suspected. Blank below(as reported) No follow-up attempts are possible. No further information is expected.


VAERS ID: 1848010 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-04
Onset:2021-10-14
   Days after vaccination:10
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: Brain stem syndrome, Cerebrovascular accident, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), 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? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high; Hyperlipidemia
Preexisting Conditions: Medical History/Concurrent Conditions: Brain stem disorder (left brain stem had damaged before); Cerebral infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Weakness of limbs/weakness in the right foot; right brain stem damaged; was diagnosed with stroke; This regulatory authority case was reported by a pharmacist and describes the occurrence of MUSCULAR WEAKNESS (Weakness of limbs/weakness in the right foot), BRAIN STEM SYNDROME (right brain stem damaged) and CEREBROVASCULAR ACCIDENT (was diagnosed with stroke) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Cerebral infarction and Brain stem disorder (left brain stem had damaged before). Concurrent medical conditions included Blood pressure high and Hyperlipidemia. On 04-Oct-2021 at 9:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced MUSCULAR WEAKNESS (Weakness of limbs/weakness in the right foot) (seriousness criterion hospitalization), BRAIN STEM SYNDROME (right brain stem damaged) (seriousness criteria hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (was diagnosed with stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 15-Oct-2021 to 22-Oct-2021 due to BRAIN STEM SYNDROME, CEREBROVASCULAR ACCIDENT and MUSCULAR WEAKNESS. At the time of the report, MUSCULAR WEAKNESS (Weakness of limbs/weakness in the right foot), BRAIN STEM SYNDROME (right brain stem damaged) and CEREBROVASCULAR ACCIDENT (was diagnosed with stroke) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. It was reported that patient age was 68 years 8 months. On 14 Oct 2021 at 12:00 patient developed dysphagia and dysarthria, weakness in the right foot. On 14 Oct 2021 at 20:00 visited the emergency department and was diagnosed with stroke. As the timing of occurrence was immediate after receiving the vaccine, so it was reported. Patient was hospitalized in the neurology ward on 15 Oct 2021 to 22 Oct 202. On 22 Oct 2021 patient was currently hospitalized in the general ward and had inability to speak with right brain stem damaged and his left brain stem had damaged before. Company Comment: This case concerns a 68-year-old female patient with medical history of hypertension, cerebral infarction (left brain stem damage) and hyperlipidemia, who experienced the unexpected and serious events of cerebrovascular accident, brain stem syndrome and muscular weakness. The events occurred approximately 10 days after the second dose of Moderna COVID-19 Vaccine was administered. The rechallenge was not applicable as there is no information regarding the first dose. Patient?s age and medical history of hypertension, cerebral infarction (left brain stem damage) and hyperlipidemia remain as confounders. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 68-year-old female patient with medical history of hypertension, cerebral infarction (left brain stem damage) and hyperlipidemia, who experienced the unexpected and serious events of cerebrovascular accident, brain stem syndrome and muscular weakness. The events occurred approximately 10 days after the second dose of Moderna COVID-19 Vaccine was administered. The rechallenge was not applicable as there is no information regarding the first dose. Patient?s age and medical history of hypertension, cerebral infarction (left brain stem damage) and hyperlipidemia remain as confounders. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1848024 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-10-14
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Polyneuropathy, Tremor
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

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

Write-up: olyneuropathy; Tremor of lips and hands; This regulatory authority case was reported by a pharmacist and describes the occurrence of POLYNEUROPATHY (olyneuropathy) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced TREMOR (Tremor of lips and hands). On an unknown date, the patient experienced POLYNEUROPATHY (olyneuropathy) (seriousness criterion medically significant). At the time of the report, POLYNEUROPATHY (olyneuropathy) and TREMOR (Tremor of lips and hands) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was treated in Infectious Disease department, no treatment medications were reported. Concomitant medications was not reported. Company Comment : This case concerns a 68-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of poyneuropathy. The events occurred approximately on an unknown day after the first dose of Moderna Covid -19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Moderna Covid -19 vaccine, is not affected by this report.; Sender''s Comments: This case concerns a 68-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of poyneuropathy. The events occurred approximately on an unknown day after the first dose of Moderna Covid -19 vaccine. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Moderna Covid -19 vaccine, is not affected by this report.


VAERS ID: 1849725 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-10-14
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 105286103255487 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Disturbance in attention, Feeding disorder, Impaired work ability, Laboratory test, Sleep disorder, Suicidal ideation, Tinnitus
SMQs:, Suicide/self-injury (narrow), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: I had herpes zoster just 2 months ago ,of which I have recovered and a month after recovery I got vaccinated.
Preexisting Conditions: none
Allergies: no
Diagnostic Lab Data: yes I have them where can I attached
CDC Split Type:

Write-up: Chronic tinitus excacerbated during night and during the whole day, wont let me eat, sleep or focus on work at all.It let to suicidal thoughts because of the intensity of the sound


VAERS ID: 1849917 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-07
Onset:2021-10-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005285 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity
SMQs:, 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: Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Pain in arm; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-PB20216643) on 29-Oct-2021 and was forwarded to Moderna on 29-Oct-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 63-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005285) for COVID-19 vaccination. Concurrent medical conditions included Hypertension arterial. On 07-Oct-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Pain in arm) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Company Comment: This case concerns a 63-year-old male patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of pain in extremity. The event occurred approximately 7 days after the first dose of mRNA-1273. The rechallenge was unknown since information about the second dose has not been disclosed. Seriousness assessments has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Translation received on 01 Nov 2021 include no new information; Sender''s Comments: This case concerns a 63-year-old male patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of pain in extremity. The event occurred approximately 7 days after the first dose of mRNA-1273. The rechallenge was unknown since information about the second dose has not been disclosed. Seriousness assessments has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1851670 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9019 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Fibrin D dimer, Fibrin D dimer increased, Malaise, Palpitations, Pyrexia
SMQs:, Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASAFLOW; DOMPERIDONE EG; IMODIUM; CRESTOR; CO BISOPROLOL EG; AMLODIPINE BESILATE EG
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure increased; Cardiac failure; Coxarthrosis; Gonarthrosis; Hearing disability (hearing prostheses bilaterally); Heart failure (risk); Hyperparathyroidism secondary; Hypertension; Postnasal drip; Renal insufficiency; Sciatica; Vitamin deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:increased
CDC Split Type: BEPFIZER INC202101437063

Write-up: Malaise; Fibrin D dimer increased; Palpitations; Subfebrile; Fatigue; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number BE-FAMHP-DHH-N2021-107841. A 88-year-old female patient received third dose of BNT162B2 (Comirnaty, Lot FG9019) via unknown route of administration on 13Oct2021 as single dose for COVID-19 immunization. Medical history included: upper-airway cough syndrome from 17Apr2021, blood pressure increased from 01Apr2021, heart failure risk from 01Apr2021, cardiac failure from 17Nov2020, lack of vitamin D from 18Feb2020, hypertension from 08Jul2019, hearing disability from 15May2019 (hearing prostheses bilaterally) , prosthesis user from 15May2019 to an unknown date , Coxarthrosis from 21Mar2019, sciatica from 05Sep2017, secondary renal hyperparathyroidism from28Feb2017, renal insufficiency from 10Feb2021, primary gonarthrosis from 18Jan2021. Patient previously received Tradonal and experienced nausea. Concomitant medication included: Co-bisoprolol EG 5 mg/12,5 mg, Asaflow 80 mg, Amlodipine besilate EG 5 mg, Crestor 10 mg, Domperidone EG 10 mg, Imodium 2 mg. Patient received previous doses of vaccine on unknown date. On 14Oct2021, patient experienced malaise, fatigue, palpitations, subfebrile, fibrin D dimer increased. On 14Oct2021, patient lab tests included: fibrin D dimer increased. Patient received symptomatic treatment. Patient recovered from events on 16Oct2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1851676 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Malaise, Myalgia, Nausea, Pyrexia, Tremor, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DAFALGAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101437015

Write-up: Fever; Nausea; Shaking of hands; Myalgia; Malaise; Injection site reaction; Flu like symptoms; Headache; Shivering; Fatigue; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-107888. This female patient was vaccinated on 14Sep2021 with Comirnaty (first dose administered). Concomitant drug(s): Dafalgan Reported ADR''s: Injection site reaction, Fever, Malaise, Shivering, Fatigue, Nausea, Myalgia, Headache, Flu like symptoms, Shaking of hands Reporter''s comments Treatment - No Evolution of the ADR - Time relationship - ADR description - First days only the known flu symptoms. Cold chills and fever do not abate. Still chills so hard I can''t hold a glass of water. Side effects still taking place. PATIENT MEDICAL HISTORY PROVIDED IN PATIENT NOTES: No No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1851689 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FE7053 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Immunisation, Interchange of vaccine products, Myalgia, Off label use, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANDROCUR; ZANIDIP; RIVOTRIL; PRAVASTATINE [PRAVASTATIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal; Prostate infection (taking ANDROCUR tablet)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101437622

Write-up: off label use; Interchange of vaccine products; third dose; Muscle aches; Headache; Joint pain; Fever; This is a spontaneous report from a contactable consumer downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number BE-FAMHP-DHH-N2021-107974. A 93-years-old male patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration on 14Oct2021 (Lot Number: FE7053) at the age of 93-years-old as single dose for covid-19 immunisation. Medical history included blood pressure problem, prostate infection (taking Androcur tablet). Concomitant medication(s) included cyproterone acetate (ANDROCUR); lercanidipine hydrochloride (ZANIDIP); clonazepam (RIVOTRIL); pravastatine (PRAVASTATIN). The patient previously received first dose of covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA) for Covid-19 immunisation and experienced fever, arthralgia, myalgia, headache; received second dose of COVID-19 Vaccine (unknown manufacturer) for Covid-19 immunisation. The patient experienced fever, arthralgia, muscle aches, headache, all on 14Oct2021. Outcome of the events was recovered on 15Oct2021. This report assessed as serious, disability.


VAERS ID: 1851722 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-10
Onset:2021-10-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PA4632 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Echocardiogram, Electrocardiogram normal, Full blood count, Pericardial effusion, Specialist consultation
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Echocardiography; Result Unstructured Data: Test Result:approx. 30 ml pericardial effusion; Test Name: ECG normal; Result Unstructured Data: Test Result:normal; Test Name: CBC; Result Unstructured Data: Test Result:basophils slightly increased; Test Name: Cardiologist consultation; Result Unstructured Data: Test Result:appr. 30 ml pericardial effusion
CDC Split Type: BGPFIZER INC202101437707

Write-up: Pericardial effusion; unusual precordial discomfort / slight inconvenience; This is a spontaneous report from a contactable consumer or other non hcp (patient) downloaded from the regulatory authority number BG-BDA-21881. A 29-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 10Oct2021 (Batch/Lot Number: PA4632) as DOSE 1, 0.3ML SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced pericardial effusion (medically significant) on 14Oct2021. The patient presented with unusual precordial discomfort and pericardial effusion diagnosed appr. 4 days after the 1st shot of Comirnaty for COVID-19 immunizartion on 10/10/2021. Duration of ADR - NA The patient underwent lab tests and procedures which included echocardiogram: approx. 30 ml pericardial effusion on an unknown date, electrocardiogram normal: normal on an unknown date, full blood count: basophils slightly increased on an unknown date, specialist consultation: appr. 30 ml pericardial effusion on an unknown date. The outcome of the event unusual precordial discomfort / slight inconvenience was unknown and for other event it was recovering. Reporter comment: This ADR caused slight inconvenience to me. No follow-up attempts possible. No further information expected.


VAERS ID: 1852093 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AZATIOPRINA [AZATHIOPRINE]; HUMIRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Granulomatous colitis (debut ileocolonic Crohn''s disease after treatment with Sekukinumab); Psoriasis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101436860

Write-up: Dose 3; Myalgia; Churning of stomach; Headache; This is a spontaneous report received from a contactable physician via regulatory authority (AEMPS) and downloaded from the regulatory authority WEB, regulatory authority number is ES-AEMPS-1029775. A 47-year-old female patient received bnt162b2 (COMIRNATY), via unspecified route of administration on 13Oct2021 (batch/lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s medical history included granulomatous colitis (debut ileocolonic Crohn''s disease after treatment with Secukinumab) and psoriasis from unspecified date. The patient''s concomitant medications included azathioprine (AZATIOPRINA) and adalimumab (HUMIRA) from unspecified date. The patient previously received bnt162b2 (COMIRNATY Solution for injection) on 08Jun2021 as dose 1, single and on 29Jun2021 as dose 2, single for COVID-19 immunization. On 14Oct2021 the patient experienced myalgia, churning of stomach and headache, all reported as serious with medically significant criterion. It was reported adverse drug reaction (RAM, as reported) at third dose. Psoriasis and debut ileocolonic Crohn''s disease after treatment with Secukinumab. The notifying physician considered the events not mild. The 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: 1852328 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-12
Onset:2021-10-14
   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 FG7387 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Carotid arteriosclerosis, Electrocardiogram, Electrocardiogram QRS complex shortened, Fibrin D dimer, Fibrin D dimer increased, Heart rate, Hypertensive encephalopathy, Immunisation, Ischaemic stroke, Leukoencephalopathy, Magnetic resonance imaging, SARS-CoV-2 test, Ultrasound Doppler, White blood cell count, White blood cell count increased
SMQs:, Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalopathy/delirium (narrow), Hypertension (narrow), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LERCAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Chronic lymphocytic leukaemia; Chronic renal failure; Drug allergy; Hip prosthesis user; Hypertension arterial; Ischemic stroke
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: ECG; Result Unstructured Data: Test Result:Regular sinus rhythm; Comments: heart rate 80 beats per minute, normal axis, P waves normal, PR space normal, narrow QRS, no ST segment shift, T waves flattened in V1; Test Date: 20211015; Test Name: D-Dimer; Result Unstructured Data: Test Result:6000 ug/L; Test Date: 20211015; Test Name: Heart rate; Result Unstructured Data: Test Result:80 beats per minute; Test Date: 20211015; Test Name: Magnetic Resonance Imaging; Result Unstructured Data: Test Result:Recent right deep sylvian ischemia; Comments: capsulo-caudate, without mismatch. Appearance since 2018 of a left occipital ischemic sequela. Imaging compatible with hypertensive microangiopathy with pronounced leukopathy.; Test Date: 20211015; Test Name: Severe Acute Respiratory Syndrome-Coronavirus-2 rapid diagnostic tes; Test Result: Negative ; Test Date: 20211015; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:Apart from calcified plaque; Comments: from the source of the right internal carotid, no visible abnormality. Removal authorized.; Test Date: 20211015; Test Name: Leukocyte count; Result Unstructured Data: Test Result:33000 /mm3
CDC Split Type: FRPFIZER INC202101437748

Write-up: booster; narrow QRS; hypertensive microangiopathy; pronounced leukopathy; calcified plaque from the source of the right internal carotid; D-Dimer: 6,000 microgram per litre; Leukocyte count: 33,000 per cubic millimeter.; Ischemic stroke; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-NY20214783. An 84-years-old female patient received the third dose of bnt162b2 (COMIRNATY), intramuscular on 12Oct2021 (Batch/Lot Number: FG7387) as dose 3 (booster), single for covid-19 immunization. Medical history included appendicectomy, hypertension arterial, hip prosthesis user, chronic renal failure, drug allergy, chronic lymphocytic leukaemia, left occipital ischemic sequela from 2018. Concomitant medication included lercanidipine hydrochloride (LERCAN) taken for hypertension. The patient previously took the first dose bnt162b2 (Right arm, Lot number: EP9605) on 10Mar2021 and the second dose (Left arm, Lot number: EW2239) on 07Apr2021 intramuscular for covid-19 immunisation. Patient previously took pneumorel and experienced drug hypersensitivity. On 14Oct2021, 2 day after the beginning of drug administration, 2 day after the last drug administration, the patient developed ischemic stroke which required hospitalization or prolongation of hospitalization on. On 14Oct2021: occurrence of Cerebrovascular accident. Emergency department visit on 15Oct2021 for difficulty in walking and discomfort referred to as a stroke by the attending physician. Diagnosis confirmed by Magnetic Resonance Imaging. Transfer to the Cardiac Intensive Care Unit. Notion of poorly controlled blood pressure. On 15Oct2021, electrocardiogram: Regular sinus rhythm, heart rate 80 beats per minute, normal axis, P waves normal, PR space normal, narrow QRS, no ST segment shift, T waves flattened in V1. On 15Oct2021, Severe Acute Respiratory Syndrome-Coronavirus-2 rapid diagnostic test: Negative. On 15Oct2021, D-Dimer: 6,000 microgram per litre. On 15Oct2021, Leukocyte count: 33,000 per cubic millimeter. On 15Oct2021, Magnetic Resonance Imaging: Recent right deep sylvian ischemia, capsulo-caudate, without mismatch. Appearance since 2018 of a left occipital ischemic sequela. Imaging compatible with hypertensive microangiopathy with pronounced leukopathy. On 15Oct2021, Doppler ultrasound (Doppler ultrasound): Apart from calcified plaque from the source of the right internal carotid, no visible abnormality. Removal authorized. Ongoing medical care with medication. Outcome of events were not recovered. Reporter comment: Ischemic stroke in an 84-year-old female 2 days after her booster of the COMIRNATY vaccine (batch FG7387). Hospitalization, ongoing medical care with medication. Not recovered. No follow up attempts are possible. No further information is expected.; Reporter''s Comments: Ischemic stroke in an 84-year-old female 2 days after her booster of the COMIRNATY vaccine (batch FG7387). Hospitalization, ongoing medical care with medication. Not recovered.


VAERS ID: 1852438 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FG6431 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dermatitis allergic, Immunisation, Off label use, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest infection (on steroids and antibiotics for chest infections.); Immunodeficiency (Had an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Lupus erythematosus (had lupus (autoimmune condition) which uncontrollable at the moment which means every 3 ish months)
Allergies:
Diagnostic Lab Data: Test Date: 20211021; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Negative
CDC Split Type: GBPFIZER INC202101429181

Write-up: allergy rash; Rash; Off-label use; Booster; This is a spontaneous report from a contactable consumer. This is a report received from The regulatory authority report number is GB-MHRA-WEBCOVID-202110221845308130-HODLF. Safety report unique identifier GB-MHRA-ADR 26110781. A 28-year-old female patient received third dose of BNT162B2(COMIRNATY), via an unspecified route of administration on 14Oct2021 (Batch/Lot Number: FG6431) as DOSE 3 (BOOSTER), SINGLE (at the age of 28-year-old) for COVID-19 immunisation. Medical history included systemic lupus erythematosus from an unknown date and the patient had lupus (autoimmune condition) which was uncontrollable at the moment which means every 3 ish months, immunodeficiency from an unknown date and she had an illness or condition, not listed above, which reduced the immune response (e.g. immunodef...), chest infections from an unknown date and she was on steroids and antibiotics. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. The patient experienced allergy rash (Dermatitis allergic) (medically significant) on an unspecified date with outcome of not recovered, rash (rash) (medically significant) on 15Oct2021 with outcome of not recovered , off-label use (off label use) on 14Oct2021 with outcome of unknown, booster (immunisation) on 14Oct2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test on 21Oct2021 with negative result. Therapeutic measures were taken as a result of events. The allergy rash that started of small on the side of the face then slowly spreads to different parts of the facial area. The rash doesn''t blister, was not itchy just sore, red and raised. The patient was advised to take strong antihistamines. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not considered relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.


VAERS ID: 1852588 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Inappropriate schedule of product administration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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: GBPFIZER INC202101456998

Write-up: Bleeding menstrual heavy; Dose 1: 12Aug2021; Dose 2: 14Oct2021; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202110262126118640-WSDRY with Safety Report Unique Identifier of GB-MHRA-ADR 26125426. A 46-year-old female patient received second dose of BNT162b2 (COMIRNATY; Lot Number: FF8222), via an unspecified route of administration on 14Oct2021 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient was not pregnant and was not breastfeeding at the time of the report. Patient is not enrolled in clinical trial. The patient previously received first dose of BNT162b2 (COMIRNATY; Lot Number: FF3319) via an unspecified route of administration on 12Aug2021 at single dose for COVID-19 immunisation. On 22Oct2021, 8 days after vaccination, the patient experienced bleeding menstrual heavy; reported as serious for being medically significant. Patient has not tested positive for COVID-19 since having the vaccine. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). The clinical outcome of bleeding menstrual heavy was recovered with sequelae on 26Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1852740 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-13
Onset:2021-10-14
   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 FF2382 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Headache, Movement disorder, SARS-CoV-2 antibody test
SMQs:, Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: serological severe acute respiratory syndrome 2 Immunoglobulin G; Result Unstructured Data: Test Result:Elevation
CDC Split Type: ITPFIZER INC202101437558

Write-up: Asthenia; Headache; Osteoarticular pain; Movement disorder; FARMAVIGITER This is a Non-Interventional Study report from a contactable physician downloaded from the regulatory authority number IT-MINISAL02-800105. A 20-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Deltoid Left on 13Oct2021 12:37 (Batch/Lot Number: FF2382; Expiration Date: 31Mar2022) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced asthenia, headache, osteoarticular pain, and movement disorder on 14Oct2021. The events were serious per medically significant. The patient underwent lab tests and procedures which included serological severe acute respiratory syndrome 2 Immunoglobulin G: elevation on an unspecified date. Treatment was received for the events with paracetamol therapy. The outcome of the events was resolving. Reporter comment: young patient in good health (serological severe acute respiratory syndrome 2 Immunoglobulin G elevation without any previous symptoms), who after the first dose of Comirnaty vaccine experienced serious osteoarticular pain with functional limitation, asthenia, and headache. The reporter''s assessment of the causal relationship of the events 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 assessment. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: young patient in good health (serological severe acute respiratory syndrome 2 Immunoglobulin G elevation without any previous symptoms), who after the first dose of Comirnaty vaccine experienced serious osteoarticular pain with functional limitation, asthenia, and headache; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Asthenia, Headache, Arthralgia, and Movement disorder and 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: 1852847 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FF4204 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Depressed level of consciousness, Dizziness, Gaze palsy, Nausea, Presyncope, Vital signs measurement
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Ocular motility disorders (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20211014; Test Name: vital sign; Result Unstructured Data: Test Result:stable
CDC Split Type: JPPFIZER INC202101432188

Write-up: Depressed level of consciousness; eyeball upturn; Vasovagal reflex; giddiness; queasy; This is a spontaneous report from a contactable physician received from the Agency (RA). Regulatory authority report number is v21129876. A 21-year and 10-month-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot number FF4204, Expiration date 31Oct2021) via an unspecified route of administration on 14Oct2021 at 11:59 (the day of vaccination, at the age of 21-year-old), as a dose 1, single for COVID-19 immunization. Medical history was none. Concomitant medication was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Body temperature before vaccination was 36.3degrees centigrade on 14Oct2021. The patient had no family history. On 14Oct2021 at 12:05 (6 minutes after the vaccination), the patient experienced vasovagal reflex. The course of the event was as follows: From around 5 minutes after the vaccination, while watching for the progress the patient experienced queasy, giddiness, other than eyeball upturn, depressed level of consciousness. The patient was treated to lie down and raise the legs. consciousness recovered immediately and vital sign was stable too. About 1 hour later the patient went back home.The outcome of event depressed level of consciousness was resolved on 14Oct2021 while on 14Oct2021 (the day of the vaccination), the outcome of other events was recovering. The reporting physician classified the event as non-serious and assessed that the event was unrelated to bnt162b2. There was no other possible cause of the event such as any other diseases. Follow attempts are completed, no further information is expected.


VAERS ID: 1852870 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   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 FK0108 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: Test Date: 20211014; Test Name: blood pressure; Result Unstructured Data: Test Result:96/ unknown value; Test Date: 20211014; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before the vaccination; Test Date: 20211014; Test Name: SpO2; Result Unstructured Data: Test Result:92-94 %; Comments: SpO2 decreased to 92-94%
CDC Split Type: JPPFIZER INC202101444930

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21129970. The patient was a 12-year-old male (age at vaccination). Body temperature before vaccination was 36.5 degrees Centigrade. The patient received BNT162B2 (COMIRNATY; Solution for injection; Lot Number: FK0108; Expiration Date: 31Jan2022), via an unspecified route of administration on 14Oct2021 10:38 (at the age of 12-years-old) as dose 1, single for COVID-19 immunization. On 14Oct2021 at 10:49 (11 minutes after the vaccination), the patient experienced anaphylaxis. The course of the event was as follows: At 10:38, the patient received vaccination. 11 minutes after vaccination, the patient experienced feeling queasy, Abdominal pain, Sweaty and Complexion ill. Diagnosed as anaphylaxis due to SpO2 decreased to 92-94% and blood pressure 96/. At 10:51, Adrenaline 0.2mg intramuscular injection was administrated. At 10:54, the symptoms tended to be recovering. At 11:11, all symptoms disappeared. The reporting physician classified the event as non-serious. the causality between the event and bnt162b2 was not provided. Outcome of event was resolved on 14Oct2021 11.11. The reporting physician commented as follows: After intramuscular injection of Adrenaline, symptoms were recovering immediately, but the patient needed received observation in pediatrics.


VAERS ID: 1852896 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-10-14
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19; Test Result: Positive
CDC Split Type: LTPFIZER INC202101446356

Write-up: COVID-19 diagnosed; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number LT-SMCA-6387N. A 25-years-old male patient received bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot Number: not provided) via an intramuscular route of administration on 29Jun2021 as DOSE NUMBER UNKNOWN, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 14Oct2021, the patient experienced covid-19 diagnosed and covid-19. On an unspecified date, the patient underwent lab tests and procedures which included SARS-CoV-2 test: positive. The outcome of covid-19 diagnosed was not recovered and other event was unknown. No follow up attempts are possible. No further information is expected.


VAERS ID: 1855140 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
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: Bell's palsy, Dysgeusia
SMQs:, Taste and smell disorders (narrow), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
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 INC202101451778

Write-up: Bell''s palsy; Dysgeusia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 646076. A 35-year-old male patient received BNT162b2 (COMIRNATY (tozinameran), Formulation: solution for injection, Lot number: Unknown), 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 14Oct2021, the patient experienced bell''s palsy, and dysgeusia. The outcome of the events was reported as not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1855161 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
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: Colitis ulcerative
SMQs:, Gastrointestinal ulceration (narrow), Ischaemic colitis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101452533

Write-up: Colitis ulcerative; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number 646624. A male patient of unspecified age (age: 37, units: unspecified) received bnt162b2 (COMIRNATY, solution for injection, lot number: Not reported) via an unspecified route of administration on an unspecified date as Dose number unknown, Single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 14Oct2021, the patient experienced colitis ulcerative. The outcome of the event was not recovered. No follow-up attempts were possible, information about lot/batch number could not be obtained. No further information was expected.


VAERS ID: 1855223 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
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: Blood phosphorus, Blood phosphorus decreased, Chest pain, Dyspnoea, Fibrin D dimer, Fibrin D dimer increased, Headache, Palpitations, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: blood phosphorus; Result Unstructured Data: Test Result:decreased; Test Date: 20211014; Test Name: fibrin d dimer; Result Unstructured Data: Test Result:increased
CDC Split Type: AUPFIZER INC202101458393

Write-up: Syncope; Blood phosphorus decreased; Chest pain; Dyspnoea; Fibrin D dimer increased; Headache; Palpitations; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority . Regulatory authority report number is 649295. A 40-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced syncope, blood phosphorus decreased, chest pain, dyspnoea, fibrin d dimer increased, headache, palpitations, all on 14Oct2021. 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: 1855693 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-10-14
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101491083

Write-up: COVID-19; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority, regulatory authority number EE-SAM-55812110156. This is the first of two reports. A 63-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 26Apr2021 (Batch/Lot number: Unknown) as DOSE 2, 0.3ML SINGLE, and first dose intramuscular on 01Mar2021 (Batch/Lot number: Unknown) as DOSE 1, 0.3ML SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced COVID-19 and vaccination failure on 14Oct2021 with outcome of not recovered (as of 15Oct2021). The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 14Oct2021. Therapeutic measures were taken for events. As the course of COVID-19 was mild, treatment symptomatically carried at home. The patient works at the sterilization department of a hospital and requires a certificate for incapacity to work. The case has been assessed as serious as per criteria of medical significance. The causal relationship is considered possible. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : EE-PFIZER INC-202101510876 the same patient, different events (loe case and at risk case)


VAERS ID: 1855929 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Dyspnoea, Electrocardiogram, Fatigue, Immunisation, Off label use, SARS-CoV-2 test, Tachycardia, X-ray
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Flu vaccination
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown; Test Name: ECG; Result Unstructured Data: Test Result:unknown; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: X-ray; Result Unstructured Data: Test Result:unknown
CDC Split Type: GBPFIZER INC202101449822

Write-up: Fatigue/unusual tiredness; Racing heart (tachycardia); Shortness of breath; booster; Off label use; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110241532055930-BTZDI. Safety Report Unique Identifier GB-MHRA-ADR 26115106. A male patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FF8288), dose 3 via an unspecified route of administration on 14Oct2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included asthma and flu vaccination, both from an unknown date and unknown if ongoing. It was reported that the patient had very few historic health issues. Childhood asthma, grown out of (no inhaler required for 20 years). Regular exercise. Patient has not had symptoms associated with COVID-19. Patient history: Start: N/A Stop: N/A Exercise Continuing: unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) taken for flu vaccination on 14Oct2021. Historical vaccine included dose 1 and dose 2 of BNT162b2 taken on 21Jan2021 and 23Mar2021 respectively for covid-19 immunization. On 18Oct2021, the patient experienced shortness of breath. On an unspecified date, patient experienced fatigue/unusual tiredness, racing heart. 14Oct2021, off label use, booster. The report was relate to possible inflammation of the heart (myocarditis or pericarditis). It was reported that shortness of breath at rest, 3 days after vaccine, continuing without improvement (day 11 now). Day 8 GP sent him to A&E who checked with ECG and X-ray and blood test. The symptoms lead to hospital stay. the hospital stay was for day case. The diagnosis was made by ED doctor. Discharged on same day recommended to rest. No treatment was given because of the symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No - Negative COVID-19 test), blood test: unknown, X-ray result: unknown and ECG result: unknown, all on an unspecified date. Events were considered serious (required hospitalization, disability and medically significant). Outcome of the event shortness of breath was not recovered. Outcome of other events was unknown. No follow-up attempts are Needed. No further information is expected.


VAERS ID: 1858835 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-14
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericardial effusion, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101453078

Write-up: Pericardial effusion; Pericarditis; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority. Regulatory authority report number is 648204. A 20-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericardial effusion and pericarditis on 14Oct2021. The 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: 1858848 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Pericarditis, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101453288

Write-up: Pericarditis; Chills; Throat tightness; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority (RA). The regulatory authority report number is 648779. A 14-year-old female patient received BNT162B2 (COMIRNATY, lot number and expiration date were not provided), via an unspecified route of administration on 14Oct2021 (at the age of 14-years-old) at dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Oct2021, the patient experienced pericarditis, chills, and throat tightness. The 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: 1780795 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pain in extremity
SMQs:, 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: Allegra. Postnatal
Current Illness:
Preexisting Conditions:
Allergies: Neomycin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Arm pain (left and right)


VAERS ID: 1782267 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: New York  
Vaccinated:2021-10-10
Onset:2021-10-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Rash, Rash erythematous, Rash pruritic
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: Lipitor, progesterone, mulivitamin, D3, C.
Current Illness: N/A.
Preexisting Conditions: N/A.
Allergies: KNA.
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Red itchy rash on chest.


VAERS ID: 1782288 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / IM

Administered by: Private       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: none
Current Illness: none
Preexisting Conditions: Hypertension, hypercholesterolemia, obesity
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient came in for his booster shot - he had gotten his first two shots at the county. they were not entered in our medical record. He did not have his card with him. The shot was given and then immunizations were reconciled in the computer and found that he had recieved Moderna for his first two and not Pfizer.


VAERS ID: 1782290 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 3 LA / IM

Administered by: Work       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: unknown.
Current Illness: unknown.
Preexisting Conditions: unknown.
Allergies: unknown.
Diagnostic Lab Data:
CDC Split Type:

Write-up: A error in administration occurred, as patient was given six doses instead one.


VAERS ID: 1782304 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-10-06
Onset:2021-10-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 005C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: pt states 1 week after receiving vaccination that the area surrounding the injection site is red, swollen, and itchy he states it resides from the top of his shoulder to his elbow he has attempted to resolve it with oral diphenhydramine


VAERS ID: 1782384 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Work       Purchased by: ?
Symptoms: Asthenia, Chills, Dizziness, Headache, Lymphadenopathy, Nausea, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Adderall XR 20mg (1x/day) Adderall 5mg (1x/day) Vitamin D3 50,000 units (1x/week) Fluoxetine 10mg (1x/day)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headache, nausea, chills, vomiting, swollen armpit lymph node, dizziness, light headed, body weakness and pain


VAERS ID: 1782399 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Flushing, Hypersensitivity, Hypertension, Tachycardia
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

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

Write-up: Patient arrived in the ER today, 10/13, post-Janssen vaccination. This individual arrived feeling very flushed after being vaccinated. They presented with tachycardia and hypertension post-vaccination and ER doctor diagnosed an allergic reaction due to the Janssen COVID-19 vaccination. Treatment: Famotidine 40mg/20mL X1 IV Methylprednisone 125mg/2mL x1 IV Vital Signs Monitoring Q30min Individual will be discharged from our care.


VAERS ID: 1782405 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 3 LA / IM

Administered by: Private       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? 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 administered Moderna vaccine 2 days past the expiration date. MFR date of 03/10/2021


VAERS ID: 1782491 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Erythema, Fatigue, Pain, Paraesthesia oral
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: pt took ibuprofen this morning for bodyaches but was vaccinated yesterday
Current Illness:
Preexisting Conditions:
Allergies: pcn, solumedrol
Diagnostic Lab Data: dexame thasone 10mg IM
CDC Split Type:

Write-up: 58-year-old female presents to the office for symptoms of possible allergic reaction. Patient reports that yesterday around 1230 patient had Pfizer Covid vaccine which is her first dose patient reported that she had her first dose 6 months ago however was not able to do a second dose so they had to repeat the first dose yesterday. Patient reports after2 hrs of having her vaccination, she started to experience fatigue and body aches. Fatigue and body aches continue to persist this morning however approximately around 1045-11 AM today, patient started to have tingling sensation on her upper lip and also redness on her face. Patient denies any difficulty breathing or swallowing there is no hives. Patient denies any allergic reaction towards administration of Covid 6 months ago. pt is allergic towards solu-medrol and penicillin. pt took ibuprofen earlier today for bodyaches


VAERS ID: 1782533 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 076C21A / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, 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: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient was supposed to get a flu shot but accidently got a covid shot. He had his 1 st pfizer vaccine on 03/20/21 and 2 nd on 04/13/21


VAERS ID: 1782564 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 076C21A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Fatigue, Headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Small Pox (estimated +20yrs ago) flu-like symptoms
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Pt. states that after receiving the 2nd dose of Moderna 10/12/2021, started experiencing symptoms 10/13/2021 of headache and fatigue. No noted Primary visit.


VAERS ID: 1782572 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Expired product 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: NA
Current Illness: NA
Preexisting Conditions: NA
Allergies: NA
Diagnostic Lab Data:
CDC Split Type:

Write-up: It was found the morning after that the vial had expired on 10/10/21, Vaccine was administered 10/12/21. Patient has had no symptoms or experienced any illness since administration.


VAERS ID: 1782576 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Expired product administered, No adverse event
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: NA
Current Illness: NA
Preexisting Conditions: NA
Allergies: NA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received 1st dose of Moderna COVID-19 vaccination. It was found the vial expired 10/10/2021. Dose administered 10/12/2021. Patient has had no symptoms/illness since the vaccination.


VAERS ID: 1782584 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: No adverse event, Product storage error
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: na
Current Illness: na
Preexisting Conditions: na
Allergies: na
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received 2nd dose of Moderna COVID-19 Vaccine 10/12/21. It was noticed the next morning, 10/13/21, that the vial had expired on 10/10/21. Patient has no symptoms of illness or adverse event at this time.


VAERS ID: 1782585 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Expired product 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: na
Current Illness: na
Preexisting Conditions: na
Allergies: na
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received 2nd dose of Moderna 10/12/21, it was found on 10/13/21 that the vial expired 10/10/21. Patient has no symptoms of illness or adverse reaction.


VAERS ID: 1782594 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-11
Onset:2021-10-13
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / IM

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: Multi-vitamin and Estroven
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approximately 36-48 hours after receiving both vaccines, I had a rash that covered my chest, breasts and stomach. With the first reaction, I took Benadryl as prescribed on the bottle and the rash cleared in a few days. Since the reaction to the second shot has just started, I plan on treating it the same way and hopefully it will also clear up in a few days.


VAERS ID: 1782599 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822809 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Nausea, Throat tightness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Flonase Multi-Vitamins
Current Illness: NKA
Preexisting Conditions: Sleep Apnea
Allergies: Seasonal Allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reported he felt tightness to his throat, nausea,at 9:28 am patient''s vital signs were taken and 25cc''s of benadryl liquid was given. At 9:39 am patient stated his nausea improved, tightness to the throat was still the same. He had 0 issues talking. At 9:45am 15 cc''s of benadryl liquid was given and patient''s wife was called and EMS was called at 10:01am, patient was evaluated by EMS and transported to hospital via EMS


VAERS ID: 1782624 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014C21A / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Feeling hot, Flushing, Visual impairment
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (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: xanax ritalin anti-hypertensive medication unable to know name and dosage
Current Illness: none as per patient
Preexisting Conditions: hypertension borderline diabetes
Allergies: none as per patient
Diagnostic Lab Data: Vital signs checked Blood sugar level taken
CDC Split Type:

Write-up: patient felt dizzy and verbalized she is seeing yellow spots. She feels hot and she was flushed no swelling over the injection site, no rashes observed


VAERS ID: 1782629 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822809 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Nausea, Throat tightness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Flonase Multi-Vitamins
Current Illness: NKA
Preexisting Conditions: Sleep Apnea
Allergies: Seasonal Allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: At 9:23 am patient reported he had tightness to his throat and nausea. At 9:28am patient''s vital signs were taken and 25 cc''s of liquid benadryl were given. At 9:39 am patient stated the nausea had improved the throat tightness was still the same patient had 0 issues talking. At 9:45am 15 cc''s of liquid benadryl was given and patient''s wife was called. total dose of benadryl was 100mg. EMS was called at 10:21am patient was evaluated by EMS and transported via EMS to emergency room.


VAERS ID: 1782635 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Nebraska  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Fatigue, Nausea
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: hydrochlorothiazide, lisiniprol, ZMA, DHEA, fish oil, vitamin d
Current Illness: n/a
Preexisting Conditions: hypertension
Allergies: opiates
Diagnostic Lab Data:
CDC Split Type:

Write-up: Heavy fatigue, nasuea


VAERS ID: 1782645 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: New York  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013L20A / 1 UN / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20L2A / 2 UN / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA173696 / N/A LA / IM

Administered by: Private       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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HCTZ 12.5 mg, vitamin B complex, vitamin D3
Current Illness: none
Preexisting Conditions: Chronic sinusitis, hypertension
Allergies: none
Diagnostic Lab Data: None
CDC Split Type:

Write-up: No adverse effects noted as of 1 hour after administration of the Pfizer dose.


VAERS ID: 1782650 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-04-15
Onset:2021-10-13
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047B21A / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Cephalexin
Diagnostic Lab Data: Positive RT-PCR COVID-19 Test
CDC Split Type:

Write-up: Tested positive for COVID-19 when fully vaccinated.


VAERS ID: 1782656 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017F21A / 1 LA / IM

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

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

Write-up: while waiting after receiving immunization, patient lost consciousness and fell onto floor , he was lying on stomach and seized a few times before regaining consciousness. we placed him on his side and had him continue to lie on floor until he felt like sitting up. we placed a cold compress on forehead and gave patient water to drink after he had recovered and was sitting up. he remained sitting on floor for approximately 30 minutes and then said he felt ok to leave


VAERS ID: 1782665 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30145BA / 3 LA / IM

Administered by: Pharmacy       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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient presented to Pharmcy Drop-off window stating they wanted a flu vaccination. The technician checked and it showed the patient had received the flu vaccine in the past week. She discussed this with the patient and the patient said "oh no, I want the COVID vaccine". The technician verified she wanted the COVID vaccine now and that we had Pfizer. The patient confirmed this. The technician then asked if patient had any COVID shots in the past to which the patient stated she had not. The technician then confirmed that this was going to be the first dose of the Pfizer COVID vaccine to which the patient confirmed. The patient filled out the paperwork indicating the desire for a COVID vaccine. The pharmacist prepared the vaccine and brought the patient into the room. She confirmed with the pharmacist she was here for the first dose of the Pfizer COVID vaccine and the patient confirmed that was what she wanted. Patient inquired into a pneumonia vaccine in the future and the pharmacist confirmed again that the patient wanted just the Pfizer COVID vaccine today and she confirmed again this is what she wanted. The pharmacist administered the vaccine and went to place the syringe in the sharps container when the patient stated "oh can you look at this card I have". The patient then proceeded to pull out a COVID vaccine card stating she had received Moderna from another facility (1st dose- Lot: 012L20A administered on 1/11/21 and 2nd dose- Lot: 031L20A administered on 2/9/21). The pharmacist discussed with her that she was not eligible for the vaccine she just received. Both cards were given to the patient and the pharmacist confirmed multiple times that the patient was set for COVID and did NOT need to get any more doses. The patient was very nice and stated " its okay I have little babies at home and I wanted to get a booster anyway". The pharmacist contacted Moderna for guidance on the administration error. They took information on the patient and what happened in the incident (Case#: MOD21152214). No adverse reaction was/has been presented by the patient.


VAERS ID: 1782666 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30130BA / 3 LA / -
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ750AC / N/A RA / IM

Administered by: Public       Purchased by: ?
Symptoms: No adverse event, Wrong product 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: This RN administered the wrong seasonal influenza vaccine to patient. Pt experienced no adverse effects from administration.


VAERS ID: 1782674 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017F21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Eye movement disorder, Fall, Head injury, Headache, Hyperhidrosis, Pallor, Seizure, Thirst
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), 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: Clonidine 0.2mg Guanfacine ER 2mg Montelukast 10mg Paroxetine 30mg Vyvanse 30mg OTCs/herbals not known.
Current Illness: Any record of illness denied by patient on release form.
Preexisting Conditions: Conditions denied by patient on release form. Medications indicate allergies/asthma and psychiatric disorders.
Allergies: Allergies denied by patient on release form.
Diagnostic Lab Data: None known to this facility''s staff.
CDC Split Type:

Write-up: Patient sat in chair, stated chest hurt. Patient stood suddenly, eyes rolled back in his head, and he grabbed the privacy screen. He fell, striking his head on the ground, and appears to seize for approximately a minute. Patient regained consciousness, sweated profusely, stated he was thirsty, complained of his head hurting. Patient was very pale. Paramedics arrived and patient/his mother refused to go to the hospital despite repeated offers from paramedics.


VAERS ID: 1782738 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: New York  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014F21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Expired product administered, No adverse event
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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: The Moderna vaccine that was pulled from the refrigerator was over 30 days from the date the vaccine was pulled from the freezer. The vaccine was pulled from the freezer on 9/8/21 (expiring 10/9/21) but given on 10/13/21. The mfg lot # was 014F21A and Exp 01/23/22. Patient has not experienced any side effects as of yet. He was informed almost immediately following receiving the vaccination. He was not upset. Awaiting response from Moderna on how to proceed was told it would take 8-10 days to receive a response,


VAERS ID: 1782757 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: California  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011F21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

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

Write-up: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: patient received 1st dose of moderna vaccine. says sometimes feel faint after. vaccine given and then patient was seated in front of pharamcy for observation. patient was sitting down and then suddenly our colleague noticed patients legs went stiff and he tipped over onto a display stand. patient fainted and bump his head into display stand. I came to the patient immediately and called to wake him. Within 3 secs he became coherent and says he was okay. given OJ and declined ice pack. pt ok


VAERS ID: 1782758 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: On 10/13/21 I was made aware of a vaccination error by pharmacist for patient. The patient had come into the pharmacy with her mother to receive the Johnson & Johnson (J&J) COVID vaccination. The patient completed the J&J Patient Consent & Release Form and screening questionnaire for COVID19 immunization from the CDC. The form was given to pharmacist to administer the vaccination. Upon completion of the vaccination, pharmacist had noticed we did not have the insurance information for the patient to process the claim. The patient?s mother called the pharmacy and provided the insurance information. After attempting to process the vaccination through the insurance, the patient?s insurance rejected the claim due to the patient?s age. Pharmacist then brought this to my attention. My course of action is to fill out a VAERS report. Additionally, I have contacted the manufacturer of J&J (Janssen) and have contacted the patient?s mother to make her aware. I explained to her that a miscalculation was made with patient''s age and she received the J&J vaccine, but it is not currently approved through EUA for her age?therefore, there is no concrete safety & efficacy data. The patient?s mother kept repeating ?we are good here? and reported no current adverse effects. I recommended for the patient to contact her primary care doctor to make them aware and to seek recommendation for further course of action as far as being evaluated for any potential adverse effects. I have attempted to contact the physician?s office personally to make them aware of the vaccination error and am currently waiting on a return phone call after having to leave a voicemail. I am following up on Friday with the patient?s mother & will also next week. We are amending our vaccination forms to include in bold print EUA ages for each respective vaccination, as well as emphasizing the importance of workflow with our staff and the necessity of a pharmacist looking at the consent/release forms & screening questionnaires prior to vaccine administration.


VAERS ID: 1782784 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 3 LA / IM

Administered by: Pharmacy       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:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

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


VAERS ID: 1782786 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild


VAERS ID: 1782790 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 3 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: NONE
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient was given a the booster pfizer shot a week early. Vaccinator misread the date by confusing the first shot date with the second date.


VAERS ID: 1782796 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Idaho  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037C21A / 2 LA / IM

Administered by: Private       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? 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 was administered 2nd Moderna vaccine. Patient is under 18 years of age.


VAERS ID: 1782802 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Idaho  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037C21A / 2 LA / IM

Administered by: Private       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? 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 was given 2nd dose of Moderna. Patient is under 18 years of age.


VAERS ID: 1782808 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Idaho  
Vaccinated:2021-10-13
Onset:2021-10-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037C21A / 2 LA / IM

Administered by: Private       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? 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 administered 2nd dose of Moderna. Patient under 18 years of age.


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