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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 412 out of 8,010

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VAERS ID: 1776473 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-04-01
Onset:2021-08-24
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 022M20A / 1 - / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006B21A / 2 - / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diabetes
Allergies:
Diagnostic Lab Data: SARS CoV 2 Antigen Positive on 8/29/2021
CDC Split Type:

Write-up: Breakthrough case after Covid vaccination. Dose #1 2/25/2021 Dose #2 04/01/2021. Asymptomatic.


VAERS ID: 1776493 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-03-19
Onset:2021-08-24
   Days after vaccination:158
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH E76201 / 1 - / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6198 / 2 - / IM

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Cough, Rhinorrhoea, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Anaphylactic reaction (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: HTN, Cholesterol
Allergies:
Diagnostic Lab Data: SARS CoV 2 Antigen Positive 9/1/2021
CDC Split Type:

Write-up: Breakthrough case after Covid vaccination. Dose #1 2/26/2021 Dose #2 3/19/2021. C/O runny nose and cough. Onset 8/24/2021


VAERS ID: 1776708 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-03-05
Onset:2021-08-24
   Days after vaccination:172
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / -

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Diarrhoea, Nausea, SARS-CoV-2 test positive, Vaccine breakthrough infection, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None Reported
Allergies:
Diagnostic Lab Data: COVID Antigen Positive on 8/25/2021
CDC Split Type:

Write-up: Breakthrough case after Covid vaccination. Dose #1 2/1/2021 Dose #2 3/5/2021. C/O nausea/vomiting and diarrhea onset 8/24/2021


VAERS ID: 1777063 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 045B21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pain, Ultrasound scan
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: blood pressure med, statin and xeralto
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Sonagram on 10/8/21 and waiting for results.
CDC Split Type:

Write-up: Within 24 hours I developed soreness in the left pectoral just under the nipple on the same side as the shot. Four weeks after the first shot I took the second in the right arm because I didn''t want to make the discomfort in the left pectoral worse. I visited my doctor on week five and he discussed with me that it is likely a side effect of the first shot. There is no mobility range of motion issues. It doesn''t impact my day unless I apply pressure to the site and pain is felt. The second shot did not have any impact. Discussed with my doctor on 10/4/21 about it persisting. Some days almost gone and then comes back. Doctor suggested a sonagram and that was completed on 10/8/21 and are awaiting results.


VAERS ID: 1782332 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / N/A RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none reported
Current Illness: none reported
Preexisting Conditions: none reported
Allergies: Dilantin: hives
Diagnostic Lab Data: none reported
CDC Split Type: ABlazis08242021

Write-up: Client received 2 doses of Moderna at a different facility and then presented as a first dose at the health department in order to receive $100 gift card incentive (per her statement: "I needed the money.". Moderna dose #1: 05-10-2021; Lot # 033B21A; RIGHT deltoid at Moderna dose #2: 06/07/2021; Lot # 033B21A; LEFT deltoid at Pfizer dose: 08/24/2021: Lot EW0172; RIGHT deltoid at


VAERS ID: 1782354 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN J&J / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Chest X-ray normal, Chest discomfort, Chest pain, Chills, Computerised tomogram, Dyspnoea, Fatigue, Hyperpyrexia, Lung disorder, Nausea, Pain, Pleurisy
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec, Vitamin D, Zinc, Pre-natal vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Chest x-ray- 9/12/21 CT scan- 9/18/21 Blood work- 9/18/21 Results reviewed again by pulmonologist on 10/8/21
CDC Split Type:

Write-up: I got the shot on 8/23. Got a high fever that evening, chills, nauseous, body aches. My chest started hurting, shortness of breath, chest heaviness also. The other symptoms decreased after 24-48 hours but my lung issue continued. I thought it would go away but it continued. When I would exercise, it felt like stabbing pains. I had a race coming up and felt concerned so I went to Urgent Care on Sept 12th to get checked out. He verified I was not sick and nothing showed on my chest X-ray. On 9/18, I had my race and had horrible pains in my chest, stabbing pains in my upper back (which later found out was chest), and this worsened as the race continued. After the race, I went to the ER as the pain was immense. The ER doctor said this could be a reaction to the vaccine after doing a CT scan and blood testing. He said pleurisy but encouraged me to go to a pulmonologist if my symptoms continued once I got home. I went home and my symptoms continued so I went to Doctor on 10/8/21. After him reviewing my symptoms, prior tests, history, he said I had I had mitosis and also called it diaphragm fatigue. Said this was my body''s reaction to the J&J vaccine. He said it would go away with time. He lectured me on getting the J&J but when I asked if this could happen with other two vaccine, he said it could....


VAERS ID: 1784812 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-04-04
Onset:2021-08-24
   Days after vaccination:142
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain lower, COVID-19, Lethargy, Malaise, Pain
SMQs:, Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: 51 year old male with no significant PMH who presents with RLQ abdominal pain for the past week. He reports that pain began last Tuesday but that he thought it was due to a Covid infection which he had at the time. When his Covid symptoms of malaise and lethargy subsided, his RLQ pain persisted which is why he presented for evaluation. Pain is described as sharp, moderate-severe, worsening, non-radiating, and not exacerbated or alleviated by any known factors.


VAERS ID: 1785188 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / IM

Administered by: Work       Purchased by: ?
Symptoms: Immunisation, Underdose
SMQs:, Medication errors (broad)

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

Write-up: Pt received Janssen dose 0.05ml instead of 0.5ml. Pt did get re-vaccinated with appropriate dose of Janseen 0,5ml on 9/8/2021.


VAERS ID: 1785192 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: No adverse event, Underdose
SMQs:, Medication errors (broad)

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

Write-up: Patient received Janssen dose 0.05ml instead of the 0.5ml recommended dose. The pt was re-vaccinated with the appropriate Janssen 0.5ml dose on 9/8/2021. No adverse events.


VAERS ID: 1786570 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Alaska  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chills, Hyperhidrosis, Hypoaesthesia, Lip swelling, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Autoimmune- scleroderma
Allergies: Nuts and fruit
Diagnostic Lab Data:
CDC Split Type:

Write-up: I received my shot around 6pm, by morning I had awoken to sweats, chills by mid day. By 8 pm I had itchy skin. The following morning 8am I had hives and a swollen lip, facial numbness and covered in hives. Hives progressively got worse as the day ended. I did seek medical care and took allergy meds during they day. Then went to the emergency room for treatment. I still have hives everyday.


VAERS ID: 1634985 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER 77743 / 1 LA / ID

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Dyspnoea, Loss of consciousness, Pharyngeal swelling, Swollen tongue
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Allergies
Preexisting Conditions: Allergies
Allergies: Pollen; Moisture; Mites; All pollen derivatives
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swollen tongue and throat, obstruction when breathing, feeling anxious, loss of consciousness. Saturation 76.


VAERS ID: 1635568 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / IM

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

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

Write-up: General aches Fever Malaise


VAERS ID: 1637399 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-08-24
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cardiomegaly, Chest X-ray abnormal, Chest pain, Computerised tomogram thorax abnormal, Dyspnoea, Electrocardiogram normal, Pericarditis, SARS-CoV-2 test negative, Ultrasound scan abnormal, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: All 08/26/2021: PCR negative, X-ray Torax: large heart, blood test: leukocytes high, Electrocardiogram: normal, CT Torax: acute pericarditis, Echography heart: pericarditis mild.
CDC Split Type:

Write-up: chest pain and difficulty respiration.


VAERS ID: 1638060 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7222 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Insomnia
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: duloxetin lexapro
Current Illness:
Preexisting Conditions:
Allergies: amoxicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Insomnia


VAERS ID: 1653456 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE426 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient had no similar adverse event reported in the facility in the past 30 days.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAJNJFOC20210854719

Write-up: BLACK OUT; This spontaneous report received from a health care professional concerned a 22 year old female with an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Patient had no similar adverse event reported in the facility in the past 30 days. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE426, and expiry: 31-MAY-2023) dose was not reported, 1 total, administered on 24-AUG-2021 12:40 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced black out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from black out on AUG-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210854719 -covid-19 vaccine ad26.cov2.s- black out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1657495 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JOPFIZER INC202101103231

Write-up: Pain on the left side of the heart; This is a spontaneous report from a contactable consumer (patient). A 26-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 22Aug2021 09:15 (Batch/Lot Number: Unknown) (at the age of 26-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pain on the left side of the heart on 24Aug2021 09:15 with outcome of not recovered. There was no treatment received. The event was reported as serious due to life threatening. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up attempts have been completed and no further information is expected.


VAERS ID: 1657930 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose abnormal, Blood pressure measurement, Coma scale, Headache, Heart rate, Oxygen saturation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: no similar Adverse event following immunization reported in the facility in past 30 days, no past medical history, previous, similar reactions or other allergies.
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Blood pressure; Result Unstructured Data: 108/63 mm/h; Test Date: 20210824; Test Name: Pulse rate; Result Unstructured Data: 70 {beats}/min; Test Date: 20210824; Test Name: Glasgow coma scale; Result Unstructured Data: Not reported; Comments: at 13:08; Test Date: 20210824; Test Name: Blood glucose abnormal; Result Unstructured Data: 5.8 mmol; Test Date: 20210824; Test Name: Oxygen saturation; Result Unstructured Data: 99 %; Comments: In room
CDC Split Type: ZAJNJFOC20210855692

Write-up: COLLAPSED SOON AFTER VACCINE ADMINISTRATION; MILD HEADACHE; This spontaneous report received from a health care professional via Regulatory authority concerned a 19 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: no similar Adverse event following immunization reported in the facility in past 30 days, no past medical history, previous, similar reactions or other allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: XE426 expiry: MAY-2022) dose was not reported, one total administered on 24-AUG-2021 13:03 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced collapsed soon after vaccine administration and mild headache. Laboratory data included: Blood glucose abnormal (NR: not provided) 5.8 mmol, Blood pressure (NR: not provided) 108/63 mm/h, Glasgow coma scale (NR: not provided) Not reported, Oxygen saturation (NR: not provided) 99 %, and Pulse rate (NR: not provided) 70 {beats}/min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from collapsed soon after vaccine administration, and mild headache on AUG-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210855692 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- collapsed soon after vaccine administration- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1660407 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Hyperhidrosis, Myalgia, SARS-CoV-2 test, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210314; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101111584

Write-up: vomiting; sweating; muscle pain; Diarrhoea; Fainting; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number: GB-MHRA-WEBCOVID-202108251729071660-BV455, safety report unique identifier: GB-MHRA-ADR 25848914. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Aug2021 (Lot Number: Ff3319) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: No-Negative COVID-19 test on 14Mar2021. The patient experienced vomiting, sweating, severe muscle pain, and diarrhoea on an unspecified date. The patient also experienced fainting on 24Aug2021. The events were considered serious: hospitalization (date/s unspecified), disability, medically significant, and life threatening. Patient has not tested positive for COVID-19 since having the vaccine. No relevant investigations or tests conducted. Fainting recovered on 24Aug2021. The outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1661939 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhage, Heavy menstrual bleeding, Menstruation irregular, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility 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: DESOGESTREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: bleeding; heavy period; Irregular periods; This case was received via a regulatory authority on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and Lactation decreased. Concomitant products included DESOGESTREL for an unknown indication. On 23-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) at an unspecified dose. On 24-Aug-2021, the patient experienced MENSTRUATION IRREGULAR (Irregular periods). On an unknown date, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant) and HEAVY MENSTRUAL BLEEDING (heavy period). At the time of the report, HAEMORRHAGE (bleeding) and HEAVY MENSTRUAL BLEEDING (heavy period) was resolving and MENSTRUATION IRREGULAR (Irregular periods) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medications were not reported. Despite being on Desogestrel and rarely experiencing periods, after the first Moderna dose I patient experienced a sudden, heavy period. Similarly, patient had her second vaccination yesterday and have started bleeding. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1664421 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Influenza like illness, 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: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMHRAWEBCOVID20210824212

Write-up: sore arm; chills; headache; Flu like symptoms; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25843550) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (chills) and HEADACHE (headache) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 23-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 24-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (chills) and HEADACHE (headache) outcome was unknown and INFLUENZA LIKE ILLNESS (Flu like symptoms) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications was not reported . Treatment history was not reported . Patient had 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.; 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: 1665038 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 FE4721 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Fibromyalgia, Gait inability, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTILIN.
Current Illness: Asthma; Fibromyalgia.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101098424

Write-up: I had an unprecedented Fibromyalgia crisis. I couldn''t walk or even move my legs much, fainted from the pain.; I had an unprecedented Fibromyalgia crisis. I couldn''t walk or even move my legs much, fainted from the pain.; I had an unprecedented Fibromyalgia crisis. I couldn''t walk or even move my legs much, fainted from the pain.; This is a spontaneous report from a contactable consumer, the patient himself. A 25-years-old female patient received second dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: FE4721), via intramuscular route, administered in Left arm on 23Aug2021 at 09:45 as dose 2, single (at the age of 25 years) for covid-19 immunization. Medical history included ongoing asthma and fibromyalgia. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amitriptyline (AMITRIPTILIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: FF0688) via intramuscular, administered in left arm on 25Jul2021 14:00 as dose 1, single (at the age of 25 years), for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient reported that, on 24Aug2021 at 08:00, she had an unprecedented fibromyalgia crisis, she could not walk or even move her legs much and she fainted from the pain. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included multiple unspecified intramuscular pain relief medications. At the time of the report, the outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1668313 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210701; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: High temperature; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 25839999) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature) in a 24-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. On 24-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 24-Aug-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). At the time of the report, PYREXIA (High temperature) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Patient experiencing high temperature roughly 6-10 hours after vaccine was administered 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. Very limited information regarding this event has been provided at this time. No further information is expected at this time. Regulatory Authority thinks the event in this RA case is non-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 event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time. Regulatory Authority thinks the event in this RA case is non-serious


VAERS ID: 1668326 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Chills, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: shivers; Fever; Aching in limb; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25840000) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivers), PYREXIA (Fever) and PAIN IN EXTREMITY (Aching in limb) in a 34-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Pregnancy (Pregnancy). On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Aching in limb) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivers) (seriousness criterion medically significant). At the time of the report, CHILLS (shivers) outcome was unknown and PYREXIA (Fever) and PAIN IN EXTREMITY (Aching in limb) 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. The night of the vaccine after going to bed, patient awoke with uncontrollable shivers and feeling of cold, this continued throughout the night with spells of extreme warmness. The arm which patient received the vaccine was exceptionally sore to even touch. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1668336 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity, SARS-CoV-2 test
SMQs:, 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:
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.MOD20212

Write-up: Painful arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25841069) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) 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 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion disability). At the time of the report, PAIN IN EXTREMITY (Painful arm) had not resolved. 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. Concomitant medications was not provided by the reporter. Treatment information was not provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected. Of note, the event was 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, the event is not 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 event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected. Of note, the event was 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, the event is not considered serious.


VAERS ID: 1668340 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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: Diarrhoea, Feeling abnormal, Malaise, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORATADIN; PARACETAMOL; SERTRALINE
Current Illness: Anxiety; Hay fever; Headache
Preexisting Conditions: Medical History/Concurrent Conditions: Suppressed lactation; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fainting; Foggy feeling in head; Diarrhea; Feeling sick; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 25841162) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), FEELING ABNORMAL (Foggy feeling in head), DIARRHOEA (Diarrhea) and MALAISE (Feeling sick) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suppressed lactation and Suspected COVID-19 (Unsure when symptoms stopped) on 07-Mar-2020. Concurrent medical conditions included Hay fever, Headache and Anxiety. Concomitant products included SERTRALINE from 10-Jan-2019 to an unknown date for Anxiety, LORATADINE (LORATADIN) from 01-Jan-2016 to an unknown date for Hay fever, PARACETAMOL from 23-Aug-2021 to an unknown date for Headache. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), FEELING ABNORMAL (Foggy feeling in head) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant) and MALAISE (Feeling sick) (seriousness criterion medically significant). On 24-Aug-2021, DIARRHOEA (Diarrhea) and MALAISE (Feeling sick) had resolved. At the time of the report, SYNCOPE (Fainting) was resolving and FEELING ABNORMAL (Foggy feeling in head) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication were not reported. Patient reported that Fainted during the night 16 hours after injection. Went in and out of consciousness for several minutes and felt very poorly 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: 1668348 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Asthma, Migraine, Myalgia, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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: SYMBICORT; TERBUTALINE SULFATE
Current Illness: Asthma; Migraine
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210819; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Arm aches; Body ache; Migraine; Swollen arm; Asthma; This case was received via RA (Reference number: GB-MHRA-ADR 25843183) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), PERIPHERAL SWELLING (Swollen arm), ASTHMA (Asthma), PAIN IN EXTREMITY (Arm aches) and MYALGIA (Body ache) in a 32-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. Concurrent medical conditions included Migraine and Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and TERBUTALINE SULFATE for Asthma. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and ASTHMA (Asthma) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm aches) (seriousness criterion medically significant) and MYALGIA (Body ache) (seriousness criterion medically significant). At the time of the report, MIGRAINE (Migraine), PERIPHERAL SWELLING (Swollen arm) and ASTHMA (Asthma) had not resolved and PAIN IN EXTREMITY (Arm aches) and MYALGIA (Body ache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, 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 information was not provided. The patient did not had a symptoms associated with COVID-19. The patient was not pregnant and was not currently breastfeeding. 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: 1668349 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-24
   Days after vaccination:2
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: Erythema, Feeling hot, Peripheral swelling, SARS-CoV-2 test, Swelling, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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: 20201018; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: COVID-19 test Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Swelling; very hot to touch; tender; Swelling arm; Redness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25843165) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), ERYTHEMA (Redness) and SWELLING (Swelling) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and Lactation decreased. On 22-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant) and ERYTHEMA (Redness) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant), FEELING HOT (very hot to touch) and TENDERNESS (tender). At the time of the report, PERIPHERAL SWELLING (Swelling arm) and ERYTHEMA (Redness) had not resolved and SWELLING (Swelling), FEELING HOT (very hot to touch) and TENDERNESS (tender) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2020, SARS-CoV-2 test: positive (Positive) COVID-19 test Positive. 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. It was reported that the patient had swelling and redness of the arm. Redness was lower to the injection site and was very hot to touch and tender. Also, redness was spreading. It was reported that patient had no symptoms associated with COVID-19 and was not enrolled in any clinical trials. Post vaccination patient not tested positive for COVID-19. Also, patient was not enrolled in any clinical trials. 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: 1668366 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Axillary mass, Body temperature, Mass, Neck mass, Odynophagia, Pyrexia, SARS-CoV-2 test, Sensitive skin, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Fibromyalgia; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test; Test Date: 20210824; Test Name: body temperature; Result Unstructured Data: 40.3
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: shoulders; Very sensative to touch my skin; Lumps on collarbones,neck; Lumps on armpits; Lumps on ribs; Fever; Swelling; Swallowing painful; Joint pain; This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulders), PYREXIA (Fever), SWELLING (Swelling), ODYNOPHAGIA (Swallowing painful) and ARTHRALGIA (Joint pain) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and Fibromyalgia. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), SWELLING (Swelling) (seriousness criterion medically significant), ODYNOPHAGIA (Swallowing painful) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (shoulders) (seriousness criterion medically significant), SENSITIVE SKIN (Very sensative to touch my skin), NECK MASS (Lumps on collarbones,neck), AXILLARY MASS (Lumps on armpits) and MASS (Lumps on ribs). At the time of the report, ARTHRALGIA (shoulders), SENSITIVE SKIN (Very sensative to touch my skin), NECK MASS (Lumps on collarbones,neck), AXILLARY MASS (Lumps on armpits) and MASS (Lumps on ribs) outcome was unknown and PYREXIA (Fever), SWELLING (Swelling), ODYNOPHAGIA (Swallowing painful) and ARTHRALGIA (Joint pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Body temperature: 40.3 40.3. On 24-Aug-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 is not enrolled in clinical trial. No concomitant medications were provided. Treatment medications was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. 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: 1668382 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Influenza like illness, Insomnia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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: Flu like symptoms; Difficulty sleeping; Light-headed; Dizziness; Short of breath; This case was received via RA (Reference number: GB-MHRA-ADR 25853534) 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 INFLUENZA LIKE ILLNESS (Flu like symptoms), DYSPNOEA (Short of breath), INSOMNIA (Difficulty sleeping), DIZZINESS (Light-headed) and DIZZINESS (Dizziness) in a 20-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced DYSPNOEA (Short of breath) (seriousness criterion medically significant), DIZZINESS (Light-headed) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 25-Aug-2021, the patient experienced INSOMNIA (Difficulty sleeping) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), DYSPNOEA (Short of breath) and INSOMNIA (Difficulty sleeping) had not resolved and DIZZINESS (Light-headed) and DIZZINESS (Dizziness) was resolving. 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) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by 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. 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: 1668387 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004222 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Decreased appetite, Dry mouth, Fatigue, Migraine, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FEXOFENADINE; FOSTAIR; SERTRALINE
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: Fever; Chills; Vomiting; Nausea; Fatigue; Aching joints; Migraine; Dry mouth; Appetite lost; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 25855211) 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 MIGRAINE (Migraine), DRY MOUTH (Dry mouth), DECREASED APPETITE (Appetite lost), VOMITING (Vomiting), NAUSEA (Nausea), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Fatigue) and ARTHRALGIA (Aching joints) in a 21-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3004222 and 3004222) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included FEXOFENADINE, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE (FOSTAIR) and SERTRALINE for an unknown indication. On 24-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 24-Aug-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), DRY MOUTH (Dry mouth) (seriousness criterion medically significant), DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and ARTHRALGIA (Aching joints) (seriousness criterion medically significant). On 25-Aug-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 26-Aug-2021, VOMITING (Vomiting) and CHILLS (Chills) had resolved. At the time of the report, MIGRAINE (Migraine) had not resolved and DRY MOUTH (Dry mouth), DECREASED APPETITE (Appetite lost), NAUSEA (Nausea), PYREXIA (Fever), FATIGUE (Fatigue) and ARTHRALGIA (Aching joints) was resolving. 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 had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial No treatment details was 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. 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: 1668405 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Chest pain, Chills, Delirium, Disturbance in attention, Fatigue, Gait inability, Pain, Pain in jaw, Palpitations, Pharyngeal swelling, Rash, SARS-CoV-2 test, Sensation of blood flow
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Osteonecrosis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101126214

Write-up: pulsating veins; palpitations; tiredness; chills; delirium; jaw pain; chest pains; swollen throat; Rash all over body; stabbing pains all over body; unable to walk; Heart racing; unable to focus; unsteady on feet; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108291858080810-ESTDZ and Safety Report Unique Identifier GB-MHRA-ADR 25865854. A 49-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Aug2021, at the age of 49 years, (Batch/Lot Number: FE3380) as dose 1, single for COVID-19 immunization. Medical history included lactation decreased and suspected covid-19 from 21Feb2020 to 29Feb2020. Patient is not pregnant; Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. On 24Aug2021, the patient had heart racing. On an unspecified date, the patient had pulsating veins, palpitations, tiredness, chills, delirium, jaw pain, chest pain, swollen throat, rash all over body, stabbing pains all over body, unable to walk, unable to focus and unsteady on feet. The clinical course was reported as follows: On receipt of vaccine had stabbing pains all over body, chills in body. After 4 hours - heart palpitations, chest pain, jaw pain, delirium, unable to walk, pulsating veins, unable to focus for 1 hour. After 24 hours - heart palpitations, chest pain, swollen throat, unable to walk, delirium, pulsating veins for at least 6 hours. Admitted to hospital. Since vaccine, Extreme tiredness, chest pains, heart racing intermittently, unsteady on feet for 5 days. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (life threatening, causing hospitalization and medically significant). The patient had COVID-19 Virus Test (Unknown date): No - Negative COVID-19 test. The outcome for the event heart racing was not recovered; outcome for pulsating veins, palpitations, tiredness, chills, delirium, jaw pain, chest pain, swollen throat, rash all over body, stabbing pains all over body and unable to walk was unknown; outcome for unable to focus (1 hr) and unsteady on feet (5 days) was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1668948 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Drug ineffective, Headache, Pyrexia, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:38.0 Centigrade; Comments: in the morning
CDC Split Type: JPPFIZER INC202101099693

Write-up: Drug ineffective; Coronavirus infection; pyrexia of 38.0 degrees Centigrade; headache; Arthralgia; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21124597. A 54 years old male patient received 2nd dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF3622, Expiration date 30Nov2021) at single dose on 23Aug2021 14:42 for COVID-19 immunisation. Medical history and concomitant drug were not provided. Body temperature before vaccination was 36.6 degrees Centigrade. On 24Aug2021 in the morning, the patient experienced pyrexia of 38.0 degrees Centigrade, headache and arthralgia. The patient had been in the PRIVACY location from 07Aug2021 to 15Aug2021. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. It was also reported that other possible cause of the event such as any other diseases was that Coronavirus infection. The outcome of the event was not recovered.


VAERS ID: 1669738 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
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: Dysmenorrhoea, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: pain; vomiting; Menses painful / menstrual cramping; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25848812) 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 PAIN (pain), VOMITING (vomiting) and DYSMENORRHOEA (Menses painful / menstrual cramping) in a 21-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 Postural hypotension, Lactation decreased and Fainting. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced DYSMENORRHOEA (Menses painful / menstrual cramping) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant) and VOMITING (vomiting) (seriousness criterion medically significant). At the time of the report, PAIN (pain) and VOMITING (vomiting) was resolving and DYSMENORRHOEA (Menses painful / menstrual cramping) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication information not provided. Treatment information not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1671640 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Migraine, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test, Salivary hypersecretion, Toothache
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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 Date: 20210823; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Salivation; Stomach ache; Painful arm; Toothache; Migraine headache; Nausea; Fever; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25846536) 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 ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Painful arm), TOOTHACHE (Toothache), SALIVARY HYPERSECRETION (Salivation), MIGRAINE (Migraine headache), NAUSEA (Nausea) and PYREXIA (Fever) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not Known) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), TOOTHACHE (Toothache) (seriousness criterion medically significant), MIGRAINE (Migraine headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 25-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant) and SALIVARY HYPERSECRETION (Salivation) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Painful arm), TOOTHACHE (Toothache), SALIVARY HYPERSECRETION (Salivation), MIGRAINE (Migraine headache), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. 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. Post vaccination patient not tested positive for COVID-19.Also patient was not enrolled in any clinical trials.It was reported that patient had no symptoms associated with COVID-19. Patient was not pregnant and was not breastfeeding at the time of reporting. 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 follow-up 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. No further follow-up information is expected at this time.


VAERS ID: 1671645 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-24
   Days after vaccination:4
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: Blister, Pemphigoid, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUOXETINE; PROGESTERONE
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 COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: blistering; Bullous pemphigoid; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25848005) 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 PEMPHIGOID (Bullous pemphigoid) and BLISTER (blistering) in a 24-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 FLUOXETINE from 01-Nov-2020 to an unknown date for Anxiety, PROGESTERONE from 20-Jun-2021 to an unknown date for Contraception. On 20-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PEMPHIGOID (Bullous pemphigoid). On an unknown date, the patient experienced BLISTER (blistering). At the time of the report, PEMPHIGOID (Bullous pemphigoid) had not resolved and BLISTER (blistering) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication included were non-specified tablets and cream for Blistering rash. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine.; 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. Event Pemphigoid was automatically upgraded as a Serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious.


VAERS ID: 1671646 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Discomfort, Hyperhidrosis, Pain, Pruritus, Pyrexia, SARS-CoV-2 test, Vaccination site pain, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE; FLUOXETINE; ZAPAIN
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.MOD20212

Write-up: agony; sweating; all over pain; discomfort; chills; Pain at the injection site; Fever; Ache/all over pain; Vomiting; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25849249) 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 PYREXIA (Fever), PAIN (Ache/all over pain), PAIN (agony), HYPERHIDROSIS (sweating), PRURITUS (all over pain), DISCOMFORT (discomfort), CHILLS (chills) and VOMITING (Vomiting) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concomitant products included AMITRIPTYLINE, FLUOXETINE and CODEINE PHOSPHATE, PARACETAMOL (ZAPAIN) for an unknown indication. On 23-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 24-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criteria disability and medically significant), PAIN (Ache/all over pain) (seriousness criteria disability and medically significant) and VOMITING (Vomiting) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced PAIN (agony) (seriousness criteria disability and medically significant), HYPERHIDROSIS (sweating) (seriousness criteria disability and medically significant), PRURITUS (all over pain) (seriousness criteria disability and medically significant), DISCOMFORT (discomfort) (seriousness criteria disability and medically significant), CHILLS (chills) (seriousness criteria disability and medically significant) and VACCINATION SITE PAIN (Pain at the injection site). On 24-Aug-2021, VOMITING (Vomiting) had resolved. At the time of the report, PYREXIA (Fever) and PAIN (Ache/all over pain) had not resolved, PAIN (agony), HYPERHIDROSIS (sweating), PRURITUS (all over pain), DISCOMFORT (discomfort) and CHILLS (chills) had resolved and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. 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. After suffering with only pain at the injection site after the first dose the patient did not expect to have such severe reactions this time round. After 12 hours patient was in agony, full body aches, fever, chills, sweating, vomiting and all over pain. Now 48hrs later and patient can just about get out of bed but still in lots of discomfort. Even pain relief doesn''t touch the pain and aches. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per overall case assessment by Authority. Very limited information regarding the event Vaccination site pain has been provided at this time. 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. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per overall case assessment by Authority. Very limited information regarding the event Vaccination site pain has been provided at this time. No further information is expected.


VAERS ID: 1671656 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOW / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Illness, Lymphadenopathy, Neck pain, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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.MOD20212

Write-up: Sickness; Swollen lymph nodes; Headache; Fatigue; Neck pain; Fainting; This case was received via The Regulatory Authority (Reference number: GB-MHRA-ADR 25852515) 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 SYNCOPE (Fainting), ILLNESS (Sickness), LYMPHADENOPATHY (Swollen lymph nodes), HEADACHE (Headache), FATIGUE (Fatigue) and NECK PAIN (Neck pain) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not know) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). On 25-Aug-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and NECK PAIN (Neck pain) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting) and ILLNESS (Sickness) had resolved and LYMPHADENOPATHY (Swollen lymph nodes), HEADACHE (Headache), FATIGUE (Fatigue) and NECK PAIN (Neck pain) had not resolved. 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. The Concomitant medications were not provided. The treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. 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: 1671658 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Chills, Night sweats, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: 20210824; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Night sweat; Fever; Chills; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 25852541) 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 NIGHT SWEATS (Night sweat), PYREXIA (Fever) and CHILLS (Chills) 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 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 25-Aug-2021, the patient experienced NIGHT SWEATS (Night sweat) (seriousness criterion medically significant). On 25-Aug-2021, PYREXIA (Fever) was resolving. At the time of the report, NIGHT SWEATS (Night sweat) was resolving and CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment details not provided. concomitant drug details not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. 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: 1671666 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Dehydration, Headache, Pyrexia, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: CERELLE; FLUOXETIN
Current Illness: Depression
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210824; 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: Dehydration; Hives; Headache; Slight temperature; This case was received via regulatory authority Reference number: GB-MHRA-ADR 25856222) 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 DEHYDRATION (Dehydration), URTICARIA (Hives), HEADACHE (Headache) and PYREXIA (Slight temperature) in a 29-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. Concurrent medical conditions included Depression. Concomitant products included DESOGESTREL (CERELLE) from 06-Aug-2013 to an unknown date for Contraception, FLUOXETINE HYDROCHLORIDE (FLUOXETIN) from 02-Jan-2017 to an unknown date for Depression. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced DEHYDRATION (Dehydration) (seriousness criterion medically significant), URTICARIA (Hives) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Slight temperature) (seriousness criterion medically significant). On 24-Aug-2021, URTICARIA (Hives) had resolved. At the time of the report, DEHYDRATION (Dehydration), HEADACHE (Headache) and PYREXIA (Slight temperature) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Medical history included Clinical trial participant. 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: 1671672 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Back pain, Fatigue, Headache, Hyperhidrosis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: fever; fatigue; Headache; Sweating; Fatigability; Backache; Feverish; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (fever), FATIGUE (fatigue), HEADACHE (Headache), HYPERHIDROSIS (Sweating), FATIGUE (Fatigability), BACK PAIN (Backache) and PYREXIA (Feverish) in a 30-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. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), FATIGUE (Fatigability) (seriousness criterion medically significant), BACK PAIN (Backache) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) (seriousness criterion medically significant), FATIGUE (fatigue) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 25-Aug-2021, HYPERHIDROSIS (Sweating), FATIGUE (Fatigability), BACK PAIN (Backache) and PYREXIA (Feverish) had resolved. At the time of the report, PYREXIA (fever) and FATIGUE (fatigue) was resolving and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medication was provided. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant. Patient is not currently breastfeeding. The reporter stated that 12-13 hours after vaccination the symptoms started. Fatigue followed by a very bad headache throughout the night. The next day the headache was worse with sweats/fever on and off throughout the day. Symptoms subsided that evening but the headache is still prevalent, but not as bad as the day after the vaccine. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. This case concerns a 30- year-old, female, who experienced the unexpected events of pyrexia (on an unknown date), fatigue (on an unknown date), headache, hyperhidrosis, fatigue (on 24-Aug-2021), back pain and pyrexia (on 24-Aug-2021). The events of hyperhidrosis, fatigue (on 24-Aug-2021), back pain and pyrexia (on 24-Aug-2021) occurred at the same day when the second dose of Moderna Covid-19 vaccine was administered. The onset dates for the events of pyrexia (on an unknown date), fatigue (on an unknown date), headache were not specified. The reporter''s assessment was not provided for the events. 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 benefit-risk relationship of Moderna Covid-19 vaccine in not affected by this report.; Sender''s Comments: This case concerns a 30- year-old, female, who experienced the unexpected events of pyrexia (on an unknown date), fatigue (on an unknown date), headache, hyperhidrosis, fatigue (on 24-Aug-2021), back pain and pyrexia (on 24-Aug-2021). The events of hyperhidrosis, fatigue (on 24-Aug-2021), back pain and pyrexia (on 24-Aug-2021) occurred at the same day when the second dose of Moderna Covid-19 vaccine was administered. The onset dates for the events of pyrexia (on an unknown date), fatigue (on an unknown date), headache were not specified. The reporter''s assessment was not provided for the events. 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 benefit-risk relationship of Moderna Covid-19 vaccine in not affected by this report.


VAERS ID: 1671673 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-24
   Days after vaccination:10
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: Chills, Decreased appetite, Headache, Nausea, SARS-CoV-2 test, Urinary tract infection, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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.MOD20212

Write-up: chills; headache; vertigo; recurrent vomiting; loss of appetite; Vomiting; Nausea; This case was received viaa regulatory authority (Reference number: GB-MHRA-ADR 25856806) 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 CHILLS (chills), HEADACHE (headache), VERTIGO (vertigo), URINARY TRACT INFECTION (recurrent vomiting), NAUSEA (Nausea), VOMITING (Vomiting) and DECREASED APPETITE (loss of appetite) in a 23-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 Lactation decreased. On 14-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 25-Aug-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant), VERTIGO (vertigo) (seriousness criterion medically significant), URINARY TRACT INFECTION (recurrent vomiting) (seriousness criterion medically significant) and DECREASED APPETITE (loss of appetite) (seriousness criterion medically significant). On 26-Aug-2021, VOMITING (Vomiting) had resolved. At the time of the report, CHILLS (chills), HEADACHE (headache), VERTIGO (vertigo) and URINARY TRACT INFECTION (recurrent vomiting) was resolving, NAUSEA (Nausea) had resolved with sequelae and DECREASED APPETITE (loss of appetite) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. 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 concomitant medications were provided. Treatment medications was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1671674 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Back pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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? 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: Suspected COVID-19 (Unsure when symptoms started)
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: Feverish; Backache; This case was received via Regulatory Agency (Reference number: GB-MHRA-ADR 25857091) 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 PYREXIA (Feverish) and BACK PAIN (Backache) in a 37-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 started) on 26-Aug-2021. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant) and BACK PAIN (Backache) (seriousness criterion medically significant). On 26-Aug-2021, PYREXIA (Feverish) and BACK PAIN (Backache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided. No treatment medication were provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1676221 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Decreased appetite, Dyspnoea, Fatigue, Illness, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: tiredness; out of breathe; Tired out; Appetite lost; Sickness; This case was received(Reference number: GB-MHRA-ADR 25862109) 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 FATIGUE (tiredness), FATIGUE (Tired out), DECREASED APPETITE (Appetite lost), ILLNESS (Sickness) and DYSPNOEA (out of breathe) in a 28-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. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced FATIGUE (Tired out) (seriousness criterion medically significant), DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant) and ILLNESS (Sickness) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (tiredness) (seriousness criterion medically significant) and DYSPNOEA (out of breathe) (seriousness criterion medically significant). At the time of the report, FATIGUE (tiredness), FATIGUE (Tired out) and DECREASED APPETITE (Appetite lost) had not resolved, ILLNESS (Sickness) was resolving and DYSPNOEA (out of breathe) 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. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by 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.; 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: 1676496 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Abdominal pain, Fatigue, Gastrointestinal pain, Pain, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: pain; Vomiting; Gut pain; Pain in arm; Abdominal pain; Tiredness; Gastrointestinal pain; This case was received via RA (Reference number: GB-MHRA-ADR 25855041) 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 ABDOMINAL PAIN (Abdominal pain), FATIGUE (Tiredness), GASTROINTESTINAL PAIN (Gastrointestinal pain), VOMITING (Vomiting), GASTROINTESTINAL PAIN (Gut pain), PAIN IN EXTREMITY (Pain in arm) and PAIN (pain) in a 22-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. Concomitant products included CODEINE for an unknown indication. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criteria disability and medically significant), FATIGUE (Tiredness) (seriousness criteria disability and medically significant), GASTROINTESTINAL PAIN (Gastrointestinal pain) (seriousness criteria disability and medically significant), GASTROINTESTINAL PAIN (Gut pain) (seriousness criteria disability and medically significant) and PAIN IN EXTREMITY (Pain in arm) (seriousness criteria disability and medically significant). On 25-Aug-2021, the patient experienced VOMITING (Vomiting) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criteria disability and medically significant). At the time of the report, ABDOMINAL PAIN (Abdominal pain), FATIGUE (Tiredness) and GASTROINTESTINAL PAIN (Gastrointestinal pain) had not resolved, VOMITING (Vomiting), GASTROINTESTINAL PAIN (Gut pain) and PAIN IN EXTREMITY (Pain in arm) was resolving and PAIN (pain) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Codeine cant stop patients pain. Patient cant sleep properly and had intense pain. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Treatment medication were not reported. 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: 1676497 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
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: Abdominal pain upper, Back pain, Chills, Decreased appetite, Dizziness, Dizziness postural, Fatigue, Migraine, Neck pain, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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: 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: Appetite lost; Migraine; Dizzy on standing; Back ache; Fever; Shivers; Fatigue; Neck pain; Dizzy spells; Stomachache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25855668) 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 ABDOMINAL PAIN UPPER (Stomachache), DECREASED APPETITE (Appetite lost), MIGRAINE (Migraine), NECK PAIN (Neck pain), DIZZINESS (Dizzy spells), DIZZINESS POSTURAL (Dizzy on standing), BACK PAIN (Back ache), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Shivers) 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 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomachache) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant), DIZZINESS (Dizzy spells) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 25-Aug-2021, the patient experienced DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant), BACK PAIN (Back ache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Shivers) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomachache), DECREASED APPETITE (Appetite lost) and MIGRAINE (Migraine) had resolved with sequelae, NECK PAIN (Neck pain), DIZZINESS (Dizzy spells), DIZZINESS POSTURAL (Dizzy on standing), BACK PAIN (Back ache), FATIGUE (Fatigue) and PYREXIA (Fever) was resolving and CHILLS (Shivers) had resolved. 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) (Intramuscular) was unknown. No concomitant medication was given. No treatment information was given. 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: 1678111 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005236 / 1 - / OT

Administered by: Unknown       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: Seafood allergy (Crab)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received (Reference number: JP-TAKEDA-2021TJP085729) on 26-Aug-2021 and was forwarded to Moderna on 06-Sep-2021. This case, initially reported by a physician, was received via the PMDA (Ref, v21124897). Anaphylaxis was assessed as serious by the MAH. On an unknown date, body temperature before the vaccination: unknown. On 24-Aug-2021, at 08:27, the patient received the 1st dose of this vaccine. At 08:47, anaphylaxis developed. The outcome of anaphylaxis was reported as recovered. Follow-up investigation will be made. Company Comment: The event 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 event, a causal relationship cannot be excluded.


VAERS ID: 1678214 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
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: SARS-CoV-2 test, Stiff leg syndrome
SMQs:, Immune-mediated/autoimmune disorders (narrow), 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: Transplant (Recently had a bone marrow transplant or taking medicines following a transplant (e.g. kidney, l...)
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 via Regulatory Authority (Reference number: GB-MHRA-ADR 25865470) 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 STIFF LEG SYNDROME (Stiff leg syndrome) in a 47-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Transplant (Recently had a bone marrow transplant or taking medicines following a transplant (e.g. kidney, l...). On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced STIFF LEG SYNDROME (Stiff leg syndrome) (seriousness criterion hospitalization). On 25-Aug-2021, STIFF LEG SYNDROME (Stiff leg syndrome) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product usage were not provided. Treatment details were not provided. The patient experienced Pain in his legs ? stiff, Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the 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: 1680005 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3308 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Breast pain, Chills, Ear pain, Eye pruritus, Migraine, Myalgia, Nausea, Nerve compression, SARS-CoV-2 test, Tremor, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Lipodystrophy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101101861

Write-up: shivering; shaking; Nausea; ear ache; Itchy eyes; Migraine; Breast pain; Joint pain/ Joint pain (more so down my spine and shoulders then anywhere else); Muscle pain/Muscle pain (from my shoulders, down my back and buttocks); Pinched nerve/ Trapped/Pinched nerve feeling from left shoulder to left breast (this pain is unbearable); Bad arm pain (where they injected it and hurts when you poke around it); This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-APPCOVID-20210824063207. Safety Report Unique Identifier GB-MHRA-ADR 25839822. A 21-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: FE3308) via an unspecified route of administration on 23Aug2021 as an unknown single dose for COVID-19 immunization. Medical history included lactation decreased and suspected COVID-19 from 16Jul2021 to 23Jul2021. Patient was not pregnant, and she was not currently breastfeeding. The patient''s concomitant medications were not reported. Patient was not enrolled in clinical trial. On 24Aug2021 at 06:45, the patient experienced shivering, shaking and nausea. On 24Aug2021, she also experienced earache, itchy eyes, migraine, breast pain, joint pain/joint pain (more so down my spine and shoulders than anywhere else), muscle pain/muscle pain (from my shoulders, down my back and buttocks) and pinched nerve/trapped/pinched nerve feeling from left shoulder to left breast (this pain is unbearable). On an unknown date in 2021, she experienced bad arm pain (where they injected it and hurts when you poke around it). On 17Jul2021, the patient underwent COVID-19 virus test which resulted positive. At 5:30, she took paracetamol (Anadin Extra) and applied deep heat rub onto her whole spinal area, shoulders, and left breast. Her back and shoulders were now a dull pain and just ache when moving but my left breast was still 7/10 on the pain scale. At 6:45, she felt nauseous and shaking/shivering despite wrapped in clothing and under a thick duvet. Outcome was not resolved for nausea, itchy eyes, migraine, breast pain, joint pain/ joint pain (more so down my spine and shoulders than anywhere else), muscle pain/muscle pain (from my shoulders, down my back and buttocks) and pinched nerve/ trapped/pinched nerve feeling from left shoulder to left breast (this pain is unbearable), was unknown for bad arm pain (where they injected it and hurts when you poke around it) and was resolving for rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1680445 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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 INC202101101845

Write-up: Urinary tract infection; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108240656550110-ZNFEB, Safety Report Unique Identifier GB-MHRA-ADR 25839828. A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection; Lot number was not reported), via an unspecified route of administration on 23Aug2021 as dose 2, single for COVID-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Patient was not pregnant; Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient historical vaccine includes first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single for Covid-19 immunisation. The patient experienced urinary tract infection on 24Aug2021. The event was assessed as serious medically significant. The patient underwent lab test which included Covid-19 virus test which showed negative (No- Negative COVID-19 test) on an unknown date. 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. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1680448 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache, Insomnia, SARS-CoV-2 test, Sweating fever
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: Paracetamol
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sweating fever; Insomnia; Headache; Dizziness; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 25839876) on 24-Aug-2021 and was forwarded to Moderna on 24-Aug-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of SWEATING FEVER (Sweating fever), INSOMNIA (Insomnia), HEADACHE (Headache) and DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included PARACETAMOL from 23-Aug-2021 to an unknown date for Head pain. On 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced SWEATING FEVER (Sweating fever) (seriousness criterion medically significant), INSOMNIA (Insomnia) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, SWEATING FEVER (Sweating fever), INSOMNIA (Insomnia), HEADACHE (Headache) and DIZZINESS (Dizziness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient has not had symptoms associated with COVID-19. Patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. 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: 1680464 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Illness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101105332

Write-up: Fainting; sickly; dizzy; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108241126293890-IGQ5D. Safety Report Unique Identifier GB-MHRA-ADR 25841047. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FE3380) via an unspecified route of administration on 23Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. On an Unspecified date of 2021, the patient experienced sickly and dizzy. On 24Aug2021, the patient experienced fainting. Woke up came downstairs felling a bit sickly. Went to get some breakfast felt dizzy and fainted. Came around very quickly. This was the first time this has ever happened. Given breakfast and rested afterwards. The Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. No details of any relevant investigations or tests conducted. The outcome of the event (fainting) was recovered on 24Aug2021 and events (sickly and dizzy) was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1680487 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
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: Dizziness, Nausea, Presyncope
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101105268

Write-up: feeling like she may faint when standing; Nausea; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108241746131380-LSVCB, Safety Report Unique is GB-MHRA-ADR 25842309. A 24-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FE8087), via an unspecified route of administration on 24Aug2021 (at the age of 24-years-old) as dose 2, single for covid-19 immunization. Medical history included depression from an unknown date and unknown if ongoing. Concomitant medication included citalopram taken for depression, start and stop date were not reported. Patient has not 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. The Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced dizzy and nausea. On 24Aug2021, constantly very dizzy and feeling like she may faint when standing. Also waves of nausea. The reporter considered the events as serious (medically significant). The outcome of events dizziness was not recovered, and other events feeling like I may faint when standing and nausea was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1680503 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy, Non-cardiac chest pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (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 ; Comments: Negative
CDC Split Type: GBPFIZER INC202101105288

Write-up: painful lymph nodes; pain that spreads to the left side of the chests; excruciating arm pain; swollen/lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108242258362330-CEUPO, Safety Report Unique Identifier GB-MHRA-ADR 25844380. A 27-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on 23Aug2021 as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. No other previous conditions. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. On an unspecified date in 2021, the patient experienced excruciating arm pain and swollen/lymph nodes. On 24Aug2021, the patient experienced painful lymph nodes and pain that spreads to the left side of the chests. All the events were medically significant. It was reported that excruciating arm pain that spreads to the left side of the chests; swollen and painful lymph nodes under the left armpit; right side (non-vaccine side) was perfectly fine. The patient underwent lab tests and procedures which included sars-cov-2 test resulted negative (no- negative covid-19 test). 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 excruciating arm pain and swollen/lymph nodes was unknown, for the event pain that spreads to the left side of the chests was recovered on an unspecified date in 2021 and for the event painful lymph nodes it was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1680518 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-24
   Days after vaccination:12
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: Feeling hot, Headache, Malaise, Pain in jaw, Palpitations, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Osteonecrosis (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: BECLOMETASONE; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101111502

Write-up: Jaw pain; Headache; Heart racing; Unwell; Blood felt hot and fizzy sensation shortly after vaccination; tingly jaw and chest; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108251406476300-FASRS, Safety Report Unique Identifier GB-MHRA-ADR 25847749. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF 33 19 and Expiration date was unknown), via an unspecified route of administration on 12Aug2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history included asthma. Patient has not had symptoms associated with COVID-19. Concomitant medications included beclomethasone (Manufacturer unknown) and salbutamol (Manufacturer unknown), both were taken for asthma. On 24Aug2021 the patient experienced jaw pain, headache, and heart racing. On an unspecified date in 2021 the patient experienced tingly jaw and chest and unwell Blood felt hot and fizzy sensation shortly after vaccination since then have suffered with constant headache, tingly jaw, and chest on and off which I have not suffered from previously. Feel generally unwell since. All the events were medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test was no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of event (feeling hot and malaise) was unknown, and event of (Paresthesia) was recovering and event of Heart racing, pain in jaw and headache was not recovered yet. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1680523 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 FE8087 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101111602

Write-up: Swollen glands; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108251712211470-XJTRK.Safety Report Unique Identifier GB-MHRA-ADR 25848753. A 27-years-old (non-pregnant) female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot Number: Fe8087), via an unspecified route of administration on 23Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased and depression from an unknown date and unknown if ongoing. Concomitant medication(s) included venlafaxine taken for depression, start and stop date were not reported. The patient took previously first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, Solution for injection), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunisation. Patient had no symptoms associated with COVID-19, Not had a COVID-19 test, Patient was not pregnant and was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient experienced swollen glands on 24Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. The event was serious (medically significant). The outcome of the event was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1680525 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Headache, Peripheral swelling, Rash erythematous, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: swelling; redness; Red rash; Swelling arm; Headache dull; This case was received via RA (Reference number: -MHRA-ADR 25850981) 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 SWELLING (swelling), ERYTHEMA (redness), PERIPHERAL SWELLING (Swelling arm), HEADACHE (Headache dull) and RASH ERYTHEMATOUS (Red rash) 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 24-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 24-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant) and HEADACHE (Headache dull) (seriousness criterion medically significant). On 25-Aug-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING (swelling) (seriousness criterion medically significant) and ERYTHEMA (redness) (seriousness criterion medically significant). On 25-Aug-2021, HEADACHE (Headache dull) was resolving. At the time of the report, SWELLING (swelling), ERYTHEMA (redness) and RASH ERYTHEMATOUS (Red rash) was resolving and PERIPHERAL SWELLING (Swelling arm) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient took a treatment medication of paracetamol but has not done much. Patient had a same experience event of tenderness across the arm, rash/redness has started to get hot with unknown outcome. 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: 1680535 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Diabetes mellitus inadequate control, Hallucination, Headache, Hyperhidrosis, Myalgia, Pyrexia, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Sweating; Shivering; Sleep; Trying; Hallucinations; aching body for 3 days; Headache; Fever; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 25858276) 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 DIABETES MELLITUS INADEQUATE CONTROL (Trying), HALLUCINATION (Hallucinations), HEADACHE (Headache), HYPERHIDROSIS (Sweating), CHILLS (Shivering), SLEEP DISORDER (Sleep) and PYREXIA (Fever) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-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 24-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced DIABETES MELLITUS INADEQUATE CONTROL (Trying) (seriousness criterion medically significant), HALLUCINATION (Hallucinations) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), SLEEP DISORDER (Sleep) (seriousness criterion medically significant) and MYALGIA (aching body for 3 days). On 25-Aug-2021, PYREXIA (Fever) had resolved. On 26-Aug-2021, HEADACHE (Headache) was resolving. At the time of the report, DIABETES MELLITUS INADEQUATE CONTROL (Trying), HALLUCINATION (Hallucinations), HYPERHIDROSIS (Sweating), CHILLS (Shivering), SLEEP DISORDER (Sleep) and MYALGIA (aching body for 3 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) High. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. Patient had not tested positive for COVID-19 since having the vaccine. The patient had very violent shivers and could not do the normal activities like, brushing teeth, get changed. Then she had sweating with a high temperature, hallucinations when trying to sleep, very bad headaches and an aching body for three days. No treatment medication information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events (headache, chills, pyrexia, hyperhidrosis, myalgia, sleep disorder), a causal relationship cannot be excluded. Very limited information regarding this events diabetes mellitus inadequate control, hallucination has been provided 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 (headache, chills, pyrexia, hyperhidrosis, myalgia, sleep disorder), a causal relationship cannot be excluded. Very limited information regarding this events diabetes mellitus inadequate control, hallucination has been provided at this time.


VAERS ID: 1680543 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
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: Erythema, Headache, Influenza, Influenza like illness, Lymphadenopathy, Nausea, Pain, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

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

Write-up: flu like symptoms; Nauseous; Redness; Ache; Swollen lymph nodes; Fever; Flu; Swelling; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25860680) 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 INFLUENZA (Flu), INFLUENZA LIKE ILLNESS (flu like symptoms), SWELLING (Swelling), ERYTHEMA (Redness) and PAIN (Ache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-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 24-Aug-2021, the patient experienced SWELLING (Swelling) and HEADACHE (Headache). On 25-Aug-2021, the patient experienced INFLUENZA (Flu), PAIN (Ache), LYMPHADENOPATHY (Swollen lymph nodes) and PYREXIA (Fever). On 27-Aug-2021, the patient experienced ERYTHEMA (Redness). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (Nauseous). At the time of the report, INFLUENZA (Flu), PAIN (Ache) and PYREXIA (Fever) was resolving, INFLUENZA LIKE ILLNESS (flu like symptoms) and NAUSEA (Nauseous) outcome was unknown and SWELLING (Swelling), ERYTHEMA (Redness), LYMPHADENOPATHY (Swollen lymph nodes) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. It was reported that the flu like symptoms started straight away. Her entire body was aching and she felt nauseous. Her arm was sore and swollen at the injection site but no redness initially. About three days after the injection her arm was red, swollen and hot to touch about 6 inches down from the actual injection site. Patient had not tested positive for COVID-19 since having the vaccine. Treatment information was not provided.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded.


VAERS ID: 1680830 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: ITJNJFOC20210905397

Write-up: LOSS OF CONSCIOUSNESS AS A RESULT OF SEVERE PAIN IN THE LEGS AND SUDDEN LOWERING OF PRESSURE. WAKING UP AFTER A FEW MINUTES, WITH LOSS OF URINE. HEADACHE, VOMITING AND NAUSEA FOR THE FOLLOWING DAY; LOSS OF CONSCIOUSNESS AS A RESULT OF SEVERE PAIN IN THE LEGS AND SUDDEN LOWERING OF PRESSURE. WAKING UP AFTER A FEW MINUTES, WITH LOSS OF URINE. HEADACHE, VOMITING AND NAUSEA FOR THE FOLLOWING DAY; LOSS OF CONSCIOUSNESS AS A RESULT OF SEVERE PAIN IN THE LEGS AND SUDDEN LOWERING OF PRESSURE. WAKING UP AFTER A FEW MINUTES, WITH LOSS OF URINE. HEADACHE, VOMITING AND NAUSEA FOR THE FOLLOWING DAY; LOSS OF CONSCIOUSNESS AS A RESULT OF SEVERE PAIN IN THE LEGS AND SUDDEN LOWERING OF PRESSURE. WAKING UP AFTER A FEW MINUTES, WITH LOSS OF URINE. HEADACHE, VOMITING AND NAUSEA FOR THE FOLLOWING DAY; This spontaneous report received from a consumer by a Regulatory authority (EVHUMAN Vaccines, IT-MINISAL02-777224) on 01-SEP-2021 and concerned a 69 year old female of unspecified race and ethnic origin. The patient''s weight was 45 kilograms, and height was 158 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 and expiry was not reported) 1 dosage forms, 1 total administered on 21-AUG-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 24-AUG-2021, the patient experienced loss of consciousness (syncope) as a result of severe pain in the legs and sudden lowering of pressure. Waked up after a few minutes, with loss of urine, headache, vomiting and nausea for the following day. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the loss of consciousness (syncope) as a result of severe pain in the legs and sudden lowering of pressure. waked up after a few minutes, with loss of urine, headache, vomiting and nausea for the following day was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1680921 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Blood pressure measurement, Body temperature, Feeling cold, Presyncope
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dermatitis atopic
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:blood pressure decreased; Test Date: 20210824; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202101099167

Write-up: Anaphylactic shock; feeling cold; the possibility of vagal reflex; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21124625. A 22-year and 3 -month-old female patient received BNT162B2 (COMIRNATY, Solution for injection; Lot Number: FF2782; Expiration Date: 30Nov2021), via an unspecified route of administration on 24Aug2021 at 15:42 (the day of vaccination), at the age of 22-years and 3-month-old as dose 1, single for COVID-19 immunization. Patient''s history according to the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) included dermatitis atopic. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.8 degrees centigrade on 24Aug2021. On 24Aug2021 at 15:45 (3 minutes after the vaccination), the patient experienced the following events. Clinical course of the events was reported as follows: At the time recorded above, consciousness was clouding, feeling cold, blood pressure decreased appeared, and the patient experienced shocked state. As an anaphylactic shock, the patient was treated with adrenaline 0.5 mg by intramuscular injection, protect peripheral venous route, ringer''s solution (RINACETO) also was administered by intravenous injection. The patient was transferred in emergency to a secondary medical institution. On an unspecified date, the outcome of the events was not provided. The reporting physician classified the events was not provided and assessed that the causality between the events and BNT162B2 as unassessable. The other possible cause of the events was the possibility of vagal reflex. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1680950 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Blood pressure measurement, Body temperature, Feeling abnormal, Flushing, Headache, Heart rate, Muscle spasms, Oxygen saturation, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: POLARAMINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Soy allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:131/85; Comments: 15:48; Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:117/76; Comments: 16:03 (15 minutes after the vaccination); Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:100/touch; Comments: 16:15 (27 minutes after the vaccination); Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:100; Comments: 16:30 (42 minutes after the vaccination); Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:108/; Comments: 17:00 (72 minutes after the vaccination); Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination; Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: 16:03 (15 minutes after the vaccination); Test Date: 20210824; Test Name: P; Result Unstructured Data: Test Result:83; Comments: 15:48; Test Date: 20210824; Test Name: P; Result Unstructured Data: Test Result:93; Comments: 16:03 (15 minutes after the vaccination); Test Date: 20210824; Test Name: P; Result Unstructured Data: Test Result:83; Comments: 16:30 (42 minutes after the vaccination); Test Date: 20210824; Test Name: P; Result Unstructured Data: Test Result:82; Comments: 17:00 (72 minutes after the vaccination); Test Date: 20210824; Test Name: oxygen saturation; Test Result: 97 %; Comments: 15:48; Test Date: 20210824; Test Name: oxygen saturation; Test Result: 98 %; Comments: 16:03 (15 minutes after the vaccination); Test Date: 20210824; Test Name: oxygen saturation; Test Result: 97 %; Comments: 16:15 (27 minutes after the vaccination); Test Date: 20210824; Test Name: oxygen saturation; Test Result: 98 %; Comments: 16:30 (42 minutes after the vaccination); Test Date: 20210824; Test Name: oxygen saturation; Test Result: 98 %; Comments: 17:00 (72 minutes after the vaccination)
CDC Split Type: JPPFIZER INC202101100727

Write-up: headache; upper abdominal pressure sensation; feels poorly; Tremulousness of hands; Cramp in left hand; flushed face; This is a spontaneous report from a contactable other HCP received from the regulatory authority. Regulatory authority report number is v21124653. A 15-year and 2-month-old female received the second dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 24Aug2021 (Lot number FF0843, Expiration date31Oct2021) at 15:48 at the age of 15-year-old as single dose for COVID-19 immunization. Medical history included soy allergy. Body temperature before vaccination was 36.9 degrees Centigrade. Concomitant medication included dexchlorpheniramine maleate (POLARAMINE). The patient previously received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and experienced pyrexia. On 24Aug2021, the patient experienced adverse events. The clinical course was as follows: At the time of the 1st dose of vaccine, side reactions such as Pyrexia experienced. Therefore a drip infusion of POLARAMINE was initiated before vaccination. On 24Aug2021 at 15:48(the day of the vaccination), just when 3/4 of POLARAMINE had been administered, Corona vaccine was given (BT 131/85, P(pulse) 83, oxygen saturation 97%). On 24Aug2021 at 16:03(15 minutes after the vaccination), tremulousness of hands and cramp in left hand, flushed face experienced, and the patient complained of Feels poorly (BP 117/76, P 93, 98%, 36.7). On 24Aug2021 at 16:15(27 minutes after the vaccination), the patient complained of upper abdominal pressure sensation (BP 100/touch, 97%). On 24Aug2021 at 16:30(42 minutes after the vaccination), the patient complained of headache. A drip infusion of SOLU-MEDROL was initiated (BP 100/, P83, 98%). On 24Aug2021 at 17:00(72 minutes after the vaccination), headache slightly remained, but the symptoms such as cramp in hand, feels poorly disappeared (BP 108/, P 82, 98%). The reporting other HCP did not provided event seriousness, but assessed the causality between the event and bnt162b2 as unassessable. The outcome of feels poorly and cramp in hand was recovered on 25Aug2021 at 17:00. The outcome of other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1681199 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 FE4721 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HARMONET
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101096810

Write-up: passed out; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in arm left on 23Aug2021 13:00 (at the age of 24-years) (Lot Number: FE4721) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included ethinylestradiol, gestodene (HARMONET). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Historical vaccine included COMIRNATY on 26Jul2021 (at the age of 24-years) (dose 1 single, lot number: FE4728, administered in arm left) for Covid-19 immunisation. On 24Aug2021 10:30 (the day after the shot), the patient passed out. No treatment was received for the event. The outcome of the event was recovering. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1682285 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OXAZEPAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210908995

Write-up: FEVER; HEADACHE; FATIGUE; SHIVERING; MYALGIA; This spontaneous report received from a consumer via Regulatory authority (EVHUMAN Vaccines, BE-FAMHP-DHH-N2021-105726) was received on 02-SEP-2021 and concerned a 23 year old female of unspecified race and ethnicity. The patient''s weight was 55 kilograms, and height was 160 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: XE393 expiry: unknown) dose was not reported, frequency one total, administered on 24-AUG-2021 for covid-19 immunisation. Concomitant medications included oxazepam. On 24-AUG-2021, the patient experienced fever, headache, fatigue, shivering and myalgia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, fatigue, shivering, and myalgia. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Treatment - Yes: Dafalgan Evolution - Recovering


VAERS ID: 1682319 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Allodynia, Chills, Fatigue, Hyperacusis, Influenza, Muscle fatigue, Musculoskeletal stiffness, Pruritus, SARS-CoV-2 test, X-ray with contrast upper gastrointestinal tract
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (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: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Coronavirus infection; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101111477

Write-up: Stiff neck; Shivering; Chronic fatigue; Flu; Hyperacusis; Allodynia; Itchy legs; Muscle fatigue; Upper GI series; Chills; This is a spontaneous report from a contactable consumer. This report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108250913034990-1FEMV. Safety Report Unique Identifier GB-MHRA-ADR 25845885. A 23-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration on 24Aug2021 (age at the time of vaccination was 23-year-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included suppressed lactation, suspected covid-19 from 14Jul2021 and ongoing, clinical trial participant, coronavirus infection; all from an unknown date and unknown if ongoing. Concomitant medication included paracetamol taken for coronavirus infection from 16Jul2021 to an unspecified stop date. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on unspecified date (Batch/Lot Number: not reported) as for covid-19 immunization. Patient is not pregnant. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine, Clinical trial participant. On 25Aug2021, the patient experienced stiff neck, shivering, chronic fatigue, flu, hyperacusis. On 24Aug2021, patient had Upper GI series, chills, itchy legs, muscle fatigue, allodynia. All the events were considered as serious- medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Jul2021 Yes - Positive COVID-19 test. The outcome of shivering, Itchy legs was recovering. The outcome of events Stiff neck, Upper GI series, Chills, Muscle fatigue, Chronic fatigue, Flu, Hyperacusis, Allodynia was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1683426 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure increased, Blood pressure measurement, Body temperature, Feeling abnormal, Head discomfort, Heart rate, Hyperventilation, Hypoaesthesia, Neck pain, Oxygen saturation, Palpitations
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Blood pressure; Result Unstructured Data: Test Result:177/99; Comments: at 12:25, 10 minutes after the vaccination; Test Date: 20210824; Test Name: Blood pressure; Result Unstructured Data: Test Result:168/98; Comments: At 14:00; Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210824; Test Name: pulse; Result Unstructured Data: Test Result:75 times/min; Comments: at 12:25, 10 minutes after the vaccination; Test Date: 20210824; Test Name: pulse; Result Unstructured Data: Test Result:82 times/min; Comments: At 14:00; Test Date: 20210824; Test Name: O2 saturation; Test Result: 98 %; Comments: at 12:25, 10 minutes after the vaccination; Test Date: 20210824; Test Name: O2 saturation; Test Result: 98 %; Comments: At 14:00
CDC Split Type: JPPFIZER INC202101103730

Write-up: Heaviness of head; feeling of weakness/ Weakness generalised; numbness of hands and feet; Blood pressure increased 177/99; floating feeling; back neck pain; palpitation; Slightly excited hyperpnoea condition; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21124651. The patient was a 55-year-old female. Body temperature before vaccination was 36.2 centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 24Aug2021 at 12:15, at the age of 55-year-old the patient received the first dose of bnt162b2 (COMIRNATY, Lot EY0572, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. First event onset date reported as 24Aug2021 at 12:25, (10 minutes after the vaccination). The course of the event was as follows: On 24Aug2021 at 12:15, the patient received the first dose of COMIRNATY. 10 minutes after the vaccination, floating feeling, back neck pain, palpitation appeared. Slightly excited hyperpnoea condition. Blood pressure increased 177/99, pulse 75 times/min, O2 saturation 98%. at 12:55, numbness of hands and feet appeared. At 14:00, Blood pressure 168/98, pulse 82 times/min, O2 saturation 98%, numbness disappeared, and there was feeling of weakness, heaviness of head, Weakness generalised, so the patient was transferred to the hospital by embulance. Outcome of the event numbness of hands and feet was recovered, other events was unknown. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1685866 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 UNKNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal dreams, Ageusia, Anosmia, Arthralgia, Back pain, Dizziness, Fatigue, Feeling abnormal, Headache, Hyperhidrosis, Malaise, Myalgia, Productive cough, Pyrexia, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MULTIVITAMIN N [ASCORBIC ACID;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101117998

Write-up: Fever; Sweating; Sharp temporal headaches/Throbbing frontal headache when cough; Cough with clear mucous; Loss of taste & smell; Loss of taste & smell; Fatigue; malaise; Myalgia; Arthralgia; Back pain; Vivid nightmares; Dizziness & some vertigo; Dizziness & some vertigo; Brain Fog; This is a spontaneous report from a contactable other health care professional (HCP). A 57-year-old male patient received BNT162B2 (COMIRNATY; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration in left arm on 24Aug2021 at 12:45 (at the age of 57-years-old) as dose 1, single for COVID-19 immunization in a doctor''s office/urgent care. The patient''s medical history was not reported. Concomitant medications/other medications received within 2 weeks included multivitamin. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever, sweating, sharp temporal headaches, cough with clear mucous, throbbing frontal headache when coughing, loss of taste and smell, fatigue and malaise, myalgia, arthralgia, back pain, vivid nightmares, dizziness, some vertigo and brain fog on 24Aug2021 at 15:00. The patient could not work for 1 day in Aug2021. No treatment was received by the patient for these events and resulted in disability or permanent damage. The outcome of these events was recovering at the time of report. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the temporal relation, the association between the events of pyrexia, hyperhidrosis, headache, productive cough, ageusia, anosmia, fatigue, malaise, myalgia, arthralgia, back pain, ab-normal dreams, dizziness, vertigo and feeling abnormal and the suspect product of BNT162B2 cannot be completely ruled out. 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: 1685910 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
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: Chills, Fatigue, Headache, Injection site reaction, Malaise, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: asthma and anemia.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210910754

Write-up: INJECTION SITE REACTION; SHIVERING; MALAISE; MYALGIA; FEVER; HEADACHE; FATIGUE; NAUSEA; This spontaneous report received from a consumer via Regulatory Authority (EVHUMAN Vaccines, BE-FAMHP-DHH-N2021-105816) on 02-SEP-2021 concerned a 25 year old female of unknown race and ethnicity. The patient''s weight was 92 kilograms, and height was 162 centimeters. The patient''s pre-existing medical conditions included: asthma and anemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE393 expiry: UNKNOWN) dose was not reported, administered on 24-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 24-AUG-2021, the patient experienced injection site reaction, shivering, malaise, myalgia, fever, headache, fatigue and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myalgia, fever, headache, malaise, injection site reaction, fatigue, nausea, and shivering. This report was serious (Disability Or Permanent Damage).


VAERS ID: 1686625 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-08-24
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004672 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood fibrinogen, C-reactive protein, Haematocrit, Lymphocyte count, Myocarditis, Neutrophil count, Troponin I, White blood cell count
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Alanine aminotransferase; Result Unstructured Data: 50 u/l; Test Date: 20210825; Test Name: Alanine aminotransferase; Result Unstructured Data: 38; Test Date: 20210824; Test Name: ASAT; Result Unstructured Data: 77 U/L; Test Date: 20210825; Test Name: ASAT; Result Unstructured Data: 129; Test Date: 20210824; Test Name: Fibrinogen; Result Unstructured Data: 506 mg/dL; Test Date: 20210824; Test Name: C-reactive protein; Result Unstructured Data: 4,28; Test Date: 20210825; Test Name: C-reactive protein; Result Unstructured Data: 3,82; Test Date: 20210824; Test Name: Hematocrit; Result Unstructured Data: 38; Test Date: 20210825; Test Name: Hematocrit; Result Unstructured Data: 41; Test Date: 20210824; Test Name: Lymphocytes; Result Unstructured Data: 7%; Test Date: 20210825; Test Name: Lymphocytes; Result Unstructured Data: 35; Test Date: 20210824; Test Name: Neutrophils; Result Unstructured Data: 85; Test Date: 20210825; Test Name: Neutrophils; Result Unstructured Data: 48; Test Date: 20210824; Test Name: Troponin I; Result Unstructured Data: 9,514 ng/ml; Test Date: 20210825; Test Name: Troponin I; Result Unstructured Data: 17,406 ng/ml; Test Date: 20210824; Test Name: WBC; Result Unstructured Data: 16; Test Date: 20210825; Test Name: WBC; Result Unstructured Data: 10
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Myopericarditis; This case was received via Regulatory Authority (Reference number: ES-AEMPS-985226) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myopericarditis) in a 27-year-old male patient who received mRNA-1273 (batch nos. 3005695 and 3004672) for COVID-19 vaccination. No Medical History information was reported. On 24-Jul-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced MYOCARDITIS (Myopericarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myopericarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Alanine aminotransferase (5-40 U/L): 50 u/l U/L (High) 50 u/l. On 24-Aug-2021, Aspartate aminotransferase (5-37 U/L): 77 U/L (High) 77 U/L. On 24-Aug-2021, Blood fibrinogen (160-400 mg/dl): 506 mg/dl (High) 506 mg/dL. On 24-Aug-2021, C-reactive protein: 4,28 mg/dl (normal) 4,28. On 24-Aug-2021, Haematocrit (39-49 %): 38 % (Low) 38. On 24-Aug-2021, Lymphocyte count (20-50 %): 7 % (Low) 7%. On 24-Aug-2021, Neutrophil count (30-70 %): 85 % (High) 85. On 24-Aug-2021, Troponin I (0,000-0,056 ng/mL): 9,514 ng/mL (High) 9,514 ng/ml. On 24-Aug-2021, White blood cell count (4,5-11 10 thousand cells per microlitre): 16 10 thousand cells per microlitre (High) 16. On 25-Aug-2021, Alanine aminotransferase (5-40 U/L): 38 U/L (normal) 38. On 25-Aug-2021, Aspartate aminotransferase (5-37 U/L): 129 U/L (High) 129. On 25-Aug-2021, C-reactive protein: 3,82 mg/dl (normal) 3,82. On 25-Aug-2021, Haematocrit (39-49 %): 41 % (normal) 41. On 25-Aug-2021, Lymphocyte count (20-50 %): 35 % (normal) 35. On 25-Aug-2021, Neutrophil count (30-70 %): 48 % (normal) 48. On 25-Aug-2021, Troponin I (0,000-0,056 ng/mL): 17,406 ng/mL (High) 17,406 ng/ml. On 25-Aug-2021, White blood cell count (4,5-11 10 thousand cells per microlitre): 10 10 thousand cells per microlitre (normal) 10. mRNA-1273 (Intramuscular) was withdrawn on 24-Jul-2021. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. On 24-Aug-2021, Chest X-ray, Echocardiogram and on 25-Aug-2021 Magnetic resonance imaging heart was done. results were unknown. No concomitant medications information was reported. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Translation document received on 07-SEP-2021 No new information added.


VAERS ID: 1687019 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH COMIRNATY EU/1/ / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Heart rate, Polymerase chain reaction, Scan
SMQs:, Arrhythmia related investigations, signs and symptoms (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, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMOXICILLIN
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Pulse; Result Unstructured Data: Test Result:Pulse dropped to 35 bpm; Test Date: 20210824; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210824; Test Name: possible scans; Result Unstructured Data: Test Result:couldn''t identify reason why he was having problem; Comments: couldn''t identify reason why he was having problem with heart given
CDC Split Type: FRPFIZER INC202101110147

Write-up: Bradycardia; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority. A 28-years-old non-pregnant female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: Comirnaty EU/1/20/1528 Biontech, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 10Aug2021 at 11:00 (at the age of 28 years) as dose 2, single and bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in left arm on 15Jul2021 08:15 PM (Batch/Lot Number: Comirnaty EU/1/20/1528 Biontech) as DOSE 1, SINGLE for covid-19 immunization. The patient had no medical history and no past drug event. No family history with heart issues. Concomitant medication included amoxicillin (unspecified trade name) taken for dental treatment from 2021 to an unspecified stop date. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was other (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Aug2021 at 03:00 AM, the patient experienced bradycardia. Indeed, his pulse dropped to 35 bpm and continued at that range for several days, he was hospitalized by ambulance on 24Aug2021 (14th day after second jab). Doctors did all possible scans and couldn''t identify reason why he was having problem with heart given, he had never had issues with his heart, neither family history. He was a healthy person, he ran every day and he never had any chest pain or any other heart issue symptoms leading up to his hospitalization. The patient was visited doctor or other healthcare professional office/clinic and emergency room/department or urgent care. Finally, the patient performed a nasal swab PCR Covid test (post vaccination) on 24Aug2021 which was negative. The patient was hospitalized for 4 days. The patient was discharged on 28Aug2021. The patient was recovering from the event. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687025 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Ear infection, Lymphadenopathy, Mumps, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101119014

Write-up: Fever & Chills - Ear, Nose & Throat (ENT) disorders like Otitis then swollen glands in both ears suggesting mumps; Fever & Chills - Ear, Nose & Throat (ENT) disorders like Otitis then swollen glands in both ears suggesting mumps; Fever & Chills - Ear, Nose & Throat (ENT) disorders like Otitis then swollen glands in both ears suggesting mumps; Fever & Chills - Ear, Nose & Throat (ENT) disorders like Otitis then swollen glands in both ears suggesting mumps; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female non-pregnant patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: J07BX03, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 10Aug2021 at 10:00 (at the age of 48 years) as dose 2, single for covid-19 immunisation. The patient had no medical history. The patient''s 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 had been tested for COVID-19. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: J07BX03, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 11Jul2021 at 10:00 (at the age of 48 years) as dose 1, single for covid-19 immunisation. The patient experienced fever, chills, ear, nose & throat (ENT) disorders like otitis then swollen glands in both ears suggesting mumps on 24Aug2021 at 08:00. The event led to doctor or other healthcare professional office/clinic visit. The events were considered as disability. Therapeutic measures were taken for all events. In response to the event, therapeutic measures were taken including acetaminophen. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687156 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Blood pressure measurement, Dizziness, Head injury, Loss of consciousness, 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Blood pressure; Result Unstructured Data: Test Result:135/70; Comments: normal
CDC Split Type: GBPFIZER INC202101105507

Write-up: Syncope; dizzy; Loss of consciousness; hitting head on the wall; This is a spontaneous report from a contactable physician. This report is received from The regulatory authority report number is GB-MHRA-WEBCOVID-202108241324135370-PNWRL, Safety Report Unique Identifier is GB-MHRA-ADR 25841136. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Aug2021 (Lot Number: FF3319) as single dose for COVID-19 immunisation. The patient has no other medical history of relevance and no medication (concomitant). The patient felt well with no recent symptoms. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Thus, patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced syncope on 24Aug2021. The patient also felt dizzy and had loss of consciousness (LOC) for 1-2 seconds, hitting head on the wall on the way down. He regained consciousness right away, no bleeding or neurological symptoms after LOC, no cardiac symptoms post collapse. Observation on 24Aug2021 showed normal BP at 135/70. This report does not relate to possible blood clots or low platelet counts. The outcome of dizzy was unknown, while for the other events was recovered on 24Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687158 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Blood pressure measurement, Dyspnoea, Feeling hot, Heart rate, Hot flush, Nausea, Oxygen saturation, Pain, Postmenopausal haemorrhage, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:110/65; Test Name: P; Result Unstructured Data: Test Result:66; Test Name: Sats; Test Result: 99 %; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101105414

Write-up: Postmenopausal bleeding; Swelling; Pain; Nausea; feeling hot; Breathlessness; Hot flush; This is a spontaneous report from a contactable consumer received from the Regulatory authority report number: GB-MHRA-WEBCOVID-202108241342046660-VAAPQ. Safety Report Unique Identifier: GB-MHRA-ADR 25841170. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Aug2021 as DOSE 2, SINGLE for COVID-19 immunisation (at the age of 37 years). Medical history included suppressed lactation decreased, and depression. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included citalopram taken for depression from 01Jun2021. Patient had undergone vaccination and expressed swelling, pain, nausea, and feeling hot about 10 min post vaccination on 24Aug2021. The patient also experienced breathlessness and hot flush on 24Aug2021. Patient was made comfortable on the bed, all observations within normal range; BP: 110/65, P: 66, and Sats: 99%. Adviced seeked from senior nurse to administer Ibuprofen 200 mg and 4 mg Chlorphenamine for symptoms. To observe and contact 111 if symptoms return. The patient experienced postmenopausal bleeding on an unspecified date. The events were considered serious: medically significant. 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 an unspecified date. The outcome of swelling was not recovered. The patient recovered from postmenopausal bleeding on an unspecified date; recovered from feeling hot on an unspecified date in Aug2021, while the other events recovered on 24Aug2021 No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1687178 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-24
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: PROPRANOLOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative.
CDC Split Type: GBPFIZER INC202101105424

Write-up: Fever; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The Regulatory authority report number GB-MHRA-WEBCOVID-202108241653407060-FXJQH, Safety Report Unique Identifier GB-MHRA-ADR 25841783. A 27-year-old patient of an unspecified gender received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 22Aug2021 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medication included propranolol. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), on unspecified date for COVID-19 immunisation. The patient experienced fever (medically significant) on 24Aug2021 with outcome of not recovered. The patient had negative COVID-19 virus test on unspecified date. No follow-up attempts are possible, information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1687190 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101105459

Write-up: Dizziness; This is a spontaneous report from a contactable consumer. This report is received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108241956200250-6VRNJ. Safety Report Unique Identifier GB-MHRA-ADR 25842960. A 33-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 24Aug2021 (Batch/Lot Number: FE3380) as dose 2, single (at the age of 33 years old) for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant, was not currently breastfeeding and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced dizziness on 24Aug2021. The event was reported as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687191 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Migraine, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: VENLAFAXINE
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101105394

Write-up: migraine; fatigue; dizziness; Nausea; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108242018237030-G6XL0. Safety Report Unique Identifier GB-MHRA-ADR 25843188. A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was FE8087), second dose via an unspecified route of administration on 23Aug2021 at unknown DOSE 2, SINGLE for COVID-19 immunization. Medical history included suspected COVID-19 from 23Aug2021 and ongoing, depression. Historical vaccine included BNT162B2 on an unspecified date for COVID-19 Immunisation and propranolol, omeprazole. Concomitant medications included venlafaxine (VENLAFAXINE) taken for depression, start and stop date were not reported. Patient experienced migraine on an unspecified date, fatigue on an unspecified date, dizziness on an unspecified date and nausea on 24Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date (No - Negative COVID-19 test). Patient was not enrolled in clinical trial. The outcome of event for nausea was not recovered and for other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687200 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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, Cold sweat, Fatigue, Headache, Hot flush, Hyperhidrosis, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Arthritis (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: 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 INC202101105544

Write-up: Headache; Hot sweat; Cold sweat; Joint ache; Tired all the time; aching joints; tiredness; Hot flush; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108242157488530-TWHHW, Safety Report Unique Identifier is GB-MHRA-ADR 25843696. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history included suppressed lactation. Concomitant medications were not reported. Historical vaccine included BNT162B2 (lot number: unknown, expiry date not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient experienced aching joints on an unspecified date with outcome of unknown, tiredness on an unspecified date with outcome of unknown, hot flush on 24Aug2021 with outcome of not recovered, headache on an unspecified date with outcome of not recovered, hot sweat on an unspecified date with outcome of not recovered, cold sweat on an unspecified date with outcome of not recovered, joint ache on an unspecified date with outcome of not recovered, and tired all the time on an unspecified date with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date, No - Negative COVID-19 test. The events were reported as serious, medically significant by the health authority. Narrative case summary: Hot then cold sweats on and off all day. Headache, aching joints and tiredness throughout full day. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1687201 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Deafness, Dizziness, Hypoaesthesia, SARS-CoV-2 test, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101105609

Write-up: Blurry vision; Hearing loss/his hearing went all distorted; Light-headed; Body numbness; 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-202108242209068910-M5NC6, Safety Report Unique Identifier GB-MHRA-ADR 25843806. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Aug2021 as dose 1, single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. The patient medical history and patient''s concomitant medications were not reported. The patient experienced blurry vision, hearing loss, light-headed and body numbness on 24Aug2021, all with outcome of recovered on 24Aug2021. The patient underwent lab tests included COVID-19 virus test: Negative. After 25 minutes after the vaccination, he started feeling light headed, and then his body went partially numb, and then his vision went blurry and his hearing went all distorted. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report was considered as serious as other medically important condition from regulatory authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687203 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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: Abdominal pain upper, Diarrhoea, Fatigue, Hot flush, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101105434

Write-up: Nausea; Muscle ache; Tiredness; Stomach ache; Diarrhea; Hot flushes; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108242218554550-VFYB8, Safety Report Unique Identifier is GB-MHRA-ADR 25843850. A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included suppressed lactation. Concomitant medications included lansoprazole (LANSOPRAZOL) taken for gastroesophageal reflux disease, start and stop date were not reported; sertraline taken for depression, start and stop date were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single for COVID-19 immunization. The patient experienced nausea on 24Aug2021 with outcome of recovering, muscle ache on 24Aug2021 with outcome of recovering, tiredness on 24Aug2021 with outcome of recovering, stomach ache on 24Aug2021 with outcome of recovering, diarrhea on 24Aug2021 with outcome of recovering, and hot flushes on 24Aug2021 with outcome of recovering. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Aug2021 No - Negative COVID-19 test. The events were reported as serious, medically significant by the health authority. Narrative case summary and further information: Case narrative: Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687213 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Fatigue, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101105550

Write-up: Very bad fever; Headache dull; Fatigue; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108250037506060-YB67D, Safety Report Unique Identifier GB-MHRA-ADR 25844422. A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), dose 2 via an unspecified route of administration on 24Aug2021 (at the age of 21 years old) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not pregnant and is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced very bad fever, headache dull, and fatigue on 24Aug2021. The events were medically significant. Patient is not enrolled in clinical trial. Outcome of the events was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687217 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-24
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Migraine, Neck pain, Pain, Photophobia
SMQs:, Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Migraine
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101105381

Write-up: pain; Migraine; pain in the neck; sensitivity to light; This is a spontaneous report from a contactable consumer or other non healthcare professional received from The regulatory authority report number is GB-MHRA-WEBCOVID-202108250633593550-KPZ4X. Safety Report Unique Identifier: GB-MHRA-ADR 25845039. A 27-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number was unknown), via an unspecified route of administration on 22Aug2021, as single dose for covid-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing, and migraine from 23Aug2021 to an unknown date. Concomitant medication included paracetamol taken for migraine from 23Aug2021 to an unspecified stop date. Patient has not had symptoms associated with COVID-19, and not had a COVID-19 test. Patient was not currently breastfeeding. 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 an unknown date, the patient experienced pain. On 24Aug2021, had migraine with pain front and back of the head and pain in the neck with sensitivity to light. The outcome of the event migraine was not recovered, and the other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


VAERS ID: 1687222 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Malaise, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: COVID-19 virus test; Test Result: Positive; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101117834

Write-up: nausea; feeling unwell; Vomiting; Fever; Headache; Painful arm/Sore arm; This is a report from a contactable consumer. This is a report received from the Regulatory authority report number is (GB-MHRA-WEBCOVID-202108250830049600-ZYHX6) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25845555). A 22-year-old female patient had received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: FE8087), via an unspecified route of administration on 24Aug2021 as dose 1, single for COVID-19 immunization. Patient was not pregnant, Patient was not currently breastfeeding. The patient medical history included suspected covid-19 from 29Jun2021 to 08Jul2021 (not ongoing), contraception from an unknown date. Concomitant medication included ethinylestradiol, levonorgestrel (RIGEVIDON[ETHINYLESTRADIOL; LEVONORGESTREL]) taken for contraception. Sore arm a couple of hours after the vaccine then during the night woke up feeling unwell with a fever, headache and nausea. Started vomiting in the morning. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient had experienced nausea and feeling unwell. On 25Aug2021,the patient had experienced vomiting, headache. On 24Aug2021, the patient had experienced painful arm/sore arm. The patient underwent lab tests and procedures which included COVID-19 virus test: Positive on 30Jun2021. This events were assessed as medically significant. The clinical outcome of the events nausea and feeling unwell was unknown; for events vomiting, Painful arm/Sore arm, fever and headache was not resolved. No follow-up attempts are possible; No further information is expected.


VAERS ID: 1687225 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-24
   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 FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Varicose vein
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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101111463

Write-up: Varicose veins; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108250845234810-95DJB, Safety Report Unique Identifier GB-MHRA-ADR 25845626. A 39-year-old male patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 via an unspecified route of administration on 21Aug2021 (Lot Number: FD8813) as single dose for covid-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced varicose veins (medically significant) on 24Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on No - Negative COVID-19 test. Started with bulbous veins in the left hand moving to the right side of wrist. This then cascaded to other parts of his body, noticeably the right leg and right hand. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687229 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Arthralgia, Hypoaesthesia, Neck pain, SARS-CoV-2 test, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101111450

Write-up: Neck pain; neck and shoulder pain radiating from injection site; neck and shoulder pain radiating from injection site; started experiencing dead arm around 4 hours later; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA).Regulatory authority report number is GB-MHRA-WEBCOVID-202108250912396220-YV7D0, Safety Report Unique Identifier GB-MHRA-ADR 25845833. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 24Aug2021 14:30 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included suspected covid-19 (Unsure when symptoms started Unsure when symptoms stopped). Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine) on unspecified date for COVID-19 immunisation. The patient''s concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced neck pain (medically significant) on 25Aug2021 03:00, started experiencing dead arm around 4 hours later (medically significant) on 24Aug2021 18:30, neck and shoulder pain radiating from injection site (medically significant) on 25Aug2021 03:00. Patient had vaccine at 14: 30pm, started experiencing dead arm around 4 hours later, woke up at 3am with neck and shoulder pain radiating from injection site. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 24Jul2021 Yes - Positive COVID-19 test. The outcome of the event Neck pain was not recovered. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687231 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Muscle twitching, SARS-CoV-2 test
SMQs:, Dyskinesia (broad), Dystonia (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: 20210824; 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: Twitching; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25845875) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Twitching) in a 40-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. No Medical History information was reported. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced MUSCLE TWITCHING (Twitching) (seriousness criterion medically significant). At the time of the report, MUSCLE TWITCHING (Twitching) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, SARS-CoV-2 test: negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications on use were not provided. No treatment information was provided. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1687244 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, Nasopharyngitis, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: NAPROXEN; PROPRANOLOL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Depression; Lactation decreased; Pain relief
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:High; Test Date: 20210825; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101111361

Write-up: Sore throat; Headache; Head cold; High temperature; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108251011208240-AXSQP, safety report unique identifier is GB-MHRA-ADR 25846231. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Aug2021 (Batch/Lot Number: FE3380) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included lactation decreased, pain relief, anxiety and depression. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications included naproxen taken for analgesic therapy, start and stop date were not reported; propranolol taken for anxiety, start and stop date were not reported; sertraline taken for depression, start and stop date were not reported. The patient experienced sore throat on 25Aug2021 with outcome of recovering, headache on 24Aug2021 with outcome of recovered on 25Aug2021, head cold on 24Aug2021 with outcome of recovered on 25Aug2021, high temperature on 24Aug2021 with outcome of recovered on 25Aug2021. The patient underwent lab tests and procedures which included body temperature: high on 24Aug2021, sars-cov-2 test: negative on 25Aug2021 (No-Negative COVID-19 test). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This is a serious report received with serious criteria other medically important condition from RA. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687248 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthritis, Chest discomfort, Hypersensitivity, Inflammatory pain, Joint swelling, Lip blister, Lip swelling, Mouth swelling, Osteitis, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Systemic lupus erythematosus (broad), Oropharyngeal allergic conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Osteonecrosis (broad), Hypersensitivity (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE; MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]; TRANEXAMIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Contraception; Fainting; Hiatus hernia; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Lactation decreased; Liver enlargement; Lymph nodes enlarged; Rash (body rash); Rheumatoid arthritis (potentially Rheumatoid and was on steroids); Shortness of breath
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 INC202101111456

Write-up: allergic reaction; swollen ankle joints; Chest tightness; Inflamed swollen sore thumb joints, wrist and ankle joints, hands and feet; Inflamed swollen sore thumb joints, wrist and ankle joints, hands and feet; Swollen mouth; Swollen lips; Lip blister; Jaw inflammation; Inflammatory pain; This is a spontaneous report from a contactable Other Health Professional received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108251043298740-SVBWQ; Safety Report Unique Identifier is GB-MHRA-ADR 25846724. A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF3319), via an unspecified route of administration on 20Aug2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. Medical history included Shortness of breath, Lymph nodes enlarged, Lactation decreased, Rheumatoid arthritis (potentially Rheumatoid and was on steroids), Arthritis, Fainting, Rash (body rash), Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response e.g. immunodef...), Enlarged liver, hiatus hernia, and contraception. Patient has not had symptoms associated with COVID-19. Concomitant medications included lansoprazole (LANSOPRAZOLE) taken for hiatus hernia; ethinylestradiol, levonorgestrel (MICROGYNON) taken for contraception; tranexamic acid (TRANEXAMIC ACID). The patient previously took sulfasalazine and experienced allergic reaction (resulting in hospitalization and enlarged liver and body rash and shortness of breath and fainting). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced allergic reaction, swollen ankle joints, and chest tightness on an unspecified date; swollen mouth, swollen lips, lip blister, jaw inflammation, and inflammatory pain on 24Aug2021. The events were assessed as serious with criteria of Other medically important condition. Case narrative: This was a similar reaction to the patient''s 1st Pfizer but took longer to appear and was worse than the 1st dose reaction. Inflamed swollen sore thumb joints, wrist and ankle joints, hands and feet along with slight tightness and inflamed feeling in chest. She has previously had allergic reaction to Sulfasalasine and other medicines. She was advised to take antihistamines the 1st reaction and so she did this on this reaction too. The patient underwent COVID-19 virus test with result negative on 20Aug2021 (No - Negative COVID-19 test). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. The report does not relate to possible blood clots or low platelet counts. Therapeutic measures were taken as a result of the events. The outcome of swollen mouth, swollen lips, lip blister, jaw inflammation, and inflammatory pain was recovering; outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-MHRA-ADR 25846724 MHRA


VAERS ID: 1687250 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 PFZ - FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Affect lability, Chills, Depressed mood, Fatigue, Feeling hot, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (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: ANADIN EXTRA; FERROUS SULFATE; IBUPROFEN; LUCETTE; PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding.
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117792

Write-up: Depressed mood; Emotional instability; Nausea; Fatigue; Feeling hot; Chills; 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-202108251052552030-OFADF. Safety Report Unique Identifier GB-MHRA-ADR 25846543. A 27-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: PFZ - FF3319) via an unspecified route of administration on 24Aug2021 (at the age of 27-years-old) as dose 2, single for COVID-19 immunization. Patient previously received first dose of bnt162b2 for COVID-19 immunization. Medical history was not reported. Concomitant medication(s) included acetylsalicylic acid, caffeine, paracetamol (ANADIN EXTRA) taken for analgesic therapy from 23Aug2021; ferrous sulfate taken for iron deficiency from 21Aug2021; ibuprofen taken for analgesic therapy; drospirenone, ethinylestradiol (LUCETTE) taken for premenstrual syndrome from 21Aug2021 and paracetamol taken for analgesic therapy. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. On 24Aug2021, the patient experienced feeling hot and chills. On 25Aug2021, the patient experienced depressed mood, emotional instability, nausea and fatigue. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: no- negative covid-19 test on 24Aug2021. The outcome of feeling hot was recovering while for the other events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687261 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Bladder irritation, Micturition urgency, Nausea, Pain, SARS-CoV-2 test, Sweating fever
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: FLUOXETINE; IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Muscle ache
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101111646

Write-up: Sweating fever; Ache; Nausea; Irritable bladder; Urgency urination; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority report number is GB-MHRA-WEBCOVID-202108251141507560-Q09LD, Safety Report Unique Identifier GB-MHRA-ADR 25846700. A 23-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 24Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation at the age of 23-year-old. Medical history included Lactation decreased, Muscle ache. It was unsure if patient has had symptoms associated with COVID-19. Patient is not pregnant; Patient is not currently breastfeeding. Concomitant medications included fluoxetine; ibuprofen taken for muscle ache from 24Aug2021. On 24Aug2021, the patient experienced sweating fever, ache, nausea, irritable bladder, urgency urination. The outcome of sweating fever, ache was not recovered, outcome of other events was recovering. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on unspecified date. The case was reported as serious: medically significant. 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.


VAERS ID: 1687286 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-24
   Days after vaccination:8
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: SARS-CoV-2 test, Vaginal haemorrhage
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: Medical History/Concurrent Conditions: Lactation decreased (Patient is not currently breastfeeding); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201116; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101111593

Write-up: Spotting vaginal; This is a spontaneous report from a contactable consumer (patient) received from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108251407522030-ZD4GY. Safety Report Unique Identifier GB-MHRA-ADR 25847731. A 30-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 16Aug2021 as single dose for COVID-19 immunization. Medical history included suppressed lactation (patient is not currently breastfeeding) and suspected covid-19 from 15Nov2020 and recovered an unknown date (unsure when symptoms stopped). COVID-19 virus test on 16Nov2020 was positive. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On 24Aug2021 (as reported) the patient experienced spotting vaginal, serious as medically significant and described as follows: on 16Aug2021 when she received her vaccine she was on her monthly menstrual cycle. This ended through the week as it should of and all weekend she can confirm she was fine and not bleeding/spotting of any kind. On 25Aug2021 she started spotting/bleeding enough that she had to wear a pad to work. The outcome of the event was not recovered. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1687294 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Arthralgia, Axillary pain, Insomnia, Lymphadenopathy, Pain, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (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: Medical History/Concurrent Conditions: Ankle swelling (stung excessively by a wasp on 21st (unspecified date) with swelling in left calf and ankle); Calf swelling (stung excessively by a wasp on 21st (unspecified date) with swelling in left calf and ankle); Swelling; Wasp sting (with swelling in left calf and ankle)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101111752

Write-up: pain; Swollen lymph nodes; Joint pain; Pins and needles; Insomnia; Armpit pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108251523512870-ALGFR. Safety Report Unique Identifier is GB-MHRA-ADR 25848097. A 24 years old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 24Aug2021, as the second single dose, in arm, for COVID-19 immunisation. Medical history included swelling, was stung excessively by a wasp on 21st (unspecified date) with swelling in left calf and ankle. Advised it would not effect vaccine. Patient has not had symptoms associated with COVID-19. The patient previously received the first dose of BNT162B2 vaccine on an unspecified date. The patient''s concomitant medications were not reported. The patient experienced pain on an unspecified date with outcome of not recovered, armpit pain on 24Aug2021 with outcome of not recovered, swollen lymph nodes on 25Aug2021 with outcome of not recovered, joint pain on 24Aug2021 with outcome of not recovered, pins and needles on 24Aug2021 with outcome of recovered on 24Aug2021, insomnia on 24Aug2021 with outcome of not recovered. The case was reported serious per other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date. Additional information: Pins and needles within 5 minutes in injected arm (L), lasting approximately 15 mins and left foot/shin intermittently pins and needles during period. Joint pain in wrist and elbow (L). Did not sleep through night of 24th. Pain in L armpit into evening of 24th and then 25th, on 25th discovered swelling in L armpit after checking due to higher pain. Pain and swelling not currently resolved. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687302 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Arthralgia, Back pain, Chills, Dysmenorrhoea
SMQs:, Retroperitoneal fibrosis (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101111735

Write-up: Period pains; Ache wrists; Low back pain; Chills; 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-202108251614559550-Q4IGN; Safety Report Unique Identifier: GB-MHRA-ADR 25848442. A 22-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 24Aug2021 (at the age of 22-year-old) (Batch/Lot Number: FE8087) at single dose for COVID-19 immunisation. Medical history included lactation decreased, and lactation decreased. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced period pains on 25Aug2021, ache wrists on 24Aug2021, low back pain on 24Aug2021, and chills on 24Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The events were assessed as medically significant. Patient had recovered from chills, ache wrists was recovering and not recovered from other events. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1687316 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-24
   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 FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Cardiac flutter, Fatigue, Palpitations
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM; LEVOTHYROXINE TEVA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Hashimoto''s disease; Hypothyroidism; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Lactation decreased; Neutropenia (immune mediated)
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:100/74
CDC Split Type: GBPFIZER INC202101111648

Write-up: This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108251833388210-Q5CZS, Safety Report Unique Identifier GB-MHRA-ADR 25849282. A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Aug2021 (Lot Number: FE3380) as dose 2, single for COVID-19 immunisation. Medical history included Lactation decreased, Neutropenia (immune mediated), immunodeficiency, Hashimoto''s disease, depression, hypothyroidism. It was unsure if patient has had symptoms associated with COVID-19, Not had a COVID-19 test. Patient is not pregnant, Patient is not currently breastfeeding. Concomitant medications included escitalopram taken for depression from an unspecified start date to 17Aug2021; levothyroxine sodium (LEVOTHYROXINE TEVA) taken for hypothyroidism from 01Mar2018 to an unspecified stop date. The patient''s blood pressure is usually exactly 120/80 and when measured was 100/74 on 24Aug2021, palpitations feel like fluttering on 24Aug2021, fatigue on 25Aug2021. The outcome of events was not recovered. The patient underwent lab tests and procedures which included blood pressure measurement: 100/74. Clinical course was reported as: Palpitations occur regularly and feel like fluttering. Blood pressure is usually exactly 120/80 and when measured was 100/74. Feel like have regular moments of short blood pressure drops. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case was reported as serious: medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687335 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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, Nausea, Syncope, Tachycardia, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101111554

Write-up: trembling; nausea; dizziness; Faint; Tachycardia; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108252038504260-NP9E1. Safety Report Unique Identifier GB-MHRA-ADR 25850068. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 23Aug2021 12:30 pm (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. The patient experienced trembling on 24Aug2021 with outcome of not recovered, nausea on 24Aug2021 with outcome of not recovered, dizziness on 24Aug2021 with outcome of not recovered, faint on 24Aug2021 with outcome of recovered on an unspecified date, tachycardia on 24Aug2021 with outcome of unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The clinical course was reported as follows: Had vaccine at 12.30 pm at 2:15 am I woke up with tachicardia trembling strong dizziness nausea and probably hight feaver (as reported, unspecific) I tried to reach the kitchen and took paracetamol but instead I found myself lying on my loo floor I had to slide to the kitchen as o could not walk took paracetamol 1000mg then I started to feel better. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687346 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 pain upper, Headache, Illness, Migraine, 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: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine; Suspected COVID-19 (unsure when symptoms started and stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101111782

Write-up: migraine; Fever; she was so sick; she constantly felt like throwing up; Stomach cramps; Headache; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108252131164200-3LPQ8. A 19 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 24Aug2021, at the age of 19 years, as the first single dose, for COVID-19 immunisation. Medical history included migraine and suspected COVID-19 (unsure when symptoms started and stopped). The patient did not have COVID-19 test. The patient''s concomitant medication included influenza virus. The patient experienced migraine on an unspecified date with outcome of recovering, stomach cramps on 24Aug2021 with outcome of not recovered, headache on 24Aug2021 with outcome of not recovered, fever on an unspecified date with outcome of not recovered. The case was reported serious per other medically important condition. Additional information: she was so sick. Her stomach was cramping so bad. She had a migraine and she constantly felt like throwing up. She wish she never got the vaccine. She never had this bad of a reaction to a shot before. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687358 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-24
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Pain, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101111623

Write-up: pain; Heavy periods; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108252301070820-CAIN8, safety report unique identifier is GB-MHRA-ADR 25850976. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 21Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. The patient experienced heavy periods (disability, medically significant) on 24Aug2021, pain (disability, medically significant) on an unspecified date. The patient experienced heavy perion bleeding, a lot of pain. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date (No - Negative COVID-19 test). Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient is enrolled in clinical trial. The outcome of the event Heavy periods was not recovered, of event pain was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1687361 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Diarrhoea, Dissociation, Dizziness, Nausea, Presyncope, SARS-CoV-2 test, Syncope, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (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: AMITRIPTYLINE; FLUOXETINE; PARACETAMOL AND CODEINE PHOSPHATE (I)
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disorder tendon; Disruptive mood dysregulation disorder; Fibromyalgia; Lactation decreased; Mood disorder
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 INC202101111690

Write-up: nauseated; feel as though I may faint at times; feel dissociated; Vertigo; Light-headed/dizzy; Presyncope; Diarrhoea; 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-202108252319363910-FHPMJ ), Safety Report Unique Identifier (GB-MHRA-ADR 25850986). A 26-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at dose 2, single on 24Aug2021 (at the age of 26-year-old) for COVID-19 immunization. Medical history included suppressed lactation, disruptive mood dysregulation disorder, mood disorder, fibromyalgia. Family history of Ehlers Danlos Syndrome. Patient has not had symptoms associated with COVID-19 Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medications included amitriptyline for disruptive mood dysregulation disorder from 01Jan2020; fluoxetine taken for mood disorder from 01Jan2018; codeine phosphate hemihydrate, paracetamol (PARACETAMOL AND CODEINE PHOSPHATE) taken for fibromyalgia from 01Jan2018. The patient experienced diarrhoea on 24Aug2021, vertigo, light-headed, presyncope on 25Aug2021. The patient felt dizzy at all times but particularly when standing up or walking around. This started slightly a couple of hours after the vaccine but has became worse around 24 hours afterwards. She felt dissociated and feel as though she may faint at times. She was nauseated and have diarrhea (type 7), although this has resolved partially with the use of immodium. 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 was negative on 25Aug2021 (No-Negative COVID-19 test). The outcome of the events vertigo, light-headed, presyncope was not resolved, the outcome of the events nauseated, dizzy, Diarrhoea was resolving, the outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687363 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Asthenia, Headache, Nausea, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; 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 INC202101111711

Write-up: frontal headache; loss of energy; whole body aching; Aching in limb; Headache; Nausea; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108252350160480-N8KQR. Safety Report Unique Identifier : GB-MHRA-ADR 25850988. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Aug2021 (Lot number was not reported) as dose 2,single (At the age of 35 years old) for COVID-19 immunization. Medical history included Lactation decreased, depression. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medication included sertraline taken for depression from 09Jul2019 to an unspecified stop date. The patient experienced frontal headache on an unspecified date, loss of energy on an unspecified date, headache on 24Aug2021, nausea on 24Aug2021, aching in limb on 25Aug2021, whole body aching on an unspecified date. Clinical course reported as: Started with nausea, then a very painful frontal headache. Next, came the whole body aching and loss of energy. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. Outcome of frontal headache, loss of energy was recovering, outcome of headache, nausea, aching in limb was not recovered, other event was unknown. Case was reported as serious medically significant. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687365 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Lymph node pain, Lymphadenopathy, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101111462

Write-up: Swollen glands; Hand pain; gland pain in armpit; pain; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108260149140420-CJ8WY, Safety Report Unique Identifier GB-MHRA-ADR 25851014. A 22-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported and Expiration date was unknown), via an unspecified route of administration on 24Aug2021 as single dose for COVID-19 immunisation. Medical history included Lactation decreased. Patient had not had symptoms associated with COVID-19. Patient was not pregnant, patient was not currently breastfeeding. The patient''s concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), for COVID-19 immunisation. The patient experienced pain in 2021, swollen glands on 25Aug2021, extreme hand pain on 24Aug2021, Severe gland pain in armpit in 2021. All the events were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test on unknown date: no - negative covid-19 test. The outcome of the events Swollen glands and Hand pain was not recovered. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1687393 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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: Cough, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: AMGEVITA.
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psoriasis.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101117584

Write-up: Sore throat; Cough; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (UK-MHRA). Regulatory authority report number is GB-MHRA-WEBCOVID-202108261033579470-OJZJS. Safety Report Unique Identifier is GB-MHRA-ADR 25852968. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot Number: FF3319), via an unspecified route of administration on 24Aug2021 as dose 1, single for COVID-19 immunization. Medical history included Psoriasis. Concomitant medication(s) included adalimumab (AMGEVITA) taken for psoriasis, start and stop date were not reported. Patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine and patient was not enrolled in clinical trial. The patient experienced sore throat and cough on 24Aug2021. The events were assessed as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date No - Negative COVID-19 test. The outcome of events was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687429 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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: Abdominal pain, Fatigue, Hyperhidrosis, Lymph node pain, Lymphadenopathy, Oesophageal pain, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210815; 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 INC202101117848

Write-up: burn sensation; sweating; Fever; Swollen lymph nodes; Tiredness; Heavy sweating; Abdominal pain; ymph nodes under the arm of the injection swell to a tennis ball size. It being very sore; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108261530199440-RJXUU. Safety Report Unique Identifier GB-MHRA-ADR 25854665. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on 23Aug2021 at 10:15 as dose 2, single for COVID-19 immunization. Medical history included endometriosis (Taking the pill), pregnancy. The patient''s concomitant medications were not reported. The patient previously received 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 single dose for COVID-19 immunization. It was unsure if patient had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. On an unspecified, date the patient experienced burn sensation, sweating. On 24Aug2021 the patient experienced fever, swollen lymph nodes, tiredness, heavy sweating, abdominal pain, lymph node pain. Seriousness criteria for the events reported as medically significant. It was reported that the patient had the vaccine at 10:15 am by 2 am the next day patient had heavy sweating and bad fever. Then during the day, lymph nodes under the arm of the injection swell to a tennis ball size. It being very sore. Patient also had a very bad inflammation of endometriosis causing lower abdominal pains (burn sensation). GP advised the patient to go for a Covid test as 3 days passed and patient still had a fever. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 15Aug2021. Outcome of abdominal pain was recovered; event tiredness was recovering; events burn sensation, sweating, fever, swollen lymph nodes, heavy sweating, was not recovered, while for the other event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


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