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From the 1/21/2022 release of VAERS data:

Found 1,049,249 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 124 out of 10,493

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VAERS ID: 2039320 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-12-22
Onset:2021-12-29
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 331308A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding, Oligomenorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: no tests have been done - lots of pads used
CDC Split Type:

Write-up: Got my 2nd vaccine on December 22 and on December 29th my spotting started and turned to heavy bleeding on January 16th. Same happened with my first vaccine (Pfizer EWO198) that I got on August 2nd at the same pharmacy. I was bleeding three weeks. This time it has been 19 days.


VAERS ID: 2039417 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-03-31
Onset:2021-12-29
   Days after vaccination:273
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Chronic obstructive pulmonary disease, Claustrophobia, Condition aggravated, Cough, Device intolerance, Dyspnoea, Faeces soft, Hypertension, Nausea, Oedema peripheral, Positive airway pressure therapy, Pyrexia, Respiratory failure, SARS-CoV-2 test positive, Transaminases increased, Vomiting
SMQs:, Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 56-year-old woman with O2 dependent COPD baseline 3 L per nasal cannula, insulin-dependent diabetes, anxiety and schizoaffective disorder
Allergies: Aspirin, Codeine, Fentanyl, Hydromorphone (Bulk), Ibuprofen, Ketorolac Tromethamine, Latex, Meperidine, Morphine, Nickel, Sulfamethoprim Ds, Tape-adhesive Porous (Nic), Tramadol
Diagnostic Lab Data: COVID PCR POSITIVE 1/5/2022
CDC Split Type:

Write-up: she states that she had been having worsening cough and felt like she could not breathe at the time of presentation to triage. She has been having fevers up to 102. She is also having some nausea and vomiting though may be some soft stools but no frank diarrhea. At the time of presentation in triage she was at 78% on 3 L and therefore was moved to the stable room. BiPAP was attempted but the patient was able to tolerate it due to claustrophobia and therefore she was placed on nonrebreather. Eventually this was able to be weaned to high flow nasal cannula, and as I see her now she is on 8 L per nasal cannula. At the time of admission, the patient was expected to have an inpatient stay of equal to or greater than 2 midnights in the hospital. Discharge occurred earlier than expected as the patient showed clinical improvement to treatment more quickly than anticipated. Acute on chronic hypoxic respiratory failure due to COPD and now Covid 19. Patient insistent on discharge to home with home hospice. She will be discharged to her home on hospice. 1/6 PROGRESS NOTE Reiterated to them that patient is welcome to stay in the hospital and we will do everything we can to help her with medical treatments. The benefit of staying in the hospital is that she would get 24/7 care from Drs, nurses, respiratory therapists. If she still chooses to go home on Hospice that is her right but she would not get the best care at home if her goal is to recover from her illness. If her goal is to just be as comfortable as possible then going home may be best but by no means is this a choice we are forcing on her. DISCHARGE DIAGNOSES: 1. Acute on chronic hypoxic respiratory failure 2. COVID-19 pneumonia 3. Acute exacerbation of COPD 4. T2DM 5. Transaminitis 6. HTN 7. Chronic LE edema 8. Depression, anxiety, schizoaffective 9. Chronic pain 10. Class III obesity


VAERS ID: 2039566 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-12-27
Onset:2021-12-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Burning sensation, Inflammation, Rash, Rash pruritic, Skin warm, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Skin rash with hives in various places on my body including feet, neck, tops of hands, back, chest and arms. The rash is itchy and burns and feel warm to the touch. If I scratch the itch, my skin reacts drastically with hives and inflammation. Eventually if I don''t touch that spot for a couple of hours, it will go away. Urgent care prescribed oral steroids for the rash which helped but after the full course of steroids, the rash still comes and goes. I do have a history of eczema but this is not normal.


VAERS ID: 2039811 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 33130BA / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hypoaesthesia, Migraine, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), 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: flu shot
Other Medications: unknown
Current Illness: migraine headaches
Preexisting Conditions: unknown
Allergies: flu shot allergy
Diagnostic Lab Data: none
CDC Split Type:

Write-up: migraine headache started at 2am after recieving vaccine, headache has persisted on an intermitent basis for 3 weeks since, experienced face numbness and an episode of syncope lasting 15 minutes with "light headedness" in the shower on 12/29/21


VAERS ID: 2039854 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: New York  
Vaccinated:2021-12-21
Onset:2021-12-29
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213D21A / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest pain, Diplopia, Dyspnoea, Electrocardiogram, Fall, Fibrin D dimer increased, Gait inability, Hypoaesthesia, Laboratory test, Magnetic resonance imaging head, Magnetic resonance imaging thoracic, Musculoskeletal disorder, Panic attack, Paraesthesia, Scan with contrast, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Ocular motility disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Levothyroxine 112mcg daily ASA 81mg daily
Current Illness: Covid-19 positive by PCR on 12/04/2021, off quarantine 12/15/2021. Had to receive the vaccine to be able to go back to work as an RN of 20 years.
Preexisting Conditions: Hx Graves Disease, s/p total thyroidectomy, stable on Levothyroxine.
Allergies: NKA
Diagnostic Lab Data: Hospitalized 12/30/2021-12/31/2021. MRI of head and chest, CT with and without contrast head and chest, EKG, labs. Elevated D-dimer. Needs f/u with Neuro for further testing, possible MRI spine, lumbar puncture. ER visit on 1/11/2022 for severe exacerbated weakness and paresthesia in all limbs. Referred to outpatient Neurology, to f/u on 1/27/2022 or sooner if can be moved up on the waiting list.
CDC Split Type:

Write-up: Numbness, parasthesia in extremities starting in feet, working way up legs to upper body, hands fingers. Complete loss of function in left leg resulting in 2 falls, but regained ability to walk. Blurred distance vision left eye, double vision that resolved, chest pain, intermittent panic attacks with SOB- no prior history.


VAERS ID: 2039862 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-12-20
Onset:2021-12-29
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Peripheral swelling, Rash, Rash pruritic, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), 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: Zyrtec
Current Illness: No illness at time have vaccination- had cold 11/22/21-12/2/21
Preexisting Conditions: Celiac Disease
Allergies: Celiac Disease- cannot have gluten
Diagnostic Lab Data:
CDC Split Type:

Write-up: Spontaneously developed full body rash/hives (both itchy and painful) , significant swelling of hands and feet. Spontaneous urticaria began nine days after vaccination, and has improved, but has not gone away, at the time of this report (twenty-eight days after vaccination, nineteen days after symptoms appeared). No other symptoms, such as fever, difficulty breathing, nausea, or stomach pain. No noticeable other potential causes (no change in diet, environment, or other external stimuli). Treated with Zyrtec, Benadryl, hydrocortisone, aloe vera, and advil for the swelling. Swelling went away after approximately one week and has not returned. Rash and hives would respond to medications/ topical treatments, but remained severe for about ten days. Though no longer severe, rash and hives have not yet gone away. No new symptoms have developed.


VAERS ID: 2039875 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-12-27
Onset:2021-12-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe pain in my left arm and numb, tingly feeling in my fingers. I have been experiencing these symptoms for almost a month after receiving my J&J booster shot.


VAERS ID: 2039911 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: California  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030H21B / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Muscle spasms, Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole 40mg,Cetrizine 10mg, Biotin 1000mcg, Flonase 50mcg, Gabapentin 600mg, Xarelto 20mg, Vitamin D@ 1.25mg
Current Illness:
Preexisting Conditions: Current - Pancreatic cancer Dec 2020. DVT - Aug 2021 CIPN - July 2021 High Blood Pressure
Allergies: Amitriptyline, Carvedilol, Hismanal, Lisinopril /HCTZ, Nickle, and bees
Diagnostic Lab Data:
CDC Split Type:

Write-up: approximately 4 hours after getting vaccine on Dec 29, 2021 I had a bad cramp in left ball/toes of left foot, got it to go away and immediately had the same in right foot and just as I got to go away both feet cramped up and pretty much stayed that way for at least 3 hours when I went to bed. Along with this was a severe increase/flare up of neuropathy in both legs and this lasted through the following day Dec 30, 2021 and went away after the next nights sleep with my CIPN being back on Dec 31, 2021 to where it was before the vaccine..


VAERS ID: 2042404 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ8762 / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Immunisation, Malaise, Peripheral swelling, Pruritus, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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)

Life Threatening? No
Birth Defect? No
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: USPFIZER INC202200004744

Write-up: I got the Covid Booster I had all kinds of side effects/my arm is still very red, swollen and itches like crazy; Fever; Not quite feeling well; I got the Covid Booster I had all kinds of side effects/my arm is still very red, swollen and itches like crazy; itches like crazy; booster; A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm, administration date 29Dec2021 (Lot number: FJ8762) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 immunization, reaction(s): "didn''t have any side effects from first 2 doses"; Covid-19 vaccine (Dose: 2, Manufacturer unknown), for COVID-19 immunization, reaction(s): "didn''t have any side effects from first 2 doses". The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "booster"; ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious), outcome "not recovered" and all described as "I got the Covid Booster I had all kinds of side effects/my arm is still very red, swollen and itches like crazy"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; MALAISE (non-serious), outcome "unknown", described as "Not quite feeling well"; PRURITUS (non-serious), outcome "not recovered", described as "itches like crazy". Additional information When probed for the concern, consumer stated, "I got the Covid Booster from my Doctor on Wednesday and my arm is still very swollen. I had all kinds of side effects (from Covid Booster) which I didn''t had with the first 2 shots (first and second dose) and I can''t call my Doctor right now because it''s Sunday but right now most of the side effects have gone away that fever, that not quite feeling well and all but my arm is still very red, slight swollen, it itches like crazy. It''s all basically all the bad side effects are in my arm right now and my question to you. I have read that all of these are possible side effects, basically I don''t have a lot of these. I don''t have the nausea or vomiting or any of that, I don''t have any heart problems or breathing problems or anything like that but I am wondering is there anything I can do about the itching."


VAERS ID: 2042577 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-12-29
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19; Test Result: Positive
CDC Split Type: USPFIZER INC202200049694

Write-up: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient. A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive. Caller was asking how long he has to wait to get the booster dose because he tested positive for Covid 10 days ago, 29Dec2021. It was unable to provide contact number, gather address and transfer because the call got disconnected. Created Manual AE form. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2043693 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: New York  
Vaccinated:2021-12-16
Onset:2021-12-29
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 060H21A / 3 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Chest discomfort, Chronic spontaneous urticaria, Mechanical urticaria, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin d once per day 2000iu 1 multi vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: Augmentin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Chronic spontaneous urticaria, dermatographia Chest tightness, itching, welts


VAERS ID: 2044487 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033H21A / 3 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Chest X-ray normal, Chest discomfort, Chills, Cough, Electrocardiogram normal, Feeling abnormal, Heart rate increased, Hyperhidrosis, Insomnia, Nasal congestion, Oropharyngeal pain, Post-tussive vomiting, Productive cough, Rhinorrhoea, SARS-CoV-2 test negative, Sinus operation, Sneezing, Sputum increased, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (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: None.
Allergies: Sulfa, Ichthammol.
Diagnostic Lab Data: EKG shows normal sinus rhythm with possible left atrial enlargement. Chest x-ray: Impression. No radiographic evidence of pneumonia. albuterol 90 mcg/actuation inhaler.
CDC Split Type:

Write-up: On the same afternoon, 3hrs after the Covid booster Moderna, I developed sore throat followed by nasal congestion. I had some thick green plaque nasal drainage. That night I had some chills and sweats followed by coughing. I also noted my heart rate was rapid. I could not fall asleep at all. These symptoms persisted over 18 days and still on-going. On January 3rd I actually felt worse with a lot of sneezing and increasing nasal discharge and excessive sputum production. The cough was much worse. Sometimes the cough was so bad that I could not stop coughing over 10 minutes and I did have some posttussive vomiting. On Jan 14th I did a telehealth visit with her PCP. They prescribed me doxycycline and Tessalon Perles. Besides the increased heart rate, I occasionally feel some pulling on the left side of my chest which is worse with movement or coughing. On Jan 15th, I visited the urgent care and emergency room, took an EKG and a chest xray. The doctor stated that I had strong immune reaction to the booster shot, and prescribed albuterol 90 mcg/actuation inhaler with assist device for inhaler. I had a negative COVID test prior to the booster and subsequently has had a PCR test which was negative.


VAERS ID: 2045454 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL3197 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary pain, Injection site pain, Lymphadenopathy, Malaise, Pain, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Systemic: Body Aches Generalized-Mild, Systemic: Fever-Medium, Systemic: Lymph Node Swelling-Medium, Additional Details: Patient stated arm was squeezed and it hurt being administered. Patient said it was deep, not subcutaneous. Her arm did not hurt at injection site, it hurt under arm and was swollen. Fever was 104. She will take covid test. Felt sick for about 5 days


VAERS ID: 2045758 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 33030BD / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Immunisation, Mass, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PRPFIZER INC202200004682

Write-up: Big Lump under left arm. Swollen and painful; Big Lump under left arm. Swollen and painful; Big Lump under left arm. Swollen and painful; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 (Lot number: 33030bd) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose product: COVID 19, Previous dose brand: Pfizer , Previous dose brand unknown: False, Previous dose lot unknown: True, Previous dose lot unknown reason: Misplaced/discarded, Previous dose dose number: 2, Previous dose vaccine location: Left arm), for Covid-19 Immunization; Bnt162b2 (Previous dose product: COVID 19, Previous dose brand: Pfizer, Previous dose brand unknown: False, Previous dose lot number: 33030BD, Previous dose lot unknown: False, Previous dose dose number: 1, Previous dose vaccine location=Left arm), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "Booster"; MASS (non-serious), PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 02Jan2022, outcome "not recovered" and all described as "Big Lump under left arm. Swollen and painful". Therapeutic measures were not taken as a result of mass, peripheral swelling, pain in extremity. Additional Information: other vaccine in four weeks reported as no. Ae resulted in reported as none of the above. covid prior vaccination and covid tested post vaccination reported as no. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2046229 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-11-02
Onset:2021-12-29
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2593 / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3590 / 1 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Blood pressure increased, Blood test, COVID-19, Chest X-ray normal, Chest pain, Ear pain, Heart rate increased, Peripheral swelling, SARS-CoV-2 test positive, Vaccination complication
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Infective pneumonia (broad), Dehydration (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Adderall, xanax, methyl folate, bioton, DIM, effexor
Current Illness: Chronic fatigue syndrome, anxiety
Preexisting Conditions: Chronic fatigue syndrome, anxiety disorder
Allergies: Sulfa, monistat, Reglan, trazadone
Diagnostic Lab Data: Chest xray, blood tests on 10/22/21. I was fully vaccinated and received a positive covid test on 12/29/21. I retested with my husband on 12/30/21 at the Medical center Pavilion. We were both positive.
CDC Split Type:

Write-up: I was sent to the ER on 10/22/21 for chest pains. My blood pressure and heart rate were elevated- and still remain elevated for my body. I''m on aspirin therapy and I was checked for heart attack and pericarditis. Both were negative. I had lower leg swelling. I continue to have Covid eye and sharp pains in my ears.


VAERS ID: 2046246 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 070H21A / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Joint injury, Limb injury, Muscle haemorrhage, Skin discolouration
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)

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

Write-up: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: blood dispersed throughout and down arm; unable to use shoulder-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: brusing at injection site; blood can be seen progressively moving down his arm (under the skin), arm is bright purple.


VAERS ID: 2047441 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ8757 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea, Fluid retention, Headache, Inflammation, Pain in extremity, Paraesthesia, Vaginal haemorrhage
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: adderall, klonopin, advil
Current Illness: none
Preexisting Conditions: none
Allergies: mangos, cilantro, meloxicam, macrolides, quinalones, penicillins - and a few more things pt could not remember
Diagnostic Lab Data: need to ask pt
CDC Split Type:

Write-up: headache, severe arm pain, diarrhea, full body water retention and inflammation, joint pains, tingling in hands and fingers, severe bleeding from vagina to date still has water retention, inflammation, tingling in fingers, arm pain


VAERS ID: 2048076 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-06-22
Onset:2021-12-29
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA O22C21A / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Nasopharyngitis
SMQs:

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

Write-up: cold like symptoms


VAERS ID: 2048133 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032H21A / 3 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Moderna Covid19 Vaccine dose 2
Other Medications: Nurtec 75mg as needed, Rosuvastatin, Pantoprazole. Centrum Women''s gummy vitamin and a Biotin gummy
Current Illness: None
Preexisting Conditions: Migraines, High Cholesterol, Acid Reflux and Dysphagia
Allergies: Codeine and Pineapple
Diagnostic Lab Data: None
CDC Split Type: vsafe

Write-up: I woke up the next morning with a severe migraine (worse than normal ones) and swollen lymph nodes on the left side of my neck. I decided to take my migraine which did not alleviate my symptoms. I ended up sleeping off and on all day, and after a few days my symptoms had resolved.


VAERS ID: 2048147 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: California  
Vaccinated:2021-03-17
Onset:2021-12-29
   Days after vaccination:287
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Acute respiratory failure, Alanine aminotransferase normal, Angiogram pulmonary normal, Anticoagulant therapy, Aspartate aminotransferase normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood chloride increased, Blood cholesterol normal, Blood creatinine normal, Blood culture, Blood glucose normal, Blood potassium normal, Blood sodium normal, Blood thyroid stimulating hormone normal, Blood triglycerides normal, Blood urea increased, Brain natriuretic peptide increased, COVID-19, COVID-19 pneumonia, Carbon dioxide normal, Cough, Dyspnoea, Exercise tolerance decreased, Fibrin D dimer increased, Glycosylated haemoglobin increased, Haematocrit normal, Haemoglobin normal, High density lipoprotein decreased, International normalised ratio normal, Liver function test normal, Low density lipoprotein normal, Mean cell volume increased, Platelet count decreased, Prothrombin time prolonged, SARS-CoV-2 test positive, Troponin, White blood cell count normal
SMQs:, Acute renal failure (broad), Cardiac failure (broad), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Dyslipidaemia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Lipodystrophy (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PTA MEDICATIONS: Prior to Admission Medications Outpatient Home Medications Taking? Aspirin 81 mg Oral Chew Tab Takes Regularly Sig: Chew and swallow 81 mg by mouth daily Atenolol (TENORMIN) 25 mg Oral Tab Takes Regularly Sig: Take 1 tablet
Current Illness:
Preexisting Conditions: past medical history of prediabetes (last HbA1c 5.8% in 04/2021), hypertension, emphysema (last PFTs in 2009), hyperlipidemia, hypothyroidism (last TSH 8.6% in 11/2021), prior prostate cancer s/p brachytherapy (in 2008
Allergies: nkda
Diagnostic Lab Data: 12/29/21 1523 WBC 5.3 HGB 14.8 HCT 44.9 PLT DECREASE* | 137* MCV 98 Recent Labs 12/29/21 1523 NA 141 K 4.2 CO2 26 CL 107 BUN 32* CR 1.04 RBS 98 Recent Labs 12/29/21 1523 TROP 0.06* BNP 143* Recent Labs 12/29/21 1523 PT 14.2 INR 1.1 Recent Labs 12/29/21 1523 AST 13 ALT 14 ALKP 79 TBILI 0.4 Lab Results Component Value Date Hgb A1c % 5.8 (H) 04/23/2021 Lab Results Component Value Date Cholesterol 183 04/23/2021 Triglyceride 76 05/09/2018 HDL 42 04/23/2021 Low density lipoprotein calculated 86 05/09/2018 LDL CALCULATED, NONFASTING 84 04/23/2021 TRIGLYCERIDE, NONFASTING 283 04/23/2021 Lab Results Component Value Date TSH 8.6 (H) 11/08/2021 No results found for: IRON, IBC, FESAT, FERRITIN, TRANSFERSAT MICROBIOLOGY: 12/29 COVID: Detected 12/29 Blood cultures: In process
CDC Split Type:

Write-up: 82 Y male with history of prediabetes, hypertension, emphysema, infrarenal abdominal aneurysm, who presented with positive home COVID test and subjective dyspnea in the setting of progressive decline in exercise tolerance, admitted for acute hypoxemic respiratory failure due to COVID pneumonia. # Acute hypoxemic respiratory failure # COVID pneumonia / History of emphysema Presented after having positive home COVID test in the setting of progressive decline in exercise tolerance for months. No other symptoms including fevers/chills, cough, chest discomfort. Confirmed to be COVID positive 12/29. Initially hypoxemic to 86% and required 2L NC on admission. Received IV remdesivir and IV Decadron 6 mg on 12/29. Also found to have elevated D-dimer (~3) but CTA chest negative for PE. Received SQ Lovenox for VTE prophylaxis. Passed ambulatory trial 12/30 (oxygen saturation 95-97% with ambulation on room air). No home oxygen ordered. LFTs within normal limits. - Monitor for progression of symptoms - Continue isolation for 20 days (until 1/18/2022) - Continue tessalon perles 100 mg TID PRN for cough # Prediabetes Last HbA1c 5.8% in 04/2021. - Follow up repeat HbA1c # Hypertension - Continue PTA atenolol 25 mg daily - Continue PTA aspirin 81 mg daily # Hypothyroidism - Continue PTA levothyroxine 150 mcg daily # Hyperlipidemia - Continue PTA lovastatin 20 mg QHS


VAERS ID: 2048182 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: California  
Vaccinated:2021-12-14
Onset:2021-12-29
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069F21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Acute kidney injury, Alanine aminotransferase normal, Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood chloride decreased, Blood cholesterol normal, Blood creatinine increased, Blood culture negative, Blood lactic acid, Blood potassium normal, Blood sodium normal, Blood triglycerides increased, Blood urea increased, C-reactive protein increased, COVID-19, Carbon dioxide increased, Computerised tomogram abdomen normal, Constipation, Cough, Culture urine positive, Dehydration, Febrile neutropenia, Full blood count, Glycosylated haemoglobin, Haematocrit normal, Haemoglobin normal, High density lipoprotein decreased, Leukopenia, Lymphocyte percentage, Malaise, Mean cell volume normal, Monocyte percentage, Nausea, Neutropenia, Neutrophil percentage, Nitrite urine absent, Platelet count decreased, Protein urine present, Pyrexia, Red blood cells urine, SARS-CoV-2 test positive, Thrombocytopenia, Troponin, Urinary tract infection, Urine ketone body absent, Urine leukocyte esterase, Urobilinogen urine decreased, White blood cell count decreased, White blood cells urine, pH urine normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Agranulocytosis (narrow), Dyslipidaemia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lipodystrophy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prior to Admission Medications Outpatient Home Medications Taking? Acetaminophen (TYLENOL) 325 mg Oral Tab Unknown Sig: Take 2 tablets by mouth every 4 hours as needed for fever or mild pain . Do not exceed 10 tablets in 24 hours. Do not ex
Current Illness: 12/3-12/15/21 for acute cholecystitis s/p cholecystostomy on 12/4/21 c/b bacteremia, buttock wounds and R leg cellulitis
Preexisting Conditions: of HTN, HLD, MDD, pulmonary HTN, bedbound status due to severe obesity and hip/knee arthritis
Allergies: nkda
Diagnostic Lab Data: Recent Labs 12/29/21 1218 WBC 2.7* HGB 13.1 HCT 41.9 PLT 106* MCV 89 NEUT 59 LYMPH 31 MONO 8 EOS 0 Recent Labs 12/29/21 1218 NA 137 K 4.4 CL 95* CO2 31 BUN 38* CR 1.37* RBS 103 Recent Labs 12/29/21 1218 AST 54* ALT 29 ALKP 65 TBILI 0.7 TROP 0.03 Lab Results Component Value Date Lactate, ser/plas 2.2 (AA) 12/29/2021 Lactate, ser/plas 0.8 12/05/2021 Lactate, ser/plas 1.0 12/04/2021 Recent Labs 12/29/21 1656 UPH 5.0 USG 1.019 UAGLU NEGATIVE UKET NEGATIVE UABILI NEGATIVE UPROTEIN 30* ULEUKESTER SMALL* UNITRITE NEGATIVE URBC 1 UWBC 7* Lab Results Component Value Date Hgb A1c % 4.9 12/06/2021 Lab Results Component Value Date Cholesterol 97 12/18/2021 Triglyceride 177 12/18/2021 HDL 31 (L) 12/18/2021 Low density lipoprotein calculated 31 12/18/2021
CDC Split Type:

Write-up: 81 Y female with hx of HTN, HLD, MDD, pulmonary HTN, bedbound status due to severe obesity and hip/knee arthritis, recent hospitalization 12/3-12/15/21 for acute cholecystitis s/p cholecystostomy on 12/4/21 c/b bacteremia, buttock wounds and R leg cellulitis, COVID-19 positive on 12/25/21, who presented with nausea and malaise. Remained non-hypoxic, received remesivir x3 days to prevent severe disease per ID recs. Was noted to be neutropenic fever likely due to COVID. Labs not suggestive of DIC. HIT labs pending, SQ heparin held. Urine cx grew enterococcus cloacae and VRE but was asymptomatic, likely colonized urine. Patient and family opted to bring patient home with home health PT, declined SNF. Patient safe to be off isolation now per current guidelines. #CORONAVIRUS COVID-19 DISEASE Received first dose Moderna vaccine on 12/14/21. Symptom onset on ~12/17/21, COVID positive on 12/25/21. Last known fever on 12/29/21. Except for cough and malaise, no respiratory symptoms, satting well on room air. No oxygen requirement. CRP mildly elevated. Risk factors: obesity. Patient remained nonhypoxic. Was treated with remdesivir for 3 days (12/29-12/31) given she has risk factor (obesity) and for prevention to severe disease per ID recommendations #NEUTROPENIC FEVER #LEUKOPENIA #THROMBOCYTOPENIA, UNSPECIFIED Neutropenia secondary to COVID. DIC labs negative. Patient was on SQ heparin at SNF and last hospitalization. 4T score for HIT is 2 points: low probability for HIT. Noted to have neutropenic fever on 12/31. Source of fever likely COVID. Blood cultures no growth. Dc''ed abx given likely from COVID. Cell lines stable. -repeat cbc in 1 week -f/u HIT serologies -hold SQH #UTI asymptomatic and ucx growing enterococcus cloacae and VRE -asymptomatic and not septic, likely colonized, hold off on tx #NAUSEA #CONSTIPATION Patient has baseline nausea even during prior hospitalization. Likely worsened by COVID infection. Ct showed no obstruction and no evidence of cholecystitis or other acute abnormalities. No abdominal pain or peritoneal signs. -f/u general surgery for chole drain #NONTRAUMATIC ACUTE KIDNEY INJURY Cr 1.37 from baseline ~1, likely from dehydration. Resolved after fluids. -daily chem7 Reason for Hospital Admission (Admitting Diagnosis): COVID-19 disease, AKI


VAERS ID: 2050483 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL3197 / 1 LA / IM

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

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

Write-up: Error: Patient Too Young for Vaccine Administered-


VAERS ID: 2050505 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3594 / 3 LA / IM

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

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

Write-up: Error: Booster Given Too Early-


VAERS ID: 2050601 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Maine  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 067H21A / 3 LA / IM

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

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

Write-up: Moderna administered to underaged patient (17 years)


VAERS ID: 2050690 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK5618 / 1 LA / IM

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

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

Write-up: PATIENT WAS ADMINSTERED 0.2ML INSTEAD OF 0.3ML ON 12-29-2021


VAERS ID: 2050807 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL0007 / 1 LA / 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: none
Preexisting Conditions: Bronchospasm, exercise induced J45.990 Diaphragmatic hernia without obstruction or gangrene K44.9 ?polyps (Gastro-esophageal reflux [GERD], without esophagitis) K21.9
Allergies: none
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: No adverse reaction noted. On January 20th, 2022 around 9am the patient was scheduled for a second Covid vaccine. MA lead realized the patient was given the wrong covid vaccine on 12/29. Patient is 13 years old and he was administered by MA lead the 5-11 covid Pfizer vaccine (0.2 ml) instead of the 12 years and up Covid vaccine. Ma lead notified PM immediately . Chart was reviewed and staff was also notified and she did admit mistake. Patient did received incorrect vaccine. Dr. was informed and mother of patient, she was informed of the incident as well. Parent was told pt. received 0.2 ml of the 5-11 Pfizer Covid vaccine. Parent understand and was ok since dose was lower. Parent is bringing back patient tomorrow Friday 1/21/22 for him to get correct Covid Pfizer vaccine.


VAERS ID: 2050810 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: California  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate increased, Heart rate irregular
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiac arrhythmia terms, nonspecific (narrow), Dehydration (broad)

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

Write-up: Elevated Heart Rate. Typical resting HR is between 50-60, I could not get resting HR down below 70. Irregular Heart Beat - My heart was beating in a very unusual way. I''m an active cyclist and I wear a heart monitor (Watch and Chest Strap Garmin) often so I''m very aware of my heart rate and rhythm. I experienced an unusual heart beat for several hours on Dec 29th.


VAERS ID: 2050941 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: California  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012A21A / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Gait disturbance, Mobility decreased, Pain
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastatin, Cozaar, Levothyroxine, Amlodipine, Mucinex D,
Current Illness: None
Preexisting Conditions: Bronchitus
Allergies: Sulfur, Iodine IV Dye
Diagnostic Lab Data:
CDC Split Type:

Write-up: This was the booster shot. Extreme pain all over body. I could barely walk. Pain was comparable to childbirth. Was immobilized to bed for a week. Original shot was mild arm pain.


VAERS ID: 2051031 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL3197 / 1 LA / IM

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

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

Write-up: Error: Patient Too Young for Vaccine Administered-


VAERS ID: 2051071 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069F21A / 3 RA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: NA
CDC Split Type:

Write-up: Resident was getting the boost, the dose on the vial stated maximum doses of 11 of 0.5ml which was given and the booster injection was suppose to be 0.25ml. No adverse reactions noted to patient


VAERS ID: 2051092 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069F21A / 3 RA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Resident was getting the boost, the dose on the vial stated maximum doses of 11 of 0.5ml which was given and the booster injection was suppose to be 0.25ml. No adverse reactions noted to patient


VAERS ID: 2051108 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069F21A / 3 RA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Resident was getting the boost, the dose on the vial stated maximum doses of 11 of 0.5ml which was given and the booster injection was suppose to be 0.25ml. No adverse reactions noted to patient


VAERS ID: 2051115 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069F21A / 3 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Resident was getting the boost, the dose on the vial stated maximum doses of 11 of 0.5ml which was given and the booster injection was suppose to be 0.25ml. No adverse reactions noted to patient


VAERS ID: 2051123 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069F21A / 3 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Resident was getting the boost, the dose on the vial stated maximum doses of 11 of 0.5ml which was given and the booster injection was suppose to be 0.25ml. No adverse reactions noted to patient


VAERS ID: 2051132 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069F21A / 3 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Resident was getting the boost, the dose on the vial stated maximum doses of 11 of 0.5ml which was given and the booster injection was suppose to be 0.25ml. No adverse reactions noted to patient


VAERS ID: 2051136 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069F21A / 3 RA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Resident was getting the boost, the dose on the vial stated maximum doses of 11 of 0.5ml which was given and the booster injection was suppose to be 0.25ml. No adverse reactions noted to patient


VAERS ID: 2051142 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069F21A / 3 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Patient was getting the boost, the dose on the vial stated maximum doses of 11 of 0.5ml which was given and the booster injection was suppose to be 0.25ml. No adverse reactions noted to patient


VAERS ID: 2051156 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 069F21A / 3 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Resident was getting the boost, the dose on the vial stated maximum doses of 11 of 0.5ml which was given and the booster injection was suppose to be 0.25ml. No adverse reactions noted to patient


VAERS ID: 2051301 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 33130BA / 3 RA / IM

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

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

Write-up: Patient made an appointment for Covid-19 booster shot, Janssen vaccine. He claimed to have a first shot on 5/30/2021 and wanted to get a booster dose. At the appointment time we only had Pfizer vaccine available and he agreed to get Pfizer as a booster dose. when processing the claim the next day, we saw that he already got a Moderna Covid-19 vaccine shot at a different location on 12/23/2021. We called the patient and confirmed that he did get Moderna vaccine as first dose 5 days ago. He said that he felt fine and had no reaction to the vaccine.


VAERS ID: 2053695 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-12-01
Onset:2021-12-29
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 - / OT
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disease, unspecified
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 rapid POC test; Result Unstructured Data: positive; Test Name: COVID-19 rapid POC test; Result Unstructured Data: positive
CDC Split Type: USJNJFOC20220123706

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 74-year-old of unspecified sex of unknown race and ethnicity. Initial information was processed along with the additional information received on 18-JAN-2022. The patient''s height and weight were not reported. The patient''s concurrent conditions included heart disease. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number:1808980, expiry: unknown)1 total, dose, start therapy date were not reported for prophylactic vaccination. The patient received non-company suspect vaccine included: mrna 1273(Dose number in series 2) (form of admin, route of admin, and batch number: unknown, expiry: unknown)1 total, dose was not reported, administered on DEC-2021 for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported. On 29-DEC-2021, the patient had covid symptoms and started feeling better. By 01-JAN-2022 was not feeling so great but not terrible, so the patient took the rapid test twice which both resulted positive (experienced suspected covid-19 infection, and suspected clinical vaccination failure) (Dose number in series 2)(Dose number in series 1), and the doctor started giving paxlovid (antiviral) which the reporter took for three days had some side effects that were not extreme like nausea. Overall was not feeling good. The patient also experienced suspected covid-19 infection, and suspected clinical vaccination failure. (Dose number in series 2)(Dose number in series 1) The action taken with covid-19 vaccine ad26.cov2.s not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report is related with product quality complaint: 90000211927.; Sender''s Comments: V0: 20220123706-covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 2053760 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-02-27
Onset:2021-12-29
   Days after vaccination:305
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012A21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Dyspnoea, Pruritus, Skin warm, Swelling, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20224

Write-up: skin gets hot and then the hives pop up, it comes and goes; felt like I could not breathe; had huge hives that spread to all over my body/had hives in my throat/had these hive all over my body, scalp, bottom of feet, hands, private area, face, I look like a monster/Anytime I get a flare up, I know it coming; they were itchy; underneath of both of my arms were swollen; underneath of both of my arms were painful; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (had huge hives that spread to all over my body/had hives in my throat/had these hive all over my body, scalp, bottom of feet, hands, private area, face, I look like a monster/Anytime I get a flare up, I know it coming), PRURITUS (they were itchy), SWELLING (underneath of both of my arms were swollen), DYSPNOEA (felt like I could not breathe) and SKIN WARM (skin gets hot and then the hives pop up, it comes and goes) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 028A21A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced SWELLING (underneath of both of my arms were swollen) and AXILLARY PAIN (underneath of both of my arms were painful). On 05-Jan-2022, the patient experienced URTICARIA (had huge hives that spread to all over my body/had hives in my throat/had these hive all over my body, scalp, bottom of feet, hands, private area, face, I look like a monster/Anytime I get a flare up, I know it coming) and PRURITUS (they were itchy). On 09-Jan-2022, the patient experienced DYSPNOEA (felt like I could not breathe). On an unknown date, the patient experienced SKIN WARM (skin gets hot and then the hives pop up, it comes and goes). The patient was treated with PREDNISONE from January 2022 to January 2022 for Adverse event, at a dose of 10 milligram and PREDNISONE from 09-Jan-2022 to January 2022 for Adverse event, at a dose of 60 milligram. At the time of the report, URTICARIA (had huge hives that spread to all over my body/had hives in my throat/had these hive all over my body, scalp, bottom of feet, hands, private area, face, I look like a monster/Anytime I get a flare up, I know it coming), PRURITUS (they were itchy), SWELLING (underneath of both of my arms were swollen), DYSPNOEA (felt like I could not breathe), SKIN WARM (skin gets hot and then the hives pop up, it comes and goes) and AXILLARY PAIN (underneath of both of my arms were painful) outcome was unknown. Concomitant medication of the patient was not reported. The patient thought the swelling and painful of underneath of both of arms was might be COVID arm. On 07-Jan-2022, the patient went to the doctor and the doctor prescribed 10 mg prednisone which did not work. On 09-Jan-2022, the patient went to the urgent care and the prednisone dose was increased from 10 mg to 60 mg. On 10-Jan-2022, the patient went to the dermatologist and the dermatologist indicated that the patient should stop taking prednisone because it was masking the symptoms. The dermatologist gave topical steroid cream instead. The reporter listed off a lot of areas where these hives were located but summarized it as all over her body.


VAERS ID: 2000757 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-29
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / SC

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Myocarditis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: None
Current Illness:
Preexisting Conditions: No smoker, no alcohol use, no drug use
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: I got vaccinated with the first dose of coronavirus vaccine and after 6 days i had pain in the chest and difficulty to breath. I was examined by a cardiologist and the conclusion was that I suffered from myocarditis


VAERS ID: 2013381 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-12-29
   Days after vaccination:175
Submitted: 0000-00-00
Entered: 2022-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9090 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: covid-19 rapid test; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: MXPFIZER INC202200003958

Write-up: COVID-19 test positive; COVID-19 test positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Agency. The reporter is the patient. A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jul2021 12:00 (Lot number: FA9090) at the age of 49 years as dose 2, single and administered in arm left, administration date 04Jun2021 12:00 (Lot number: FC2495) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "COVID-19 test positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: Nasal Swab.


VAERS ID: 2020223 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Photopsia, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Retinal disorders (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Flashing vision; Light-headed; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26417186) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Light-headed) and PHOTOPSIA (Flashing vision) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced DIZZINESS (Light-headed) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced PHOTOPSIA (Flashing vision) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Light-headed) and PHOTOPSIA (Flashing vision) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-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. Concomitant medications were not reported. No treatment information was provided by the reporter. Patient felt very light-headed and vision has sparky stars and pricks of light which come and go. Patient not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. Company Comment: This is a regulatory case concerning a male patient of an unknown age with no medical history, who experienced the unexpected serious events of Dizziness and Photopsia. The events occurred on the same day after the third dose of mRNA-1273 vaccine. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report due to important medical condition.; Sender''s Comments: This is a regulatory case concerning a male patient of an unknown age with no medical history, who experienced the unexpected serious events of Dizziness and Photopsia. The events occurred on the same day after the third dose of mRNA-1273 vaccine. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report due to important medical condition.


VAERS ID: 2020395 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Aching joints; Vomiting; Shivering; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26407950) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Aching joints), VOMITING (Vomiting) and CHILLS (Shivering) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On 29-Dec-2021, ARTHRALGIA (Aching joints), VOMITING (Vomiting) and CHILLS (Shivering) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-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. Treatment details not provided. concomitant drug details not provided. Woke during night after injection with joint pain, shivering, heavy sweating then vomiting. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. The report is not relate to possible inflammation of the heart (myocarditis or pericarditis); Sender''s Comments: This case concerns a female patient of an unknown age with no medical history, who experienced the unexpected serious events of Arthralgia, Vomiting, and Chills, the events were medically significant as reported by the regulatory authority. The event occurred 1 day after receiving the third dose of mRNA-1273. The rechallenge was reported as unknown by the regulatory authority. No clinical or treatment details were given. It is reported that the outcome of the event has resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2020399 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Dizziness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26415517) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 36-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment information were reported. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No possible inflammation of the heart (myocarditis or pericarditis). Company Comment: This is a regulatory case concerning a 36-year-old female patient with medical history of suspected covid-19, who experienced the unexpected serious event of Dizziness. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The outcome of the event Dizziness was reported as not resolved. Patient was tested sars cov-2 positive on an unknown date, remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report.; Sender''s Comments: This is a regulatory case concerning a 36-year-old female patient with medical history of suspected covid-19, who experienced the unexpected serious event of Dizziness. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The outcome of the event Dizziness was reported as not resolved. Patient was tested sars cov-2 positive on an unknown date, remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report.


VAERS ID: 2020400 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-17
Onset:2021-12-29
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deep vein thrombosis, Fibrin D dimer, Pain in extremity, Platelet factor 4
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: Fibrin D dimer; Result Unstructured Data: D-dimer was not $g4000; Test Name: Platelet factor 4; Result Unstructured Data: Anti-PF4 antibodies were not identified
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: dvt; calf pain; DVT of legs; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26415590) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEEP VEIN THROMBOSIS (dvt), PAIN IN EXTREMITY (calf pain) and DEEP VEIN THROMBOSIS (DVT of legs) in a 25-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Non-smoker. Concurrent medical conditions included Asthma. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT of legs) (seriousness criterion medically significant). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (dvt) (seriousness criterion medically significant) and PAIN IN EXTREMITY (calf pain) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (dvt) and PAIN IN EXTREMITY (calf pain) had not resolved and DEEP VEIN THROMBOSIS (DVT of legs) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Fibrin D dimer: d-dimer was not $g4000 (abnormal) D-dimer was not $g4000. On an unknown date, Platelet factor 4: anti-pf4 antibodies were not identified (normal) Anti-PF4 antibodies were not identified. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had Moderna booster on 17-DEC-2021, on 19-DEC-2021 developed right calf pain. presented to hospital, had negative Dimer and normal Well''s score, on 29-DEC-2021, DVT was diagnosed as symptoms which did not resolve. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. The laboratory exam was done that includes US and the diagnosed by distal femoral right DVT Diagnosis was done by US on 29-DEC-2021.on 29-D-EC-2021 the D-dimer platelet count measured, and the result was found Unknown. on Unknown date the platelet count after vaccination measured and the result was found 192 and 202 which was Normal.The laboratory exam was done that includes PT and the result found 10.3, Activated Partial Thromboplastin Clotting Time 21.3, and Fibrinogen found to be 2.8.Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Company comment:This RA case concerns a male patient of 25 years with medical history of Interchange of vaccine products (was with TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) before current vaccination) and concurrent medical history of Asthma and nonsmoker, who experienced the unexpected serious AESI events of Deep vein thrombosis (DVT) and Deep vein thrombosis (DVT of legs) and unexpected serious event of Pain in extremity (Medically significant). The event Deep vein Thrombosis occurred 12 days and pain in extremity and Deep vein thrombosis occurred from unknown date after the third dose of mRNA1273 vaccine. Reportedly, Fibrin D dimer: d-dimer was not $g4000 (abnormal) and Platelet factor 4: anti-pf4 antibodies were not identified. The outcome was reported not resolved for Deep vein thrombosis (DVT) and resolving for Pain in extremity and Deep vein thrombosis (DVT of legs). The Interchange of vaccine products remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This RA case concerns a male patient of 25 years with medical history of Interchange of vaccine products (was with TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) before current vaccination) and concurrent medical history of Asthma and nonsmoker, who experienced the unexpected serious AESI events of Deep vein thrombosis (DVT) and Deep vein thrombosis (DVT of legs) and unexpected serious event of Pain in extremity (Medically significant). The event Deep vein Thrombosis occurred 12 days and pain in extremity and Deep vein thrombosis occurred from unknown date after the third dose of mRNA1273 vaccine. Reportedly, Fibrin D dimer: d-dimer was not $g4000 (abnormal) and Platelet factor 4: anti-pf4 antibodies were not identified. The outcome was reported not resolved for Deep vein thrombosis (DVT) and resolving for Pain in extremity and Deep vein thrombosis (DVT of legs). The Interchange of vaccine products remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2020403 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Headache, Hyperhidrosis, Nausea, Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test
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), Vestibular disorders (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Sore throat; Aching joints; Pain in arm; Dizzy spells; Headache; Sweating; Nausea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26418728) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Aching joints), PAIN IN EXTREMITY (Pain in arm), DIZZINESS (Dizzy spells), HEADACHE (Headache), HYPERHIDROSIS (Sweating), NAUSEA (Nausea) and OROPHARYNGEAL PAIN (Sore throat) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), DIZZINESS (Dizzy spells) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Aching joints), PAIN IN EXTREMITY (Pain in arm) and DIZZINESS (Dizzy spells) had not resolved, HEADACHE (Headache) had resolved with sequelae and HYPERHIDROSIS (Sweating), NAUSEA (Nausea) and OROPHARYNGEAL PAIN (Sore throat) 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) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment drug information was not provided. Patient last menstrual period date was mentioned as 20-DEC-2021. Patient felt like whole body ached head to toe her arm still hurts 2 days later sharp stabbing pains, headache that then led to dizziness like the room was spinning which lasted 2 days and still got the headache now. Had weird taste in mouth and sore throat almost instantly after the vaccine Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This case concerns a 29-year-old female patient with no medical history, who experienced the unexpected serious events of Arthralgia, Pain In Extremity, Dizziness, Headache, Hyperhidrosis, Nausea, Oropharyngeal Pain, the events were medically significant as reported by the regulatory authority. The event occurred 1 day after receiving the third dose of mRNA-1273. The rechallenge was reported as unknown by the regulatory authority. No clinical or treatment details were given. It is reported that the outcome of the event has resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 29-year-old female patient with no medical history, who experienced the unexpected serious events of Arthralgia, Pain In Extremity, Dizziness, Headache, Hyperhidrosis, Nausea, Oropharyngeal Pain, the events were medically significant as reported by the regulatory authority. The event occurred 1 day after receiving the third dose of mRNA-1273. The rechallenge was reported as unknown by the regulatory authority. No clinical or treatment details were given. It is reported that the outcome of the event has resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2020453 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Maternal exposure during breast feeding, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Neonatal exposures via breast milk (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: PFIZER BIONTECH COVID-19 VACCINE; IBUPROFEN; PARACETAMOL
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: dizzy; Maternal exposure during breast feeding; Dizziness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26411995) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and DIZZINESS (Dizziness) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Breast feeding. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 13-Jun-2021 to an unknown date, IBUPROFEN and PARACETAMOL for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (dizzy) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). On 29-Dec-2021, DIZZINESS (Dizziness) had resolved. At the time of the report, DIZZINESS (dizzy) had not resolved and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-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 medication reported. Company Comment: This regulatory case concerns a 39-year-old, female patient currently breast feeding, with an Interchange of vaccine products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) 6 months before the current vaccination, who experienced the unexpected serious events of Dizzy and Dizziness. Maternal exposure during breast feeding is also reported. The event Dizziness occurred on the same day and the event Dizzy on an unknown date after the third dose of mRNA-1273 vaccine. The outcome of the event Dizziness is reported as resolved and Dizzy as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report.; Sender''s Comments: This regulatory case concerns a 39-year-old, female patient currently breast feeding, with an Interchange of vaccine products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) 6 months before the current vaccination, who experienced the unexpected serious events of Dizzy and Dizziness. Maternal exposure during breast feeding is also reported. The event Dizziness occurred on the same day and the event Dizzy on an unknown date after the third dose of mRNA-1273 vaccine. The outcome of the event Dizziness is reported as resolved and Dizzy as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s.


VAERS ID: 2020464 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-29
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Nausea, SARS-CoV-2 test, Sinus pain, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Weakness; Sinus pain; Nausea; Stomach ache; Diarrhea; Vomiting; This case was received via Regulatory Authority RA (Reference number: GB-MHRA-ADR 26412083) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), SINUS PAIN (Sinus pain), NAUSEA (Nausea), ABDOMINAL PAIN UPPER (Stomach ache), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ASTHENIA (Weakness) (seriousness criterion medically significant), SINUS PAIN (Sinus pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). At the time of the report, ASTHENIA (Weakness), SINUS PAIN (Sinus pain), NAUSEA (Nausea) and ABDOMINAL PAIN UPPER (Stomach ache) had not resolved and DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-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. Treatment information was not provided. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 42-year-old female patient, with no reported medical history, who experienced the serious, unexpected events of asthenia, sinus pain, nausea, abdominal pain upper, diarrhea, and vomiting 7 days after she received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). At the time of report, events weakness, sinus pain, nausea and abdominal pain upper had not resolved, while diarrhea and vomiting had resolved with sequelae. Patient received COVID-19 VACCINE ASTRAZENECA on unspecified date.The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 42-year-old female patient, with no reported medical history, who experienced the serious, unexpected events of asthenia, sinus pain, nausea, abdominal pain upper, diarrhea, and vomiting 7 days after she received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). At the time of report, events weakness, sinus pain, nausea and abdominal pain upper had not resolved, while diarrhea and vomiting had resolved with sequelae. Patient received COVID-19 VACCINE ASTRAZENECA on unspecified date.The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 2020472 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-29
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005287 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Armpit pain; Painful arm; Shivering; Headache; Muscle ache; Joint pain; Feverish; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26418656) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Armpit pain), PAIN IN EXTREMITY (Painful arm), CHILLS (Shivering), HEADACHE (Headache), MYALGIA (Muscle ache), ARTHRALGIA (Joint pain) and PYREXIA (Feverish) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005287) for an unknown indication. No Medical History information was reported. In 2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant) and PYREXIA (Feverish) (seriousness criterion medically significant). On 30-Dec-2021, PYREXIA (Feverish) had resolved. At the time of the report, AXILLARY PAIN (Armpit pain) and PAIN IN EXTREMITY (Painful arm) had not resolved and CHILLS (Shivering), HEADACHE (Headache), MYALGIA (Muscle ache) and ARTHRALGIA (Joint pain) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not tested for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial Patient is not currently breast feeding. No concomitant medications were provided by reporter No treatment medications were provided by reporter Re-challenge was reported as unknown. Company comment: This case concerns a 36-year-old female patient, with no reported medical history, who experienced the serious, unexpected events of axillary pain, pain in extremity, chills, headache, myalgia, arthralgia, and pyrexia after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). Authority reports the interval between the start of events and vaccine was 12 months, however, date of the vaccine was not provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 36-year-old female patient, with no reported medical history, who experienced the serious, unexpected events of axillary pain, pain in extremity, chills, headache, myalgia, arthralgia, and pyrexia after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). Authority reports the interval between the start of events and vaccine was 12 months, however, date of the vaccine was not provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 2021934 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-12-29
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2022-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: Covid test; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: AUPFIZER INC202200009925

Write-up: Contracted COVID-19 in December 2021.; vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non healthcare professional). The reporter is the patient. A 35 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 31Jul2021 (Batch/Lot number: unknown) at the age of 35 years as dose 2, single and administered in arm left, administration date 08Jul2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 29Dec2021, outcome "recovering", described as "Contracted COVID-19 in December 2021."; VACCINATION FAILURE (medically significant) with onset 29Dec2021, outcome "recovering", described as "vaccination failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of covid-19, vaccination failure. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2022487 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PCA0002 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Fatigue, Feeling hot, Headache, Immunisation, Muscle tightness, Paraesthesia, Pharyngeal swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DIENOGEST; IBUPROFEN; NOVAMINSULFON
Current Illness: Asthma; Fructose intolerance; Pollen allergy; Seafood allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Adenomyosis; Endometriosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101885542

Write-up: Anaphylaxis by vaccination; tightness in the neck; feeling that the larynx swelled; Tingling in the legs/Tingling of the face; Feeling hot on the face, like the face is glowing; Headache; Tiredness; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 24 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 29Dec2021 07:45 (Lot number: PCA0002) at the age of 24 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "Endometriosis" (unspecified if ongoing); "Adenomyosis" (unspecified if ongoing); "Pollen allergy" (ongoing); "Seafood allergy" (ongoing); "Fructose intolerance" (ongoing). Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: dienogest; ibuprofen; metamizole (NOVAMINSULFON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: bnt162b2 (COMIRNATY) (Dose Number: 1, Batch/Lot No: EX8679), administration date: 13May2021, for COVID-19 Immunisation; bnt162b2 (COMIRNATY) (Dose Number: 2, Batch/Lot No: EX7823), administration date: 10Jun2021, for COVID-19 Immunisation. On 29Dec2021 20:00, the patient experienced anaphylaxis by vaccination, tightness in the neck, feeling that the larynx swelled, tingling in the legs/tingling of the face, feeling hot on the face, like the face is glowing, headache, tiredness. The events "anaphylaxis by vaccination", "tightness in the neck", "feeling that the larynx swelled", "tingling in the legs/tingling of the face", "feeling hot on the face, like the face is glowing", "headache" and "tiredness" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of anaphylactic reaction, muscle tightness, pharyngeal swelling, paraesthesia, feeling hot, headache, fatigue, for which included 250mg prednisolon, 4mg dimetindene maleate (FENISTIL). Since the vaccination, it was unknown if the patient had been tested for COVID-19. The outcome of the "anaphylaxis by vaccination", "tightness in the neck", "feeling that the larynx swelled", "tingling in the legs/tingling of the face", "feeling hot on the face, like the face is glowing", "headache" and "tiredness" was resolving.


VAERS ID: 2022752 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Agitation, Back pain, Headache, Nausea, Pain in extremity, Renal pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (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: COVID-19 VACCINE ASTRAZENECA
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.MOD20214

Write-up: Leg pain; Agitation; Nausea; Back pain; Kidney pain; Headache; Painful arm; This case was received via the RA (Reference number: GB-MHRA-ADR 26418143) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), AGITATION (Agitation), HEADACHE (Headache), PAIN IN EXTREMITY (Painful arm), NAUSEA (Nausea), BACK PAIN (Back pain) and RENAL PAIN (Kidney pain) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced PAIN IN EXTREMITY (Leg pain) (seriousness criterion medically significant), AGITATION (Agitation) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), BACK PAIN (Back pain) (seriousness criterion medically significant) and RENAL PAIN (Kidney pain) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Leg pain), HEADACHE (Headache), PAIN IN EXTREMITY (Painful arm), NAUSEA (Nausea), BACK PAIN (Back pain) and RENAL PAIN (Kidney pain) had not resolved and AGITATION (Agitation) 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 was on antidepressants and prevailing and omeprazole. Most of the patient symptoms began overnight following the injection. Regarding the leg pain, it was in both legs from thigh to calf and was quite severe. Patient did not relate the report to possible inflammation of the heart (myocarditis or pericarditis) No treatment medication was provided by the reporter. Company comment: This is a regulatory authority case concerning a 42-year-old female patient with no relevant medical history who experienced events of pain in extremity (leg pain and painful arm), back pain, headache, nausea, renal pain and agitation (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. Treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 42-year-old female patient with no relevant medical history who experienced events of pain in extremity (leg pain and painful arm), back pain, headache, nausea, renal pain and agitation (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. Treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2022785 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 1 - / OT
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse drug reaction, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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: BOOTS COLD AND FLU RELIEF HOT LEMON
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Tingling arm; Tingling; This regulatory authority case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Tingling arm) and PARAESTHESIA (Tingling) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for COVID-19 vaccination. Co-suspect product included mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for COVID-19 vaccination. Concomitant products included ASCORBIC ACID, PARACETAMOL (BOOTS COLD AND FLU RELIEF HOT LEMON) for Ill-defined disorder. On 29-Dec-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form and first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 29-Dec-2021, the patient experienced ADVERSE DRUG REACTION (Tingling arm) (seriousness criterion disability) and PARAESTHESIA (Tingling) (seriousness criterion disability). At the time of the report, ADVERSE DRUG REACTION (Tingling arm) and PARAESTHESIA (Tingling) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) was unknown. mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) dosing remained unchanged. No treatment medication reported. Patient had heavy, painful arm with constant tingling all the way from shoulder to fingers. Feels cold, aside from the injection site, which is hot, red, hard and painful. Pain in armpit. Unable to lift arm. Is continuing to get worse. Since starting to fill in this form, my lower arm feels as though it is being strangled. The patient was taking Moderna Vaccine for: COVID-19 vaccination. The patient was taking Moderna Vaccine for: COVID-19 vaccination. This is a regulatory authority case concerning a 39-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of adverse drug reaction, Paraesthesia. The events occurred approximately on the same day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The events were reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 39-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of adverse drug reaction, Paraesthesia. The events occurred approximately on the same day after the first dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was not applicable, as the event happened after the first dose. The events were reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2023212 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
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), 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: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Headache; Fever; Muscle ache; Nausea; Tiredness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26406993) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), MYALGIA (Muscle ache), NAUSEA (Nausea) and FATIGUE (Tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included (PFIZER BIONTECH COVID-19 VACCINE) and (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), MYALGIA (Muscle ache) and FATIGUE (Tiredness) had not resolved and NAUSEA (Nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical history information was provided. No treatment details were reported. The patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. Company comment: This case concerns a female patient of an unknown age with no medical history provided who experienced serious unexpected events of Headache, Pyrexia, Myalgia, Nausea and Fatigue. The events occurred one day after the third, booster dose of mRNA-1273. At the time of the report, Nausea was resolving whereas all the other events were still ongoing. No further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient also received PFIZER BIONTECH COVID-19 VACCINE, Interchange of vaccine products should have been considered in this particular case.; Sender''s Comments: This case concerns a female patient of an unknown age with no medical history provided who experienced serious unexpected events of Headache, Pyrexia, Myalgia, Nausea and Fatigue. The events occurred one day after the third, booster dose of mRNA-1273. At the time of the report, Nausea was resolving whereas all the other events were still ongoing. No further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient also received PFIZER BIONTECH COVID-19 VACCINE, Interchange of vaccine products should have been considered in this particular case.


VAERS ID: 2023213 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dizziness, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fever; Headache; Dizziness; Weakness; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26406998) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), DIZZINESS (Dizziness) and ASTHENIA (Weakness) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and ASTHENIA (Weakness) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), HEADACHE (Headache), DIZZINESS (Dizziness) and ASTHENIA (Weakness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment This is a regulatory case concerning a 29-year-old female patient with no medical history reported, who experienced the serious unexpected, according to reporter, events of pyrexia, headache, dizziness and asthenia. The events occurred the day after the third dose of mRNA-1273 vaccine and, at the moment of the report, was recovering. The rechallenge is unknown according to SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 29-year-old female patient with no medical history reported, who experienced the serious unexpected, according to reporter, events of pyrexia, headache, dizziness and asthenia. The events occurred the day after the third dose of mRNA-1273 vaccine and, at the moment of the report, was recovering. The rechallenge is unknown according to SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2023225 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular 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:
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.MOD20214

Write-up: Fever chills; Dizziness; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26407479) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever chills) and DIZZINESS (Dizziness) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever chills) and DIZZINESS (Dizziness) had not 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 information was provided. No treatment medication was provided. Company comment. This case concerns a male patient of unknown age, with no reported medical history, who experienced the serious (medically significant) unexpected events of PYREXIA and DIZZINESS. The events occurred 1 day after receiving a third dose of mRNA-1273. No information about previous vaccination schedule was provided. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This case concerns a male patient of unknown age, with no reported medical history, who experienced the serious (medically significant) unexpected events of PYREXIA and DIZZINESS. The events occurred 1 day after receiving a third dose of mRNA-1273. No information about previous vaccination schedule was provided. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2023265 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness postural, Fatigue, Headache, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Headache; Fatigue; Generalised muscle aches; Dizziness postural; This case was received via RA (Reference number: GB-MHRA-ADR 26408290) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Generalised muscle aches) and DIZZINESS POSTURAL (Dizziness postural) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), MYALGIA (Generalised muscle aches) (seriousness criterion medically significant) and DIZZINESS POSTURAL (Dizziness postural) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Generalised muscle aches) and DIZZINESS POSTURAL (Dizziness postural) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-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 concomitant medication information was provided. No treatment medication was provided. Company comment: This case concerns a female patient of an unknown age with no medical history provided who experienced serious unexpected events of Headache, Fatigue, Myalgia and Dizziness postural. The events occurred one day after the third dose of mRNA-1273. At the time of the report, all the events were still ongoing and no further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a female patient of an unknown age with no medical history provided who experienced serious unexpected events of Headache, Fatigue, Myalgia and Dizziness postural. The events occurred one day after the third dose of mRNA-1273. At the time of the report, all the events were still ongoing and no further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2023275 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac flutter, Diarrhoea, Fatigue, Headache, Muscular weakness, Nausea, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211112; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: racing heart; Fatigue/unusual tiredness; Fever; Heart palpitations; Racing heart (tachycardia); Diarrhea; Heart fluttering; Tiredness; Muscle weakness; Nausea; Headache; Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26408740) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (racing heart), MUSCULAR WEAKNESS (Muscle weakness), NAUSEA (Nausea), HEADACHE (Headache), the first episode of PYREXIA (Fever), FATIGUE (Fatigue/unusual tiredness), the second episode of PYREXIA (Fever), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)), DIARRHOEA (Diarrhea), CARDIAC FLUTTER (Heart fluttering) and FATIGUE (Tiredness) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 09-Nov-2021 to 18-Nov-2021. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 30-May-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 30-May-2021 to an unknown date for COVID-19 vaccination. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), the first episode of PYREXIA (Fever) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant), CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). 29-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced PALPITATIONS (racing heart) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), the second episode of PYREXIA (Fever) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (racing heart), MUSCULAR WEAKNESS (Muscle weakness), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved, FATIGUE (Fatigue/unusual tiredness), the last episode of PYREXIA (Fever), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown and DIARRHOEA (Diarrhea), CARDIAC FLUTTER (Heart fluttering) and FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication were reported Patient was not currently breastfeeding and the last menstrual period date was on 18-Dec-2021. The report related to possible inflammation of the heart (myocarditis or pericarditis) without leading to hospital stay, with no diagnosis and no blood tests were made. Company comment This is a regulatory case concerning a 31-year-old female patient with medical history of Suspected COVID-19 from 09-Nov-2021 to 18-Nov-2021, who experienced the serious unexpected, according to Regulatory Authority, events of cardiac flutter, palpitations, muscular weakness, nausea, headache, the first episode of pyrexia, fatigue the second episode of pyrexia, palpitations, tachycardia, diarrhoea, fatigue. the events muscle weakness, headache, the first episode of pyrexia, diarrhoea, cardiac flutter and fatigue occurred the day after the third dose of mRNA-1273. Palpitations, fatigue, the second episode of pyrexia and tachycardia occurred on an unknown date after the third dose of mRNA-1273. The rechallenge is unknown according to reporter. The medical history of Suspected COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 31-year-old female patient with medical history of Suspected COVID-19 from 09-Nov-2021 to 18-Nov-2021, who experienced the serious unexpected, according to Regulatory Authority, events of cardiac flutter, palpitations, muscular weakness, nausea, headache, the first episode of pyrexia, fatigue the second episode of pyrexia, palpitations, tachycardia, diarrhoea, fatigue. the events muscle weakness, headache, the first episode of pyrexia, diarrhoea, cardiac flutter and fatigue occurred the day after the third dose of mRNA-1273. Palpitations, fatigue, the second episode of pyrexia and tachycardia occurred on an unknown date after the third dose of mRNA-1273. The rechallenge is unknown according to reporter. The medical history of Suspected COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023278 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Dizziness, Pyrexia, Vision blurred, Vomiting, Xanthopsia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Felt faint; Vomiting; Fever; Vision yellow; Blurred vision; Stomach cramps; Dizziness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26408884) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Felt faint), VOMITING (Vomiting), PYREXIA (Fever), XANTHOPSIA (Vision yellow), VISION BLURRED (Blurred vision), ABDOMINAL PAIN UPPER (Stomach cramps) and DIZZINESS (Dizziness) in a 20-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2021, the patient experienced DIZZINESS (Felt faint) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), XANTHOPSIA (Vision yellow) (seriousness criterion medically significant), VISION BLURRED (Blurred vision) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach cramps) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 29-Dec-2021, VOMITING (Vomiting), PYREXIA (Fever), XANTHOPSIA (Vision yellow), VISION BLURRED (Blurred vision), ABDOMINAL PAIN UPPER (Stomach cramps) and DIZZINESS (Dizziness) had resolved. At the time of the report, DIZZINESS (Felt faint) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test and Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. No treatment information was reported. Company Comment: This is a regulatory case concerning a 20-year-old female patient with no medical history, who experienced the unexpected serious events of Dizziness, vomiting, Pyrexia, Xanthopsia, vision blurred, Abdominal Pain upper and Dizziness. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The outcome of the event Dizziness was reported as resolving and vomiting, Pyrexia, Xanthopsia, vision blurred, Abdominal Pain upper and Dizziness was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report.; Sender''s Comments: This is a regulatory case concerning a 20-year-old female patient with no medical history, who experienced the unexpected serious events of Dizziness, vomiting, Pyrexia, Xanthopsia, vision blurred, Abdominal Pain upper and Dizziness. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The outcome of the event Dizziness was reported as resolving and vomiting, Pyrexia, Xanthopsia, vision blurred, Abdominal Pain upper and Dizziness was reported as resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report.


VAERS ID: 2023286 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia, Influenza like illness, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (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: Hypermobility syndrome; Comments: Hypermobility Patient has not had symptoms associated with COVID-19
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.MOD20214

Write-up: Numbness in hand; Numbness in fingers; Flu-like aching; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26409112) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in hand), HYPOAESTHESIA (Numbness in fingers) and INFLUENZA LIKE ILLNESS (Flu-like aching) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Hypermobility Patient has not had symptoms associated with COVID-19. The patient''s past medical history included Hypermobility syndrome. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HYPOAESTHESIA (Numbness in hand) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in fingers) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (Numbness in hand), HYPOAESTHESIA (Numbness in fingers) and INFLUENZA LIKE ILLNESS (Flu-like aching) had not 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. Patient had partial loss of mobility in hands/lack of dexterity, severe aching in both arms and shoulders. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient report was not related to possible inflammation of the heart. No concomitant medications were reported. No treatment medications were reported. Company Comment: This case concerns a 24-year-old female, with no relevant reported medical history in this case, who experienced the serious unexpected events of Hypoaesthesia (reported as Numbness in hand), Hypoaesthesia (reported as Numbness in fingers) and Influenza like illness. The events occurred one day after the administration of the 3rd dose of mRNA-1273 vaccine and at the time of the report, the outcome for the event was Not Recovered/Not Resolved. The rechallenge could be considered not applicable since the events occurred after the 23rd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 24-year-old female, with no relevant reported medical history in this case, who experienced the serious unexpected events of Hypoaesthesia (reported as Numbness in hand), Hypoaesthesia (reported as Numbness in fingers) and Influenza like illness. The events occurred one day after the administration of the 3rd dose of mRNA-1273 vaccine and at the time of the report, the outcome for the event was Not Recovered/Not Resolved. The rechallenge could be considered not applicable since the events occurred after the 23rd dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023287 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26409096) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. No concomitant medications were reported. No treatment information was provided. Patient was not enrolled in clinical trial. Company comment: This case concerns a female patient of an unknown age with no medical history provided who experienced serious unexpected event of Headache. The event occurred one day after the third dose of mRNA-1273. At the time of the report, the event was still ongoing and no further information regarding clinical course of the event was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per regulatory authority and kept as such. Event seriousness assessed as per Regulatory Authority reporting. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a female patient of an unknown age with no medical history provided who experienced serious unexpected event of Headache. The event occurred one day after the third dose of mRNA-1273. At the time of the report, the event was still ongoing and no further information regarding clinical course of the event was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per regulatory authority and kept as such. Event seriousness assessed as per Regulatory Authority reporting. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2023291 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Fatigue, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fatigue/unusual tiredness; Chest pain; Fever; Racing heart (tachycardia); racing heart; Chest pain; This case was received via RA (Reference number: GB-MHRA-ADR 26409393) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (racing heart), the first episode of CHEST PAIN (Chest pain), FATIGUE (Fatigue/unusual tiredness), the second episode of CHEST PAIN (Chest pain), PYREXIA (Fever) and TACHYCARDIA (Racing heart (tachycardia)) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 05-Jun-2021 to an unknown date for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced PALPITATIONS (racing heart) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (racing heart), FATIGUE (Fatigue/unusual tiredness), the last episode of CHEST PAIN (Chest pain), PYREXIA (Fever) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, 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 had Intermittent chest pain Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial No medical history was provided by the reporter. No treatment medication details were provided by reporter. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. This report relate to possible inflammation of the heart (myocarditis or pericarditis). Company comment: This regulatory authority case concerns a 28-year-old female patient, with no reported medical history, who experienced the serious (medically significant) unexpected events of PALPITATIONS, CHEST PAIN, FATIGUE, PYREXIA and TACHYCARDIA. The event of chest pain occurred 1 day after receiving a dose of mRNA-1273 and had not resolved by the time of this report. Patient previous vaccination schedule included at least 1 dose of Tozinameran. No onset date was reported for other events. According to source document narrative, patient experienced intermittent chest pain. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory authority case concerns a 28-year-old female patient, with no reported medical history, who experienced the serious (medically significant) unexpected events of PALPITATIONS, CHEST PAIN, FATIGUE, PYREXIA and TACHYCARDIA. The event of chest pain occurred 1 day after receiving a dose of mRNA-1273 and had not resolved by the time of this report. Patient previous vaccination schedule included at least 1 dose of Tozinameran. No onset date was reported for other events. According to source document narrative, patient experienced intermittent chest pain. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2023299 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Chills, Dizziness postural, Headache, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Tight chest; Headache; Dizzy on standing; Chills; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26410101) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Chills), CHEST DISCOMFORT (Tight chest), HEADACHE (Headache) and DIZZINESS POSTURAL (Dizzy on standing) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST DISCOMFORT (Tight chest) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant). At the time of the report, CHILLS (Chills), CHEST DISCOMFORT (Tight chest), HEADACHE (Headache) and DIZZINESS POSTURAL (Dizzy on standing) had not 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 was reported No treatment information was provided Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Company comment: This regulatory authority case concerns a 45-year-old female patient with no relevant medical history who experienced serious unexpected event of chills, chest discomfort, headache and dizziness, that occurred on the same day after the third dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 45-year-old female patient with no relevant medical history who experienced serious unexpected event of chills, chest discomfort, headache and dizziness, that occurred on the same day after the third dose of the mRNA-1273. The rechallenge was not applicable due to occurrence after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2023319 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Urine output
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Urine output; This case was received via Regulatory Authority on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of URINE OUTPUT (Urine output) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced URINE OUTPUT (Urine output) (seriousness criterion medically significant). At the time of the report, URINE OUTPUT (Urine output) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case refers to a 31-year-old female patient with no known medical history who experienced the unexpected event of Urine output on the same day after receiving the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case refers to a 31-year-old female patient with no known medical history who experienced the unexpected event of Urine output on the same day after receiving the third dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2023320 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000050A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Muscle pain; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26411430) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) in a 25-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000050A) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle pain) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was given. Unsure if patient had symptoms associated with COVID-19 Not had a COVID-19 test. It was reported that patient woke up with unable to move body severely stiff with muscle cramp. Patient had not tested positive for COVID-19 since having the vaccine. No treatment medication was given. Company Comment: This case concerns a 25-year-old male patient, with no medical history reported, who experienced the unexpected and serious event of Myalgia. The event is assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The event occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 25-year-old male patient, with no medical history reported, who experienced the unexpected and serious event of Myalgia. The event is assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The event occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023322 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Night sweats, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fever; Night sweats; Fever chills; Painful L arm; High temperature; Muscle ache; This case was received via RA (Reference number: GB-MHRA-ADR 26410870) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NIGHT SWEATS (Night sweats), PYREXIA (Fever chills), PAIN IN EXTREMITY (Painful L arm), PYREXIA (High temperature) and MYALGIA (Muscle ache) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 18-Apr-2020 to 03-May-2020. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), NIGHT SWEATS (Night sweats) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful L arm) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), NIGHT SWEATS (Night sweats), PYREXIA (Fever chills) and PYREXIA (High temperature) was resolving and PAIN IN EXTREMITY (Painful L arm) and MYALGIA (Muscle ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive covid-19 test (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Date of LMP was reported on 01-Dec-2021. Patient had covid in April 2020, had covid jabs 05-Feb-2021 and 16-Apr-2021 and moderna booster - had reacted the same way every time. Not able to go to work or do any normal day to day activities. Patient was not tested positive for COVID-19 since having the vaccine and was enrolled in clinical trial. This case concerns a 22-year-old female patient, with no relevant medical history reported, who experienced the serious (medically significant) unexpected events of PYREXIA (reported as fever, fever chills and high temperature), NIGHT SWEATS, PAIN IN EXTREMITY and MYALGIA. The events occurred 1 day after receiving a booster dose of mRNA-1273. No information about previous vaccination schedule was reported. Patient states on the source document narrative that she experienced similar symptoms with previous vaccination; however, it is unknown which COVID 19 vaccine was administered. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This case concerns a 22-year-old female patient, with no relevant medical history reported, who experienced the serious (medically significant) unexpected events of PYREXIA (reported as fever, fever chills and high temperature), NIGHT SWEATS, PAIN IN EXTREMITY and MYALGIA. The events occurred 1 day after receiving a booster dose of mRNA-1273. No information about previous vaccination schedule was reported. Patient states on the source document narrative that she experienced similar symptoms with previous vaccination; however, it is unknown which COVID 19 vaccine was administered. No further clinical information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2023324 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Nephritis, Renal pain, SARS-CoV-2 test, Vertigo
SMQs:, Acute renal failure (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Vestibular disorders (narrow), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart attack
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: kidney inflammation; pain in the back area; Kidney pain; Vertigo; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26411058) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RENAL PAIN (Kidney pain), VERTIGO (Vertigo), NEPHRITIS (kidney inflammation) and BACK PAIN (pain in the back area) in a 27-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. The patient''s past medical history included Heart attack. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced RENAL PAIN (Kidney pain) (seriousness criterion medically significant) and VERTIGO (Vertigo) (seriousness criterion medically significant). On an unknown date, the patient experienced NEPHRITIS (kidney inflammation) (seriousness criterion medically significant) and BACK PAIN (pain in the back area) (seriousness criterion medically significant). At the time of the report, RENAL PAIN (Kidney pain) and VERTIGO (Vertigo) had not resolved and NEPHRITIS (kidney inflammation) and BACK PAIN (pain in the back area) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-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 reported that he was not taking any pills or medications. Patient had not had symptoms associated with COVID-19. In the morning after the vaccine patient woke feeling like having a severe flu. patient took sick day. Took paracetamol 500mg one pill and took a nap. Woke up after 2-3 hours, ate, drink light coffee and plenty of water. Pain in the back area, where were the kidneys hurts whole day. Started to Google it and it appears that it was a rare side effect having kidney inflammation. Patient''s family had a history or kidney and liver cancers, heart attacks and strokes any other illnesses related to kidneys. So, he was very concerned at the moment, as he did not have any serious issues before with my health, as he lived fairly healthy. Patient had not tested positive for COVID-19 since having the vaccine. No concomitant medication was reported. No treatment information was provided.; Sender''s Comments: This case concerns a 27-year-old, female patient with relevant medical history of myocardial infarction and family history of kidney cancer, liver cancer, myocardial infarction, strokes, and other illness related to kidney (not specified), who experienced the unexpected serious events of Renal Pain, Vertigo, Nephritis, and Back Pain. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after third dose. This patient underlying medical condition and multiple family history remains a contributory/risk factor. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2023327 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Nausea; Aches & pains in legs; Dizziness; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26411271) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PAIN IN EXTREMITY (Aches & pains in legs) and DIZZINESS (Dizziness) in a 47-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 26-Apr-2021 to an unknown date for COVID-19, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea), PAIN IN EXTREMITY (Aches & pains in legs) and DIZZINESS (Dizziness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical history was reported. Treatment information was not provided. Patient''s last menstrual period date was reported as 1-DEC-2021. Patient has not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This is a regulatory authority case concerning a 47-year-old female patient with no medical history reported, who experienced events of pain in extremity, dizziness and nausea (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 47-year-old female patient with no medical history reported, who experienced events of pain in extremity, dizziness and nausea (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023336 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy, Maternal exposure during breast feeding, SARS-CoV-2 test
SMQs:, Neonatal exposures via breast milk (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Maternal exposure during breast feeding; Swollen lymph nodes; This case was received via RA (Reference number: GB-MHRA-ADR 26411785) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Breast feeding. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) had not resolved and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) 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) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment and concomitant mediations are reported Company comment This is a regulatory case concerning 34-year-old female patient currently Breast feeding with no other relevant medical history reported, who experienced the serious expected, according CCDS, events of LYMPHADENOPATHY and MATERNAL EXPOSURE DURING BREAST FEEDING. The event PYREXIA occurred on the same day after the third dose of mRNA-1273. The event LYMPHADENOPATHY occurred 2 days after the third dose of mRNA-1273. The event MATERNAL EXPOSURE DURING BREAST FEEDING occurred on an unknown date after the third dose of mRNA-1273. The rechallenge is unknown according to SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning 34-year-old female patient currently Breast feeding with no other relevant medical history reported, who experienced the serious expected, according Agency, events of LYMPHADENOPATHY and MATERNAL EXPOSURE DURING BREAST FEEDING. The event PYREXIA occurred on the same day after the third dose of mRNA-1273. The event LYMPHADENOPATHY occurred 2 days after the third dose of mRNA-1273. The event MATERNAL EXPOSURE DURING BREAST FEEDING occurred on an unknown date after the third dose of mRNA-1273. The rechallenge is unknown according to SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2023337 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Back pain, Influenza, Pain in extremity, Palpitations, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211225; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Back pain; Palpitations; Painful arm; Flu symptoms; Chronic back pain; Loss of taste; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26411817) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PALPITATIONS (Palpitations), PAIN IN EXTREMITY (Painful arm), INFLUENZA (Flu symptoms), BACK PAIN (Chronic back pain) and AGEUSIA (Loss of taste) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), INFLUENZA (Flu symptoms) (seriousness criterion medically significant), BACK PAIN (Chronic back pain) (seriousness criterion medically significant) and AGEUSIA (Loss of taste) (seriousness criterion medically significant). On an unknown date, the patient experienced BACK PAIN (Back pain) (seriousness criterion medically significant). At the time of the report, BACK PAIN (Back pain) was resolving and PALPITATIONS (Palpitations), PAIN IN EXTREMITY (Painful arm), INFLUENZA (Flu symptoms), BACK PAIN (Chronic back pain) and AGEUSIA (Loss of taste) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-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 concomitant medications were reported. Treatment information was not provided. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Symptoms started after approxmately 16 hours of vaccination. Began with intense fly symptoms, then progressed with headaches, back pain, increased heart rate. Loss of taste was also present. Company Comment: This is a regulatory case concerning a 41-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of Ageusia (AESI), palpitations, pain in extremity, chronic back pain and influenza, on the next day (16 hours) after the third dose of mRNA-1273 vaccine. Back pain was also reported at an unknown date. A negative SARS-CoV-2 test was reported 3 days before vaccination). The medical history remains as a confounder/ remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.; Sender''s Comments: This is a regulatory case concerning a 41-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of Ageusia (AESI), palpitations, pain in extremity, chronic back pain and influenza, on the next day (16 hours) after the third dose of mRNA-1273 vaccine. Back pain was also reported at an unknown date. A negative SARS-CoV-2 test was reported 3 days before vaccination). The medical history remains as a confounder/ remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.


VAERS ID: 2023341 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Muscle spasms, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE MODERNA
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: cramp; breathlessness; Hand pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26412217) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramp), DYSPNOEA (breathlessness) and PAIN IN EXTREMITY (Hand pain) in a 28-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Suspected COVID-19 since 29-Dec-2021. Concomitant products included ELASOMERAN (COVID-19 VACCINE MODERNA) for COVID-19. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PAIN IN EXTREMITY (Hand pain) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCLE SPASMS (cramp) (seriousness criterion medically significant) and DYSPNOEA (breathlessness) (seriousness criterion medically significant). At the time of the report, MUSCLE SPASMS (cramp) and DYSPNOEA (breathlessness) outcome was unknown and PAIN IN EXTREMITY (Hand pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient reported, the vaccine has caused his left hand (arm injected) to cramp and become painful, it did this for the previous two doses earlier in the year. It causes his nervous system to be more sensitive to touch. He had noticed a breathlessness too. Patient is not enrolled in clinical trial. Patient not had a COVID-19 test. Treatment medication was not provided by the reporter. Company comment: This is a regulatory case concerning a 28-year-old male patient with no medical history reported who experienced the unexpected and serious events of muscle spasms, dyspnoea and pain in extremity. The pain in extremity occurred the following day a third dose of mRNA-1273 vaccine was administered while the rest of the events occurred on an unknown day after vaccine was given. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 28-year-old male patient with no medical history reported who experienced the unexpected and serious events of muscle spasms, dyspnoea and pain in extremity. The pain in extremity occurred the following day a third dose of mRNA-1273 vaccine was administered while the rest of the events occurred on an unknown day after vaccine was given. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023344 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Headache, SARS-CoV-2 test
SMQs:, Dementia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: spaced out; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26412699) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (spaced out) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (spaced out) (seriousness criterion medically significant). At the time of the report, FEELING ABNORMAL (spaced out) had not resolved and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was verbally reported that, 12 hours after booster experienced headache which required paracetamol. Had also felt very spaced out and tired all day despite sleeping for 11 hours the previous night. Patients knees also hurt when walking up stairs, had never experienced this before and stomach had been unsettled. No Concomitant drugs were reported. Company comment: This Regulatory Authority case concerns a 40-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) events of feeling abnormal and headache. The patient developed headache along with feeling abnormal and tired 12 hours after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. It was reported that she took paracetamol and that her knees hurt when walking up stairs as well as unsettled stomach. It was not reported if the previous two doses of her COVID-19 vaccination schedule were mRNA-1273 vaccines as well. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This Regulatory Authority case concerns a 40-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) events of feeling abnormal and headache. The patient developed headache along with feeling abnormal and tired 12 hours after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. It was reported that she took paracetamol and that her knees hurt when walking up stairs as well as unsettled stomach. It was not reported if the previous two doses of her COVID-19 vaccination schedule were mRNA-1273 vaccines as well. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 2023345 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Eye pain, Headache, Neck pain, Pain in extremity, Renal pain, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), Glaucoma (broad), Arthritis (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: CERELLE; PROPRANOLOL; SUKKARTO; VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
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.MOD20214

Write-up: Eye pain; Pain in hip; Leg pain; Pain back; Neck pain; Kidney pain; Headache; This case was received via RA (Reference number: GB-MHRA-ADR 26412722) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), EYE PAIN (Eye pain), ARTHRALGIA (Pain in hip), PAIN IN EXTREMITY (Leg pain), BACK PAIN (Pain back), NECK PAIN (Neck pain) and RENAL PAIN (Kidney pain) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). Concomitant products included VENLAFAXINE from 2011 to an unknown date for Mixed anxiety and depressive disorder, PROPRANOLOL for Panic attacks, METFORMIN HYDROCHLORIDE (SUKKARTO) for Type 2 diabetes mellitus, DESOGESTREL (CERELLE) for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced EYE PAIN (Eye pain) (seriousness criterion medically significant), ARTHRALGIA (Pain in hip) (seriousness criterion medically significant), PAIN IN EXTREMITY (Leg pain) (seriousness criterion medically significant), BACK PAIN (Pain back) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant) and RENAL PAIN (Kidney pain) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), EYE PAIN (Eye pain), ARTHRALGIA (Pain in hip), PAIN IN EXTREMITY (Leg pain), BACK PAIN (Pain back), NECK PAIN (Neck pain) and RENAL PAIN (Kidney pain) had not 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. Patient felt that one side of the body had gone into spasm. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company comment: This is a regulatory case concerning a 44-year-old, female patient with a history of Mixed anxiety and depressive disorder, Panic attack, Type 2 diabetes mellitus and Suspected COVID-19, who experienced the serious unexpected , according RA, events of Eye pain, Pain in extremity, Back pain, Neck pain, Renal pain, Arthralgia, and Headache. The event Headache occurred approximately 1 day after the booster dose of mRNA-1273 vaccine, no onset was reported for the other events. The rechallenge was reported as unknown. The medical history of Mixed anxiety and depressive disorder, Panic attack, Type 2 diabetes mellitus, Suspected COVID-19, and the use of concomitant medication cerelle, propranolol, sukkarto and venlafaxine, negative rechallenge remain as confounders. No treatment was provided for reported events. The case was assessed as serious as per Regulatory Authority?s report due to important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 44-year-old, female patient with a history of Mixed anxiety and depressive disorder, Panic attack, Type 2 diabetes mellitus and Suspected COVID-19, who experienced the serious unexpected , according RA, events of Eye pain, Pain in extremity, Back pain, Neck pain, Renal pain, Arthralgia, and Headache. The event Headache occurred approximately 1 day after the booster dose of mRNA-1273 vaccine, no onset was reported for the other events. The rechallenge was reported as unknown. The medical history of Mixed anxiety and depressive disorder, Panic attack, Type 2 diabetes mellitus, Suspected COVID-19, and the use of concomitant medication cerelle, propranolol, sukkarto and venlafaxine, negative rechallenge remain as confounders. No treatment was provided for reported events. The case was assessed as serious as per Regulatory Authority?s report due to important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023348 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / 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:
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.MOD20214

Write-up: Fever chills; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever chills) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever chills) had not 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 was provided. No treatment medication was provided. It was reported that the symptoms just feel like this is what death feels like, freezing cold, boiling and can not move. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Company comment: This case concerns a 28-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of pyrexia. The event occurred the same day after the booster dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 28-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) event of pyrexia. The event occurred the same day after the booster dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2023353 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Forehead headache; Nausea; Dizzy on standing; Fever; Chills; Failed lactation; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26414518) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), SUPPRESSED LACTATION (Failed lactation), HEADACHE (Forehead headache), NAUSEA (Nausea) and DIZZINESS POSTURAL (Dizzy on standing) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and SUPPRESSED LACTATION (Failed lactation) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Forehead headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant). On 30-Dec-2021, CHILLS (Chills) had resolved. At the time of the report, PYREXIA (Fever) was resolving, SUPPRESSED LACTATION (Failed lactation) had resolved and HEADACHE (Forehead headache), NAUSEA (Nausea) and DIZZINESS POSTURAL (Dizzy on standing) had not resolved. 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. No concomitant medication details was reported. No treatment medication details was reported. 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. COMPANY COMMENT: This is a regulatory case concerning a 30-year-old female patient with no clinical history who experienced the unexpected events of HEADACHE, NAUSEA, DIZZINESS POSTURAL, PYREXIA, CHILLS and SUPPRESSED LACTATION The events occurred 1 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority; Sender''s Comments: COMPANY COMMENT: This is a regulatory case concerning a 30-year-old female patient with no clinical history who experienced the unexpected events of HEADACHE, NAUSEA, DIZZINESS POSTURAL, PYREXIA, CHILLS and SUPPRESSED LACTATION The events occurred 1 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority


VAERS ID: 2023355 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / 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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210222; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26412872) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 46-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 20-Feb-2021. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. It was reported that patient had regular hot sweats for over 24 hrs, started around 3 hrs after booster vaccine. 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: This is a regulatory case concerning a 46-year-old male patient with no medical history reported who experienced the unexpected and serious event of pyrexia. The event occurred the same day a third dose of mRNA-1273 vaccine was administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 46-year-old male patient with no medical history reported who experienced the unexpected and serious event of pyrexia. The event occurred the same day a third dose of mRNA-1273 vaccine was administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023358 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / 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:
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.MOD20214

Write-up: High temperature; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26412930) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). At the time of the report, PYREXIA (High temperature) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant products were reported. No treatment drugs were reported Patient had not had symptoms associated with COVID-19 . Patients symptoms started with achy joints followed by chills and feeling extremely cold after few hours she was extremely hot with really bad headache. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected, serious (medically significant) event of pyrexia. The event occurred the same day after the booster dose of mRNA-1273. The patient also experienced arthralgia, chills, and headache. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected, serious (medically significant) event of pyrexia. The event occurred the same day after the booster dose of mRNA-1273. The patient also experienced arthralgia, chills, and headache. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2023359 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Muscle spasms, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Vestibular 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: Suspected COVID-19; Comments: Fit, healthy, no prexisting conditions
Allergies:
Diagnostic Lab Data: Test Date: 20211223; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Shivering; High temperature; Dizziness; Cramps; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26412949) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivering), PYREXIA (High temperature), DIZZINESS (Dizziness) and MUSCLE SPASMS (Cramps) in a 49-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Fit, healthy, no prexisting conditions. The patient''s past medical history included Suspected COVID-19 from 01-May-2020 to 03-May-2020. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant) and MUSCLE SPASMS (Cramps) (seriousness criterion medically significant). At the time of the report, CHILLS (Shivering), DIZZINESS (Dizziness) and MUSCLE SPASMS (Cramps) was resolving and PYREXIA (High temperature) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-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. No concomitant medication provided. No treatment information mentioned. Patient was Fit, healthy, no prexisting conditions. Patient stated Onset approx 5 hours after vaccine Full body cramps and uncontrolled shivering. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Company comment: This is a regulatory case concerning a 49 year-old, male patient with no relevant medical history, who experienced the serious (due to medically important condition) unexpected, according data set, events of chills, pyrexia, dizziness and muscle spasms. Events were assessed as serious by the Regulatory Authority. The events occurred the same day after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 49 year-old, male patient with no relevant medical history, who experienced the serious (due to medically important condition) unexpected, according data set, events of chills, pyrexia, dizziness and muscle spasms. Events were assessed as serious by the Regulatory Authority. The events occurred the same day after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023361 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-29
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Epistaxis, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nose bleed (Patient stated only had 2 nosebleeds in his entire life not including this one so its a cause of concern).
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.MOD20214

Write-up: Nosebleed; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26412952) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EPISTAXIS (Nosebleed) in a 43-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Nose bleed (Patient stated only had 2 nosebleeds in his entire life not including this one so its a cause of concern). On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EPISTAXIS (Nosebleed) (seriousness criterion medically significant). On 30-Dec-2021, EPISTAXIS (Nosebleed) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company comment: This is a regulatory case concerning a 43-year-old, male patient with a history of Epistaxis, who experienced the serious unexpected, according CCDS, event of Epistaxis. The event occurred approximately 6 days after the booster dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. The medical history of Epistaxis remains as a confounder. At the time of the report the outcome of the event was recovering/resolving, no treatment was provided for reported event. The case was assessed as serious as per Regulatory Authority?s report due to important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender''s Comments: This is a regulatory case concerning a 43-year-old, male patient with a history of Epistaxis, who experienced the serious unexpected, according CCDS, event of Epistaxis. The event occurred approximately 6 days after the booster dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. The medical history of Epistaxis remains as a confounder. At the time of the report the outcome of the event was recovering/resolving, no treatment was provided for reported event. The case was assessed as serious as per Regulatory Authority?s report due to important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023366 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Flushing, Headache, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: flushed; headache; severe shivering; Fever; This case was received (Reference number: GB-MHRA-ADR 26413679) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FLUSHING (flushed), HEADACHE (headache), CHILLS (severe shivering) and PYREXIA (Fever) in a 29-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced FLUSHING (flushed) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant) and CHILLS (severe shivering) (seriousness criterion medically significant). At the time of the report, FLUSHING (flushed), HEADACHE (headache) and CHILLS (severe shivering) had not resolved and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The concomitant history was not reported. Patient had experiencing severe shivering, feeling flushed in the face and hot despite being cold from the neck down and headache. The treatment history was not provided. Patient is not tested positive for COVID-19 since having the vaccine, not enrolled in clinical trial. Company Comment: This is a regulatory case concerning a 29-year-old, male patient with no medical history reported, who experienced the unexpected serious event of pyrexia, on the same day after the third dose of mRNA-1273 vaccine. He also experienced flushing, headache and chills at an unknown date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.; Sender''s Comments: This is a regulatory case concerning a 29-year-old, male patient with no medical history reported, who experienced the unexpected serious event of pyrexia, on the same day after the third dose of mRNA-1273 vaccine. He also experienced flushing, headache and chills at an unknown date. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.


VAERS ID: 2023369 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Lymphadenopathy, Musculoskeletal stiffness, Pyrexia, Vaccination site swelling, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CILIQUE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101882559

Write-up: Vomiting; Fever; Headache; Stiffness; Vaccination site swelling; Axillary lymph nodes enlarged; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112300750286650-Y1XD6. Other Case identifier(s): GB-MHRA-ADR 26413924. A female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: CILIQUE. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; VOMITING (medically significant), outcome "recovering", described as "Vomiting"; PYREXIA (medically significant), outcome "recovering", described as "Fever"; HEADACHE (medically significant), outcome "not recovered", described as "Headache"; MUSCULOSKELETAL STIFFNESS (medically significant), outcome "not recovered", described as "Stiffness"; VACCINATION SITE SWELLING (medically significant), outcome "unknown", described as "Vaccination site swelling"; LYMPHADENOPATHY (medically significant), outcome "unknown", described as "Axillary lymph nodes enlarged". Clinical course: Patient had no symptoms associated with COVID-19 Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional reaction 48hrs post vaccination swollen injection site, and swollen arm pit lymph nodes on injection side. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2023373 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000025 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chills, Dizziness, Fatigue, Feeling abnormal, Headache, Hypopnoea, Limb discomfort, Nausea, SARS-CoV-2 test, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Respiratory failure (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Feeling dazed; Lightheadedness; Breathing shallow; Headache; Shaking; Nausea; Heavy feeling in arms & legs; Tiredness; Shivering; Back pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26414098) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), TREMOR (Shaking), NAUSEA (Nausea), LIMB DISCOMFORT (Heavy feeling in arms & legs), FATIGUE (Tiredness), CHILLS (Shivering), BACK PAIN (Back pain), FEELING ABNORMAL (Feeling dazed), DIZZINESS (Lightheadedness) and HYPOPNOEA (Breathing shallow) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000025) for an unknown indication. Previously administered products included for an unreported indication: B12 [CYANOCOBALAMIN] (Have B12 injections every 12 weeks and other than that nothing). Concurrent medical conditions included Suspected COVID-19 (Unsure when symptoms started). On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), TREMOR (Shaking) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), LIMB DISCOMFORT (Heavy feeling in arms & legs) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), BACK PAIN (Back pain) (seriousness criterion medically significant), DIZZINESS (Lightheadedness) (seriousness criterion medically significant) and HYPOPNOEA (Breathing shallow) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced FEELING ABNORMAL (Feeling dazed) (seriousness criterion medically significant). On 30-Dec-2021, TREMOR (Shaking) and CHILLS (Shivering) had resolved. At the time of the report, HEADACHE (Headache), NAUSEA (Nausea), LIMB DISCOMFORT (Heavy feeling in arms & legs), FATIGUE (Tiredness), BACK PAIN (Back pain), FEELING ABNORMAL (Feeling dazed) and DIZZINESS (Lightheadedness) had not resolved and HYPOPNOEA (Breathing shallow) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication were provided Patient had vaccine at 1pm. started feeling like flu type symptoms about 9pm. Shaking and shivering in the night even though had put 2 blankets and thick socks on, couldn''t get warm yet patient was sweating patient was that hot to touch. Woke up feeling like patient was magneted to the bed and could barely move but once patient got up and moving she just feel achey with bad head ache. Feel like patient breathing deeper than usual and it''s causing a tickling cough. Still feel dreadful. patient felt a bit like this after her first dose of Astrazenica (not as bad but similar sort if symptoms) but 2nd does of Astrazenica was fine. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. COMPANY COMMENT: This is a regulatory case concerning a 31-year-old female patient with no clinical history who experienced the unexpected events of HEADACHE, TREMOR, NAUSEA, LIMB DISCOMFORT, FATIGUE, CHILLS, BACK PAIN, FEELING ABNORMAL, DIZZINESS and HYPOPNOEA The events occurred 1 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority; Sender''s Comments: COMPANY COMMENT: This is a regulatory case concerning a 31-year-old female patient with no clinical history who experienced the unexpected events of HEADACHE, TREMOR, NAUSEA, LIMB DISCOMFORT, FATIGUE, CHILLS, BACK PAIN, FEELING ABNORMAL, DIZZINESS and HYPOPNOEA The events occurred 1 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority


VAERS ID: 2023379 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211031; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fever; Nausea; Muscle soreness; Fatigue; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26414170) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Muscle soreness) and FATIGUE (Fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 01-Nov-2021 to 03-Nov-2021. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), MYALGIA (Muscle soreness) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), NAUSEA (Nausea), MYALGIA (Muscle soreness) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Concomitant medication provided. No treatment medication reported. Last menstrual period date was reported as 15-Nov-2021. Re-challenge was reported as unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Company comment: This is a regulatory authority case concerning a 48-year-old female patient with no relevant medical history, who experienced events of pyrexia, nausea, myalgia and fatigue (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). The events occurred on the same date after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 48-year-old female patient with no relevant medical history, who experienced events of pyrexia, nausea, myalgia and fatigue (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). The events occurred on the same date after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023382 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Migraine, Myalgia, Pyrexia, Rash pruritic, Rhinorrhoea, SARS-CoV-2 test, Thirst
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Back pain; Muscle ache; Itchy rash; Thirst excessive; Runny nose; Fever; Migraine; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26414247) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), BACK PAIN (Back pain), RHINORRHOEA (Runny nose), PYREXIA (Fever), MYALGIA (Muscle ache), RASH PRURITIC (Itchy rash) and THIRST (Thirst excessive) in a 20-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), RHINORRHOEA (Runny nose) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), RASH PRURITIC (Itchy rash) (seriousness criterion medically significant) and THIRST (Thirst excessive) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced BACK PAIN (Back pain) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, MIGRAINE (Migraine), PYREXIA (Fever), MYALGIA (Muscle ache) and RASH PRURITIC (Itchy rash) had not resolved, BACK PAIN (Back pain) and THIRST (Thirst excessive) was resolving and RHINORRHOEA (Runny nose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details were provided. No treatment medication details were provided. Company comment: This regulatory authority case concerns a 20-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Migraine, Back pain, Rhinorrhoea, Pyrexia, Myalgia, Rash pruritic and Thirst after mRNA- 1273 vaccine. The onset of the events occurred on the day after the third dose of mRNA- 1273 vaccine (reported as 3a dose). Thirst may be in connection with pyrexia. Pyrexia, Myalgia and Rash - according to RA - are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. Very limited information is available regarding clinical course of the events. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report. Patient was not enrolled in clinical trial.; Sender''s Comments: This regulatory authority case concerns a 20-year-old male patient with no medical history reported, who experienced the unexpected serious (medically significant) events of Migraine, Back pain, Rhinorrhoea, Pyrexia, Myalgia, Rash pruritic and Thirst after mRNA- 1273 vaccine. The onset of the events occurred on the day after the third dose of mRNA- 1273 vaccine (reported as 3a dose). Thirst may be in connection with pyrexia. Pyrexia, Myalgia and Rash - according to RA- are consistent with the known safety profile of the vaccine, but since they were reported with a seriousness criteria they are considered unexpected. Very limited information is available regarding clinical course of the events. The seriousness criteria of the events was assessed as per regulatory authority report. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 2023392 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2; COVID-19 MRNA VACCINE BNT162B2
Current Illness: Asthma; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fever; Sore throat; Fatigue; Muscle ache; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26415053) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), FATIGUE (Fatigue), MYALGIA (Muscle ache) and HEADACHE (Headache) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 18-Feb-2021 to 18-Mar-2021 and Clinical trial participant. Previously administered products included for Asthma: SALBUTAMOL SULPHATE and FOSTAIR. Past adverse reactions to the above products included No adverse reaction with FOSTAIR and SALBUTAMOL SULPHATE. Concurrent medical conditions included Asthma and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 23-Jun-2021 to an unknown date and TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 29-Dec-2021, OROPHARYNGEAL PAIN (Sore throat) had resolved. On 30-Dec-2021, HEADACHE (Headache) had resolved. At the time of the report, PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Muscle ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient mentioned that on 29-12-2021 at 11:00 vaccine she had her booster dose. AT 14:00 she had fatigue onset, at 17:00 severe fatigue, at 19:00 fever onset, at 23:00 severe fever/chills, muscle tremors/spasm and pain, and dry cough continued throughout the night. On 30-12-2021 at 07:00 patient had fatigue, headache and muscle pain continued but was relieving. Patient mentioned that at 11:00 fatigue and headache continued but was relieving further. Patient had not tested positive for COVID-19 since having the vaccine Patient was Clinical trial participant Company comment This is a regulatory case concerning a 27-year-old female patient with medical history of asthma, who experienced the serious unexpected, according RA, events of pyrexia, oropharyngeal pain, fatigue, myalgia and headache. The events occurred the same day after the third dose of mRNA-1273 vaccine and were either recovered or recovering at the moment of the report. The rechallenge is unknown according to RA. The medical history of asthma remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 27-year-old female patient with medical history of asthma, who experienced the serious unexpected, according RA, events of pyrexia, oropharyngeal pain, fatigue, myalgia and headache. The events occurred the same day after the third dose of mRNA-1273 vaccine and were either recovered or recovering at the moment of the report. The rechallenge is unknown according to RA. The medical history of asthma remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2023402 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fainting; This case was received via regulatory authority on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-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. Concomitant product use was not provided by the reporter. No treatment information was provided. Patient experienced of fainting episode roughly 9 hours after vaccine given. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.; Sender''s Comments: This case concerns a 28-year-old, female patient with no relevant medical history, who experienced the unexpected serious event of Syncope. The event occurred approximately 9 hours after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2023405 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Influenza, SARS-CoV-2 test
SMQs:, 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: COVID-19 VACCINE ASTRAZENECA
Current Illness: Blood pressure high (just below threshold before having to take medication); Food allergy; Irritable bowel syndrome (long term)
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high
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.MOD20214

Write-up: Headache; Flu symptoms; This case was received via RA (Reference number: GB-MHRA-ADR 26415675) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and INFLUENZA (Flu symptoms) in a 48-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Family history included Blood pressure high. Concurrent medical conditions included Blood pressure high (just below threshold before having to take medication), Irritable bowel syndrome (long term) and Food allergy. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced INFLUENZA (Flu symptoms) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) had not resolved and INFLUENZA (Flu symptoms) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Initially there was no reaction that evening, just booster site was mildly sore. Following morning developed flu-like symptoms, aching everywhere, and headache. Later that night, heart rate appeared to average around 110-120. Next day, 2 days after the vaccination, still mild aching but getting energy back. Patient has not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Treatment medication use information was not provided by reporter. Company comment: This case concerns a 48-year-old male patient with relevant medical history of Blood pressure high who experienced serious unexpected events of Headache and Influenza. As per Case narrative of the RA, on the day after the third, booster dose of mRNA-1273 the patient experienced vaccination site pain whereas one day following vaccination, in the morning, the patient experienced flu-like symptoms, generalized aching and headache, while, in the night, the patient experienced increased heart rate of approximately 110-120 bpm. Furthermore, it was reported that two days after the vaccination, the patient was still experiencing mild aching but was getting his energy back. As per RA, outcome of the event Headache was reported as ongoing whereas outcome of the event Influenza was reported as resolving. No further information was provided. The rechallenge and action taken with the suspect product were reported as unknown as per RA and kept as such. Event terms, onset dates and outcomes captured per RA Authority reporting. Event seriousness per overall case assessment by Authority. Causality is confounded with patient''s reported medical history. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient also received COVID-19 VACCINE ASTRAZENECA, Interchange of vaccine products should have been considered in this particular case.; Sender''s Comments: This case concerns a 48-year-old male patient with relevant medical history of Blood pressure high who experienced serious unexpected events of Headache and Influenza. As per Case narrative of the RA, on the day after the third, booster dose of mRNA-1273 the patient experienced vaccination site pain whereas one day following vaccination, in the morning, the patient experienced flu-like symptoms, generalized aching and headache, while, in the night, the patient experienced increased heart rate of approximately 110-120 bpm. Furthermore, it was reported that two days after the vaccination, the patient was still experiencing mild aching but was getting his energy back. As per RA, outcome of the event Headache was reported as ongoing whereas outcome of the event Influenza was reported as resolving. No further information was provided. The rechallenge and action taken with the suspect product were reported as unknown as per RA and kept as such. Event terms, onset dates and outcomes captured per RA Authority reporting. Event seriousness per overall case assessment by Authority. Causality is confounded with patient''s reported medical history. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient also received COVID-19 VACCINE ASTRAZENECA, Interchange of vaccine products should have been considered in this particular case.


VAERS ID: 2023407 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling of body temperature change, Hallucination
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Feeling of body temperature change; Hallucination; This case was received via Regulatory Authority, MHRA (Reference number: GB-MHRA-ADR 26415909) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Feeling of body temperature change) and HALLUCINATION (Hallucination) in a 57-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). Concomitant products included ESCITALOPRAM for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feeling of body temperature change) (seriousness criterion medically significant) and HALLUCINATION (Hallucination) (seriousness criterion medically significant). On 30-Dec-2021, HALLUCINATION (Hallucination) had resolved. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Feeling of body temperature change) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced shivering 12 hrs after jab and arm started to hurt. she became extremely cold Patient was sleeping in a shop doorway. Wrapped up in blankets, later skin became very hot and with pains shooting down both arms and legs. Removed blankets and was shivering again within the hour. Feet and hands very cold. Wrapped up again. Woke thinking she could see a swan in her room. No treatment medications were reported Symptoms were subsided but head/limbs still aching. Patient not had a COVID-19 test Company comment: This regulatory authority case concerns a 57-year-old female patient, with no reported medical history, who experienced the serious (medically significant) unexpected events of FEELING OF BODY TEMPERATURE CHANGE and HALLUCINATION. The events occurred on the same day after receiving a third dose of mRNA-1273. No information about previous vaccination schedule was provided. The event oh hallucination had recovered by the time of this report while the event of feeling of body temperature change was recovering. According to source document, patient experienced chills, pain in extremity and peripheral cold, associated with hallucinations. Body temperature measurement was not provided and neither were any other clinical relevant information such as medical consultations or treatment received. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory authority case concerns a 57-year-old female patient, with no reported medical history, who experienced the serious (medically significant) unexpected events of FEELING OF BODY TEMPERATURE CHANGE and HALLUCINATION. The events occurred on the same day after receiving a third dose of mRNA-1273. No information about previous vaccination schedule was provided. The event oh hallucination had recovered by the time of this report while the event of feeling of body temperature change was recovering. According to source document, patient experienced chills, pain in extremity and peripheral cold, associated with hallucinations. Body temperature measurement was not provided and neither were any other clinical relevant information such as medical consultations or treatment received. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2023411 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site erythema, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: pain and redness around injection site; Local swelling; This case was received (Reference number: GB-RA-ADR 26416232) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (pain and redness around injection site) and SWELLING (Local swelling) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced SWELLING (Local swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (pain and redness around injection site) (seriousness criterion medically significant). At the time of the report, INJECTION SITE ERYTHEMA (pain and redness around injection site) and SWELLING (Local swelling) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-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 concomitant medication were reported. Patient had not symptoms associated with COVID-19. At the time of reporting patient was not breastfeeding. Patient last menstrual period date was 2021. Patient experienced pain and mild swelling in the collarbone in the side of the body the injection was administered. Pain and redness around injection site, difficulty moving arm. No treatment medication were reported. Patient had not tested positive for COVID-19 since having the vaccine. Company comment: This is a regulatory case concerning a 25-year-old female patient with no medical history reported who experienced the unexpected and serious events of injection site erythema and swelling. The event swelling occurred the following day a third dose of mRNA-1273 vaccine was administered while injection site erythema occurred on an unknown day after vaccine was given. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 25-year-old female patient with no medical history reported who experienced the unexpected and serious events of injection site erythema and swelling. The event swelling occurred the following day a third dose of mRNA-1273 vaccine was administered while injection site erythema occurred on an unknown day after vaccine was given. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023414 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Insomnia, Migraine, Musculoskeletal discomfort, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2; COVID-19 MRNA VACCINE BNT162B2; INFLUENZA VIRUS; BEDRANOL; CITALOPRAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Appetite lost; Hip discomfort; Migraine; Muscle ache; Fever chills; Weakness; Sleeplessness; This case was received (Reference number: GB-RA-ADR 26416542) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), MYALGIA (Muscle ache), PYREXIA (Fever chills), ASTHENIA (Weakness), INSOMNIA (Sleeplessness), DECREASED APPETITE (Appetite lost) and MUSCULOSKELETAL DISCOMFORT (Hip discomfort) in a 23-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included PROPRANOLOL HYDROCHLORIDE (BEDRANOL) and CITALOPRAM from 03-Oct-2020 to an unknown date for Anxiety, TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2), TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) and INFLUENZA VACCINE (INFLUENZA VIRUS) for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant), INSOMNIA (Sleeplessness) (seriousness criterion medically significant) and MUSCULOSKELETAL DISCOMFORT (Hip discomfort) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant). At the time of the report, MIGRAINE (Migraine), MYALGIA (Muscle ache), PYREXIA (Fever chills), ASTHENIA (Weakness), INSOMNIA (Sleeplessness) and DECREASED APPETITE (Appetite lost) was resolving and MUSCULOSKELETAL DISCOMFORT (Hip discomfort) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information were reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This is a regulatory authority case concerning a 23-year-old female patient with no relevant medical history, who experienced events of Musculoeskeletal discomfort, migraine, myalgia, pyrexia, asthenia, insomnia and decreased appetite (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). The events occurred on the same date after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 23-year-old female patient with no relevant medical history, who experienced events of Musculoeskeletal discomfort, migraine, myalgia, pyrexia, asthenia, insomnia and decreased appetite (seriousness criterion of medically significant assessed as per Regulatory Authority reporting). The events occurred on the same date after the third dose of mRNA-1273 vaccine. Clinical course and treatment details were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023420 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA COVID 19 VACCIN / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fever; Headache; Stiffness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26416824) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and MUSCULOSKELETAL STIFFNESS (Stiffness) in a 57-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Covid 19 vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and MUSCULOSKELETAL STIFFNESS (Stiffness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication were provided Patient had sore arm Company comment: This case concerns a 57-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of pyrexia, headache, and musculoskeletal stiffness. The events occurred the same day after the booster dose of mRNA-1273. Information regarding clinical presentation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 57-year-old female patient with no medical history reported, who experienced the unexpected, serious (medically significant) events of pyrexia, headache, and musculoskeletal stiffness. The events occurred the same day after the booster dose of mRNA-1273. Information regarding clinical presentation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2023429 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Pain, Pain in extremity, Palpitations, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Tiredness; Ache; Tingling skin; Heart racing; Pain in arm; This case was received via (Reference number: GB-MHRA-ADR 26417173) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), PAIN (Ache), PARAESTHESIA (Tingling skin), PALPITATIONS (Heart racing) and PAIN IN EXTREMITY (Pain in arm) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 06-Sep-2021 to an unknown date for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), PARAESTHESIA (Tingling skin) (seriousness criterion medically significant) and PALPITATIONS (Heart racing) (seriousness criterion medically significant). At the time of the report, FATIGUE (Tiredness), PAIN (Ache), PALPITATIONS (Heart racing) and PAIN IN EXTREMITY (Pain in arm) had not resolved and PARAESTHESIA (Tingling skin) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had nothing out of the ordinary. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient started feeling a bit of tingling and heavy in the chest during the night of 29th, restless sleep and a bit achey. Still ongoing. No treatment medications were reported. Patient last menstrual period date was 09-DEC-2021. Company comment: This Regulatory Authority case concerns a 25-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) events of fatigue, pain, paraesthesia, palpitations and pain in extremity. The patient developed pain in extremity on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved with tingling and heavy in the chest during the night of vaccination day, restless sleep and a bit ache. It was reported that the patient received previously one dose of Pfizer''s COVID-19 vaccine. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This Regulatory Authority case concerns a 25-year-old, female patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) events of fatigue, pain, paraesthesia, palpitations and pain in extremity. The patient developed pain in extremity on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved with tingling and heavy in the chest during the night of vaccination day, restless sleep and a bit ache. It was reported that the patient received previously one dose of Pfizer''s COVID-19 vaccine. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 2023435 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Flushing, Hot flush, Influenza like illness, Pain in extremity, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Shivering; Hot flushes; Flushed; Flu like symptoms; Fatigue; Painful arm; This case was received (Reference number: GB-RA-ADR 26417692) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivering), HOT FLUSH (Hot flushes), PAIN IN EXTREMITY (Painful arm), FLUSHING (Flushed), FATIGUE (Fatigue) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced FLUSHING (Flushed) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant) and HOT FLUSH (Hot flushes) (seriousness criterion medically significant). At the time of the report, CHILLS (Shivering), HOT FLUSH (Hot flushes) and INFLUENZA LIKE ILLNESS (Flu like symptoms) was resolving and PAIN IN EXTREMITY (Painful arm), FLUSHING (Flushed) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: ngeative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient first felt very sore arm radiating from site of injection into arm pit and into neck. Muscle aches and fatigue from 12 hours post vaccine. Over 24 hours later, the patient had shivering and hot flushes with very sore arm. Impossible to use arm or raise above head. The patient felt flu like symptoms after 30 hours which continue to nearly 48 hours, and 48 hours later, the arm was still very painful. The patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No concomitant product use was provided by the reporter. No treatment medications were reported. Company comment: This is a regulatory case concerning a female patient of unknown age, with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according CCDS, events of chills, hot flush, pain in extremity, flushing, fatigue and Influenza like illness. Events were assessed as serious by the Regulatory Authority. The events pain in extremity, flushing, fatigue and Influenza like illness occurred the same day to 1 day after the booster dose of mRNA-1273 vaccine and the events chills, hot flush on an unknown date. The outcome of the events pain in extremity, flushing, fatigue was reported as not recovered; and the events chills, hot flush and Influenza like illness as recovering. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a female patient of unknown age, with no reported medical history, who experienced the serious (due to medically important condition) unexpected, according CCDS, events of chills, hot flush, pain in extremity, flushing, fatigue and Influenza like illness. Events were assessed as serious by the Regulatory Authority. The events pain in extremity, flushing, fatigue and Influenza like illness occurred the same day to 1 day after the booster dose of mRNA-1273 vaccine and the events chills, hot flush on an unknown date. The outcome of the events pain in extremity, flushing, fatigue was reported as not recovered; and the events chills, hot flush and Influenza like illness as recovering. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023439 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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.MOD20214

Write-up: Muscle pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26417851) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) in a 59-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle pain) had not 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 drug information provided. Patient experienced severe pain at the injection site muscle ache, joint ache, very tired, headache. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No treatment drug information provided. Company Comment: This case concerns a 59-year-old female patient, with no relevant medical history, who experienced the unexpected and serious event of Myalgia. The event is assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The event occurred the same day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 59-year-old female patient, with no relevant medical history, who experienced the unexpected and serious event of Myalgia. The event is assessed as serious by the Regulatory Authority; lack of evidence of seriousness from a clinical or regulatory standpoint. The event occurred the same day after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in RA. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023447 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Chest pain, Dyspnoea, Fatigue, Headache, Migraine, Musculoskeletal chest pain, Myocarditis, Neck pain, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: AMITRIPTYLINE; CITALOPRAM; OMEPRAZOLE; PROPRANOLOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Headache; Myocarditis; Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Fever; Chest pain; Neck pain; Migraine; Rib pain; Armpit pain; Heart racing; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26418205) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYOCARDITIS (Myocarditis), the first episode of PYREXIA (Fever), AXILLARY PAIN (Armpit pain), PALPITATIONS (Heart racing), the first episode of CHEST PAIN (Chest pain), NECK PAIN (Neck pain), MIGRAINE (Migraine), MUSCULOSKELETAL CHEST PAIN (Rib pain), FATIGUE (Fatigue/unusual tiredness), the second episode of CHEST PAIN (Chest pain), the second episode of PYREXIA (Fever), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) in a 27-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 000014A) for an unknown indication. Concomitant products included OMEPRAZOLE from September 2019 to an unknown date for Acid reflux (esophageal), AMITRIPTYLINE from September 2017 to an unknown date and CITALOPRAM from May 2018 to an unknown date for Anxiety, PROPRANOLOL from February 2021 to an unknown date for Migraine. On 29-Dec-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant) and PALPITATIONS (Heart racing) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced the first episode of PYREXIA (Fever) (seriousness criterion medically significant), the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), NECK PAIN (Neck pain) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant) and MUSCULOSKELETAL CHEST PAIN (Rib pain) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), the second episode of PYREXIA (Fever) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), MYOCARDITIS (Myocarditis), NECK PAIN (Neck pain) and MUSCULOSKELETAL CHEST PAIN (Rib pain) was resolving, AXILLARY PAIN (Armpit pain), PALPITATIONS (Heart racing) and MIGRAINE (Migraine) had not resolved and FATIGUE (Fatigue/unusual tiredness), the last episode of CHEST PAIN (Chest pain), the last episode of PYREXIA (Fever), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had vaccine at 4pm - felt slightly unwell before going to bed, with a sore arm and underarm. Woke up in the night boiling hot, with a racing, pounding heart. Pt''s smartwatch/fitness tracker showed heart rate was 135 when just standing up. It was approximately 110 when lying and continued like that for most of the night. Usually patient''s resting heart rate was between 55-75. Additionally, patient also had chest pain which had persisted most of the day. At the time of writing (8pm on the day after vaccination), patient''s heart rate was approximately 90 bpm, so still higher than normal. Patient also had a pounding headache - stemming from the very base of skull/top of neck. That happened after the 2nd Pfizer dose, and lasted several days before patient took an aspirin. That time it was so bad it felt like patient''s head could have exploded, and lying down did not help. Patient took an aspirin, 2 paracetamol, and a sumatriptan. It felt better after taking medicines. Patient had selected related to possible myocarditis, as patient saw from the patient''s information leaflet that the racing heart and chest pain were symptoms. Patient had not tested + for COVID-19 since having the vaccine. Patient not had symptoms associated with COVID-19. No treatment information reported. This is a regulatory case concerning a 27-year-old male patient with no clinical history who experienced the unexpected events of HEADACHE, PYREXIA (1st.episode), AXILLARY PAIN, PALPITATIONS, CHEST PAIN (1st.episode), NECK PAIN, MIGRAINE, MUSCULOSKELETAL CHEST PAIN, FATIGUE, CHEST PAIN (2nd.episode), PYREXIA (2nd.episode), DYSPNOEA, PALPITATIONS, TACHYCARDIA and the expected (AESI) event of MYOCARDITIS The events occurred 1 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: COMPANY COMMENT: This is a regulatory case concerning a 27-year-old male patient with no clinical history who experienced the unexpected events of HEADACHE, PYREXIA (1st.episode), AXILLARY PAIN, PALPITATIONS, CHEST PAIN (1st.episode), NECK PAIN, MIGRAINE, MUSCULOSKELETAL CHEST PAIN, FATIGUE, CHEST PAIN (2nd.episode), PYREXIA (2nd.episode), DYSPNOEA, PALPITATIONS, TACHYCARDIA and the expected (AESI) event of MYOCARDITIS The events occurred 1 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023451 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test, Vomiting
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fever; Vomiting; Muscle ache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26418273) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VOMITING (Vomiting) and MYALGIA (Muscle ache) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), VOMITING (Vomiting) and MYALGIA (Muscle ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Treatment information was not provided by reporter. Patient had not had symptoms associated with COVID-19, patient had not tested positive for COVID-19 since having the vaccine, patient was not enrolled in clinical trial. Company comment: This is a regulatory case concerning a 24-year-old female patient with no medical history reported who experienced the unexpected and serious events of pyrexia, vomiting and myalgia. The events occurred the same day a third dose of mRNA-1273 vaccine was administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 24-year-old female patient with no medical history reported who experienced the unexpected and serious events of pyrexia, vomiting and myalgia. The events occurred the same day a third dose of mRNA-1273 vaccine was administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023459 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Nasopharyngitis, Pain in extremity, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (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: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210929; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: headache; arm hurt; chills; cold; fever; Shaking; This case was received (Reference number: GB-RA-ADR 26418479) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (arm hurt), CHILLS (chills), NASOPHARYNGITIS (cold), PYREXIA (fever) and TREMOR (Shaking) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 02-Apr-2021 to 30-May-2021 for Vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced TREMOR (Shaking) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant), PAIN IN EXTREMITY (arm hurt) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant), NASOPHARYNGITIS (cold) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). On 30-Dec-2021, TREMOR (Shaking) was resolving. At the time of the report, HEADACHE (headache), PAIN IN EXTREMITY (arm hurt), CHILLS (chills), NASOPHARYNGITIS (cold) and PYREXIA (fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical history was provided. Patient''s last menstrual period date was 21-DEC-2021. Patient had arm hurt, felt fine. approx 12hrs later uncontrollable shaking of entire body. Unable to walk. Reports from partner that her body was drained of color, cold, more than usual chills, breath was ice. Took approx 2 hrs to control the shaking which then went to intermittent shaking for another 3 hrs. Unsettled night. High fever and then slept the following day with a severe headache. Patient has not had symptoms associated with COVID-19, patient has not tested positive for COVID-19 since having the vaccine, patient was not enrolled in clinical trial. Treatment medications were not provided by reporter. Company comment: This case concerns a 40-year-old female patient with no medical history provided who experienced serious unexpected events of Tremor, Headache, Pain in extremity, Chills, Nasopharynghitis and Pyrexia. The event Tremor occurred on the same day after the third, booster dose of mRNA-1273 and resolved the following day. The precise temporal relationship for the remaining events cannot be determined, having in mind that the exact start date of the reported events was not provided. At the time of the report, all the events except Tremor were still ongoing. Furthermore, it was reported that patient''s body was drained of color. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient received COVID-19 VACCINE ASTRAZENECA prior to Company product, Interchange of vaccine products should have been considered in this particular case.; Sender''s Comments: This case concerns a 40-year-old female patient with no medical history provided who experienced serious unexpected events of Tremor, Headache, Pain in extremity, Chills, Nasopharynghitis and Pyrexia. The event Tremor occurred on the same day after the third, booster dose of mRNA-1273 and resolved the following day. The precise temporal relationship for the remaining events cannot be determined, having in mind that the exact start date of the reported events was not provided. At the time of the report, all the events except Tremor were still ongoing. Furthermore, it was reported that patient''s body was drained of color. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient received COVID-19 VACCINE ASTRAZENECA prior to Company product, Interchange of vaccine products should have been considered in this particular case.


VAERS ID: 2023460 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Influenza, Oropharyngeal pain, Pain in extremity
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Painful arm; Flu; Headache; Throat pain; This case was received (Reference number: GB-RA-ADR 26418503) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), INFLUENZA (Flu), HEADACHE (Headache) and OROPHARYNGEAL PAIN (Throat pain) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). Previously administered products included for Product used for unknown indication: PROPRANOLOL. Past adverse reactions to the above products included No adverse event with PROPRANOLOL. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), INFLUENZA (Flu) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and OROPHARYNGEAL PAIN (Throat pain) (seriousness criterion medically significant). On 30-Dec-2021, PAIN IN EXTREMITY (Painful arm), INFLUENZA (Flu), HEADACHE (Headache) and OROPHARYNGEAL PAIN (Throat pain) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment medication were reported. The patient Height was 5 cm. Patient last menstrual period was 30-DEC-2021. The patient had extreme pain within 3 hours, and patient was not enrolled in clinical trial. Company comment: This case concerns a 48-year-old female patient with medical history Immunodeficiency, who experienced the serious unexpected events of Pain in extremity, Influenza, Headache and Oropharyngeal pain. The events occurred on the same day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The medical history of Immunodeficiency remains a confounder for influenza. Moreover Influenza could be contributory for headache and oropharyngeal pain. No concomitant medications were reported. No treatment medications were reported. Events seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender''s Comments: This case concerns a 48-year-old female patient with medical history Immunodeficiency , who experienced the serious unexpected events of Pain in extremity, Influenza, Headache and Oropharyngeal pain. The events occurred on the same day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The medical history of Immunodeficiency remains a confounder for influenza. Moreover Influenza could be contributory for headache and oropharyngeal pain. No concomitant medications were reported. No treatment medications were reported. Events seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


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