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From the 9/17/2021 release of VAERS data:

Found 711,579 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 335 out of 7,116

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VAERS ID: 1622873 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004224 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Insomnia, Malaise, Myalgia, Pyrexia, Thirst, Vulvovaginal discomfort
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DAFALGAN
Current Illness: Asthma; Penicillin allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: This case was received via the Regulatory Authority (Reference number: 103701) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), INSOMNIA, MALAISE (Malaise), HEADACHE, BACK PAIN, PYREXIA, BACK PAIN, ARTHRALGIA, HEADACHE, MYALGIA, VULVOVAGINAL DISCOMFORT and THIRST in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004224) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy and Asthma. Concomitant products included PARACETAMOL (DAFALGAN) for an unknown indication. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion disability), INSOMNIA (seriousness criterion disability), MALAISE (Malaise) (seriousness criterion disability), HEADACHE (seriousness criterion disability), BACK PAIN (seriousness criterion disability), PYREXIA (seriousness criterion disability), BACK PAIN (seriousness criterion disability), ARTHRALGIA (seriousness criterion disability), HEADACHE (seriousness criterion disability), MYALGIA (seriousness criterion disability), VULVOVAGINAL DISCOMFORT (seriousness criterion disability) and THIRST (seriousness criterion disability). At the time of the report, FATIGUE (Fatigue), INSOMNIA, MALAISE (Malaise), HEADACHE, BACK PAIN, PYREXIA, BACK PAIN, ARTHRALGIA, HEADACHE, MYALGIA, VULVOVAGINAL DISCOMFORT and THIRST was resolving. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1622907 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye pain, Fatigue, Headache, Prostatitis
SMQs:, Glaucoma (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: ESJNJFOC20210838591

Write-up: PROSTATE INFLAMMATION; INTENSE HEADACHE; ABNORMAL LEG FATIGUE; PAIN ON EYE MOVEMENT; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, ES-AEMPS-973029] concerned a 60 year old male, unspecified race and ethnicity. The patient''s weight was 80 kilograms, and height was 175 centimeters. 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, and batch number; unknown expiry: unknown) dose was not reported, 01 total, administered on 11-JUL-2021 on left arm for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 30-JUL-2021, the patient experienced pain on eye movement. On 31-JUL-2021, the patient experienced abnormal leg fatigue. On 02-AUG-2021, the patient experienced prostate inflammation and intense headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain on eye movement on 07-AUG-2021, and intense headache on 06-AUG-2021, and had not recovered from prostate inflammation, and abnormal leg fatigue. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210838591-COVID-19 VACCINE AD26.COV2.S-pain on eye movement, prostate inflammation. 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). V0: 20210838591-COVID-19 VACCINE AD26.COV2.S-intense headache, abnormal leg fatigue. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1622973 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210831342

Write-up: AFTER 2 DOSE PFIZER COVID VACCINE I HAD SUPERFICIAL THROMBOSIS OF SAPHENOUS VEIN.SOME SYMPTOMS HAVE OCCURRED SINCE THE 1 DOSE; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, IT-MINISAL02-769195] concerned a 31year old female. The patient''s weight was 85 kilograms, and height was 153 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: FF2752 expiry: UNKNOWN) dose was not reported, administered 1 total on 29-JUL-2021 for covid-19 vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced after 2 dose pfizer covid vaccine she had superficial thrombosis of saphenous vein some symptoms have occurred since the 1 dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from after 2 dose pfizer covid vaccine she had superficial thrombosis of saphenous vein some symptoms have occurred since the 1 dose. This report was serious (Other Medically Important Condition).; Reporter''s Comments: No I have other chronic pathologies or allergies.; Sender''s Comments: V0 20210831342- COVID-19 VACCINE AD26.COV2.S- after 2 dose pfizer covid vaccine I had superficial thrombosis of saphenous vein some symptoms have occurred since the 1 dose. 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).


VAERS ID: 1622988 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial pain, Lip oedema, Pain in extremity, Rash maculo-papular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Latent tuberculosis (prior latent tuberculosis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: LUJNJFOC20210838952

Write-up: LIP EDEMA; PRURITIC RASH; PAIN OF EXTREMITIES; RASH MACULO-PAPULAR; PAIN IN FACE; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, LU-ALMPS-202102971] concerned a 47 year old female. The patient''s weight was 70 kilograms, and height was 168 centimeters. The patient''s past medical history included: latent tuberculosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE389 expiry: UNKNOWN) 1 dosage forms, 1total administered on 29-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 30-JUL-2021, the patient experienced pain in face. On 05-AUG-2021, the patient experienced lip edema, pruritic rash, pain of extremities, maculo-papular rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The drug start period period for latency was 7 days. The patient was recovering from lip edema, pain in face, pruritic rash, pain of extremities, and maculo-papular rash. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210838952-covid-19 vaccine ad26.cov2.s -Lip Edema, Pain In Face. 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). 20210838952-covid-19 vaccine ad26.cov2.s -Pruritic Rash, Pain Of Extremities, Rash Maculo-Papular. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1623100 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Fatigue, Pyrexia, Renal pain, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: ATPFIZER INC202101016265

Write-up: Pyrexia; Application site pain; Fatigue; Kidney pain (but it can also come from the spine); Reddening of the skin all over the body, subsiding; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-39039. A 59-year-old male patient received bnt162b2 (COMIRNATY), (at the age of 59 years old) via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: ff0680) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from 20Dec2020 to 21Jan2021. The patient''s concomitant medications were not reported. The patient experienced pyrexia, application site pain, fatigue, kidney pain (but it can also come from the spine) and reddening of the skin all over the body, subsiding on 30Jul2021. The event pyrexia was assessed as medically significant. The outcome of the events perirenal pain and redness generalized was recovering while the other events were not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1624680 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Pain in extremity
SMQs:, Retroperitoneal fibrosis (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: NUCLOSINA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Herniated disc
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101017078

Write-up: Left leg pain; lower back discomfort/Left lumbar pain; This is a spontaneous report from a contactable consumer (patient) downloaded from the Medicines Agency (MA) WEB ES-AEMPS-963328. A 29-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FE8244), via unknown route of administration, administered in Arm Left on 30Jul2021 18:20 (at age of 29 years old) as single dose for COVID-19 immunisation. Medical history included herniated disc. Concomitant medication included omeprazole (NUCLOSINA). Patient was given the Pfizer COVID-19 vaccine at 6:20 p.m. and about half an hour later (30Jul2021 18:50) patient started to notice lower back discomfort, left leg pain, Left lumbar pain (all medically significant). The next day, 31Jul2021 and after taking tramadol and enantyum patient still had severe pain, as it has barely diminished with the medication. Patient have taken enantyum and tramadol, which is what patient usually take when had low back pain. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1624686 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, Headache, Myalgia, Pain, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SALOFALK [MESALAZINE]; PENTASA; IMUREL [AZATHIOPRINE SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Colitis ulcerative
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101017189

Write-up: Fever; Head pain; Muscular pain/it reached back (trapezius); it could even take it to the bones; it ran through entire body; pain in arm; This is a spontaneous report from a contactable consumer (patient) downloaded from the Medicines Agency (MA) WEB ES-AEMPS-963636. A 31-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (COMIRNATY) at single dose on 30Jul2021 via an unknown route at 31-year-old for COVID-19 immunisation. Medical history included colitis ulcerative. Concomitant drugs included mesalazine (SALOFALK), mesalazine (PENTASA), azathioprine sodium (IMUREL). Historical vaccine included 1st dose of BNT162B2 (COMIRNATY) at single dose on 09Jul2021 for COVID-19 immunisation. Patient did not have passed COVID-19. On 30Jul2021, patient experienced fever, head pain, muscular pain. The muscle pain was general, it could even take it to the bones, it ran through entire body until patient thought the first night that she would have to go to the emergency room because she could not get up. Currently (as of 09Aug2021) she still had the typical pain in arm "that you always have when you get vaccinated" (as reported) and it reached back (trapezius). Description of the treatment followed for ADR included paracetamol. Outcome of pain in arm and Muscular pain/it reached back (trapezius) was not resolved. Outcome of fever, head pain was resolved on 01Aug2021. Outcome of the other events was unknown. The event fever, head pain, muscular pain were assessed as serious with medically significant. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1624695 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Vaccination site bruising, Vaccination site haematoma, Vaccination site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101016261

Write-up: Vaccination site hematoma; Vaccination site pain; large bruise, which is getting worse, on my left arm, right at the injection side; This is a spontaneous report from a non-contactable consumer downloaded from a regulatory authority. A 38-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in left arm on 28Jul2021 (Batch/Lot Number: FE8405) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received first dose of bnt162b2 for covid-19 immunisation on 06Jul2021. On 30Jul2021, the patient experienced vaccination site hematoma and vaccination site pain. It was reported that the patient has a large bruise, which was getting worse on his left arm, right at the injection side. Outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1624697 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9309 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101017188

Write-up: Pulmonary thromboembolism; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB ES-AEMPS-964745. A 33 years old male patient received 1st dose of BNT162B2 (COMIRNATY, lot number FD9309) at single dose via an unknown route on 21Jul2021 for COVID-19 immunisation. Medical history and concomitant drug were not provided. It was unknown if patient had passed COVID-19. Patient experienced pulmonary thromboembolism on 30Jul2021 (also reported as 6 days later he required hospitalization for pulmonary thromboembolism). Outcome of the events was resolving.


VAERS ID: 1624699 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Constipation, Flatulence, Haematemesis, Haematochezia, Urinary tract infection
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (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: ESPFIZER INC202101017197

Write-up: Urine infection; bleeding in vomit; bleeding in feces; have a lot of gas; constipation; This is a spontaneous report from a contactable consumer (patient) downloaded from a Regulatory Authority ES-AEMPS-964750. A 35-year-old male patient received second dose of BNT162B2 (COMIRNATY), intramuscularly on 29Jul2021 (Lot number: FE8405) at the right arm as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical Vaccine included first dose of Comirnaty on 08Jul2021 (Lot number: FE1248) for COVID-19 immunization. The patient stated "In addition to the urine infection I have a lot of gas, constipation and bleeding in vomit and feces." All events onset date were 30Jul2021. Treatment received for the events included paracetamol and currently antibiotic. The outcome of the events were resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1624700 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Arthralgia, Dyspnoea, Malaise, Myalgia, Pyrexia, Suspected COVID-19
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (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: TARDYFERON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute anemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101017204

Write-up: Breathing difficult; Arthralgia; Ageusia; Anosmia; General malaise; Febrile state without rise in temperature but with loss of taste and smell. Muscle and joint pain Difficulty breathing and general malaise. I think they have infected me with the covid in the hospital; Myalgia; I think they have infected me with the covid; This is a spontaneous report from a contactable consumer (patient) downloaded from the Medicines Agency (MA) WEB, regulatory authority number ES-AEMPS-964897. A 46-year-old male patient received bnt162b2 (COMIRNATY; Lot Number: FE8244 and expiration date was not reported),intramuscular, administered in Left Arm on 29Jul2021 at dose 2 singe for covid-19 immunization. Medical history included acute anemia. Concomitant medications included ferrous sulfate (TARDYFERON) taken for anaemia from Jan2020 to an unspecified stop date. Historical vaccine included bnt162b2 (COMIRNATY; Lot Number: FE6208 and expiration date was not reported),administered intramuscularly on 08Jul2021 at dose 1 singe for covid-19 immunization. After vaccination, Patient was in febrile state without rise in temperature but with loss of taste and smell. He had muscle and joint pain, difficulty breathing and general malaise. He thought they have infected him with the covid in the hospital. The outcome of the events was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1624708 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Body temperature, Electrocardiogram, Emergency care examination, Myocarditis, Pyrexia, Troponin
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Coronary angiography; Result Unstructured Data: Test Result:coronary arteries without lesions; Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:39.8 ? C; Test Date: 20210730; Test Name: electrocardiographic picture; Result Unstructured Data: Test Result:picture compatible with acute Myopericarditis; Test Date: 20210730; Test Name: clinical picture; Result Unstructured Data: Test Result:picture compatible with acute Myopericarditis; Test Date: 20210730; Test Name: Troponin; Result Unstructured Data: Test Result:19000; Comments: elevation
CDC Split Type: ESPFIZER INC202101016385

Write-up: Acute myocarditis/elevation of troponin up to 19 thousand; fever of up to 39.8 ? C; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number ES-AEMPS-965831. A 38-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 27Jul2021 (Lot Number: FE3065) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that on 30Jul2021, 3 days after receiving the second dose of the Pfizer vaccine, the patient presented with a fever of up to 39.8 ? C, so the patient consulted the Emergency Department, presenting a clinical, electrocardiographic and analytical picture compatible with acute Myopericarditis with an elevation of troponin up to 19 thousand and precise in addition to Coronary angiography, to rule out STEMI that finally reports coronary arteries without lesions, confirming the initial presumptive diagnosis. The patient was hospitalized in Jul2021 due to the events. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1624867 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101020799

Write-up: Loss of consciousness; broken teeth; high right condylar fracture; Malaise; vagal discomfort; This is a spontaneous report from a contactable consumer downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB FR-AFSSAPS-NT20213109. A 31-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in left arm on 30Jul2021 (at the age of 31-year-old) (Batch/Lot Number: FF4213) as dose 1, single for covid-19 immunisation. The patient had no medical history. The patient had no covid19 and was not tested. Concomitant medications were not reported. On 30Jul2021, the patient experienced malaise. It was reported that five minutes after vaccination, the patient had vagal discomfort with loss of consciousness which resulted in 4 stitches in the chin, broken teeth and a high right condylar fracture with surgical indication. The patient was taken care of by the SAMU (emergency medical services) and firemen and went to the emergency room. Evolution of events was healing. Outcome of events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1624934 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypersensitivity, Hypertension, Lip swelling, Odynophagia, Oxygen saturation, Palatal swelling, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity; Pollen allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: hypertension arterial; Result Unstructured Data: Test Result:158/100; Test Date: 20210730; Test Name: saturation; Result Unstructured Data: Test Result:ok
CDC Split Type: FRPFIZER INC202101016791

Write-up: Hypersensitivity reaction; feeling of swelling lips palate face; feeling of swelling lips palate face; feeling of swelling lips, palate, face; vent; hypertension arterial 158/100; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. A 35-year-old male patient received bnt162b2 (COMIRNATY), intramuscularly on 30Jul2021 (Batch/Lot Number: FE8244) (at the age of 35-years-old) at single dose for covid-19 immunisation. Medical histories included ongoing obesity, ongoing Pollen allergy. The patient''s concomitant medications were not reported. The patient experienced hypersensitivity reaction on 30Jul2021, feeling of swelling lips/palate/ face, discomfort in swallowing on 30Jul2021, hypertension arterial 158/100 on 30Jul2021. The patient underwent lab tests and procedures which included saturation: ok on 30Jul2021, hypertension arterial: 158/100 on 30Jul2021. The outcome of the events was unknown. This report was considered as serious due to hospitalization. Reporter''s comments: Information contained in the declaration: ''''feeling of swelling lips, palate, face, discomfort in swallowing without laryngeal or respiratory discomfort, stable hemodynamics, saturation ok, hypertension arterial 158/100''''. In total, occurrence of a hypersensitivity reaction leading to hospital, 10 min after vaccine injection of Comirnaty in a patient with atopic ground. No follow-up attempts posszible. No further information expected.; Reporter''s Comments: Information contained in the declaration: ''''feeling of swelling lips, palate, face, discomfort in swallowing without laryngeal or respiratory discomfort, stable hemodynamics, saturation ok, hypertension arterial 158/100'''' In total, occurrence of a hypersensitivity reaction leading to hospital, 10 min after vaccine injection of Comirnaty in a patient with atopic ground.


VAERS ID: 1624967 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Influenza, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014901

Write-up: Upset stomach; Nausea; Flu symptoms; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061441418550-X5HAN, Safety Report Unique Identifier GB-MHRA-ADR 25766399. This consumer or other non hcp reported information for both mother and baby. This is a maternal report. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 29Jul2021, as 2nd single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had not tested positive for COVID-19 since having the vaccine, and was not enrolled in clinical a trial. The mother stated that her 10 weeks old infant son whom she was breastfeed, suffered an unknown gastric illness two days after the patient received her second vaccine. It caused him sickness and diarrhoea, resulting in a trip to AE with concerns about dehydration. It resolved after approximately 48 hours and no treatment was required. The mother herself suffered flu symptoms including an upset stomach and nausea the day after the vaccine and on the day before his symptoms had started. A stool sample from infant was taken at the hospital, whose results were unknown. According to the regulatory authority the patient recovered from fly symptoms on 31Jul2021, while the outcome of upset stomach and nausea were unknown. The case was reported as serious due to important medical condition and since involving hospitalization. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101022861 Mother-Child Case


VAERS ID: 1625020 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101021813

Write-up: Diarrhea; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108081242343810-2URAP. Safety Report Unique Identifier GB-MHRA-ADR 25771346. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jul2021 (Batch/Lot Number: FD8813) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced diarrhea on 30Jul2021. Event seriousness criteria was medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: No- Negative COVID-19 test on 31Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1625745 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, COVID-19 immunisation, Dysstasia, Feeling cold, Headache, Influenza like illness, Interchange of vaccine products, Nausea, Neck pain, Pain in extremity, Retching
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MULTIVITAMINS [VITAMINS NOS]; MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20212

Write-up: MAJOR PAIN IN LEGS; FEELING COLD; RETCHING; FLU LIKE SYMPTOMS; BACK PAIN; DIFFICULTY IN STANDING; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; NECK PAIN; Interchange of vaccine product; HEAD PAIN; NAUSEA; This case was received via regulatory authority (Reference number: NO-NOMAADVRE-E2B_00040795) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (MAJOR PAIN IN LEGS) in a 29-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication. Previously administered products included for Vaccination: Comirnaty. Past adverse reactions to the above products included Drug use for unknown indication with Comirnaty. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]) for Contraception, MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 30-Jul-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (COMIRNATY) (unknown route) at an unspecified dose. On 30-Jul-2021, the patient experienced PAIN IN EXTREMITY (MAJOR PAIN IN LEGS) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING COLD (FEELING COLD), RETCHING (RETCHING), INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), BACK PAIN (BACK PAIN), DYSSTASIA (DIFFICULTY IN STANDING), COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE), NECK PAIN (NECK PAIN), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), HEADACHE (HEAD PAIN) and NAUSEA (NAUSEA). At the time of the report, PAIN IN EXTREMITY (MAJOR PAIN IN LEGS) was resolving and FEELING COLD (FEELING COLD), RETCHING (RETCHING), INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), BACK PAIN (BACK PAIN), DYSSTASIA (DIFFICULTY IN STANDING), COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE), NECK PAIN (NECK PAIN), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), HEADACHE (HEAD PAIN) and NAUSEA (NAUSEA) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Treatment details not provided. Company Comment: For the event Pain in extremity, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the remaining events onset dates has been provided at this time and insufficient to assess the temporal association. A causal relationship cannot be excluded.; Reporter''s Comments: Contact with healthcare professionals: Physician. Patient reports about no diseases and healthy lifestyle. Patient reports about problems with keeping legs still, due to MAJOR PAIN IN LEGS. Patient reports about visiting a physician, due to the condition, and was then referred to hospital.; Sender''s Comments: For the event Pain in extremity, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the remaining events onset dates has been provided at this time and insufficient to assess the temporal association. A causal relationship cannot be excluded.


VAERS ID: 1625834 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Mobility decreased, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101017027

Write-up: Weakness in extremity; had problems to seize/ difficulties in grasping/can not raise her left arm; This is a spontaneous report from a contactable consumer (patient) downloaded from the Agency Regulatory Authority, regulatory authority number SE-MPA-2021-068228. A 33-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 29Jul2021 (Batch/Lot Number: unknown) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced weakness in extremity on 30Jul2021. The clinical course details of the event was as follows: Reported suspect adverse event was weakness in extremity. The woman experienced severe weakness in her left arm and had problems to seize. Sometimes the woman can not raise her left arm. Report assessed as serious, disability. Reported suspected adverse reactions were diminished strength. The woman suffered from extreme reduced strength in her left arm and difficulties in grasping. The arm only wanted to hang and the woman could barely lift it at certain moments. The case was assessed as a serious, permanent physical impairment. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1627879 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hyperhidrosis, Illness, Menstruation irregular, Pyrexia, Skin odour abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Fertility disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210846703

Write-up: VAGINAL BLEEDING; FEVER; SICKNESS; IRREGULAR MENSTRUAL CYCLE; SMELLY BODY; SWEATING INCREASED; This spontaneous report received from a consumer by a Business partner (EVHUMAN Vaccines, BE-FAMHP-DHH-N2021-105119) on 23-AUG-2021 and concerned a 21 year old female. The patient''s weight was 62 kilograms, and height was 163 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C14-02) dose was not reported, administered on 30-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 30-JUL-2021, the patient experienced vaginal bleeding. On 30-JUL-2021, the patient experienced fever. On 30-JUL-2021, the patient experienced sickness. On 30-JUL-2021, the patient experienced irregular menstrual cycle. On 30-JUL-2021, the patient experienced smelly body. On 30-JUL-2021, the patient experienced sweating increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaginal bleeding, fever, smelly body, sickness, sweating increased, and irregular menstrual cycle. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: ADR treatment:NoSpecial situations:Medication error


VAERS ID: 1630487 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cold sweat, Dysphoria, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101032161

Write-up: darkness in front of eyes; Dysphoria; cold sweat; This is a spontaneous report from a contactable pharmacist. Regulatory authority report number is v21123528. The patient was a 14-year-old female. Body temperature before vaccination was 36.7 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). On 30Jul2021 at 12:45 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY), Solution for injection, Lot number FF4204, Expiration date 31Oct2021, via an unspecified route of administration as a single dose for COVID-19 immunization at the age of 14-year-old. On 30Jul2021 at 12:50 (5 minutes after the vaccination), the patient experienced events. On 30Jul2021 (the same day as vaccination), the outcome of the event was recovered. The course of the event was as follows: on 30Jul2021, 5 minutes after the vaccination, the patient experienced darkness in front of eyes, cold sweat, Dysphoria. The patient received 500ml of saline solution for intravenous drip. Then the symptoms were gradually recovering. After 30 minutes, symptoms were improved. The reporting pharmacist classified the event as non-serious and assessed that the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1630746 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Disease recurrence, Fatigue, Malaise, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angio-edema (week before vaccination she also had a flare-up of angio edema); Grass allergy (Allergy: My daughter has angioedema and house dust mite and grass pollen allergy.); House dust mite allergy (Allergy: My daughter has angioedema and house dust mite and grass pollen allergy.); Pollen allergy (Allergy: My daughter has angioedema and house dust mite and grass pollen allergy.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101024244

Write-up: swelling of the throat, eyes and tongue, daughter has angioedema; possibly triggered by vaccine; swelling of the throat, eyes and tongue, daughter has angioedema; possibly triggered by vaccine; Fatigue; Muscle pain; Fever: not measured; Not feeling well; This is a spontaneous report from a contactable consumer (patient''s parent) downloaded from the WEB, regulatory authority number NL-LRB-00647041. A 15-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 30Jul2021 at 15 years old (Batch/Lot Number: FE4728) as single dose for covid-19 immunization. Medical history included house dust mite allergy, grass allergy, pollens allergy, angio edema with unknown cause; week before vaccination she also had a flare-up of angio edema. The patient didn''t have Previous COVID-19 infection. The patient''s concomitant medications were not reported. The patient experienced swelling of the throat, eyes and tongue, daughter has angioedema; possibly triggered by vaccine 2 minutes after start on 30Jul2021, fatigue 20 minutes after start on 30Jul2021, muscle pain 1 hours after start on 30Jul2021, fever: not measured 4 hours after start on 30Jul2021, not feeling well 2 minutes after start on 30Jul2021. Additional information ADR: My daughter has angioedema. My daughter had an attack earlier this week. I suspect that the vaccine has triggered it again. We didn''t know what caused the angio oedema attacks. Other diagnostic procedures was no. Angio edema is treated with Tavegyl and desloratedine. The patient has not recovered from angio-edema, has not recovered from fatigue, has not recovered from fever, has not recovered from malaise and has not recovered from myalgia. No follow-up attempts possible. No further information expected.


VAERS ID: 1630849 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210841577

Write-up: ABDOMINAL PAIN; This spontaneous report received from a consumer via regulatory authority (EMEA EVHUMAN NLP, PT-INFARMED-R202108-95) and concerned a 24 year old male patient of unspecified race and ethnicity. The patient''s weight was 52 kilograms, and height was 168 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393, expiry: unknown) 0.5 ml, 1 total administered on 23-JUL-2021 for covid-19 immunization. No concomitant medications were reported. On 30-JUL-2021, the patient experienced abdominal pain (Severe pain in the abdominal area and bladder). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of abdominal pain was not reported. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Concomitant Medication - No Medication Error Occurred? - No Other information - Severe pain in the abdominal area and bladder; Sender''s Comments: V0: 20210841577-covid-19 vaccine ad26.cov2.s- abdominal pain. 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).


VAERS ID: 1630860 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling cold, Headache, Myalgia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210840518

Write-up: MUSCLE ACHES; HEADACHE; PAIN AT THE INJECTION SITE; EXCESSIVE COLD; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202108-33] concerned an 18 year old male of unknown race and ethnicity. The patient''s weight was 68 kilograms, and height was 178 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C17-05, expiry: unknown) 0.5 ml, 1 total, administered on 30-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 30-JUL-2021, the patient experienced excessive cold, headache, pain at the injection site and on 31-JUL-2021, experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from excessive cold on 30-JUL-2021, muscle aches, and headache on 31-JUL-2021, and pain at the injection site on 01-AUG-2021. This report was serious (Disability Or Permanent Damage).; Sender''s Comments: V0. 20210840518-COVID-19 VACCINE AD26.COV2.S- excessive cold, headache, pain at the injection site, muscle aches. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1630861 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (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: PTJNJFOC20210840937

Write-up: TOLERANCE (VACCINE FAILURE); This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202108-56] concerned a 60 year old female. 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, batch number: 21C11-05 expiry: UNKNOWN) 1 total, 0.5 ml, administered on 29-MAY-2021 for covid-19 immunisation. Drug start period was 32 days. No concomitant medications were reported. On 30-JUL-2021, the patient experienced tolerance (vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tolerance (vaccine failure) was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190421.; Sender''s Comments: V0: 20210840937- Covid-19 vaccine ad26.cov2.s - Tolerance (vaccine failure). This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1631910 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Suspected COVID-19
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, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210846551

Write-up: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a physician via a company representative concerned a patient of an unspecified age, sex, race and ethnic origin. 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: unknown, expiry: unknown) dose was not reported, frequency time 1 total administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 30-JUL-2021, the patient had started to experienced Covid-19 symptoms (suspected covid-19 infection) for which the patient was hospitalized for 7 days on a unspecified date. The patient was completing self-quarantine at home. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210846551-Covid-19 vaccine ad26.cov2.s-suspected covid-19 infection. 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).


VAERS ID: 1633196 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Magnetic resonance imaging, Myocarditis, Troponin, Ultrasound scan
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Creatine Kinase; Result Unstructured Data: Test Result:2500; Test Date: 20210730; Test Name: cardio MR; Result Unstructured Data: Test Result:marked myocarditis; Test Date: 20210730; Test Name: Troponin; Result Unstructured Data: Test Result:2500; Test Date: 20210730; Test Name: echo; Result Unstructured Data: Test Result:borderline norm LV with low norm LV systolic func; Comments: borderline normal LV with low normal LV systolic function
CDC Split Type: DEPFIZER INC202101026738

Write-up: Myocarditis; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100157053. An 18-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 27Jul2021 (at the age of 18years) as dose 2, 0.3ml single for Covid-19 immunization. The patient previously received the 1st dose of Comirnaty on an unspecified date for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 30Jul2021, the patient experienced myocarditis. The patient underwent lab tests and procedures on 30Jul2021 which included Creatine Kinase (blood creatine phosphokinase): 2500, cardio MRI (magnetic resonance imaging): marked myocarditis, troponin: 2500, and echo (ultrasound scan): borderline norm lv with low norm lv systolic func (borderline normal LV with low normal LV systolic function). The outcome of event was not recovered. This report is serious - hospitalization. Senders comments: Did the symptoms of the above-mentioned suspected vaccination complication reoccur in the patient without a temporal connection to the vaccination? No Was outpatient treatment necessary?: No Relatedness of drug to reaction(s)/event(s): D. Unclassifiable Batch/ lot number: unknown No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1640644 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210852094

Write-up: COUGH; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300100206] concerned a 45 year old male of unknown 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, batch number: 205C21A, expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 20:00, the patient experienced cough, and fever. The patient was hospitalized (date and days unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cough and fever was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210852094-Covid-19 vaccine ad26.cov2.s-Cough. 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). 20210852094-Covid-19 vaccine ad26.cov2.s-Fever. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1640776 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-27
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: ATJNJFOC20210851898

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician by a Regulatory Authority (EMEA EVHUMAN NLP, AT-BASGAGES-2021-041675) was received on 24-AUG-2021 and concerned a 22 year old male of unknown ethnicity and race. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and expiry date not reported, batch number: XD975) dose was not reported, 1 total administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1640777 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-27
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: ATJNJFOC20210852991

Write-up: VACCINATION FAILURE; SARS COV 2 INFECTION; This spontaneous report received from a physician by a Regulatory Authority (EMEA EVHUMAN NLP, AT-BASGAGES-2021-041684) on 24-AUG-2021 concerned a 23 year old male of unspecified race and ethnic origin. 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: XD985 expiry: UNKNOWN) dose was not reported, 1 total, administered on 25-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced vaccination failure and severe acute respiratory syndrome (SARS CoV-2) infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and severe acute respiratory syndrome (SARS CoV-2) infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1654207 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-30
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: ATJNJFOC20210852049

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via regulatory authority (AT-BASGAGES-2021-041685) on 24-AUG-2021 concerned a 24 year old male of unknown 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: XD975 expiry: UNKNOWN) dose was not reported, 1 total, administered on 28-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, experienced sars-cov-2 infection and had vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1654833 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-30
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gestational diabetes
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: Examination; Result Unstructured Data: Test Result:Fetal heartbeat had stopped
CDC Split Type: JPPFIZER INC202101058227

Write-up: Stillbirth; This is a spontaneous report from a contactable physician. A pregnant 36-year-old female (gestational period was 35 weeks) received BNT162b2 (COMIRNATY) intramuscular injection in the left arm, on 06Jul2021 at 11:00 (Lot number FA2453, Expiration date 31Aug2021), as first single dose, for COVID-19 immunization. Relevant medical history included gestational diabetes. The patient received Insulin self-injection within 2 weeks of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 29Jul2021, it was found that the fetal heartbeat had stopped, and the patient was hospitalized. On 30July2021, the patient experienced stillbirth and the exact cause of the stillbirth was unknown. The outcome of the event was unknown. It was unknown whether there was any treatment performed to the patient or not. It was unknown whether the patient had been tested for COVID-19 or not since the vaccination. The reporter classified the events as serious and stated the events resulted in hospitalization.; Sender''s Comments: Based on the close temporal association there is possibility of causal association between the event Stillbirth and the suspect drug BNT162B2.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1656635 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7011 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Hypotension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: blood pressure; Result Unstructured Data: Test Result:85/40 mmHg; Test Date: 20210730; Test Name: heart rate; Result Unstructured Data: Test Result:60
CDC Split Type: DEPFIZER INC202101055441

Write-up: Syncope; blood pressure 85/40; heart rate 60; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, WWID reported as company number DE-PEI-202100163751, received via regulatory authority. A 18-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 30Jul2021 at 18-years-old (Batch/Lot Number: FE7011) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced syncope on 30Jul2021 with outcome of recovered on 30Jul2021, blood pressure 85/40; heart rate 60 on 30Jul2021 with outcome of recovered on 30Jul2021. Result of assessment (hypotension; source: regulatory authority) - unclassifiable, Result of assessment (syncope; source: regulatory authority) - indeterminate. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1656927 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Pyrexia, Syncope, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (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:
CDC Split Type: FRPFIZER INC202101055004

Write-up: Fainting; Blurry vision; Fever; dizzying sensations; This is a spontaneous report from a contactable consumer (reporter''s daughter) downloaded from the regulatory authority number FR-AFSSAPS-PB20215179. A 14-year-old female patient received BNT162B2 (COMIRNATY; Batch/Lot number was not reported), via intramuscular route on 30Jul2021 (at the age of 14-year-old) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 30Jul2021, the patient fainted a few seconds after injection then when she woke up the patent was accompanied with blurry vision, fever, and dizzying sensations. The outcome was reported as recovered on 30Jul2021 for fainting and recovered on an unknown date in 2021 for blurry vision and dizzying sensations whereas the outcome was recovering for fever. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1663544 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E029A / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Immune thrombocytopenia, Petechiae
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Dementia (broad), Noninfectious encephalopathy/delirium (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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: not known
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101069728

Write-up: immune thrombocytopenic purpura; Anamnestic about half hour after vaccination development of petechiae first knee pit - in furthercourse upper body; Anamnestic about half hour after vaccination development of petechiae first knee pit - in furthercourse upper body; This is a spontaneous report from a contactable physician. A 16-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 30Jul2021 13:00 (at the age of 16-year-old) (Batch/Lot Number: 1E029A) as single dose for COVID-19 immunization. Medical history was unknown. Patient''s allergies were unknown. There were no concomitant medications. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced anamnestic about half hour after vaccination development of petechiae first knee pit - in further course on the upper body on 30Jul2021 14:00 with outcome of not recovered, immune thrombocytopenic purpura has been diagnosed. The adverse events result in Doctor or other healthcare professional office/clinic visit/Emergency room/department or urgent care. The events were considered medically significant. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events ITP , Petechiae and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1664099 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CYCLOGEST; FOLIC ACID; PROGYNOVA [ESTRADIOL VALERATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Infertility; Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Scan; Result Unstructured Data: Test Result:No heart beat; Comments: No heart beat at 8 week scan
CDC Split Type: GBPFIZER INC202101069251

Write-up: Maternal exposure during pregnancy first-trimester (1-12 weeks).; Miscarriage; This is a spontaneous report from a contactable consumer or other non HCP. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108170908318680-YSLOM. Safety Report Unique Identifier GB-MHRA-ADR 25809022. A 41-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Lot number was unknown), via an unspecified route of administration on 17Jul2021, as dose 2, single for COVID-19 immunisation. Medical history included suppressed lactation, pregnancy (Patient no longer pregnant at the time of reporting), infertility, and Folic acid supplementation, all were from an unknown date and unknown if ongoing. Concomitant medications included progesterone (CYCLOGEST) taken for infertility, start and stop date were not reported; folic acid, 400ug taken for vitamin supplementation, start and stop date were not reported; estradiol valerate (PROGYNOVA [ESTRADIOL VALERATE]) taken for infertility, start and stop date were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Unsure the medicine has an adverse effect on any aspect of the pregnancy. The patient previously received first dose of BNT162B2((PFIZER BIONTECH COVID-19 Vaccine, Solution for injection, Lot number was unknown), via an unknown route on unspecified date as dose 1, single for COVID-19 immunisation. The patient experienced maternal exposure during pregnancy first-trimester (1-12 weeks) on an unspecified date. On 30Jul2021, 13 days after second dose the patient had miscarriage. Patient was exposed to the medicine first-trimester (1-12 weeks). The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No - Negative COVID-19 test), scan: no heartbeat (No heartbeat at 8 week scan) on unspecified date. The outcome of the event miscarriage was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1665814 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-09-02
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: ATJNJFOC20210901340

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via regulatory authority (EVHUMAN Vaccines, AT-BASGAGES-2021-042590) on 31-AUG-2021 and concerned a 26 year old female of unknown 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: XD 975 expiry: UNKNOWN) dose was not reported, 1 total, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.


VAERS ID: 1667235 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7011 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:95/60 mmHg; Test Name: pulse; Result Unstructured Data: Test Result:32; Test Name: oxygen saturation; Test Result: 100 %; Comments: 10 min
CDC Split Type: DEPFIZER INC202101055451

Write-up: Syncope; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from theMedicines Agency (MA) EudraVigilance-WEB, regulatory authority number DE-PEI-202100163748. A 17-year-old female patient received BNT162B2 (COMIRNATY, lot number: EF7011), at the age of 17 years old, via intramusular on 30Jul2021 at single dose for COVID-19 immunisation. The patient''s medical history was not reported. There were no concomitant medications. The patient experienced syncope on 30Jul2021. The patient underwent lab tests and procedures which included blood pressure: 95/60 mmHg, pulse: 32, SaO2: 100 % 10 min. Event syncope was assessed as medically significant. Result of assessment (source: PEI) was indeterminate. The outcome of event syncope was recovered on 30Jul2021. Sender''s comment: Blood pressure 95/60, pulse 32, SaO2 100 % 10 min. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1667692 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Generalised tonic-clonic seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC202101088624

Write-up: One tonic clonic seizure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number DK-DKMA-WBS-0084967. A 12-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 30Jul2021 (Lot Number: FE2090; Expiration Date: 31Oct2021), at the age of 12-years-old, as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. There is no information regarding patient concurrent conditions. There is no information regarding past medication. On 30Jul2021, the same day as the 1st vaccination, the patient developed one tonic-clonic seizure. The event ''Tonic-clonic seizures'' was by the reporter reported as resulting in hospitalization (July and/or August 2021). There is no information regarding test results. The patient is now being examined for epilepsy. No treatment or medical procedure due to the ADRs was reported. The outcome of the event ''tonic-clonic seizures'' was recovered on 30Jul2021. Causality: The physician reported that the patient has never had a seizure before but that her mother has epilepsy. The patient is currently being examined for epilepsy. No follow-up attempts possible. No further information expected.


VAERS ID: 1667905 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-30
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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

Write-up: Nosebleed


VAERS ID: 1671102 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Hypotension
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow), 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: DEJNJFOC20210906366

Write-up: CIRCULATORY COLLAPSE; HYPOTENSION; This spontaneous report received from consumer a via Regulatory Authority (DE-PEI-202100177343) on 01-SEP-2021 and concerned a 17 year old of unspecified sex of unknown 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: XE395 expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced circulatory collapse and hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the circulatory collapse and hypotension was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: RR: 110/70 HF: 68


VAERS ID: 1671497 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-07-30
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Historical COVID-19: YES, with ENT symptoms and COVID toes.)
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: SARS-CoV-2 PCR; Test Result: Positive ; Test Date: 20201110; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Date: 20210730; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101079051

Write-up: drug ineffective; Covid-19; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-PC20213087. A 16-years-old female patient received first dose of BNT162B2 (Comirnaty, Solution for injection, Lot number: FC5435, Expiry date: 30Sep2021), via intramuscular route of administration in left arm on 18Jun2021 (at the age of 16-years-old) as 0.3 ml single for COVID-19 immunisation. The patient''s medical history included COVID-19 with ENT symptoms and COVID toes from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 30Jul2021, the patient experienced Covid-19. Symptomatic Cov2 SAR infection. The symptoms (fever, lymphadenopathy) were more intense than during her first COVID infection. Time Interval between last dose of drug and start of reaction / event was 43 days. On 10Nov2020, the patient was tested by PCR. Positive antigen test on 30Jul2021 confirmed by PCR on 31Jul202121. Search for the viral delta variant. The outcome of the event was recovering. Conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FC5435. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The 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. Follow-up (PRD/SRD 25Aug2021): This is a follow-up report from Product Complaint Team. New information provided from regulatory authority. No follow-up attempts possible. No further information expected.


VAERS ID: 1672198 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Dizziness, Foetal movement disorder, Maternal exposure during pregnancy, Nausea, Syncope, Uterine contractions during pregnancy, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow), 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: NIFEDIPINE
Current Illness:
Preexisting Conditions: Comments: Past medical history were not reported by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Nausea; Vomiting; contractions of the womb; intense fetal movement; dizzy; backbone pain; Syncope; exposure during pregnancy; This regulatory authority prospective pregnancy case was reported by a pharmacist and describes the occurrence of SYNCOPE (Syncope), MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy), UTERINE CONTRACTIONS DURING PREGNANCY (contractions of the womb), FOETAL MOVEMENT DISORDER (intense fetal movement) and DIZZINESS (dizzy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product NIFEDIPINE for an unknown indication. Past medical history were not reported by the reporter. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 and NIFEDIPINE (unknown route) 10 mg. Last menstrual period and estimated date of delivery were not provided. On 30-Jul-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy). On 02-Aug-2021, the patient experienced UTERINE CONTRACTIONS DURING PREGNANCY (contractions of the womb), FOETAL MOVEMENT DISORDER (intense fetal movement) and VOMITING (Vomiting). 02-Aug-2021, the patient experienced DIZZINESS (dizzy). On 03-Aug-2021, the patient experienced NAUSEA (Nausea). In August 2021, the patient experienced SYNCOPE (Syncope) and BACK PAIN (backbone pain). The patient was treated with METOCLOPRAMIDE HYDROCHLORIDE (PROMERAN) at a dose of 1 amp and RITODRINE HYDROCHLORIDE (ANPO) (oral) at a dose of 1 tab. At the time of the report, SYNCOPE (Syncope), UTERINE CONTRACTIONS DURING PREGNANCY (contractions of the womb), FOETAL MOVEMENT DISORDER (intense fetal movement), DIZZINESS (dizzy), BACK PAIN (backbone pain), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered SYNCOPE (Syncope), UTERINE CONTRACTIONS DURING PREGNANCY (contractions of the womb), FOETAL MOVEMENT DISORDER (intense fetal movement), DIZZINESS (dizzy), BACK PAIN (backbone pain), VOMITING (Vomiting) and NAUSEA (Nausea) to be unlikely related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient gestation period was more than 20 weeks. She was experiencing acute backbone pain of moderate degree (4-7), there is a record in 2002, AP32+4wks. Patient was advised to transfer to the emergency room of our hospital.After that, she was discharged.The doctor suspected that she was experiencing side effects from taking Nifedipine 10mg and advised to stop taking it. After she stopped, patient condition gradually improved. The patient was pregnant for nine months at that time; patient received the COVID-19 vaccine on July 30. She took medication from July 31-August 1 to save the pregnancy as patient experienced frequent contractions of the womb. patient was returned to Women''s Hospital, where she had her prenatal check-ups, for a follow up visit. The doctor said that patient symptoms of nausea, vomiting, and syncope were due to the medication for saving the pregnancy. Company Comment: This is a case of product exposure during pregnancy with some associated AEs for this 32-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the drug nifedipine is a co suspect for the events. Event syncope was automatically upgraded as a serious event as per Regulatory Authority list. However, based on the information available and as per medical judgment it is classified as Non-serious.; Sender''s Comments: This is a case of product exposure during pregnancy with some associated AEs for this 32-year-old female. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the drug nifedipine is a co suspect for the events. Event syncope was automatically upgraded as a serious event as per Regulatory Authority list. However, based on the information available and as per medical judgment it is classified as Non-serious.


VAERS ID: 1680707 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-07-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood count, Blood pressure measurement, Body mass index, Electrocardiogram, Head injury, Headache, Nausea, Orthostatic hypotension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood count; Result Unstructured Data: Test Result:Normal; Test Name: Blood pressure; Result Unstructured Data: Test Result:Low; Test Name: BMI; Result Unstructured Data: Test Result:20.1; Test Name: ECG; Result Unstructured Data: Test Result:Normal
CDC Split Type: ILPFIZER INC202101108581

Write-up: Nausea; Syncope while changing position; Head injury; Headache; Orthostatic hypotension; This is a spontaneous report received from a contactable physician via the . A 14-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration on 25Jul2021 (at the age of 14-years-old) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Jun2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. On 30Jul2021, the patient experienced syncope while changing position, head injury, headache and orthostatic hypotension. On an unspecified date, the patient experienced short nausea with no vomiting. The event syncope while changing position resulted in emergency room visit. There was still headache but no aggravation. It was reported that it was important to indicate that there was no chest pain after second vaccine administration on 25Jul2021. The patient underwent lab tests and procedures which included blood count: normal, blood pressure: low, body mass index (BMI): 20.1, and electrocardiogram (ECG): normal. Therapeutic measures were not taken as result of the events. The outcome of event headache was not recovered while the outcome of the remaining events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.


VAERS ID: 1685937 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-07-30
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER 210281 / 1 RA / OT
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UJ609AA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute febrile neutrophilic dermatosis, Alanine aminotransferase, Amylase, Angiogram, Aspartate aminotransferase, Basophil count, Bilirubin conjugated, Bilirubin urine, Biopsy, Blood alkaline phosphatase, Blood bilirubin, Blood bilirubin unconjugated, Blood calcium, Blood creatine phosphokinase, Blood creatinine, Blood iron, Blood lactate dehydrogenase, Blood magnesium, Blood parathyroid hormone, Blood phosphorus, Blood potassium, Blood sodium, Blood testosterone, Blood testosterone free, Blood thyroid stimulating hormone, Blood urea, Body temperature, C-reactive protein, Chest pain, Complement factor, Complement factor C3, Computerised tomogram, Decreased appetite, Dehydration, Eosinophil count, Erythema nodosum, Fibrin D dimer, Gamma-glutamyltransferase, Glucose urine, Haematocrit, Haemoglobin, Headache, Hepatitis B virus test, Laboratory test, Lipase, Lymphocyte count, Magnetic resonance imaging, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count, Nausea, Neutrophil count, Nitrite urine, Oestradiol, Pain in extremity, Papule, Peripheral swelling, Phonophobia, Physical examination, Platelet count, Polyuria, Procalcitonin, Protein urine, Pustule, Pyrexia, Rash macular, Red blood cell count, Red blood cell sedimentation rate, Red cell distribution width, Rheumatoid factor, SARS-CoV-2 test, Serum ferritin, Skin lesion, Smear test, Streptococcus test, Thyroxine free, Transferrin saturation, Treponema test, Tuberculin test, Upper respiratory tract infection, Urinary sediment present, Urine analysis, Urine ketone body, Urobilinogen urine, Vitamin B12, Vitamin D, Vomiting, White blood cell count
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Proteinuria (narrow), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Hypokalaemia (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: TESTOSTERONE ENANTHATE
Current Illness: Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Hydrocele; Inguinal hernia repair; Non-smoker; Polydactyly of fingers; Vasectomy (more than two years)
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: TGP (glutamic pyruvic transaminase); Test Result: 13 {DF}; Test Date: 20210805; Test Name: TGP (glutamic pyruvic transaminase); Test Result: 31 {DF}; Test Date: 20210802; Test Name: amylase; Test Result: 114 {DF}; Test Date: 20210803; Test Name: Chest CT angiograpgy; Result Unstructured Data: No signs of pulmonary thromboembolism or other significant; Test Date: 20210802; Test Name: TGO (glutamic-oxaloacetic transaminase); Test Result: 14 {DF}; Test Date: 20210805; Test Name: TGO (glutamic-oxaloacetic transaminase); Test Result: 27 {DF}; Test Date: 20210808; Test Name: TGO (glutamic-oxaloacetic transaminase); Test Result: 18 {DF}; Test Date: 20210802; Test Name: basophils; Test Result: 0.1 %; Test Date: 20210803; Test Name: basophils; Test Result: 0.0 %; Test Date: 20210804; Test Name: basophils; Test Result: 0.0 %; Test Date: 20210805; Test Name: basophils; Test Result: 0.0 %; Test Date: 20210806; Test Name: basophils; Test Result: 0.0 %; Test Date: 20210807; Test Name: basophils; Test Result: 0.1 %; Test Date: 20210808; Test Name: basophils; Test Result: 0.0 %; Test Date: 20210809; Test Name: basophils; Test Result: 0.1 %; Test Date: 20210823; Test Name: basophils; Test Result: 0.3 %; Test Date: 20210802; Test Name: bilirubin Direct; Test Result: 0.20 {DF}; Test Date: 20210805; Test Name: bilirubin Direct; Test Result: 0.23 {DF}; Test Date: 20210805; Test Name: biluribin (urine); Test Result: Negative ; Test Date: 202108; Test Name: Biopsy; Result Unstructured Data: right leg - non-specific dermal reparative alterations and right neck - neutrophilic dermatosis, favoring Sweet''s Syndrome [acute febrile neutrophilic dermatosis]; Test Date: 20210802; Test Name: ALP (Blood alkaline phosphatase); Test Result: 64 {DF}; Test Date: 20210805; Test Name: ALP (Blood alkaline phosphatase); Test Result: 50 {DF}; Test Date: 20210802; Test Name: Bilirubin Total; Test Result: 0.48 {DF}; Test Date: 20210805; Test Name: Bilirubin Total; Test Result: 0.43 {DF}; Test Date: 20210802; Test Name: bilirubin indirect; Test Result: 0.28 {DF}; Test Date: 20210805; Test Name: bilirubin indirect; Test Result: 0.20 {DF}; Test Date: 20210802; Test Name: calcium; Test Result: 9.7 {DF}; Test Date: 20210803; Test Name: calcium; Test Result: 1.30 {DF}; Test Date: 20210804; Test Name: calcium; Test Result: 1.28 {DF}; Test Date: 20210805; Test Name: calcium; Test Result: 1.26 {DF}; Test Date: 20210806; Test Name: calcium; Test Result: 1.28 {DF}; Test Date: 20210802; Test Name: CPK (creatine phosphokinase); Test Result: 322 {DF}; Test Date: 20210805; Test Name: CPK (creatine phosphokinase); Test Result: 873 {DF}; Test Date: 20210802; Test Name: creatinine; Test Result: 1.16 {DF}; Test Date: 20210803; Test Name: creatinine; Test Result: 1.12 {DF}; Test Date: 20210804; Test Name: creatinine; Test Result: 1.11 {DF}; Test Date: 20210805; Test Name: creatinine; Test Result: 1.00 {DF}; Test Date: 20210806; Test Name: creatinine; Test Result: 1.12 {DF}; Test Date: 20210808; Test Name: creatinine; Test Result: 1.03 {DF}; Test Date: 20210809; Test Name: Blood iron; Result Unstructured Data: 73 microgram per deciliter; Test Date: 20210823; Test Name: Blood iron; Result Unstructured Data: 146 microgram per deciliter; Test Date: 20210802; Test Name: DHL (lactate dehydrogenase); Test Result: 169 {DF}; Test Date: 20210804; Test Name: DHL (lactate dehydrogenase); Test Result: 198 {DF}; Test Date: 20210802; Test Name: magnesium; Test Result: 2.0 {DF}; Test Date: 20210803; Test Name: magnesium; Test Result: 2.0 {DF}; Test Date: 20210804; Test Name: magnesium; Test Result: 2.0 {DF}; Test Date: 20210805; Test Name: magnesium; Test Result: 2.0 {DF}; Test Date: 20210823; Test Name: Parathormone; Test Result: 18.3 {DF}; Test Date: 20210803; Test Name: Inorganic phosphorus; Test Result: 3.1 {DF}; Test Date: 20210804; Test Name: Inorganic phosphorus; Test Result: 3.4 {DF}; Test Date: 20210805; Test Name: Inorganic phosphorus; Test Result: 3.0 {DF}; Test Date: 20210806; Test Name: Inorganic phosphorus; Test Result: 2.7 {DF}; Test Date: 20210802; Test Name: Potassium; Test Result: 4.3 {DF}; Test Date: 20210803; Test Name: Potassium; Test Result: 4.3 {DF}; Test Date: 20210804; Test Name: Potassium; Test Result: 4.0 {DF}; Test Date: 20210805; Test Name: Potassium; Test Result: 4.2 {DF}; Test Date: 20210808; Test Name: Potassium; Test Result: 3.6 {DF}; Test Date: 20210802; Test Name: Sodium; Test Result: 139 {DF}; Test Date: 20210803; Test Name: Sodium; Test Result: 136 {DF}; Test Date: 20210804; Test Name: Sodium; Test Result: 133 {DF}; Test Date: 20210805; Test Name: Sodium; Test Result: 133 {DF}; Test Date: 20210806; Test Name: Sodium; Test Result: 139 {DF}; Test Date: 20210808; Test Name: Sodium; Test Result: 139 {DF}; Test Date: 20210823; Test Name: total testosterone; Test Result: 110.9 {DF}; Test Date: 20210823; Test Name: calculated free testosterone; Test Result: 2.85 {DF}; Test Date: 20210823; Test Name: TSH; Result Unstructured Data: 1.55 Milli-international units per litre; Test Date: 20210802; Test Name: urea; Test Result: 26 {DF}; Test Date: 20210803; Test Name: urea; Test Result: 25 {DF}; Test Date: 20210804; Test Name: urea; Test Result: 24 {DF}; Test Date: 20210805; Test Name: urea; Test Result: 22 {DF}; Test Date: 20210806; Test Name: urea; Test Result: 24 {DF}; Test Date: 20210808; Test Name: urea; Test Result: 24 {DF}; Test Date: 20210801; Test Name: Body temperature; Test Result: 38.5 {DF}; Test Date: 20210809; Test Name: Total Compliment factor; Result Unstructured Data: 145 units; Test Date: 20210809; Test Name: complement C3; Test Result: 95 {DF}; Test Date: 202108; Test Name: CT Scan (Computerised tomogram); Result Unstructured Data: No midline shifts deviations, intraparenchymal hemorrhages or extra-axial collections. No other findings in the context of the emergency. Awaiting definitive report.; Test Date: 20210802; Test Name: C -reactive protein; Test Result: 5.36 {DF}; Test Date: 20210803; Test Name: C -reactive protein; Test Result: 5.33 {DF}; Test Date: 20210804; Test Name: C -reactive protein; Test Result: 3.4 {DF}; Test Date: 20210805; Test Name: C -reactive protein; Test Result: 4.63 {DF}; Test Date: 20210806; Test Name: C -reactive protein; Test Result: 2.84 {DF}; Test Date: 20210808; Test Name: C -reactive protein; Test Result: 1.51 {DF}; Test Date: 20210809; Test Name: C -reactive protein; Test Result: 0.97 {DF}; Test Date: 20210802; Test Name: eosinophils; Test Result: 0.1 %; Test Date: 20210803; Test Name: eosinophils; Test Result: 0.0 %; Test Date: 20210804; Test Name: eosinophils; Test Result: 0.0 %; Test Date: 20210805; Test Name: eosinophils; Test Result: 0.0 %; Test Date: 20210806; Test Name: eosinophils; Test Result: 0.1 %; Test Date: 20210807; Test Name: eosinophils; Test Result: 0.0 %; Test Date: 20210808; Test Name: eosinophils; Test Result: 0.3 %; Test Date: 20210809; Test Name: eosinophils; Test Result: 1.3 %; Test Date: 20210823; Test Name: eosinophils; Test Result: 1.1 %; Test Date: 20210803; Test Name: d dimers; Result Unstructured Data: 347ng/ml FEU (fibrinogen equivalent units); Test Date: 20210802; Test Name: GAMAGT (Gamma-glutamyltransferase); Test Result: 10 {DF}; Test Date: 20210802; Test Name: GAMAGT (Gamma-glutamyltransferase); Test Result: 19 {DF}; Test Date: 20210805; Test Name: GAMAGT (Gamma-glutamyltransferase); Test Result: 66 {DF}; Test Date: 20210805; Test Name: Glucose (urine); Result Unstructured Data: less than 0.3 grams per liter; Test Date: 20210802; Test Name: hematocrit; Test Result: 43.4 %; Test Date: 20210803; Test Name: hematocrit; Test Result: 41.5 %; Test Date: 20210804; Test Name: hematocrit; Test Result: 38.5 %; Test Date: 20210805; Test Name: hematocrit; Test Result: 37.7 %; Test Date: 20210806; Test Name: hematocrit; Test Result: 40.8 %; Test Date: 20210807; Test Name: hematocrit; Test Result: 45.1 %; Test Date: 20210808; Test Name: hematocrit; Test Result: 42.3 %; Test Date: 20210809; Test Name: hematocrit; Test Result: 40.5 %; Test Date: 20210823; Test Name: hematocrit; Test Result: 42.4 %; Test Date: 20210802; Test Name: hemoglobin; Test Result: 15.1 {DF}; Test Date: 20210803; Test Name: hemoglobin; Test Result: 14.2 {DF}; Test Date: 20210804; Test Name: hemoglobin; Test Result: 13.0 {DF}; Test Date: 20210805; Test Name: hemoglobin; Test Result: 12.7 {DF}; Test Date: 20210806; Test Name: hemoglobin; Test Result: 13.9 {DF}; Test Date: 20210807; Test Name: hemoglobin; Test Result: 15.4 {DF}; Test Date: 20210808; Test Name: hemoglobin; Test Result: 14.5 {DF}; Test Date: 20210809; Test Name: hemoglobin; Test Result: 13.9 {DF}; Test Date: 20210823; Test Name: hemoglobin; Test Result: 14.0 {DF}; Test Date: 20210809; Test Name: Helatitis B serology; Result Unstructured Data: done (results not reported); Test Date: 20210802; Test Name: Intracellular antigens; Result Unstructured Data: IgG (immunoglobulin G)/IgM (immunoglobulin M)/rapid NS1(nonstructural protein 1) antigen test, dengue: not reagent;; Test Date: 20210804; Test Name: Intracellular antigens; Result Unstructured Data: IgG/IgM /quantitative rapid NS1 antigen test, dengue: not reagent; zika virus IgG/IgM not reagent; Chikungunya IgG and IgM not reagent;; Test Date: 20210808; Test Name: Intracellular antigens; Result Unstructured Data: Intracellular antigens (FAN) nuclear nonreactive; nucleolar nonreactive; metaphasic chromosome plate non reagent; cytoplasmic non reagent; mitotic apparatus mitotic apparatus unreactive; HIV1/HIV2 antibody and antigen unreactive; neutrophil cytoplasm neutrophil antibodies [(c-ANCA (cytoplasmic- Antineutrophil Cytoplasmic Antibodies) and p-ANCA (perinuclear- Antineutrophil Cytoplasmic Antibodies)] unreactive; syphilis unreactive.; Test Date: 20210809; Test Name: Intracellular antigens; Result Unstructured Data: erythrovirus b19 IgG (immunoglobulin G)greater than 46; Test Date: 20210802; Test Name: lipase; Test Result: 44 {DF}; Test Date: 20210802; Test Name: lymphocytes (Lymphocyte count); Test Result: 8.4 %; Test Date: 20210803; Test Name: lymphocytes (Lymphocyte count); Test Result: 7.5 %; Test Date: 20210804; Test Name: lymphocytes (Lymphocyte count); Test Result: 12.9 %; Test Date: 20210805; Test Name: lymphocytes (Lymphocyte count); Test Result: 16.1 %; Test Date: 20210806; Test Name: lymphocytes (Lymphocyte count); Test Result: 16.5 %; Test Date: 20210807; Test Name: lymphocytes (Lymphocyte count); Test Result: 8.8 %; Test Date: 20210808; Test Name: lymphocytes (Lymphocyte count); Test Result: 12.2 %; Test Date: 20210809; Test Name: lymphocytes (Lymphocyte count); Test Result: 24.2 %; Test Date: 20210823; Test Name: lymphocytes (Lymphocyte count); Test Result: 31.6 %; Test Date: 20210803; Test Name: MRI (Magnetic resonance imaging); Result Unstructured Data: normal; Test Date: 20210802; Test Name: mean corpuscular hemoglobin; Test Result: 30.4 ug; Test Date: 20210803; Test Name: mean corpuscular hemoglobin; Test Result: 29.9 ug; Test Date: 20210804; Test Name: mean corpuscular hemoglobin; Test Result: 29.7 ug; Test Date: 20210805; Test Name: mean corpuscular hemoglobin; Test Result: 29.5 ug; Test Date: 20210806; Test Name: mean corpuscular hemoglobin; Test Result: 29.7 ug; Test Date: 20210808; Test Name: mean corpuscular hemoglobin; Test Result: 29.7 ug; Test Date: 20210809; Test Name: mean corpuscular hemoglobin; Test Result: 29.8 ug; Test Date: 20210823; Test Name: mean corpuscular hemoglobin; Test Result: 30.1 ug; Test Date: 20210802; Test Name: MCHC (Mean cell haemoglobin concentration); Test Result: 34.8 %; Test Date: 20210803; Test Name: MCHC (Mean cell haemoglobin concentration); Test Result: 34.2 %; Test Date: 20210804; Test Name: MCHC (Mean cell haemoglobin concentration); Test Result: 33.8 %; Test Date: 20210805; Test Name: MCHC (Mean cell haemoglobin concentration); Test Result: 33.7 %; Test Date: 20210806; Test Name: MCHC (Mean cell haemoglobin concentration); Test Result: 34.8 %; Test Date: 20210807; Test Name: MCHC (Mean cell haemoglobin concentration); Test Result: 34.1 %; Test Date: 20210808; Test Name: MCHC (Mean cell haemoglobin concentration); Test Result: 32.3 %; Test Date: 20210809; Test Name: MCHC (Mean cell haemoglobin concentration); Test Result: 34.3 %; Test Date: 20210823; Test Name: MCHC (Mean cell haemoglobin concentration); Test Result: 32.9 %; Test Date: 20210802; Test Name: MCV (Mean cell volume); Result Unstructured Data: 87.3 per square microns; Test Date: 20210803; Test Name: MCV (Mean cell volume); Result Unstructured Data: 87.4 per square microns; Test Date: 20210804; Test Name: MCV (Mean cell volume); Result Unstructured Data: 87.9 per square microns; Test Date: 20210805; Test Name: MCV (Mean cell volume); Result Unstructured Data: 87.5 per square microns; Test Date: 20210806; Test Name: MCV (Mean cell volume); Result Unstructured Data: 87.2 per square microns; Test Date: 20210807; Test Name: MCV (Mean cell volume); Result Unstructured Data: 87.6 per square microns; Test Date: 20210808; Test Name: MCV (Mean cell volume); Result Unstructured Data: 86.7 per square microns; Test Date: 20210809; Test Name: MCV (Mean cell volume); Result Unstructured Data: 86.7 per square microns; Test Date: 20210823; Test Name: MCV (Mean cell volume); Result Unstructured Data: 91.5 per square microns; Test Date: 20210802; Test Name: MPV (mean platelet volume); Test Result: 10.4 {DF}; Test Date: 20210803; Test Name: MPV (mean platelet volume); Test Result: 10.4 {DF}; Test Date: 20210804; Test Name: MPV (mean platelet volume); Test Result: 10.3 {DF}; Test Date: 20210805; Test Name: MPV (mean platelet volume); Test Result: 10.3 {DF}; Test Date: 20210806; Test Name: MPV (mean platelet volume); Test Result: 10.4 {DF}; Test Date: 20210823; Test Name: MPV (mean platelet volume); Test Result: 9.7 {DF}; Test Date: 20210802; Test Name: monocytes (Monocyte count); Test Result: 8.6 %; Test Date: 20210803; Test Name: monocytes (Monocyte count); Test Result: 8.7 %; Test Date: 20210804; Test Name: monocytes (Monocyte count); Test Result: 2.3 %; Test Date: 20210805; Test Name: monocytes (Monocyte count); Test Result: 3.4 %; Test Date: 20210806; Test Name: monocytes (Monocyte count); Test Result: 7.3 %; Test Date: 20210807; Test Name: monocytes (Monocyte count); Test Result: 0.5 %; Test Date: 20210808; Test Name: monocytes (Monocyte count); Test Result: 7.3 %; Test Date: 20210809; Test Name: monocytes (Monocyte count); Test Result: 7.5 %; Test Date: 20210823; Test Name: monocytes (Monocyte count); Test Result: 5.0 %; Test Date: 20210802; Test Name: neutrophils; Test Result: 82.8 %; Test Date: 20210803; Test Name: neutrophils; Test Result: 83.8 %; Test Date: 20210804; Test Name: neutrophils; Test Result: 84.8 %; Test Date: 20210805; Test Name: neutrophils; Test Result: 80.5 %; Test Date: 20210806; Test Name: neutrophils; Test Result: 76.1 %; Test Date: 20210807; Test Name: neutrophils; Test Result: 90.6 %; Test Date: 20210808; Test Name: neutrophils; Test Result: 80.2 %; Test Date: 20210809; Test Name: neutrophils; Test Result: 66.9 %; Test Date: 20210823; Test Name: neutrophils; Test Result: 62.0 %; Test Date: 20210805; Test Name: Nitirite (Urine); Test Result: Negative ; Test Date: 20210823; Test Name: estradiol; Test Result: 5.79 {DF}; Test Date: 202108; Test Name: Physical exam; Result Unstructured Data: Regular general state, awake and oriented, pale, hydrated, anicteric, acyanotic, eupneic and afebrile. Apparatus Cardiovascular system: regular heartbeat with two clicks, normal heart sounds, no murmurs. Respiratory system: audible vesicular murmur bilaterally, without adventitious sounds. Abdomen: flaccid, painless on palpation. Hydroaereal sounds were present.; Test Date: 20210802; Test Name: Platelets; Test Result: 218000 {DF}; Test Date: 20210803; Test Name: Platelets; Test Result: 240000 {DF}; Test Date: 20210804; Test Name: Platelets; Test Result: 218000 {DF}; Test Date: 20210805; Test Name: Platelets; Test Result: 244000 {DF}; Test Date: 20210806; Test Name: Platelets; Test Result: 259000 {DF}; Test Date: 20210807; Test Name: Platelets; Test Result: 286000 {DF}; Test Date: 20210808; Test Name: Platelets; Test Result: 342000 {DF}; Test Date: 20210809; Test Name: Platelets; Test Result: 309000 {DF}; Test Date: 20210823; Test Name: Platelets; Test Result: 256000 {DF}; Test Date: 20210805; Test Name: Procalcitonin; Test Result: 0.12 {DF}; Test Date: 20210805; Test Name: Protein (urine); Result Unstructured Data: about 0.25 grams per liter; Test Date: 20210802; Test Name: erythrocyte count; Test Result: 4.97 {DF}; Test Date: 20210803; Test Name: erythrocyte count; Test Result: 4.75 {DF}; Test Date: 20210804; Test Name: erythrocyte count; Test Result: 4.38 {DF}; Test Date: 20210805; Test Name: erythrocyte count; Test Result: 4.31 {DF}; Test Date: 20210806; Test Name: erythrocyte count; Test Result: 4.68 {DF}; Test Date: 20210807; Test Name: erythrocyte count; Test Result: 5.15 {DF}; Test Date: 20210808; Test Name: erythrocyte count; Test Result: 4.88 {DF}; Test Date: 20210809; Test Name: erythrocyte count; Test Result: 4.67 {DF}; Test Date: 20210823; Test Name: erythrocyte count; Test Result: 4.64 {DF}; Test Date: 20210807; Test Name: erythrocyte sedimentation; Test Result: 47 mm; Test Date: 20210808; Test Name: erythrocyte sedimentation; Test Result: 17 mm; Test Date: 20210809; Test Name: erythrocyte sedimentation; Test Result: 17 mm; Test Date: 20210802; Test Name: RDW (Red cell distribution width); Test Result: 13.1 %; Test Date: 20210803; Test Name: RDW (Red cell distribution width); Test Result: 13 %; Test Date: 20210804; Test Name: RDW (Red cell distribution width); Test Result: 13.2 %; Test Date: 20210805; Test Name: RDW (Red cell distribution width); Test Result: 12.9 %; Test Date: 20210806; Test Name: RDW (Red cell distribution width); Test Result: 13.1 %; Test Date: 20210807; Test Name: RDW (Red cell distribution width); Test Result: 13.0 %; Test Date: 20210808; Test Name: RDW (Red cell distribution width); Test Result: 13.2 %; Test Date: 20210809; Test Name: RDW (Red cell distribution width); Test Result: 13.3 %; Test Date: 20210823; Test Name: RDW (Red cell distribution width); Test Result: 13.4 %; Test Date: 20210809; Test Name: Rheumatoid factor; Result Unstructured Data: 20 IU/nL(international unit per nano liter); Test Date: 20210823; Test Name: Rheumatoid factor; Result Unstructured Data: 14.9 IU/nL; Test Date: 20210802; Test Name: PCR test for Covid-19; Test Result: Negative ; Test Date: 20210803; Test Name: PCR test for Covid-19; Test Result: Negative ; Test Date: 20210823; Test Name: Serum ferritin; Test Result: 351.10 {DF}; Test Date: 20210809; Test Name: Smear test; Result Unstructured Data: done (results not reported); Test Date: 20210808; Test Name: ASLO; Test Result: 55 {DF}; Test Date: 20210823; Test Name: Free T4; Test Result: 1.70 {DF}; Test Date: 20210809; Test Name: Transferrin saturation; Result Unstructured Data: 73 microgram per deciliter (30 percent); Test Date: 20210808; Test Name: VDRL Test (Venereal disease research laboratory test); Result Unstructured Data: Done (results not reported); Test Date: 202108; Test Name: PPD (Tuberculin test); Result Unstructured Data: done (results not reporetd); Test Date: 20210805; Test Name: epithelial cells (urine); Result Unstructured Data: leukocytes less than 10,000/mL, erythrocytes less than10,000/mL and absent cylinders Note: Presence of amorphous crystals; Test Date: 20210805; Test Name: Type I Urine; Result Unstructured Data: urine: yellow color, appearance: slightly turbid; PH 8; density 1.010; Test Date: 20210805; Test Name: Ketone bodies (urine); Test Result: Negative ; Test Date: 20210805; Test Name: urobilinogen; Result Unstructured Data: less than 1.0 milligram per deciliter; Test Date: 20210823; Test Name: Vitamin B12; Test Result: 439 {DF}; Test Date: 20210823; Test Name: 25-hydroxy vitamin D; Result Unstructured Data: 25-hydroxy vitamin D (33.8 nanogram per milliliter); Test Date: 20210802; Test Name: leukocytes (leukocyte count); Test Result: 10690 {DF}; Test Date: 20210803; Test Name: leukocytes (leukocyte count); Test Result: 12700 {DF}; Test Date: 20210804; Test Name: leukocytes (leukocyte count); Test Result: 11500 {DF}; Test Date: 20210805; Test Name: leukocytes (leukocyte count); Test Result: 10840 {DF}; Test Date: 20210806; Test Name: leukocytes (leukocyte count); Test Result: 9680 {DF}; Test Date: 20210807; Test Name: leukocytes (leukocyte count); Test Result: 11380 {DF}; Test Date: 20210808; Test Name: leukocytes (leukocyte count); Test Result: 11310 {DF}; Test Date: 20210809; Test Name: leukocytes (leukocyte count); Test Result: 10890 {DF}; Test Date: 20210823; Test Name: leukocytes (leukocyte count); Test Result: 8060 {DF}
CDC Split Type: BRSA2021SA285288

Write-up: phonophobia worsening with movement, with progressive worsening; ventilator-dependent chest pain; vomiting; loss of appetite; fever 38.5 degree Clesius; legs from the knee down and ankles also began to pain; legs from the knee down and ankles became swollen; reddish patches that hurt to the touch macular skin rash; erythema nodosum/ presence of painful erythematous nodules in the lower limbs and bilaterally/ erythematous subcutaneous nodules in legs; Sweet''s syndrome; headache which was increasing in intensity/Bilateral frontal Cephalea, throbbing type/ holocranial headache; dehydration; nausea; edematous papules with pseudo vesiculation; Skin lesion/ sparse central ulceration on the neck, back and left forearm, and a pustule on the right leg; Diuresis present; pustule on the right leg; upper airway infection; Initial information was received on 25-Aug-2021 regarding an unsolicited valid serious courtesy case received from a consumer/ non-healthcare professional (patient). This case involves a 38-years-old male patient (height: 186 cm and weight: 92 kg) who had upper airway infection (upper respiratory infection), Sweet''s Syndrome, headache which was increasing in intensity, the patient had holocranial headache, mild to moderate intensity, frontal cephalea, throbbing type (headache), dehydration, diuresis present (polyuria), pustule on the right leg (pustule), nausea, skin lesion/sparse central ulceration on the neck, back and left forearm (skin lesion), edematous papules with pseudo vesiculation (papule), feverreached 38.5 degree Celsius (pyrexia), legs from the , knee down and ankles also began to pain, became swollen [(pain in extremity) and (peripheral swelling)], reddish patches that hurt to the touch macular skin rash (rash macular), ventilator-dependent chest pain (chest pain), erythema nodosum/ presence of painful erythematous nodules in the lower limbs and bilaterally/erythematous subcutaneous nodules in legs (erythema nodosum), phonophobia worsening with movement, with progressive worsening (phonophobia), vomiting and loss of appetite (decreased appetite) after receiving INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and COVID-19 VACCINE INACT (VERO) CZ02 [CORONAVAC]. The patient''s medical history included vasectomy, inguinal hernia repair, hydrocele and polydactyly of fingers. The patient''s past medical treatments, vaccinations and family history were not provided. The patient allergic to benzetacil (Penicillin G benzathine), does not smoke (non-tobacco user), and does not use drugs or alcohol. Concomitant medications included TESTOSTERONE ENANTHATE (TESTOSTERONE ENANTHATE) (1ml per week intramuscularly) for unknown indication, "Omega 3" and "Multivitamins". It was reported, before the symptoms, the patient had applied four doses spread over four weeks, (1 ml on each Sunday); he also took Omega 3 and a multivitamin concomitantly. On 22-Apr-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number: UJ609AA; expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination. On 23-Jul-2021, the patient received a first dose of suspect COVID-19 VACCINE INACT (VERO) CZ02 [CORONAVAC] not produced by Sanofi Pasteur (lot number: 210281; expiry date: not reported) via unknown route in the right arm for prophylactic vaccination. On 30-Jul-2021, the patient developed a serious headache which was increasing in intensity, the patient had holocranial headache, mild to moderate intensity, frontal cephalea, throbbing type (headache) 3 months 8 days following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and 7 days following the administration of CORONAVAC. The patient was hospitalized for these events. The patient used metamizole and paracetamol as treatment but without success as reported. On 01- Aug-2021 the patient developed a serious fever, fever reached 38.5 degree Celsius (pyrexia), legs from the knee down and ankles also began to pain, became swollen [(pain in extremity) and (peripheral swelling)], reddish patches that hurt to the touch (rash macular), erythema nodosum/presence of painful erythematous nodules in the lower limbs and bilaterally/erythematous subcutaneous nodules in legs (erythema nodosum) 3 months 10 days following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and 9 days following the administration of CORONAVAC. The patient was hospitalized for these events. For treatment of these events the patient continued to use Paracetamol and/or Metamizole. On 02-Aug-2021 the patient developed a serious vomiting and loss of appetite (decreased appetite) 3 months 11 days following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and 10 days following the administration of CORONAVAC. The patient was hospitalized on the same day this event occurred. On an unknown date in Aug -2021, the patient developed a serious phonophobia worsening with movement, with progressive worsening (phonophobia) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and CORONAVAC. The patient was hospitalized for this event. On an unknown date in 2021, the patient developed a serious dehydration, diuresis present (polyuria), pustule on the right leg (pustule), nausea, skin lesion/sparse central ulceration on the neck, back and left forearm (skin lesion), edematous papules with pseudo vesiculation (papule) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and CORONAVAC. The patient was hospitalized for these events. On an unknown date in 2021, the patient had non-serious upper airway infection (upper respiratory infection) unknown latency following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and CORONAVAC. Also, the patient underwent Polymerase chain reaction (PCR) test for Corona virus disease-19 (Covid-19) with a negative result. On the same date on 02-Aug-2021, the patient sought medical attention at the hospital due to the persistence of the events, the patient received an unspecified medication and saline solution due to dehydration. According to the doctor who attended the patient, suspected that the Covid-19 test might have given a false-negative result, requesting the test to be performed again. However, due to the persistence of symptoms, the patient had to be admitted to the same hospital. Due to the persistence of symptoms, the patient had to be admitted to the same hospital. On physical exam it was revealed - Regular general state, awake and oriented, pale, hydrated, anicteric, acyanotic, eupneic and afebrile. Apparatus Cardiovascular system: regular heartbeat with two clicks, normal heart sounds, no murmurs. Respiratory system: audible vesicular murmur bilaterally, without adventitious sounds. Abdomen: flaccid, painless on palpation. Hydroaereal sounds were present. Absence of masses or visceromegaly. Extremities: symmetrical, absence of jamming edema pulse palpable and symmetrical. The patient was suggested of the exams to investigate dengue, zika and chikungunya but all results were negative. Also, and according to the patient received treatment (not specified) the pains continued, improving only in the fifth day of hospitalization after administration of the drug Bextra (valdecoxib). On an unknown date in Aug-2021, upon re-evaluation, the patient reported maintaining headache, and reported onset of ventilator-dependent chest pain (chest pain) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and CORONAVAC. Also, it was reported the patient did not have this type of headache before. On an unknown date in Aug-2021, the patient was using DECADRON, NOVALGINA, TYLENOL, AND TRAMAL remains in case of emergency, but the patient reported no need for its use at the moment. On an unknown date in Aug-2021, the reddish spots were increasing, it was requested an evaluation by a dermatologist, who suspected Sweet''s Syndrome (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and CORONAVAC. This event was assessed as medically significant. Diagnosis impression was erythema nodosum secondary to neutrophilic dermatosis: Sweet''s syndrome and Pyoderma Pustulosum of question. Due to this, a biopsy was requested of the right leg and of a rash on the right side of the neck. On an unknown date in Aug, the biopsy was performed of the right leg and of a rash on the right side of the neck. On an unknown date, the patient sought care with dermatologist to present the result of the biopsy, where he informed that the doctor could not identify the cause of the syndrome, only said that one of the forms of manifestation of this disease was a contact with a virus, even if inactivated, therefore, not ruling out the vaccine as the suspect. On 09-Aug-2021 the biopsy report was available: right leg, biopsy: reparative dermal alterations, nonspecific, and skin, right cervical, biopsy: neutrophilic dermatosis, favoring SWEET syndrome. Replaced dexamethasone intravenously with Oral prednisone 40mg, maintain for 10 days and weaning. This was further reported as, after diagnosis the patient started treatment with prednisone 20 mg, 2 tablets in the first 8 days, 1 tablet from the ninth day and half a pill between the fourteenth and nineteenth day, patient emphasizes that at his hospitalization he was already receiving treatment with corticoids as well. He denied diarrhea and anosmia. No antibiotics were ever used. Neurological exam normal and absence of stiffness in the nape of the neck. Conduct: If no cause was found for the current symptom, request a new neurological evaluation. Have generated a considerable improvement in symptoms. He was at oriented in time and space. Breathing in room air, eupneic. Hemodynamically stable. Accepting oral diet. Diuresis present. Afebrile more than 48 hours. Relevant laboratory test results included: Alanine aminotransferase - On 02-Aug-2021: 13 U/L; on 05-Aug-2021: 31 U/L (microns per liter) Amylase - On 02-Aug-2021: 114 U/L Angiogram - On 03-Aug-2021: [No signs of pulmonary thromboembolism or other significant] Aspartate aminotransferase - On 02-Aug-2021: 14 U/L; on 05-Aug-2021: 27 U/L; on 08-Aug-2021: 18 U/L Basophil count - On 02-Aug-2021: 0.1 percent; on 03-Aug-2021: 0.0 percent; on 04-Aug-2021: 0.0 percent; on 05-Aug-2021: 0.0 percent; on 06-Aug-2021: 0.0 percent; on 07-Aug-2021: 0.1 percent; on 08-Aug-2021: 0.0 percent; on 09-Aug-2021: 0.1 percent; on 23-Aug-2021: 0.3 percent Bilirubin conjugated - On 02-Aug-2021: 0.20 mg/dL; on 05-Aug-2021: 0.23 mg/dL Bilirubin urine - On 05-Aug-2021: Negative Biopsy - In August 2021: [right leg - non-specific dermal reparative alterations and right neck - neutrophilic dermatosis, favoring Sweet''s Syndrome [acute febrile neutrophilic dermatosis]] Blood alkaline phosphatase - On 02-Aug-2021: 64 U/L; on 05-Aug-2021: 50 U/L Blood bilirubin - On 02-Aug-2021: 0.48 mg/dL; on 05-Aug-2021: 0.43 mg/dL (microgram per deciliter) Blood bilirubin unconjugated - On 02-Aug-2021: 0.28 mg/L; on 05-Aug-2021: 0.20 mg/L Blood calcium - On 02-Aug-2021: 9.7 mg/dL; on 03-Aug-2021: 1.30 mg/dL; on 04-Aug-2021: 1.28 mg/dL; on 05-Aug-2021: 1.26 mg/dL; on 06-Aug-2021: 1.28 mg/dL Blood creatine phosphokinase - On 02-Aug-2021: 322 U/L; on 05-Aug-2021: 873 U/L Blood creatinine - On 02-Aug-2021: 1.16 mg/dL; on 03-Aug-2021: 1.12 mg/dL; on 04-Aug-2021: 1.11 mg/dL; on 05-Aug-2021: 1.00 mg/dL; on 06-Aug-2021: 1.12 mg/dL; on 08-Aug-2021: 1.03 mg/dL Blood iron - On 09-Aug-2021: [73 microgram per deciliter]; on 23-Aug-2021: [146 microgram per deciliter] Blood lactate dehydrogenase - On 02-Aug-2021: 169 U/L; on 04-Aug-2021: 198 U/L Blood magnesium - On 02-Aug-2021: 2.0 mg/dL; on 03-Aug-2021: 2.0 mg/dL; on 04-Aug-2021: 2.0 mg/dL; on 05-Aug-2021: 2.0 mg/dL Blood parathyroid hormone - On 23-Aug-2021: 18.3 pg/mL (picogram per milliliter) Blood phosphorus - On 03-Aug-2021: 3.1 mg/dL; on 04-Aug-2021: 3.4 mg/dL; on 05-Aug-2021: 3.0 mg/dL; on 06-Aug-2021: 2.7 mg/dL Blood potassium - On 02-Aug-2021: 4.3 meq/L; on 03-Aug-2021: 4.3 meq/L; on 04-Aug-2021: 4.0 meq/L; on 05-Aug-2021: 4.2 meq/L; on 08-Aug-2021: 3.6 meq/L (milliequivalent per liter) Blood sodium - On 02-Aug-2021: 139 meq/L; on 03-Aug-2021: 136 meq/L; on 04-Aug-2021: 133 meq/L; on 05-Aug-2021: 133 meq/L; on 06-Aug-2021: 139 meq/L; on 08-Aug-2021: 139 meq/L Blood testosterone - On 23-Aug-2021: 110.9 ng/dL (nanogram per deciliter) Blood testosterone free - On 23-Aug-2021: 2.85 ng/dL Blood thyroid stimulating hormone - On 23-Aug-2021: [1.55 Milli-international units per litre] Blood urea - On 02-Aug-2021: 26 mg/dL; on 03-Aug-2021: 25 mg/dL; on 04-Aug-2021: 24 mg/dL; on 05-Aug-2021: 22 mg/dL; on 06-Aug-2021: 24 mg/dL; on 08-Aug-2021: 24 mg/dL C-reactive protein - On 02-Aug-2021: 5.36 mg/L; on 03-Aug-2021: 5.33 mg/L; on 04-Aug-2021: 3.4 mg/L; on 05-Aug-2021: 4.63 mg/L; on 06-Aug-2021: 2.84 mg/L; on 08-Aug-2021: 1.51 mg/L; on 09-Aug-2021: 0.97 mg/L Complement factor - On 09-Aug-2021: [145 units] Complement factor C3 - On 09-Aug-2021: 95 mg/dL Computerized tomogram - In August 2021: [No midline shifts deviations, intraparenchymal hemorrhages or extra-axial collections. No other findings in the context of the emergency. Awaiting definitive report.] Eosinophil count - On 02-Aug-2021: 0.1 percent; on 03-Aug-2021: 0.0 percent; on 04-Aug-2021: 0.0 percent; on 05-Aug-2021: 0.0 percent; on 06-Aug-2021: 0.1 percent; on 07-Aug-2021: 0.0 percent; on 08-Aug-2021: 0.3 percent; on 09-Aug-2021: 1.3 percent; on 23-Aug-2021: 1.1 percent Fibrin D dimer - On 03-Aug-2021: [347ng/ml FEU (fibrinogen equivalent units)] Gamma-glutamyltransferase - On 02-Aug-2021: 10 U/L then 19 U/L; on 05-Aug-2021: 66 U/L Glucose urine - On 05-Aug-2021: [less than 0.3 grams per liter] Haematocrit - On 02-Aug-2021: 43.4 percent; on 03-Aug-2021: 41.5 percent; on 04-Aug-2021: 38.5 percent; on 05-Aug-2021: 37.7 percent; on 06-Aug-2021: 40.8 percent; on 07-Aug-2021: 45.1 percent; on 08-Aug-2021: 42.3 percent; on 09-Aug-2021: 40.5 percent; on 23-Aug-2021: 42.4 percent. Haemoglobin - On 02-Aug-2021: 15.1 g/dL; on 03-Aug-2021: 14.2 g/dL; on 04-Aug-2021: 13.0 g/dL; on 05-Aug-2021: 12.7 g/dL; on 06-Aug-2021: 13.9 g/dL; on 07-Aug-2021: 15.4 g/dL; on 08-Aug-2021: 14.5 g/dL; on 09-Aug-2021: 13.9 g/dL; on 23-Aug-2021: 14.0 g/dL. Hepatitis B virus test - On 09-Aug-2021: [done (results not reported)]. Laboratory test - On 02-Aug-2021: [ Immunoglobulin G (IgG)/ Immunoglobulin M (IgM)/rapid NS1nonstructural protein 1) antigen test, dengue: not reagent;]; on 04-Aug-2021: [IgG/IgM /quantitative rapid NS1 antigen test, dengue: not reagent; zika virus IgG/IgM not reagent; Chikungunya IgG and IgM not reagent;]; on 08-Aug-2021: [Intracellular antigens (FAN) nuclear nonreactive; nucleolar nonreactive; metaphasic chromosome plate non reagent; cytoplasmic non reagent; mitotic apparatus mitotic apparatus unreactive; human immunodeficiency virus (HIV) 1/ HIV 2 antibody and antigen unreactive; neutrophil cytoplasm neutrophil antibodies [cytoplasmic- Antineutrophil Cytoplasmic Antibodies (c-ANCA) and perinuclear- Antineutrophil Cytoplasmic Antibodies (p-ANCA)] unreactive; syphilis unreactive.]; on 09-Aug-2021: [erythrovirus b19 IgG immunoglobulin G) greater than 46]. Lipase - On 02-Aug-2021: 44 U/L. Lymphocyte count - On 02-Aug-2021: 8.4 percent; on 03-Aug-2021: 7.5 percent; on 04-Aug-2021: 12.9 percent; on 05-Aug-2021: 16.1 percent; on 06-Aug-2021: 16.5 percent; on 07-Aug-2021: 8.8 percent; on 08-Aug-2021: 12.2 percent; on 09-Aug-2021: 24.2 percent; on 23-Aug-2021: 31.6 percent. Magnetic resonance imaging - On 03-Aug-2021: [normal]. Mean cell haemoglobin - On 02-Aug-2021: 30.4 ug; on 03-Aug-2021: 29.9 ug; on 04-Aug-2021: 29.7 ug; on 05-Aug-2021: 29.5 ug; on 06-Aug-2021: 29.7 ug; on 08-Aug-2021: 29.7 ug; on 09-Aug-2021: 29.8 ug; on 23-Aug-2021: 30.1 ug. Mean cell haemoglobin concentration - On 02-Aug-2021: 34.8 percent; on 03-Aug-2021: 34.2 percent; on 04-Aug-2021: 33.8 percent; on 05-Aug-2021: 33.7 percent; on 06-Aug-2021: 34.8 percent; on 07-Aug-2021: 34.1 percent; on 08-Aug-2021: 32.3 percent; on 09-Aug-2021: 34.3 percent; on 23-Aug-2021: 32.9 percent. Mean cell volume - On 02-Aug-2021: [87.3 per square microns]; on 03-Aug-2021: [87.4 per square microns]; on 04-Aug-2021: [87.9 per square microns]; on 05-Aug-2021: [87.5 per square microns]; on 06-Aug-2021: [87.2 per square microns]; on 07-Aug-2021: [87.6 per square microns]; on 08-Aug-2021: [86.7 per square microns]; on 09-Aug-2021: [86.7 per square microns]; on 23-Aug-2021: [91.5 per square microns]. Mean platelet volume - On 02-Aug-2021: 10.4 per cubic millimeter; on 03-Aug-2021: 10.4 per cubic millimeter; on 04-Aug-2021: 10.3 per cubic millimeter; on 05-Aug-2021: 10.3 per cubic millimeter; on 06-Aug-2021: 10.4 per cubic millimeter; on 23-Aug-2021: 9.7 per cubic millimeter. Monocyte count - On 02-Aug-2021: 8.6 percent; on 03-Aug-2021: 8.7 percent; on 04-Aug-2021: 2.3 percent; on 05-Aug-2021: 3.4 percent; on 06-Aug-2021: 7.3 percent; on 07-Aug-2021: 0.5 percent; on 08-Aug-2021: 7.3 percent; on 09-Aug-2021: 7.5 percent; on 23-Aug-2021: 5.0 percent. Neutrophil count - On 02-Aug-2021: 82.8 percent; on 03-Aug-2021: 83.8 percent; on 04-Aug-2021: 84.8 percent; on 05-Aug-2021: 80.5 percent; on 06-Aug-2021: 76.1 percent; on 07-Aug-2021: 90.6 percent; on 08-Aug-2021: 80.2 percent; on 09-Aug-2021: 66.9 percent; on 23-Aug-2021: 62.0 percent. Nitrite urine - On 05-Aug-2021: Negative. Oestradiol - On 23-Aug-2021: 5.79 pg/mL. Physical examination - In August 2021: [Regular general state, awake and oriented, pale, hydrated, anicteric, acyanotic, eupneic and afebrile. Apparatus Cardiovascular system: regular heartbeat with two clicks, normal heart sounds, no murmurs. Respiratory system: audible vesicular murmur bilaterally, without adventitious sounds. Abdomen: flaccid, painless on palpation. Hydroaereal sounds were present]. Platelet count - On 02-Aug-2021: 218000 per cubic millimeter; on 03-Aug-2021: 240000 per cubic millimeter (per cubic millimeter); on 04-Aug-2021: 218000 per cubic millimeter; on 05-Aug-2021: 244000 per cubic millimeter; on 06-Aug-2021: 259000 per cubic millimeter; on 07-Aug-2021: 286000 per cubic millimeter; on 08-Aug-2021: 342000 per cubic millimeter; on 09-Aug-2021: 309000 per cubic millimeter; on 23-Aug-2021: 256000 per cubic millimeter. Procalcitonin - On 05-Aug-2021: 0.12 ng/mL. Protein urine - On 05-Aug-2021: [about 0.25 grams per liter]. Red blood cell count - On 02-Aug-2021: 4.97 million per cubic millimeter; on 03-Aug-2021: 4.75 million per cubic millimeter; on 04-Aug-2021: 4.38 million per cubic millimeter; on 05-Aug-2021: 4.31 million per cubic millimeter; on 06-Aug-2021: 4.68 million per cubic millimeter; on 07-Aug-2021: 5.15 million per cubic millimeter; on 08-Aug-2021: 4.88 million per cubic millimeter; on 09-Aug-2021: 4.67 million per cubic millimeter; on 23-Aug-2021: 4.64 million per cubic millimeter. Red blood cell sedimentation rate - On 07-Aug-2021: 47 mm; on 08-Aug-2021: 17 mm (millimeter); on 09-Aug-2021: 17 mm. Red cell distribution width - On 02-Aug-2021: 13.1 percent; on 03-Aug-2021: 13 percent; on 04-Aug-2021: 13.2 percent; on 05-Aug-2021: 12.9 percent; on 06-Aug-2021: 13.1 percent; on 07-Aug-2021: 13.0 percent; on 08-Aug-2021: 13.2 percent; on 09-Aug-2021: 13.3 percent; on 23-Aug-2021: 13.4 percent. Rheumatoid factor - On 09-Aug-2021: [20 IU/nL (international unit per nano liter)]; on 23-Aug-2021: [14.9 IU/nL]. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test - On 02-Aug-2021: Negative; on 03-Aug-2021: Negative. Serum ferritin - On 23-Aug-2021: 351.10 ng/mL Smear test - On 09-Aug-2021: [done (results not reported)] Streptococcus test - On 08-Aug-2021: 55 iU/mL (international unit per milliliter). Thyroxine free - On 23-Aug-2021: 1.70 ng/dL. Transferrin saturation - On 09-Aug-2021: [73 microgram per deciliter (30 percent)]. Treponema test - On 08-Aug-2021: [Done (results not reported)]. Tuberculin test - In August 2021: [done (results not reported)]. Urinary sediment present - On 05-Aug-2021: [leukocytes less than 10,000/mL, erythrocytes less than10,000/mL and absent cylinders Note: Presence of amorphous crystals]. Urine analysis - On 05-Aug-2021: [urine: yellow color, appearance: slightly turbid; PH 8; density 1.010]. Urine ketone body - On 05-Aug-2021: Negative. Urobilinogen urine - On 05-Aug-2021: [less than 1.0 milligram per deciliter]. Vitamin B12 - On 23-Aug-2021: 439 pg/mL. Vitamin D - On 23-Aug-2021: [25-hydroxy vitamin D (33.8 nanogram per milliliter)]. White blood cell count - On 02-Aug-2021: 10690 per cubic millimeter; on 03-Aug-2021: 12700 per cubic millimeter; on 04-Aug-2021: 11500 per cubic millimeter; on 05-Aug-2021: 10840 per cubic millimeter; on 06-Aug-2021: 9680 per cubic millimeter; on 07-Aug-2021: 11380 per cubic millimeter; on 08-Aug-2021: 11310 per cubic millimeter; on 09-Aug-2021: 10890 per cubic millimeter; on 23-Aug-2021: 8060 per cubic millimeter. The patient was treated with PARACETAMOL (from 30-Jul-2021), METAMIZOLE (from: 30-Jul-2021) for Headache, Erythema nodosum, Pain in extremity, Peripheral swelling, Pyrexia, Arthralgia and Rash macular, VALDECOXIB (BEXTRA) (from: AUG-2021) for Headache, Arthralgia and Pain in extremity, PREDNISONE, for Acute febrile neutrophilic dermatosis, DEXAMETHASONE (from: AUG-2021); DEXAMETHASONE (DECADRON) (from: AUG-2021) for Headache, METAMIZOLE SODIUM (NOVALGINA) (from: AUG-2021), PARACETAMOL (TYLENOL) (from: AUG-2021) and TRAMADOL HYDROCHLORIDE (TRAMAL) (from: AUG-2021). The patient was discharged from the hospital on 10-Aug-2021. The patient complements that the doctor''s final report suggests the Sweet Syndrome, due to the skin lesions and the result of the biopsy, and that currently using corticoids (unspecified) the picture was evolving to a progressive improvement, and the second dose of the same would be postponed to 06-Sep-2021. The patient had an expressive improvement and had already finished the treatment with corticoids. The outcome of the event was unknown for the event upper respiratory infection. At the time of this report the patient was not recovered from the event polyurea. On an unknown date in Aug-2021, the patient recovered from the events headache and pyrexia. The patient was recovering from all the other events at the time of reporting.; Sender''s Comments: This case concerns a 38-years-old male patient who had Sweet''s Syndrome, headache, dehydration, polyuria, pustule, nausea, skin lesion, papule, pyrexia, pain in extremity, peripheral swelling, rash macular, erythema nodosum, phonophobia, vomiting, decreased appetite, chest pain and upper respiratory infection after vaccination with FLUZONE and CORONAVAC (not produced by Sanofi Pasteur). The time to onset is compatible with the role of the vaccines for the events headache, pyrexia, pain in extremity, arthralgia, peripheral swelling, rash macular, erythema nodosum, decreased appetite and vomiting. The time to onset is unknown for the other events. The patient''s past medical history included Vasectomy, Inguinal hernia repair, Hydrocele and Polydactyly of fingers. The patient allergic to benzetacil (Penicillin G benzathine), does not smoke (Non-tobacco user), and does not use drugs or alcohol. Concomitant medications included TESTOSTERONE ENANTHATE, Omega 3 and Multivitamins. Before the symptoms, the patient had applied four doses spread over four weeks, (1 ml on each Sunday); he also took Omega 3 and a multivitamin concomitantly. The patient was treated with PARACETAMOL, METAMIZOLE, BEXTRA, PREDNISONE, DEXAMETHASONE, DECADRON, NOVALGINA, TYLENOL and TRAMAL. Additional information regarding condition at the time of vaccination needs for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.


VAERS ID: 1686162 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-30
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Multisystem inflammatory syndrome in children
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Toxic-septic shock conditions (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: SARS-CoV-2 infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101114303

Write-up: Pediatric multisystem inflammatory syndrome; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority-WEB DE-PEI-202100171714. A 16-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 01Jul2021 (at the age of 16-years-old) (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included SARS-CoV-2 infection. The patient''s concomitant medications were not reported. On 30Jul2021, the patient experienced pediatric multisystem inflammatory. The patient was hospitalized for the event. The outcome of the event was recovered on 06Aug2021. No follow-up attempts are possible, information on batch number and expiry date cannot be obtained.


VAERS ID: 1697712 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F030A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Seizure
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101130967

Write-up: Seizure cerebral; This is a spontaneous report received from a non-contactable Physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100177263. A 16-year-old male patient received second dose of bnt162b2 (COMIRNATY, mRNA TOZINAMERAN) at the age of 16-year-old, dose 2 via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: 1F030A) as dose 2, single for covid-19 immunisation. Medical history included seizure from 2020 to an unknown date. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY, strength: 0.3ml) on 05Jul 2021 for covid-19 immunization. The patient experienced seizure cerebral on 30Jul2021 with outcome of unknown. Seriousness criteria of the events was hospitalization, medically significant. This report is serious - hospitalization. For event: Seizure cerebral: Relatedness of drug to reaction(s)/event(s): Source of assessment : HA; Result of Assessment: D. Unclassifiable. No follow-up attempts possible. No further information expected.


VAERS ID: 1701141 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7011 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Circulatory collapse, Heart rate, Hypotension, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Riva-Rocci; Result Unstructured Data: Test Result:95/60; Test Name: Puls; Result Unstructured Data: Test Result:22; Test Name: O2 saturation; Result Unstructured Data: Test Result:100
CDC Split Type: DEPFIZER INC202101135288

Write-up: Circulatory collapse; Acute hypotension/95/60; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100177341. A 17-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FE7011, expiry date not reported), via an unspecified route of administration on 30Jul2021 (at the age of 17 years old) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 30Jul2021, the patient experienced circulatory collapse and acute hypotension, which were reported as medically significant. The patient underwent lab tests and procedures which included Puls (as reported) (heart rate): 22 on unknown date, Riva-Rocci (as reported) (blood pressure) 95/60 on an unknown date, and oxygen saturation: 100 on unknown date. The events recovered on 30Jul2021. The causality assessment for suspect drug to all events was reported as follows: source of assessment was PEI with indeterminate result of assessment. Sender''s Comment: Riva-Rocci 95/60, Puls 22, o2 100. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1701145 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7011 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Circulatory collapse, Heart rate, Hypotension
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow), 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: Test Name: blood pressure; Result Unstructured Data: Test Result:85/40; Test Name: Heart rate; Result Unstructured Data: Test Result:60
CDC Split Type: DEPFIZER INC202101135487

Write-up: Circulatory collapse; Acute hypotension; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100177342. An 18-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: FE7011) (at age 18-year-old) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced circulatory collapse and acute hypotension on n 30Jul2021. The patient underwent lab tests and procedures which included blood pressure measurement: 85/40 and heart rate: 60. Outcome of the events was unknown. Relatedness of drug to reaction(s)/event(s). Source of assessment: HA. Result of Assessment: B. Indeterminate.


VAERS ID: 1705598 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101145367

Write-up: Nausea; Tiredness; This is a spontaneous report from a contactable consumer received from the . The regulatory authority report number is GB-MHRA-WEBCOVID-202109011222236810-RMD3X, Safety Report Unique Identifier is GB-MHRA-ADR 25879570. A 17-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (at the age of 17 years) at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Thus, patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced nausea and tiredness; both on 30Jul2021. The outcome of nausea was recovering, while for tiredness was recovered on 01Aug2021. The events were considered serious, medically significant. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1511667 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2021-07-26
Onset:2021-07-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026A21A / 1 LA / IM

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

Write-up: urticaria, improved with Benadryl


VAERS ID: 1512377 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-07-09
Onset:2021-07-29
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 AR / SC

Administered by: Private       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: Patient developed a DVT 2 weeks after second Moderna shot. He had been on a 5 hour car ride during that time as well
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: ultrasound
CDC Split Type:

Write-up: Patient developed a DVT in right leg, pain started one week after shot but also on long car ride


VAERS ID: 1512568 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 1 RA / IM

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

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

Write-up: Concentration of the vaccine was higher than anticipated; ~1mL of diluent was used instead of intended 1.8mL. Only one vaccine from this batch was administered to this patient and the rest of the vaccines were disposed upon recognition of the error, which was discovered after reviewing the remaining quantity of diluent. The patient showed no adverse reaction upon administration or the following observation time. The patient was informed of this larger concentration after recognition of the error, patient was okay with resolution, and facility plans follow up the with patient on the week of 8/1/21. Future quantities will be evaluated by a pharmacist.


VAERS ID: 1512569 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 - / IM

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

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

Write-up: She had a history of vasovagal response & let me know ahead of time. Mom was also present. I got an ice pack, crackers, hard candy & water ready for her. Had her sit in a seat with feet elevated. A few minutes post she said she could feel it coming on & lost consciousness for about 15 seconds. She came back to & we put an ice pack on her neck. Mom & I had her lay on the floor with feet elevated & ice pack on the back of her head. Her color came back & she asked for some water. She said she was much better & we let her lay there for the 15 minutes. Mom & her left 30 minutes after


VAERS ID: 1512577 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: NONE
Preexisting Conditions: UNKNOWN
Allergies: NONE
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: PATIENT CAME BACK TO THE PHARMACY AROUND 1130AM THE DAY AFTER THE VACCINATION, SHE SAID SHE WOKE UP WITH A RASH ALL OVER HER ARMS AND LEGS. TOLD HER TO TAKE SOME BENADRYL AND IF THE SYMPTOMS GOT WORSE OR DID NOT IMPROVE THEN GO SEE A DR.


VAERS ID: 1512580 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA66780 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Discomfort, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: penicillin allergy
Diagnostic Lab Data: EMTS took BP and pulse ox- all normal values
CDC Split Type:

Write-up: Pt felt dizzy, "heavy body", lightheaded, slightly nauseous at times. EMTs were called, checked vitals (all were okay), she chose to not leave in ambulance, was advised not to drive home so husband came to pick her up. She was counseled on monitoring symptoms if she felt she needed to go to hospital later. Signed waiver with EMTs


VAERS ID: 1512585 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

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

Write-up: Patient felt dizzy and nauseated few minutes after getting her 1st Pfizer dose. Mother stated her daughter didn?t eat anything since morning. 3 ice packs were used, 2 on her neck and 1 on her head. Two crackers and bottle water was offered. Blood pressure at 10:45am 107/66 Hg/mm. Blood pressure at 10:55 am 126/75 Hg/mm. She states I feel much better and no longer feel dizzy or nauseous.


VAERS ID: 1512587 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-01-19
Onset:2021-07-29
   Days after vaccination:191
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011J20A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anger, Crying, Fatigue, Feeling abnormal, Limb discomfort, Mood altered, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (narrow), Depression (excl suicide and self injury) (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: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: No
CDC Split Type:

Write-up: I feel very tired and fatigue all the time. On edge all the time. I feel empty on the inside, my head feels like I am in a fog all the time. Am very emotional all the time. I consider myself a very strong person. But every since the vaccine, am very mody, crying and angry all the time. I have no patience for people anymore. I was never like that at first. I was a out going type and now I always want to be a lone. Both of my arms feel very heavy and tingling all the time.


VAERS ID: 1512588 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Throat tightness, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: clonidine, famotidine, haloperidol, hydroxyzine pamoate, lidoderm patch, melatonin, nabumetone, prednisone, sertraline, trazodone
Current Illness:
Preexisting Conditions: anxiety, fibromyalgia, back pain, hx substance use, depression, PTSD
Allergies: Latex - hives, anaphylaxis Pineapple - anaphylaxis Shellfish - anaphylaxis Iodinated contrast - dyskinesia/dystonia promethazine - unknown
Diagnostic Lab Data:
CDC Split Type:

Write-up: Within 30 seconds of vaccine, patient began vomiting continuously and felt like her throat was closing. She was given IM epinephrine in the clinic and transported to the ED. By ED arrival, she stated her throat no longer felt tight. In the ED, was given 25mg IV benadryl, 20mg IV famotidine, 125mg IV methylprednisolone and 1L of saline. She was monitored prior to discharge.


VAERS ID: 1512593 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Incorrect dose administered, Syringe issue
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: Upon administration of Covid 19 vaccine, needle accidentally dislodged from syringe causing zero to a miniscule amount of vaccine be administered. OK to redose vaccine, and to report to VAERS. Patient was then administered Covid vaccine and tolerated without any complications or incidents


VAERS ID: 1512596 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Vaccination 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: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: After giving the vaccine I realized that I gave it wrong. I did not know that the vials were not diluted already. I thought that the amount in the vial was what was left in the vial from previous doses. I didn''t see posted anywhere how to give this vaccine. Since I know most vaccines are 0.5 ml that''s what I assumed. All the other medical assistants and nurses were busy so I didn''t have anyone to ask. I normally do not work at this location and any other time I''ve given covid vaccines they were done at other locations, with instructions on drawing up and administering.


VAERS ID: 1512602 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: No adverse event
SMQs:

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

Write-up: no adverse reactions


VAERS ID: 1512621 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: no adverse reactions just moderna vaccine given to under age patient


VAERS ID: 1512623 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-01-20
Onset:2021-07-29
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Infection, 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: covid test
CDC Split Type:

Write-up: Breakthrough COVID case. Patient completed series and became positive 7/29/21


VAERS ID: 1512627 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Accidental exposure to product, Exposure to contaminated device
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: After giving Covid19 immunization to patient, technician attempted to recap syringe, resulting in a poke to her left hand.


VAERS ID: 1512633 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: after 30 mins pt started having stomach pain and nausea


VAERS ID: 1512634 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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

Write-up: Blood nose left nostril


VAERS ID: 1512636 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 2 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: no adverse reactions just Moderna vaccine given to 15 year old


VAERS ID: 1512643 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-07-16
Onset:2021-07-29
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004D21A / 1 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Infection
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:

Write-up: REFER TO DR. AS INFECTION DEVELOPED 2 WEEKS AFTER VACCINE


VAERS ID: 1512665 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-07-16
Onset:2021-07-29
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pain, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (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: Vitamin D3, generic Paxil, atenelol, IUD, amittriphline? Depressant for sleep
Current Illness:
Preexisting Conditions: Hypertension
Allergies: Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: Circular rash around injection site, soreness


VAERS ID: 1512673 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: New York  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1816022 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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? 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:
CDC Split Type:

Write-up: UPON WAKING UP, PATIENT HAD A 100.3 FEVER. HALF HOUR LATER, PATIENT FAINTED.


VAERS ID: 1512698 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-07-01
Onset:2021-07-29
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 2 LA / IM

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

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

Write-up: n/a


VAERS ID: 1512703 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939893 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hypotonia, Pallor, Pulse abnormal, Unresponsive to stimuli
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Patient had received vaccine and was in waiting area for observance. After around 10 minutes wife came to counter and said he was feeling dizzy. RPH walked out to check on patient whom had sit back down from standing up briefly. Patient seemed responsive until his head drifted down, unresponsive to voice and touch for one minute or less. Pulse on wrist was faint, but present and no signs of struggled breathing. No swelling or redness near throat present. Patient woke up shortly with pale skin, but responded well and water was given. Ambulance arrived to further assist.


VAERS ID: 1512704 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Confusional state, Eye movement disorder, Hyperhidrosis, Loss of consciousness, Nausea, Pallor, Seizure, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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

Write-up: During the post-vaccine monitoring period , a bout 5-10 minutes after the first dose injection of Moderna Covid Vaccine, pt felt nausea and had seizure episode for about 2-3 minutes. Pharmacist noticed rolling eye balls and body shake with brief unconsciousness. Pt was alerted 2-3 min after with sweats and slight confusion. Meanwhile, 911 was called and paramedics came and checked patient. out . Pt was pale but all vitals were normal and returned to stable condition. Pt was released and his wife accompanied back home. Pharmacist is planning to l follow up with patient .


VAERS ID: 1512717 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / N/A LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRINTELLIX, GABAPENTIN, WELLBUTRIN, BUSPIRONE, ABILIFY, ZIPRASIDONE
Current Illness:
Preexisting Conditions: SEIZURES, HISTORY OF OTHER MENTAL HEALTH DISORDERS AS WELL (NOT SPECIFIED)
Allergies: CEFZIL
Diagnostic Lab Data: NONE; PATIENT WAS EVALUATED BY EMTS HOWEVER AND NOTHING OF NOTE FOUND
CDC Split Type:

Write-up: PATIENT UPON RECEIVING VACCINE IMMEDIATELY PASSED OUT IN CHAIR; SHE SLID AND BUMPED HEAD SLIGHTLY AGAINST WALL. PATIENT WAS OUT FOR ABOUT 30 SECONDS. UPON COMING TO, PATIENT WAS FINE. EMTS WERE CALLED TO EVALUATE PATIENT AND PATIENT WAS DEEMED OK AND LEFT WITH HER MOTHER WHO WAS WITH HER AT THE TIME. SHE HAD NO OTHER COMPLAINTS AND MOTHER HAD STATED PRIOR THAT THIS HAD HAPPENED IN PAST WITH OTHER VACCINES. PATIENT IS OTHERWISE OK AT THIS TIME AND WENT HOME WITH HER MOTHER; SHE IS TO CONTACT US AND MD IF ANY OTHER CONCERNS ARISE.


VAERS ID: 1512723 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: blood pressure medication
Current Illness: unknown
Preexisting Conditions: high blood pressure
Allergies: erythromycin, macrobid, lorabid, rhinocort, bactrim
Diagnostic Lab Data: BP 161/107 HR 48 BPM
CDC Split Type:

Write-up: PATIENT REPORTED DIZZINESS AND CHEST TIGHTNESS 5 MINUTES AFTER RECEIVING VACCINE. GAVE PATIENT WATER AND MONITORED. TOOK PATIENTS BLOOD PRESSURE AND HEART RATE. BP 161/107 HR 48 BPM. PATIENT REPORTED DIZZINESS WAS GETTING WORSE. CALLED 911


VAERS ID: 1512728 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 3 RA / IM

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

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

Write-up: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted as soon as the needle come out of her body and the fainting lasted for less than a minute


VAERS ID: 1512731 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026D21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anaphylactic reaction, Chest discomfort, Chest pain, Dysphagia, Dyspnoea, Flushing, Hyperhidrosis, Paraesthesia, Tachycardia, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe


VAERS ID: 1512734 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fall, Flushing, Head injury, Hyperhidrosis, Loss of consciousness, Nausea, Syncope, Unresponsive to stimuli, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

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

Write-up: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: After shot told patient to sit by pharmacy for monitoring, patient refused and walked around store. Patient fell and hit his head, loss consciousness for 3 seconds, woke up and threw up. Insturcted patient to sit by pharmacy for 30 minutes, patient refused and walked to car. Walked patient to car and spoke to girlfriend. Spoke to mother on phone as well, she informed me he has a history of anxiety with shots and needles and ALWAYS faints after a vaccination (usual reaction).


VAERS ID: 1512737 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? 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: Numbness (specify: facial area, extremities)-Medium, Additional Details: left arm numbness prior to becoming unresponsive


VAERS ID: 1512762 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Dyspnoea, Migraine, Muscle spasms, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), 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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Adderall, Daily Vitamin, Fish oil, Vit D, Vit B Complex, Viviscal
Current Illness:
Preexisting Conditions: psoriasis, eczema
Allergies: Sulfa Abx
Diagnostic Lab Data:
CDC Split Type:

Write-up: Heart Rate in 130''s, short of breath, pulse ox 92-93%, low grade fever (99.9-100.5), chills, generalized body aches & cramping, frontal migraine. Fever seemed to occur in early morning (about 01:00 am). By 04:30 am, all of the other listed symptoms were present. Treatment was related to symptom management; 1L of water, Tylenol Cold & Sinus Severe (acetaminophen, phenylephrine, guaifenesin), and sleep.


VAERS ID: 1512782 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 1 LA / IM

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

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

Write-up: Found patient slumped over wheel in car post vaccine. She was alert and oriented and said she felt dizzy. EMS checked her out and she said she felt fine and left the site


VAERS ID: 1512791 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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

Write-up: Nosebleed that lasted for over 25 minutes. I have not had a nose bleed since I was a child nor am I currently sick or have irritated nostrils.


VAERS ID: 1512794 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: New York  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN A420A21 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Disorientation, Muscle spasms, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: After receiving a vaccine patient became disoriented fainted and exhibit muscle spasms. Treat it with Aromatic ammonia salt and water. Upon arrival of EMS patient got some glucose as well. Last report he was felling better, EMS took patient to the bus for check up. Unknown if patient went to the emergency room.


VAERS ID: 1512796 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-27
Onset:2021-07-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Cough, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre 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: Tylenol
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Since receiving the vaccine, my fingertips underneath the fingernails all felt as though they had frostbite/tingling on and off. This has reduced in effect over time. I have developed strong chest discomfort and a cough exactly 48 hours after receiving my second dose.


VAERS ID: 1512801 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenopia, Chest pain, Dizziness, Hypoaesthesia, Limb discomfort, Paraesthesia, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Corneal disorders (broad), Vestibular 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? No
Hospitalized? No
Previous Vaccinations: arm swelling with Hep A/B
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: sulfa
Diagnostic Lab Data: All vitals were normal per the paramedics
CDC Split Type:

Write-up: SHE HAD NUMBNESS AND TINGLING IN THROAT, HEAD, FACE, ARM. LIGHTHEADEDNESS, MILD CHEST PAIN. she had heaviness in her eyes and arm . This was all starting about 15 min after receiving the vaccine


VAERS ID: 1512806 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 LA / -

Administered by: Public       Purchased by: ?
Symptoms: Chest discomfort, Pruritus, Rash, Rash macular
SMQs:, Anaphylactic reaction (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: Trazodone 50 mg 1/2 HS birth control pills Tylenol
Current Illness: None
Preexisting Conditions: GB issues
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pressure center of chest lasted a few seconds within the hour of the injection. Onset of red, pinpoint rash over anterior chest and shoulders. Red with some itching. No SOB, no swelling


VAERS ID: 1512847 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 2 - / -

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
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT RECIEVED MODERNA FOR SECOND DOSE, FIGURED OUT AFTERWARDS THAT PATIENT GOT PFIZER FOR 1ST SHOT


VAERS ID: 1512879 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-01-30
Onset:2021-07-29
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Atrial fibrillation, Blood culture negative, Blood lactate dehydrogenase normal, Brain natriuretic peptide increased, C-reactive protein normal, COVID-19, Condition aggravated, Cough, Fibrin D dimer, Pain, SARS-CoV-2 test positive, Streptococcus test negative, Troponin, White blood cell count decreased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuterol inhaler PRN, Spiriva inhaler, Flomax, finasteride, apixaban, metoprolol, atorvastatin, olmesartan, mirtazapine, zolpidem, cholecalciferol, vitamin B complex
Current Illness:
Preexisting Conditions: Atrial fibrillation, HTN, BPH, hyperlipidemia, OSA
Allergies: NKA
Diagnostic Lab Data: 7/28 COVID PCR+, 7/28 blood cx NGTD, Strept PNA antigen negative 7/28 WBC 3.11, d-dimer 0.22, CRP 0.59, LDH 180 7/28 BNP 1277, Troponin up to 139
CDC Split Type:

Write-up: Completed 2 dose vaccination series on 1/30/21 w/ Moderna Vaccine. Admitted 7/28/21 to Medical Center w/ complaints of weakness, body aches, dry cough. COVID PCR+ on 7/28. Also patient in atrial fibrillation. So far treated w/ dexamethasone, remdesivir x 1, vitamin D, zinc, vitamin C; O2 has improved from 3L NC to room air (sat 92-94%).


VAERS ID: 1512881 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Product administration 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: Brought the patient back into the room for his first COVID-19 Pfizer vaccination. Verified name/birthdate. Went to inject the vaccine, inserted the tip of the needle into the right deltoid as I realized I had not pulled up the vaccine into the syringe. Quickly removed the tip of the needle and stated, "I am so sorry I got ahead of myself and did not pull up the vaccine into the syringe. I typically do that before the patient comes back, I''m so sorry." Pt stated, "It''s okay, its fine no problem." Nothing was administered, there were no air, vaccine or medication in the syringe when the needle was inserted. Pt did not appear upset. Changed needles, pulled up the vaccine into the syringe in front of patient, showed it to him, injected the vaccine into the right deltoid no issues. Pt waited 15 minutes in the lobby with no reaction. Left without questions, complaints or issues. Occurrence report submitted.


VAERS ID: 1512886 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / IM

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

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

Write-up: 2ND DOSE OF VACCINE GIVEN TOO SOON. FIRST DOSE ADMINISTERED 7/14/21 SECOND DOSE GIVEN TODAY 7/29/21


VAERS ID: 1512898 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 1 RA / IM

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

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

Write-up: Patient was given a concentrated dose of Pfizer. Diluted with 0.8ml of sodium chloride instead of the 1.8ml


VAERS ID: 1512904 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Excessive eye blinking, Hyperhidrosis, Loss of consciousness, Seizure, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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

Write-up: Patient sitting for prescribed observation time. I noticed her blinking rapidly and stepped out to ask if she was ok, she stated her vision was blurred and then proceeded to have what appeared to be a very brief seizure (5-10 seconds in length) then passed out briefly (10-15 seconds) when she came to she seemed completely normal again. We had her lie down on the bench and she drank some water, she was sweating more than normal. After 30 minutes or so she sat up for 5 minutes or so then stood and walked with mom out of store. Mom called pediatrician to see if they could have her seen.


VAERS ID: 1512906 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Chest discomfort, Discomfort, Dyspnoea, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad)

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

Write-up: Within a few moments pt complained of shortness of breath and chest tightness. We immediately called 911. I grabbed the emergency kit and sat with the patient. She became nauseous and seemed very uncomfortable, sitting and attempting to lay down. Fortunately, she remained awake and alert until emergency personnel arrived. No medication was administered by me. The emergency personnel evaluated her and determined that the pt was likely having an anxiety attack. The pt did not leave with EMS.


VAERS ID: 1512914 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050C21A / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Musculoskeletal stiffness, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (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: MIRTAZAPINE, IBUPROFEN
Current Illness:
Preexisting Conditions: ASTHMA, NARCOLEPSY (IDIOPATHIC HYPERSOMNIA), Tourette''s SYNDROME
Allergies: NO KNOWN ALLERGIES
Diagnostic Lab Data:
CDC Split Type:

Write-up: tingling in right hand and stiffness in all fingers


VAERS ID: 1512917 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-11
Onset:2021-07-29
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 01M20A / 1 - / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 044A21A / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise
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:

Write-up: pt admitted to the hospital for COVID 19 symptoms post vaccination.


VAERS ID: 1512919 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-07-26
Onset:2021-07-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Dyspnoea, Fibrin D dimer normal, Troponin normal
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily multivitamin and probiotic
Current Illness: Summer cold at beginning of July (7/5-7/7) and underwent Covid PCR test the following week and was negative.
Preexisting Conditions: Diagnosed ADHD and was on Concerta (36 mg QD) from 07/01/2018 through 06/10/2021. Has not taken any ADHD medications since 06/10/2021.
Allergies: N/A
Diagnostic Lab Data: 07/29/2021: complete blood workup for cardiac markers, tryponins, d-dimer, etc. No abnormalities detected 07/29/2021: chest X-ray administered in ED, results normal
CDC Split Type:

Write-up: Symptoms for 14 year old male were chest pains on left side, with difficulty taking deep breath?s. Symptoms worse when lying down. Symptoms began at 3:00 AM and Continued until the morning when mother took son to local emergency room. Bloodwork and diagnostic x-ray showed no abnormalities, patient was discharged at 11:49 AM with recommendation of rest, ibuprofen or Tylenol as needed for chest discomfort. Advice to return to ED for worsening pain.


VAERS ID: 1512928 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 017C21A / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9264 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Wrong product administered
SMQs:, Medication errors (narrow)

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

Write-up: Patient was a walk in for her second (booster) dose. At check in patient did not have vaccine card. Patient was checked in, sent to receive vaccine and had not yet been added to the schedule. Her vaccination card was being filled out while being sent to receive second dose. Vaccination was administered (Moderna Covid-19 Vaccine) and patient was being monitored for 15 minutes. When writer was told patient had been added to the schedule and went to chart administration, writer noticed that patient had received her first dose on 02/05/2021 of Pfizer Covid-19 Vaccine.


VAERS ID: 1512932 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: New York  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808986 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Injection site pain, Paraesthesia, Visual impairment
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: Id say approximately 60 seconds after administration of the vaccine, I started to become the most lightheaded I''ve ever felt, like I was really about to pass out. I felt a very extreme pins and needles feeling in both my hands and my feet, and my vision began to fade. After about 30 seconds of that and beginning to panic, I stood up and knocked on the doctors door and asked for water and told him how I was feeling. After about a few minutes of sitting and drinking Gatorade my vision returned fully and I began feeling stronger again. Since then I only feel a slight pain around the injection site.


VAERS ID: 1512948 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 2 LA / IM

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

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

Write-up: Patient blacked out while sitting during the observation time. He hit his head in the fall and was observed having some convulsions.


VAERS ID: 1512954 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Headache
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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Aching chest pain and headache


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