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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 321 out of 7,116

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VAERS ID: 1683213 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-03-06
Onset:2021-07-31
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Back Issues (Spinal Stenosis, etc) Minor Depression
Allergies: None
Diagnostic Lab Data: Tested positive on 8/3/2021 for COVID-19
CDC Split Type:

Write-up: Positive COVID test and minor symptoms occurred 6 months after vaccination.


VAERS ID: 1683334 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Idaho  
Vaccinated:2021-01-27
Onset:2021-07-31
   Days after vaccination:185
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011J20A / 2 UN / SYR

Administered by: Private       Purchased by: ?
Symptoms: Herpes zoster, Neuralgia, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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: Premarin, Flonase, Claritin
Current Illness: none
Preexisting Conditions: hormone replacement, seasonal allergies
Allergies: none
Diagnostic Lab Data: 8/1/2021 visual inspection by provider to confirm shingles.
CDC Split Type:

Write-up: Received 2-dose Modena COVID-19 vaccine on 12/30/2020 & 1/27/2021 (same lot and hospital administration). Developed shingles on 7/31/2021 at age of 52. Morning of 8/1/2021, evaluated within 12 hours of onset. Given prescription for Valtrex 1000mg twice daily for 7 days. Given Gabapentin pills and lidocaine cream for nerve pain. Rash spread to cover 4" swatch from middle of back/spine to middle of front/midline just under shoulder and armpit. Rash resolved after 7-10 days. Nerve pain continued. Refilled lidocaine cream on 8/23/2021. Nerve pain still continues now 6 weeks after diagnosis.


VAERS ID: 1684473 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088D / 3 LA / IM

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

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

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


VAERS ID: 1685589 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Unknown  
Location: Missouri  
Vaccinated:2021-02-01
Onset:2021-07-31
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

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

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

Write-up: Covid.


VAERS ID: 1685994 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Antibody test, Blood immunoglobulin G, C-reactive protein, Cardiac flutter, Cyanosis, Electrocardiogram, Limb mass, Peripheral swelling, Red blood cell sedimentation rate, Rheumatoid factor
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tachyarrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (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: Estrodial .05, Levoxyl 88, vitamin D, calcium,
Current Illness: None
Preexisting Conditions: I have no thyroid
Allergies: Erythromycin, augmentin and quinolones
Diagnostic Lab Data: 8/25/2021 had tests C-reactive protein, rheumatoid factor, cyclic citrul peptide AB, IGG, high sensitivity CRP, sedimentation rate, automatef and an EKG
CDC Split Type:

Write-up: Within 24 hours my fingers started to turn blue/purple and i literally watched blood vessels burst in my hands and dark purple lumps followed and my index finger became so swollen i could no longer bend it. I had noticed a little earlier that I was experiencing my heart fluttering.


VAERS ID: 1689353 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-24
Onset:2021-07-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Influenza like illness, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

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

Write-up: Flu like symptoms


VAERS ID: 1692102 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-06-10
Onset:2021-07-31
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Menstrual disorder, Vaginal haemorrhage
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:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101109023

Write-up: She stated it was most likely due to the COVID shot messing up my menstrual cycle and causing excessive bleeding; vaginal bleeding was out of control/causing excessive bleeding; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer (Patient) reported. A 43-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in arm right on 10Jun2021 09:00 (at the age of 43-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After the vaccination, the patient did not have a menstrual cycle the rest of the month or most of July. Then on Sat. 31Jul2021 7:00 AM patient started bleeding bright red blood vaginally and Sunday 01Aug2021 she was rushed to the Emergency Room because the vaginal bleeding was out of control. she went to her Doctor on 04Aug2021 and was tested for everything. Nothing came back abnormal. She stated it was most likely due to the COVID shot messing up my menstrual cycle and causing excessive bleeding. The patient was not diagnosed with covid prior vaccination and patient didn''t test for covid post vaccination. No allergies reported. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1692211 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Autoimmune thyroiditis, Body temperature, Chills, Dizziness, Feeling abnormal, Headache, Heart rate increased, Pain in extremity, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FERROUS GLUCONATE; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Allergy to animal; Dust allergy; Ferritin low; Grass allergy; Hashimoto''s disease; Iron low; Milk allergy; Subclinical hypothyroidism; Vitamin B complex deficiency; Vitamin D deficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: fever; Result Unstructured Data: Test Result:102 Fahrenheit; Test Date: 20210731; Test Name: fever; Result Unstructured Data: Test Result:101-102 Fahrenheit; Test Date: 20210731; Test Name: fever; Result Unstructured Data: Test Result:103.8 Fahrenheit; Test Date: 20210731; Test Name: fever; Result Unstructured Data: Test Result:102-103.8 Fahrenheit; Test Date: 20210731; Test Name: fever; Result Unstructured Data: Test Result:around 101 Fahrenheit
CDC Split Type: USPFIZER INC202101127003

Write-up: was advised that if the fever reached 104 to go to the ER and that the chills and rare high fever could be due to having Hashimoto Thyroiditis; At 18hrs after 2nd shot, sore arm with headache and fever around 101.; At 18hrs after 2nd shot, sore arm with headache and fever around 101.; At 18hrs after 2nd shot, sore arm with headache and fever around 101.; Around 24hrs after, chills were off and on throughout the day; I felt dizzy; At 30hrs after, uncontrollable shivering/shaking for about 15 minutes; unstable, raised heartrate and had brain fog; unstable, raised heartrate and had brain fog; This is a spontaneous report from a non-contactable consumer (patient). A 39-years-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0191) via an unspecified route of administration in Arm Left on 30Jul2021 at 15:00 (at the age of 39-years-old) as dose 2, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The medical history included hashimoto disease, Subclinical Hypothyroidism, Low Ferritin and Iron, Vitamin D and B deficient, allergies, Known allergies to dairy/Milk, Outdoor allergens (Trees, Grass, Dust) and dogs from an unknown date and unknown if ongoing. The concomitant medications included (other medications taken in two weeks) ferrous gluconate (FERROUS GLUCONATE) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0187) via an unspecified route of administration in Arm Left on 08Jul2021 at 03:30 PM (at the age of 39-years-old) as dose 1, single for COVID-19 immunisation. The patient had no COVID prior vaccination, was not COVID tested post vaccination, did not take other vaccine in four weeks. The patient stated that at 18hrs after 2nd shot, she experienced sore arm with headache and fever (31Jul2021) around 101. Around 24hrs after, chills (31Jul2021) were off and on throughout the day, constant headache, dizzy and fever (31Jul2021) around 101-102. At 30hrs after, had uncontrollable shivering/shaking (31Jul2021) for about 15 minutes and fever spiked to 103.8, felt dizzy, unstable, raised heartrate (31Jul2021) and had brain fog (31Jul2021). Fever of 102-103.8 remained for about 2 hours. The next two days, fever stayed between 101-102 and she felt dizzy to be at work or to stand, she called a consulting nurse and was advised that if the fever reached 104 to go to the ER and that the chills and rare high fever could be due to having Hashimoto Thyroiditis (31Jul2021). No treatment was taken for events except fever and sore arm; After taking 500mg acetaminophen and a cool shower, fever lowered to around 102. The patient underwent lab test and procedure which included fever: 102 Fahrenheit, fever: 101-102 Fahrenheit, fever: 103.8 Fahrenheit, fever: 102-103.8 Fahrenheit, fever: around 101Fahrenheit all on 31Jul2021. The patient stated that after 4 full days, she was feeling normal again. The outcome of event I felt dizzy was recovered on an unspecified date in 2021 while rest of events were recovered on 04Aug2021. No follow up attempts were possible. No further information was expected.


VAERS ID: 1693024 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 RA / IM

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

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

Write-up: Patient was given 3rd dose on 7/31/21.


VAERS ID: 1693026 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025C21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Epistaxis, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (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), Vestibular disorders (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Patient self reported adverse event on 09/11/2021 upon presentation for 2nd dose in the series at which time a brief medical history and questionnaire was administered. Provider was not aware of event on 7/31/2021 until 09/11/2021. No other test were performed as patient stated she had recovered.
CDC Split Type:

Write-up: Patient reported a bloody nose that she could not get to stop for approximately 3 minutes. After the bloody nose stopped, patient reported feeling light headed and passed out for approximately 10 seconds.


VAERS ID: 1694761 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088D21A / 1 LA / SYR
UNK: VACCINE NOT SPECIFIED (OTHER) / UNKNOWN MANUFACTURER - / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Chest discomfort, Chest pain, Fatigue, Injection site pain, Malaise
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Febuxostat
Current Illness: None
Preexisting Conditions: Gout
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sore arm at site of injection, zero energy, feeling sick/weak without fever, and tiredness for three days. After the first few days I had stress/panic flashes in my chest randomly during the day for two weeks. Also had less common pain or twinge in chest during this time period.


VAERS ID: 1695771 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Injection site pain
SMQs:, Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad)

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

Write-up: Arm where I received the first vaccine started hurting like it''s sprained/broken. The pain never went away and I went to the doctor and she said it''s sprained and I need physical therapy in order to get better. The pain is coming from my shoulders all the way to my fingers, shooting pain, my elbow also hurts, kind of like tennis elbow problems. Lastly, I lost my strength and it''s just painful, especially the more I use this arm.


VAERS ID: 1696767 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006021A / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back injury, Condition aggravated, Intervertebral disc degeneration, Intervertebral disc protrusion, Magnetic resonance imaging spinal abnormal, Muscular dystrophy, Sciatica, Spinal stenosis, Vertebral foraminal stenosis
SMQs:, Congenital, familial and genetic disorders (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: hypertrophic cardiomyopathy,
Allergies:
Diagnostic Lab Data: mri lumbar spine, FINDINGS: There is normal alignment and marrow signal of the lumbar spine. Paraspinal musculature and visualized retroperitoneum and upper sacroiliac joints are unremarkable. Levels not mentioned below appear unremarkable. L4-L5: Disc desiccation with posterior disc bulge which produces moderate to severe canal stenosis. There is mild to moderate left foraminal narrowing. Right foramen is patent. L5-S1: Disc desiccation with posterior disc bulge abutting and potentially compressing the traversing S1 nerve roots. This produces moderate canal stenosis. Moderate to severe left foraminal narrowing. Mild right foraminal stenosis.
CDC Split Type:

Write-up: within an hour of getting the shot I experienced muscular dystrophy and and a flare up of an old back injury that causes me severe sciatic pain.


VAERS ID: 1697200 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 09/28/2021 COVID 19 Moderna
Other Medications: Hydrochlorothiazide, Levothyroxine, Losartan Potassium, Metformin HCL, Glipizide, Metoprolol , Asprin, simvastatin, Potassium
Current Illness:
Preexisting Conditions: Diabetis
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dizzyness, Nausea, fatigue, Tiredness, Joint Pane, Vommiting


VAERS ID: 1700209 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Chest pain, Chills, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: 102 fever, chills for 12 hours Chest pain near heart for 1 month after fever subsided.


VAERS ID: 1704151 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006B21A / 2 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Condition aggravated, Disturbance in attention, Fatigue, Headache
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

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

Write-up: My asthma took a turn for the worse. I have had more headaches than I have had before. I am also more tired. My ability to focus has also decreased. I went to the doctor regarding my asthma. I was prescribed an allergy medication to deal with the asthma opposed to another inhaler. It has been a few days so I have not noticed a difference yet.


VAERS ID: 1707724 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100995136

Write-up: Radial Nerve tingling; pain in right hand; This is a spontaneous case received from a contactable consumer (patient himself). A 21-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number was not reported), via an unspecified route of administration in left arm on 31Jul2021 at 15:30 (age at vaccination 21-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Jul2021 16:15, the patient experienced radial nerve tingling and pain in right hand. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment taken for the events was unknown. The outcome of the events was recovering. Follow-up attempts are completed. No further information was expected.


VAERS ID: 1707779 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7483 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Allergy test, Blister, Dizziness, Fear of injection, Headache, Pruritus, Rash, Skin mass
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alpha-gal allergy (Verbatim: Alpha-gal allergy from five years)
Allergies:
Diagnostic Lab Data: Test Name: Allergy test; Result Unstructured Data: Test Result:reacted to a COVID vaccine like substance; Comments: reacted to a COVID vaccine like substance
CDC Split Type: USPFIZER INC202101028413

Write-up: scared to get the next injection; rash/had a rash that peeled on her hip/The rash happened like two days later, mainly her upper extremities, anywhere that was exposed to sunlight, it was a severe rash; Itching; small blisters; still has a few bumps; debilitating headache; dizziness; This is a spontaneous report from a female contactable consumer (Patient). A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number FA7483, Expiration Date: 31Jul2021), via an unspecified route of administration on 31Jul2021 at 17:15(at the age of 50-years-old) administered in Arm Left as a single dose for COVID-19 immunisation. Medical history included Alpha-gal allergy from an unknown date and unknown if ongoing Verbatim: Alpha-gal allergy from five years. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXIN) taken for hypothyroidism, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Jul2021 at 17:15, the patient experienced debilitating headache, dizziness. On 02Aug2021, the patient experienced still has a few bumps, small blisters, Itching. she had debilitating headache, dizziness and rash that has almost been resolved with her first dose of the Pfizer-BioNTech COVID-19 Vaccine on 31Jul2021. She is asking if the reported side effects are from the first dose or the second dose of the vaccine. She said that she is just concerned for her second dose and is preparing herself next time. She is asking if these has been reported before and how long should these symptoms last. She''s already done going this over with her doctor and would see him before 2 days. She is currently taking off work. She has had debilitating headaches since she got the vaccination. She went to see a chiropractor because she thought it was something else. Adds she can''t work, she is sitting on a desk for now. Adds she is scared to get the next injection. Mentions she also had a rash that peeled on her hip. Adds nothing she has done has worked, not Tylenol, or drinking a lot of water. She does not have the Tylenol available to provide product information; it is at work, No UPC, NDC, lot or expiration date known to caller. Reports within of 30 minutes of receiving the vaccination she experienced extreme dizziness and headache that is persisting. Mentions when the headaches come on there is dizziness but it is improved. The rash happened like two days later, mainly her upper extremities, anywhere that was exposed to sunlight, it was a severe rash, with itching and small blisters, tiny little annoying ones. Today she still has a few bumps. She went to the allergist and did an allergy test. Her alpha gal was fine, she didn''t react, it was totally mild. Reports she had a reaction to a COVID like vaccine substance and the doctor states she should have come to me first. Consumer reporting an AE for Pfizer COVID 19 vaccine mentions nothing she has done has worked, not Tylenol, or drinking a lot of water. She does not have the Tylenol available to provide product information; it is at work, No UPC, NDC, lot or expiration date known to caller. Therapeutic measures were taken for the events. The adverse event did not result emergency room visit. The patient was visited to Physician (the allergist) office for the events. The patient underwent lab tests and procedures which included allergy test: reacted to a covid vaccine like substance on an unknown date reacted to a COVID vaccine like substance. The outcome of the events was unknown for small blisters, scared to get the next injection and not recovered for debilitating headache, still has a few bumps and recovering for other events.


VAERS ID: 1518597 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Headache, Illness, Pain in extremity
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Duloxetine (60 mg) Omega-3 (EPA 500, DHA 250) Vitamin D3 (Cholecalciferol from Lanolin 125 mcg)
Current Illness: None
Preexisting Conditions: Insulin resistance Recurrent depressive disorder (ICD-10: F33)
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pain in left arm Temperature 36,9 Asthenia Headache Stomachache and diarrhea Sickness


VAERS ID: 1527259 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: GBMODERNATX, INC.MOD20212

Write-up: Headache; Muscle ache; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) had not resolved and MYALGIA (Muscle ache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter Patient had covid-19 test and result was unknown. Company Comment: 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.; Sender''s Comments: 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.


VAERS ID: 1528055 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C14-01 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Chest pain, Dyspepsia, Frequent bowel movements, Headache, Injection site pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210801236

Write-up: SLIGHT HEADACHE; VERY SLIGHT PAIN WHERE THE VACCINE WAS GIVEN; FAINTED; BURNING SENSATION IN THE CHEST; FEELING THAT DIGESTION STOPPED; OPENED BOWELS A LOT OF TIMES (NO DIARRHEA); BURNING SENSATION WENT TO HEAD, THAT RAN ALONG THE RIGHT AND LEFT SIDES; This spontaneous report received from a patient concerned a 47 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: 21C14-01 and expiry: unknown) dose was not reported, 1 total administered on 31-JUL-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, 5 minutes after receiving the vaccine injection patient felt burning sensation started in the chest but then went to his head, that ran along the right and left sides (that was very scary), followed by a feeling of hypotension, after which he fainted. Patient recovery was quick and there was a need to elevate the upper limbs and rest for 1 hour and 20 minutes to feel good again and return to the daily life. Patients seems like his digestion stopped and his bowels was opening a lot of times, but no diarrhea. On 01-AUG-2021, the patient experienced slight headache for which he had taken acetaminophen/ paracetamol 500 mg, as per advised at the vaccination center. The patient experienced very slight pain where the vaccine was given. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, burning sensation in the chest, and burning sensation went to head, that ran along the right and left sides on 31-JUL-2021, and feeling that digestion stopped, opened bowels a lot of times (no diarrhea), and slight headache on 01-AUG-2021, and had not recovered from very slight pain where the vaccine was given. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210801236-covid-19 vaccine ad26.cov2.s- fainted. 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: 1529920 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210730; Test Name: body temperature measurement; Result Unstructured Data: 38.5 degrees Celsius
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: muscle aches; shivering; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (muscle aches), CHILLS (shivering) and PYREXIA (Fever) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (muscle aches) (seriousness criterion medically significant) and CHILLS (shivering) (seriousness criterion medically significant). At the time of the report, MYALGIA (muscle aches) and CHILLS (shivering) outcome was unknown and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Body temperature: 38.5 (High) 38.5 degrees Celsius. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment: 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.; Sender''s Comments: 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.


VAERS ID: 1529926 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Thrombosis
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Vestibular disorders (broad)

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

Write-up: blood clots; Dizzy; This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOSIS (blood clots) in a 21-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced DIZZINESS (Dizzy). On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant). On 31-Jul-2021, DIZZINESS (Dizzy) had resolved. At the time of the report, THROMBOSIS (blood clots) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment information was provided. Patient after 10 mins post vaccine patient felt hot and dizzy. Taken to lay down and given a drink of water and a biscuit, symptoms resolved. Patient was not enrolled in clinical trial Company Comment: 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.; Sender''s Comments: 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.


VAERS ID: 1529928 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Syncope, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Vestibular disorders (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: Medical History/Concurrent Conditions: Syncope
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Blood clots; Syncope; Dizzy; This regulatory authority prospective pregnancy case was reported by an other health care professional and describes the occurrence of THROMBOSIS (Blood clots) and SYNCOPE (Syncope) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Syncope. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 31-Jul-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant). On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant) and DIZZINESS (Dizzy). On 31-Jul-2021, SYNCOPE (Syncope) had resolved. At the time of the report, THROMBOSIS (Blood clots) and DIZZINESS (Dizzy) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product was reported. Treatment information was not provided. Patient had a syncope episode and fell from their chair onto the floor. Patient was laid down and given water to drink. Patient was 7 weeks pregnant. Company''s comment: 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.; Sender''s Comments: 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.


VAERS ID: 1529932 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chills, Fatigue, Feeling cold, Feeling hot, Hyperhidrosis, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Hay fever
Preexisting Conditions: Medical History/Concurrent Conditions: Fever
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: sweating; weakness; feeling hot; feeling cold; shivering; Fever; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), ASTHENIA (weakness), FEELING HOT (feeling hot), FEELING COLD (feeling cold), CHILLS (shivering), PYREXIA (Fever) and FATIGUE (Fatigue) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Fever. Concurrent medical conditions included Hay fever. Concomitant products included PARACETAMOL for Headache. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant), ASTHENIA (weakness) (seriousness criterion medically significant), FEELING HOT (feeling hot) (seriousness criterion medically significant), FEELING COLD (feeling cold) (seriousness criterion medically significant) and CHILLS (shivering) (seriousness criterion medically significant). On 31-Jul-2021, PYREXIA (Fever) had resolved, FATIGUE (Fatigue) had not resolved. At the time of the report, HYPERHIDROSIS (sweating), ASTHENIA (weakness), FEELING HOT (feeling hot), FEELING COLD (feeling cold) and CHILLS (shivering) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment of event fever included paracetamol. Vaccination took place at 13:29, around midnight started to develop fever which lasted till 5:30 am, since then feeling of fatigue and weakness. Periods of feeling hot and sweating or feeling cold and shivering occurred throughout the day. Company comment: 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.; Sender''s Comments: 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.


VAERS ID: 1529941 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Leg pain; Fever; Nausea; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), PYREXIA (Fever) and NAUSEA (Nausea) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 31-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) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced PAIN IN EXTREMITY (Leg pain) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Leg pain), PYREXIA (Fever) and NAUSEA (Nausea) had not resolved. No concomitant medications were reported. Treatment information was not provided. Company Comment: 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.; Sender''s Comments: 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.


VAERS ID: 1529944 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Maternal exposure during pregnancy, Mental fatigue
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 virus test positive
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: fatigue; Maternal exposure during pregnancy; Mental fatigue; This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MENTAL FATIGUE (Mental fatigue) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included COVID-19 virus test positive on 01-Oct-2020. 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) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 31-Jul-2021, the patient experienced MENTAL FATIGUE (Mental fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (fatigue) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). On 01-Aug-2021, MENTAL FATIGUE (Mental fatigue) had resolved. At the time of the report, FATIGUE (fatigue) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Patient is 24 weeks pregnant at time of report. Patient had extreme fatigue to the point of not being able to move / close to unresponsive - not a usual pregnancy symptom. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. No concomitant medication reported. No treatment information was provided. Company comment: This is a case of Maternal exposure during pregnancy with associated AEs (Fatigue and mental fatigue) for this 34-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. This being a report from a regulatory authority, there are no contact details, hence no further information is expected.; Sender''s Comments: This is a case of Maternal exposure during pregnancy with associated AEs (Fatigue and mental fatigue) for this 34-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. This being a report from a regulatory authority, there are no contact details, hence no further information is expected.


VAERS ID: 1530382 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C14-01 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Hypotension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
CDC Split Type: PTJNJFOC20210801190

Write-up: FAINTED; FEELING OF HYPOTENSION; BURNING SENSATION IN CHEST THAT RAN ALONG THE RIGHT AND LEFT SIDES; This spontaneous report received from a patient concerned a male of unknown age, 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: 21C14-01, and expiry: UNKNOWN) dose was not reported, 1 total administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021 (five minutes after receiving the vaccine), the patient felt a burning sensation in chest that ran along the right and left sides, followed by a feeling of hypotension, after which the patient fainted. Recovery was quick and there was a need to elevate the upper limbs and rest for 1 hour and 20 minutes to feel good again and patient return to daily life activities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted, feeling of hypotension, and burning sensation in chest that ran along the right and left sides on 31-JUL-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210801190- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fainted. 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: 1539028 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Fall, Malaise
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100980449

Write-up: left popliteal vein thrombosis; patient was collapsed at home; Malaise; This is a spontaneous report received from a contactable physician communicated to a Pfizer sales representative. A 9-decade-old (in her 80s) female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown), via an unspecified route of administration on 28Jul2021 at 12:12 (the day of vaccination), as Dose 2 single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received (historical vaccine) first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown), via an unspecified route of administration, on 07Jul2021 at 12:00, as Dose 1 single, for COVID-19 immunisation. After received the second single dose of vaccination, the patient complained of malaise, on an unspecified date in 2021. On 31Jul2021, the patient''s family contacted the patient, but did not get a response so the patient''s family went to visit the patient and found the patient was collapsed at home. When she was taken to Medical Centre and examined, she was diagnosed with left popliteal vein thrombosis. The causality with the vaccine is suspected. The patient returned home without being hospitalized on the day of treatment. The reporter didn''t provide seriousness assessment. The reporter stated that the events may be related to the BNT162B2. The event manifested after use of the product. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events : Deep Vein thrombosis, Fall and the administration of the vaccine 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: 1541579 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Nausea, Pruritus, Thrombosis, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976853

Write-up: blood clots; Urticaria; nausea; Erythema; Itching; This is a spontaneous report from a contactable other Healthcare Professional received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107311806196920-VA6RM, Safety Report Unique Identifier GB-MHRA-ADR 25737386. A 30-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: FE3380, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 31Jul2021 (age at vaccination was 30 years) as dose 2, single for COVID-19 immunization. The patient''s medical history included lactation decreased from an unknown date. The patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient was not currently breastfeeding. The patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced blood clots and urticaria. On 31Jul2021, the patient experienced erythema, itching and nausea. Approx 15 min post immunization, patient described feeling nauseas. Symptoms progressively developed until complaining of severe erythema and urticaria, worse to face, chest and limbs. No respiratory involvement. Therapeutic measures were taken as a result of erythema, itching and urticaria. The patient received treatment with 10mg chlorphenamine IV and transport to ED for further assessment and management. The report did not relate to possible blood clots or low platelet counts. The outcome of the events erythema and itching was not resolved. The outcome of the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1541580 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Lymphadenopathy, Pain, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984661

Write-up: left deep vein thrombosis; pain across collar bone on left side and pain in left elbow; Swollen glands; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108012230282430-GAEWL. A 38-years-old non pregnant female patient received second dose of BNT162B2 (BNT162B2, solution for injection), via an unspecified route of administration on 30Jul2021 as dose 2, single for COVID-19 immunisation. She was not pregnant at time of vaccination. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Patient has not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced left deep vein thrombosis and on 31Jul2021, she was swollen glands. Additional information reported was vaccine given in left arm. Swollen glands in left arm pit, pain across collar bone on left side and pain in left elbow. On 20Jul2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative (No-Negative COVID-19 test). The outcome of the event left deep vein thrombosis, pain was unknown, and event swollen glands was not resolved. Follow-up activities closed: Follow up not-Possible as standard follow-up requests are not accepted by the UK MHRA.


VAERS ID: 1546673 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Inappropriate schedule of product administration, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210128; Test Name: COVID-19 virus test; Test Result: Negative; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101022609

Write-up: Fever; Exhaustion; Shoulder pain; Inappropriate schedule of vaccine administered; The initial safety information received was reporting only non-serious adverse drug reaction, upon receipt of follow-up information on 06Aug2021, this case now contains serious adverse reaction. Information processed together. This is a solicited report from the RA from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-YCVM-202106111412400660-SNPOO, Safety Report Unique Identifier GB-MHRA-ADR 25459185. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8813), dose 2 via an unspecified route of administration on 31Jul2021 at the age of 28-year-old as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Batch/lot number: EW3143) on 07Jun2021 and experienced shoulder pain and high temperature. Unsure if patient had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced fever, exhaustion, and shoulder pain on 31Jul2021. The patient underwent lab tests and procedures which included COVID-19 virus test Negative COVID-19 test on 28Jan2021. This case was reported as serious due to medically significant. The outcome of events fever and exhaustion was recovered on 01Aug2021, shoulder pain was recovered on 03Aug2021. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected. Based on available information and the drug temporal relationship, the causality between the events pyrexia, fatigue, arthralgia and the suspect drug "BNT162B2" cannot be completely excluded. Linked Report(s): GB-PFIZER INC-2021692935 same patient/product and different dose/event


VAERS ID: 1549890 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Blood pressure measurement, Body temperature, Dizziness, Hypotension, Lymphadenopathy, Nausea, Pain in extremity, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELOINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: blood pressure; Result Unstructured Data: Low; Test Name: body temperature; Result Unstructured Data: over 38 degrees Celsius; Test Date: 20210729; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PERIPHERAL SWELLING (swollen gl), DIZZINESS (dizzy), ABDOMINAL PAIN UPPER (stomach cramps), HYPOTENSION (Low blood pressure), NAUSEA (nauseous) and PYREXIA (fever) in a 27-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. The patient''s past medical history included Lactation decreased. Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (ELOINE) from 03-Mar-2021 to an unknown date for Contraception. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced HYPOTENSION (Low blood pressure) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain) (seriousness criterion medically significant), PERIPHERAL SWELLING (swollen gl) (seriousness criterion medically significant), DIZZINESS (dizzy) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (stomach cramps) (seriousness criterion medically significant), NAUSEA (nauseous) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant) and LYMPHADENOPATHY (Swollen gland). The patient was treated with PARACETAMOL ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm pain), PERIPHERAL SWELLING (swollen gl), DIZZINESS (dizzy), ABDOMINAL PAIN UPPER (stomach cramps), NAUSEA (nauseous) and PYREXIA (fever) was resolving, HYPOTENSION (Low blood pressure) had not resolved and LYMPHADENOPATHY (Swollen gland) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. On 31-Jul-2021, Blood pressure measurement: low (Low) Low. On an unknown date, Body temperature: over 38 (High) over 38 degrees Celsius. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced swollen gland after vaccination. Treatment medication information included Paracetamol for fever. Company Comment : 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.; Sender''s Comments: 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.


VAERS ID: 1549892 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase increased, Myalgia, Pyrexia, Restless legs syndrome
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: GBMODERNATX, INC.MOD20212

Write-up: peak temperature; restless legs; Fever; Legs restless; Muscle pain; This regulatory authority case was reported by a consumer and describes the occurrence of ALANINE AMINOTRANSFERASE INCREASED (peak temperature), RESTLESS LEGS SYNDROME (restless legs), PYREXIA (Fever), RESTLESS LEGS SYNDROME (Legs restless) and MYALGIA (Muscle pain) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), RESTLESS LEGS SYNDROME (Legs restless) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). On an unknown date, the patient experienced ALANINE AMINOTRANSFERASE INCREASED (peak temperature) (seriousness criterion medically significant) and RESTLESS LEGS SYNDROME (restless legs) (seriousness criterion medically significant). At the time of the report, ALANINE AMINOTRANSFERASE INCREASED (peak temperature) and RESTLESS LEGS SYNDROME (restless legs) was resolving and PYREXIA (Fever), RESTLESS LEGS SYNDROME (Legs restless) and MYALGIA (Muscle pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. No concomitant product use was reported Patients fever began 7 hours after vaccination (2nd dose), reaching the peak temperature of 39.1 degrees 15hours after the vaccination. Restless legs and muscle pain also began 7 hours after vaccination. Currently (about 22 hours after vaccination) all above mentioned symptoms still persist, although the temperature had gone down to 38.2. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company Comment: 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.; Sender''s Comments: 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.


VAERS ID: 1549907 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-07-31
   Days after vaccination:112
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: COVID-19 antibody test; Result Unstructured Data: Test Result:blood specimen tested positive for anti-spike; Comments: protein antibody; Test Date: 20210710; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210731; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:positive with L452R mutant strain
CDC Split Type: HKPFIZER INC202101021252

Write-up: Tested positive with L452R mutant strain; Tested positive with L452R mutant strain/patient was asymptomatic; This is a spontaneous report from a non-contactable healthcare professional via (Regulatory authority report number: not provided), based on information received by Pfizer from BioNTech SE (manufacturer control number: -Fosun-2021FOS002878), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via . The regulatory authority report number is not applicable. As of 0:00 am, 02-Aug-2021, DH announced that three additional confirmed cases of COVID-19 after vaccination. This case was split for 1 of 3 cases that confirmed COVID-19 after vaccination. A 55-years-old male patient (case No. 11989) started to receive two doses of tozinameran (bnt162b2) (COMIRNATY, Solution for injection) (lot number: unknown) on 20Mar2021 (dose 1, single) and 10Apr2021 (dose 2, single) respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 05Jul2021, the patient''s blood specimen tested positive for anti-spike protein antibody. The patient departed Hong Kong on 11Jul2021 for his testing result on 10Jul2021 before his departure was negative. On 31Jul2021, the patient arrived atpositive with L452R mutant strain. The patient was asymptomatic. The events COVID-19 and vaccination failure were considered as important medical event. At the time of the report, the outcomes of the event were unknown. Initial report was received on 03Aug2021. This is one of three reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS002878 (master case), 2021FOS002882 and 2021FOS002883. Follow-up closed; no further information is possible.; Sender''s Comments: Linked Report(s) : reporter/drug/events and different patients


VAERS ID: 1553472 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dizziness, Electrocardiogram, Hypotension, Loss of consciousness, Malaise, Nausea, 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: ZOLOFT; VIT D [VITAMIN D NOS]; VIT B COMPLEXE [VITAMINS NOS]; IRON; OMEGA DAILY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Faint; Vaso vagal attack
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: BP; Result Unstructured Data: Test Result:low; Test Name: temp; Result Unstructured Data: Test Result:fine; Test Name: ECG; Result Unstructured Data: Test Result:fine
CDC Split Type: AUPFIZER INC202100978549

Write-up: Was unwell and dizzy for 24 hrs; Was unwell and dizzy for 24 hrs; vomited; BP was low; passed out briefly; felt like i was going to vomit / nausea; This is a spontaneous report from a contactable consumer reporting for herself. A 39-years-old female patient (non-pregnant) received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 31Jul2021 09:30 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation (at the age of 39 years old) at workplace clinic. Medical history included vasovagal syncope overactive and faint easily. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for overactive Vagal Nerve; vit d [vitamin d nos] (VIT D); vitamins nos (VIT B COMPLEXE); iron (IRON) taken for an unspecified indication, start and stop date were not reported; fish oil (OMEGA DAILY). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 31Jul2021 09:30 for COVID-19 immunisation at the age of 39 years old. Clinical course was as follows. The patient experienced passed out briefly (loss of consciousness) (medically significant) on 03Aug2021 00:45 with outcome of recovering, felt like she was going to vomit / nausea (nausea) (non-serious) on 31Jul2021 09:30 with outcome of recovered on unknown date, was unwell and dizzy for 24 hrs (dizziness) (non-serious) (malaise) (non-serious) on 03Aug2021 00:45 with outcome of recovering, vomited (vomiting) (non-serious) on 03Aug2021 00:45 with outcome of recovering, bp was low (hypotension) (non-serious) on 03Aug2021 00:45 with outcome of recovering. The patient reported that within 2min of the Jab (as reported) she felt like she was going to vomit. She asked to lay down as she had an existing condition where she faint easily. Was fine with a little food and water. The patient was nauseas throughout the day. No treatment was received. Tuesday (03Aug2021) 12:45am she woke up feeling dizzy and sick. She laid on the floor, vomited and passed out briefly. Called an ambulance due to history of passing out. BP was low everything was fine (ECG temp etc). Did not go hospital. Was unwell and dizzy for 24hrs (as reported). Unwell, dizzy, passed out briefly, BP was low and vomited resulted in Emergency room/department or urgent care and their final outcome was reported as recovering. The patient underwent lab tests and procedures which included blood pressure measurement: low on 03Aug2021, body temperature: fine on unknown date, electrocardiogram: fine on unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.


VAERS ID: 1554657 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Myocarditis
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ulcerative colitis (in remission)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202100994555

Write-up: chest pain; myocarditis; This is a spontaneous report from a contactable consumer (patient''s brother a Pfizer employee). A 40-year-old female patient received first dose of BNT162b2 (COMIRNATY), intramuscular on 30Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ulcerative colitis (in remission) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 31Jul2021, the patient experienced chest pain, the event caused hospitalization. The hospital doctors told her that she had not pericarditis, but she may have had myocarditis. The patient 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: 1554829 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood tests; Result Unstructured Data: Test Result:unknown results; Test Name: CT scan; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC202101004261

Write-up: Lung embolism; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority. This consumer reported different events for both doses of Comirnaty for the same patient. This is the first of two reports. The regulatory authority report number for the first, serious report is [NL-LRB-00647698]. A 25-years-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 29Jul2021 (Batch/Lot Number: FC5089) at single dose, covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no previous COVID-19 infection. The patient previously took first dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date not provided), via an unspecified route of administration, on 24Jun2021, at single dose, for COVID-19 immunization, and experienced dyspnoea and nausea. The patient experienced lung embolism (life threatening) on 31Jul2021 (2 days after start). The patient underwent lab tests and procedures which included blood test and CT scan (Computerised tomogram), both with unknown results. Therapeutic measures were taken as a result of lung embolism with anticoagulants. The outcome of event was not recovered. Reporter Comment: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty)was yes. Adverse drug reactions was How stuffy and nauseous. Date was 24Jun2021. No previous COVID-19 infection. Other diagnostic procedures included Blood test CT scan. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reporter Comment: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty)was yes. Adverse drug reactions was How stuffy and nauseous. Date was 24Jun2021. No previous COVID-19 infection. Other diagnostic procedures included Blood test CT scan.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101011395 the same patient, different doses and events


VAERS ID: 1555457 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, Hypothermia, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Accidents and injuries (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: AUPFIZER INC202100976572

Write-up: Hypothermia; nausea; bad headache; bad body aches; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (COMIRNATY, Lot number was not reported), intramuscular, administered in arm left on 30Jul2021 13:45 (at the age of 50-years-old) as dose 2, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient previously received bnt162b2 (COMIRNATY) on 09Jul2021 01:00 PM (at the age of 50-years-old) as dose 1, single for covid-19 immunisation. On 31Jul2021, the patient experienced hypothermia, nausea, bad headache and bad body aches. Therapeutic measures were taken as a result of events as the patient received paracetamol and ibuprofen. The outcome of the events was recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.


VAERS ID: 1555581 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Headache, Nausea, Pain, SARS-CoV-2 test, Tearfulness, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MELATONIN; SENNA; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Constipation; Depression; Hypermobility syndrome; Insomnia; Intentional self-injury; Lactation decreased; Migraine; Patella injury; Sciatica; Suicidal ideation; Uterine malposition
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977354

Write-up: Injection site tenderness; Nausea; Persistent headache; Stomach cramps; Tearfulness; Pain dull; This is a spontaneous report from a contactable consumer (patient). This is a report received from a regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107312254082980-LME7N, Safety Report Unique Identifier GB-MHRA-ADR 25737668. A 17-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 31Jul2021 (at the age of 17-years-old) as dose 1, single for COVID-19 immunisation. Medical history included patella injury, suicidal ideation, suppressed lactation, constipation, depression, sciatica, insomnia, anxiety, migraine, hyper mobility, chrondomalacia patella, self harm and retroverted womb. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included melatonin taken for insomnia from 01Jan2018 to an unspecified stop date; sennoside a+b (SENNA) taken for chronic constipation from 28Mar2021 to an unspecified stop date; sertraline taken for depression from 01Jan2020 to an unspecified stop date. On 31Jul2021 the patient experienced injection site tenderness, nausea, persistent headache, stomach cramps, tearfulness and pain dull. The events were reported as serious (medically significant). The patient described the events as: Narrative case summary and further information: injection sight became painful and sore- even when no pressure was being applied. Since her vaccination she also had a constant persistent headache. She experienced nausea and stomach cramps unrelated to her menstrual cycle. Feeling as if she was absolutely starving even though she has eaten the same as she would typically. She also observed that she felt much more sensitive emotionally. Very tearful and feeling as if she was overtired. No investigations or tests conducted. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on an unspecified date. The outcome of 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: 1558478 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature fluctuation, Influenza like illness, Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KARVEZIDE; LAMICTAL; NEURONTIN; FAMPYRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Blood pressure high; Multiple sclerosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100994337

Write-up: MS (multiple sclerosis) symtoms increased; flu like, symptoms; cold and then hot feverish; This is a spontaneous report from other healthcare professional (patient). A 50-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), intramuscular, administered in Arm Left on 30Jul2021 15:00 (at the age of 50years) as dose number unknown, single for Covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included hypertension, multiple sclerosis, and asthma from an unknown date and unknown if ongoing. Concomitant medication included hydrochlorothiazide, irbesartan (KARVEZIDE); lamotrigine (LAMICTAL); gabapentin (NEURONTIN); and fampridine (FAMPYRA) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Jul2021 03:00AM, the patient MS (multiple sclerosis) symptoms increased, she couldn''t move her legs, tingling of hands/numbness, and flu like, symptoms (cold and then hot feverish). No treatment was received for the events. The patient was not diagnosed with COVID-19 prior to vaccination, was the patient. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered on an unspecified date. Information about lot/batch number has been requested.; Sender''s Comments: Based on plausible temporal relationship, a possible causal association between the event multiple sclerosis and the 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: 1558527 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977368

Write-up: Tingling; Numbness; Painful arm; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number: GB-MHRA-APPCOVID-202107312255460650 and Safety Report Unique Identifier is GB-MHRA-ADR 25737664. A 39-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number FF3319), via an unspecified route of administration, on 31Jul2021 (at the age of 39-year-old) at single dose for COVID-19 immunisation. On 30Jul2021 (before vaccination), a COVID-19 test was done and resulted negative. Relevant medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding and she is not enrolled in clinical trial. On 31Jul2021, the patient had tingling, numbness, painful arm. The events were assessed as medically significant. Patient had not tested positive for COVID-19 since having the vaccine. The patient had not recovered from the events. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1558610 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Lethargy, Maternal exposure during breast feeding, Myalgia, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Neonatal exposures via breast milk (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DICLOFENAC; TRANEXAMIC ACID
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Heavy periods
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977349

Write-up: Maternal exposure during breast feeding; Drug use in unapproved population; Off-label use; lethargy; Fatigue; Muscle ache; Washed-out; Lethargic; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107311147529380-FKA4N, Safety Report Unique Identifier GB-MHRA-ADR 25736903. A 33-year-old (Non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Formulation: Solution for injection, Lot number was not reported, via an unspecified route of administration on 30Jul2021 as dose 2, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included ongoing breast feeding, heavy menstrual bleeding. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. The patient concomitant medication(s) included diclofenac taken for an unspecified indication; tranexamic acid taken for heavy menstrual bleeding. The patient previously received first dose of BNT162B2 via an unspecified route of administration received for COVID-19 immunisation. Patient is not enrolled in clinical trial. It was reported that on an unspecified date, the patient experienced maternal exposure during breast feeding, drug use in unapproved population, off-label use, lethargy. On 31Jul2021, fatigue, ache, washed-out and lethargic. Extreme fatigue, lethargy, muscle aches and pains the day after the vaccine. No relief from ibuprofen or paracetamol. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test was negative (No - Negative COVID-19 test). Therapeutic measures were taken as a result of lethargy, fatigue, muscle ache, washed-out, lethargic. The outcome of event for maternal exposure during breast feeding, drug use in unapproved population, off-label use, lethargy was unknown and for fatigue, muscle ache, washed-out, lethargic was not recovered. 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-202100986041 Maternal case


VAERS ID: 1558621 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100977371

Write-up: pain; Shoulder pain; my arm was hurting; neck pain; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107312304130850-S5XMH. Safety Report Unique Identifier GB-MHRA-ADR 25737666. A 25-year-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot Number: Not known), via an unspecified route of administration on 31Jul2021 as single dose (at age of 25-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. On an unspecified date patient experienced pain. On 31Jul2021 patient experienced shoulder pain, her arm was hurting and neck pain. Events considered serious as medically significant. Patient stated that after having the vaccine, later on in the evening her arm was hurting which was normal. But then the pain spread into her shoulder and neck, very intense. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient recovered from pain on unknown date, while outcome of the other mentioned 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: 1558626 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Insomnia, Paraesthesia, SARS-CoV-2 test, Seizure
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976748

Write-up: tingling sensation; can''t sleep; Classic fit; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108010142226040-Z4EBY. A male patient of an unspecified age had received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection, Lot Number: FD8813), via an unspecified route of administration on 31Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tingling sensation and on 31Jul2021 can''t sleep, classic fit. The patient underwent lab tests and procedures which included COVID-19 virus test was negative (No Negative COVID-19 test). The clinical outcome of the events for classic fit was recovered on 31Jul2021, tingling sensation was recovered on an unspecified date 2021 and outcome of can''t sleep was unknown. I was absolutely fine going into the clinic, went in the room had my needle, came out the room feeling fine too, then told to wait for 15 minutes, about 1-3 minutes into waiting started having a fit after my eye went all weird & back, only for my mum after it telling me I had a fit. Now I have tingling sensation in body, mainly hands & legs/ feet & I can''t sleep. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1558628 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Chest discomfort, Discomfort, Feeling abnormal, Hypoaesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Irritable bowel
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984342

Write-up: slight sharp notes in heart area; some discomfort, blocked feeling, no pain as such but tight restrictive feeling; Sort of inflaming feeling; numbness/ numbness in the left arm, fingers; discomfort in the chest area; This is a spontaneous report from a contactable consumer (patient), received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108011028498410-SOYQL, Safety Report Unique Identifier GB-MHRA-ADR 25737913. A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 30Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included irritable bowel syndrome from an unknown date and unknown if ongoing (but no actual diagnosis, no other conditions of note). Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. On 31Jul2021 the patient experienced slight sharp notes in heart area. On unspecified date in 2021 patient experienced numbness/ numbness in the left arm, fingers, discomfort in the chest area, some discomfort, blocked feeling, no pain as such but tight restrictive feeling and sort of inflaming feeling. It was reported that it was worse when lying down. She could not sleep on her left side as she felt restricted and discomfort in the chest area. If she slept on her right and extend her arms out it felt better. If she lay on her back she could feel some discomfort, blocked feeling, no pain as such but tight restrictive feeling and then slight sharp notes in heart area. Sort of inflaming feeling. Also sort of numbness in the left arm, fingers, which took the vaccine but this comes and goes. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The case was reported as serious (medically significant). The outcome for numbness, discomfort in chest, some discomfort, blocked feeling, no pain as such but tight restrictive feeling area was recovering, slight sharp notes in heart area was not recovered and unknown for sort of inflaming feeling. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1558634 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Lymphadenopathy, Maternal exposure during pregnancy, Product use issue, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Comments: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: negative; Comments: Patient has not tested positive for COVID-19 since having the vaccine.
CDC Split Type: GBPFIZER INC202100984586

Write-up: Fatigue; Swollen lymph nodes; Headache; Maternal exposure during pregnancy; Drug use in unapproved population; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The Regulatory authority report number GB-MHRA-WEBCOVID-202108012139543860-DOJSH, Safety Report Unique Identifier GB-MHRA-ADR 25738416. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FE1510), dose 2 via an unspecified route of administration on 31Jul2021 (at 38-years age) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing pregnancy, folic acid supplementation. Concomitant medication(s) included FOLIC ACID taken for folic acid supplementation. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) for covid-19 immunisation. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test negative. Patient was exposed to the medicine Third trimester (29-40 weeks). The patient experienced maternal exposure during pregnancy and drug use in unapproved population on 31Jul2021, fatigue, swollen lymph nodes, headache on 01Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Seriousness for the events was reported as medically significant. Outcome for event fatigue, headache was resolving, swollen lymph nodes was not resolved. No follow-up attempts are possible. No further information is expected. Linked Report(s): GB-PFIZER INC-202100998937 Mother-child case.


VAERS ID: 1558637 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Fatigue, Insomnia, Pain, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; PARACETAMOL; SUDAFED SINUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deafness; Dysmenorrhoea; Family history of diabetes (Family History of Diabetes.); Lactation decreased; Tight chest
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100992143

Write-up: feeling unusually; pain; Ache; Swelling; Tiredness; Sleeplessness; This is a spontaneous report from a contactable consumer or other non-Healthcare Professsional. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202108020953504920-ACODV, Safety Report Unique Identifier GB-MHRA-ADR 25739902. A 30-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 31Jul2021 at 10:00 am (age at vaccination was 30 years) as dose 1, single for COVID-19 immunization. The patient''s medical history included familial risk factor (family history of diabetes), chest discomfort, lactation decreased, deafness and dysmenorrhoea. No known history of items on the list affecting immune response in the list. The patient has not had symptoms associated with COVID-19. The patient was not currently breastfeeding. The patient was not enrolled in clinical trial. Concomitant medication included ibuprofen taken for dysmenorrhoea, paracetamol taken for an unspecified indication from 31Jul2021 to an unspecified stop date and paracetamol, pseudoephedrine hydrochloride (SUDAFED SINUS) taken for deafness from 28Jul2021 to an unspecified stop date. On an unspecified date, the patient experienced feeling unusually and pain. On 31Jul2021, the patient experienced tiredness, sleeplessness, ache and swelling. The top of the patient''s arm swelled and ached to the degree she couldn''t lift it all weekend. This started almost immediately after having the vaccine at 10 am on Saturday morning. Within 8 hours the pain spread through her left shoulder (Vaccinated in left arm), up her neck and later into her right shoulder. It was painful to move her neck or her arm. The pain lessened after 36 hours but persists to a milder degree even today, 48 hours after the vaccine. She had very little sleep the night after the vaccine due to the pain and feeling unusually alert, this resolved the night after. The patient underwent lab test which included COVID-19 virus test: negative, no - negative COVID-19 test on an unknown date. The patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event sleeplessness was resolved on 01Aug2021. The outcome of the event tiredness was resolved on 02Aug2021. The outcome of the events feeling unusually and pain was resolved on an unspecified date in 2021. The outcome of the events ache and swelling was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1558678 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0348 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Depressed level of consciousness, Dizziness, Heart rate, Heart rate decreased, Nausea, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: BP; Result Unstructured Data: Test Result:133/74; Comments: At 14:42; Test Date: 20210731; Test Name: BP; Result Unstructured Data: Test Result:110/55; Comments: At 14:55; Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 degrees Centigrade; Comments: Before vaccination; Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 degrees Centigrade; Comments: After vaccination At 14:42; Test Date: 20210731; Test Name: HR; Result Unstructured Data: Test Result:44; Comments: At 14:42; Test Date: 20210731; Test Name: HR; Result Unstructured Data: Test Result:16; Comments: At 14:55; Test Date: 20210731; Test Name: SpO2; Test Result: 98 %; Comments: At 14:42; Test Date: 20210731; Test Name: SpO2; Test Result: 97 %; Comments: At 14:55
CDC Split Type: JPPFIZER INC202100978102

Write-up: Anaphylaxis; Consciousness decreased; HR 44/HR 16; Queasy; Light-headed feeling/Giddiness; This is a spontaneous report from a contactable physician received from the regulatory authority; report number is v21119525. A 28-year and 9-month-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FD0348, Expiration date 31Oct2021), via an unspecified route of administration on 31Jul2021 14:38 (the day of vaccination, at the age of 28-years-old) at dose 2, single for COVID-19 immunization. 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). The patient''s medical history and concomitant medications were reported as none. The patient''s body temperature before vaccination on 31Jul2021 was 36.5 degrees Centigrade. On 31Jul2021 at 14:42 (the day of vaccination), the patient experienced anaphylaxis. On 31Jul2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: At 14:38, the patient was vaccinated. At 14:42, the patient was experienced queasy, light-headed feeling, giddiness, and had consciousness decreased. BT (body temperature) was 36.5 degrees Centigrade (after vaccination), SpO2 was 98%, HR was 44, BP was 133/74. The patient took a rest in a supine position, Allelock (5) was orally taken, no infusion request. At 14:55, BP was 110/55,HR was 16, SpO2 was 97%. At 15:00, No giddiness and dizziness when sitting and standing position. There was slight nausea remained, and the patient returned home slowly. The reporting physician classified the event as non-serious and assessed that the event as related to BNT162B2. There were no other possible causes of the events such as any other diseases. The reporting physician commented as follows: The first vaccine had no side effects, and the second vaccine had reaction. There was a reaction immediately after vaccination, and the symptoms became stable immediately after oral administration in the supine position. Outcome of all the events was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1565987 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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: LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984531

Write-up: This is a spontaneous report from a contactable consumer or other received from the Agency. A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on 26Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history included lactation decreased, hypothyroidism. The patient concomitant medication included levothyroxine (LEVOTHYROXINE) taken for hypothyroidism from 01Jun2018. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient not had symptoms associated with COVID-19. The patient did not have a COVID-19 test. The patient was not currently breastfeeding. The patient was not enrolled in clinical trial. On 31Jul2021, the patient experienced menorrhagia and on an unspecified date, the patient had a very heavy period, soaking through a towel and extra protection every 1-2 hours, lots of clots and generally very painful. This has never happened before. The patient had not tested positive for COVID-19 since having the vaccine. The events were serious (medically significant). The outcome of the events was not recovered for menorrhagia, and unknown for very heavy period, lots of clots, generally very painful. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


VAERS ID: 1565989 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Computerised tomogram, Imaging procedure, Infection, Jugular vein occlusion, Jugular vein thrombosis, Microbiology test, Platelet count, Prothrombin time prolonged, SARS-CoV-2 test, Sepsis, Swelling
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage laboratory terms (broad), Embolic and thrombotic events, venous (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CO-AMOXICLAV [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]; NITROFURANTOIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (one month prior to first vaccine); Lactation decreased; Sepsis; Smoker; Streptococcal abscess; Unwell; UTI; Comments: Normally fit and well. Had reportedly been treated with Nitrofurantoin for UTI prior to presentation. No recent unwell contacts. No contacts with TB. No other preceding illness. No recent tattoos/piercings. Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Name: Activated Partial Thromboplastin Clotting Time; Result Unstructured Data: Test Result:39; Test Date: 20210731; Test Name: CT neck with contrast, US neck and US Duplex neck; Result Unstructured Data: Test Result:IJV occlusive thrombus noted on presentation; Test Name: imaging; Result Unstructured Data: Test Result:have occlusion of left IJV on imaging (thrombus) w; Comments: have occlusion of left IJV on imaging (thrombus) with associated left neck collection; Test Name: Infectious screen; Result Unstructured Data: Test Result:HIV not detected; Test Name: Microbiology samples; Result Unstructured Data: Test Result:positive for Group A Strep; Test Name: Platelet count; Result Unstructured Data: Test Result:292; Comments: lowest platelet count after vaccine 292; Test Date: 20210731; Test Name: Platelet count; Result Unstructured Data: Test Result:Unknown results; Test Name: PT; Result Unstructured Data: Test Result:10.9; Test Date: 20210731; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101006101

Write-up: sepsis; neck swelling; Internal jugular vein occlusion; IJV occlusive thrombus noted on presentation; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041210571830-OU8YI. Safety Report Unique Identifier: GB-MHRA-ADR 25753086. A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Jul2021 (lot number was not provided) as single dose for COVID-19 immunisation. Medical history included lactation decreased, malaise, urinary tract infection, sepsis, tobacco user, streptococcal abscess. Normally fit and well. No recent unwell contacts. No contacts with TB. No other preceding illness. No recent tattoos/piercings. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient has a previous history of COVID-19 infection one month prior to first vaccine. Concomitant medications included amoxicillin sodium, clavulanate potassium (CO-AMOXICLAV) taken for streptococcal abscess from 31Jul2021; nitrofurantoin taken for urinary tract infection. The patient previously took heparin. The patient experienced sepsis (hospitalization, medically significant, life threatening) on 31Jul2021, neck swelling (hospitalization, medically significant, life threatening) on 31Jul2021, internal jugular vein occlusion (hospitalization, medically significant, life threatening) on 31Jul2021, IJV occlusive thrombus noted on presentation (hospitalization, medically significant, life threatening) on 31Jul2021. Clinical course: Patient presented on 31Jul2021 with left neck swelling and signs of sepsis. Was noted to have occlusion of left IJV on imaging (thrombus) with associated left neck collection. Taken to theatre for exploration, washout and drainage. Microbiology samples have since tested positive for Group A Strep. Patient has a previous history of COVID-19 infection one month prior to first vaccine. Clotting team at UCLH have requested that this case be reported to Yellow Card. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The physician considered the report was related to possible blood clots or low platelet counts. Relevant investigations or tests conducted: CT neck with contrast, US neck and US Duplex neck (31Jul2021): IJV occlusive thrombus noted on presentation. The platelet count was measured on 31Jul2021 with unknown results. No history/family history related to previous venous or arterial thromboses. The patient did not have confirmed or suspected autoimmune or inflammatory disease, including vasculitis. The patient did not have history of, or current, malignancy. The lowest platelet count after vaccine (usual normal range 150-450) was 292. The patient was discussed with Haematology who are advising re:anticoagulation. The patient did not have a history of, or concurrent, intracranial malignancy. The patient did not have concurrent or recent intracranial infections. The patient has not had recent surgical or medical interventions to the central nervous system (including lumbar puncture). The patient has not had a recent trauma/head injury. PT: 10.9 on an unspecified date. Activated Partial Thromboplastin Clotting Time (aPTT): 39 on an unspecified date. Infectious screen (eg HIV, hepatitis C/B, herpes zoster/ CMV): HIV not detected. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 31Jul2021. The outcome of the event internal jugular vein occlusion was not recovered, of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1571292 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-31
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Arthralgia, Foaming at mouth, Haematocrit, Mean cell haemoglobin, Mean cell volume, Platelet count, Seizure, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (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: Alcohol use (Patient drinks ETOH, 8 bottles wine per week, 2 bottles at once.); Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Head injury; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: APTT; Test Result: Inconclusive ; Result Unstructured Data: APTT 24.5; Test Date: 20210731; Test Name: ALT; Test Result: Inconclusive ; Result Unstructured Data: ALT 153; Test Date: 20210731; Test Name: Hct; Test Result: Inconclusive ; Result Unstructured Data: Hct 0.327; Test Date: 20210731; Test Name: MCHb; Test Result: Inconclusive ; Result Unstructured Data: MCHb 25.9; Test Date: 20210731; Test Name: MCV; Test Result: Inconclusive ; Result Unstructured Data: MCV 102; Test Date: 20210731; Test Name: Platelet count; Result Unstructured Data: Thrombocytopenia, lowest platelet count after vaccine-150; Test Date: 20210731; Test Name: Platelet count; Result Unstructured Data: Platelet decreased.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: seizures; frothing at mouth; shoulder pain; Thrombocytopenia; Seizure; This regulatory authority case was reported by a physician and describes the occurrence of SEIZURE (Seizure), SEIZURE (seizures), THROMBOCYTOPENIA (Thrombocytopenia), FOAMING AT MOUTH (frothing at mouth) and ARTHRALGIA (shoulder pain) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Head injury and Lactation decreased. Previously administered products included for Product used for unknown indication: Heparin. Concurrent medical conditions included Smoker and Alcohol use (Patient drinks ETOH, 8 bottles wine per week, 2 bottles at once.). On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant) and THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criterion medically significant). On an unknown date, the patient experienced SEIZURE (seizures) (seriousness criterion medically significant), FOAMING AT MOUTH (frothing at mouth) (seriousness criterion medically significant) and ARTHRALGIA (shoulder pain) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) was resolving, SEIZURE (seizures), FOAMING AT MOUTH (frothing at mouth) and ARTHRALGIA (shoulder pain) outcome was unknown and THROMBOCYTOPENIA (Thrombocytopenia) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, Activated partial thromboplastin time: 24.5 (Inconclusive) APTT 24.5. On 31-Jul-2021, Alanine aminotransferase: 153 (Inconclusive) ALT 153. On 31-Jul-2021, Haematocrit: 0.327 (Inconclusive) Hct 0.327. On 31-Jul-2021, Mean cell haemoglobin: 35.9 (Inconclusive) MCHb 25.9. On 31-Jul-2021, Mean cell volume: 102 (Inconclusive) MCV 102. On 31-Jul-2021, Platelet count (150-450): <150 ?? 109/l (Low) Thrombocytopenia, lowest platelet count after vaccine-150 and 144 (Low) Platelet decreased.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient ''s RCC lab test result was 3.20. Concomitant medication and treatment medication were not reported. Patient experienced right shoulder pain, shock pain in arm, then experienced 2 seizures next day it was self terminating for 2 and 5 mins. Second seizures was witnessed by nurse. Very limited information regarding this events has been provided at this time. 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. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this events has been provided at this time. 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. Further information can''t be requested.


VAERS ID: 1571329 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal distension, Blood pressure measurement, Heart rate, Presyncope, Thrombosis
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Current Illness: Fear of needles (The patient had a needle phobia and had fainted in the past when receiving an injection.)
Preexisting Conditions: Medical History/Concurrent Conditions: Fainting
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Blood pressure; Result Unstructured Data: 83/52; Test Date: 20210731; Test Name: Blood pressure; Result Unstructured Data: 117/88; Test Date: 20210731; Test Name: Pulse; Result Unstructured Data: 43; Test Date: 20210731; Test Name: Pulse; Result Unstructured Data: 50
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: blood clots; gradually sat up over 10mins; Near syncope; This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOSIS (blood clots) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Fainting. Concurrent medical conditions included Fear of needles (The patient had a needle phobia and had fainted in the past when receiving an injection.). On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced PRESYNCOPE (Near syncope). On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant) and ABDOMINAL DISTENSION (gradually sat up over 10mins). On 31-Jul-2021, PRESYNCOPE (Near syncope) had resolved. At the time of the report, THROMBOSIS (blood clots) and ABDOMINAL DISTENSION (gradually sat up over 10mins) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, Blood pressure measurement: 83/52 (Low) 83/52 and 117/88 (normal) 117/88. On 31-Jul-2021, Heart rate: 43 (Low) 43 and 50 (Low) 50. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that patient felt unwell immediately post vaccine, assisted to a couch to lay down. As a treatment patient was given a drink and reassurance and patient gradually sat up over 10mins. Based on the current available information and temporal association between the use of the product and the start date of the event ''Presyncope'', a causal relationship cannot be excluded. Very limited information regarding the event ''Thrombosis'' has been provided at this time. No further information is expected at this time. Of note, the patient''s history of needle phobia and fainting in the past when receiving an injection are confounding factors that may play possible contributory roles.; 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 ''Presyncope'', a causal relationship cannot be excluded. Very limited information regarding the event ''Thrombosis'' has been provided at this time. No further information is expected at this time. Of note, the patient''s history of needle phobia and fainting in the past when receiving an injection are confounding factors that may play possible contributory roles.


VAERS ID: 1571330 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA Y0D2C / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Malaise, Palpitations, Pericarditis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EMTRICITABINE
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: short of breath; palpitations; generally unwell; Pericarditis; This regulatory authority case was reported by an other health care professional and describes the occurrence of PERICARDITIS (Pericarditis) in a 22-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Y0D2C) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included EMTRICITABINE for Prophylaxis against AIDS. On 29-Jul-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPNOEA (short of breath), PALPITATIONS (palpitations) and MALAISE (generally unwell). At the time of the report, PERICARDITIS (Pericarditis) had not resolved and DYSPNOEA (short of breath), PALPITATIONS (palpitations) and MALAISE (generally unwell) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Company Comment: 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.; Sender''s Comments: 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.


VAERS ID: 1571337 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Pain, Sciatica
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976990

Write-up: pain; Joint pain; a bit like sciatica but sharper pain shooting down leg; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107311844422380-SYOD0, Safety Report Unique Identifier GB-MHRA-ADR 25737437. A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FF3319), via an unspecified route of administration, administered in left arm on 30Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included endometriosis and lactation decreased. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant and is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced pain on an unspecified date, joint pain and a bit like sciatica but sharper pain shooting down leg on 31Jul2021. The events were medically significant. Outcome of the joint pain was not recovered while of the remaining events was unknown. The clinical course was reported as follows: Woke up with severe hip pain localised in left hip. Vaccine was administered in left arm. Was previously fit and well and have no history of hip pain so wondering if sudden onset of severe sharp pain in hip is linked to the vaccine. Pain is sharp and shooting down leg, starting at hip, a bit like sciatica but sharper. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1571351 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Nausea, Pain
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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: headache; Shivers; Frontal headache; Nausea; Ache; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), HEADACHE (headache), CHILLS (Shivers), HEADACHE (Frontal headache) and NAUSEA (Nausea) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), HEADACHE (Frontal headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant). At the time of the report, PAIN (Ache) and CHILLS (Shivers) had not resolved, HEADACHE (headache) had resolved and HEADACHE (Frontal headache) and NAUSEA (Nausea) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided Treatment medication was not provided 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.; Sender''s Comments: 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.


VAERS ID: 1571367 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure fluctuation, Headache, Hyperhidrosis, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

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

Write-up: Sweating; Ache; Headache; Change in blood pressure; This regulatory authority case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Change in blood pressure), HYPERHIDROSIS (Sweating), PAIN (Ache) and HEADACHE (Headache) in a 36-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced BLOOD PRESSURE FLUCTUATION (Change in blood pressure) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, BLOOD PRESSURE FLUCTUATION (Change in blood pressure), HYPERHIDROSIS (Sweating), PAIN (Ache) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Company comment: 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.; Sender''s Comments: 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.


VAERS ID: 1571375 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Feeling hot, Myalgia, Neck pain, Pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COCODAMOL; NAPROXEN
Current Illness: Fibromyalgia; Hypermobility syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Shoulder pain; Tiredness
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Aches; Feeling hot; High temperature; Chills; Muscle ache; Tiredness; Shivering; Shoulder pain; Neck pain; Coldness; This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain), NECK PAIN (Neck pain), MYALGIA (Muscle ache), PAIN (Aches), CHILLS (Shivering), FEELING HOT (Feeling hot), FATIGUE (Tiredness), FEELING COLD (Coldness), PYREXIA (High temperature) and CHILLS (Chills) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Shoulder pain, Tiredness and Lactation decreased. Concurrent medical conditions included Fibromyalgia and Hypermobility syndrome. Concomitant products included CODEINE PHOSPHATE HEMIHYDRATE, PARACETAMOL (COCODAMOL) and NAPROXEN for an unknown indication. On 30-Jul-2021 at 2:45 PM, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant) and NECK PAIN (Neck pain) (seriousness criterion medically significant). 31-Jul-2021, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 31-Jul-2021 at 1:00 AM, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant). On 31-Jul-2021 at 10:00 AM, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Aches) (seriousness criterion medically significant), FEELING HOT (Feeling hot) (seriousness criterion medically significant) and FEELING COLD (Coldness) (seriousness criterion medically significant). On 31-Jul-2021 at 1:00 PM, CHILLS (Chills) had resolved. On 01-Aug-2021, PYREXIA (High temperature) had resolved. At the time of the report, ARTHRALGIA (Shoulder pain) and NECK PAIN (Neck pain) had not resolved, MYALGIA (Muscle ache) was resolving and PAIN (Aches), CHILLS (Shivering), FEELING HOT (Feeling hot), FATIGUE (Tiredness) and FEELING COLD (Coldness) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. Patient had shivering and coldness lasted a around 3 hours. Then began feeling hot and neck and shoulder pain started. Neck and shoulder pain has been increasingly worse and not relieved by pain killers. Top arm of injection arm had also been painful since couple of hours after injection. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial Treatment for the adverse events included unspecified pain killers. Company Comment: 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, patient history of fibromyalgia could be a confounding factor to the occurrence of the events.; Sender''s Comments: 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, patient history of fibromyalgia could be a confounding factor to the occurrence of the events.


VAERS ID: 1571377 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MERCILON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: vomiting; Vomited; Chills; Nausea; Headache; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue), VOMITING (vomiting), CHILLS (Chills) and VOMITING (Vomited) in a 31-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. The patient''s past medical history included Lactation decreased. Concomitant products included DESOGESTREL, ETHINYLESTRADIOL (MERCILON) for an unknown indication. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and NAUSEA (Nausea). On 01-Aug-2021, the patient experienced VOMITING (Vomited) (seriousness criterion medically significant). On an unknown date, the patient experienced VOMITING (vomiting) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved, VOMITING (vomiting) outcome was unknown and CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomited) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication were provided. 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.; Sender''s Comments: 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.


VAERS ID: 1571378 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Miscarriage; Fever; Maternal exposure during pregnancy; Early miscarriage; Feverish; This regulatory authority pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage), ABORTION SPONTANEOUS (Early miscarriage), PYREXIA (Feverish) and PYREXIA (Fever) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Miscarriage, Lactation decreased and Pregnancy (Patient no longer pregnant at the time of reporting.). Concomitant products included FOLIC ACID for Folic acid supplementation. 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. Last menstrual period and estimated date of delivery were not provided. On 31-Jul-2021, the patient experienced ABORTION SPONTANEOUS (Early miscarriage) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On an unknown date, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 31-Jul-2021, PYREXIA (Feverish) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage), PYREXIA (Fever) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown and ABORTION SPONTANEOUS (Early miscarriage) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient''s pregnancy symptoms all suddenly disappeared by the morning after her fever had resolved. Spotting started approximately 12 hours after fever and then progressed to a miscarriage. It was unknown whether the fever caused the early miscarriage. Patient was exposed to the medicine first-trimester (1-12 weeks). On 28-Jul-2021, patient had a positive pregnancy test. This is a case of product exposure during pregnancy with associated AEs for this 31-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. Patient''s past medical history of miscarriages may be contributory to the occurrence of this pregnancy loss. No further follow-up information is expected.; Sender''s Comments: This is a case of product exposure during pregnancy with associated AEs for this 31-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. Patient''s past medical history of miscarriages may be contributory to the occurrence of this pregnancy loss. No further follow-up information is expected.


VAERS ID: 1571427 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hemiparesis, Magnetic resonance imaging head, Thalamic infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before the first dose vaccination; Test Date: 20210727; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before the second dose vaccination; Test Date: 20210731; Test Name: Head MRI; Result Unstructured Data: Test Result:cerebral infarction in the left thalamus; Comments: cerebral infarction in the left thalamus
CDC Split Type: JPPFIZER INC202100979292

Write-up: a cerebral infarction in the left thalamus; right half of my body became weak; This is a spontaneous report from a contactable other HCP received from the Agency Regulatory Authority. Regulatory authority report number is v21119520. A 73-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: FC8736; Expiration Date: 30Sep2021), via an unspecified route of administration on 27Jul2021 (at the age of 73-years-old) as dose 2, single for COVID-19 immunization. Medical history included hypertension that was untreated. The patient''s concomitant medications were not reported. On 06Jul2021, in the afternoon, the patient previously received BNT162B2(COMIRNATY Lot number EY5422, Expiration date 31Aug2021) via an unspecified route of administration as dose 1, single for COVID-19 immunization. On 06Jul2021, body temperature before the first dose vaccination was 36.9 centigrade. On 21Jul2021, the patient experienced weakness in right half of body. On 27Jul2021, body temperature before the second dose vaccination was 36.3 centigrade. On 27Jul2021 in the afternoon (the day of vaccination), the patient received the second dose of the vaccine. On 31Jul2021 around 7:00 (4 days after the vaccination), the patient experienced the following events: On 31Jul2021 in the morning around 7:00 (4 days after the vaccination), the patient got up, right half of body became weak. The patient went to an outpatient clinic. (The patient experienced the same thing 10 days ago). Head MRI test performed and revealed a cerebral infarction in the left thalamus.The patient was taken to the hospital in emergency. Event outcome was unknown (not reported) and seriousness criteria was not provided. The causality between the event and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was Hypertension. No follow up attempts are possible. No further information is expected.


VAERS ID: 1574982 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-31
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, Pulmonary embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ROACTEMRA
Current Illness: Rheumatoid arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Pollen allergy; Thrombosis (in the past)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101010088

Write-up: pulmonary artery embolism; right leg thrombosis; pain in the right calf; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority WEB DE-PEI-CADR2021154456, Safety Report Unique Identifier DE-PEI-202100155604. This is a report from a German Medical Information received by Pfizer from Biontech, license party for Comirnaty. This is the first of two reports. This is the report with events related to the second vaccine dose. A 66-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: unknown, strength: 0.3 ml) (mRNA tozinameran) on 20Jul2021 at 0.3 ml single dose for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis, not ongoing probably had a thrombosis in the past and pollen allergy. The patient was confirmed no off-label use. Concomitant medication included tocilizumab (ROACTEMRA) at 162 mg, cyclic (every two weeks) via subcutaneous taken for rheumatoid arthritis from Apr2011. The patient did not take any other medication. The patient previously received the first dose of BNT162B2 (lot number: unknown) on 29Jun2021 at single dose for COVID-19 immunisation and experienced shortness of breath on 04Jul2021. On 31Jul2021, the patient experienced pain in the right calf and right leg thrombosis. On 01Aug2021, the patient experienced pulmonary artery embolism and he was resuscitated because of a pulmonary embolism and was still in the intensive care unit, then Venoarterial extracorporeal membrane oxygenation (VA-ECMO) implantation, intensive care stay. In retrospect, the patient had a leg vein thrombosis a few days before the pulmonary embolism, which may have been the cause of the pulmonary embolism, according to the doctor. The relatedness of drug to events was D. Unclassifiable (PEI). The outcome of the events pulmonary artery embolism, right leg thrombosis and pain in the right calf was not recovered. Sender''s comments: Information on risk factors or previous illnesses: rheumatoid arthritis and pollen allergy. The patient received the first vaccination on 29Jun2021, second vaccination on 20Jul2021, since 04Jul2021 dysponea, since 31Jul2021 pain in the right calf, on 01Aug2021 resuscitation required for pulmonary artery embolism, then VA-ECMO implantation, intensive care stay. 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) : DE-PFIZER INC-202101038668 same patient, different dose&event


VAERS ID: 1575187 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100984568

Write-up: Fever; Chills; General body pain; dose 1 on 05Jun2021/dose 2 on 31Jul2021; headache; arm pain; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-APPCOVID-20210801213713, Safety Report Unique Identifier GB-MHRA-ADR 25738417. This is the first of two reports. This report concerns events occurred after the second dose of BNT162B2. A 23-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Jul2021 (at the age of 23-years-old) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient received the first dose of BNT162B2 on 05Jun2021 for COVID-19 immunisation and experienced arm pain and arm discomfort. The patient experienced headache and arm pain in 2021, fever, chills, general body pain on 31Jul2021. The events were reported as serious as important medical events. The clinical course was reported as follows: second vaccine: full body aches, fever, headache, chills, arm pain. The patient underwent lab tests and procedures which included COVID-19 virus test: negative. The patient had recovered from general body pain, chills and fever on 01Aug2021, the outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575202 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Medication error, Off label use
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Medication errors (narrow)

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

Write-up: Medication error; Ill-defined disorder; Dizziness; This case was received via regulatory authority, MHRA (Reference number: 25748592) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and MEDICATION ERROR (Medication error) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Ill-defined disorder. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced MEDICATION ERROR (Medication error) (seriousness criterion medically significant) and OFF LABEL USE (Ill-defined disorder). At the time of the report, DIZZINESS (Dizziness) had not resolved and MEDICATION ERROR (Medication error) and OFF LABEL USE (Ill-defined disorder) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment history were reported. Constant dizzy spells when moving around or tilting head at any time. Incorrect and not enough testing. The patient was taking Moderna vaccine for Pressure. Company comment: This report refers to a case of medication error and off label use for mRNA-1273 (lot # unknown) with associated AE reported as dizziness.; Sender''s Comments: This report refers to a case of medication error and off label use for mRNA-1273 (lot # unknown) with associated AE reported as dizziness.


VAERS ID: 1575389 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: COVID-19 virus test; Test Result: Negative .
CDC Split Type: GBPFIZER INC202100984718

Write-up: Chills and Shivers; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-APPCOVID-202108010814289270-YOWQB. Safety Report Unique Identifier GB-MHRA-ADR 25737825. A 33-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Lot Number: FD8813) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified date (lot number and expiry date were unknown) for COVID-19 immunisation. The patient experienced chills and shivers but no temperature on 31Jul2021. The patient had negative COVID-19 virus test on 09Jul2021. The outcome of the event was recovered on 31Jul2021. The event was considered serious, medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575390 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: 20210729; Test Name: COVID-19 virus test; Test Result: Negative.
CDC Split Type: GBPFIZER INC202100984703

Write-up: Fatigue; Nausea; Fever; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-APPCOVID-20210801114206. Safety Report Unique Identifier GB-MHRA-ADR 25737967. A 32-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) on 30Jul2021 (Lot Number: FE1510) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. The patient experienced fatigue and nausea on 31Jul2021 with outcome of recovering and fever on 31Jul2021 with outcome of recovered on 31Jul2021. The patient underwent lab test which included Covid-19 virus test negative on 29Jul2021. The events were assessed as serious and medically significant by regulatory authority. No follow up attempts are possible. No further information is expected.


VAERS ID: 1575770 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Eye pain, Fatigue, Headache, Influenza like illness, Nausea, Pyrexia, Sensitive skin, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Tiredness
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984597

Write-up: with the first dose of vaccine i only experienced arm pain around injection site; fever; chills; flu like symptoms; Headache; Fever chills; Joint pain; Sensitive skin; Sore eyes; Nausea; Tiredness; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-APPCOVID-20210801223035, Safety Report Unique Identifier is GB-MHRA-ADR 25738463. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Jul2021 (Batch/Lot Number: FD3319) as single dose for COVID-19 immunisation. Medical history included tiredness and headache both from an unknown date. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 and experienced arm pain around injection site. The patient experienced fever, chills and with the first dose of vaccine i only experienced arm pain around injection site all on an unspecified date; headache, fever chills, flu like symptoms, joint pain, sensitive skin, sore eyes, nausea and tiredness all on 31Jul2021. The events were reported as serious (medically significant). Clinical course was reported as follows: Symptoms started around late afternoon with a headache, and around 12 hours after my vaccine (second one) the flu like symptoms started- fever chills, joint pain, sore eyes etc. With the first dose of vaccine I only experienced arm pain around injection site, which resolved within 3 days. I had the same arm pain with the second dose, but it''s already resolving and is not as noticeable as the first. Still suffering from a headache and tiredness. While noting headaches and tiredness, worth noting that the vaccine was taken at the start of a mean trial cycle where headache and tiredness can occur. The patient recovered from fever chills, joint pain, sensitive skin, sore eyes, nausea all on 01Aug2021 while patient was recovering from fever, chills, flu like symptoms, with the first dose of vaccine i only experienced arm pain around injection site, headache and tiredness. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575817 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Mastitis, Maternal exposure during breast feeding
SMQs:, Functional lactation disorders (narrow), Neonatal exposures via breast milk (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976731

Write-up: Maternal exposure during breast feeding; Mastitis; This is a spontaneous report from a contactable consumer received from the. The regulatory authority report number is GB-MHRA-WEBCOVID-202107310741254930-V8AVH and Safety Report Unique Identifier is GB-MHRA-ADR 25736600. A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), dose 2 via an unspecified route of administration on 30Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing breast feeding. The patient concomitant medications were not reported. The patient previously received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, the patient experienced maternal exposure during breast feeding (maternal exposure during breast feeding) (medically significant). On 31Jul2021, the patient experienced mastitis (mastitis) (medically significant). It was reported that Blocked milk duct, sudden oversupply of milk, suspecting mastitis. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event mastitis was not resolved. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101047763 Baby/Fetus case


VAERS ID: 1575849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Pain, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (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: SERTRALINE.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976726

Write-up: pain; period pain; Heavy periods; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202107311302453940-WGP1J, and Safety Report Unique Identifier is GB-MHRA-ADR 25737024. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Jul2021 (Lot Number: FD5613, Expiry date not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included suppressed lactation (lactation decreased), and anxiety from an unknown date and unknown if ongoing. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medication included sertraline taken for anxiety from 01Mar2020 to an unspecified stop date. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), as dose 1 single on an unspecified date for COVID-19 immunization. The patient experienced pain on an unspecified date with outcome of recovered on an unspecified date, heavy periods on 31Jul2021 with outcome of not recovered, and period pain on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date, No - Negative COVID-19 test. The events were reported as serious, medically significant by the health authority. Case narrative: This is my 2nd jab and my period is a lot more heavy than normal and my period pain is a lot more severe. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575852 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977088

Write-up: Muscle pain; High temperature; Joint pain; Headache; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107311317105050-187ZO. Safety Report Unique Identifier (GB-MHRA-ADR 25737069). A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 30Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at single dose for COVID-19 immunization. The patient experienced muscle pain, high temperature, joint pain, headache, all on 31Jul2021 with outcome of not recovered. All the events were assessed serious as medically significant. The lab tests included no - negative covid-19 test. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1575854 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness, Ophthalmic migraine
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal 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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976866

Write-up: terrible ocular migraine; loss of vision; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202107311354141780-JGRWA, Safety Report Unique Identifier GB-MHRA-ADR 25737107. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Jul2021 (Lot Number: FA1027) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant and is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient have never had a migraine in life and today (31Jul2021), she was experiencing a terrible ocular migraine and loss of vision. The events were medically significant and caused disability. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the events was terrible ocular migraine was not recovered while of the loss of vision was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575862 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100977256

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107311448541670-UZCPT; safety report unique identifier: GB-MHRA-ADR 25737184). A 30-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Jul 30, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. Patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. The patient experienced lightheadedness and blackout on Jul 31, 2021. This happened when standing up, even when going slowly. The case reported serious (medically important condition); with outcome of recovering. Patient has not tested positive for COVID-19 since the vaccination. Patient not enrolled in a clinical trial. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1575875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling hot, Paraesthesia, SARS-CoV-2 test, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Blotchy; Depression; Lactation decreased; Swelling arm
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977113

Write-up: pins needles arms & legs/shaking/hot; pins needles arms & legs/shaking/hot; pins needles arms & legs/shaking/hot; Syncope vasovagal; This is a spontaneous report from a contactable other HCP. This is a report received from the regulatory authority. The regulatory authority report number is . Safety Report Unique Identifier . A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 31Jul2021 (Batch/Lot Number: FD8813) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Lactation decreased, Blotchy, Allergy, depression. Allergy to anti-emetic disclosed at pre-screen prior to vaccination. Advised that had reaction to anti-emetic given via IV drip previously. The patient went ''blotchy'' over body and arm swelled up. In view of this discussed vaccination today with pharmacist and advised no concerns and to continue to administer vaccination. Patient is not pregnant, Patient is not currently breastfeeding. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medications included sertraline taken for depression, start and stop date were not reported. The patient experienced syncope vasovagal (reported as non-serious) on 31Jul2021 with outcome of recovering, pins needles arms & legs/shaking/hot (reported as non-serious) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575879 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100976864

Write-up: Syncope; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107311816248990-JGSCF, Safety Report Unique Identifier is GB-MHRA-ADR 25737395. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 31Jul2021 (Lot Number: FD8813) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medication was not reported. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced syncope on 31Jul2021. The event was assessed as non-serious. The patient recovered from syncope on 31Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575880 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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 INC202100976727

Write-up: left arm hurting; Chest pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202107311838480040-JUMS3 and Safety Report Unique Identifier GB-MHRA-ADR 25737417. A 31-year-old male patient received the second dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE) (Batch/Lot number: Unknown), via an unspecified route of administration on 31Jul2021, at the age of 31 years, at dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On 31Jul2021, patient experienced chest pain. On an unspecified date, the patient experienced left arm hurting. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient had COVID-19 Virus test (31Jul2021): No - Negative COVID-19 test. The case is serious (medically significant). The outcome for chest pain was not recovered; outcome for left arm hurting was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575881 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Headache, Lymph node pain, Lymphadenopathy, Malaise, Neck pain, Pain in extremity, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Migraine
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976780

Write-up: feeling unwell; Pain/tenderness from neck to fingertips; Pain/tenderness from neck to fingertips; Lymph node pain; Neck swelling; Armpit pain; Swollen lymph nodes; Headache; Malaise; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107311839263510-WWQ8C and Safety Report Unique Identifier GB-MHRA-ADR 25737426. A 35-year-old female patient received 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE, Batch/Lot number: Unknown), on 30Jul2021 as dose 2, single for COVID-19 immunization. Medical history included lactation decreased and migraine. Patient has not had symptoms associated with COVID-19. Patient is not pregnant; Patient is not currently breastfeeding. Concomitant medication included paracetamol taken for migraine from 18Jul2021 to an unspecified stop date. On 31Jul2021, the patient experienced lymph node pain, neck swelling, armpit pain, swollen lymph nodes, headache and malaise. On an unspecified date, the patient experienced feeling unwell, pain/tenderness from neck to fingertips. The clinical course was reported as follows: Pain/tenderness from neck to fingertips on side of vaccine. Generally feeling unwell. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The patient had COVID-19 Virus test (Unknown date): No - Negative COVID-19 test. The case is serious (medically significant). The outcome for the events lymph node pain, neck swelling, armpit pain, swollen lymph nodes, headache and malaise was not recovered; outcome for the events feeling unwell, pain/tenderness from neck to fingertips was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575885 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Body temperature, Dizziness postural, Fatigue, Feeling of body temperature change, Myalgia, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE; CO-CODAMOL; GABAPENTIN; HYDROXYZINE; ORAMORPH [MORPHINE SULFATE]; TEMAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Complex regional pain syndrome; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Test Date: 20210614; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976758

Write-up: slightly dizzy anytime I stand up; Fatigue; Muscle ache; going hot and cold; Fever chills; Vomiting; knees, shoulders, ankles and hips are also hurting; feel very weak; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202107311909014990-MHECH, Safety Report Unique Identifier GB-MHRA-ADR 25737479. A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number was not reported), via an unspecified route of administration at dose 2, single on 30Jul2021 for COVID-19 immunization. Medical history included lactation decreased, allergy and complex regional pain syndrome. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications included cetirizine taken for allergy from 01Jan2016 to an unspecified stop date; codeine phosphate, paracetamol (CO-CODAMOL) taken for complex regional pain syndrome from 01Jun2019 to an unspecified stop date; gabapentin taken for complex regional pain syndrome from 01Jun2019 to an unspecified stop date; hydroxyzine taken for allergy from 01Jan2014 to an unspecified stop date; morphine sulfate (ORAMORPH [MORPHINE SULFATE]) taken for complex regional pain syndrome from 01Jan2016 to an unspecified stop date; and temazepam taken for complex regional pain syndrome from 01Jun2019 to an unspecified stop date. The patient previously received the first dose of bnt162b2 on an unknown date and experienced injection site being slightly sore. After the second dose, on 31Jul2021, the patient experienced fever chills with highest of 38.8 degrees Celsius, extreme muscle aches all over the body, muscles were so painful that she was struggling to get dressed or changed, cannot stretch arms or legs fully, knees, shoulders, ankles and hips were also hurting. The patient was going hot and cold, and feel very weak even lying down, but especially fatigued and slightly dizzy anytime she stand up. The patient also developed vomiting. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events fatigue, muscle ache, fever chills, joint pain and weak was not recovered; the outcome of the events dizzy, hot and cold, and vomiting was recovering. The events were medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Jun2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1575887 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Depressed mood, Depression, Dizziness, SARS-CoV-2 test, Vertigo
SMQs:, Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (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: DAPSONE; SALBUTAMOL.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Dermatitis herpetiformis; Lactation decreased.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976893

Write-up: low mood/feelings of depression; Vertigo (excl dizziness); Dizziness; Depression; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107311937232110-WWXIM, Safety Report Unique Identifier GB-MHRA-ADR 25737500. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 27Jul2021 (Lot Number: FD8813) as second dose, single for COVID-19 immunisation. Medical history included lactation decreased, depression and dermatitis herpetiformis. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and not currently breastfeeding. Concomitant medications included dapsone for dermatitis herpetiformis from 2016 and salbutamol from 1995. On unspecified date, the patient experienced low mood. On 31Jul2021, the patient experienced Vertigo (excl dizziness), dizziness, and depression. "This morning I woke up with very distinct feelings of depression, not just low mood. There is no reasonable explanation I can think of apart from the vaccine. This evening I also began experiencing dizziness and vertigo." Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included covid-19 virus test: No - Negative COVID-19 test on an unspecified date. Outcome of the event depression was not recovered. Outcome of all the other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575889 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Allergy test, Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Heart rate increased, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypertension (narrow), Hypersensitivity (narrow), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: tested for PEG allergens; Result Unstructured Data: Test Result:came back negative; Test Name: Blood pressure; Result Unstructured Data: Test Result:170; Test Name: Heart rate; Result Unstructured Data: Test Result:101; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976923

Write-up: heart rate increased; BP rose to 170; Anaphylaxis; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number [GB-MHRA-WEBCOVID-202107311950020830-OLJCE], Safety Report Unique Identifier [GB-MHRA-ADR 25737511]. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (Lot/batch number was not known), at the age of 33-years-old, as dose 2, single for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included sertraline taken for an unspecified indication, start and stop date were not reported. The patient previously took cetirizine. The patient experienced anaphylaxis on 31Jul2021; heart rate increased and BP rose to 170 on an unspecified date. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date, heart rate increased: 101 on an unspecified date, blood pressure: 170 on an unspecified date and tested for PEG allergens: came back negative on an unspecified date. Therapeutic measures were taken as a result of anaphylaxis. The outcome of the event ''anaphylaxis'' was recovered on 31Jul2021; event ''heart rate increased'' was not recovered; and event ''BP rose to 170'' was unknown. The clinical course was reported as follows: Second reaction to the vaccine, patient has been tested for PEG allergens and came back negative, received the 2nd dose today and experienced the same symptoms but where effectively reduced by taking 20mg of Cetirizine 1 hour before administration. No bloods where taken during his episode but heart rate increased to 101 and BP rose to 170. Was under obvservation for 40 minutes. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional Information: Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1575899 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Diarrhoea
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Pseudomembranous colitis (broad), Oropharyngeal allergic conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100977123

Write-up: Giant hives; Diarrhea; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107312123377760-38IOE, Safety Report Unique Identifier GB-MHRA-ADR 25737600. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of on 31Jul2021 (Lot Number: Ff3319) (at the age of 27-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced giant hives and diarrhea on 31Jul2021. Clinical course reported as: Red lumps all over stomach super itchy and spreading. Also diarrhea. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Outcome of giant hives was not recovered, outcome of diarrhea was recovered on 31Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575915 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Lymphoedema, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100976856

Write-up: Enlarged axillary lymph node; Painful axillary lymph node; Lymphedema; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202107312334203950-GB15J, Safety Report Unique Identifier is GB-MHRA-ADR 25737682. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Lot Number: FD8813) as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 single on an unspecified date for COVID-19 immunization. The patient experienced lymphedema on 31Jul2021 with outcome of not recovered, enlarged axillary lymph node on an unspecified date with outcome of unknown, and painful axillary lymph node on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date, No - Negative COVID-19 test. The events were reported as serious, medically significant by the health authority. Case narrative: Enlarged and painful axillary lymph node on side of injection site. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575917 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100977056

Write-up: Stomach cramps; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107312346244350-I4LFF. Safety Report Unique Identifier GB-MHRA-ADR 25737697. A 30-year-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 31Jul2021 (Lot number was not reported) (at the age of 30 year old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant, Patient is not currently breastfeeding. Historical vaccine included dose 1 BNT162B2 on an unspecified date for COVID-19 Immunisation. The patient''s concomitant medications were not reported. The patient experienced stomach cramps on 31Jul2021 with outcome of recovered on 31Jul2021. The events were serious due to medically significant. Detail information was reported: In the evening after second jab, the patient started getting stomach cramps that felt exactly like period cramps. She was half a month away from when her period was due so it wasn''t expected. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.


VAERS ID: 1575921 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decreased lactation; menstrual cramps.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100976803

Write-up: This is a spontaneous report from a contactable consumer (patient), received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202108010253209960-B0SHI; safety report unique identifier: GB-MHRA-ADR 25737736). A 34-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# FE1510), via an unspecified route of administration on Jul 29, 2021, single dose, for COVID-19 immunisation. Medical history included decreased lactation and menstrual cramps. She has not had symptoms associated with COVID-19. Patient not pregnant, nor currently breastfeeding. Patient not enrolled in a clinical trial. The patient''s concomitant medications not reported. The patient experienced cramps/period pains on Jul 31, 2021. Case narrative: Most severe period cramps she can ever remember. She has not had period cramps like this for many, many years. In recent years if she did have them, they were never as painful as this. She has not tested positive for COVID-19 since the vaccination. She underwent lab tests and procedures, which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of the event: not recovered. Case reported medically significant. No follow-up attempts possible. No further information expected.


VAERS ID: 1575923 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-07-31
   Days after vaccination:93
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Postmenopause (I was told by a doctor earlier in the year that I was post-menopausal (blood tests confirmed).)
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:post-menopausal confirmed
CDC Split Type: GBPFIZER INC202100984552

Write-up: bleeding; Heavy periods; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108010534503090-FFBMB, Safety Report Unique Identifier GB-MHRA-ADR 25737963. A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0171), via an unspecified route of administration at single dose on 29Apr2021 for COVID-19 immunization. Medical history included suppressed lactation, postmenopause (I was told by a doctor earlier in the year that I was post-menopausal (blood tests confirmed)). I do not take any medication, prescription or otherwise. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. The patient was previously taken first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: ER2613), on 08Apr2021 for COVID-19 immunization. Patient''s body weight was 58 kg and height was 155 cm. There were no concomitant medications. The patient experienced bleeding on an unspecified date with outcome of recovering, heavy periods on 31Jul2021 with outcome of not recovered. The patient underwent lab tests and procedures which included Blood test: post-menopausal confirmed on an unspecified date. Additional information: I have not had a period for 1.5 years until yesterday. I was told by a doctor earlier in the year that I was post-menopausal (blood tests confirmed). Then, yesterday, I started bleeding again for the first time in a very long time. I read and article and decided to complete this form just in case it was relevant to your study. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575924 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CONJUGATED OESTROGENS; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; No reaction on previous exposure to vaccine; Period pains
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100977103

Write-up: painful axilar glands; Glands swollen; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108010553325120-TIVXF. Safety Report Unique Identifier is GB-MHRA-ADR 25737787 . A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 30Jul2021 (Lot Number: FF3319) as single dose for COVID-19 immunisation. Medical history included lactation decreased, period pains, no reaction on previous exposure to drug. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications included conjugated oestrogens taken for period pains from 01Jun2011; paracetamol taken for no reaction on previous exposure to drug from 12Jun2021. The patient experienced glands swollen on 31Jul2021 which considered as medically significant. The patient also had swollen and painful axilar glands. The COVID-19 virus test on unspecified date was No - Negative COVID-19 test. The outcome of the event swollen was not recovered. The outcome of other event was unknown. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575926 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Headache, Myalgia, Nausea, Palpitations, Taste disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Taste and smell disorders (narrow), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result: Normal; Comments: Checked temperature, within normal range
CDC Split Type: GBPFIZER INC202100977160

Write-up: Chills; Nausea; Headache; Taste changed; Muscle ache; Palpitations; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108010651518830-ZTLIX. Safety Report Unique Identifier GB-MHRA-ADR 25737795. A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF3319), via an unspecified route of administration at the age of 30-year-old on 31Jul2021 at single dose for COVID-19 immunisation. Medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medications were not reported. The patient experienced chills, nausea, headache, taste changed, muscle ache and palpitations on 31Jul2021. The events were serious for being medical significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests included temperature: normal on unspecified date (Checked temperature, within normal range). The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575935 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Dysmenorrhoea, Heavy menstrual bleeding, SARS-CoV-2 test, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984310

Write-up: clots; back pain; Period pains; Heavy periods; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108010828292630-QUECS, Safety Report Unique Identifier GB-MHRA-ADR 25737831. A 22-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 30Jul2021 as dose 2 single for COVID-19 immunization. Medical history included lactation decreased, anxiety. Concomitant medication included sertraline for anxiety. Patient has not had symptoms associated with COVID-19. Patient was not pregnant at the time of vaccination, patient was not currently breastfeeding. On an unspecified, patient experienced clots, back pain. On 31Jul2021, patient experienced period pains, heavy periods. Clinical course was reported severe period cramps for longer period of time than usual. Back pain worsened from period effects. Period is heavier and there are more clots than normal. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of events (clots, back pain) were recovered and events (period pains, heavy periods) were not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1575941 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Lymph node pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984299

Write-up: Painful, swollen underarm on the side that vaccine was given; Painful, swollen underarm on the side that vaccine was given; Lymph node pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108010916103010-VAR5O. Safety Report GB-MHRA-ADR 25737865. A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: FF3319) via an unspecified route of administration (non-pregnant at the time of vaccination) on 30Jul2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history included suppressed lactation. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On 31Jul2021, the patient experienced lymph node pain. On an unspecified date, the patient had swollen underarm. Painful, swollen underarm on the side that vaccine was given. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The outcome of event for lymph node pain was not recovered and for painful and swollen underarm was unknown. No follow-up attempts are possible. No further information was expected.


VAERS ID: 1575946 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Axillary pain, Chest pain, Chills, Fatigue, Headache, Illness, Nausea, Neck pain, Pain, Pelvic pain, Pyrexia, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984556

Write-up: Armpit pain; Chills; Fever; sick; Neck pain; entire body was in pain (everywhere imaginable ached); Nausea; Chest pain; Stomach ache; Fatigue; Pelvic pain; Headache; muscle pain at the site of the injection; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108010954023330-CGGQL, Safety Report Unique Identifier GB-MHRA-ADR 25737884. A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 31Jul2021 (at the age of 31 years old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not currently breastfeeding. The patient experienced muscle pain at the site of the injection on 31Jul2021; nausea, chest pain, stomach ache, fatigue, pelvic pain, and headache on 01Aug2021; armpit pain, chills, fever, sick, neck pain, and entire body was in pain on 01Aug2021 03:00. The events were medically significant. Outcome of the stomach ache, fever, pelvic pain, headache, and sick was recovering while of the remaining events was not recovered. The clinical course was reported as follows: Started to develop muscle pain at the site of the injection the same day then awoke at 3am to be sick, mild fever, chills, entire body was in pain (everywhere imaginable ached) acute neck pain and armpit pain the side I had the injection. Still feeling chills, aching and nauseous. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575957 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984735

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011201542190-I4XSH, Safety Report Unique Identifier GB-MHRA-ADR 25737981. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 30Jul2021 (Lot number was not reported) as second dose, single for COVID-19 immunisation. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced swollen lymph nodes on 31Jul2021 with outcome of recovering. The patient underwent lab tests and procedures which included covid-19 virus test: No - Negative COVID-19 test on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575958 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FO8817 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Breast pain, Breast swelling, Disease recurrence, Galactostasis, Mastitis, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (broad), Angioedema (broad), Lipodystrophy (broad), Functional lactation disorders (narrow), Hypersensitivity (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding; Mastitis
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984759

Write-up: mastitis; mastitis; blocked duct in breast; bleb; currently breastfeeding; currently breastfeeding; Breast pain; Breast swelling; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011203474550-5MFLM, Safety Report Unique Identifier GB-MHRA-ADR 25737991. This consumer reported information for both mother and baby. This is the maternal report. Only this case is serious. A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FO8817) via an unspecified route of administration on 31Jul2021 (at the age of 34 years old), as second dose, single for COVID-19 immunisation. Medical history included lactation decreased, ongoing mastitis, and ongoing breast feeding. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. The patient''s concomitant medications were not reported. On 31Jul2021, the patient experienced breast pain, breast swelling. The patient is also reported as currently breastfeeding on 31Jul2021. On unspecified date, the patient experienced mastitis, blocked duct in breast and bleb. "Developed blocked duct in breast nearest jab site approximately 8 hours after jab. Developed into swollen breast, blocked duct and bleb by the next morning. Currently trying to shift it to prevent mastitis. Feel well in myself otherwise. " Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included covid-19 virus test: No - Negative COVID-19 test on an unspecified date. Outcome of the events mastitis, breast pain, breast swelling was not recovered. Outcome of all the other events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100997976 Baby Case


VAERS ID: 1575966 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache
SMQs:, Arthritis (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: GBPFIZER INC202100984652

Write-up: Joint pain; Headache; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011231476970-Safety Report Unique Identifier GB-MHRA-ADR 25738011. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), DOSE 2 via an unspecified route of administration on 31Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced joint pain on 01Aug2021 with outcome of not recovered, headache on 31Jul2021 with outcome of not recovered. Seriousness criteria of the event was reported as serious due to disability. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1575973 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Inappropriate schedule of product administration, Pain
SMQs:, Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FERROUS SULFATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Iron low; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984499

Write-up: Chest pain; Ache; Inappropriate schedule of vaccine administered; Dizziness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108011315180180-MGFY1, Safety Report Unique Identifier GB-MHRA-ADR 25738051. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration on 31Jul2021 (Lot Number: FF3319, Expiry date: Unknown) (at age of 30-year-old) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased and iron low. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medication included ferrous sulfate taken for blood iron decreased from 30Jul2021 to an unspecified stop date. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: Et8885, Expiry date: Unknown) as dose 1, single on 02Jun2021 for COVID-19 immunization. The patient experienced dizziness and inappropriate schedule of vaccine administered on 31Jul2021, chest pain and ache on 01Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. Therapeutic measures were taken as a result of ache and Paracetamol was not working for pain. The outcome of the events dizziness, chest pain and ache was not recovered and inappropriate schedule of vaccine administered was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575978 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative
CDC Split Type: GBPFIZER INC202100984672

Write-up: under arm/is now painful to put my arm down; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108011423337280-RXIUY. Safety Report Unique Identifier GB-MHRA-ADR 25738105. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 30Jul2021 (Lot Number: PF3319) as single dose for COVID-19 immunisation. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE on unknown date for COVID-19 immunisation. The patient experienced swollen lymph nodes on 31Jul2021 with outcome of not recovered, under arm/is now painful to put my arm down on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: Negative on unknown date. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, patient was not currently breastfeeding. Seriousness criteria of the events was reported as serious (medically significant). Additional information: Lymph node under arm where vaccine was administered began hurting then become very swollen. It is now painful to put my arm down. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1575979 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510-L758 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hyperphagia, Polydipsia, SARS-CoV-2 test, Urine output increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984482

Write-up: Hungry and the need eat more regularly.; drink water a lot more; Urine output/Urinating every 30-45 minutes; This is a spontaneous report from a contactable consumer . This is a report received from the Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011428435250-JSKSW.Safety Report Unique Identifier GB-MHRA-ADR 25738117. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FE1510-L758 and expiry date were not reported ), dose 2 via an unspecified route of administration, on 31Jul2021 as single dose for COVID-19 immunization. No Medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient did not have any medical conditions. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and expiration date were not reported) unspecified route of administration, on an unspecified date as single dose for COVID-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 31Jul2021, the patient experienced urine output/urinating every 30-45 minutes and on an unspecified date, experienced hungry and the need eat more regularly, drink water a lot more. Further explained that however, it appears the Pfizer vaccine may gave triggered something in my body to react therefore resulting in very frequent toilet visits and the need to eat and drink water a lot more. Urinating every 30-45 minutes during the day and frequently feeling Hungary and the need eat more regularly. The events accessed as a medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unknown date. The outcome of urine output/urinating every 30-45 minutes is not recovered and other events were unknown. No follow-up attempts are possible ,No further information is expected.


VAERS ID: 1575981 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984484

Write-up: Fever; Glands swollen; This is a spontaneous report from a contactable Consumer received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202108011435229110-LFMXM, Safety Report Unique Identifier GB-MHRA-ADR 25738115. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch no; not reported; Lot number: FD8813) via an unspecified route of administration on 30Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced fever and glands swollen on 31Jul2021. Events considered as medically significant. The outcome of the event fever was resolving, and outcome of glands swollen was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576012 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-31
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling abnormal, Hyperhidrosis, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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 INC202100984474

Write-up: Fever/feverish; Fatigue; Muscle ache; brain fog; sweaty; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108011819267720-MK22H, Safety Report Unique Identifier GB-MHRA-ADR 25738278. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 07Jul2021 (Batch/Lot Number: Ff3319) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced sweaty, feverish, fatigue, brain fog, muscle ache on an unspecified date in 2021. She had fever since 31Jul2021. Patient had not tested positive for COVID-19 since having the vaccine. Outcome of the events fever, fatigue, muscle ache was not recovered; brain fog, feverish, sweaty was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576015 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Pain, Pelvic pain, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Miscarriage
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984302

Write-up: pain; miscarriage; Pelvic pain; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108011837093110-LVAG3, Safety Report Unique Identifier GB-MHRA-ADR 25738290. A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on 31Jul2021 (at the age of 36-years-old) as second dose, single for COVID-19 immunization. Medical history included abortion spontaneous and suppressed lactation. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Patient had not tested positive for COVID-19 since having the vaccine. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced pain, miscarriage. On 31Jul2021 (same day of vaccination), the patient experienced pelvic pain. Further explained that miscarriage within the last 10 days. The pain was exactly like the pain during the miscarriage. Which had previously stopped 9 days ago. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on an unspecified date. The outcome of pain, miscarriage was recovered on an unspecified date while for pelvic pain was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1576021 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoglycaemia, Insulin resistance
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Lipodystrophy (broad), Hypoglycaemia (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: NOVORAPID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: insulin sensitivity; Result Unstructured Data: Test Result:Increased
CDC Split Type: GBPFIZER INC202100984327

Write-up: Hypoglycemia; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number GB-MHRA-WEBCOVID-202108011926157430-CD4FP, Safety Report Unique Identifier GB-MHRA-ADR 25738331. A 30-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Ff3319), via an unspecified route of administration on 31Jul2021 (at 30-years age) as dose 1 single for COVID-19 immunisation. Medical history included type 1 diabetes mellitus. The patient previously took insulin degludec. Concomitant medication(s) included insulin aspart (NOVORAPID) taken for type 1 diabetes mellitus. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included insulin sensitivity and result was increased on an unknown date. On 31Jul2021 the patient experienced hypoglycemia and the event was reported as medically significant. The outcome of the event was reported as not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576023 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness postural, Headache, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLENIL MODULITE; LORATADINE; PARACETAMOL; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma; Lactation decreased; Pain; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984716

Write-up: Headache; Fever; Dizziness upon standing; Painful arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108011934491710-NQKYJ, Safety Report Unique Identifier GB-MHRA-ADR 25738337. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FE3380), via an unspecified route of administration on 31Jul2021 (at the age of 30 years old) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased, suspected COVID-19 from 23Dec2019 (unsure when symptoms stopped), steroid therapy (taking regular steroid treatment (e.g. orally or rectally)), asthma, allergy, and pain. Patient not had a COVID-19 test. Patient is not pregnant and is not currently breastfeeding. Concomitant medications included beclometasone dipropionate (CLENIL MODULITE) taken for asthma, loratadine taken for allergy, paracetamol taken for pain, and salbutamol taken for asthma. The patient experienced painful arm on 31Jul2021; headache, fever, and dizziness upon standing on 01Aug2021. The events were medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the painful arm was recovering while of the remaining events was recovered on 01Aug2021. No follow-up attempts are possible. No further information is expected.


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