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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 257 out of 8,753

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VAERS ID: 1841512 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6431 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Full blood count, Immunisation, Off label use, Platelet count, Platelet count decreased, Product use issue, Rash, SARS-CoV-2 test, Thrombocytopenia
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN (E.C.)
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Chemotherapy; Clinical trial participant; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Radiotherapy
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: blood count; Result Unstructured Data: Test Result:Normal range; Test Date: 20211018; Test Name: platelet count; Result Unstructured Data: Test Result:low; Test Date: 20211018; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101417904

Write-up: Bruising; Thrombocytopenia; Blood spot rash; Off label use; Booster; Product use for unapproved combination; Low platelet; This is a spontaneous report from a contactable consumer. This is a report from the Regulatory Authority (RA). Regulatory authority report number -MHRA-WEBCOVID-202110191146595170-S8UZP, Safety Report Unique Identifier -MHRA-ADR 26091636. A 48-year-old female patient (not pregnant) received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FG6431), via an unspecified route of administration, on 05Oct2021 (at the age of 48 years), as dose 3 (booster), single for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered on 08Jan2021, and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered on 26Mar2021, both for COVID-19 immunisation. Medical history included breast cancer, radiotherapy from 2017 to Jun2017, chemotherapy from 2017 to Jun2017, and immunodeficiency. The patient was a clinical trial participant. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Relevant concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)) from Aug2017 to 17Oct2021 and influenza vaccine (FLU VACCINE VII) taken on 05Oct2021 for immunization. On 14Oct2021, the patient had thrombocytopenia and bruising. On unknown date in 2021, after vaccination, the patient had low platelets. The events were reported serious as medically significant. The clinical course was reported as follows: Pfizer booster received on 05Oct2021 at same time as flu vaccine. 9 days later spontaneous bruising appeared on stomach followed by significant bruising on arms and legs. Blood spot rash appeared the following day predominately on legs. Currently on Add ASPIRIN trial for the past 4 years so already had increased tendency to bruise but not to this degree. No previous side effects from the trial. Trial medication (daily dose of either 100 mg or 300 mg ASPIRIN stopped on 17Oct2021) and agreed with research nurse on 18Oct2021 re: probable low platelet count. Full blood count last taken in September 2021 prior to vaccine and all bloods were in the normal range. On 18Oct2021, a COVID-19 test was done and resulted negative. The patient was recovering from thrombocytopenia; the patient had not recovered from bruising and low platelet. The outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : -PFIZER INC-202101426318 same patient, different dose (2n dose)


VAERS ID: 1841733 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-17
Onset:2021-10-05
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Erythema multiforme
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Autoimmune pancytopenia; LE systemic
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101404507

Write-up: Appearance of polymorphic erythema minor all over the body, reaction that appeared 12 years earlier after a vaccine; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-799050. A 49-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FG6273, Expiry date not reported), intramuscularly on 17Sep2021 as dose number unknown, single for COVID-19 immunization. Medical history included autoimmune pancytopenia from 01Nov1994 to an unknown date, and systemic lupus erythematosus from 01Oct1994 to an unknown date. The patient''s concomitant medications were not reported. On 05Oct2021, the patient experienced appearance of polymorphic erythema minor all over the body, reaction that appeared 12 years earlier after a vaccine. Therapeutic measures were taken as a result of event and patient received treatment with topical and oral cortisone. The outcome of event was recovering. Reporter''s comment: Appearance of polymorphic erythema minor one week after the vaccine. The same symptomatology was present 12 years earlier after a vaccine Sender''s comment: 15Oct2021: LOT - FG6273 on 17Sep2021, correction of the onset date in 05Oct2021, improvement. No follow-up activities possible. No further information expected.


VAERS ID: 1841883 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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 FH4092 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abnormal uterine bleeding, Maternal exposure during pregnancy, Premature separation of placenta
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Fertility disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101461768

Write-up: Placental separation in gestational week 26/ massive intrauterine haemmorhage; Placental separation in gestational week 26; pregnancy week 26, 12 days after receiving the second dose; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number NO-NOMAADVRE-FHI-2021-Urmqw8. The physician reported different events for two doses and a child. This is the first of three reports. A 28-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: FH4092), via intramuscular, administered in right arm on 05Oct2021 (28-year-old at time of vaccination) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY, Lot Number: FG2975) on 27Aug2021 for COVID-19 immunisation and experienced maternal exposure during pregnancy, second trimester. The patient experienced "placental separation in gestational week 26/ massive intrauterine haemmorhage" on 17Oct2021, "placental separation in gestational week 26" on 17Oct2021. The events were assessed as serious with criteria of life threatening. The mother was 26 weeks pregnant at the onset of the event. The mother delivered the pregnancy on an unknown date via cesarean delivery. The baby was delivered premature. Narrative: A 28-year-old pregnant woman experienced probable premature separation of placenta, antepartum in pregnancy week 26, 12 days after receiving the second dose of COVID-19 vaccine Comirnaty. The patient was admitted to hospital with massive intrauterine haemmorhage. The child was delivered by emergency Caesarean section. The patient is retrospectively evaluated for possible risk factors but none was found. The outcome of the events was unknown. Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : NO-PFIZER INC-202101474306 mother/child case;NO-PFIZER INC-202101474307 Same reporter, same patient, different doses, different events


VAERS ID: 1841889 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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 FH4092 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Premature baby
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101474306

Write-up: Placental separation in gestational week 26; Maternal exposure during pregnancy, second trimester; This is a spontaneous report from a physician reporting information for a child. This is the third of three reports. The first report is a report downloaded from the Regulatory Agency-WEB NO-NOMAADVRE-FHI-2021-Urmqw8. A neonate patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 2 transplacental on 05Oct2021 (Batch/Lot Number: FH4092) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included the patient''s mother received first dose of Comirnaty on 27Aug2021 (Batch/lot number: FG2975) for covid-19 immunisation and experienced Maternal exposure during pregnancy, second trimester. The patient''s pregnant mother experienced probable premature separation of placenta, antepartum in pregnancy week 26, 12 days after receiving the second dose of COVID-19 vaccine Comirnaty on 17Oct2021. The child (patient) was delivered by emergency Caesarean section. The outcome of the events was unknown. The event "Placental separation in gestational week 26" was reported as serious due to life-threatening. Reporter comment: Pregnant woman experienced probable premature separation of placenta, antepartum in pregnancy week 26, 12 days after receiving the second dose of COVID-19 vaccine Comirnaty. The patient was admitted to hospital with massive intrauterine haemmorhage. The child was delivered by emergency Caesarean section. The patient is retrospectively evaluated for possible risk factors but none was found. The Regulatory Authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Pregnant woman experienced probable premature separation of placenta, antepartum in pregnancy week 26, 12 days after receiving the second dose of COVID-19 vaccine Comirnaty. The patient was admitted to hospital with massive intrauterine haemmorhage. The child was delivered by emergency Caesarean section. The patient is retrospectively evaluated for possible risk factors but none was found. (...); Sender''s Comments: Linked Report(s) : NO-PFIZER INC-202101474307 mother case;NO-PFIZER INC-202101461768 mother case


VAERS ID: 1842406 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-10-05
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Immune thrombocytopenia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

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

Write-up: Severe thrombocytopenia with bleeding; This regulatory authority case was reported by a physician and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Severe thrombocytopenia with bleeding) in a 47-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for SARS-CoV-2 immunisation. Co-suspect product included non-company product ROSUVASTATINE [ROSUVASTATIN] for Hypercholesterolemia. Concurrent medical conditions included Psoriasis (Psoriasis treated) and Hypercholesterolemia (Hypercholesterolemia treated). Concomitant products included ADALIMUMAB (HUMIRA) for Psoriasis. On 23-Sep-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 26-Sep-2021, the patient started ROSUVASTATINE [ROSUVASTATIN] (Oral) 5 milligram. On 05-Oct-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced IMMUNE THROMBOCYTOPENIA (Severe thrombocytopenia with bleeding) (seriousness criteria hospitalization and medically significant). On 15-Oct-2021, IMMUNE THROMBOCYTOPENIA (Severe thrombocytopenia with bleeding) had resolved. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered IMMUNE THROMBOCYTOPENIA (Severe thrombocytopenia with bleeding) to be possibly related. The patient experienced two episodes of haematochezia, severe fatigue and spontaneous hematomas upper, lower limbs and at the buccal level on 04-Oct-2021. He was hemodynamically stable, afebrile, with an unremarkable clinical examination. The laboratory data indicated evidence of deep thrombocytopenia. The vitamin tests were in normal range. His laboratory data included Leukocytes 8 G/ (4-10 G/L), Hb 151 g/L (140-180 g/L), Thrombocytes 1 G/L (150-370 G/L), with anisocytosis of thrombocytes and giant thrombocytes, ferritin 106 mcg/L (50-350 mcg/L), vitamin B12 473 pg/mL (197-771 pg/mL), folic acid 5.3 ng / mL (4-20 ng/mL), CRP <5 mg/L , LDH 188 U/L (135-250 U/L), TP 80% (70-100%), PTT 27 sec (26- 36 sec), fibrinogen 2.1 g/L (2-4.5 g/L), D-dimer <190 ng/mL (<500 ng/mL). Anti-nuclear factors negative (<80) Electrophoresis of serum proteins: Albumin 61% (57-71%), alpha-1-globulins 2% (1.9-4.5%), alpha-2-globulins 11% (5.5-10.5%), Beta-1 + 2-globulins 13% (8-13.5%), gammaglobulins 13% (9-18%), haptoglobin 1.01 g/L (0.35-2 g/L) was performed on 5-OCT-2021. His laboratory tests include platelet count performed on 16-FEB-2017, 05-OCT-2021, 08-OCT-2021, and 15-OCT-2021. It also included Thrombocytes 242 G/L on 16 -OCT-2017, G/L 74 on 08-OCT-2021, G/L 356 10-OCT-2021. The serological assessment HIV, CMV,EBV, HBV, HCV does not show any acute infection. The Serology for Helicobacter pylori shows an old infection IgG: 3.9 (0.8). Patient treatment information Rosuvastatin treatment was stopped on 05-Oct-2021. Pantoprazole 40 mg intravenous on 05/10/2021, oral relay methylprednisolone 125 mg IV on 05-Oct-2021 and 06-Oct-2021, prednisone 1 mg/kg/day , Human immunoglobulins 1 g/kg iv on 05-Oct and 06-Oct-2021. Patient was discharged 08-OCT-2021. Company comment: This case concerns a 47-year-old, male patient, with no relevant medical history and recently started Rosuvastatin (co-suspect drug, known to possibly cause thrombocytopenia in rare cases), who experienced the serious, unexpected, AESI event of immune thrombocytopenia. The event occurred 12 days after first dose of Moderna vaccine and 9 days after start of rosuvastatin. The rechallenge is not applicable as patient only received first dose. The event was considered related to the product per the reporter''s assessment. The co-suspect drug rosuvastatin remains as a confounder to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Translation received on 29-Oct-2021 contains patient''s medical history and updated i narrative.; Reporter''s Comments: Sender''s Comments: This case concerns a 47-year-old, male patient, with no relevant medical history and recently started Rosuvastatin (co-suspect drug, known to possibly cause thrombocytopenia in rare cases), who experienced the serious, unexpected, AESI event of immune thrombocytopenia. The event occurred 12 days after first dose of Moderna vaccine and 9 days after start of rosuvastatin. The rechallenge is not applicable as patient only received first dose. The event was considered related to the product per the reporter''s assessment. The co-suspect drug rosuvastatin remains as a confounder to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.


VAERS ID: 1842430 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Nausea, Oropharyngeal pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Angina pectoris (Other forms of angina); Aortic valve insufficiency (Non-rheumatic aortic insufficiency); Atherosclerotic cardiovascular disease (Atherosclerotic heart disease of native coronary artery with unspecified angina pectoris); Chronic kidney disease stage 3; Hypertensive heart disease; Pure hypercholesterolemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Aversion to cold, Sore throat; Fever; Nausea; chills; This regulatory authority case was reported by a pharmacist and describes the occurrence of OROPHARYNGEAL PAIN (Aversion to cold, Sore throat), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Angina pectoris (Other forms of angina), Chronic kidney disease stage 3, Pure hypercholesterolemia, Hypertensive heart disease, Aortic valve insufficiency (Non-rheumatic aortic insufficiency) and Atherosclerotic cardiovascular disease (Atherosclerotic heart disease of native coronary artery with unspecified angina pectoris). On 05-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, the patient experienced OROPHARYNGEAL PAIN (Aversion to cold, Sore throat) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization), NAUSEA (Nausea) (seriousness criterion hospitalization) and CHILLS (chills) (seriousness criterion hospitalization). The patient was hospitalized from 06-Oct-2021 to 08-Oct-2021 due to CHILLS, NAUSEA, OROPHARYNGEAL PAIN and PYREXIA. The patient was treated with SODIUM CHLORIDE (SODIUM CHLORIDE IV) on 06-Oct-2021 for Adverse event, at a dose of 0.9% 500ML 1bag; PARACETAMOL (ACETAMOL [PARACETAMOL]) on 06-Oct-2021 for Adverse event, at a dose of 1G 1AMP; DICLOFENAC SODIUM (CATAFLAM [DICLOFENAC SODIUM]) for Adverse event, at a dose of 25 milligram three times a day and TAITA NO.5 for Adverse event, at a dose of 400 milliliter twice a day. At the time of the report, OROPHARYNGEAL PAIN (Aversion to cold, Sore throat), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (chills) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On October 6, 2021 the patient had visited the Emergency Room at 10:15 p.m and as evaluated by the doctor, patient underwent blood test, E.K.G. and chest X-ray test and was immediately given treatment. The patient was hospitalized and was given long-term medication for chronic diseases. On October 8, 2021 the patient''s symptoms were improved at 10:38 a.m., and was discharged with oral medication for seven days,CATAFLAM 25MG, TID. Patient was advised for follow-up visits to the outpatient department. Company Comment : This case concerns a 69-year-old, female patient with previous relevant medical history of angina pectoris and chronic kidney disease, who experienced the unexpected serious events of oropharyngeal pain, pyrexia, nausea, and chills. The events pyrexia, nausea, and chills are unexpected as they are retained as serious per the source document Authority reporting. The events occurred on the same day after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable as patient received treatment for the events. The medical history of angina pectoris and chronic kidney disease could be confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 69-year-old, female patient with previous relevant medical history of angina pectoris and chronic kidney disease, who experienced the unexpected serious events of oropharyngeal pain, pyrexia, nausea, and chills. The events pyrexia, nausea, and chills are unexpected as they are retained as serious per the source document Authority reporting. The events occurred on the same day after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable as patient received treatment for the events. The medical history of angina pectoris and chronic kidney disease could be confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1842501 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-05
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20211108835

Write-up: COVID-19; VACCINATION FAILURE; This spontaneous report received from a consumer via a Regulatory Authority [DE-PEI-202100214549] concerned a 37 year old male of unspecified race and ethnicity . The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C1001 expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-OCT-2021, the patient experienced covid-19 and vaccination failure. The drug reaction relatedness for covid-19 and vaccination failure with covid-19 vaccine ad26.cov2.s was reported as intermediate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint and reference requested.


VAERS ID: 1844479 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-03
Onset:2021-10-05
   Days after vaccination:2
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: Varicocele
SMQs:, Fertility disorders (narrow)

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

Write-up: Pampinocele; This case was received via regulatory authority (Reference number: FR-AFSSAPS-MA20214214) on 27-Oct-2021 and was forwarded to Moderna on 27-Oct-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of VARICOCELE (Pampinocele) in a 13-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included COVID-19 in August 2021. On 03-Oct-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Oct-2021, the patient experienced VARICOCELE (Pampinocele) (seriousness criterion medically significant). At the time of the report, VARICOCELE (Pampinocele) had resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. This is a regulatory case concerning a 13 years old, male patient with clinical history of Covid-19 who experienced the unexpected serious event of varicocele. The event occurred three days after a dose of Moderna Covid 19 vaccine The rechallenge was not applicable since only information about one dose was disclosed The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Translated document received on 28-OCT-2021 contains NNI.; Sender''s Comments: This is a regulatory case concerning a 13 years old, male patient with clinical history of Covid-19 who experienced the unexpected serious event of varicocele. The event occurred three days after a dose of Moderna Covid 19 vaccine The rechallenge was not applicable since only information about one dose was disclosed The benefit-risk relationship of Moderna Covid 19 vaccine is not affected by this report.


VAERS ID: 1844591 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Influenza, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; PIRITON
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101418152

Write-up: flu symptoms; widespread rash; Booster; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-EYC 00263678. Safety Report Unique Identifier GB-MHRA-ADR 26085453. A 50-year-old female patient received bnt162b2 (COMIRNATY), parenteral on 05Oct2021 (at the age of 50 years) (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included citalopram and chlorphenamine maleate (PIRITON). The patient experienced widespread rash and flu symptoms on 15Oct2021. Rash not responding to antihistamines. The events were assessed as serious (medically significant). The outcome of the events flu symptoms and widespread rash was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1844606 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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: Body temperature, Headache, Hot flush, Interchange of vaccine products, Lethargy, Malaise, Nausea, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (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), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RIGEVIDON (28)
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Influenza immunisation; Oral contraceptive
Allergies:
Diagnostic Lab Data: Test Date: 20211006; Test Name: temperature; Result Unstructured Data: Test Result:High; Test Date: 20210719; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101418154

Write-up: Headache; Nausea; Hot flush; Lethargic; High temperature; Feeling unwell; Off label use; Interchange of vaccine products; This is a spontaneous report from a contactable other HCP received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110181336474900-FRPMZ. Safety Report Unique Identifier GB-MHRA-ADR 26086484. A 37-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number: unknown) third dose via an unspecified route of administration on 05Oct2021 (at the age of 37 years old) as dose 3 (booster), single for COVID-19 immunization. Medical history included COVID-19 from 19Jul2021 to an unknown date, oral contraception, and influenza immunization. The patient previously received COVID-19 VACCINE ASTRAZENECA, dose 1 on 18Jan2021 and dose 2 on 30Mar2021 for COVID-19 immunization. Concomitant medication(s) included influenza vaccine (INFLUENZA VIRUS) taken for influenza immunization from 05Oct2021 to 05Oct2021; ethinylestradiol, levonorgestrel (RIGEVIDON (28)) taken for oral contraception from 15Feb2021, unknown if ongoing. On 05Oct2021, the patient received third dose and on 06Oct2021, the patient experienced headache, nausea, hot flush, lethargic, high temperature, feeling unwell. It was reported that the patient was advised to take paracetamol, Ibuprofen and plenty of fluids as well as rest. Sought general practitioner (GP) review twice and sign off fit to work for 5 days. Took 8 working days off work to recover. GP reviewed, Ears and chest for other possible eliments. This report relates to no possible blood clots or low platelet counts, no possible myocarditis or pericarditis. The patient underwent lab tests and procedures which included SARS-CoV-2 test: Positive (Yes - Positive COVID-19 test) on 19Jul2021, and body temperature: high on 06Oct2021. The outcome of event nausea was recovered on 10Oct2021, high temperature was recovered on 11Oct2021, hot flush was recovered on 14Oct2021, lethargic was recovered on 15Oct2021 and for feeling unwell and headache was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1844612 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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 FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Chest pain, Dizziness, Dyspnoea, Fatigue, Immunisation, Insomnia, Nasal congestion, Neuralgia, Off label use, Oropharyngeal pain, Pain, Palpitations, Rash pruritic, Renal pain, SARS-CoV-2 test, Tachycardia, Tendonitis, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYER PLUS EXTRA STRENGTH; CHLORPHENAMINE; DESOGESTREL; FEXOFENADINE; FOSTAIR; GABAPENTIN; IVABRADINE; LORATADINE; OMEPRAZOLE; PREDNISOLONE; SALBUTAMOL; SELENIUM; VITAMIN D3; ZAPAIN; ZOLMITRIPTAN; ZOPICLONE
Current Illness: Chronic pain (I have been having cycling flares of pre-existing chronic pain); Long COVID; Tendinitis (intermittent tendinitis for thirteen years)
Preexisting Conditions: Medical History/Concurrent Conditions: Acute migraine; Angioedema; Chronic heartburn; Chronic migraine; Dysmenorrhoea; Generalised urticarial rash; Generalized pruritus; Immunodeficiency; Indigestion; Infection (viral-like); Infection (viral-like); Insomnia; Multiple allergies; Pain; Sinus tachycardia; Suspected COVID-19; Urticaria (Viral-like illness in August that seemed to trigger several days of urticaria and angioedema); Vitamin D low; Wheeze
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101417689

Write-up: Fatigue/unusual tiredness; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Wheeze worsened; Itchy rash; Chest pain with radiation to left arm; Dizziness; Insomnia exacerbated; Kidney pain; Thoracic back pain; Peripheral neuropathic pain; Tendinitis; Migratory arthralgia; Nasal congestion; Sore throat; Off label use; booster; chronic pain; This is a spontaneous report from a contactable consumer or other non Hcp (patient). This is a report received from the regulatory authority report number GB-MHRA-WEBCOVID-202110190121495350-I3NIQ, Safety Report Unique Identifier GB-MHRA-ADR 26090369. A 44-years-old non pregnant female patient received the third dose of BNT162B2 (COMIRNATY,solution for injection, Batch/Lot Number: FF8222) via an unspecified route of administration on 05Oct2021(age of 44-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient received BNT162B2 1st dose on 18Jan2021 and 2nd dose on 24Mar2021 for covid-19 immunisation. Medical history included suspected covid-19 from 20Mar2020 to an unknown date., immunodeficiency, Taking other treatments or medicines, not listed above, known to lower the immune response and Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef), ongoing post-acute covid-19 syndrome, tendonitis from 2008 and ongoing intermittent tendinitis for thirteen years, wheezing, insomnia, angioedema from Aug2021 to Aug2021, infection from Aug2021 to Aug2021 viral-like, infection from Sep2021 to Sep2021 viral-like. Concomitant medication included acetylsalicylic acid, calcium carbonate, magnesium carbonate, magnesium oxide (BAYER PLUS EXTRA STRENGTH) taken for dyspepsia, chlorphenamine taken for multiple allergies, desogestrel taken for dysmenorrhoea from Apr2010 to an unspecified stop date; fexofenadine taken for urticaria from 06Aug2021 to 06Sep2021; beclometasone dipropionate, formoterol fumarate (FOSTAIR) taken for wheezing from Nov2020 to an unspecified stop date; gabapentin taken for migraine from Mar2019 to an unspecified stop date; ivabradine taken for sinus tachycardia from Apr2021 to an unspecified stop date; loratadine (taken for pruritus, start and stop date were not reported; omeprazole taken for dyspepsia from Jul2018 to an unspecified stop date; prednisolone taken for urticaria from 05Aug2021 to 13Aug2021; salbutamol taken for wheezing from 12Aug2020 to an unspecified stop date; selenium taken for an unspecified indication from Jan2021 to an unspecified stop date; vitamin d3 (VITAMIN D3) taken for vitamin d decreased from 2016 to an unspecified stop date; codeine phosphate, paracetamol (ZAPAIN) taken for pain from Aug2020 to an unspecified stop date; zolmitriptan taken for migraine from 2010 to an unspecified stop date; zopiclone (ZOPICLONE) taken for insomnia from Sep2020 to an unspecified stop date. Patient is not currently breastfeeding. Unsure if patient is enrolled in clinical trial. The patient experienced chronic pain, fatigue/unusual tiredness, shortness of breath, heart palpitations, racing heart on an unspecified date; tendinitis, sore throat on 06Oct2021 nasal congestion on 07Oct2021; migratory arthralgia on 08Oct2021; peripheral neuropathic pain, kidney pain, thoracic back pain on 09Oct2021; insomnia exacerbated on 10Oct2021; dizziness on 11Oct2021;itchy rash on 12Oct2021; wheeze worsened on 15Oct2021, Off label use and booster on 05Oct2021. The patient had suffered from mild, intermittent tendinitis for thirteen years. Since this booster vaccine, she have suffered the worst flare she had in all that time. This started 2-3 days after the vaccine. she then couldnot move right index finger for 2 days due to severe pain radiating from the metacarpophalangeal (MCP) joint (never experienced before). Tonight, she have the same pain in the equivalent joint on my big toe (no injury). she have been having cycling flares of pre-existing chronic pain (e.g.knees, neuropathic pain) with these new pains and allergic-type symptoms such as wheeze, itchy rash on chest and sore throat. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 03Sep2021. The report do not relate to possible inflammation of the heart (myocarditis or pericarditis). relevant investigations or tests conducted was none. symptoms did not lead to a hospital stay. The blood tests such as for certain proteins (called troponin) that signal heart muscle damage was not taken. The patient had Viral-like illness in August that seemed to trigger several days of urticaria and angioedema (possible urticarial vasculitis), followed by another viral-like illness a month later. At the time of reportMigratory arthralgia, Wheeze worsened, Kidney pain was not recovered;chronic pain , Tendinitis, Itchy rash, Nasal congestion, Sore throat, Thoracic back pain, Dizziness was recovering; Peripheral neuropathic pain was recovered on 10Oct2021, Chest pain with radiation to left arm red on 10Oct2021, Insomnia exacerbated recovered on 13Oct2021, Chest pain with radiation to left arm recovered on 12 Oct 2021; Fatigue/unusual tiredness, Shortness of breath, Heart palpitations, Racing heart was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1844811 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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 FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Immunisation, Lymphadenitis, Myalgia, Off label use
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal); Clinical trial participant (Study details:)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101426675

Write-up: Myalgia; Lymphadenitis; Tight chest; BNT162B2 (COMIRNATY), on 05Oct2021 as third booster dose; BNT162B2 (COMIRNATY), on 05Oct2021 as third booster dose; This is a spontaneous report from a contactable consumer. This is report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110211429260350-0O7AX, Safety Report Unique Identifier number is (GB-MHRA-ADR 26104068). A 33-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 05Oct2021 (Lot Number: fj5782) at the age of 33 years old, as third booster dose, single for COVID-19 immunisation. Medical history included clinical trial participant (Study details:) and acid reflux. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant and not currently breastfeeding. Last menstrual period was on 29Sep2021. The patient''s concomitant medications were not reported. The patient previously took BNT162B2 (lot number: not reported) on unspecified date as first dose, single and on unspecified date as second dose, single for COVID-19 immunisation. On 06Oct2021, the patient experienced myalgia, lymphadenitis, tight chest. Outcome of the event myalgia was recovered on 08Oct2021; event lymphadenitis was recovered on 11Oct2021; event tight chest was recovered on 07Oct2021. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1845118 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-10-05
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101418625

Write-up: ASYMPTOMATIC COVID-19 CONFIRMED; ASYMPTOMATIC COVID-19 CONFIRMED; 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-300111285. A 22-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 11Aug2021 (lot Number: FD5996; expiry date: unknown) at the age of 22-years-old, as dose number unknown, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 05Oct2021 08:00, the patient experienced asymptomatic Covid-19 (confirmed). The patient recovered from the event on unspecified date. On 27Oct2021, the Product Quality Complaint group provided the following investigational results: This lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 6168537. The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. 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 lot of the reported lot FD5996. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. regulatory authority concluded that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1845209 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Body temperature, Chills, Dizziness, Dizziness postural, Fatigue, Nausea, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211005; Test Name: Body temperature; Test Result: Inconclusive; Result Unstructured Data: mild fever (37.2 C.).
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Syncope; Chills; Nausea; Increased blood pressure; unsteady standing; dizziness; fatigue; mild fever (37.2 ?); This regulatory authority case was reported by a pharmacist and describes the occurrence of SYNCOPE (Syncope), BLOOD PRESSURE INCREASED (Increased blood pressure), DIZZINESS POSTURAL (unsteady standing), DIZZINESS (dizziness), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (fatigue) and PYREXIA (mild fever (37.2 C.)) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced FATIGUE (fatigue) (seriousness criterion medically significant) and PYREXIA (mild fever (37.2 C.)) (seriousness criterion medically significant). On 13-Oct-2021, the patient experienced BLOOD PRESSURE INCREASED (Increased blood pressure) (seriousness criterion medically significant), DIZZINESS POSTURAL (unsteady standing) (seriousness criterion medically significant), DIZZINESS (dizziness) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). The patient was treated with AMINO ACIDS NOS (NOVAMIN [AMINO ACIDS NOS]) (oral) on 13-Oct-2021 at an unspecified dose and frequency. At the time of the report, SYNCOPE (Syncope) and CHILLS (Chills) outcome was unknown, BLOOD PRESSURE INCREASED (Increased blood pressure), DIZZINESS POSTURAL (unsteady standing), DIZZINESS (dizziness) and NAUSEA (Nausea) was resolving and FATIGUE (fatigue) and PYREXIA (mild fever (37.2 C.)) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Oct-2021, Body temperature: mild fever (37.2 C.) (Inconclusive) mild fever (37.2 C.). 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. No concomitant medication details were provided by reporter. Company Comment: This case concerns a 71-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of Syncope, Blood pressure increased, Dizziness postural, Dizziness, Chills, Nausea, Fatigue, Pyrexia. The events occurred approximately on the same day after the unknown dose of Moderna Covid -19 vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The benefit-risk relationship of Moderna Covid -19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 71-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of Syncope, Blood pressure increased, Dizziness postural, Dizziness, Chills, Nausea, Fatigue, Pyrexia. The events occurred approximately on the same day after the unknown dose of Moderna Covid -19 vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The benefit-risk relationship of Moderna Covid -19 vaccine is not affected by this report.


VAERS ID: 1845210 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-04
Onset:2021-10-05
   Days after vaccination:1
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: Altered state of consciousness, Chest discomfort, Chest pain, Dizziness, Myocardial infarction, Pruritus
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: conscious; dizziness; chest pain; chest tightness; itching; Myocardial infarction; This regulatory authority case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction), ALTERED STATE OF CONSCIOUSNESS (conscious), DIZZINESS (dizziness), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest tightness) and PRURITUS (itching) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Oct-2021, the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria hospitalization and medically significant), DIZZINESS (dizziness) (seriousness criterion hospitalization), CHEST PAIN (chest pain) (seriousness criterion hospitalization), CHEST DISCOMFORT (chest tightness) (seriousness criterion hospitalization) and PRURITUS (itching) (seriousness criterion hospitalization). On 21-Oct-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (conscious) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 19-Oct-2021 to 23-Oct-2021 due to ALTERED STATE OF CONSCIOUSNESS, CHEST DISCOMFORT, CHEST PAIN, DIZZINESS, MYOCARDIAL INFARCTION and PRURITUS. The patient was treated with ENOXAPARIN for Adverse reaction, at an unspecified dose and frequency; EDOXABAN (oral) for Adverse reaction, at a dose of 30 mg and Surgery (Heart stent implant) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Myocardial infarction), ALTERED STATE OF CONSCIOUSNESS (conscious), DIZZINESS (dizziness), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest tightness) and PRURITUS (itching) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant Medication use information was not provided by reporter. On 20-Oct-2021, Patient had done nondrug treatment of heart stent implant On 18-Oct-2021, Patient had done laboratory test of ECG and cardiac ultrasound and results were unknown. Company Comment: This case concerns a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced serious unexpected event of myocardial infarction one day after receiving the second dose of the vaccine. Patient''s age is a confounding factor. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report; Sender''s Comments: This case concerns a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced serious unexpected event of myocardial infarction one day after receiving the second dose of the vaccine. Patient''s age is a confounding factor. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report


VAERS ID: 1845222 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   Days after vaccination:0
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: Rash, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Skin rash; Mild sweling; This regulatory authority case was reported by an other health care professional and describes the occurrence of RASH (Skin rash) and SWELLING (Mild sweling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced RASH (Skin rash) (seriousness criterion medically significant) and SWELLING (Mild sweling) (seriousness criterion medically significant). At the time of the report, RASH (Skin rash) and SWELLING (Mild sweling) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. On 11-Oct-2021 the patient visited the doctor for 4 limbs skin rashes & mild swelling. After the diagnosis and treatment, the patient had intravenous injection for blood draw and oral administration. Company comment: This case concerns a 70-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of rash and swelling. The events occurred on the same day after the second dose of Moderna Covid-19 vaccine. The rechallenge is not applicable since no information about the first dose was disclosed. The benefit-risk relationship of the 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 70-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of rash and swelling. The events occurred on the same day after the second dose of Moderna Covid-19 vaccine. The rechallenge is not applicable since no information about the first dose was disclosed. The benefit-risk relationship of the 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: 1845548 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-05
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREDNISOLONE; METHOTREXATE CIPLA
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 38 degrees; Test Name: Body temperature; Result Unstructured Data: Approx. 39/40 degrees
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: lump in armpit; Fever; High fever; Swollen lymph node in the armpit of the left arm; This case was received via Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00055080) 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 AXILLARY MASS (Swollen lymph node in the armpit of the left arm), AXILLARY MASS (lump in armpit), PYREXIA (Fever) and PYREXIA (High fever) in a 39-year-old female patient who received mRNA-1273 (Spikevax) for Vaccination. No Medical History information was reported. Concomitant products included PREDNISOLONE from 2002 to an unknown date for Low platelets, METHOTREXATE (METHOTREXATE CIPLA) from 2010 to an unknown date for Rheumatism and Mixed connective tissue disease. In 2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Oct-2021 at 7:20 AM, received third dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 05-Oct-2021, the patient experienced AXILLARY MASS (Swollen lymph node in the armpit of the left arm) (seriousness criterion hospitalization). On an unknown date, the patient experienced AXILLARY MASS (lump in armpit) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization) and PYREXIA (High fever) (seriousness criterion hospitalization). At the time of the report, AXILLARY MASS (Swollen lymph node in the armpit of the left arm) had not resolved and AXILLARY MASS (lump in armpit), PYREXIA (Fever) and PYREXIA (High fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 38 (High) 38 degrees and 39/40 (High) Approx. 39/40 degrees. No treatment information was provided. Patient experienced axillary lump (dose 2), high fever (dose 2), axillary lump in left arm (dose 3) and fever (dose 3). Patient had high fever approx. 39/40 degrees with hospitalization approximately of 14 days after dose 2 of corona vaccine. Company comment: This case concerns a 39-year-old female patient with medical history of mix connective tissue disease, who experienced the unexpected and serious events of axillary mass and pyrexia (required hospitalization). The first events of axillary mass and fever occurred on an unknown number of days after the second dose of Moderna COVID-19 vaccine was administered, the second event of axillary mass occurred the following day the third dose of vaccine was given and the second event of fever occurred on an unknown day after third dose was administered. The rechallenge was not applicable since there is no information regarding events (happening after second dose) outcome. Medical history of mix connective tissue disease remains as a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Translated document received on 01 Nov 2021 contains translated event terms, dosage text for concomitant medications and reporter''s comments.; Reporter''s Comments: Contact with healthcare professionals: Physician. The patient reported high fever approx. 39/40 degrees with hospitalization approx. 14 days after dose 2 of corona vaccine.; Sender''s Comments: This case concerns a 39-year-old female patient with medical history of mix connective tissue disease, who experienced the unexpected and serious events of axillary mass and pyrexia (required hospitalization). The first events of axillary mass and fever occurred on an unknown number of days after the second dose of Moderna COVID-19 vaccine was administered, the second event of axillary mass occurred the following day the third dose of vaccine was given and the second event of fever occurred on an unknown day after third dose was administered. The rechallenge was not applicable since there is no information regarding events (happening after second dose) outcome. Medical history of mix connective tissue disease remains as a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1845679 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-04
Onset:2021-10-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Balance disorder, Dizziness, Heart rate irregular, Muscle spasms, Nausea, Palpitations, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEGA 3 [FISH OIL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: Muscle cramps around the heart; Heart rate irregular; Heart palpitations; Poor balance; Sudden and prolonged dizziness; Extreme nausea; Fever; Fainting; This case was received via Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00056560) 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 (Fainting) in a 44-year-old female patient who received mRNA-1273 (Spikevax) for Vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included FISH OIL (OMEGA 3 [FISH OIL]) for an unknown indication. On 04-Oct-2021 at 9:15 AM, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Oct-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), BALANCE DISORDER (Poor balance), DIZZINESS (Sudden and prolonged dizziness), NAUSEA (Extreme nausea) and PYREXIA (Fever). On an unknown date, the patient experienced MUSCLE SPASMS (Muscle cramps around the heart), HEART RATE IRREGULAR (Heart rate irregular) and PALPITATIONS (Heart palpitations). At the time of the report, SYNCOPE (Fainting), BALANCE DISORDER (Poor balance), DIZZINESS (Sudden and prolonged dizziness) and NAUSEA (Extreme nausea) had resolved with sequelae, MUSCLE SPASMS (Muscle cramps around the heart), HEART RATE IRREGULAR (Heart rate irregular) and PALPITATIONS (Heart palpitations) outcome was unknown and PYREXIA (Fever) had not resolved. No treatment medication details was reported. Company comment -This case concerns a 44 year-old female patient with no reported medical history who experienced the unexpected serious event of syncope. The event occurred approximately 1 day after vaccination with Moderna COVID-19 vaccine. The rechallenge was not applicable as the dose sequence information was not provided. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. The case was changed from serious criteria (Disability Or Permanent Damage) to serious criteria Other Important Medical Events)) because the report does not fulfil the criteria Disability or Permanent damage at reporting time. Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Translation document received on 02-Nov-2021 and sender'' comment was updated.; Sender''s Comments: This case concerns a 44 year-old female patient with no reported medical history who experienced the unexpected serious event of syncope. The event occurred approximately 1 day after vaccination with Moderna COVID-19 vaccine. The rechallenge was not applicable as the dose sequence information was not provided. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1845689 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-05
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005885 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Electric shock sensation, Hyperhidrosis, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (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: BRINTELLIX
Current Illness: Bronchitis asthmatic; Tinnitus (Ringing in ears)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTMODERNATX, INC.MOD20213

Write-up: Feeling faint; Electric shock sensation; Upper limbs are trembling a lot; Heavy sweating; This case was received via regulatory authority (Reference number: PT-INFARMED-J202110-460) 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 DIZZINESS (Feeling faint), ELECTRIC SHOCK SENSATION (Electric shock sensation), TREMOR (Upper limbs are trembling a lot) and HYPERHIDROSIS (Heavy sweating) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3005885 and 3005885) for COVID-19 immunisation. The patient''s past medical history included Tinnitus (Ringing in ears) since an unknown date. Concurrent medical conditions included Bronchitis asthmatic. Concomitant products included VORTIOXETINE HYDROBROMIDE (BRINTELLIX) for an unknown indication. In 2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 04-Oct-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 05-Oct-2021, the patient experienced DIZZINESS (Feeling faint) (seriousness criterion disability), ELECTRIC SHOCK SENSATION (Electric shock sensation) (seriousness criterion disability), TREMOR (Upper limbs are trembling a lot) (seriousness criterion disability) and HYPERHIDROSIS (Heavy sweating) (seriousness criterion disability). At the time of the report, DIZZINESS (Feeling faint), ELECTRIC SHOCK SENSATION (Electric shock sensation), TREMOR (Upper limbs are trembling a lot) and HYPERHIDROSIS (Heavy sweating) outcome was unknown. No treatment details were reported. Brintellix 20 mg had no medication error occurred. Symptoms did not occur on the first dose. Patient had asthmatic bronchitis treatment for depression with the medication and had ringing in ears tendency to form thrombi in hands. Company Comment: This case concerns a 44-year-old male patient with a previous medical history of Vortioxetine hydrobromide (Brintellix) use for Depression, who experienced serious unexpected events of Dizziness, Electric shock sensation, Tremor, and Hyperhidrosis. The events occurred 1 day after the second dose of Moderna COVID-19 vaccine. The rechallenge information is not applicable as the events occurred after the second dose. The medical history of Vortioxetine hydrobromide (Brintellix) use for Depression is a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine 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: Translation document received on 01-Nov-2021 contains translated verbatim and reporter comment was updated.; Sender''s Comments: This case concerns a 44-year-old male patient with a previous medical history of Vortioxetine hydrobromide (Brintellix) use for Depression, who experienced serious unexpected events of Dizziness, Electric shock sensation, Tremor, and Hyperhidrosis. The events occurred 1 day after the second dose of Moderna COVID-19 vaccine. The rechallenge information is not applicable as the events occurred after the second dose. The medical history of Vortioxetine hydrobromide (Brintellix) use for Depression is a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1845755 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-30
Onset:2021-10-05
   Days after vaccination:5
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: Blood pressure measurement, Dizziness, Hypertension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202110; Test Name: Blood pressure; Result Unstructured Data: 198/105 .
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Syncope; Dizziness; High blood pressure; This regulatory authority case was reported by a pharmacist and describes the occurrence of SYNCOPE (Syncope), DIZZINESS (Dizziness) and HYPERTENSION (High blood pressure) in a 70-year-old female 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) 1 dosage form. On 05-Oct-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant) and HYPERTENSION (High blood pressure) (seriousness criterion medically significant). On 17-Oct-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant). The patient was treated with METOCLOPRAMIDE HYDROCHLORIDE (PROMERAN) for Adverse event, at a dose of 2 ml; NIFEDIPINE (ATANAAL) (oral) for Adverse event, at a dose of 5 mg and DIPHENIDOL [DIFENIDOL] for Adverse event, at a dose of 25 mg. At the time of the report, SYNCOPE (Syncope), DIZZINESS (Dizziness) and HYPERTENSION (High blood pressure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Blood pressure measurement: 198/105 (High) 198/105 .. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Additional treatment medications included were N/S 500 ml medication. Company Comment This case concerns a 70-year-old, female patient with no relevant medical history, who experienced the unexpected events of syncope, dizziness, hypertension. The events occurred approximately 5 days after the second dose of Moderna Covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna Covid -19 vaccine, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a permanent incapacity.; Sender''s Comments: This case concerns a 70-year-old, female patient with no relevant medical history, who experienced the unexpected events of syncope, dizziness, hypertension. The events occurred approximately 5 days after the second dose of Moderna Covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna Covid -19 vaccine, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a permanent incapacity.


VAERS ID: 1845868 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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 - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthritis, Interchange of vaccine products, Off label use, Swelling, Uveitis
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Ocular infections (broad), Arthritis (narrow), Medication errors (broad), Immune-mediated/autoimmune disorders (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: FLAREX; SALAZOPYRINE; PREDNISOLONE
Current Illness: Retinal vasculitis
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy NOS; Systemic necrotising vasculitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101429524

Write-up: Agitation of ongoing/ bilateral Uveitis; Severe swelling of neck over Thyroid region; Agitation of ongoing Reactive Arthritis; Note RA and Uveitis was post Astra Zeneca; Note RA and Uveitis was post Astra Zeneca; This is a spontaneous report from a contactable consumer (patient) received via COVAES. A 61-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 05Oct2021 12:00 (at the age of 61-year-old), as dose 2 (initial Pfizer dose), single, for COVID-19 immunisation in hospital. Medical history included systemic vasculitis, retinal vasculitis HLAB27 positive and allergy. Concomitant medications included fluorometholone acetate (FLAREX); sulfasalazine (SALAZOPYRINE) and prednisolone. Historical vaccine included COVID-19 VACCINE ASTRAZENECA via an unspecified route of administration, administered in Arm Right on 30May2021 08:00 (at the age of 61-year-old), as dose 1, single, for COVID-19 immunisation and experienced RA and uveitis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Oct2021, the patient had interchange of vaccine and had off-label use of vaccine. On 12Oct2021, the patient experienced severe swelling of neck over thyroid region. The patient had agitation of ongoing reactive arthritis and bilateral uveitis. The patient visited doctor or other healthcare professional office/clinic visit due to the events. The patent received treatment and was continued with medications. The outcome of the events was not recovered. The lot number for BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1847046 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-04
Onset:2021-10-05
   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 FD0350 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pityriasis rosea
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101443029

Write-up: Rose lichen Diagnosed by Dr. [privacy] on 06Oct2021; This is a spontaneous report from a contactable consumer via Regulatory Authority, the regulatory authority. Regulatory Authority report number CH-SM-2021-27306 A 15-year-old female patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number FD0350), via an unspecified route of administration, on 04Oct2021 (at the age of 15-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (COMIRNATY, solution for injection, lot number unknown), via an unspecified route of administration, on 08Sep2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 05Oct2021, after vaccine, the patient experienced Pityriasis rosea. The event was reported serious as medically significant. The diagnosis of Pityriasis rosea was done on 06Oct2021 by the physician. The patient had not recovered from the event. Due to the time relationship, causality is considered possible for all adverse drug reactions. The reported Pityriasis rosea reaction is not listed in the Regulatory Authority (not labeled). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1847142 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-03
Onset:2021-10-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (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: Delivery
Allergies:
Diagnostic Lab Data:
CDC Split Type: EEMODERNATX, INC.MOD20213

Write-up: Abortion spontaneous; This case was received via regulatory authority (Reference number: EE-SAM-545521100728) on 29-Oct-2021 and was forwarded to Moderna on 29-Oct-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Abortion spontaneous) in a 25-year-old female patient (gravida 1) who received mRNA-1273 (Spikevax) for Active immunization. The patient''s past medical history included Delivery on 21-Jan-2021. On 03-Oct-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. The patient''s last menstrual period was on 19-Aug-2021 and the estimated date of delivery was 26-May-2022. On 05-Oct-2021, after starting mRNA-1273 (Spikevax), the patient experienced ABORTION SPONTANEOUS (Abortion spontaneous) (seriousness criterion medically significant). The patient received mRNA-1273 (Spikevax) beginning around the seventh week of the pregnancy. The delivery occurred on 06-Oct-2021, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 06-Oct-2021, ABORTION SPONTANEOUS (Abortion spontaneous) had resolved. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. It was reported as possible coincidence, abortions occur regardless of vaccination. This is a regulatory pregnancy case concerning a 25-year-old female patient with no reported medical history, who experienced the serious unexpected event Abortion spontaneous. Patient received the first dose mRNA-1273 (Spikevax) at 6 weeks of gestation, and event occurred 3 days after. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Reporter''s Comments: Possible coincidence, abortions occur regardless of vaccination.; Sender''s Comments: This is a regulatory pregnancy case concerning a 25-year-old female patient with no reported medical history, who experienced the serious unexpected event Abortion spontaneous. Patient received the first dose mRNA-1273 (Spikevax) at 6 weeks of gestation, and event occurred 3 days after. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.


VAERS ID: 1847471 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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: Deep vein thrombosis, Immunisation, Off label use, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APIXABAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211019; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101429174

Write-up: DVT of legs; Off label use; Booster; This is a spontaneous report from a contactable Other Health Professional received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110221521454010-MZGSK, safety report unique identifier is GB-MHRA-ADR 26109916. An 82-year-old male patient received BNT162B2 (COMIRNATY) dose 3 via an unspecified route of administration on 05Oct2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization. The patient medical history was not reported. Referral for anticoagulation states previously well. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included apixaban from 13Oct2021 to an unspecified stop date. Referral states unprovoked, previously well. Historical Vaccine included the first dose and second dose of BNT162b2 for COVID-19 immunization. The patient experienced off label use on 05Oct2021, Booster on 05Oct2021, DVT of legs on 13Oct2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 19Oct2021. Outcome of the events off label use and booster was unknown; of the event was DVT of legs was recovering. The case was reported as serious with medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1847512 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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: Fatigue, Immunisation, Off label use, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis or other types of arthritis except osteoarthr...)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101428877

Write-up: Tiredness; off label use; Booster; 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-202110230108197250-GE1GD, Safety Report Unique Identifier GB-MHRA-ADR 26112874. A 60-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 05Oct2021 (at the age of 60 years old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included rheumatoid arthritis from an unknown date (Taking regular medicines for rheumatoid arthritis or other types of arthritis except osteoarthr...). Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient previously took benepali and methotrexate, both from unspecified date. The patient previously received the first dose and the second dose of BNT162b2, both on an unspecified date for COVID-19 immunisation. The patient experienced tiredness on 06Oct2021 with outcome of recovered on 08Oct2021. 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. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date (No - Negative COVID-19 test). No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1847586 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Joint range of motion decreased, Limb injury
SMQs:, Accidents and injuries (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101428907

Write-up: Shoulder injury; Limited range of motion; shoulder pain; 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-202110232033523770-ESCQG. Safety Report Unique Identifier is GB-MHRA-ADR 26114172. A 36-year-old male patient received BNT162B2 (COMIRNATY), dose 1 (at the age of 36-years-old) via an unspecified route of administration on 05Oct2021 (Lot Number: FF8222) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced shoulder pain in 2021, shoulder injury on 05Oct2021, Limited range of motion in 2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was Healthy as an ox. Patient had not had symptoms associated with COVID-19, and Not had a COVID-19 test. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). The outcome of the events shoulder pain; shoulder injury was not recovered. The outcome of other event was unknown. This report was considered serious due to medically significant. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1847694 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-05
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: Test Result:3458.8 AU/ML; Test Name: SARS-CoV-2 IgM antibody test; Result Unstructured Data: Test Result:5.34 S/CO; Test Name: Troponin; Result Unstructured Data: Test Result:137.1; Test Name: Troponin; Result Unstructured Data: Test Result:103.4; Test Name: Troponin; Result Unstructured Data: Test Result:173.6
CDC Split Type: GRPFIZER INC202101437139

Write-up: Myocarditis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number GR-GREOF-202108751. A 15-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Lot Number: FE8235) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 05Oct2021, the patient experienced myocarditis. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: 3458.8 au/ml on unknown date, sars-cov-2 antibody test: 5.34 s/co on unknown date, troponin: 137.1 on unknown date, troponin: 103.4 on unknown date, troponin: 173.6 on unknown date. Therapeutic measures were taken as a result of myocarditis (myocarditis). The outcome of event was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1847999 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-10-05
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7898 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chest pain, Dizziness, Dyspnoea, Electrocardiogram, Laboratory test, Pallor, SARS-CoV-2 test, X-ray
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), 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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20211005; Test Name: ECG; Result Unstructured Data: Test Result:abnormal; Test Date: 202110; Test Name: ECG; Result Unstructured Data: Test Result:did not improve; Test Date: 202110; Test Name: Tests; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20211005; Test Name: covid test; Test Result: Negative ; Comments: Nasal Swab; Test Date: 202110; Test Name: X-rays; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: SEPFIZER INC202101428753

Write-up: Back pain; Chest pain; Shortness of breath; Dizziness; Pale; This is a spontaneous report from a contactable consumer (patient). A 16-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in the left arm on 09Sep2021 at 15:45 (Lot Number: FG7898) as dose 1, single for COVID-19 immunization. The patient had no known allergies, no relevant medical history and no concomitant medications. The patient had not received any other vaccine within 4 weeks. The patient had not been diagnosed with COVID-19 prior to vaccination. The patient experienced back pain, chest pain, shortness of breath, dizziness and was pale on 05Oct2021. The events required a visit to the emergency room. The patient was hospitalized at the emergency department for 1 day from 05Oct2021 to an unknown date in Oct2021. ECG (electrocardiogram) was abnormal and covid test (nasal swab) was negative both on 05Oct2021. The ECG did not improve but tests (unspecified) and X-ray showed no abnormalities on Oct2021. It was unknown whether the patient had received any treatment or not. The outcome of the events was not recovered. The patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: fj8372), via an unspecified route of administration, administered in left arm on 11Oct2021 at 15:45 for COVID-19 immunization.


VAERS ID: 1848002 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-10-05
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4721 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Dyspnoea, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hormonal contraception
Allergies:
Diagnostic Lab Data: Test Date: 20211005; Test Name: body temperature; Result Unstructured Data: Test Result:increased
CDC Split Type: SIPFIZER INC202101440860

Write-up: Dyspnea, increased body temperature, pulmonary embolism.; Dyspnea, increased body temperature, pulmonary embolism.; Dyspnea, increased body temperature, pulmonary embolism.; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB. Regulatory Authority number is SI-JAZMP-NCPHV-2021SI0961_0961 and Safety Report Unique Identifier JAZMP-300016609. An 18-year-old female patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: FE4721), via intramuscular, on 01Sep2021 at single dose for COVID-19 immunisation. Historical vaccine includes the first dose COVID-19 vaccine (Manufacturer unknown) administered on unknown date for COVID-19 immunisation. Relevant medical history included hormonal contraception. No relevant concomitant medications were provided. On 05Oct2021, the patient had pulmonary embolism (PE), serious because requiring hospitalization. The clinical course was reported as follows: pulmonary embolism without increased work load of right heart. The patient presented with dyspnea and body temperature increased. The patient was recovering from the events. The reporting physician commented as follows: risk factor for PE is also hormonal contraception. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1848029 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, C-reactive protein, Decreased appetite, Dizziness, Muscular weakness, Platelet count, Platelet count decreased, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Drug allergy (Chlorzoxazone. Suspected [skin (local)- itchy.]); Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Colon cancer; Colon operation NOS (colon cancer s/p)
Allergies:
Diagnostic Lab Data: Test Date: 20211007; Test Name: Blood pressure; Result Unstructured Data: 171/92 mmHg; Test Date: 20211007; Test Name: Body temperature; Result Unstructured Data: 39.4? / 108/20; Test Date: 20211007; Test Name: CRP; Result Unstructured Data: 214.9 mg/L; Test Date: 20211007; Test Name: Platelet count; Result Unstructured Data: 85 10 cubic per uL
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: platelet count low; Loss of appetite; Dizziness; Vomiting; Weakness of limbs; Fever; This regulatory authority case was reported by a pharmacist and describes the occurrence of DECREASED APPETITE (Loss of appetite), MUSCULAR WEAKNESS (Weakness of limbs), PYREXIA (Fever), DIZZINESS (Dizziness), VOMITING (Vomiting) and PLATELET COUNT DECREASED (platelet count low) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Colon cancer and Colon operation NOS (colon cancer s/p). Concurrent medical conditions included Hypertension, Diabetes mellitus and Drug allergy (Chlorzoxazone. Suspected [skin (local)- itchy.]). On 05-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced DECREASED APPETITE (Loss of appetite) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization prolonged), DIZZINESS (Dizziness) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). On 07-Oct-2021, the patient experienced MUSCULAR WEAKNESS (Weakness of limbs) (seriousness criterion hospitalization prolonged) and PLATELET COUNT DECREASED (platelet count low) (seriousness criterion hospitalization). The patient was hospitalized on 07-Oct-2021 due to DECREASED APPETITE, DIZZINESS, MUSCULAR WEAKNESS and VOMITING. At the time of the report, DECREASED APPETITE (Loss of appetite), MUSCULAR WEAKNESS (Weakness of limbs), PYREXIA (Fever) and PLATELET COUNT DECREASED (platelet count low) outcome was unknown and DIZZINESS (Dizziness) and VOMITING (Vomiting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2021, Blood pressure measurement: 171/92 (High) 171/92 mmHg. On 07-Oct-2021, Body temperature: 39.4 (High) 39.4? / 108/20. On 07-Oct-2021, C-reactive protein: 214.9 (High) 214.9 mg/L. On 07-Oct-2021, Platelet count: 85 (Low) 85 10 cubic per uL. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporter. No treatment medications provided by the reporter. This case concerns a 75 year old male with relevant medical history of Hypertension and Diabetes mellitus, who experienced Serious unexpected events of Loss of appetite , Dizziness and expected events of fever and vomiting on the same day after vaccination with the 2nd dose of Moderna Covid 19 Vaccine. Two days after the vaccination with the 2nd dose , he experienced serious unexpected event of muscular weakness. The re-challenge for this case is not applicable. The benefit-risk relationship of Moderna Covid 19 Vaccine is not affected by this report. Per medical reviewer''s assessment event of platelet count , low should be coded for this case although this is RA case.; Sender''s Comments: This case concerns a 75 year old male with relevant medical history of Hypertension and Diabetes mellitus, who experienced Serious unexpected events of Loss of appetite , Dizziness and expected events of fever and vomiting on the same day after vaccination with the 2nd dose of Moderna Covid 19 Vaccine. Two days after the vaccination with the 2nd dose , he experienced serious unexpected event of muscular weakness. The re-challenge for this case is not applicable. The benefit-risk relationship of Moderna Covid 19 Vaccine is not affected by this report. Per medical reviewer''s assessment event of platelet count , low should be coded for this case although this is RA case.


VAERS ID: 1849940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-05
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Adverse event, Dizziness, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: KRJNJFOC20211112997

Write-up: DIZZINESS; OTHER EVENT; VOMITING; HEADACHE; This spontaneous report received from a health care professional via a Regulatory Authority concerned a 6 decade old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 207A21A expiry: 21-SEP-2021) dose was not reported, 1 total administered on 06-SEP-2021 in deltoid for an unspecified indication. No concomitant medications were reported. On 05-OCT-2021, the patient experienced dizziness, other events, vomiting and headache. The patient was hospitalized (date unspecified) and received inpatient treatment. The number of days of hospitalization and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, dizziness, headache and insert other was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20211112997-JANSSEN COVID-19 VACCINE Ad26.COV2.S -dizziness,other event -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211112997-JANSSEN COVID-19 VACCINE Ad26.COV2.S- vomiting, headache- This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1849948 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006273 / 2 - / 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: Myopericarditis; This case was received via the Regulatory Agency (Reference number: SE-MPA-2021-090444) on 29-Oct-2021 and was forwarded to Moderna on 29-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myopericarditis) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3006273) for COVID-19 vaccination. No Medical History information was reported. On 05-Oct-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Oct-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (Myopericarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myopericarditis) was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter considered MYOCARDITIS (Myopericarditis) to be possibly related. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment : This case concerns a 24-year-old, male patient with no relevant medical history, who experienced the expected AESI of myocarditis. The event occurred on the same day after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The patient''s gender remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Translation received on 02-NOV-2021, verbatim translated.; Sender''s Comments: This case concerns a 24-year-old, male patient with no relevant medical history, who experienced the expected AESI of myocarditis. The event occurred on the same day after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The patient''s gender remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1852731 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-10-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Herpes zoster, Neurological examination
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211006; Test Name: Brain CT; Result Unstructured Data: Test Result:otic herpes Zoster; Test Date: 20211006; Test Name: neurologic consultation; Result Unstructured Data: Test Result:otic herpes Zoster
CDC Split Type: ITPFIZER INC202101437567

Write-up: Shingles; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority , regulatory authority number IT-MINISAL02-800019. A 44-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Deltoid Left on 27Sep2021 (Lot Number: FG3739) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation . The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced shingles on 05Oct2021 with outcome of not recovered. Impact on quality of life (10/10). Admission to Accident and Emergency Department on 06Oct2021 for buccal rim deviation and right ear swelling, with crusted and exudate lesions. Brain computed tomography scan and neurologic consultation performed. Otolaryngologist confirms diagnosis of otic herpes Zoster and referred antiviral therapy. At the check-up of 18Oct2021 complete disappearance of skin lesions, complete right side facial paralysis remains. Scheduled angiography Magnetic Resonance Imaging in 10 days and neurological examination. Seriousness criteria reported as hospitalization. No follow-up attempts are possible. No further information expected.


VAERS ID: 1852799 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-04
Onset:2021-10-05
   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 - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Glossodynia, Hemianaesthesia, Hypoaesthesia oral, Neurological examination, Pain, Pharyngeal hypoaesthesia
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DIBASE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211018; Test Name: Neurological examination; Result Unstructured Data: Test Result:unknown results; Comments: with a request for a Magnetic Resonance Imaging scan
CDC Split Type: ITPFIZER INC202101438084

Write-up: Numbness throat; numbness of the tongue; Hemifacial anaesthesia; intense agitation; discomfort in their tongue tip; stabbing pain; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority.-WEB, regulatory authority number IT-MINISAL02-801185. A 47-years-old female patient received the first dose of bnt162b2 (COMIRNATY) intramuscular on 04Oct2021 18:15 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included colecalciferol (DIBASE, Oral drops, strength: 10.000 IU/ml). The patient experienced numbness throat (hospitalization) on 05Oct2021, numbness of the tongue (hospitalization) on 05Oct2021, hemifacial anaesthesia (hospitalization) on 05Oct2021, discomfort in their tongue tip on 20Oct2021, stabbing pain on 20Oct2021, agitation on an unspecified date. The patient was very anxious and not convinced of wanting the vaccine, which was administered for work-related reasons. The day after the administration of the vaccine, she complained of numbness of the tongue and throat but reported that it was only a sensation that she perceived but that was not visually evident. Following the recommendation of her attending physician, she went to the emergency room where she was given a vial of Artrosilene and a sedative due to her state of intense agitation. Then, she was sent home. 18Oct2021: Neurological examination with a request for a Magnetic Resonance Imaging scan. The patient reported having discomfort in their tongue tip and stabbing pain on 20Oct2021, for which reason they took Kestine Lio 10 mg following the recommendation of her general practitioner. Actions taken (the patient was sent to the emergency room, where she was administered a vial of Artrosilene and a sedative due to her state of intense agitation). All events received treatment and resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included neurological examination: unknown results with a request for a Magnetic Resonance Imaging scan on 18Oct2021. Outcome of the events numbness throat, numbness of the tongue, hemifacial anaesthesia was recovered on 05Oct2021; of the events discomfort in their tongue tip, stabbing pain, agitation was unknown. Reporter comment: The patient is a customer of the Pharmacy and could not send the report herself, so she turned to us. Sender comment: no data regarding the batch and expiration date are currently available. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: The patient is a customer of the Pharmacy and could not send the report herself, so she turned to us.


VAERS ID: 1852831 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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 1F1006A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Fibrin D dimer, Specialist consultation, Syncope, Underdose
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: chest angiotac; Test Result: Negative ; Comments: Negative chest angiotac was performed; Test Name: d dimer; Result Unstructured Data: Test Result:665 ng/ml; Test Name: neurological investigation; Result Unstructured Data: Test Result:comment below; Comments: Investigations for neurological damage are underway.
CDC Split Type: ITPFIZER INC202101491974

Write-up: Two syncopal episodes without prodromes; underdose; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority WEB, regulatory authority number IT-MINISAL02-803545. A 49-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: 1F1006A), via intramuscular on 05Oct2021 as DOSE NUMBER UNKNOWN, 0.5 ug SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 05Oct2021, the patient had underdose with COMIRNATY. The patient experienced two syncopal episodes without prodromes (syncope) on 20Oct2021. The patient underwent lab tests and procedures which included angiogram which results negative, Negative chest angiotac was performed, fibrin d dimer: 665 ng/ml, specialist consultation: Investigations for neurological damage are underway on an unknown date. At the time of reporting, the outcome of events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1852844 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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 FF2782 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Arterial thrombosis, Body temperature, Feeling abnormal, Investigation, Metamorphopsia, Vision blurred, Visual field defect, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211005; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 2021; Test Name: various tests; Result Unstructured Data: Test Result:No abnormal findings were made; Comments: No abnormal findings were made
CDC Split Type: JPPFIZER INC202101334917

Write-up: transient arterial thrombosis; Visual impairment/hard to see; Narrow field; it felt distorted; It was a little hard to focus; a little peculiar when the patient was driving/feeling strange; the patient could not shake off his anxiety about receiving vaccination of the 2nd dose; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 25Oct2021, this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report received from a contactable physician via medical information team. Information also received by the same physician via Regulatory Authority (Regulatory authority report number is v21129084). A 55-year-old male patient received first dose bnt162b2 (COMIRNATY), intramuscular on 05Oct2021 10:00 (Lot Number: FF2782; Expiration Date: 28Feb2022) as single dose (at age of 55-year-old) for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. On 05Oct2021 21:00 patient experienced transient arterial thrombosis, visual impairment/hard to see, narrow field, it felt distorted, it was a little hard to focus, a little peculiar when the patient was driving/feeling strange, the patient could not shake off his anxiety about receiving vaccination of the 2nd dose. Events resulted in physician office visit. The clinical course was reported as follows: The patient was a 55-year and 10-month-old male. Body temperature before vaccination was 36.4 degrees Centigrade. 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, etc.). On 05Oct2021 at 10:00 (the day of the vaccination), the patient received the first dose of bnt162b2 (COMIRNATY intramuscular injection, Lot number: FF2782, Expiration date 28Feb2022) by intramuscular. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient received any other medications within 2 weeks of vaccination. It was unknown if the patient had Relevant medical history. It was unknown if patient received relevant tests. On 05Oct2021 at 21:00 (also reported as 10:00) (the same day of the vaccination), the patient experienced Visual impairment. The course of the event was as follows: Visual impairment occurred at night on the day of the vaccination. Narrow field were also observed (as per the patient''s report). It was reported that the patient had feeling strange although the patient could get back to the normal life after then. The outcome of the event was not reported. The patient called that night that started to have Visual impairment. It was hard to see, it felt distorted. It was a little hard to focus. Today in the morning, patient wife called and said that the patient seemed to have recovered, but there was a little peculiar when the patient was driving. The visual impairment had disappeared by the following day, however, since the patient could not shake off his anxiety about receiving vaccination of the 2nd dose, he visited the department of Ophthalmology of PRIVACY Hospital. No abnormal findings were made on various tests performed in 2021. But it has been reported that a conclusion was that transient arterial thrombosis could not completely be ruled out. It was decided to leave it up to him whether to receive the 2nd dose of the vaccine. Patient recovered on unknown date from the events. The reporting physician classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Causal relationship with the vaccination is unknown although the symptom occurred on the day of the vaccination. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1852853 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-10-05
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2018 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood smear test, Blood test, Chest X-ray, Chest pain, Computerised tomogram, Deep vein thrombosis, Fibrin D dimer, Fibrin D dimer increased, Haematocrit, Haemoglobin, Platelet count, Pulmonary embolism, Red blood cell count, SARS-CoV-2 test, Thrombosis with thrombocytopenia syndrome, Ultrasound scan, White blood cell count
SMQs:, Haemorrhage laboratory terms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (narrow), 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? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antiphospholipid syndrome; Antithrombin III deficiency; Disseminated intravascular coagulation; Malignant tumour; Obesity (BMI: 25.1); Protein C deficiency; Protein S deficiency; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: aggregation findings of smear; Result Unstructured Data: Test Result:no aggregation findings of smear; Test Date: 20211015; Test Name: Blood test; Result Unstructured Data: Test Result:D-dimer increased; Test Date: 20211015; Test Name: Chest radiography; Result Unstructured Data: Test Result:no findings of thrombus/thrombosis; Test Date: 20211015; Test Name: Contrast-enhanced CT; Result Unstructured Data: Test Result:Pulmonary embolism was diagnosed; Comments: Photographing site(s): chest and Abdomen, the detailed site(s) and findings: As per the attachment; Test Date: 20211015; Test Name: D-dimer; Result Unstructured Data: Test Result:8.71?g/mL; Test Date: 20211015; Test Name: Hematocrit; Test Result: 44.9 %; Test Date: 20211015; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.8 g/dl; Test Date: 20211015; Test Name: Platelet count; Result Unstructured Data: Test Result:23.3; Comments: Lowest value or highest value during the course: 29.6; Test Date: 20211015; Test Name: Red blood cell count; Result Unstructured Data: Test Result:523; Test Date: 20211013; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Negative; Comments: Nucleic acid amplification test (PCR / LAMP); Test Date: 20211016; Test Name: Ultrasonography; Result Unstructured Data: Test Result:findings of thrombus/thrombosis; Comments: Photographing site(s): heart and Lower limb, the detailed site(s) and findings: As per the attachment; Test Date: 20211015; Test Name: White blood cell count; Result Unstructured Data: Test Result:7890/?L
CDC Split Type: JPPFIZER INC202101441033

Write-up: chest pain; Pulmonary embolism; Thrombosis with Thrombocytopenia Syndrome; Deep vein thrombosis; D-dimer increased; This is a spontaneous report from a contactable physician (hospitalization physician) received from the Regulatory authority report number is v21129855. A 40-year and 2-month-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection; Batch/Lot Number: FF2018; Expiration Date: 31Dec2021), via an unspecified route of administration on 25Sep2021 (the day of vaccination, at the age of as 40-year and 2-month-old) as dose 2, single for covid-19 immunisation. Medical history included Disseminated intravascular coagulation syndrome, Antiphospholipid syndrome, Malignant tumour, Antithrombin III deficiency, Protein C deficiency, Protein S deficiency, Smoking, Obesity (BMI: 25.1) from an unknown date and unknown if ongoing. No history of COVID-19; no Heparin administration history, Factor(s) that become(s) the risk of thrombus: Smoking, Obesity (BMI: 25.1). The patient had no family history. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FF9942, expiration date: 30Nov2021) via an unspecified route of administration on 04Sep2021 as dose 1, single for COVID-19 immunization. On 05Oct2021 (10 days after the vaccination), the patient experienced Thrombosis with Thrombocytopenia Syndrome. The course of the event was as follows: On 13Oct2021, chest pain. Blood test on 15Oct2021 revealed D-dimer increased. Based on the result of Contrast-enhanced CT, Pulmonary embolism was diagnosed. The reporting physician (hospitalization physician) commented as follows: it was presumed to be Thrombosis after vaccination. A close examination on the cause of the thrombus was performed, but no abnormalities were found. Thrombosis (including thromboembolism) (with thrombocytopenia only) (TTS) Investigation form included clinical symptom(s)/finding(s): chest pain, onset date: 13Oct2021. Test findings: 1st test date: 15Oct2021, blood count: no aggregation findings of smear, White blood cell count: 7890/?L, Red blood cell count: 523?104/?L, Hemoglobin: 14.8g/dL, Hematocrit: 44.9 percent, Platelet count: 23.3?104/?L (Lowest value or highest value during the course: 29.6?104/?L), Platelet count under usual condition: unknown; Coagulation system test: D-dimer: 8.71?g/mL; Anti-platelet 4th factor antibody (Anti-4 antibody): Not performed; Anti-HIT antibody (Anti-PF4-heparin complex antibody): Not performed; SARS-CoV-2 test: Test date: 13Oct2021, Negative and Nucleic acid amplification test (PCR / LAMP). Imaging examination: Ultrasonography: performed on 16Oct2021, Photographing site(s): heart and Lower limb, there were findings of thrombus/thrombosis, the detailed site(s) and findings: As per the attachment; Computed tomography: performed on 15Oct2021, Imaging: Yes, Photographing site(s): chest and Abdomen, the detailed site(s) and findings: As per the attachment; MRI scan: Not performed; Angiography: Not performed; Lung ventilation-perfusion scintigraphy: Not performed; Chest radiography: performed on 15Oct2021, no findings of thrombus/thrombosis. Surgical treatment/pathological examination: Surgical treatment: Not performed; Pathological examination: Not performed. Others: Diagnosed disease name: Pulmonary thromboembolism and Deep vein thrombosis. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Oct2021 Nucleic acid amplification test (PCR / LAMP), blood smear test: no aggregation findings of smear on 15Oct2021, blood test: d-dimer increased on 15Oct2021, chest x-ray: no findings of thrombus/thrombosis on 15Oct2021, computerised tomogram: pulmonary embolism was diagnosed on 15Oct2021, Photographing site: chest and Abdomen, the detailed site and findings: As per the attachment , fibrin d dimer: 8.71?g/ml on 15Oct2021, haematocrit: 44.9 percent on 15Oct2021, haemoglobin: 14.8 g/dl on 15Oct2021, platelet count: 23.3 on 15Oct2021 Lowest value or highest value during the course: 29.6 , red blood cell count: 523 on 15Oct2021, ultrasound scan: findings of thrombus/thrombosis on 16Oct2021 Photographing site: heart and Lower limb, the detailed site and findings: As per the attachment, white blood cell count: 7890/?l on 15Oct2021. On 22Oct2021 (1 month after the vaccination), the outcome of the event was recovering. The reporting physician (hospitalization physician) classified the event as serious (hospitalization from 15Oct2021 to 22Oct2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. Follow up attempts are completed. Further information is not expected.


VAERS ID: 1855131 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-05
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: Deep vein thrombosis, Dizziness, Hypotension, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Vestibular disorders (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101451403

Write-up: Deep vein thrombosis; Pulmonary embolism; Dizziness; Hypotension; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 645707. A 39-years-old male patient received bnt162b2 (COMIRNATY solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 05Oct2021 the patient experienced deep vein thrombosis, pulmonary embolism, dizziness, hypotension. The outcome of events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1855135 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-05
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: Demyelination, Dizziness, Hypoaesthesia, Nausea, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Demyelination (narrow), Vestibular disorders (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (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 INC202101451414

Write-up: Demyelination; Dizziness; Hypoaesthesia; Nausea; Paraesthesia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 645793. A 32-year-old female patient received BNT162B2 (COMIRNATY, solution for injection; Batch/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 medical history and concomitant medications were not reported. The patient experienced demyelination, dizziness, hypoaesthesia, nausea, paraesthesia on 05Oct2021. The clinical outcome of the events was recovered on unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.


VAERS ID: 1855152 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-10-05
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: Chest pain, Dizziness, Dysgeusia, Dyspnoea, Nausea, Suicidal ideation
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Suicide/self-injury (narrow), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101452433

Write-up: Suicidal ideation; Chest pain; Dizziness; Dysgeusia; Dyspnoea; Nausea; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 646472. A 42-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 05Oct2021, patient experienced suicidal ideation, chest pain, dizziness, dysgeusia dyspnoea, and nausea. Seriousness of the event suicidal ideation was medically significant and other events was non-serious. The outcome of all 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: 1855222 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthritis reactive, Inappropriate schedule of product administration, Swelling, Uveitis
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Arthritis (narrow), Medication errors (narrow), 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 INC202101458381

Write-up: Arthritis reactive; Uveitis; Swelling; dose 2 should be 05Oct2021 and for dose 1 should be 27May2021; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 649188. A 61-year-old female patient received the first dose of BNT162B2 (COMIRNATY) on 27May2021 (lot number: unknown) via unknown route of administration at single dose; the second dose of BNT162B2 (COMIRNATY) on 05Oct2021 (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 11Oct2021, patient experienced Arthritis reactive; Swelling; Uveitis. The outcome of the events Arthritis reactive; Swelling; Uveitis was not recovered. The outcome of other event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1855415 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-10-05
   Days after vaccination:245
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EUTHYROX; LORISTA
Current Illness: Allergy multiple (oxymykoin, patches, cold); Eczema atopic (of the eye-lids); Hypertension arterial; Hypothyreosis; Spinal haemangioma (in the vertebral bodies L2-5,); Uterine fibroids; Vertebrogenic pain syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Cervical conization; Hormonal contraception; Menstruation normal; Non-smoker; Thyroid disorder
Allergies:
Diagnostic Lab Data: Test Date: 20211008; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: CZPFIZER INC202101474379

Write-up: Drug ineffective; COVID-19; Subfebrile; Loss of smell; Cough; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, Regulatory authority number CZ-CZSUKL-21011237. A 57-year-old female patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EK9788) via intramuscular on 02Feb2021 as dose 2, single and first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown) via intramuscular on 21Jan2021 as dose 1, single for COVID-19 immunization. Medical history included ongoing Eczema atopic of the eyelids, ongoing multiple allergies to oxymykoin, patches, cold, ongoing Hypothyreosis, ongoing Hypertension arterial, ongoing Vertebrogenic pain syndrome, ongoing Spinal haemangioma in the vertebral bodies L2-5, ongoing Uterine fibroids, Cervical conization not ongoing, non-smoker, thyroidopathy, hormonal contraception, regular menstruation hormonal contraception; all from an unknown date. Concomitant medication included levothyroxine sodium (EUTHYROX), losartan potassium (LORISTA) taken both for an unspecified indication, start and stop date were not reported. On 05Oct2021, after receiving both doses of vaccine the patient experienced covid-19, subfebrile, loss of smell and cough. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Oct2021. The outcome of the event subfebrile was resolved on unspecified date in 2021 and other events was resolving. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Sender''s Comments: Linked Report(s) : CZ-PFIZER INC-202101510086 same patient, different dose


VAERS ID: 1855799 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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 FG3716 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Angiogram, Asthenia, Blood pressure measurement, Blood test, Chest discomfort, Chest pain, Cough, Dizziness, Dyspnoea, Fibrin D dimer increased, Headache, Hypertension, Hyperthermia, Immunisation reaction, Musculoskeletal stiffness, Oxygen saturation, Oxygen saturation decreased, Pulse pressure increased, Tachycardia, Trismus, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drepanocytosis; Sickle-cell anaemia
Allergies:
Diagnostic Lab Data: Test Name: Computed tomography angiography; Result Unstructured Data: Test Result:negative; Test Name: Blood pressure; Result Unstructured Data: Test Result:150/110; Comments: No units provided; Test Name: Blood test; Result Unstructured Data: Test Result:increased D-dimers; Test Name: oxygen saturation; Test Result: 91 %; Test Name: pulse; Result Unstructured Data: Test Result:120/minute
CDC Split Type: FRPFIZER INC202101436985

Write-up: dizziness; cough; increased d-dimers,; stiff neck; vomiting; feeling of tightness; epigastric pain radiating to the back; desaturation (91%); lockjaw; tachycardia 120/minute; Asthenia; Stethalgia; Dyspnea; Hypertension arterial; Reactogenicity event; Hyperthermia; Intense headache; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BX20219713. Case Summary: This non-serious case, of the Spontaneous Notification type, received by the Ministry Portal - SAS, was notified by a patient (medical confirmation not provided). A 42-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 05Oct2021 (Batch/Lot Number: FG3716) as DOSE 2,SINGLE for covid-19 immunisation. Medical history included heterozygous for sickle cell anemia from an unknown date and unknown if ongoing, sickle cell anaemia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced stethalgia, dyspnea, hypertension arterial and reactogenicity event on 05Oct2021, hyperthermia for 3 days, intense headache for 2 days, stiff neck, vomiting, feeling of tightness, epigastric pain radiating to the back, desaturation (91%), lockjaw, tachycardia 120/minute, asthenia, dizziness and cough on an unspecified date. Clinical summary: Impossibility to go to work (loss of 5 days of work, freelance work). The patient underwent lab tests and procedures which included angiogram: negative, blood pressure measurement: 150/110 No units provided, 15/11 (as reported), blood test: increased d-dimers, oxygen saturation: 91 %, pulse pressure increased: 120/minute and Computed tomography angiography negative. The outcome of stethalgia, dyspnea, hypertension arterial and reactogenicity event was recovering and unknown for hyperthermia, intense headache, stiff neck, vomiting, feeling of tightness, epigastric pain radiating to the back, desaturation (91%), lockjaw, tachycardia 120/minute, asthenia, dizziness and cough. NOTE: A medicine is coded in terms of substance if the brand name is not known. Accountability without prejudice to the elements of investigations that could be carried out as part of legal or amicable compensation procedures. No follow-up attempts are possible. No further information expected.


VAERS ID: 1855952 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-10-05
   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 FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Hypoaesthesia, Immunisation, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:Unknown Results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101450120

Write-up: Numbness/bilateral numbness pain in both feet and ankles. This has also radiated up outside of calves; Numbness/bilateral numbness pain in both feet and ankles. This has also radiated up outside of calves; Off label use; Booster; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110251140030020-RXHN8, safety report unique identifier is GB-MHRA-ADR 26116895. A 60-year-old male patient received third dose of BNT162B2 (COMIRNATY; batch/lot number: fj5782l; expiration date not provided) via an unspecified route of administration on 05Oct2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Patient''s medical history was not reported. It was reported that patient was fit and healthy - no pre-existing condition. Run 30 miles a week and swim 4 miles a week. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medications were not reported. Historical vaccine included dose 1 and dose of BNT162B2 for COVID-19 immunisation. The patient experienced ''Numbness/bilateral numbness pain in both feet and ankles. This has also radiated up outside of calves'' on 07Oct2021; off label use and booster on 05Oct2021. Patient''s clinical course was as follows: Patient reported that since that date, he have had bilateral numbness pain in both feet and ankles. This has also radiated up outside of calves. Only alleviated by cold water swimming. Patient added that he is a fit athlete and this is highly unusual. Symptoms remain now 3 weeks later and unabated. Causing pain at night. The events ''Numbness/bilateral numbness pain in both feet and ankles. This has also radiated up outside of calves'' was assessed as serious (medically significant), the remaining events was assessed as non-serious. The patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included blood tests with unknown results and COVID-19 virus test with result of ''negative; No - Negative COVID-19 test'' on unspecified dates. Outcome of the events ''Numbness/bilateral numbness pain in both feet and ankles. This has also radiated up outside of calves'' was not recovered; outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1757645 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-09-13
Onset:2021-10-04
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017E21A / 1 LA / SYR

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

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

Write-up: No issue until 3 weeks later. Sudden pain in chest. Hurts if any pressure is applied. Worse when lay down or take deep breaths. Seems to be worse right behind sternum.


VAERS ID: 1757880 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-10-03
Onset:2021-10-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 019F21A / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Cold sweat, Dizziness, Dysstasia, Feeling cold, Headache, Pain
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Arthritis (broad), Hypoglycaemia (broad)

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

Write-up: 1:00am headache body and joint pain dizziness cold and clammy temperature 100.2 weakness unable to stand.


VAERS ID: 1757919 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-10-03
Onset:2021-10-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Feeling hot, Hot flush, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: Cymbalta 30mg qd Atenolol 25 mg qd
Current Illness: Fibromalgya
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shortness of breath, hot flashes, feeling hot from the inside, having to breath fast, tired, sleepy


VAERS ID: 1758573 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-03-11
Onset:2021-10-04
   Days after vaccination:207
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031A21A / 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: Aspirin, Lisinopril, Multivitamin, Keppra
Current Illness: N/A
Preexisting Conditions: Seizures
Allergies: NKA
Diagnostic Lab Data: Positive COVID-19 RT-PCR Test
CDC Split Type:

Write-up: Positive COVID-19 when fully vaccinated


VAERS ID: 1758575 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event
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: Migraine Hearing loss hip pain bilateral knee pain hypertension GERD Sleep apnea Fibromyalgia neuropathy
Allergies: Shellfish, peanuts
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Pt had received two Moderna vaccines and I gave the pt Pfizer vaccine as a booster. Pt did not have any adverse events at the time.


VAERS ID: 1758578 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: New York  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness:
Preexisting Conditions: n/a
Allergies: seasonal allergies
Diagnostic Lab Data: 11:11am: hr:78, r 17, bp 120/80/ sat 99%.
CDC Split Type:

Write-up: Within ten minutes of receiving first dose of pfizer patient reported itchiness of both arms and spread to neck.


VAERS ID: 1758613 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301458A / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Device connection issue, Syringe issue, Underdose
SMQs:, Medication errors (broad)

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

Write-up: Needle was not properly connected to syringe, which resulted in some leakage from the injection site. More than half was administered to the patient.


VAERS ID: 1758617 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822809 / 1 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Moderna
Other Medications: UNKNOWN
Current Illness: UNKNOWN
Preexisting Conditions: UNKNOWN
Allergies: UNKNOWN
Diagnostic Lab Data: No
CDC Split Type:

Write-up: The patient got the Moderna vaccine on 9/11/2021. She got J&J vaccine today from our office. She did not report she got the Moderna before got the J&J. We found it from system. Per the patient, she had adverse reactions from the Moderna and she did not want to get the Moderna 2nd dose. However, her workplace required COVID 19 vaccine. That''s why she got J&J today per patient.


VAERS ID: 1758627 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30145BA / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Incorrect dose 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: empagliflozin (JARDIANCE) 10 MG tablet Take 1 tablet by mouth daily (before breakfast). nitrofurantoin, macrocrystal-monohydrate, (MACROBID) 100 MG capsule Take 1 capsule by mouth 2 times daily for 10 days. AMIODarone (PACERONE) 200 MG tabl
Current Illness: none
Preexisting Conditions: Coronary atherosclerosis of unspecified type of vessel, native or graft Essential hypertension, benign Hyperlipidemia Status post abdominal aortic aneurysm repair PVD (peripheral vascular disease) (CMS/HCC) Atrial fibrillation with RVR (CMS/HCC) Wide-complex tachycardia (CMS/HCC) Endocrine and Metabolic Type II or unspecified type diabetes mellitus without mention of complication, not stated as uncontrolled Eye Exophthalmos Myopia Old retinal detachment, partial Presbyopia Genitourinary and Reproductive Elevated PSA Impotence of organic origin
Allergies: nka
Diagnostic Lab Data: none
CDC Split Type:

Write-up: patient recieved 1.3ml pfizer vaccine instead of the 0.3ml thus far patient has not had any adverse reaction to the increased dose given


VAERS ID: 1758633 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: California  
Vaccinated:2021-02-26
Onset:2021-10-04
   Days after vaccination:220
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / IM

Administered by: Public       Purchased by: ?
Symptoms: Blindness, Imaging procedure, Retinal artery occlusion
SMQs:, Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol
Current Illness: Asthma Centronuclear Myopathy
Preexisting Conditions: Asthma Centronuclear myopathy
Allergies: NKDA
Diagnostic Lab Data: Ophthalmology Consultations, Imaging
CDC Split Type:

Write-up: Acute eye stroke - loss of vision


VAERS ID: 1758649 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Cough, Ear discomfort, Mouth swelling, Pharyngeal swelling, Throat clearing, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levonorgestrel Ulipristal Ibuprofen Cyclobenzaprine
Current Illness: none indicated by pt
Preexisting Conditions: endometriosis scoliosis
Allergies: Ceftriaxone Dilaudid Naproxen Shell fish per pt
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Pt reported that "within 5 seconds" of receiving her 1st Pfizer (30155BA) vaccine she developed "itching to my throat" but denied any swelling to her mouth or throat. Pt ambulated with very steady gait to monitoring area and continued to speak full and clear sentences. Within 3 minutes of monitoring, pt began having persistent clearing of her throat and coughing", pt also indicated that she was having a burning sensation to her bilateral ears. Call out to ER MD and verbal orders obtained for Cetirizine 10mg po now. Pt was medicated and tolerated very well. Approximately 10 minutes post medication, pt reported "feeling much better" with her itching and burning decreasing. Lung sounds remained clear to auscultation bilaterally. Pt was -stridor or wheezing. No rash or swelling noted on physical exam. She remained calm and very cooperative. Within 30 minutes of monitoring pt, her symptoms continued to get better, minimizing to a 2-3/10 from initially a 6/10 itching to her throat. She was speaking full and very clear sentences with no other complaints upon discharge.


VAERS ID: 1758669 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050E21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blindness transient, Gastrointestinal disorder, Hyperhidrosis, Skin warm
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal 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: none reported
Current Illness: none reported
Preexisting Conditions: none reported
Allergies: none reported
Diagnostic Lab Data: unknown Paramedics arrived and transported the patient.
CDC Split Type:

Write-up: Patient reported that he could not see five minutes after administration of second dose of Moderna. Upon examination, patient was profusely sweating, warm to the touch and hunched over grabbing his stomach. He was conscious but could not communicate to me what he felt. I administered 25mg (10ml) of Benadryl 12.5mg/5ml and applied a cold compress to the neck. Paramedics arrived and transported the patient.


VAERS ID: 1758688 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 2 RA / IM
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 292R2 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dysphagia, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: amoxicillin (10th day) Fluconazole EpiPen 2-Pk
Current Illness: Strep throat and yeast infection
Preexisting Conditions: None
Allergies: tree nuts and peanuts
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Patient present with mother for second dose of covid pfizer vaccine. Patient has allergies to peanuts and tree nuts - was waiting 30 minutes. Vaccine administered at 1054. At 1115 patient called RN over to bedside for itchiness and hives developing on chest. Denies difficulty breathing at this time. Dr. called to bedside and put orders for 5ml of benadryl. 1120 Benadryl administered. Mother decided to stay additional 10 minutes for observation. 1127 patient stated she was having minimal difficulty swallowing her saliva. Denied difficulty breathing at this time. Vital signs were taken with continuous o2 sats. Dr. notified and additional orders placed. Benadryl 37.5mg (15ml) given to patient. Dr. prescribed prednisone 60mg at 1211. Patient took medication in office and observed for 30 additional minutes.


VAERS ID: 1758721 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-10-02
Onset:2021-10-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Limb mass, Neck mass
SMQs:

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

Write-up: Lump on neck and shoulder.


VAERS ID: 1758748 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: New York  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chills, Dizziness, Dysgeusia, Feeling cold, Feeling hot, Flank pain, Hypoaesthesia, Limb discomfort, Mobility decreased, Muscle contracture, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No known medications.
Current Illness: No known illnesses noted.
Preexisting Conditions: No known chronic conditions.
Allergies: Allergy to pollen.
Diagnostic Lab Data: No known medical tests or laboratory results.
CDC Split Type:

Write-up: Patient first stated that he felt dizzy around 11:40AM and was moved to the floor to lay down. Vital signs were initiated. Patient stated feeling "tightening" in his chest and both upper extremities and was experiencing contractions and unable to move his fingers. The patient stated feeling numbness and tingling in his left fingers and feet. Patient stated feeling hot when experiencing numbness and tingling. Patient stated tasting metal on his tongue. Patient stated feeling sharp pain in his left flank area. Patient turned to his side and started shivering and stated feeling cold and having chills. Patient reported improvement in mobility in lower extremities and left hand. EMS was called at 11:47AM and arrived onsite 25 minutes later. Assessment was initiated and patient was taken to the nearest hospital. Patient left the vaccine site at 12:18PM via EMS.


VAERS ID: 1758754 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, Injection site pruritus
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: unknown
Current Illness: no
Preexisting Conditions: unknown
Allergies: no
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient states " it feels a little itchy where I got my shot" approximately 15 minutes after immunization. Denies any adverse effects after first 2 doses. Site and surrounding skin assessed and no redness, no swelling, and no rashes noted. Denies any shortness of breath, difficulty breathing, chest pain/palpitations, difficulty swallowing, throat irriatation, dizziness, or nausea. Patient remained in clinic for an additional 15 minutes and site reassessed prior to patient leaving clinic with no redness, rash, or swelling noted. No rashes, swelling, or redness noted to other visible parts of skin. Patient states that itching has resolved prior to discharge from clinic. Discussed with patient should she develop any shortness of breath, difficulty breathing, difficulty swallowing, swelling of tongue/throat, chest pain, or dizziness to call 911 as this may indicate a severe allergic reaction requiring immediate medical attention. Patient alert and oriented x 4 and ambulatory with steady gait when leaving clinic.


VAERS ID: 1758756 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212A21A / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Incorrect product formulation administered, Interchange of vaccine products, 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: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type: 23A

Write-up: Client seen for COVID-19 Pfizer vaccine, RN inadvertently gave Janssen & Janssen and not 3rd booster of Pfizer COVID-19 vaccine. Client had no adverse reaction or signs/symptoms of adverse reaction.


VAERS ID: 1758793 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2587 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysphagia, Eructation, Rash, Rash erythematous, Rash pruritic, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: 5 minutes after vaccination the patient started to get a red itchy rash on forearm of the arm that it was administered. She Took 50mg of benadryl to treat the symptoms. Symptoms progressed into difficulty swallowing, belching, and vomitting. An ambulance was called for the patient''s further care.


VAERS ID: 1758803 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-10-03
Onset:2021-10-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pain, Intermenstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu Vaccine
Other Medications: Omeprazole 40 PRN Nortrel Goody powder PRN
Current Illness: No
Preexisting Conditions: NA
Allergies: Flu shot Augmentin Adhesive on bandaids Ortho-evra
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Patient was c/o menstrual bleeding at 11 am today 10/04/21. She did state she was having pain at the injection site at 3 am today--10/04/21


VAERS ID: 1758895 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-10-03
Onset:2021-10-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 076C21A / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Small bumps around the injection site, hives on chest and neck.


VAERS ID: 1758923 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-06
Onset:2021-10-04
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Dizziness, Electrocardiogram, Feeling hot, Hyperhidrosis, Immediate post-injection reaction, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: At the hospital, I did blood work, EKG, and Xray on chest/lungs.
CDC Split Type:

Write-up: Immediately after the shot, I sat down and became hot, sweaty and dizzy. After a few moments, I had a seizure in the waiting room of the pharmacy while sitting in the chair. Pharmacists and former EMT were in the vicinity to help immediately. I was then taken by ambulance to the hospital.


VAERS ID: 1758925 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Mississippi  
Vaccinated:2021-09-30
Onset:2021-10-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 2 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Asthenia, Blood pressure increased, Fatigue, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (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: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: patient is having elevated BP readings (without history of BP issues), weakness (generalized), fatigue (severe) and nausea/vomiting.


VAERS ID: 1758990 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Nevada  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 211A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cold sweat, Nausea, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Fainted, pale, skin felt cold and clammy, patient reported nausea, BP was 107/73, pulseox: 98%, Pulse: 65 bpm. Patient given a lollipop, cookies, and water as well as an ice pack. Patient sat and rested for approximately 20 minutes after event after which he reported feeling much better and left.


VAERS ID: 1759022 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: California  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822809 / UNK - / IM

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular 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: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sweating, dizziness


VAERS ID: 1759023 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-03-05
Onset:2021-10-04
   Days after vaccination:213
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / IM

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: positive for covid 10/4/2021


VAERS ID: 1759033 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 024C21A / 1 LA / SYR

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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flovent HFA, fluticasone propionate, ProAir HFA
Current Illness: none
Preexisting Conditions: Asthma
Allergies: Ibuprofen
Diagnostic Lab Data: Not medically necessary at this time.
CDC Split Type:

Write-up: Patient came in to receive COVID 19 vaccination. Grandmother asked for patient to receive Moderna, as that was the vaccine she received. After administration of the vaccine, it was realized that patient was not 18 years old.


VAERS ID: 1759034 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 3 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Third dose of Pfizer COVID vaccine given earlier than 6 months since second dose.


VAERS ID: 1759035 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-03-25
Onset:2021-10-04
   Days after vaccination:193
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: positive for covid today


VAERS ID: 1759045 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-02-09
Onset:2021-10-04
   Days after vaccination:237
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / IM

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: positive for covid


VAERS ID: 1759050 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 4 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Extra dose administered, Inappropriate schedule of product administration, 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: unknown
Current Illness: none known
Preexisting Conditions: Multiple Sclerosis
Allergies: Amantadine, Aspirin, Ibuprofen, Naproxen
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Covid third dose clinic for pfizer vaccine was held 10/4/2021 at Nursing Home for residents. Facility Director of Nursing took Public Health Nursing staff room to room to administer vaccine. Director of Nursing already had paper forms made out ahead of time. This resident had already had three doses of the covid vaccine and was inadvertently given a fourth dose today. This was not caught until entering the vaccines in the registry later in the day. No adverse effects reported at this time. Primary Care physician notified of incident.


VAERS ID: 1759057 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-02-24
Onset:2021-10-04
   Days after vaccination:222
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: positive for covid


VAERS ID: 1759058 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-09-30
Onset:2021-10-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822809 / UNK - / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Muscle spasms, Neck pain
SMQs:, Dystonia (broad), Arthritis (broad)

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

Write-up: The patient has extremely painful charley horse like pain in his neck, beginning this morning. He has tried to resolve the pain by taking a steam shower, taking ibuprofen, and drinking plenty of water. He has been alternating hot and cold, additionally.


VAERS ID: 1759067 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Wrong patient
SMQs:, Medication errors (narrow)

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

Write-up: Error: Wrong Patient (documentation in EMR)-


VAERS ID: 1759072 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-02-12
Onset:2021-10-04
   Days after vaccination:234
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Patient received Pfizer vaccine with 1st dose on 01/20/2021 and 2nd dose on 02/12/2021. Covid + on 10/04/2021 and hospitalized Per ED Note: Patient is a pleasant 77year old male presented today to emergency department for evaluation of shortness of breath. He has been feeling this way for the past 2 days. He does admit to fevers and cough at home. He took Tylenol prior to coming in. Patient denies any chest pain, abdominal pain, vomiting, focal paresthesias or weakness, headache, change in bowel or bladder habits, dizziness, leg pain or edema or history of blood clots, or changes in medications. He denies any other modifying precipitating or relieving factors.


VAERS ID: 1759075 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8839 / N/A RA / 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none reported
Current Illness: none reported per patient questionnaire.
Preexisting Conditions: none reported per patient questionnaire.
Allergies: none per patient questionnaire.
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Patient had come in for second Moderna vaccine. Incorrectly administered Pfizer vaccine instead.


VAERS ID: 1759085 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Headache, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (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:

Write-up: Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Mild, Systemic: Weakness-Medium, Additional Details: pt mentioned that she do faint after vaccins usually. we called the mom she was nearby location (she came in 5 min). blood pressure was10.05/5.6. we made her lie flat. then she drink water and eat salty chips. she was all right after 15 min.


VAERS ID: 1759088 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 043B21A / 3 LA / IM

Administered by: Public       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: unknown
Current Illness: unknown
Preexisting Conditions: Patient Self-Attests to being immunocompromised.
Allergies: no known allergies
Diagnostic Lab Data: none currently
CDC Split Type: N/A

Write-up: None currently - Patient received moderna booster dose on 10/04/21 Intramuscularly in the Left Arm. Moderna Vaccine expired 10/03/21.


VAERS ID: 1759099 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033C21A / 2 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (broad)

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

Write-up: Pt was administered Moderna instead of Pfizer. Pt was in with mother and both were receiving the vaccine. Mother received Moderna and pt was to receive Pfizer but given Moderna in error.


VAERS ID: 1759147 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-10-02
Onset:2021-10-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Headache, Injection site swelling, Neck pain, Pain in extremity
SMQs:, Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Pain in calves, feet, quads, hamstrings, lower and upper back, neck and head ache. Swelling in the shot location.


VAERS ID: 1759167 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-10-02
Onset:2021-10-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 2 LA / IM

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

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

Write-up: Nausea, vomiting, vertigo, cold sweat, fever, fatigue


VAERS ID: 1759210 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-10-03
Onset:2021-10-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Swollen left axilla lymph node same side as vaccine


VAERS ID: 1759224 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 4 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Extra dose 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: unknown
Current Illness: unknown
Preexisting Conditions: Alzheimers Disease
Allergies: Erythromycin
Diagnostic Lab Data: none
CDC Split Type:

Write-up: COVID vaccine clinic for third dose held for residents at the HCF on 10/4/2021. Facility Director of Nursing took Public Health Staff around to resident''s rooms to administer vaccine. Director of Nursing had already completed the paper forms ahead of time. This resident was inadvertently given a fourth dose of the pfizer covid vaccine and it wasn''t discovered until entering the information into the immunization registry. No adverse effects reported at this time. Physician ARNP notified of incident.


VAERS ID: 1759259 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 4 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Extra dose 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: unknown
Current Illness: unknown
Preexisting Conditions: Parkinsons Disease
Allergies: Clindamycin, Hydrocodone, Penicillin
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Covid Clinic scheduled for residents at Home on 10/4/2021. Facility Director of Nursing took Public Health Staff room to room to administer vaccine. Director of Nursing had already completed the needed paper forms prior to clinic. This resident inadvertently received a fourth dose of the pfizer covid 19 vaccine and it was not discovered until entering data into the immunization registry. No adverse effects at this time. Physician notified of the incident.


VAERS ID: 1759297 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301358A / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Product preparation error
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: Extra Dose given - 0.3 mL of undiluted Pfizer dose given. (Explained to patient about the situation and the expected side effects, if any)


VAERS ID: 1759298 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30135BA / 3 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: not known
Current Illness: not known
Preexisting Conditions: not known
Allergies: nkda
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient came for 3rd vaccine; verified with patient that he was here for 3rd dose of Pfizer and he verbally verified this. Gave Pfizer vaccine and on vaccine record patient had received 2 doses of Moderna vaccine. Patient was observed for 15 minutes post vaccination with no adverse reaction noted.


VAERS ID: 1759324 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 31035BA / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Incorrect dose administered, Product preparation error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NOT KNOWN
Current Illness: NOT KNOWN
Preexisting Conditions: NOT KNOWN
Allergies: NOT KNOWN
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: I FORGOT TO DILUTE THE VACCINE AND ADMINISTERED 0.3ML OF PFIZER VACCINE WITHOUT DILUTING


VAERS ID: 1759363 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 3 LA / -

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

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

Write-up: Pt came in to receive 2nd shot but after he got his shot staff realized he had already received 2nd shot and this one would be the third.


VAERS ID: 1759429 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30135BA / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Confusional state, Dyspnoea, Feeling hot, Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Pfizer - 51 years old - Same reaction
Other Medications: Denies
Current Illness: Denies
Preexisting Conditions: Denies
Allergies: Denies
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient reported "felt hot", confusion, tingling to right hand and forearm, itching, "felt winded"


VAERS ID: 1759440 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037F21A / 3 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Extra dose 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: Advair, Hyzarr, Flomax, Coumadin
Current Illness: N/A
Preexisting Conditions: TIA, SSS, DVT, Cardiovascular and Mediastinum
Allergies: NKA
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Patient given Moderna (booster) by this nurse. Moderna has not been FDA approved for a booster at this time. Patient did not have any issues with the first 2 doses. Patient waited the 15mins to monitor. Physician came out and spoke with patient . Patient did not show any signs or symptoms of adverse reaction to this dose.


VAERS ID: 1759496 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8841 / 3 LA / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR UJ742AA / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Hypoaesthesia
SMQs:, Anaphylactic reaction (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Unknown
Preexisting Conditions: None listed
Allergies: Dye (IVP) per pt
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient stated chest tightness and her arm felt numb. started about 10 minutes after patient had vaccine.


VAERS ID: 1759526 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-05-10
Onset:2021-10-04
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0165 / 2 LA / IM

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

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

Write-up: Pt tested positive for COVID on 9/24/21 s/p 2 doses of Pfizer (last dose 5/10/21); was admitted to hospital on 10/4/21. Of note, pt is immunocompromised w/ Lupus receiving tx w/ Rituxan


VAERS ID: 1759555 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050E21A / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Cold sweat, Dizziness, Flushing, Hyperhidrosis, Tunnel vision
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Optic nerve disorders (broad), Retinal disorders (narrow), Vestibular disorders (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: ADHD
Preexisting Conditions:
Allergies: Bee stings Red dye
Diagnostic Lab Data:
CDC Split Type: MED001C

Write-up: dizzy, tunnel vision, weaving on chair, flushed, diaphoretic, cold & clammy


VAERS ID: 1759575 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3590 / N/A LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: celexa, glucophage
Current Illness: unknown
Preexisting Conditions: diabetes
Allergies: PCNs, sulfas, cephalexin, erythromycin base, amoxicillin
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Patient requested a booster. Patient inadvertently given Pfizer when patient has already had a two dose Moderna series.


VAERS ID: 1759577 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: South Dakota  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30145BA / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, Interchange of vaccine products, 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: Pt. had completed Moderna covid vaccines and got a Pfizer booster vaccine.
Current Illness: None
Preexisting Conditions: None
Allergies: NKDA
Diagnostic Lab Data: Pt. discharged after 15 minutes. No adverse reactions are noted. Pt. made aware of vaccine given.
CDC Split Type:

Write-up: New Pt. to our clinic. Present for a pfizer booster vaccine. Found out after booster injection was given that the pateint had completed the Moderna vaccines.


VAERS ID: 1759596 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Unknown  
Location: Iowa  
Vaccinated:2021-10-04
Onset:2021-10-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 1 LA / 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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rash after 10 min arm cheast and back. 25mg diphenhydramine given, 10mg Zyrtec given. monitored patient for 30 min and rash faded. Checked with allergy in dbq and Dr said not to give epi at this time as rxn improving and not to give 2nd dose.


VAERS ID: 1759627 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-30
Onset:2021-10-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30155BA / 3 LA / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal discomfort, Dizziness, Hypotension, Injection site erythema, Injection site pain, Myalgia, Nasal congestion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 1) Steroid: Eye drops :Loteprednol Etabone Ophthalmic Suspension (0.5%) 2) Pataday eye allergy Twice daily. 3) Vitamin C (500 mg) 4) Vitamin D (prescribed: 50,000 units per week)
Current Illness: Tachicardia
Preexisting Conditions: High Cholesterol
Allergies: Penicillin and
Diagnostic Lab Data: None. I stayed home.
CDC Split Type:

Write-up: Pain at the injection site started on Friday 10/01: it hurts to elevate the left arm but can tolerate the discomfort. Redness at site of injection started on Saturday, 10/02: not a big deal either. However, scary symptoms commenced this morning (10/04/2021), approximately at 9:30/10:00 --it gradually started with muscle pain (back and neck), fainting feelings, strange stomach discomfort; low blood pressure (103/67; heartbeat: 74. Started to feel packnicky and my heartbeat accelerated. Now I feel I am getting a stuffy nose.


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