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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 385 out of 8,010

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VAERS ID: 1768862 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088D21A / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Condition aggravated, Fatigue, Migraine, Muscle spasms, Nausea
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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: Moderna 3/8/21 &4/5/21 same as previously described but only lasted a few weeks as the third shot was side effects up to about a
Other Medications: Venefexaline, Lynparza, Celebrex, magnesium, ginger, synthroid, atavastatin, and probiotic
Current Illness: I was exposed to mold while cleaning a family member?s house around the same time
Preexisting Conditions: Metastatic Breast Cancer, hypothyroidism, ankylosing spondylitis, and chronic migraines which cause me to have limitations on my daily activities. I experienced intensity of my daily symptoms after I each vaccine and the last vaccine has been the worst for side effects since August.
Allergies: Chocolate and opioid sensitivity
Diagnostic Lab Data:
CDC Split Type:

Write-up: Migraines, extreme fatigue and joint pain, nausea and muscle cramps, much worse than on a daily basis


VAERS ID: 1770401 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Poor quality product administered, Product storage error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211011486

Write-up: VACCINE TEMPERATURE EXCRUSION FROM 3.1 C TO 0.77 C TO 3.0 C WITHIN 30 MINUTES; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 40 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-AUG-2021, the patient experienced vaccine temperature excrusion from 3.1 c to 0.77 c to 3.0 c within 30 minutes, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine temperature excrusion from 3.1 c to 0.77 c to 3.0 c within 30 minutes and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210855173.


VAERS ID: 1770562 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 LA / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UJ689AA / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Bradykinesia, Decreased appetite, Depressed mood, Insomnia
SMQs:, Parkinson-like events (narrow), Depression (excl suicide and self injury) (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: SIMVASTATIN; VYTORIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101116306

Write-up: Difficulty sleeping; Generally feel gloomy, down; in slow motion; some loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Aug2021 10:00 (Batch/Lot Number: FC3182) (at the age of 66 years old) as single dose for Covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), via an unspecified route of administration on 26Aug2021 (as reported) (Batch/Lot Number: UJ689AA) dose 1, single for immunization. The patient medical history was not reported. The patient has no known allergies. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 05Aug2021 10:45 (lot number: FA7485) (at the age of 66 years old) via an unspecified route of administration in left arm for Covid-19 immunisation and the patient experienced dull headache across front lobe forehead including right and left side temples. Concomitant medications included simvastatin (SIMVASTATIN); ezetimibe, simvastatin (VYTORIN); both taken for an unspecified indication, start and stop date were not reported. After the second jab on 26Aug2021, the patient experienced difficulty sleeping, generally feel gloomy and down, in slow motion, and some loss of appetite. The patient did not receive any treatment for the adverse events. The patient was not tested for Covid-19 post vaccination. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1770568 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO185 / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Emotional disorder, Fatigue, Injury
SMQs:, Accidents and injuries (narrow), Hostility/aggression (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: APTIOM; ONFI; GABAPENTIN; BUSPAR; VIT C; VIT D [COLECALCIFEROL]; ZINC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Back injury (Verbatim: Injury back); Knee injury (Verbatim: injured knee); Latex allergy; Neuropathy (Verbatim: neuropathy in left thigh); Penicillin allergy (known allergies: penicillin); Refractory epilepsy; Sleep apnea; Soy allergy; Sulfonamide allergy (known allergies: sulfa)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101226272

Write-up: Too injured to notice anything else; Overly tired; very emotional; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 59-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EWO185), via an unspecified route of administration (at the age of 59-years), administered in arm right on 26Aug2021 at 11:45 as dose 1, single for COVID-19 immunization. Medical history included refractory epilepsy, asthma, sleep apnea, injury back, injured knee, neuropathy in left thigh and known allergies with latex, penicillin, soy, sulfa from an unknown date and unknown if ongoing. Concomitant medications included eslicarbazepine acetate (APTIOM), clobazam (ONFI), gabapentin (GABAPENTIN), buspirone hydrochlo-ride (BUSPAR), ascorbic acid (VIT C), colecalciferol (VIT D [COLECALCIFEROL]), zinc (ZINC) taken for an unspecified indication, start and stop date were not reported. The patient previously took polyethylene glycol and experienced known allergies. The facility where the most recent COVID-19 vaccine was administered was reported as unknown. The patient did not receive any other within 4 weeks pri-or to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Aug2021, the patient experienced too injured to notice anything else, overly tired, very emotional. It was further reported that after dose 1, I was overly tired and very emotional. Too injured to notice anything else. The treatment was not received for all the adverse events. The clinical outcome for all the events was reported as recovering. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1771123 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-01-12
Onset:2021-08-26
   Days after vaccination:226
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Off label use
SMQs:

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

Write-up: receiving 3rd dose without being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (receiving 3rd dose without being immunocompromised) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced OFF LABEL USE (receiving 3rd dose without being immunocompromised). On 26-Aug-2021, OFF LABEL USE (receiving 3rd dose without being immunocompromised) had resolved. Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.


VAERS ID: 1771136 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-23
Onset:2021-08-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Amenorrhoea, Joint swelling
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Fertility disorders (broad), Arthritis (broad), Tendinopathies and ligament 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: Alcohol
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swollen ankles and loss of menstrual cycle


VAERS ID: 1771691 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030B21A / 3 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: None known
Diagnostic Lab Data: none - there have been no concerns or issues reported
CDC Split Type:

Write-up: Patient''s first 2 Covid vaccines were Pfizer. Her first Pfizer shot was 12/23/2020. Her second Pfizer shot was 01/20/2021. I did not have her vaccine card in front of me when I administered the 3rd Covid vaccine. Her 3rd vaccine was administered on 08/26/2021. She was administered Moderna. All literature states what you start with is what you should stick with. She has reported no issues or concerns. Main campus noticed the error and brought it to my attention which is why I am just now reporting.


VAERS ID: 1771751 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-02-24
Onset:2021-08-26
   Days after vaccination:183
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0140 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0332 / 2 RA / IM

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1771756 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Alaska  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 2 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

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

Write-up: Son developed fever of 103 that was treated with Tylenol and ibuprofen. Fever lasted for 2 days. He also felt short of breath with general chest pain, especially when breathing deeper. This gradually subsided over 4-5 days. He had an increased heart rate over 100 at rest for about 2-3 days. Normal at rest heart rate in the 70s.


VAERS ID: 1771915 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-06-01
Onset:2021-08-26
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037B21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037B21A / 2 LA / IM

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

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

Write-up: Tested Positive for Covid


VAERS ID: 1771946 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-16
Onset:2021-08-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3187 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Electromyogram, Full blood count normal, Laboratory test normal, Magnetic resonance imaging, Motor dysfunction, Neuralgic amyotrophy, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Valsartan 40mg daily; Myrbetriq 25mg daily; Cimzia 400mg monthly; Prednisone 5mg daily; Flomax 0.4mg BID; Omeprazole 20mg daily; Celebrex 200mg daily; Morphine Sulfate ER 15mg q12h; Multivitamin daily, Vitamin D 1500mg daily; Colace 250mg H
Current Illness: none
Preexisting Conditions: Ankylosing Spondylitis; Seronegative Polymyalgia Rheumatica; Hypertension; Pseudoarthrosis C4-C6 post spinal fusion year 2011; S/P hemicolectomy due to obstructive diverticulitis; Benign Prosthetic Hypertrophy
Allergies: Oxycodone; Percocet
Diagnostic Lab Data: CBC, Chemistry Profiles all negative. MRI of brachial plexus, Cervical Spine, elbow and thoracic spine are unremarkable except for evidence of spinal fusion. EMG also performed.
CDC Split Type:

Write-up: On August 26th developed acute excruciating pain starting initially in left elbow which over 24 hours radiated up into axilla, left infrascapular area and down into hand with paresthesia and decrease motor function of 4th and 5th fingers. Initially received methylprednisolone 24mg daily and 14 days with NSAIA with no improvement. Saw Rheumatologist, Hand/Arm orthopod and eventually neurologist. Diagnnosis of Parsanage-Turner Syndrome occurred and presently on course of high dose IV steroids 1 gram followed by 250mg Iv daily for 3 days along with intravenous immunoglobulins IV for 3 days 2mg/kg.


VAERS ID: 1772151 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-02-10
Onset:2021-08-26
   Days after vaccination:197
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea, Fatigue, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Chronic lung disease (COPD and emphysema), Cardiovascular disease
Allergies:
Diagnostic Lab Data: 08/26/2021 PCR+ COVID-19 test; 09/03/2021 PCR+ COVID-19 test
CDC Split Type:

Write-up: Breakthrough COVID-19 case with symptom onset 8/28/2021: Runny Nose/Congestion, Shortness of breath/difficulty breathing, Fatigue or tiredness, Cough. Patient states he was admitted to hospital for close monitoring on 09/03 due to his COPD and emphysema. Discharged 9/5/2021.


VAERS ID: 1773449 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-03-11
Onset:2021-08-26
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011A21A / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Anticoagulant therapy, Computerised tomogram thorax abnormal, Laboratory test, Pulmonary embolism, Renal vein thrombosis, Syncope, Vascular catheterisation, Vena cava thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Renovascular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Factor V Leiden Interrupted IVC
Allergies: None
Diagnostic Lab Data: To numerous to report here, can provide upon follow-up
CDC Split Type:

Write-up: Extensive IVC and renal vein thrombus, multiple PEs, hospitalized for 5 days. Experienced syncopal episode due to decreased preload secondary to thrombus. Emergent evaluation in the ED. CTs revealed extensive clotting and PE. Required emergent cath procedure now on lifelong anti coagulation. Plan for further evaluation and additional cath procedures.


VAERS ID: 1775875 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Intentional product use issue, Rash, Rash macular
SMQs:, Anaphylactic reaction (broad), Drug abuse and dependence (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: HCTZ (not an allergy, it just works too well and drops blood pressure too much) CT Dye (actual allergy to the dye NOT IODINE. Symptoms include rash which starts on chest and back, nausea, vomiting, burning in veins, feeling like I have been poisoned, flu like aches for up to 3 days following CT Dye Infusion)
Diagnostic Lab Data: I have not gone to get checked but I will be going to be checked soon. For now that is all I know.
CDC Split Type:

Write-up: Widespread Rash, began on back within 60-90 min of administration. Has continued to spread and change. Does not itch very much, started as wide finger print sized splotches on back, with tiny red dots the size of the ball on a ball point pen spread around and in between. The small head of a pen sized one''s have spread to chest and arms. Again no itching really or pain. But it has been there without even fading a little bit sinceI got the vaccine. I did not go for the second or 3rd dose because of the reaction.it has been approximately 45 days since the vaccine with no signs of fading or going away.


VAERS ID: 1776465 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH WE01867 / 2 UN / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Choking, Cough, Tachycardia
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypersensitivity (broad), Dehydration (broad)

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

Write-up: Pt presented to clinic to report "tachycardia" and that her heart "lightens or eases" a little which makes her choke. Gets relief when she coughs. She received her vaccines at another facility but came here to report adverse effect. Advised her to see a physician asap. She has attempted to do so but has been unable to reach anyone to schedule. Provided her with phone numbers and addresses to two safety net providers.


VAERS ID: 1776528 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-30
Onset:2021-08-26
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033C21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Cardiac stress test, Chest pain, Computerised tomogram, Electrocardiogram, Tachycardia, Ultrasound scan
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Yes
Current Illness: No
Preexisting Conditions: High blood pressure
Allergies: No
Diagnostic Lab Data: blood work EKG CAT scan Ultrasound Stress test on 10/11/2021
CDC Split Type: vsafe

Write-up: I had chest pains. I ended up in the emergency room and diagnosed with tachycardia.


VAERS ID: 1776611 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 3 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Arthritis, Chills, Condition aggravated, Extra dose administered, Facial pain, Haemorrhage, Headache, Inflammation, Mobility decreased, Neuralgia, Pain, Pyrexia, Toothache, Vein rupture, X-ray dental
SMQs:, Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Glaucoma (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Eliquis, Farxiga, Glimepiride, Tradjenta, Omeprazole, Vitamin B12, Vitamin C, Vitamin D3, Super-B Complex Vitamins, Biotin. PRN: prednisone, albuterol, Duo-Neb,
Current Illness:
Preexisting Conditions: Asthma, Diabetes, Osteo-arthritis, History DVT & pulmonary emoboli;
Allergies: Byetta
Diagnostic Lab Data: Dental Xrays--October 4, 2021, and October 7, 2021.
CDC Split Type:

Write-up: Twelve hours after my booster shot I developed fever, chills, aches, and severe headache, which lasted over twelve hours. The second day I ached all over, but I felt better on day three. At midnight on day 4 (Saturday) I had a leg vein open and bleed uncontrollably. I had to use Blood Stop to stop the bleeding. I saw my vein doctor the following Monday, and he injected the vein to shut it down. That same week I developed a worsening of my arthritic knee--much more pain and loss of mobility. It feels like burning nerve pain from my knee down to my ankle and up to my hip. It hurts to even drive my car. A few days after that I began having terrible tooth pain on the upper AND lower left side teeth. Two of those top teeth already have root canals. The lower teeth have repairs. The pain slams my face and radiates to the front teeth. I saw my dentist. His X-rays did not show anything conclusive. I saw the periodontist. His X-rays didn''t really show anything either. I have a visit scheduled with my endodontist this week to evaluate the roots and try to determine where the pain is coming from. The pain is debilitating. I''ve begun Advil around the clock to keep it from becoming overwhelming. I have no idea if any of this is related to the vaccine. But it all came on within days of the shot. As a nurse, I''m wondering if I''ve mounted an inflammatory response that is causing me all this pain.


VAERS ID: 1776877 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-08-19
Onset:2021-08-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041B21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anticoagulant therapy, Chest X-ray, Dehydration, Diarrhoea, Dyspnoea, Feeling abnormal, Hyperhidrosis, Intensive care, Laboratory test, Malaise, Nausea, Oxygen saturation decreased, Pulmonary embolism, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None.
Current Illness: None.
Preexisting Conditions: None.
Allergies: None.
Diagnostic Lab Data: As above in Hospital.
CDC Split Type:

Write-up: She got her vaccine, she just didn''t feel good afterwards. About a week later she had nausea, vomiting and diarrhea for a week. She went to ER and was dehydrated and received a couple of liters of fluid. She had all the symptoms of COVID except for loss of taste. They did a chest X-ray, she desatted a little bit and then they sent her home. A week later she was at work and all of a sudden she became extremely short of breath, diaphoretic, broke out into a sweat and they sent her to the ER. They admitted her to CICU, worked her up for a heart attack and PE and could not find anything. After her work up they found nothing. A week later the same thing happened and they sent her to the ER again and they found multiple PE''s in her right lung. She is now on Eliquis for the PE''s. This was approximately a month ago . She is still short of breath. She was referred to a cardiologist and a pulmonologist. The pulmonologist requested that she have a CT scan in January to FU to see if the PE''s are resolving, and her insurance is declining that.


VAERS ID: 1776905 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 2 RA / SYR

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

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

Write-up: Reoccurring events of chest feeling abnormally hot. Random events of a sporadic heart rate while relaxed and at rest. Each event is unique such that I have never felt either symptom in these manners previously to getting this vaccine. The former symptom has gone away. The rapid heart rate at abnormal times is reoccurring.


VAERS ID: 1776989 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F63181 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Dyspnoea, Fatigue, Headache, X-ray
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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: NA
Current Illness: NA
Preexisting Conditions: NA
Allergies: NA
Diagnostic Lab Data: BLOOD WORK AND XRAY
CDC Split Type:

Write-up: SHORTNESS OF BREATH, PRESSURE ON MY HEART , CHRONIC FATIGUE AND HEADACHES. SIGNS AND SYMPTOMS LASTED 30 DAYS UNTIL I SAW MY PCP.


VAERS ID: 1777325 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Anxiety, Autoscopy, Crying, Dizziness, Dyskinesia, Fatigue, Fear, Headache, Hypoaesthesia, Muscle spasms, Pain, Paraesthesia, Psychomotor hyperactivity, Pyrexia, Sensory disturbance, Sleep disorder
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Akathisia (broad), Dyskinesia (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

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

Write-up: I received the vaccine on August 26th at about 1330. I initially felt ok, but started to get tired around 1930 and decided to crawl in to bed. Shortly after, I broke a fever and my body was starting to feel achy. As I starting to fall asleep, my body started to feel tingly. This was alarming, but as I continued to try to fall asleep, I felt as if my body was ballooning over my body, like an out of body experience. This terrified me so I got out of bed and started pacing back and forth, afraid to fall asleep in fear of this out of body like experience happening again. After pacing for as long as my body could, I laid back down again, and began to feel the tingly again which then turned to the numbness. I sat up and turned the light on and decided that trying to sleep was not a good idea. I sat there as my body went numb again, and this time felt the numbness in my brain. Even more terrified now, I paced for hours occasionally needing to lay down on the floor in child''s pose (the only comfortable position for my very achy, fatigued body, and now also the worst headache I have had in my entire life). I was unable to stop moving for long as the body numbness would set in again shortly after I would stop moving. I was then experience muscle spasms/jerks in my arms. When I was finally able to lay down long enough to fall asleep, I would wake myself up crying due to the terrible headaches. Thankfully my numbness was better the next day. The headaches stayed for days. Dizziness for weeks.


VAERS ID: 1779116 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-04
Onset:2021-08-26
   Days after vaccination:144
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Headache, Hyperhidrosis, Pain, Productive cough, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

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

Write-up: Patient describes 2 weeks with high fevers and diaphoresis. He has been having temperatures over 100 for several days despite taking extra strength Tylenol 2 tabs every 4-6 hours. Patient has also been having body aches and headache. Also with productive cough of clear phlegm. Denies shortness of breath


VAERS ID: 1782291 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-05-26
Onset:2021-08-26
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / 1 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue, Nausea, SARS-CoV-2 test positive, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: On dialysis.
Allergies:
Diagnostic Lab Data: SARS CoV + SARS CoV 2 Antigen Positive on 8/27/2021.
CDC Split Type:

Write-up: Breakthrough case after Covid vaccination. Dose # 1 5/26/2021. C/O loss of taste/smell, fatigue, cough, and nausea/vomiting. Onset 8/26/2021.


VAERS ID: 1782314 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Photopsia, Vision blurred, Visual impairment, Vitreous detachment, Vitreous floaters
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: PVD to right eye following Flu Vaccine in 2017
Other Medications: Melatonin, Vitamin D, Multi vitamin, Zinc Picolinate
Current Illness: None
Preexisting Conditions: Migraine
Allergies: Latex
Diagnostic Lab Data: Friday 8/27/2021 I experienced increased flashes and floaters. I went to my eye doctor for an exam and was diagnosed with a posterior vitreous detatcnhmemt.
CDC Split Type:

Write-up: Thursday 8/26/2021 I started to experience flashes of bright white light on the left side of my vision in my left eye. The following day I began to experience increased flashes of light and numerous floaters affecting my vision causing to to be blurry


VAERS ID: 1783786 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-03-27
Onset:2021-08-26
   Days after vaccination:152
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient hospitalized 5 months after completing the the Pfizer COVID vaccine series.


VAERS ID: 1785572 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-01
Onset:2021-08-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyskinesia, Facial discomfort, Headache, Swelling face, Vision blurred
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Verapamill, Lisinopril, chlonozepham
Current Illness: Back pain, nerve pain, osteoarthritis
Preexisting Conditions: High blood pressure, High Cholesterol, Gastrointestinal Disease
Allergies: None/Unknown
Diagnostic Lab Data: I went to my primary doctor and reported these side effects to him and his response was that my immune system is just probably reving up to protect me from the virus. He never recommended any test be done. I?m afraid to go to the E.R. For fear of catching the vaccine so I don?t know what to do now. I?m at a lost.
CDC Split Type:

Write-up: About two days after taking the vaccine my face was twisting up as if I was having a stroke. Then my vision became blurry, my face was swollen and I had headaches, now the left side of my face keeps twisting like the nerves are jumping in my face. My left eye and bottom left side of my face keeps jumping like something to do with my nerves.


VAERS ID: 1786347 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Guam  
Vaccinated:2021-03-23
Onset:2021-08-26
   Days after vaccination:156
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6204 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 2 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Abortion spontaneous, Emotional distress, First trimester pregnancy, Pregnancy test negative, Ultrasound antenatal screen abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Depression (excl suicide and self injury) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (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: NONE
Allergies: NONE
Diagnostic Lab Data: FIRST TRIMESTER MISCARRIAGE CONFIRMED POST VACCINE BY ULTRASOUND AND BETA HCG Patient is recovering from physical and emotional trauma. Will continue to follow.
CDC Split Type:

Write-up: LMP 7/13/2021 patient states vaginal spotting with blood clots consistent with miscarriage starting 8/26/2021 confirmed post vaccine first trimester miscarriage by ultrasound by beta hcg


VAERS ID: 1637085 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C16-03 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pain, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

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

Write-up: Strong headeaches, entire body pain. Strong pain in the arm (vaccine side)


VAERS ID: 1637607 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0810 / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Chest pain, increased heart rate, age 32, may 13th, Pfizer covid vaccine
Other Medications: Fluconazole pill was taken the day before to treat a suspected yeast infection.
Current Illness: Localized genital yeast infection.
Preexisting Conditions: None.
Allergies: Bees. No other known allergies.
Diagnostic Lab Data: None available to the patient filling out this form. ECG was taken on 08/24. Heart rate BPM was between 65-70 from what I could see on the monitor.
CDC Split Type:

Write-up: 2 days before shot patient had an ECG taken and was informed by his Doctor everything looked good. Chest tightness occurred five minutes after shot followed by sharp chest pain twenty minutes later. Both symptoms continued for 2 hours after injection and slowly began to wane after the first hour. This mirrored symptoms experienced after the first shot except there was no increased heart rate. Nurse took blood pressure and other basic vitals and everything was in normal range. Patient left clinic after an hour as the symptoms had begun to subside rather than opting in for more monitoring at a hospital.


VAERS ID: 1638437 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, Pain in extremity
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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: Nothing
Current Illness: Nothing
Preexisting Conditions: allergic coryza
Allergies: Nothing
Diagnostic Lab Data:
CDC Split Type:

Write-up: I get shot to left arm, but after 2 days, i got lots of bruises in right arm which the place is symmetry exactly from the shot spot in left. The bruises shape look like hives but its not hives( no ithcing, no red color) I have a same pain in right arm as like i first got shot in left(similar as muscular pain)


VAERS ID: 1641088 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014E21A / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Diarrhoea, Eye pruritus, Injection site pain, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), 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: Paracetamol started on 25-AUG-2021 at 12:00 noon 1 gr PO every 8 hours. Nothing else
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: This was the second dose of SpikeVax 28 days after the first dose (VAERS e-report No: 598855). First Adverse event (AE) was pain at site of injection 8 hours after administration of the second dose. Around 3 am of the following day (26-AUG-2021) chills, myalgia, arthralgia began. Around 24 h post vaccination, diarrhea (liquid stool) started. Diarrhea happened 3 times. Last one today (27-AUG-2021) at 9:00 am. Currently still experiencing myalgias, itchy eyes (began 26-AUG-2021 around 8:00 am). OF note, the reporter is a physician.


VAERS ID: 1657976 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD975 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ventricular septal defect (Suffered since birth)
Preexisting Conditions: Comments: The patient did not experience any adverse reaction after vaccination. The patient did not have any illness at the time of vaccination. The patient was healthy. The patient did not have history of hospitalization in last 30 days. The patient did not have any symptoms pertaining to tachycardia, dyspnea, the patient did not declare anything. The patient did not have any echocardiography reports available. The patient did not take any medication. The patient did not declare any recent illness or infection. The patient did not have positive test for COVID-19 prior to vaccination. The patient did not declare anything regarding any other significant medical history.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROJNJFOC20210855323

Write-up: 16 YEAR OLD WAS VACCINATED WITH JANSSEN COVID 19 VACCINE (INAPPROPRIATE AGE AT VACCINE ADMINISTRATION ); OFF LABEL USE; This spontaneous report received from a physician concerned a 16-year-old male patient of unspecified race and ethnic origin. The reporter did not know the exact weight of patient but he thought the patient was around 90 kilograms and height was 180 centimeters. The patient''s concurrent conditions included: ventricular septal defect, and other pre-existing medical conditions included: The patient did not experience any adverse reaction after vaccination. The patient did not have any illness at the time of vaccination. The patient was healthy. The patient did not have history of hospitalization in last 30 days. The patient did not have any symptoms pertaining to tachycardia, dyspnea, the patient did not declare anything. The patient did not have any echocardiography reports available. The patient did not take any medication. The patient did not declare any recent illness or infection. The patient did not have positive test for COVID-19 prior to vaccination. The patient did not declare anything regarding any other significant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD975, and expiry: unknown) dose was not reported, 1 total, administered on 26-AUG-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 26-AUG-2021, it was reported that a patient of 16-year-old was vaccinated with JANSSEN COVID-19 VACCINE (inappropriate age at vaccine administration) and an off label use of product was noted. The reporter explained that the patient wanted to be vaccinated with this vaccine and also there was a problem of misunderstanding between the staff that carried the triage and staff that administered the vaccine to the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a patient of 16-year-old was vaccinated with JANSSEN COVID-19 VACCINE (inappropriate age at vaccine administration) and off label use was not reported. This report was serious (Other Medically Important Condition). Additional information was received from physician on 30-AUG-2021. The following information was updated and incorporated into the case narrative: Patient demographics (height and weight) and Patient history text were updated.; Sender''s Comments: V1: Additional information received during follow up updates: Patient''s demographics (Height and weight), Patient medical history. This updated information does not alter the causality of previously reported events. 20210855323-COVID-19 VACCINE AD26.COV2.S-DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 YEAR OLD WAS VACCINATED WITH JANSSEN COVID 19 VACCINE), OFF LABEL USE. These events are considered not related. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1658835 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Burning sensation, Pain in extremity, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: Apo Fluoxitin, Vitamin B complex, Vitamin C, Calcium, Magnesium
Current Illness: Ae/Cfs - Chronic fatigue syndrom, depression, anxiety
Preexisting Conditions: Ae/Cfs - Chronic fatigue syndrom, depression, anxiety
Allergies: Toxic reaction (not allergy!) to ALL local anesthetics
Diagnostic Lab Data: none
CDC Split Type:

Write-up: burning sensations in different limbs, feverish, intense pain on vaccination arm, swelling, soreness, pain around vaccination site, joint pain. Took Tylenol extra strength every few hours for four days, On day 4 1ADVIL on day 5 1 Advil so far. Still redness, slight swelling soreness at touch and burning sensation around vaccination site


VAERS ID: 1664043 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 21C11-02 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Negative
CDC Split Type: FRJNJFOC20210855380

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age 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, and batch number: 21C11-02, expiry: unknown) dose was not reported, 1 total, administered on 12-JUL-2021 to right deltoid (shoulder) for prophylactic vaccination. No concomitant medications were reported. On 26-AUG-2021, patient underwent a blood test to detect antibodies (confirmed immunological vaccine failure). Laboratory data included: SARS-CoV-2 antibody test which was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191164.; Sender''s Comments: V0 20210855380-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.


VAERS ID: 1665114 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101117210

Write-up: 26Aug2021 my mother gets a massive cerebral hemorrhage due to vaccine Pfizer dose 2; This is a spontaneous report from a contactable other HCP reporting on her mother. A 72-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration at the age of 72-year-old on 25Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was not pregnant. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination. The patient previously took first dose bnt162b2 (COMIRNATY) via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) for COVID-19 immunisation. The patient experienced ''''26Aug2021 my mother got a massive cerebral hemorrhage due to vaccine Pfizer dose 2'''' (life threatening) on 26Aug2021 00:45. The patient visited the emergency room due to the event. The patient had not been tested since the vaccination. Treatment received for the event was blood preassure lowering medication. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events cerebral haemorrhage and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1668389 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy, Neck pain, SARS-CoV-2 test
SMQs:, Arthritis (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: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Swollen lymph nodes; Neck pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25857083) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) and NECK PAIN (Neck pain) in a 33-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 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant) and NECK PAIN (Neck pain) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) and NECK PAIN (Neck pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced extremely pain in neck same side as jab also with a lump (lymph nodes). Concomitant product use was not provided by reporter. Treatment information was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.; 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. Very limited information regarding these events has been provided at this time. No further information is expected. Of note, the events were assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.


VAERS ID: 1668390 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003657 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Hyperhidrosis, Skin warm
SMQs:, Neuroleptic malignant syndrome (broad), Arthritis (broad), Hypoglycaemia (broad)

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

Write-up: Headache; Skin warm; Sweating; Joint ache; This case was received via Regulatory Authority MHRA (Reference number: GB-MHRA-ADR 25857120) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SKIN WARM (Skin warm), HYPERHIDROSIS (Sweating), ARTHRALGIA (Joint ache) and HEADACHE (Headache) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003657) for COVID-19 vaccination. The patient''s past medical history included Pregnancy. On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced SKIN WARM (Skin warm) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, SKIN WARM (Skin warm), HYPERHIDROSIS (Sweating), ARTHRALGIA (Joint ache) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medication details were reported. No treatment medication details was reported. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Adverse reaction did not occur as a result of an exposure during pregnancy. 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. Events seriousness captured as per Regulatory Authority assessment in the Source Document.; 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. Events seriousness captured as per Regulatory Authority assessment in the Source Document.


VAERS ID: 1668399 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3380 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Body temperature, Cerebrovascular accident, Headache, Heart rate irregular, Hypertension, Loss of control of legs, Nervousness, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; FLUDROCORTISONE; PROPRANOLOL; SUMATRIPTAN; ZAPAIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine; Pain; Postural hypotension; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Stroke
Allergies:
Diagnostic Lab Data: Test Name: listened to heart rate; Result Unstructured Data: Test Result:irregular heart beat; Test Date: 20210826; Test Name: High temperature; Result Unstructured Data: Test Result:High; Test Date: 20210826; Test Name: high blood pressure; Result Unstructured Data: Test Result:170/120; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118985

Write-up: heart beat; stroke; Hypertension arterial; High temperature; Vomiting; Headache; Loss of control of legs; Shaky feelings; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108281116080620-KMXKA, Safety Report Unique Identifier is GB-MHRA-ADR 25864483. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Aug2021 (Lot Number: FF3380) as single dose for COVID-19 immunization. Medical history included stroke, steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)), pain, migraine and postural hypotension all from an unknown date. Concomitant medications included amitriptyline (AMITRIPTYLINE) taken for pain, start and stop date were not reported; fludrocortisone (FLUDROCORTISONE) taken for postural hypotension from 03Apr2012 to an unspecified stop date; propranolol (PROPRANOLOL) taken for migraine, start and stop date were not reported; sumatriptan (SUMATRIPTAN) taken for migraine, start and stop date were not reported; codeine phosphate, paracetamol (ZAPAIN) taken for pain, start and stop date were not reported. The patient experienced heart beat and stroke both on an unspecified date; vomiting, hypertension arterial, high temperature, headache, loss of control of legs and shaky feelings all on 26Aug2021. The events were reported as serious (medically significant, life threatening). Clinical course was reported as follows: Woke up first day with really bad headache, vomiting , high temperature, shake and a high blood pressure, slept most of day when woke up later blood pressure had risen to over 170/120 spoke to ambulance service had doctors call, next day blood pressure still the same spoke to doctor on phone made me go up the doctors had blood pressure done there which she stated it was very high and prescribed felodapine to reduce blood pressure, advised could lead to a stroke and if tablet doesn''t help will be admitted to hospital for further treatment. She also stated that I now have a irregular heart beat which I never had before and have now been sighed off work till they can stabilise these issues. 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 SARS-COV-2 test with No - Negative COVID-19 test result and listened to heart rate with irregular heartbeat on an unknown date, blood pressure with 170/120 on 26Aug2021. The patient has not recovered from the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1668422 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Maternal exposure during pregnancy, Pain in extremity, 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), 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: Pregnancy (Estimated due date: 29-JAN-2022)
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201224; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Maternal exposure during pregnancy; Pain in arm; High temperature; Joint ache; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25856104) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), PYREXIA (High temperature), ARTHRALGIA (Joint ache), HEADACHE (Headache) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 18-Dec-2020 to 25-Dec-2020. Concurrent medical conditions included Pregnancy (Estimated due date: 29-JAN-2022). On 26-Aug-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 dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) at an unspecified dose. The patient''s last menstrual period was on 21-Apr-2021 and the estimated date of delivery was 29-Jan-2022. On 26-Aug-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna CoviD-19 Vaccine) beginning around the eighteenth week of the pregnancy. At the time of the report, PAIN IN EXTREMITY (Pain in arm), PYREXIA (High temperature), ARTHRALGIA (Joint ache) and HEADACHE (Headache) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Patient is not enrolled in clinical trial Patient did not take folic acid supplement during pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time; 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. Very limited information regarding these events has been provided at this time. No further information is expected at this time


VAERS ID: 1668954 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101128388

Write-up: Peripheral nerve disorder NOS; limbs to become numb; This is a spontaneous report from a contactable physician communicated via a Pfizer sales representative. A 12-year-old male patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration on 19Aug2021 (the day of vaccination), Dose 1, Single for COVID-19 immunization. The patient''s detailed information was not provided. The patient''s medical history and concomitant medications were not reported. From 26Aug2021 (after the vaccination), the patient experienced the limbs to become numb. The pain likely the Peripheral nerve disorder NOS occurred and appeared intermittently for several minutes about 6 times a day. The adverse events occurred after using the product. The seriousness was not provided. The outcome of events was still ongoing and not recovered. 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 information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of peripheral neuropathy. The case will be reassessed once new information is available. 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: 1671652 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Headache; Feeling cold; Shivering; Nausea; Fever; This case was received via Regulatory Authority (Reference number: ) on 26-Aug-2021 and was forwarded to Moderna on 26-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FEELING COLD (Feeling cold), CHILLS (Shivering), NAUSEA (Nausea) and PYREXIA (Fever) 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 Lactation decreased. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), FEELING COLD (Feeling cold) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), FEELING COLD (Feeling cold), CHILLS (Shivering), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Heart rate increased. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. Patient had fitted Copper IUD in November 2020.Also patient was not enrolled in any clinical trials.Post vaccination patient not tested positive for COVID-19. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.


VAERS ID: 1671662 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Diarrhoea, Headache, Hyperhidrosis, Illness, Myalgia, Myositis, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210821; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: joint pain; shivering; Sweating; Sickness; Myositis; Shivers; Headache; Fever; Diarrhea; Myalgia; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25854345) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOSITIS (Myositis), CHILLS (Shivers), HEADACHE (Headache), PYREXIA (Fever), DIARRHOEA (Diarrhea), MYALGIA (Myalgia), ARTHRALGIA (joint pain), CHILLS (shivering), HYPERHIDROSIS (Sweating) and ILLNESS (Sickness) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced MYOSITIS (Myositis) (seriousness criterion disability), CHILLS (Shivers) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability), DIARRHOEA (Diarrhea) (seriousness criterion disability), MYALGIA (Myalgia) (seriousness criterion disability), HYPERHIDROSIS (Sweating) (seriousness criterion disability) and ILLNESS (Sickness) (seriousness criterion disability). On an unknown date, the patient experienced ARTHRALGIA (joint pain) (seriousness criterion disability) and CHILLS (shivering) (seriousness criterion disability). At the time of the report, MYOSITIS (Myositis), CHILLS (Shivers), HEADACHE (Headache), PYREXIA (Fever), DIARRHOEA (Diarrhea) and MYALGIA (Myalgia) had not resolved and ARTHRALGIA (joint pain), CHILLS (shivering), HYPERHIDROSIS (Sweating) and ILLNESS (Sickness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Patient underwent lateral flow test and the result were negative. 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: 1671675 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bone pain, Insomnia, Nausea, Pyrexia, SARS-CoV-2 test, Tension headache
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Osteonecrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210819; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fever chills; Tension headache; Nausea; Insomnia; Bone pain; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 25857737) on 27-Aug-2021 and was forwarded to the company on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever chills), TENSION HEADACHE (Tension headache), NAUSEA (Nausea), INSOMNIA (Insomnia) and BONE PAIN (Bone pain) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), INSOMNIA (Insomnia) (seriousness criterion medically significant) and BONE PAIN (Bone pain) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant) and TENSION HEADACHE (Tension headache) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever chills), TENSION HEADACHE (Tension headache), NAUSEA (Nausea), INSOMNIA (Insomnia) and BONE PAIN (Bone pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not provided by the reporter. 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: 1671826 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210904583

Write-up: BLACKOUT; AUTOMOBILE ACCIDENT; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, IT-MINISAL02-777356) on 01-SEP-2021 concerned a 65 year old male. The patient''s weight was 78 kilograms, and height was 178 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Xd974 expiry: UNKNOWN) .5 ml, 1 total, administered on 26-AUG-2021 for covid-19 vaccination. No concomitant medications were reported. On 26-AUG-2021, the patient experienced blackout and automobile accident and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blackout and automobile accident. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1675114 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Blood test, Chest X-ray, Chest pain, Condition aggravated, Dyspnoea, Electrocardiogram abnormal, Hypertension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None.
Current Illness: Covid in july.
Preexisting Conditions: High Blood pressure (controlled with diet and exercise) got worse with the vaccine.
Allergies: Lactose intolerant
Diagnostic Lab Data: x ray, ekg and blood tests.
CDC Split Type:

Write-up: Severe chest pain after receiving the vaccine. Shortness of breath and elevated blood pressure ( near 150/100). Doctor prescribed High blood pressure medications. Arrhythmias were frequent and until today problem is still there. Doctor ordered x rays and ekg. Doctor suspects heart inflammation.


VAERS ID: 1676491 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chest discomfort, Dizziness, Dizziness postural, Electrocardiogram ST segment, Eye pain, Headache, Limb discomfort, Nausea, Pain in extremity, Palpitations, SARS-CoV-2 test, Spinal pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness: Ache
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ST segement; Result Unstructured Data: ST elevated; Test Date: 20210802; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No-Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Pain in spine; Headache; Dizziness; Swollen heart; Dizzy; Frontal headache; Eye ache; Nausea; Dizzy on standing; Backache; Foot pain; Tight chest; Frontal headache; Calf discomfort; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 25853029) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SPINAL PAIN (Pain in spine), HEADACHE (Headache), DIZZINESS (Dizziness), PALPITATIONS (Swollen heart), DIZZINESS (Dizzy), the first episode of HEADACHE (Frontal headache), EYE PAIN (Eye ache), NAUSEA (Nausea), DIZZINESS POSTURAL (Dizzy on standing), BACK PAIN (Backache), PAIN IN EXTREMITY (Foot pain), CHEST DISCOMFORT (Tight chest), the second episode of HEADACHE (Frontal headache) and LIMB DISCOMFORT (Calf discomfort) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not Known) for COVID-19 vaccination. Concurrent medical conditions included Ache. Concomitant products included IBUPROFEN from 25-Aug-2021 to an unknown date for Ache. On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced the first episode of HEADACHE (Frontal headache) (seriousness criterion disability), EYE PAIN (Eye ache) (seriousness criterion disability), NAUSEA (Nausea) (seriousness criterion disability), DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion disability), BACK PAIN (Backache) (seriousness criterion disability), PAIN IN EXTREMITY (Foot pain) (seriousness criterion disability), CHEST DISCOMFORT (Tight chest) (seriousness criterion disability), the second episode of HEADACHE (Frontal headache) (seriousness criterion disability) and LIMB DISCOMFORT (Calf discomfort) (seriousness criterion disability). On an unknown date, the patient experienced SPINAL PAIN (Pain in spine) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), DIZZINESS (Dizziness) (seriousness criterion disability), PALPITATIONS (Swollen heart) (seriousness criterion disability) and DIZZINESS (Dizzy) (seriousness criterion disability). On 26-Aug-2021, CHEST DISCOMFORT (Tight chest) had resolved. At the time of the report, SPINAL PAIN (Pain in spine), HEADACHE (Headache), DIZZINESS (Dizziness), PALPITATIONS (Swollen heart), DIZZINESS (Dizzy) and LIMB DISCOMFORT (Calf discomfort) was resolving and EYE PAIN (Eye ache), NAUSEA (Nausea), DIZZINESS POSTURAL (Dizzy on standing), BACK PAIN (Backache), PAIN IN EXTREMITY (Foot pain) and the last episode of HEADACHE (Frontal headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, SARS-CoV-2 test: negative (Negative) No-Negative COVID-19 test. On an unknown date, Electrocardiogram ST segment: elevated (High) ST elevated. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications provided by the reporter. Patient drank lots of water after vax, took an ibuprofen 200mg before sleep, didn''t sleep great, definitely had something akin to the inflamed/swollen heart, could feel it when breathed deeply and lay on side. Woke with most intense headache in the front head, eyes included. standing makes dizzy. Patient had spine aches, calf muscles the muscles around the talus in foot going up shins, some nausea, not too bad but definitely noticeable when trying to drink more water. Headache and dizziness take a big boost when stand up. Head and eye ache come out as clear noticeable winners. Glad to booked time of work, remaining in bed to nurse headache, but need breakfast. Patient has not tested positive for COVID-19 since having the vaccine and 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: 1676492 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Illness, Middle insomnia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (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: night sleeping; Fever; Sickness; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25853087) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIDDLE INSOMNIA (night sleeping), ILLNESS (Sickness), HEADACHE (Headache) and PYREXIA (Fever) in a 23-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 26-Aug-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 26-Aug-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced MIDDLE INSOMNIA (night sleeping) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, MIDDLE INSOMNIA (night sleeping), ILLNESS (Sickness) and PYREXIA (Fever) was resolving and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product information were provided by the reporter. No treatment information was provided by the reporter. 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. Events seriousness captured as per Regulatory Authority assessment in the Source Document.; 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. Events seriousness captured as per Regulatory Authority assessment in the Source Document.


VAERS ID: 1676494 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Pain, SARS-CoV-2 test, Temperature perception test abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: FEMODENE; IBUPROFEN; XAGGITIN XL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Interstitial lung disease; Lactation decreased; Rheumatoid arthritis; Comments: Juvenile localised rheumatoid arthritis in teens. Received steroid and methotrexate treatment, disease burnt out before hitting 18. No other medical issues in the 13 years following. Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: At 1450 now feeling tired, achey, swinging temperatures; At 1450 now feeling tired, achey, swinging temperatures; At 1450 now feeling tired, achey, swinging temperatures; Vomiting; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25854199) on 27-Aug-2021 and was forwarded to Moderna on 27-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), FATIGUE (At 1450 now feeling tired, achey, swinging temperatures), PAIN (At 1450 now feeling tired, achey, swinging temperatures) and TEMPERATURE PERCEPTION TEST ABNORMAL (At 1450 now feeling tired, achey, swinging temperatures) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Juvenile localised rheumatoid arthritis in teens. Received steroid and methotrexate treatment, disease burnt out before hitting 18. No other medical issues in the 13 years following. Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Rheumatoid arthritis, Lactation decreased and Interstitial lung disease. Previously administered products included for Rheumatoid arthritis: METHOTREXATE; for Product used for unknown indication: DEPO-MEDRONE. Concomitant products included METHYLPHENIDATE HYDROCHLORIDE (XAGGITIN XL) from 30-Dec-2020 to an unknown date for Attention deficit hyperactivity disorder, ETHINYLESTRADIOL, GESTODENE (FEMODENE) from 16-Sep-2016 to an unknown date for Contraception, IBUPROFEN for an unknown indication. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (At 1450 now feeling tired, achey, swinging temperatures) (seriousness criterion medically significant), PAIN (At 1450 now feeling tired, achey, swinging temperatures) (seriousness criterion medically significant) and TEMPERATURE PERCEPTION TEST ABNORMAL (At 1450 now feeling tired, achey, swinging temperatures) (seriousness criterion medically significant). On 26-Aug-2021, VOMITING (Vomiting) was resolving. At the time of the report, FATIGUE (At 1450 now feeling tired, achey, swinging temperatures), PAIN (At 1450 now feeling tired, achey, swinging temperatures) and TEMPERATURE PERCEPTION TEST ABNORMAL (At 1450 now feeling tired, achey, swinging temperatures) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced feeling tired, achy, swinging temperatures but otherwise okay. Patient received steroid and methotrexate treatment for rheumatoid arthritis in teens. 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. No further information is expected.; 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. No further information is expected.


VAERS ID: 1676505 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Rash; This case was received via RA (Reference number: GB-MHRA-ADR 25858215) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash) in a 27-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. Concomitant products included PARACETAMOL from 25-Aug-2021 to an unknown date for an unknown indication. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). At the time of the report, RASH (Rash) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1676507 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspepsia, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 virus test Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Indigestion; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25858746) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPEPSIA (Indigestion) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced DYSPEPSIA (Indigestion) (seriousness criteria disability and medically significant). On 26-Aug-2021, DYSPEPSIA (Indigestion) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID-19 virus test Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient had severe indigestion, worst the patient had ever experienced. Sounds related to Heart inflammation linked to Pfizer and Moderna jabs. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Seriousness of the event is based on the Regulatory Report received. As per medical judgement the event for this case is non-serious. As this a RA, reported event seriousness is kept as per RA assessment.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Seriousness of the event is based on the Regulatory Report received. As per medical judgement the event for this case is non-serious. As this a RA, reported event seriousness is kept as per RA assessment.


VAERS ID: 1676514 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), LYMPHADENOPATHY (Swollen lymph nodes) and PAIN IN EXTREMITY (Painful arm) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included PARACETAMOL from 27-Aug-2021 to 27-Aug-2021 for Pain. On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). On 28-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) had not resolved and PAIN IN EXTREMITY (Painful arm) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment details were 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: Bqased 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: 1676521 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Discomfort, Lymphadenopathy, SARS-CoV-2 test, Vaccination site pain
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: MIRTAZAPIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201028; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: COVID-19 virus test Positive
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Discomfort; I experienced pain in the arm; Swollen lymph nodes; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25864659) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort), LYMPHADENOPATHY (Swollen lymph nodes) and VACCINATION SITE PAIN (I experienced pain in the arm) in a 22-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 26-Oct-2020. Concomitant products included MIRTAZAPINE (MIRTAZAPIN) from 24-Aug-2021 to an unknown date for Mixed anxiety & depressive. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). On an unknown date, the patient experienced DISCOMFORT (Discomfort) (seriousness criterion medically significant) and VACCINATION SITE PAIN (I experienced pain in the arm) (seriousness criterion medically significant). At the time of the report, DISCOMFORT (Discomfort) and VACCINATION SITE PAIN (I experienced pain in the arm) outcome was unknown and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2020, SARS-CoV-2 test: covid-19 virus test positive (Positive) COVID-19 virus test Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient experienced pain in the arm, and surrounding area, that received the vaccine. The area has since become swollen, mostly around the armpit and left breast (of a male), causing considerable discomfort and pain. Patient was not enrolled in clinical trial. No treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company comment: Very limited information regarding this events has been provided at this time. Further information is not expected.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information is not expected.


VAERS ID: 1676646 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Injection site warmth, Pain in extremity, Peripheral swelling, Pruritus, Rash erythematous, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), 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; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: itch; Itchy; Red rash; Backache; Injection site warmth; Painful arm; Swollen arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25866675) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (itch), PERIPHERAL SWELLING (Swollen arm), RASH ERYTHEMATOUS (Red rash), BACK PAIN (Backache), INJECTION SITE WARMTH (Injection site warmth), PAIN IN EXTREMITY (Painful arm) and PRURITUS (Itchy) in a 26-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 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), INJECTION SITE WARMTH (Injection site warmth) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 27-Aug-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant) and BACK PAIN (Backache) (seriousness criterion medically significant). On 28-Aug-2021, the patient experienced PRURITUS (Itchy) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (itch) (seriousness criterion medically significant). At the time of the report, PRURITUS (itch) had resolved, PERIPHERAL SWELLING (Swollen arm), RASH ERYTHEMATOUS (Red rash), BACK PAIN (Backache), INJECTION SITE WARMTH (Injection site warmth) and PRURITUS (Itchy) had not resolved and PAIN IN EXTREMITY (Painful arm) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative negative (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details were reported. No treatment medication details was reported. Big red round rash around injection site, which did no go down (its been 5 days since receiving the second dose). The injection site was swollen, red, hot to touch and was now starting to itch. Full body and back aches from the morning after having the jab. Immediately after the jab the arm was very sore for 3 days, struggled to lift it up. 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. Seriousness of the events are based on the Regulatory Report received. As per medical judgement the events for this case are non-serious. As this a RA, reported events seriousness is kept as per RA assessment.; 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. Seriousness of the events are based on the Regulatory Report received. As per medical judgement the events for this case are non-serious. As this a RA, reported events seriousness is kept as per RA assessment.


VAERS ID: 1676772 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005235 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Blood pressure; Result Unstructured Data: 120 mmHg; Test Name: Body temperature; Result Unstructured Data: 36.6 degree Celsius
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Loss of consciousness; Fall; Vasovagal reflex; This case was received via regulatory authority (Reference number: 2021TJP085400) on 27-Aug-2021 and was forwarded to Moderna on 06-Sep-2021. This case, initially reported to the regulatory authority by a person who set up the venue, was received via the RA (Ref, v21124874). Loss of consciousness was assessed as serious by the RA. On an unknown date, body temperature before the vaccination: 36.7 degrees Celsius. On 26-Aug-2021, at 10:49, the patient received the 1st dose of the vaccine. At 10:58, during observation for 15 minutes, the patient experienced feels poorly, loss of consciousness, and fall. At the time of vaccination, level of consciousness was level, and radial pulse was weak. The patient was considered to have vasovagal reaction. The patient was placed on a stretcher in the supine position and became awake and alert in a few minutes. Blood pressure (BP) was 120 mmHg. The patient did not have vasovagal reaction in the past. The outcome of vasovagal reflex was reported as resolved. The outcome of fall was unknown. The outcome of loss of consciousness was reported as resolving. No follow-up investigation is possible. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported.; 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: 1678475 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 085D21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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: GLUTATHIONE; TYLENOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAMODERNATX, INC.MOD20213

Write-up: Bleed on his depositions; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleed on his depositions) in a 40-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 085D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included PARACETAMOL (TYLENOL) for Adverse drug reaction, GLUTATHIONE for Supplementation therapy. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced PYREXIA (Fever). On 27-Aug-2021, the patient experienced HAEMORRHAGE (Bleed on his depositions) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (Bleed on his depositions) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided.; 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: 1680534 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Illness, Pain
SMQs:

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

Write-up: Shivers; Ache; Headache; Sickness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25858209) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivers), PAIN (Ache), HEADACHE (Headache) and ILLNESS (Sickness) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and ILLNESS (Sickness) (seriousness criterion medically significant). At the time of the report, CHILLS (Shivers) and ILLNESS (Sickness) was resolving and PAIN (Ache) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Patient has not tested positive for COVID-19 since having the vaccine. 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. The events doesn?t seem to be serious by medical judgement, but they were assessed as serious as per regulatory authority report.; 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. The events doesn?t seem to be serious by medical judgement, but they were assessed as serious as per regulatory authority report.


VAERS ID: 1680540 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-08-26
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Dizziness, Headache, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Chills; Dizziness; Vomiting; Joint aches; Aching joints; Headache; Nausea; Vomited; Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25858733) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This Regulatory Authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ARTHRALGIA (Aching joints), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomited), PYREXIA (Fever), VOMITING (Vomiting) and ARTHRALGIA (Joint aches) 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 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), VOMITING (Vomited) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and ARTHRALGIA (Joint aches) (seriousness criterion medically significant). On 26-Aug-2021, NAUSEA (Nausea) and VOMITING (Vomited) had resolved. At the time of the report, DIZZINESS (Dizziness), CHILLS (Chills), VOMITING (Vomiting) and ARTHRALGIA (Joint aches) had resolved and ARTHRALGIA (Aching joints), HEADACHE (Headache) and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Patient received vaccine at 9am, felt dizziness/out of energy at 12pm which lasted an hour. Around 10pm, chills/fever began and lasted all night as well as headache. Around midnight vomiting happened lasting about 45mins. Fever, Headaches and joint aches lasted until morning and have eased. 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: 1680544 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Apnoea, Maternal exposure during breast feeding, Menstruation irregular
SMQs:, Acute central respiratory depression (narrow), Neonatal exposures via breast milk (narrow), Fertility disorders (broad), Respiratory failure (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: GBMODERNATX, INC.MOD20213

Write-up: Apnoea; Maternal exposure during breast feeding; Menstruation irregular; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25860707) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of APNOEA (Apnoea) in a 35-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. Concurrent medical conditions included Breast feeding. On 25-Aug-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 26-Aug-2021, the patient experienced MENSTRUATION IRREGULAR (Menstruation irregular). On an unknown date, the patient experienced APNOEA (Apnoea) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). At the time of the report, APNOEA (Apnoea) and MENSTRUATION IRREGULAR (Menstruation irregular) was resolving and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment was reported. The patient started menstruating on 17/JUN/2021. Then the next month one day late on 16/JUL/2021, the patient''s period was normally regular, averaging 28 days based on over a year and a half of data. Then she was due this month on 13/MAY/2021 but no period appeared. The patient had a baby on 13/MAY/2021. She was small and therefore needed small amount of milk. She was breast fed. The patient supposed that since her girl was getting bigger and needed more milk her hormones were compensating and stopped her period. Then she had the Moderna vaccine and got her period the next day - 13 days late. Patient had not tested positive for COVID-19 since having the vaccine. The patient had no symptoms associated with covid-19. Company Comment: This is a case of Maternal exposure during breastfeeding with associated AEs of apnea and menstruation irregular 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 is not expected. This case was linked to MOD-2021-302134 (Parent-Child Link). See case MOD-2021-302134 for details regarding the child case.; Sender''s Comments: This is a case of Maternal exposure during breastfeeding with associated AEs of apnea and menstruation irregular 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 is not expected.


VAERS ID: 1682291 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-08-26
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA 9099 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Headache, Inappropriate schedule of product administration, Off label use
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101116951

Write-up: 1st dose: 04May2021; 2nd dose: 09Jul2021; 1st dose: 04May2021; 2nd dose: 09Jul2021; Sudden facial paralysis, drooping of right eye and lips.Headache; Sudden facial paralysis, drooping of right eye and lips.Headache; Sudden facial paralysis, drooping of right eye and lips.Headache; This is a spontaneous report received via the RA from a contactable healthcare professional (patient itself) regarding product BNT162B2, the following information was reported. A 36-years-old female (age at vaccination: 36 years) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FA 9099 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 09Jul2021 at 06:00 PM, as a single dose for COVID-19 immunization and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW 0193 and expiry date was not reported), via an unspecified route of administration, in Arm Left, 04May2021 at 06:00 PM, as a single dose for COVID-19 immunization at hospital. It was unknown that if the patient was pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 26Aug2021 at 08:00, the patient experienced sudden facial paralysis, drooping of right eye and lips. headache. The patient also had off label use and Inappropriate schedule of vaccine administered (1st dose: 04May2021; 2nd dose: 09Jul2021). The adverse events sudden facial paralysis, drooping of right eye and lips.headache. result in emergency room/department or urgent care. The patient received oral steroids, lubricant eye drops, and eye patch as treatment for the events sudden facial paralysis, drooping of right eye and lips.Headache. Outcome of the events was unknown.


VAERS ID: 1682346 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117732

Write-up: Painful periods; Prolonged heavy periods; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108261338478570-I8CKQ, Safety Report Unique Identifier GB-MHRA-ADR 25853738. A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 23Aug2021 (Lot Number: FE8087) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 on an unknown date for COVID-19 immunisation. On 26Aug2021, the patient experienced painful periods and prolonged heavy periods. The patient periods started earlier than expected and were extremely painful and heavy. The patient never had that before and not taking any medication or seeing any other reason why that might be. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1682356 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Illness, Maternal exposure during breast feeding, Pyrexia, Vertigo
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (narrow), Neonatal exposures via breast milk (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117626

Write-up: Vertigo; Headache; Sickness; Fatigue; Maternal exposure during breast feeding; Fever chills; This is a spontaneous report from a contactable consumer. This is report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108261728507310-X3SME, Safety Report Unique Identifier number is (GB-MHRA-ADR 25855256). The 28-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Lot Number: FE3380) via an unspecified route of administration on 25Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. The medical history included ongoing breast feeding. The patient concomitant medications were not reported. The historical vaccine included dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Lot Number: unknown) via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunization. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date the patient experienced maternal exposure during breast feeding, vertigo, headache, sickness, fatigue and on 26Aug2021 fever chills. The outcome of the event maternal exposure during breast feeding was unknown, fever chills, vertigo, headache, sickness and fatigue was not recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101127205 Original Case : 202101117626 mother/baby case


VAERS ID: 1682357 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117666

Write-up: Skin rash; This is a spontaneous report from a contactable consumer or other non healthcare professional. This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202108261847237710-IQGMY, Safety Report Unique Identifier GB-MHRA-ADR 25855717. . A 43-year-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection, Lot Number: FE3380), via an unspecified route of administration at single dose on 24Aug2021 for COVID-19 immunisation. Medical history included pregnancy, and drug hypersensitivity (Allergic to penicillin), were from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously took nitroglycerin and experienced drug hypersensitivity. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was unknown), via an unspecified route of administration on an unknown date as a single dose for covid-19 immunisation. On 26Aug2021, the patient experienced skin rash continues to increase on all parts of the body. Adverse reaction did not occur as a result of an exposure during pregnancy. Reported to NHS and GP, both stated normal reaction. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (no, negative COVID-19 test). The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1682372 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-26
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, SARS-CoV-2 test, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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 Date: 20210826; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118536

Write-up: This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108271709069690-JTPIT, Safety Report Unique Identifier GB-MHRA-ADR 25860730. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FE8087), on 17Aug2021 as a single dose for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient''s concomitant medications were not reported. Patient was not enrolled in clinical trial. The patient experienced groggy on an unspecified date and headache on 26Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No - Negative COVID-19 test) on 26Aug2021. Therapeutic measures were taken as a result of headache (headache). The outcome of the event headache was recovered on 27Aug2021. The outcome of the event groggy was recovered on an unspecified date. Very bad headache out of the blue - not had one like that before. Not sure if related to vaccine or not, but given I do not often get headaches, and have not had one like this one (paracetamol did nothing to help) I thought I should report it. Completely wiped me out yesterday - spent most of afternoon in bed with a black T-shirt covering my eyes. Slept a lot. Feel better today but groggy. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1682373 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Mastitis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Functional lactation disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Test Name: Body temperature; Result Unstructured Data: Test Result:increased/ Fever
CDC Split Type: GBPFIZER INC202101118518

Write-up: Fever; Mastitis; This is a spontaneous report from a contactable consumer. This report received from the Regulatory Authority report number is GB-MHRA-WEBCOVID-202108281056134300-E6YSX. Safety Report Unique Identifier GB-MHRA-ADR 25864398. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: FF3319 and Expiration date: unknown), via an unspecified route of administration on 25Aug2021 as dose 1, single for covid-19 immunisation. 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. The patient experienced mastitis on 26Aug2021 and fever on 27Aug2021 with outcome of not recovered. The case was assessed as serious (disability). Patient had not tested positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included body temperature: increased/ fever on an unspecified date. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1685925 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   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 FD7222 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Face oedema, Inappropriate schedule of product administration, Swelling face, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRIMULA SPP. EXTRACT; BORAGE OIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101115802

Write-up: Dose 1: 02Jun2021; Dose 2: 25Aug2021; Facial swelling; mild edema in the face region, where hyaluronic acid filling had been injected; local pain; This is a spontaneous report from a contactable consumer (patient) received. A 33-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: FD7222), dose 2 via an unspecified route of administration on 25Aug2021 20:45 PM (at the age of 33-year-old), in Arm Right as dose 2, single for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included asthma, covid-19. Concomitant medications reported as Oil for an unspecified indication, start and stop date were not reported. No known allergies. The patient historical vaccine included BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: FA7478), via an unspecified route of administration on 02Jun2021 10:00 AM in Arm Right as dose 1, single for COVID-19 immunization. The patient past drug event reported as no. Patient reported no other vaccine taken. Patient reported COVID prior vaccination was yes and post vaccination reported as no. On 26Aug2021 23:00, the patient experienced facial swelling, local pain, dose 1 on 02jun2021 and dose 2 on 25aug2021, mild edema in the face region, where hyaluronic acid filling had been injected. Treatment was taken with Predsim 40 mg. The event of Inappropriate schedule of vaccine administered was unknown. Rest of the events was recovering.


VAERS ID: 1685931 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7222 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood urine present, Diarrhoea, Eye irritation, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: INSULIN
Current Illness: Type 1 diabetes mellitus (I am type 1 diabetic)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101117528

Write-up: very high fever; vomiting; diarrhea; urine with blood; burning eyes; This is a spontaneous report from a contactable consumer, the patient. A 25-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, lot number: FD7222), via an unspecified route of administration, administered in arm left on 26Aug2021 10:15 as dose 1, single (at the age of 25-years-old) for covid-19 immunization. Medical history included ongoing type 1 diabetes mellitus. Concomitant medication included insulin taken for diabetes mellitus.The patient was not allergic to any medications, food or other products. On 26Aug202110:00 PM, the patient experienced very high fever, vomiting, diarrhea, urine with blood and burning eyes. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not taken any other medications/products within 2 weeks of vaccination. The patient went to emergency room/department or urgent care. It was unknown whether the treatment received for the events or not. The patient had not diagnosed with COVID-19 and since vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolving.


VAERS ID: 1685938 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-08-26
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER 210074 / 2 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Back pain, COVID-19, Colonoscopy, Diverticulitis, Inguinal hernia, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific inflammation (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VASOPRIL [ENALAPRIL MALEATE]
Current Illness: Prostate cancer
Preexisting Conditions: Medical History/Concurrent Conditions: Radiotherapy (submitted to 37 radiotherapy sessions)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: colonoscopy; Result Unstructured Data: detected a diverticulitis; Test Date: 20210826; Test Name: COVID-19 test; Test Result: Positive
CDC Split Type: BRSA2021SA291236

Write-up: SARs-COV-2 virus, and the result was positive for covid-19; regular cardiac arrhythmia; diverticulitis; lumbar pain; inguinal region; This initial Information regarding this unsolicited and serious case was received on 30-Aug-2021 from a non-healthcare professional through Business Partner, which was forwarded to a regulatory authority on 31-Aug-2021. On 28-Aug-2021 the a regulatory authority received, through the a research authority, the report of the non-serious adverse event after the use of the covid-19 (Coronavirus Disease) adsorbed vaccine (inactivated) and the trivalent influenza vaccine (fragmented and inactivated). The reporter and patient, male, (age, comorbidity, continuous medication use and unknown demographic data), reports that after receiving the first and second dose of the adsorbed vaccine covid-19 (inactivated) and the influenza vaccine (dates, lot, validity and route of administration not informed), was diagnosed with Covid-19 virus [Covid-19] on an unspecified date. No further details were provided. such as when the events started, intensity, duration, possible treatments or any other information relevant to the case. We await additional information. Follow up 1: On 30-Aug-2021 the a regulatory authority received additional information about the case through the a research authority, where it was reclassified as serious due to new events reported by the patient after using the adsorbed vaccine covid-19 (inactivated) and the trivalent influenza vaccine (fragmented and inactivated). The reporter and patient, male, from PRIVATE, commercial representative profession, 74 years old, weight 65 kg, height 157cm, medical history of on an unknown date of 2019 diagnosis of prostate cancer and submitted to 37 radiotherapy sessions; uses concomitant medication such as Vasopril 10mg (enalapril maleate; indication for cardiac arrhythmia); received on 19-Mar-2021 the first dose of adsorbed vaccine covid-19 (inactivated) batch 210074 in the left arm (expiration date unknown, and on 16-Apr-2021 received the second dose of adsorbed vaccine covid-19 (inactivated) lot 210134 in the left arm, and 15 days after this immunization the patient received the influenza vaccine (lot unknown). On 20 and/or 21-Aug-2021 the patient had symptoms such as intestinal gas, retention of feces and mild prostration; in 26-Aug-2021 was submitted to an examination to detect the SARs-COV-2 virus (severe acute respiratory syndrome coronavirus 2), and the result was positive for [covid-19], so he was medicated with paracetamol 750mg for 3 days. Regarding the events mentioned and started in 2021 (it is not clear whether they started before or after the use of the suspected product, so conservatively they will be considered as adverse events): lumbar pain [back pain] and in the inguinal region [inguinal hernia], was diagnosed with regular cardiac arrhythmia [arrhythmia], anal bleeding thus underwent colonoscopy which detected a diverticulitis [diverticulitis] smaller arteries generated due to radiotherapy of cancer of the prostate. The patient concludes that the events (intestinal gas, stool retention, and mild prostration) still persist. Medical opinion 31-Aug-2021: Temporality inconsistent, because the interval between vaccination and onset of symptoms was too long; the diagnoses presented have etiologies unrelated to the inactivated virus vaccine. Final Opinion: unlikely and not expected. It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any additional medical history, concomitant disease or risk factor. It is unknown if there were laboratory data/results available.; Sender''s Comments: This case concerns a 74 years old male patient who had arrhythmia, diverticulitis, back pain, COVID-19 and inguinal hernia after vaccination with INFLUENZA VACCINE(unknown manufacturer) and COVID-19 VACCINE (not produced by Sanofi Pasteur). At the time of the event, the patient has prostate cancer and submitted to 37 radiotherapy sessions. Concomitant medications included VASOPRIL for Cardiac arrhythmia. Relevant laboratory test results included:SARS-CoV-2 test- Positive and Colonoscopy - detected a diverticulitis. The interval between vaccination and onset of symptoms was too long. The diagnoses presented have etiologies unrelated to the inactivated virus vaccine. Final opinion was reported as unlikely and not expected. Based upon the reported information, the role of an individual vaccine cannot be assessed.


VAERS ID: 1686421 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Myocarditis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210911499

Write-up: PYREXIA; ARRHYTHMIA; MYOCARDITIS; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, DE-PEI-CADR2021172933) on 07-SEP-2021 concerned a 26 year old male. The patient''s weight was 88 kilograms, and height was 182 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C18-01 expiry: UNKNOWN) dose was not reported, 1 total, administered on 23-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-AUG-2021, the patient experienced arrhythmia, and myocarditis On an unspecified date, the patient experienced pyrexia. On an unspecified date, the patient was hospitalized due to arrhythmia, myocarditis and pyrexia. Number of days of hospitalization were not reported. It was unknown if the patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pyrexia, and recovered with sequelae from arrhythmia, and myocarditis on 31-AUG-2021. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1686629 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-08-26
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Heavy menstrual bleeding, Menstruation irregular, Migraine
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility 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: CONCERTA; LEXATIN [BROMAZEPAM]; LORMETAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD; Fibroids
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101115554

Write-up: She had the menstruation 10 days earlier than usual; Migraine; Advanced menstruation, very abundant and with strong abdominal pains; Advanced menstruation, very abundant and with strong abdominal pains; This is a spontaneous report from a contactable consumer or other non HCP (patient herself) received from database. A 44-years-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Lot Number-FE3065), via intramuscular route of administration in left arm on 08Jul2021 as dose 2, single (at the age of 44 years-old) for COVID-19 immunization. Patient medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing and uterine leiomyoma from 26Jan2021 to an unknown date and she underwent an operation to remove intramucosive fibroids from the uterus. The concomitant medication included methylphenidate hydrochloride (CONCERTA) (reported as 27 ml), bromazepam (LEXATIN [BROMAZEPAM] and lormetazepam (LORMETAZEPAM) taken for attention deficit hyperactivity disorder, start and stop date were not reported. Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number- FC5436) via an unspecified route of administration on 17Jun2021 as dose 1, single for COVID-19 immunization. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19, post vaccination. The patient experienced advanced menstruation, very abundant and with strong abdominal pains on an unspecified date, she had the menstruation 10 days earlier than usual on 26Aug2021 16:00, migraine on an unspecified date. Reporter stated that, she was given a second dose of on 08Jul2021. That day she was on the third of her period. No problem. The next menstruation was not without problems either. Yesterday she got the period 10 days earlier than usual, it should have been on 03Sep2021 or 04Sep2021. On 26Jan2021, the patient underwent an operation to remove intramucosive fibroids from the uterus, which caused very long and heavy periods. Since the operation she had normal menstruations and with habitual bleeding; however, since yesterday she had advanced menstruation, very abundant and with strong abdominal pains, in addition to migraine. The outcome of the events was not recovered.


VAERS ID: 1687397 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Feeling hot, Headache, Hyperhidrosis, Nausea, SARS-CoV-2 test, Syncope, Tinnitus
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117692

Write-up: nausea; ears ringing; dizzy; sweats; headache; hot/hot sweats; Fainting; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108261055351760-LUQWB. Safety Report Unique Identifier: GB-MHRA-ADR 25853100. A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 25Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included suspected COVID-19 from 05Apr2020 to 15Apr2020. The patient''s concomitant medications were not reported. Patient was not enrolled in clinical trial. On 26Aug2021, the patient experienced fainting. On an unspecified date, the patient experienced nausea, ears ringing, dizzy, sweats, headache and hot/hot sweats. The Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test (sars-cov-2 test): Negative on 26Aug2021 No - Negative COVID-19 test. The outcome of the event (fainting) was recovered on 26Aug2021; outcome of events (nausea, ears ringing, dizzy, sweats, headache and hot) was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


VAERS ID: 1687409 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MEFENAMIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Period pains
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117556

Write-up: Felt faint; Dizzy spells; 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-202108261225586760-JOG5T, Safety Report Unique Identifier GB-MHRA-ADR 25853580. A 17-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Aug2021 (Batch/Lot Number: FE8087) as dose 1, single for COVID-19 immunisation. Medical history included lactation decreased and period pains. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, and she was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medication included mefenamic acid taken for period pains, start and stop date were not reported. On 26Aug2021 the patient experienced felt faint and dizzy spells. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 26Aug2021. Felt faint was resolved with sequelae, dizzy spells were resolving. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1687441 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Functional neurological symptom disorder.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117807

Write-up: Seizures; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Authority (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202108261734189020-IXAX9, Safety Report Unique Identifier GB-MHRA-ADR 25855271. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 26Aug2021 (Batch/Lot Number: fe3380) as dose 1, single for COVID-19 immunisation.Medical history included functional neurological symptom disorder from an unknown date and unknown if ongoing. Concomitant medication included amitriptyline (AMITRIPTYLINE) taken for an unspecified indication, start and stop date were not reported.The patient experienced seizures on 26Aug2021. The patient had 8 seizures and ambulance was called as he had previous medical history of functional neurological disorder. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report does not relate to possible blood clots or low platelet counts. The outcome of seizure was recovered on 26Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687446 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Palpitations; Penicillin allergy.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117772

Write-up: Anaphylaxis; This is a spontaneous report from a contactable other hcp received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108261807138500-VPDDM, Safety Report Unique Identifier GB-MHRA-ADR 25855422. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), via an unspecified route of administration on 26Aug2021 (Batch/Lot Number: FE3380) as single dose for COVID-19 immunization. Medical history included palpitations, drug hypersensitivity; all from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took penicilline. 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. Patient did not have a COVID-19 test. Patient stated she has heart problem. On 26Aug2021, the patient experienced anaphylaxis. She has had 3 other episodes of Anaphylaxis previously once after MRI investigations. The outcome of event was recovered on 26Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687447 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Chest pain
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (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: LYMECYCLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117571

Write-up: Chest pain; Heart fluttering; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number: GB-MHRA-WEBCOVID-202108261828048050-YQQCC, Safety Report Unique Identifier: GB-MHRA-ADR 25855665. A 16-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: FF3319), via an unspecified route of administration on 26Aug2021 (at the age of 16-years-old) at DOSE 1, SINGLE for COVID-19 immunisation. Medical history included acne. Unsure if patient has had symptoms associated with COVID-19 as patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication included lymecycline (LYMECYCLINE) taken for acne from 26May2021 to 23Aug2021. The patient experienced chest pain and heart fluttering on 26Aug2021. The events were considered serious: medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687448 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117578

Write-up: Very heavy and sudden start to period, which is very unusual for me, never happened before; Painful periods; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108261835459590-DUVGI. Safety Report Unique Identifier GB-MHRA-ADR 25855661. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: FE3380), dose 2 via an unspecified route of administration on 23Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that the patient experienced Painful periods on 26Aug2021 and very heavy and sudden start to period, which was very unusual for her, never happened before on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 26Aug2021 (No - Negative COVID-19 test). Outcome of the event painful periods was reported as recovering and outcome of the event very heavy and sudden start to period, which is very unusual for me, never happened before was reported as Unknown at this time of the report. No follow-up attempts are possible. No further information is expected. Case Narrative: Very heavy and sudden start to period, which is very unusual for me, never happened before.


VAERS ID: 1687449 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (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: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117661

Write-up: she could not see or hear felt dizzy; then she puther head on the table and was fainted for few seconds; She then said i cannot stand at the min; Vasovagal reaction; This is a spontaneous report from a contactable other healthcare professional received from the RA. The regulatory authority report number is GB-MHRA-WEBCOVID-202108261846068320-HM5RO. Safety Report Unique Identifier : GB-MHRA-ADR 25855716. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Fe8087), via an unspecified route of administration on 26Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On 26Aug2021, patient experienced vasovagal reaction. On an unknown date, she felt funny, she could not see or hear, felt dizzy and then she put her head on the table and was fainted for few seconds. She could not stand at the min and she transferred into a wheelchair with minimal help. Taken to a quiet area and observation were taken all where within normal limits given water and biscuit monitored for 15 mins and reassessed and able to leave. Given instructions if needed further medical advice or care. Patient was not enrolled in clinical trial. The case was assessed as serious (medically significant). Outcome of the events were resolved on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687451 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Diarrhoea, Dizziness, Fall, Head injury, Headache, Illness, Loss of consciousness, SARS-CoV-2 test, Syncope
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), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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 INC202101117583

Write-up: Fainting; headache; dizziness; Sickness; Shivering; Fall; Diarrhea; blacking out; Hurt my head; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is -MHRA-WEBCOVID-202108261911472600-ON5ST, Safety Report Unique Identifier -MHRA-ADR 25855933. A 22-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration on 25Aug2021 as dose 2, single for covid-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient did not have symptoms associated with COVID-19. Patient was not currently breastfeeding. Concomitant medications were not reported. The patient reported that, on 26Aug2021, she experienced headache with outcome of recovering, dizziness with outcome of recovering, fainting with outcome of recovering, sickness with outcome of recovering, shivering with outcome of recovered, fall with outcome of recovered, diarrhea with outcome of recovering, blacking out with outcome of unknown, hurt my head with outcome of unknown. All the events were reported as serious (medically significant). As per the additional details, it was reported that, the patient woke up in the morning with severe dizziness, went to the toilet and then woke up on the floor having fallen and fainted and blacking out. Consequently, it hurt the head and while being sick crawled to bed where the dizziness eased a little after 1 hour. Massive headache from falling and throughout the day. Shivering started at around midday followed by being sick 3 times. The patient underwent lab tests and procedures which included COVID-19 virus test (sars-cov-2 test) with negative result on an unspecified date (No - Negative COVID-19 test). Patient was not enrolled in clinical trial. The outcome for the events blacking out and hurt my head was unknown; outcome for the events shivering and fall was reported as recovered (fall recovered on same day, on 26Aug2021 and shivering recovered on unknown date in Aug2021) and outcome for the rest of the events was reported as recovering, at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687454 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117686

Write-up: Heart throbbing; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority report number is GB-MHRA-WEBCOVID-202108261946182160-QF9AL. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25856073. A 23-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on 20Aug2021 as dose 2, single for COVID-19 immunization. The patient''s medical history was not reported. Patient not had symptoms associated with COVID-19 and not had a COVID-19 test. The patients concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced heart throbbing on 26Aug2021. The adverse event was considered as serious with seriousness criteria. Patient not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient got pushed to take the vaccine by media pressure and threats that mean they can''t live. Patient had COVID in between doses so patient had natural immunity. The outcome of the event was reported as not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687456 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Hot flush, Hyperhidrosis, Myalgia, Nausea, Retching, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117690

Write-up: Sweating; Muscular pains and aches in both arms and legs; Tiredness; Nausea; Hot flushes; Light gagging; Tight feeling in the stomach; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108262001101730-XE9ZL. Safety Report Unique Identifier GB-MHRA-ADR 25856187. A 20-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 26Aug2021 (age at vaccination was 20 years) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No previous medical faults within the last 3 months or significant medical history. Patient did not had symptoms associated with COVID-19. The patient was not enrolled in clinical trial. On an unspecified date after receiving the vaccine the patient experienced dizziness, tiredness upon leaving the testing sight followed by nausea and light gagging. Returned home and felt muscular pains and aches in both arms and legs along with a tight feeling in the stomach, as well as hot flushes and sweating more than usual. The patient underwent lab tests and procedures which included COVID-19 virus test: Negative on an unspecified date. The events were medically significant. The outcome of the events light gagging, tight feeling in the stomach was unknown, hot flushes and muscular pains and aches in both arms and legs was recovering and other events were recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687460 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

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? 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 INC202101117828

Write-up: Fainting; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108262032380240-EWRJ6, Safety Report Unique Identifier GB-MHRA-ADR 25856381. A 16-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FF3319), via an un-specified route of administration on 26Aug2021 (at the age of 16-years-old) as dose 1, single for covid-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient was not pregnant. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19 and had not been tested for COVID-19. On 26Aug2021, the patient reported woke up from a nap, went to go to the bathroom but fainted on the way. The event was considered as medically significant. The outcome of event fainting was reported as recovering. No follow-up attempts were possible. No further information was expected.


VAERS ID: 1687463 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MEZAVANT XL.
Current Illness: Colitis ulcerative (only taken steroids for 2-3 months in 2019.)
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease; Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohna''s disease, ulcerative colitis)); Lactation decreased.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117779

Write-up: Dizzy spells; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108262045558280-DNPU9, Safety Report Unique Identifier GB-MHRA-ADR 25856451. A 32-year-old non-pregnant female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot Number: FE3380), via an unspecified route of administration on 26Aug2021 (at the age of 32-years-old) as dose 2, single for covid-19 immunisation. Medical history included lactation decreased, inflammatory bowel disease (taking medicines for inflammatory bowel disease (Crohnas disease, ulcerative colitis), crohnas disease, colitis ulcerative (only taken steroids for 2-3 months in 2019) from Sep2019 and ongoing. She had been taken steroids for 2-3 months in 2019, when the condition was discovered, but not since. She also takes vitamin D regularly. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Concomitant medication included mesalazine (MEZAVANT XL) for colitis ulcerative from 30Sep2019 to an unspecified stop date. The patient previously received Vitamin D and mesalazine. The patient experienced dizzy spells on 26Aug2021. The event considered as medically significant. The outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687464 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Lactation decreased.
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117760

Write-up: Pins and needles; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority (MHRA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108262108370140-PFPLH, Safety Report Unique Identifier GB-MHRA-ADR 25856597. A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE), Solution for injection, Lot number: not reported), dose 2 via an unspecified route of administration on 25Aug2021 as 2nd dose, single for COVID-19 immunization. Patient''s medical history included endometriosis, suppressed lactation, and ongoing immunodeficiency. The patient''s concomitant medications were not reported. Patient did not have symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient was not tested positive for COVID-19 since having the vaccine. T Patient is not enrolled in clinical trial. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported) via an unspecified route on an unknown date for covid-19 immunization. The patient experienced pins and needles on 26Aug2021. This was started with shooting pain in her shin, which then turns into pins and needles in her foot and now up her thighs and arms on the same side she had the jab. This event was considered as medically significant. The patient underwent lab tests and procedures which included negative COVID-19 virus test on 20Aug2021. The outcome of event was reported as not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1687466 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Cough, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (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: FLUOXETINE.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Lactation decreased; Suspected COVID-19 (Unsure when symptoms started.)
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117714

Write-up: Fever; Myalgia; Chills; Headache; Weakness; Cough; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108262125106960-JMYVO. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25856710. A 23-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 2 via an unspecified route of administration on 25Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included lactation decreased and depression from an unknown date and unknown if ongoing, ongoing suspected covid-19 Unsure when symptoms started. Concomitant medication(s) included fluoxetine (FLUOXETINE) taken for depression from Jun2021 to an unspecified stop date. The patient previously took bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Patient had not tested positive for COVID-19 since having the vaccine and patient was not enrolled in clinical trial. The patient experienced fever, myalgia, chills, headache, weakness and cough on 26Aug2021. All events were assessed as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 25Aug2021 No - Negative COVID-19 test. The outcome of event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687470 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Body temperature, Heart rate normal, 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: DESOGESTREL.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy; Suspected COVID-19 (Unsure when symptoms stopped.)
Allergies:
Diagnostic Lab Data: Test Name: Blood sugar; Result Unstructured Data: Test Result:normal; Test Name: Body temperature; Result Unstructured Data: Test Result:normal; Test Name: Pulse; Result Unstructured Data: Test Result:normal
CDC Split Type: GBPFIZER INC202101117555

Write-up: Fainting; This is a spontaneous report from a contactable consumer (patiemt parent). This is a report received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108262147149660-ACVWY, Safety Report Unique Identifier GB-MHRA-ADR 25856814. A 20-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included pregnancy, suspected COVID-19 from 05Apr2020 (unsure when symptoms stopped). Not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medications included desogestrel taken for oral contraception from 07Apr2021. The patient previously took gardasil and experienced syncope. The patient Fainted after her second gardasil vaccine and took a long time to come round. The patient experienced fainting on 26Aug2021. It was reported that patient fainted about 32 hours after the vaccine was given. No reason could be found for her to faint. She worked in a nursing home and her blood sugars, pulse and temperature were all normal. Patient has not tested positive for COVID-19 since having the vaccine. Adverse reaction did not occur as a result of an exposure during pregnancy. The event was resolved on 26Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.


VAERS ID: 1687487 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Insomnia, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101117849

Write-up: Headache; Arms has been aching; Cannot sleep; This is a spontaneous report from a contactable other hcp received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108270400339950-YNMRW, Safety Report Unique Identifier GB-MHRA-ADR 25857131. A 30-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 26Aug2021 11:00 (at the age of 30-years-old) as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included paracetamol taken for headache from 26Aug2021 to an unspecified stop date. Patient had not tested positive for COVID-19 since having the vaccine. Unsure if patient had symptoms associated with COVID-19 and not had a COVID-19 test. Historical vaccine included that patient received first dose of 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. Patient was not enrolled in clinical trial. On 26Aug2021, had his COVID vaccine at around 11am, his arms had been aching but could handle that but around 11pm he started having a strong headache, could not sleep or anything. Taken paracetamol but not helping. The report does not relate to possible blood clots or low platelet counts. The reporter considered events as serious (medically significant). The outcome of event headache was not recovered, and other events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687496 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness, Lymph node pain, 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: ASPRIN; PROCLORPERAZINA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Labyrinthitis; Pain
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118857

Write-up: flu type symptoms; Lymph node pain; This is a spontaneous report from a contactable consumer. This is the first of 2 reports. This is a report received from the RA). Regulatory authority report number: GB-MHRA-WEBCOVID-202108270822463230-BTMBQ; Safety Report Unique Identifier: GB-MHRA-ADR 25858253. A 33-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Aug2021 (Lot Number: EW3143) as single dose for covid-19 immunization. First dose was taken on an unknown date and had flu like symptoms. The patient medical history included pain and labyrinthitis. Concomitant medications included acetylsalicylic acid (ASPRIN) taken for pain management, start and stop date were not reported; proclorperazina taken for labyrinthitis, start and stop date were not reported. The patient experienced flu type symptoms on an unspecified date with outcome of unknown, lymph node pain on 26Aug2021 with outcome of not recovered. It was reported ''After each vaccination I''ve had flu type symptoms''. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial No follow-up attempts are needed. No further information is expected.


VAERS ID: 1687498 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (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: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101118878

Write-up: Injection site pain; Muscle ache; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108270825199880-2MHUJ. Safety Report Unique Identifier GB-MHRA-ADR 25858267 A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: FE3380), via an unspecified route of administration on 26Aug2021 as single dose for COVID-19 immunisation. Medical history included suspected covid-19 from 06Jul2021 to 09Jul2021. The patient''s concomitant medications were not reported. On 26Aug2021 the patient experienced injection site pain and muscle ache, both with outcome of recovering. The events were assessed serious as medically significant. The patient underwent sars-cov-2 test which resulted positive on 07Jul2021. It was also reported that patient was not enrolled in clinical trial and has not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687503 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrioventricular septal defect (She had a complete AVSD repair in 2008.); Constipation chronic; Down''s syndrome; Feeling down; Pericarditis; Pregnancy; Surgery (complications with peri carditis which needed a further admission and surgery to resolve.)
Allergies:
Diagnostic Lab Data: Test Date: 20210810; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118709

Write-up: diarrhea; vomiting; Bilious vomiting; This is a spontaneous report from a contactable consumer received from the The regulatory authority report number is GB-MHRA-WEBCOVID-202108270920271920-HLMUL, Safety Report Unique Identifier GB-MHRA-ADR 25858603. A 13-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: FF3319) via an unspecified route of administration on 26Aug2021 at the age of (13-years-old) as dose 1, single for covid-19 immunisation. Medical history included feeling down from an unknown date and unknown if ongoing , pregnancy from an unknown date and unknown if ongoing , constipation chronic from an unknown date and unknown if ongoing , down syndrome from an unknown date and unknown if ongoing , She had a complete AVSD repair in 2008 to an unknown date, pericarditis from an unknown date and unknown if ongoing , complications with peri carditis which needed a further admission and surgery to resolve from an unknown date and unknown if ongoing. Patient did not had symptoms associated with COVID-19 Concomitant medication(s) included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE]) taken for constipation from 01Jan2008 to an unspecified stop date. It was reported that vaccine at 6pm on 26Aug2021 by midnight the patient started experienced vomiting and diarrhoea. These was continued approximately every 40 minutes from midnight to 7am. Patient further reported that she was typing these at 09.25am and she did not vomit for 2 hours. Each time she was vomiting and experienced severe diarrhoea that was uncontrollable on an unspecified date. Patient did not test positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. On 10Aug2021 the patient underwent lab tests and procedures which included covid-19 virus test negative (No - Negative COVID-19 test). The patient was recovered from the events of diarrhoea, vomiting on an unspecified date in 2021. The patient was recovering from the event bilious vomiting at the time of report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687506 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Ear pain, Headache, Lethargy, Malaise, Off label use, Product use issue, Vaccination site erythema
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118754

Write-up: Application site redness; Earache; Lethargy; Joint ache; Headache; Off label use; Drug use in unapproved population; feeling ill; This is a spontaneous report from a contactable consumer (patient). This is the first of 2 reports. The first report is a report received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108270935589400-L2FIS. Safety Report Unique Identifier is GB-MHRA-ADR 25858617. A 38-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on 25Aug2021 (Lot number was not reported) as single dose for COVID-19 immunization. Medical history included ongoing breast feeding. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. On an unspecified date in 2021, the patient felt ill, and was breastfeeding. On 26Aug2021, she experienced application site redness, earache, lethargy, joint ache, and headache. Patient reported she was feeling ill, as well as breastfeeding, and baby was unusually grumpy and clingy since the evening of vaccine administration. Outcome of event application site redness, earache, lethargy? joint ache and headache was not resolved and was unknown for rest of the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101126991 Baby case


VAERS ID: 1687509 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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; Test Result: Negative
CDC Split Type: GBPFIZER INC202101118841

Write-up: tired; chest pains; headache; Shortness of breath / Hard to breathe; Acute chest pain; Fever; sore arm; whole body aches; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108270950345900-7RIUC Safety Report Unique Identifier GB-MHRA-ADR 25858394. A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered via an unspecified route in left arm on 26Aug2021 (at the age of 24-year-old) (Lot number was not reported) as single dose for COVID-19 immunization. Medical history included suppressed lactation from an unknown date. It was unsure if the patient has had symptoms associated with COVID-19. The patient was not pregnant an was not currently breastfeeding. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. She was not enrolled in clinical trial. The patient reported that, on 26Aug2021, after the vaccine, she had a sore arm that moved up to her neck by the evening. She had a headache and whole body aches and had a fever in the night. Just before bed when she was lying down she had sharp pains in her chest around about between her left peck and her sternum (she had the vaccine in her left arm). She found it hard to breathe. In the morning she had the "after feelings" of a fever so "she was aches and tired". The chest pains were less regular now in the morning but she was still getting them and when she stands up or does something with a slight exertion, she finds it hard to breath. For example, she stepped out of the slow down a low step and she got chest pain again and she had to lean on the sink until she got her breath back. All the reported events were assessed as medically significant. On an unspecified date the patient underwent lab tests and procedures which included SARS-CoV-2 test: negative. Outcome of the events sore arm, whole body aches and tired was unknown at the time of the report, the events chest pains, headache and fever were resolving, whereas the events shortness of breath and acute chest pain had not resolved yet at the time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687514 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Anxiety; COVID-19; Depression; Liver disorder; Lung scarring (from Covid 19 from February/ March 2021)
Allergies:
Diagnostic Lab Data: Test Name: temp; Result Unstructured Data: Test Result:38.5c; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118833

Write-up: Vomiting; High temperature; This is a spontaneous report from a contactable consumer (Parent). This is the first of two reports. The first report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108271038504460-TNLHJ Safety Report Unique Identifier GB-MHRA-ADR 25858749. A 22-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 26Aug2021 (at the age of 22 year old) as DOSE 2, SINGLE for COVID-19 immunisation, Historical Vaccine was Added For first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported) and experienced Scarring and Chest pain - cardiac. Medical history included depression, scarring in his lung from Covid 19 from February/ March 2021, anxiety and liver disorder. The patient''s concomitant medications were not reported. On 26Aug2021 the patient experienced vomiting and high temperature with outcome of not recovered. The events were assessed as medically significant. The patient underwent lab tests and procedures which included body temperature: 38.5c on an unspecified date , sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. It was also reported that patient has not tested positive for COVID-19 since having the vaccine and 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: 1687524 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diarrhoea, Dizziness, Headache, Illness, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), 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: Test Name: high temperature; Result Unstructured Data: Test Result:High; Comments: High temperature
CDC Split Type: GBPFIZER INC202101118659

Write-up: body aches; sickness; high temperature; dizziness; Headaches; Diarrhea; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108271158384160-JFYME, Safety Report Unique Identifier GB-MHRA-ADR 25859015. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Aug2021, as Dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. 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. On 26Aug2021, the patient experienced diarrhoea. On an unspecified date, the patient experienced body aches, sickness, very high temperature, dizziness, and headache. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included body temperature: high. The outcome of the events body aches, sickness, very high temperature, dizziness and headache was unknown, Outcome of the event diarrhoea was not recovered. No follow-up at tempts are possible, information about Lot/Batch number cannot be obtained. No further information is expected.


VAERS ID: 1687542 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Headache, Pyrexia, SARS-CoV-2 test
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), 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: 08/10/2021; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101118565

Write-up: This is a spontaneous report from a contactable consumer or other non healthcare professional, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202108271447273400-UWVPR; safety report unique identifier: GB-MHRA-ADR 25859873). A 25-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), at the age of 25, via an unspecified route of administration, on Aug 26, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Patient did not have symptoms associated with COVID-19. On Aug 26, 2021, patient experienced fever, headache and chest pain. All the events reported serious (medically significant). The patient underwent lab tests and procedures, which included COVID-19 virus test (SARS-CoV-2 test) with negative result on Aug 10, 2021: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since the vaccination. Patient not enrolled in a clinical trial. The outcome of the fever reported recovered on Aug 27, 2021. The outcome for headache and chest pain reported not recovered, at the time of report. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1687561 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Maternal exposure during pregnancy, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: 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 INC202101118728

Write-up: Vomiting; Shivers; Maternal exposure during pregnancy/Patient was exposed to the medicine first-trimester (1-12 weeks); This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108271631003880-B8B3U, Safety Report Unique Identifier GB-MHRA-ADR 25860675. A 26-year-old pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration, on 26Aug2021 (at the age of 26-year-old), as dose 2, single for COVID-19 immunization. Patient was pregnant at the time of vaccination. Medical history included lactation decreased and ongoing pregnancy. The patient''s concomitant medications were not reported. The patient previously took folic acid. Patient did not take folic acid supplement during pregnancy. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 26Aug2021, the patient experienced maternal exposure during pregnancy/patient was exposed to the medicine first-trimester (1-12 weeks). Patient also experienced vomiting and shivers on 26Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on unspecified date. Outcome of the events vomiting, and shivers was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687565 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Heart rate decreased, Hypotension, Palpitations, SARS-CoV-2 test, Tinnitus
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Vestibular disorders (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:Low; Test Name: heart rate; Result Unstructured Data: Test Result:50bpm; Comments: very low for me, it''s usually around 70bpm.; Test Date: 20210623; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101118563

Write-up: lightheaded; heart rate; dizzy; Palpitations; Dizziness; Slow pulse; Low BP; Ear ringing; 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-202108271701453910-AEA6L, Safety Report Unique Identifier GB-MHRA-ADR 25860826. A 35-years-old non-pregnant female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Aug2021 as Dose 1, Single for covid-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing, suspected covid-19 from 22Jun2021 to 06Jul2021. The patient concomitant medications were not reported. The patient was not currently breastfeeding. On an unspecified date, the patient experienced lightheaded, heart rate, dizzy. On 26Aug2021, the patient experienced ear ringing. On 27Aug2021, the patient experienced palpitations, dizziness, slow pulse, low bp. The patient has not tested positive for COVID-19 since having the vaccine. The patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included blood pressure measurement: low, heart rate: 50bpm on very low for me, it''s usually around 70bpm, sars-cov-2 test: positive on 23Jun2021 Yes - Positive COVID-19 test. The outcome of the events lightheaded, heart rate, dizzy was recovering while the outcome of the remaining all events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1687567 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; 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 INC202101118626

Write-up: headache; unwell; Sickness; This is a spontaneous report from a contactable consumer. This report is received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108271741245550-HDSFI. Safety Report Unique Identifier GB-MHRA-ADR 25860951. A 16-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number and Expiration date: not provided) via an unspecified route of administration on 26Aug2021 (age at vaccination 16-year-old) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not tested positive for Covid-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. On 26Aug2021, the patient experienced sickness. On an unspecified date, the patient experienced headache and unwell. The patient underwent lab tests and procedures which included SARS-CoV-2 test: no -negative Covid-19 test on 24Aug2021. Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of event illness was not resolved. The outcome of events headache and unwell was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687570 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? 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 INC202101119000

Write-up: Chest pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from the Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108271815301710-H6US8 and Safety Report Unique Identifier GB-MHRA-ADR 25861158. A 28-year-old non pregnant female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration on 25Aug2021, as a single dose for COVID-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. The patient did not have a COVID-19 test. The patient was not currently breastfeeding. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number was unknown), via unknown route on an unknown date, as a single dose for covid-19 immunization. On 26Aug2021, the patient experienced chest pain. The outcome event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1687575 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Breast pain, Breast swelling, SARS-CoV-2 test
SMQs:, Angioedema (broad), Lipodystrophy (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: COVID-19 (Recently had Covid (over 28 days ago)); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101118748

Write-up: Sore and swollen armpit/breast; Armpit pain; Breast pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108271851382770-OEZQO, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25861313. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: FE3380), dose 1 via an unspecified route of administration on 25Aug2021 as dose 1, single for covid-19 immunisation. Medical history included suspected covid-19 from 20Jul2021 to an unknown date. Unsure when symptoms stopped, covid-19, Recently had Covid (over 28 days ago). Had a drug in hospital that lowers immune system. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced armpit pain on 26Aug2021, breast pain on 26Aug2021, sore and swollen armpit/breast on an unspecified date. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on an unspecified date. The outcome of the event sore and swollen armpit/breast was reported as unknown and outcome of all the other events was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687582 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Decreased appetite, Pain in extremity, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118925

Write-up: Sore ache in opposite arm from second vaccine; Loss of appetite; Slight sharp pain in right side of chest; Vomiting; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108272032126050-PJEKW, Safety Report Unique Identifier GB-MHRA-ADR 25861934. A 25-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Aug2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included pain . Concomitant medication(s) included paracetamol (coated al 90%) taken for pain from 25Aug2021 to an unspecified stop date. The patient experienced vomiting (medically significant) on 26Aug2021 with outcome of recovered with sequelae , sore ache in opposite arm from second vaccine ) on an unspecified date with outcome of unknown , loss of appetite (medically significant) on an unspecified date with outcome of unknown , slight sharp pain in right side of chest (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date No - Negative COVID-19 test.The clinical course was :Sore ache in opposite arm from second vaccine. Loss of appetite. Vomiting. Slight sharp pain in right side of chest. Additional information:The patient has not had symptoms associated with COVID-19.Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687584 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
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), 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; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118803

Write-up: muscle pain; headache; shivering; Fever; This is a spontaneous report from a contactable consumer (patient) or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108272055583700-2Q0RR,Safety Report Unique Identifier(GB-MHRA-ADR 25862023. A 17-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on 26Aug2021 (at the age of 17-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing. Unsure if patient has had symptoms associated with COVID-19 Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. On 26Aug2021, patient experienced fever. On an unspecified date the patient experienced muscle pain, headache, shivering. events reported as medically significant. it was reported that a few hours after getting her first dose she got a really bad fever and muscle pain and headache and could not stop shivering even after like 3 blankets and a thick dressing gown on. her boyfriend and she have both tested negative multiple times on the lateral flow tests but she feel awful and not been this ill ever. she could barely get any sleep as she felt so bad and still do but hoping this will go away soon. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No - Negative COVID-19 test) on an unspecified date. The outcome of event fever was not recovered and outcome of events muscle pain, headache, shivering were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


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