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

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



Case Details (Reverse Sorted by Onset Date)

This is page 298 out of 7,116

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VAERS ID: 1691430 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-07-27
Onset:2021-08-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 091D2119 / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Gait disturbance, Hypoaesthesia, Neurological symptom, Pain in extremity, Paraesthesia, Product dose omission issue
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR; MULTIVITAMINS [VITAMINS NOS]; DIURETIC [HYDROCHLOROTHIAZIDE]; MIGRAENE [CAFFEINE;PHENAZONE]; VITAMINE C; CETIRIZINE HYDROCHLORIDE ALLERGY; TREXIMET; ZINC; COBALAMIN
Current Illness: Allergy; Migraine
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: not got the second shot; HCP feels having neorological event due to vaccine; Numbness and sharp pain has spread into my knees and lower back.; Numbness and sharp pain has spread into my knees and lower back.; says she cannot walk barefoot due to pain; accidentally hit hand on something and shooting pain went up her arm; numbness and tingling is occurring in both arms, both legs and both feet which started this past Monday 2Aug; tingling and numbness in hands and feet/toes; This spontaneous case was reported by a consumer and describes the occurrence of NEUROLOGICAL SYMPTOM (HCP feels having neorological event due to vaccine), GAIT DISTURBANCE (says she cannot walk barefoot due to pain), PARAESTHESIA (tingling and numbness in hands and feet/toes), PAIN IN EXTREMITY (accidentally hit hand on something and shooting pain went up her arm) and HYPOAESTHESIA (numbness and tingling is occurring in both arms, both legs and both feet which started this past Monday 2Aug) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D2119) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Migraine and Allergy. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ALLERGY) for Allergy, ASCORBIC ACID (VITAMINE C), ZINC and CYANOCOBALAMIN (COBALAMIN) for Immune system disorder, CAFFEINE, PHENAZONE (MIGRAENE [CAFFEINE;PHENAZONE]) and NAPROXEN SODIUM, SUMATRIPTAN SUCCINATE (TREXIMET) for Migraine, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation, HYDROCHLOROTHIAZIDE (DIURETIC [HYDROCHLOROTHIAZIDE]) for an unknown indication. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced PARAESTHESIA (tingling and numbness in hands and feet/toes). On 06-Aug-2021, the patient experienced GAIT DISTURBANCE (says she cannot walk barefoot due to pain), PAIN IN EXTREMITY (accidentally hit hand on something and shooting pain went up her arm) and HYPOAESTHESIA (numbness and tingling is occurring in both arms, both legs and both feet which started this past Monday 2Aug). On 23-Aug-2021, the patient experienced BACK PAIN (Numbness and sharp pain has spread into my knees and lower back.) and ARTHRALGIA (Numbness and sharp pain has spread into my knees and lower back.). On 30-Aug-2021, the patient experienced NEUROLOGICAL SYMPTOM (HCP feels having neorological event due to vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not got the second shot). The patient was treated with PARACETAMOL (TYLENOL ARTHRITIS) at a dose of 1 dosage form. At the time of the report, NEUROLOGICAL SYMPTOM (HCP feels having neorological event due to vaccine), GAIT DISTURBANCE (says she cannot walk barefoot due to pain), PAIN IN EXTREMITY (accidentally hit hand on something and shooting pain went up her arm), BACK PAIN (Numbness and sharp pain has spread into my knees and lower back.) and ARTHRALGIA (Numbness and sharp pain has spread into my knees and lower back.) outcome was unknown, PARAESTHESIA (tingling and numbness in hands and feet/toes) and HYPOAESTHESIA (numbness and tingling is occurring in both arms, both legs and both feet which started this past Monday 2Aug) had not resolved and PRODUCT DOSE OMISSION ISSUE (not got the second shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow-up document received on 30-AUG-2021 contains Reporter address, Patient demographics- race and ethnicity , medical history, new concomitant medications, new events and event outcome were updated.


VAERS ID: 1693327 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-07-30
Onset:2021-08-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / UNK RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Condition aggravated
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
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: Asthma
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Daily asthma flair ups multiple times a day.


VAERS ID: 1693717 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-04-23
Onset:2021-08-02
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0161 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood iron normal, Blood test, Insomnia, Restless legs syndrome, Serum ferritin normal
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Anxiety/panic attack after influenza vaccine; I do not remember the exact date or my age at the time, but I was probably in my 2
Other Medications: Clindamycin and Benzoyl Peroxide Gel 1%/5%, Tretinoin Gel, USP 0.025%, Sertraline HCl 100 mb Tablet, Calcium (600 mg) and Vitamin D3 (20 mcg) Dietary Supplement Tablet
Current Illness: None.
Preexisting Conditions: Prostatitis, Acne, Generalized Anxiety Disorder.
Allergies: None.
Diagnostic Lab Data: Blood was drawn at my primary care physician?s office on 08/05/2021 in order to send to lab to test ferritin and iron levels. The results were reported back to me via phone on 08/06/2021 in general terms, just stating that the results were normal.
CDC Split Type:

Write-up: Restless legs syndrome started as a consistent nightly issue interfering with my sleep on 08/02/2021. Saw primary care physician about this on 08/05/2021, who assessed that it was restless legs syndrome. Shortly thereafter, I reported to the CDC v-safe tool that I had a change in medical condition since getting vaccinated, referring to the onset of RLS. Primary care physician prescribed over-the-counter 400-500 mg magnesium glycinate as an initial attempt to treat the restless legs syndrome. I was told this can help with sleep and anxiety. Primary care physician also noted that sertraline and other SSRIs can cause RLS as a side effect, and asked me to continue to work with my therapist on my anxiety, and if the RLS symptoms persist, we can consider another medication instead of sertraline or start medication for RLS. However, I have not started taking magnesium glycinate or looked into alternatives to sertraline or any RLS medications, as the RLS symptoms seem to have since mostly subsided on their own. The symptoms are not gone 100%, but they no longer interfere with my sleep. Before 08/02/2021, I would occasionally have RLS symptoms sporadically as well, but not in such a way that it interfered with my sleep, so I never reported it to a doctor until it began to interfere with my sleep. The symptoms nowadays seem to have returned to what they were like before 08/02/2021 - sporadic, infrequent, and they don?t interfere with my sleep.


VAERS ID: 1694435 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-03-08
Onset:2021-08-02
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002A2V11A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cough, Headache, Hepatic enzyme increased, Malaise, Oropharyngeal pain, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control norethindrone
Current Illness: No
Preexisting Conditions: IGA deficient
Allergies: No
Diagnostic Lab Data: COVID-19 test, negative, blood panel prior to getting sick, results liver enzymes were elevated.
CDC Split Type: vsafe

Write-up: On 08/02/2021 I started to feel generally sick cough, running nose, real bad headache. On 08/03/2021 I was given a COVID-19 test, the results were negative. It wasn''t getting better so I went to the urgent care on 08/05/2021, I saw a NP he told me it might be pneumonia and sent me home with antibiotic, Z-pack. I started to feel a little bit better but the cough just lingered. I used an inhaler I had, and it made the cough go away eventually. Months prior to getting sick I had a blood panel done. and my liver enzymes were elevated. I don''t know if that is relevant. I recovered from my AEs but as of 2 days ago, I started feeling sick again sore throat, really bad headache, stuffy congested. I have not tested for COVID-19. I will probably go today or tomorrow.


VAERS ID: 1694690 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-16
Onset:2021-08-02
   Days after vaccination:108
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 008B21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Mechanical ventilation
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: colace, vitamin D3, Cymbalta, lipitor, asa, ferrous gluconate, lisinopril and pantoprazole.
Current Illness: AKI, joint pain , chronic back pain with radiculopathy
Preexisting Conditions: see above and morbid obesity (no DM2)
Allergies: codiene
Diagnostic Lab Data: recrods are not currently available
CDC Split Type:

Write-up: She went on to develop severe covid in Early August and ended up hospitalized in on a vent. She did survive without known sequellae at this point.


VAERS ID: 1694828 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-03-04
Onset:2021-08-02
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / SYR

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest pain, Cough, Ear, nose and throat examination, Electrocardiogram, Pneumonia, Pseudomonas infection, Pyrexia, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (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: Singulair, Pantoprazole, Flonase, Azelastine spray, zinc, vitamin C, vitamin D3, vitamin B complex, Centrum silver, fish oil, Mucinex, meloxicam, Montelukast, Fluoxetine
Current Illness: None
Preexisting Conditions: chronic bronchitis due to acid reflux
Allergies: None
Diagnostic Lab Data: drainage - pseudomonas covid tests- negative EKG- negative blood work- negative chest x-ray- pneumonia
CDC Split Type: vsafe

Write-up: I started with a cough. I went to the ENT and she took some drainage and it was an infection, pseudomonas. I started taking antibiotics for that. I still have pseudomonas and I am taking more antibiotics. I went to the ER because I had fever and my chest was hurting, I had 2 covid tests and they were both negative. They did a chest x-ray, EKG, blood work- they were all negative, except the chest x-ray which said I had pneumonia.


VAERS ID: 1695280 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-06-22
Onset:2021-08-02
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Amenorrhoea
SMQs:, Fertility 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: NONE
Current Illness: NO
Preexisting Conditions: NO
Allergies: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: Absence of (two) menstrual cycles.


VAERS ID: 1696145 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-07-12
Onset:2021-08-02
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0169 / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Hypoaesthesia, Impaired work ability, Malaise, Muscular weakness, Musculoskeletal stiffness, Pain in extremity, Paraesthesia, Vaccination complication, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Estradiol
Current Illness: No
Preexisting Conditions: No
Allergies: codeine
Diagnostic Lab Data: Blood work, and x-rays
CDC Split Type:

Write-up: I was sick for 6 days, but when I went to bed about 13 hours after the 2nd shot my left hand and arm felt like it was asleep. That never went away thru the night and when I woke up it had gone into my right hand and arm. the next day same thing only when I went to pick up my drinking glass I dropped it because hands were actually numb. each day it it would get worse so went to the emergency room and said it was a side effect from vaccine. gave me steroids that did absolutely nothing. so I went to the doctor and they gave me Gabapentin which has done absolutely nothing as well. very difficult to work. aside from numbness and tingling there as been lots of pain and stiffness in hands , and arms become weak and give out on me. my 2nd shot was given on 08/02/2021 and nothing has changed as of today 09/14/2021. definitely need help on what to do. obviously doctors have know idea what to do. not happy about this situation and want answers!!!!!


VAERS ID: 1700440 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: New York  
Vaccinated:2021-02-11
Onset:2021-08-02
   Days after vaccination:172
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 024M20A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032M20A / 2 LA / SYR

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

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

Write-up: Developed COVID in August 2021


VAERS ID: 1700462 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: New York  
Vaccinated:2021-03-05
Onset:2021-08-02
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal discomfort, Depression, Gastrooesophageal reflux disease, Stress
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Losartan, Rosuvastatin, Glargine, Humalog, baby aspirin, Calcium, multi vitamin, coQ10
Current Illness: None
Preexisting Conditions: Diabetes type I
Allergies: None known
Diagnostic Lab Data: None
CDC Split Type:

Write-up: I have recent had bowel and acid reflux issues. I am also very depressed. I consulted my primary doctor on these. My tummy is better now, and I am working with my doctor on depression / stress management. I have NOT been diagnosed with nor think I have had COVID since my vaccination, and my doctor did not suggest there was a direct relationship between my vaccine and these current health concerns. When the check-in app asked if I have had any recent medical issues, I answered generally and truthfully.


VAERS ID: 1704408 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-21
Onset:2021-08-02
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK UN / SYR

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Chest X-ray, Cough, Electrocardiogram, Full blood count, Metabolic function test, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amlodipine, bisoprolol, aspirin, HCTZ, lisinopril, Multiple vitamins, Protonix, Zyrtec, glucosamine
Current Illness:
Preexisting Conditions: HTN, colon cancer, osteoarthritis
Allergies: morphine, penicillin
Diagnostic Lab Data: CBC, CXR, EKG,CMP,
CDC Split Type:

Write-up: cough, fever, positive COVID swab


VAERS ID: 1705907 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (broad)

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

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


VAERS ID: 1706845 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-08-31
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 3 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UJ702AA / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Feeling hot, Interchange of vaccine products, Pyrexia, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210901; Test Name: Body temperature; Result Unstructured Data: 100.1 F
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Dose 1 and 2 Pfizer, Dose 3 Moderna; Felt warm briefly but drank water and that went away; Injection site hurt; Slight chills; Temp of 100.1 F/ The toilet seat felt extra cool which probably means I was running a temperature; Mild chills for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Dose 1 and 2 Pfizer, Dose 3 Moderna), FEELING HOT (Felt warm briefly but drank water and that went away), VACCINATION SITE PAIN (Injection site hurt), CHILLS (Slight chills) and PYREXIA (Temp of 100.1 F/ The toilet seat felt extra cool which probably means I was running a temperature) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product INFLUENZA VACCINE (FLU SYRINGE) for an unknown indication. Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (First dose on 09-Feb-2021 and the second on 02-Mar-2021) on 09-Feb-2021. On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU SYRINGE) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced CHILLS (Mild chills for 2 days). On 31-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Dose 1 and 2 Pfizer, Dose 3 Moderna), FEELING HOT (Felt warm briefly but drank water and that went away), VACCINATION SITE PAIN (Injection site hurt), CHILLS (Slight chills) and PYREXIA (Temp of 100.1 F/ The toilet seat felt extra cool which probably means I was running a temperature). On 31-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Dose 1 and 2 Pfizer, Dose 3 Moderna) had resolved. At the time of the report, FEELING HOT (Felt warm briefly but drank water and that went away) and CHILLS (Mild chills for 2 days) had resolved and VACCINATION SITE PAIN (Injection site hurt), CHILLS (Slight chills) and PYREXIA (Temp of 100.1 F/ The toilet seat felt extra cool which probably means I was running a temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, Body temperature: 100.1 (High) 100.1 F. No concomitant medications were provided. No treatment medications were provided. The patient received the third dose of the Moderna Covid-19 Vaccine at the same time as the High Dose Flu Shot. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up received contains updated events- Feeling of warmth ,Temperature elevation, Vaccination site pain, Chills, Pyrexia and Chills


VAERS ID: 1707706 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100986426

Write-up: Fever; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 2nd dose of bnt162b2 (Pfizer Covid 19 vaccine,Batch/Lot number was not reported), via an unspecified route of administration on 01Aug2021 as Dose 2,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced fever on 02Aug2021.Therapeutic measures were taken as a result of fever.The caller stated that after giving her daughter Tylenol,after two hours the fever goes back up.Caller was asking what should be given to her daughter now.The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1707712 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Axillary mass, Chest pain, Pain, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (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: Asthma; Shellfish allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Sars-CoV2 Real Time PCR; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202100988841

Write-up: Body and joint pain; lump under armpit; chest pain; heart racing; Body and joint pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number FC3180) via an unspecified route of administration in arm left on 01Aug2021 10:30 dose 2, single (age at vaccination: 48 years) for COVID-19 immunisation. Medical history included asthma, allergies: shellfish, both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took iodine and experienced allergy. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number FA7485) via an unspecified route of administration in arm left on 11Jul2021 12:00 dose 1, single for COVID-19 immunisation. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and covid was tested post vaccination. On 02Aug2021 at 02:00 PM, the patient experienced lump under armpit, had chest pain and heart racing, body and joint pain. No treatment was received. The patient underwent lab tests and procedures which included sars-cov-2 real time PCR test resulted as negative on 31Jul2021 nasal swab. The clinical outcome of the events was not resolved. No follow attempts are possible; no further information is expected


VAERS ID: 1530048 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK RA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Fever, chills, headache


VAERS ID: 1531863 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD985 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: 9.6 (unit not reported); Comments: The antibody titer was too low (about 9.6 only).
CDC Split Type: DEJNJFOC20210803011

Write-up: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD985, expiry: UNKNOWN) dose was not reported, administered, 1 total, to left arm on 16-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced suspected immunological vaccine failure. Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) 9.6 (unit not reported), antibody titer was too low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210803011 -COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1533345 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Lymph node pain, Neck pain, Pain in extremity
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COLESEVELAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bile acid malabsorption; Reactive hypoglycaemia; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101005446

Write-up: Neck pain; Lymph node pain; Headache; Fatigue; Dose 1 on 05Jun2021 and dose 2 on 02Aug2021; Pain in arm; The initial safety information received was reporting only non-serious adverse drug reactions, Upon the receipt of follow-up information on 04Aug2021, this case now contains serious adverse reactions. Information processed together. This is a solicited report from the regulatory authority from a contactable consumer. This is the second of 2 reports. The first report is a report received from the regulatory authority. An adult (31 or 32 years old) non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # PD8813), via an unspecified route of administration on 02Aug2021 as single dose for COVID-19 vaccination. Medical history included suspected covid-19 from 19Mar2020 to 26Mar2020, not ongoing; Reactive hypoglycaemia from an unknown date and unknown if ongoing; Bile acid malabsorption/Bile acid diarrhea from an unknown date and unknown if ongoing. Patient also reported a menstrual period date 27May2021. Patient Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included colesevelam from 10Apr2021 to an unspecified stop date taken for Bile acid diarrhea, taken only when required, not daily. Historical vaccine included first dose of BNT162B2 (Lot # ELO3143), on 05Jun2021 (at the age of 31-year-old) as single dose for COVID-19 vaccination. On 02Aug2021, the patient experienced pain in arm. On 03Aug2021, the patient experienced neck pain, headache, fatigue, and lymph node pain. The report was considered as serious due to Other medically important condition by the regulatory authority. The outcome of the event lymph node pain was recovering, while for the rest of events was not recovered. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the plausible temporal relation, the association between the events of neck pain, Lymph node pain, pain in arm, headache, fatigue and inappropriate schedule of vaccine administration and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1534536 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 209A214 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood cholesterol, Fibrin D dimer, Headache, Injection site bruising, Injection site pain, Platelet count, Pyrexia, Rash, Thrombosis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient was on unspecified cholesterol medication.
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Platelet count; Result Unstructured Data: 323 (Normal); Test Date: 20210802; Test Name: Cholesterol; Result Unstructured Data: 6.2 (Normal); Test Date: 20210802; Test Name: Fibrin D dimer; Result Unstructured Data: 0.65
CDC Split Type: ZAJNJFOC20210805070

Write-up: RASH ON THE BACK; SUSPECTED CLOTTING (NOT SURE WHETHER VENOUS OR ARTERIAL); PERSISTING ABDOMINAL PAIN; BRUISING ON INJECTION SITE (15 CM IN DIAMETER AND GROWING); HEADACHE; LOW FEVER; TENDERNESS ON THE SITE OF INJECTION; This spontaneous report received from a health care professional concerned a 45 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. Patient was on unspecified cholesterol medication. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 209A214, expiry: UNKNOWN) dose was not reported, 1 total, administered in left deltoid on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced persisting abdominal pain, bruising on injection site (15 cm in diameter and growing), headache, low fever and tenderness on the site of injection. Laboratory data included: Cholesterol (NR: not provided) 6.2 (Normal), Fibrin D dimer (NR: not provided) 0.65 (higher than reference of 0.5), and Platelet count (NR: not provided) 323 (Normal). On 03-AUG-2021, health care professional (HCP) made a follow up call and stated that patient had rash on the back and persisting abdominal pain. The bruising and tenderness on arm was growing. Patient was not admitted to hospital and was at home. HCP sounded very worried about the persisting abdominal pain and suspected clotting (not sure whether venous or arterial). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from bruising on injection site (15 cm in diameter and growing), headache, persisting abdominal pain, low fever, rash on the back, and suspected clotting (not sure whether venous or arterial), and the outcome of tenderness on the site of injection was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210805070-covid-19 vaccine ad26.cov2.s -Suspected clotting (not sure whether venous or arterial), Persisting abdominal pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210805070-covid-19 vaccine -Rash on the back. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1537976 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-08-02
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Heart rate, Nervous system disorder, Seizure, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: tachycardia; Result Unstructured Data: Test Result:tachycardia
CDC Split Type: ECPFIZER INC202100993076

Write-up: neurological issue; convulsed; tachycardia; This is a spontaneous report from a contactable consumer (patient''s husband). An unspecified age female patient (unknown pregnant) received the first dose of BNT162B2 via intramuscular on the left arm on 05Jul2021 at 12:30 at the age of 41-year-old as single dose for COVID-19 immunization. Reporter did not know the lot number or expiration date because no vaccination certificate was provided (as reported). The patient did not had any disease prior to vaccination. She did not received any other vaccines than the suspected Pfizer vaccine. She did not received concomitant medication. On 02Aug2021, the patient experienced convulsed and tachycardia. A physician went to see the patient and a "neurological issue". The patient underwent many tests, but the reporter did not specify which ones. Reporter confirmed that the second dose of the vaccine was scheduled for 02Aug2021 (as reported), but the patient did not receive it. The outcome of the events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1540230 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-02
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4825 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Polymerase chain reaction
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: AZITHROMYCIN.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: PCR; Result Unstructured Data: Test Result:Positive; Comments: Nasal Swab
CDC Split Type: COPFIZER INC202100993425

Write-up: Positive Covid PCR Test; Positive Covid PCR Test; This is a spontaneous report from a contactable consumer or other non hcp (patient) from the COVAES portal. A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EY4825) as a dose 2, via an unspecified route of administration, administrated at Arm left on 21Jul2021 08:00 as (age at the time of vaccination was 44 years) DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on Jun2021 at 13:00 (Batch/Lot Number: EW4109) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history was not reported. There was no other vaccine in four weeks. There was not Covid prior vaccination. The concomitant medication includes azithromycin from an unspecified date for unspecified indication. The patient informed positive Covid PCR Test on 02Aug2021 at 09:00. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR) was positive on 02Aug2021 through nasal swab. The patient did not receive the any medication for the event. Outcome of the event was recovering.


VAERS ID: 1541874 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202100993153

Write-up: Fainted 2 times in the night; This is a spontaneous report from a contactable physician. A 39-years-old female patient (reporter''s wife) received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) on 02Aug2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had no data on hypertension, not generally clinically healthy with diabetes. And at night when getting up to the bathroom the patient fainted two times, gave her fluids, her legs were placed up and she improved 100% but in the morning, she thought she felt fine, she got up and the problem recurred, now I had her at rest absolute, liquid and ascor drops, stable. The reporter needed some recommendations. The patient would like to know how long could the clinical picture last and could the second dose be applied. The outcome of the event was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1544798 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-08-02
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2083 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: RT-PCR in real time; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: BRPFIZER INC202100997970

Write-up: Since the vaccination, has the patient been tested for COVID-19? Yes/ RT-PCR in real time/ Result: Positive; Since the vaccination, has the patient been tested for COVID-19? Yes/ RT-PCR in real time/ Result: Positive; This is a spontaneous report from a contactable consumer or other non HCP (patient himself) received via regulatory authority. A 46-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FE2083), dose 1 via an unspecified route of administration, administered in Arm Left on 03Jul2021 08:00 (at the age of 46-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history was not reported. The patient was not allergic to any medications, food or other products. The patient had no other diagnosed illnesses/medical history/chronic health conditions. The patient''s concomitant medications were not reported. The patient did the patient receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not taking any other medications/products within 2 weeks of vaccination (include prescribed medicines, store bought medicines, dietary supplements, and herbal remedies). Prior to vaccination, the patient was not diagnosed with COVID-19. On 23Jul2021, the patient experienced cough, tiredness, headache and pains in the body. On 24Jul2021, the patient only had fever. The adverse events required visit to emergency room. On 02Aug2021, since the vaccination, the patient has been tested for COVID-19. Nasal swab taken and done with reverse transcription polymerase chain reaction (RT-PCR) in real time which showed positive result. The adverse events cough, tiredness, headache, pains in the body and fever required treatment included antibiotic and anti-thermal. The outcome of the event fever recovered on 24Jul2021 and outcome of the events cough, tiredness, headache, pains in the body was recovered on 27Jul2021, the outcome of other events was unknown.


VAERS ID: 1553520 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-02
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Drug ineffective, Fatigue, Feeling abnormal, Influenza, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: caught COVID (got the result today); Result Unstructured Data: Test Result:covid
CDC Split Type: BRPFIZER INC202100999304

Write-up: took the Pfizer vaccine / got COVID/ feeling very bad since the day before yesterday. She reports having a flu, very weak leg, tiredness, muscle pain, a lot of fever, shortness of breath; took the Pfizer vaccine / got COVID/ feeling very bad since the day before yesterday. She reports having a flu, very weak leg, tiredness, muscle pain, a lot of fever, shortness of breath; took the Pfizer vaccine / got COVID/ feeling very bad since the day before yesterday; took the Pfizer vaccine / got COVID/ feeling very bad since the day before yesterday. She reports having a flu, very weak leg, tiredness, muscle pain, a lot of fever, shortness of breath; took the Pfizer vaccine / got COVID/ feeling very bad since the day before yesterday. She reports having a flu, very weak leg, tiredness, muscle pain, a lot of fever, shortness of breath; took the Pfizer vaccine / got COVID/ feeling very bad since the day before yesterday. She reports having a flu, very weak leg, tiredness, muscle pain, a lot of fever, shortness of breath; This is a spontaneous report from a contactable consumer (patient) from Customer Service. A female patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date in Jun2021 (at the age of 40-year-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. Dose/Dosage Form was reported as 225 g in 0.45 ml of injectable suspension (6 doses/vial). Patient got in touch and informed that she took the Pfizer vaccine two months ago, caught COVID (got the result that day, on 04Aug2021) and has been feeling very bad since the day before yesterday (02Aug2021). She reported she had a flu, very weak leg, tiredness, muscle pain, a lot of fever, shortness of breath. She informed that she was medicated and was going to another private physician. She would like to know if the first dose was effective and gives protection. She thought she got the new variant. She asked was the vaccine effective against the new variants. Patient informed that she was in doubt about the effectiveness of the vaccine if it even worked. She informed that she didn''t go to bars and still got COVID. Pfizer''s program should check better or should put the interval between vaccine doses at 21 days to prevent people from getting COVID, as was done in other countries. If the vaccine was as effective, people take the first dose and no longer need to wear a mask. She used it, took care of herself and still got COVID. She cannot understand. She informed that she was in doubt whether the vaccine was applied, as she got COVID even after receiving the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: covid on 04Aug2021. The clinical outcome of vents was unknown. The batch number will be requested in follow-up activities.


VAERS ID: 1554698 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-08-02
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Base excess, Blood bicarbonate, Blood calcium, Blood chloride, Blood glucose, Blood lactic acid, Blood methaemoglobin, Blood pH, Blood potassium, Blood pressure measurement, Blood sodium, Body temperature, Carbon dioxide, Carboxyhaemoglobin, Electrocardiogram, Fraction of inspired oxygen, Haematocrit, Haemoglobin, Heart rate, Oxygen saturation, PCO2, PO2, Palpitations, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (previous episodes of atrial fibrillation already subjected to ablation); Cardiac catheter ablation
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: BE(B); Result Unstructured Data: Test Result:4.2 mmol/L; Test Date: 20210802; Test Name: BEecf; Result Unstructured Data: Test Result:6.4 mmol/L; Test Date: 20210802; Test Name: HCO3std; Result Unstructured Data: Test Result:26.3 mmol/L; Test Date: 20210802; Test Name: Blood calcium; Result Unstructured Data: Test Result:1.33 mmol/L; Test Date: 20210802; Test Name: Blood chloride; Result Unstructured Data: Test Result:103 mmol/L; Test Date: 20210802; Test Name: Blood glucose; Test Result: 77 mg/dl; Test Date: 20210802; Test Name: Blood lactic acid; Result Unstructured Data: Test Result:1.8 mmol/L; Test Date: 20210802; Test Name: MetHb; Test Result: 1.8 %; Comments: High (normal up to 1.5); Test Date: 20210802; Test Name: Blood ph; Result Unstructured Data: Test Result:7.32; Comments: Low; Test Date: 20210802; Test Name: Blood potassium; Result Unstructured Data: Test Result:5.0 mmol/L; Test Date: 20210802; Test Name: blood pressure; Result Unstructured Data: Test Result:110-65; Test Date: 20210802; Test Name: Blood sodium; Result Unstructured Data: Test Result:139 mmol/kg; Test Date: 20210802; Test Name: Body temperature; Result Unstructured Data: Test Result:37 and 36 Centigrade; Test Date: 20210802; Test Name: TCO2; Result Unstructured Data: Test Result:34.4 mmol/L; Test Date: 20210802; Test Name: COHb; Test Result: 0.9 %; Test Date: 20210802; Test Name: ECG; Result Unstructured Data: Test Result:Nonspecific alterations of repolarization; Comments: Sinus rhythm. Nonspecific alterations of repolarization. Vent rate: 67;PR int: 166 ms; QRS dur: 90 ms; QT/QTc: 362/377 ms; P-R-T axes: 61 37 44; Test Date: 20210802; Test Name: FlO2; Test Result: 21 %; Test Date: 20210802; Test Name: Hct(c); Test Result: 45 %; Test Date: 20210802; Test Name: tHB; Result Unstructured Data: Test Result:15 g/dl; Test Date: 20210802; Test Name: Heart rate; Result Unstructured Data: Test Result:70; Test Date: 20210802; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:98; Comments: in ambient air; Test Date: 20210802; Test Name: Blood pCO2; Result Unstructured Data: Test Result:63 mmHg; Comments: High; Test Date: 20210802; Test Name: pO2; Result Unstructured Data: Test Result:21 mmHg; Comments: Low
CDC Split Type: ITPFIZER INC202100996968

Write-up: feeling of heartbeat/heart palpitations; tachycardia; This is a spontaneous report from a contactable consumer (brother of the patient), via a Pfizer colleague. A 44-year-old male patient received second dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: FF0688), via an unspecified route of administration on 15Jul2021 as dose 2, single (at the age of 44-year-old), for COVID-19 immunization. Medical history included previous episodes of atrial fibrillation already subjected to ablation. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: FC3098), via an unspecified route of administration on 14Jun2021 as dose 1, single (at the age of 44-year-old), for COVID-19 immunization. Patient vaccinated with 2 doses. It was stated that, the patient experienced feeling of heartbeat/heart palpitations and tachycardia. It was reported that, for about 1 hour, feeling of heartbeat in a patient with known atrial fibrillation with previous ablation. Arrived at the hospital autonomously (by own means) with free access (own decision). As per physical examinations on 02Aug2021 at 20:20: Objective Exam: symmetrical, expandable chest. Clear lung sound. Mobile pulmonary bases. Vesicular murmur on auscultation. Clear heart tones, free pauses. Negative chest due to cardiogenic states, absence of declining edema in the lower limbs: no clinical signs referable to circulation compensation are in progress. Abdomen: nothing pathological. Heart rate was 70, Blood pressure: max 110, min 65, oxygen saturation in ambient air: 98, Temperature: 36. Additional tests performed on 02Aug2021: blood calcium: 1.33 mmol/l; blood chloride: 103 mmol/l; blood glucose: 77 mg/dl; blood lactic acid: 1.8 mmol/l; blood pH: 7.32 low (range 7.35 to 7.45); blood potassium: 5.0 mmol/l; blood pressure measurement: 110-65; blood sodium: 139 mmol/kg (range 133 to 145) on 02Aug2021, body temperature: 37 centigrade and 36 centigrade; pco2: 63 mmhg (range 35 to 48); pO2: 21 mmhg (range 83 to 108), tHB 15g/dl; =2Hb 33.5 %; COHb 0.9%; MetHb 1.8 % (High) (normal up to 1.5); HHb 63.8 %; s=2 34.4% (Low) (normal range 94.0 -98.0) ; TCO2 34,4 mmol/l BEecf 6.4 mmol/l; BE(B) 4.2 mmol/l; P/F ratio 100 mmHg; O2ct 32.5 mmol/l (High) ( normal range 22.0-26.0); HCO3std 26.3 mmol/l; Hct(c) 45%; FlO2 21%. ECG results: Sinus rhythm. Nonspecific alterations of repolarization. Vent rate: 67;PR int: 166 ms; QRS dur: 90 ms; QT/QTc: 362/377 ms; P-R-T axes: 61 37 44. The patient was discharged to home on 02Aug2021 at 21:34. Prescription: to be reevaluated in case of new episodes of heartbeat. No corrective treatment received for the events. The outcome of the events was reported as recovered on the same day 02Aug2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1554920 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Covid-19 test; Test Result: Positive
CDC Split Type: PTPFIZER INC202100997233

Write-up: patient developed cough and on 2Aug2021 was positive to COVID-19, 24 days after 2nd dose; patient developed cough and on 2Aug2021 was positive to COVID-19, 24 days after 2nd dose; This is a spontaneous report from a contactable consumer (patient''s parent). This report was received via a sales representative. A 22-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number: FA5831), via an unspecified route of administration, on an unspecified date, as single dose and received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot number: FA5831), via an unspecified route of administration, on 09Jul2021, as single dose, both for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient developed cough and on 2Aug2021 was positive to COVID-19, 24 days after 2nd dose. The patient underwent lab tests and procedures which included sars-cov-2 test/ covid-19 test: positive on 02Aug2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1555663 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Anaphylactic shock, Blood pressure decreased, Blood pressure measurement, Body temperature, Cardiovascular symptom, Cold sweat, Dysmenorrhoea, Dysphoria, Gastrointestinal disorder, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: blood pressure; Result Unstructured Data: Test Result:74/42 mmHg; Test Date: 20210802; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101010932

Write-up: cold sweat; vomiting; BP 74/42 mmhg decreased; Anaphylaxis; Anaphylactic shock; dysphoria; abdominal pain lower like period pains; gastrointestinal symptoms; cardiovascular symptoms; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21123151. A 21-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FC5295, Expiration date 30Sep2021), via an unspecified route of administration on 02Aug2021 14:05 (the day of vaccination) (at the age of 21-year-old) as dose 2, single for COVID-19 immunisation. Body temperature before vaccination was 36.5 degrees Centigrade on 02Aug2021. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 02Aug2021 at 14:16 (11 minutes after the vaccination), the patient experienced Anaphylaxis. On 02Aug2021 (the day of the vaccination), the patient was admitted to the hospital. On 02Aug2021 (the day of the vaccination), the outcome of the event was recovering. The course of the event was as follows: After the second dose of vaccination (vaccinated at 14:05), since the patient complained of dysphoria, she was placed in a supine position for bed rest. At 14:16, the patient complained of abdominal pain lower like period pains, and experienced cold sweat, and vomiting. BP 74/42 mmhg decreased. Judged as Anaphylactic shock. The reporting physician classified the event as serious (caused hospitalized from 02Aug2021 to 03Aug2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Judged as Anaphylactic shock after the second dose of vaccination. From 10 minutes after the vaccination, the patient experienced dysphoria, gastrointestinal symptoms and cardiovascular symptoms. Started intramuscular injection and fluid replacement of BOSMIN 0.3mg, called for emergency. The patient underwent lab tests and procedures which included blood pressure measurement: 74/42 mmhg on 02Aug2021, body temperature: 36.5 centigrade on 02Aug2021 Before vaccination. The outcome of anaphylaxis, anaphylactic shock, dysphoria, cold sweat and vomiting was recovering and for other events outcome was unknown. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1558640 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100992372

Write-up: Very heavy very painful periods; Very heavy very painful periods.; This is a spontaneous report from a contactable consumer or other non-health care professional received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108030450230240-RNPWK. A 33-years-old female (not-pregnant and not currently breastfeeding) patient received bnt162b2 (COMIRNATY; PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: FF3319) via an unspecified route of administration on 29Jul2021 as dose 2, single for covid-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 02Aug2021, the patient experienced very heavy very painful periods. Enough to stop her going to work. The events considered as medically significant. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1571370 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-08-02
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Hypersensitivity, Inappropriate schedule of product administration, Malaise, Myalgia, Nausea, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: stomach; generally unwell; feeling sick; Nausea; Muscle ache; Inappropriate schedule of vaccine administered; Hypersensitivity; Dizziness; This regulatory authority case was reported by a consumer and describes the occurrence of VERTIGO (stomach), MALAISE (generally unwell), HYPERSENSITIVITY (Hypersensitivity), DIZZINESS (Dizziness), MALAISE (feeling sick), NAUSEA (Nausea) and MYALGIA (Muscle ache) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3002332 and 3001659) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced VERTIGO (stomach) (seriousness criterion medically significant), MALAISE (generally unwell) (seriousness criterion medically significant) and MALAISE (feeling sick) (seriousness criterion medically significant). On 02-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VERTIGO (stomach), MALAISE (generally unwell) and MALAISE (feeling sick) was resolving and HYPERSENSITIVITY (Hypersensitivity), DIZZINESS (Dizziness), NAUSEA (Nausea) and MYALGIA (Muscle ache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications or treatment medications were reported. Patient woke up with light sensitivity to natural sunlight and bright artificial lights Company comment: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #3002332 with associated AEs (Nausea, dizziness, hypersensitivity, myalgia, vertigo, malaise). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #3002332 with associated AEs (Nausea, dizziness, hypersensitivity, myalgia, vertigo, malaise). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1571386 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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.MOD20212

Write-up: Sore throat; Headache; Fatigue; Shivers; This case was received via RA (Reference number: ADR 25752715) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Shivers) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Flu-like symptoms, at an unspecified dose and frequency and IBUPROFEN for Flu-like symptoms, at an unspecified dose and frequency. On 04-Aug-2021, OROPHARYNGEAL PAIN (Sore throat), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Shivers) had 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 felt like flue symptoms, treated with paracetamol, ibuprofen and fluids. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. No concomitant medication details were provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1571551 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210824484

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA ,PH-PHFDA-300096105] concerned a 42 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 19:10, the patient experienced elevated BP. Laboratory data included: Blood pressure (NR: not provided) 180/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0; 20210824484 -covid-19 vaccine ad26.cov2.s -Elevated BP. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1573722 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 52C21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, Skin swelling, Tenderness, Vaccination site joint warmth, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAMODERNATX, INC.MOD20212

Write-up: more bumps appeared later and it became worst; Bumps on injection site from elbow up to shoulder; Tender vaccinated arm (Elbow to Shoulder); Burning from elbow up to shoulder; Hot to the touch from elbow up to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender vaccinated arm (Elbow to Shoulder)), BURNING SENSATION (Burning from elbow up to shoulder), VACCINATION SITE JOINT WARMTH (Hot to the touch from elbow up to shoulder), SKIN SWELLING (more bumps appeared later and it became worst) and VACCINATION SITE SWELLING (Bumps on injection site from elbow up to shoulder) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 52C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced TENDERNESS (Tender vaccinated arm (Elbow to Shoulder)) (seriousness criterion hospitalization), BURNING SENSATION (Burning from elbow up to shoulder) (seriousness criterion hospitalization), VACCINATION SITE JOINT WARMTH (Hot to the touch from elbow up to shoulder) (seriousness criterion hospitalization) and VACCINATION SITE SWELLING (Bumps on injection site from elbow up to shoulder) (seriousness criterion hospitalization). On an unknown date, the patient experienced SKIN SWELLING (more bumps appeared later and it became worst) (seriousness criterion hospitalization). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Adverse event, at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) for Adverse event, at an unspecified dose and frequency and RANITIDINE HYDROCHLORIDE (ZANTAC) for Adverse event, at an unspecified dose and frequency. At the time of the report, TENDERNESS (Tender vaccinated arm (Elbow to Shoulder)), BURNING SENSATION (Burning from elbow up to shoulder), VACCINATION SITE JOINT WARMTH (Hot to the touch from elbow up to shoulder), SKIN SWELLING (more bumps appeared later and it became worst) and VACCINATION SITE SWELLING (Bumps on injection site from elbow up to shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient visited the emergency room last night on 03-Aug-2021, and they prescribed her steroid cream. She had an appointment to see her family doctor on 05-Aug-2021. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1575176 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic obstructive airways disease; Dyslipidaemia; Hypertension arterial; Peripheral obliterative arteriopathy; Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210824170

Write-up: COVID-19 PNEUMONITIS; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, FR-AFSSAPS-TO20216340] concerned a 61 year old male. Initial information was processed along with additional information on 12-AUG-2021. The patient''s weight was 80 kilograms, and height was 172 centimeters. The patient''s concurrent conditions included: hypertension arterial, peripheral obliterative arteriopathy, dyslipidaemia, type 2 diabetes mellitus, and chronic obstructive airways disease. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: JO7BX03, expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 12-MAY-2021 for covid-19 vaccination. The drug start period and last period was 83 days and duration of drug was 1 day. No concomitant medications were reported. On 02-AUG-2021, the patient experienced covid-19 pneumonitis and vaccination failure, and was hospitalized (date unspecified). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vaccination failure, and covid-19 pneumonitis. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210824170-covid-19 vaccine -COVID-19 Pneumonia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210824170-covid-19 vaccine -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: 1575195 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Headache; Tiredness; Joint ache; This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Tiredness) and ARTHRALGIA (Joint ache) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included PARACETAMOL from 01-Aug-2021 to 01-Aug-2021 for Neck pain. On 01-Aug-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and ARTHRALGIA (Joint ache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), FATIGUE (Tiredness) and ARTHRALGIA (Joint ache) 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment information was not provided. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1575196 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Tiredness; Headache; Fever; This case was received via Regulatory Authority (Reference number: ADR 25749916) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever) in a 30-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 03-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, FATIGUE (Tiredness) had not resolved and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded


VAERS ID: 1575197 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Hyperaesthesia, Hyperhidrosis, Myalgia, Nausea, Palpitations, Respiratory tract irritation, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210627; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: sweating; muscle ache; Lung irritation; Increased skin sensitivity; Heart pounding; Muscle pain; Headache; Tiredness; Nausea; This case was received via RA (Reference number: 25752367) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERAESTHESIA (Increased skin sensitivity), RESPIRATORY TRACT IRRITATION (Lung irritation), HYPERHIDROSIS (sweating), PALPITATIONS (Heart pounding), MYALGIA (muscle ache), NAUSEA (Nausea), MYALGIA (Muscle pain), HEADACHE (Headache) and FATIGUE (Tiredness) in a 33-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 02-Aug-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced HYPERAESTHESIA (Increased skin sensitivity) (seriousness criterion medically significant), PALPITATIONS (Heart pounding) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 04-Aug-2021, the patient experienced RESPIRATORY TRACT IRRITATION (Lung irritation) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant) and MYALGIA (muscle ache) (seriousness criterion medically significant). At the time of the report, HYPERAESTHESIA (Increased skin sensitivity), PALPITATIONS (Heart pounding), NAUSEA (Nausea) and MYALGIA (Muscle pain) was resolving, RESPIRATORY TRACT IRRITATION (Lung irritation) had not resolved, HYPERHIDROSIS (sweating) and MYALGIA (muscle ache) outcome was unknown and HEADACHE (Headache) and FATIGUE (Tiredness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jun-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No relevant concomitant medication was reported. Treatment information was not provided by reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded


VAERS ID: 1576074 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Illness, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984459

Write-up: nausea; vomiting; headache; Sickness; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number (GB-MHRA-WEBCOVID-202108020050317400-L8RI7), Safety Report Unique Identifier (GB-MHRA-ADR 25738522). A 19-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location (on 29Jul2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient''s medical history included lactation decreased and birth control. The patient has not had symptoms associated with COVID-19. The patient was not currently breastfeeding. The patient was not enrolled in clinical trial. Concomitant medications included ethinylestradiol, levonorgestrel (MICROGYNON) taken for birth control from 01Aug2016 to 19Jul2021. On an unspecified date, the patient experienced nausea, vomiting and headache. On 02Aug2021, the patient experienced sickness. The patient had nausea and vomiting, bad headache. Lasting headache 2-3 days after vaccine was given. The patient underwent lab test which included COVID-19 virus test: negative, no-negative COVID-19 test on 26Jul2021. The patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events nausea, vomiting and headache was unknown. The outcome of the event sickness was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1576083 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Insomnia, Myalgia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100984414

Write-up: Chills; Insomnia; Muscle ache; Vomiting; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108020337008850-0XWXC. A 25-years-old female patient received second dose of bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 31Jul2021as dose2, single for covid-19 immunisation. Medical history included suppressed lactation, suspected covid-19 from 06Jun2021 to 09Jun2021 , depression. The patient was not enrolled in clinical trial. Concomitant medications included citalopram taken for depression. The patient experienced vomiting on 02Aug2021, chills on an unspecified date, insomnia, muscle ache on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No Negative COVID-19 test. The patient has not tested positive for COVID-19 since having the vaccine. The outcome of events of vomiting, chills, and muscle ache was reported as resolving, however the outcome of the event of insomnia was reported as not resolved. The events were assessed as serious (medically significant). No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected.


VAERS ID: 1576086 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100984488

Write-up: Nausea; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108020632080980-JXVNC. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown), dose 1 via an unspecified route of administration on 01Aug2021 as dose 1, single for covid-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient''s medical history and concomitant medications were not reported. The patient experienced nausea, headache on 02Aug2021. reporter assessed events as medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1576102 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Nausea, Pain, Paraesthesia, Retching, SARS-CoV-2 test, Sinus headache, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: DUAC; IBUPROFEN; PARACETAMOL; VENLAFAXINE; PIRINASE HAYFEVER
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Retching; Headache sinus; Ache; Stomachache; Pins and needles; Nausea; Chills; Faint; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Faint), RETCHING (Retching), SINUS HEADACHE (Headache sinus), PAIN (Ache), ABDOMINAL PAIN UPPER (Stomachache), PARAESTHESIA (Pins and needles), NAUSEA (Nausea) and CHILLS (Chills) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included BENZOYL PEROXIDE, CLINDAMYCIN PHOSPHATE (DUAC) for Acne, FLUTICASONE PROPIONATE (PIRINASE HAYFEVER) for Allergic rhinitis, VENLAFAXINE for Anxiety, IBUPROFEN from 02-Aug-2021 to an unknown date and PARACETAMOL from 02-Aug-2021 to an unknown date for Pain. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant), SINUS HEADACHE (Headache sinus) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomachache) (seriousness criterion medically significant), PARAESTHESIA (Pins and needles) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced RETCHING (Retching) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Faint) had resolved, RETCHING (Retching) outcome was unknown, SINUS HEADACHE (Headache sinus) had not resolved and PAIN (Ache), ABDOMINAL PAIN UPPER (Stomachache), PARAESTHESIA (Pins and needles), NAUSEA (Nausea) and CHILLS (Chills) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient spoke to a doctor who advised hydration. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576131 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deafness, Dizziness, Malaise, Phobia
SMQs:, Anticholinergic syndrome (broad), Hearing impairment (narrow), Vestibular disorders (broad)

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

Write-up: phobia; unwell; Hearing loss; Felt giddy; This case was received via the Regulatory Authority RA (Reference number: ADR 25741582) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEAFNESS (Hearing loss) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant) and DIZZINESS (Felt giddy). On an unknown date, the patient experienced PHOBIA (phobia) and MALAISE (unwell). On 02-Aug-2021, DEAFNESS (Hearing loss) and DIZZINESS (Felt giddy) had resolved. At the time of the report, PHOBIA (phobia) and MALAISE (unwell) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient reported that she also suffers from needle phobia . Symptoms got resolved when patient lied down and with a glass of water.Normotensive hen BP checked . Concomitant medications was not reported . Treatment history was not reported . Company comment: Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected.


VAERS ID: 1576134 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

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

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

Write-up: Sweating; Chills; Faint; Nausea; This case was received via Regulatory authority (Reference number: ADR 25741612) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Faint), HYPERHIDROSIS (Sweating), NAUSEA (Nausea) and CHILLS (Chills) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Faint), NAUSEA (Nausea) and CHILLS (Chills) had not resolved and HYPERHIDROSIS (Sweating) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. Patient has not tested positive for COVID-19 since having the vaccine Concomitant product usage were not provided. Treatment details were not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further follow-up information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further follow-up information is expected at this time.


VAERS ID: 1576136 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-08-02
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Maternal exposure during breast feeding, Muscle spasms, Pain
SMQs:, Dystonia (broad), Neonatal exposures via breast milk (narrow)

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

Write-up: pain; cramps; Maternal exposure during breast feeding; Menstrual cramps; This case was received via Regulatory Agency (Reference number: 25741780) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of PAIN (pain), MUSCLE SPASMS (cramps) and DYSMENORRHOEA (Menstrual cramps) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Breast feeding. On 23-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Transmammary) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced DYSMENORRHOEA (Menstrual cramps) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant), MUSCLE SPASMS (cramps) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). At the time of the report, PAIN (pain) and MUSCLE SPASMS (cramps) had resolved, DYSMENORRHOEA (Menstrual cramps) had not resolved and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Transmammary) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Patient had cramps on day 1 of her period without exception. Post vaccination patient had experienced bad cramps on day 1 and 2 for 2 cycles after first dose of Moderna. Post 2nd dose day 1 of menstruation was pain free but day 2 was painful. This is a case of Maternal exposure during breastfeeding with associated AEs (Pain, muscle spasms, dysmenorrhea) for this 42-year-old female. There were no reported AEs in the child. This being a report from a regulatory authority, no further information is expected. This case was linked to MOD-2021-278775 (Parent-Child Link). See case MOD-2021-278775 for details regarding the child case.; Sender''s Comments: This is a case of Maternal exposure during breastfeeding with associated AEs (Pain, muscle spasms, dysmenorrhea) for this 42-year-old female. There were no reported AEs in the child.This being a report from a regulatory authority, no further information is expected.


VAERS ID: 1576159 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; PROPRANOLOL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), PYREXIA (Fever) and NAUSEA (Nausea) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concomitant products included PROPRANOLOL for Anxiety, SERTRALINE for Depression, PARACETAMOL for Menstrual cramps. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced VERTIGO (Vertigo) (seriousness criteria disability and medically significant), PYREXIA (Fever) (seriousness criteria disability and medically significant) and NAUSEA (Nausea) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts too). At the time of the report, VERTIGO (Vertigo), PYREXIA (Fever) and NAUSEA (Nausea) had not resolved and PAIN IN EXTREMITY (Arm hurts too) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient was unable to move without extreme vertigo and nausea. The patient''s arm hurt but that was the least of her worries. The patient could not move anymore or faint or vomit or both. The slightest movement causes extreme vertigo and nausea. The treatment medications were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1576164 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain, Musculoskeletal stiffness, Nausea, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: DESOGESTREL; LEVOTHYROXINE
Current Illness: Contraception; Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: stiff neck; arm pain; tiredness; Nausea; Shivering; Headache; Ache; Weakness; Neck stiff; Injection site pain; Fatigue; This case was received via Regulatory Authority RA (Reference number: ADR 25744098) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck), PAIN IN EXTREMITY (arm pain), FATIGUE (tiredness), NAUSEA (Nausea), CHILLS (Shivering), HEADACHE (Headache), PAIN (Ache), ASTHENIA (Weakness), MUSCULOSKELETAL STIFFNESS (Neck stiff), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Contraception and Hypothyroidism. Concomitant products included DESOGESTREL from 27-Jul-2021 to an unknown date for Contraception, LEVOTHYROXINE from 01-Aug-2016 to an unknown date for Hypothyroidism. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Neck stiff) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck) (seriousness criterion medically significant), PAIN IN EXTREMITY (arm pain) (seriousness criterion medically significant) and FATIGUE (tiredness) (seriousness criterion medically significant). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck), PAIN IN EXTREMITY (arm pain) and FATIGUE (tiredness) outcome was unknown and NAUSEA (Nausea), CHILLS (Shivering), HEADACHE (Headache), PAIN (Ache), ASTHENIA (Weakness), MUSCULOSKELETAL STIFFNESS (Neck stiff), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment drug information provided. Company Comment : Based on the current available information and temporal association between the use of the product mRNA-1273 and the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the events, a causal relationship cannot be excluded.


VAERS ID: 1576170 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Facial pain, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Facial pain; Facial swelling; This case was received via regulatory authority (Reference number: 25744796) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FACIAL PAIN (Facial pain) and SWELLING FACE (Facial swelling) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Ovarian hyperstimulation syndrome and Hypothyroidism. Concomitant products included LEVOTHYROXINE from 01-Jan-2016 to an unknown date for Hypothyroidism, CABERGOLINE from 28-Jul-2021 to an unknown date for Ovarian hyperstimulation syndrome. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced FACIAL PAIN (Facial pain) (seriousness criterion medically significant) and SWELLING FACE (Facial swelling) (seriousness criterion medically significant). At the time of the report, FACIAL PAIN (Facial pain) and SWELLING FACE (Facial swelling) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1576172 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness postural, Fatigue, Headache, Hyperhidrosis, Myalgia, Pyrexia, SARS-CoV-2 test, Skin warm, Swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sweating; Swelling; Skin warm; Dizziness upon standing; Muscle ache; Muscle pain; Tiredness; Headache; Fever; This case was received via RA (Reference number: ADR 25744915) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), SWELLING, SKIN WARM (Skin warm), DIZZINESS POSTURAL (Dizziness upon standing), MYALGIA (Muscle ache), MYALGIA (Muscle pain), FATIGUE (Tiredness), HEADACHE and PYREXIA (Fever) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), SWELLING (Swelling) (seriousness criterion medically significant), SKIN WARM (Skin warm) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizziness upon standing) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, HYPERHIDROSIS (Sweating), SWELLING (Swelling), SKIN WARM (Skin warm), DIZZINESS POSTURAL (Dizziness upon standing), MYALGIA (Muscle ache), MYALGIA (Muscle pain), FATIGUE (Tiredness), HEADACHE (Headache) and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. 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. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The events appear to be non-serious. However, details including medical history, concomitant medications, treatment details and outcome are required to determine serious criteria and for further assessment. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The events appear to be non-serious. However, details including medical history, concomitant medications, treatment details and outcome are required to determine serious criteria and for further assessment.


VAERS ID: 1576174 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Pain in extremity, 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: CITALOPRAM; MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness: Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy))
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Painful arm; Myalgia; This case was received via Regulatory Authority (Reference number: 25745204) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) and MYALGIA (Myalgia) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)). Concomitant products included CITALOPRAM for Anxiety, ETHINYLESTRADIOL, LEVONORGESTREL (MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]) for Contraception. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and MYALGIA (Myalgia) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm) was resolving and MYALGIA (Myalgia) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1576179 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Hypersensitivity, Limb discomfort, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Pain; Tiredness; Hypersensitivity; Arm discomfort; Headache; Muscle soreness; This case was received via Regulatory Authority (Reference number: 25745595) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity), PAIN (Pain), LIMB DISCOMFORT (Arm discomfort), HEADACHE (Headache), MYALGIA (Muscle soreness) and FATIGUE (Tiredness) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Depression. Concomitant products included SERTRALINE from 07-Jan-2021 to an unknown date for Depression, PARACETAMOL from 02-Aug-2021 to an unknown date for an unknown indication. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity) (seriousness criterion medically significant), LIMB DISCOMFORT (Arm discomfort) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and MYALGIA (Muscle soreness) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Pain) (seriousness criterion medically significant). At the time of the report, HYPERSENSITIVITY (Hypersensitivity), LIMB DISCOMFORT (Arm discomfort), HEADACHE (Headache), MYALGIA (Muscle soreness) and FATIGUE (Tiredness) had not resolved and PAIN (Pain) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information provided included that the patient was advised by the nurse at the vaccine facility to take paracetamol after their injection. The patient also reported that their head, eyes, and skin were very sensitive to touch. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576180 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise, 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: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: unwell; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (unwell) and PYREXIA (Fever) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Suspected COVID-19 (Unsure when symptoms stopped) on 30-Mar-2020. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (unwell) (seriousness criterion medically significant). At the time of the report, MALAISE (unwell) and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-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 provided by the reporter. It was reported that Around 12 hours post-vaccine patient started to feel unwell and on trying to get to sleep patient felt unusually warm. By 1pm patient was so uncomfortable and checked reading with a thermometer and it was 38.8 degrees. After taking paracetamol it reduced to 38.5 degrees. Upon waking at 7am, temperature was nearly back down to my normal at around 37.2.Patient also had a high heart rate of 78-80 (resting is normally 52-54) Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded


VAERS ID: 1576194 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Fatigue, Headache, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: MORPHINE.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Weakness; Muscle pain; Headache dull; Nauseated; Tiredness; This case was received via Regulatory Authority (Reference number: ADR 25747317) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), MYALGIA (Muscle pain), HEADACHE (Headache dull), NAUSEA (Nauseated) and FATIGUE (Tiredness) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included MORPHINE from 14-May-2021 to 15-May-2021 for Caesarean section. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced ASTHENIA (Weakness) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), HEADACHE (Headache dull) (seriousness criterion medically significant), NAUSEA (Nauseated) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, ASTHENIA (Weakness), MYALGIA (Muscle pain), HEADACHE (Headache dull), NAUSEA (Nauseated) and FATIGUE (Tiredness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications was reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576195 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Cough, Dizziness, Headache, Hyperhidrosis, Illness, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Coughing; Chest ache; Sickness; High temperature; Lightheadedness; Ache; Headache; Sweating; This case was received via RA (Reference number: ADR 25747347) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (Coughing), CHEST PAIN (Chest ache), ILLNESS (Sickness), PYREXIA (High temperature), DIZZINESS (Lightheadedness), PAIN (Ache), HEADACHE (Headache) and HYPERHIDROSIS (Sweating) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced COUGH (Coughing) (seriousness criterion medically significant), CHEST PAIN (Chest ache) (seriousness criterion medically significant), ILLNESS (Sickness) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), DIZZINESS (Lightheadedness) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and HYPERHIDROSIS (Sweating) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for High temperature, at an unspecified dose and frequency. At the time of the report, COUGH (Coughing), CHEST PAIN (Chest ache), ILLNESS (Sickness), PYREXIA (High temperature), DIZZINESS (Lightheadedness), PAIN (Ache) and HEADACHE (Headache) had not resolved and HYPERHIDROSIS (Sweating) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further follow-up information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further follow-up information is expected at this time.


VAERS ID: 1576197 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Electrocardiogram, Laboratory test, Loss of personal independence in daily activities, Lymphadenopathy, Non-cardiac chest pain, Pain, Peripheral swelling, Pyrexia, Respiration abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: chills; Swelling arm; Swelling of the lymph nodes; Abnormal breathing; Activities of daily living impaired; fever; pain; Non-cardiac chest pain; This case was received via Regulatory authority(Reference number: GB-MHRA-ADR 25747569) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (fever), PAIN (pain), NON-CARDIAC CHEST PAIN (Non-cardiac chest pain) and CHILLS (chills) in a 33-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced NON-CARDIAC CHEST PAIN (Non-cardiac chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) (seriousness criterion medically significant), PAIN (pain) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swelling arm), LYMPHADENOPATHY (Swelling of the lymph nodes), RESPIRATION ABNORMAL (Abnormal breathing) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired). On 03-Aug-2021, NON-CARDIAC CHEST PAIN (Non-cardiac chest pain) was resolving. At the time of the report, PYREXIA (fever), PAIN (pain) and CHILLS (chills) had resolved and PERIPHERAL SWELLING (Swelling arm), LYMPHADENOPATHY (Swelling of the lymph nodes), RESPIRATION ABNORMAL (Abnormal breathing) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) Normal. On an unknown date, Laboratory test: normal (normal) Normal. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant information was not provided. Treatment information was not provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness was captured as such by Regulatory Authority.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness was captured as such by Regulatory Authority.


VAERS ID: 1576200 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Fatigue, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: tiredness; shivering; Fever; Nausea; Diarrhea; This case was received via Regulatory Authority(Reference number: 25747830) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), CHILLS (shivering), PYREXIA (Fever), NAUSEA (Nausea) and DIARRHOEA (Diarrhea) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced FATIGUE (tiredness) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and DIARRHOEA (Diarrhea) (seriousness criterion medically significant). The patient was treated with PARACETAMOL at an unspecified dose and frequency. On 03-Aug-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, FATIGUE (tiredness) and CHILLS (shivering) outcome was unknown and PYREXIA (Fever) and NAUSEA (Nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication of the patient was not reported. It was reported that the patient had vaccine at 09:00 on 02/08/21. Took paracetamol during day. It was also reported that the patient had tiredness during the day and that at 21.00 had some shivering. Furthermore, it was reported that the patient woke up at 03:00 on 03/08/21 with high fever, nausea and diarrhea. Took paracetamol and used cold towel to cool forehead. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576218 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Ear pain, Oropharyngeal pain, Pain
SMQs:, Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sore throat; Ear ache; Ache; Diarrhea; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), DIARRHOEA (Diarrhea), OROPHARYNGEAL PAIN (Sore throat) and EAR PAIN (Ear ache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No medical history was reported. Concomitant products included PARACETAMOL from 02-Aug-2021 to an unknown date for Aching joints. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant) and EAR PAIN (Ear ache) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). At the time of the report, PAIN (Ache), OROPHARYNGEAL PAIN (Sore throat) and EAR PAIN (Ear ache) had not resolved and DIARRHOEA (Diarrhea) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. It was reported that patient had no symptoms associated with COVID-19 and was not enrolled in any clinical trials Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576234 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Decreased appetite, Fatigue, Nausea, Pain in extremity, Peripheral swelling, Pyrexia, Vaccination site induration, Vaccination site warmth
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 38.2 degree Celsius, Low grade fever; Test Name: Body temperature; Result Unstructured Data: 39 degree Celsius
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: became very swollen across the full upper arm; painful arm; Arm Hot to touch; loss of appetite; Arm hard; Fever; Nausea; Swollen arm; Fatigue; This case was received via RA (Reference number: ADR 25750392) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (became very swollen across the full upper arm), PAIN IN EXTREMITY (painful arm), PERIPHERAL SWELLING (Swollen arm), FATIGUE (Fatigue), PYREXIA (Fever) and NAUSEA (Nausea) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Asthma. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (became very swollen across the full upper arm) (seriousness criterion medically significant), PAIN IN EXTREMITY (painful arm) (seriousness criterion medically significant), VACCINATION SITE WARMTH (Arm Hot to touch), DECREASED APPETITE (loss of appetite) and VACCINATION SITE INDURATION (Arm hard). The patient was treated with PARACETAMOL (oral) for Adverse event, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (became very swollen across the full upper arm) and PAIN IN EXTREMITY (painful arm) was resolving, PERIPHERAL SWELLING (Swollen arm), FATIGUE (Fatigue), PYREXIA (Fever) and NAUSEA (Nausea) had not resolved and VACCINATION SITE WARMTH (Arm Hot to touch), DECREASED APPETITE (loss of appetite) and VACCINATION SITE INDURATION (Arm hard) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 38.2 (High) 38.2 degree Celsius, Low grade fever and 39 (High) 39 degree Celsius. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Patient was experiencing painful arm which became very swollen across the full upper arm, shoulder to elbow crease. It was hot to touch and hard. Patient was also experiencing loss of appetite, fatigue, fever and nausea. The fever was not reducing with the use of Paracetamol. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576235 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Hallucination, Headache, Hyperhidrosis, Musculoskeletal stiffness, Nausea, Night sweats, Nightmare, Pyrexia, SARS-CoV-2 test, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: hallucination; stomach; sweating; shivering; chills; Aching joints; Headache; Fever chills; Fever; Nausea; Stiffness; Night sweat; Nightmares; This case was received via Regulatory Authority(Reference number: 25750400) on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucination), MUSCULOSKELETAL STIFFNESS (Stiffness), NIGHT SWEATS (Night sweat), NIGHTMARE (Nightmares), VERTIGO (stomach), HYPERHIDROSIS (sweating), PYREXIA (Fever chills), PYREXIA (Fever), NAUSEA (Nausea), ARTHRALGIA (Aching joints), CHILLS (shivering), CHILLS (chills) and HEADACHE (Headache) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Anxiety. Concomitant products included SERTRALINE HYDROCHLORIDE (LUSTRAL) from 01-Jul-2020 to an unknown date for Anxiety, MEFENAMIC ACID from 01-Sep-2005 to an unknown date for Period pains. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant), NIGHT SWEATS (Night sweat) (seriousness criterion medically significant), NIGHTMARE (Nightmares) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant). On an unknown date, the patient experienced HALLUCINATION (hallucination) (seriousness criterion medically significant), VERTIGO (stomach) (seriousness criterion medically significant), HYPERHIDROSIS (sweating) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant) and CHILLS (chills) (seriousness criterion medically significant). On 03-Aug-2021, HEADACHE (Headache) had resolved. At the time of the report, HALLUCINATION (hallucination), MUSCULOSKELETAL STIFFNESS (Stiffness), NIGHT SWEATS (Night sweat), NIGHTMARE (Nightmares), VERTIGO (stomach), HYPERHIDROSIS (sweating), PYREXIA (Fever chills), PYREXIA (Fever), NAUSEA (Nausea), ARTHRALGIA (Aching joints), CHILLS (shivering) and CHILLS (chills) 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. The patient was not able to sleep due to the adverse drug reactions. The patient felt very thirsty and had unsettled stomach. The patient experienced complete loss of appetite the next day after vaccination. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. A possible confounding factor in the causality of the vent of Hallucination is the patient''s medical history of Anxiety. Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. A possible confounding factor in the causality of the vent of Hallucination is the patient''s medical history of Anxiety.


VAERS ID: 1576250 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-02
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Fatigue, Headache, Inappropriate schedule of product administration, Myalgia, Pain of skin, Pyrexia, SARS-CoV-2 test, Sensitive skin
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Body temperature; Result Unstructured Data: high; Test Date: 20210712; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: sensitive skin; Inappropriate schedule of vaccine administered; Fever; Headache; Fatigue; Joint pain; Muscle pain; Skin tenderness; High temperature; This case was received via a regulatory authority (Reference number: ADR 25751899) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (sensitive skin), PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PAIN OF SKIN (Skin tenderness) and PYREXIA (High temperature) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003608 and 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concomitant products included CETIRIZINE HYDROCHLORIDE for Hay fever. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), PAIN OF SKIN (Skin tenderness) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced SENSITIVE SKIN (sensitive skin) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PARACETAMOL at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 03-Aug-2021, PYREXIA (Fever), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PAIN OF SKIN (Skin tenderness) and PYREXIA (High temperature) had resolved. At the time of the report, SENSITIVE SKIN (sensitive skin) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. On 02-Aug-2021, Body temperature: high (High) high. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576258 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dehydration, Headache, Hyperhidrosis, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

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

Write-up: Dehydration; Sweating; Fever; Chills; Headache; This case was received via Regulatory Authority (Reference number: ADR 25752678) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEHYDRATION (Dehydration), HYPERHIDROSIS (Sweating), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced DEHYDRATION (Dehydration) (seriousness criterion medically significant) and HYPERHIDROSIS (Sweating) (seriousness criterion medically significant). On 03-Aug-2021, PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, DEHYDRATION (Dehydration) had not resolved and HYPERHIDROSIS (Sweating) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. Patient not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. and was not enrolled in clinical trial. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576267 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache, Injection site pain, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Nauseous; chills; high temperature/fever; Joint pain; Diarrhea; Nausea; Generalised joint pain; Headache; Fatigue; Injection site pain; Fever chills; This case was received via MHRA (Reference number: 25753188) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), CHILLS (chills), PYREXIA (high temperature/fever), ARTHRALGIA (Generalised joint pain), HEADACHE (Headache), FATIGUE (Fatigue), INJECTION SITE PAIN (Injection site pain), PYREXIA (Fever chills), DIARRHOEA (Diarrhea), NAUSEA (Nausea) and ARTHRALGIA (Joint pain) in a 33-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included High temperature, Lactation decreased and Suspected COVID-19 from 23-Mar-2021 to 26-Mar-2021. Concomitant products included DESOGESTREL for Contraception. On 02-Aug-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced ARTHRALGIA (Generalised joint pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). 03-Aug-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Nauseous) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant), PYREXIA (high temperature/fever) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On 04-Aug-2021, HEADACHE (Headache) had resolved. At the time of the report, NAUSEA (Nauseous), CHILLS (chills), PYREXIA (high temperature/fever), ARTHRALGIA (Generalised joint pain), INJECTION SITE PAIN (Injection site pain), PYREXIA (Fever chills) and ARTHRALGIA (Joint pain) was resolving and FATIGUE (Fatigue), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient took the vaccination around 3pm. Patient was unable to find a position to sit or lie in that despite taking pain medication (unspecfified). Patient was struggling to walk due to the pain in hips and lower back and difficult to eat. Patient also had soreness at the site of the jab. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576282 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Feeling hot, Headache, Pain in extremity, Peripheral swelling, Rash erythematous
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), 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: Medical History/Concurrent Conditions: Joint pain; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Red rash; Swollen arm; Painful arm; Feeling hot; Joint pain; Headache; This case was received via the Regulatory Authority (Reference number: 25754493) on 05-Aug-2021 and was forwarded to the company on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Painful arm), FEELING HOT (Feeling hot), ARTHRALGIA (Joint pain) and HEADACHE (Headache) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Joint pain and Lactation decreased. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), FEELING HOT (Feeling hot) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, RASH ERYTHEMATOUS (Red rash), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Painful arm), FEELING HOT (Feeling hot), ARTHRALGIA (Joint pain) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient''s medical history of joint pain is a confounder for arthralgia.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient''s medical history of joint pain is a confounder for arthralgia.


VAERS ID: 1576289 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Fatigue, Injection, Musculoskeletal stiffness, Pain in extremity, Pyrexia, SARS-CoV-2 test, Seizure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Arthritis (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: SERTRALINE
Current Illness: Anxiety
Preexisting Conditions: Medical History/Concurrent Conditions: Suppressed lactation
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of SEIZURE (Seizure), ERYTHEMA (Localised erythema), MUSCULOSKELETAL STIFFNESS (muscle stiffness), PAIN IN EXTREMITY (Pain in arm), INJECTION (injection), PYREXIA (High temperature), FATIGUE (fatigue) and PYREXIA (Fever) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Suppressed lactation. Concurrent medical conditions included Anxiety. Concomitant products included SERTRALINE from 26-Sep-2016 to an unknown date for Anxiety. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), ERYTHEMA (Localised erythema) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (muscle stiffness) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), INJECTION (injection) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and FATIGUE (fatigue) (seriousness criterion medically significant). On 03-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, SEIZURE (Seizure), ERYTHEMA (Localised erythema), MUSCULOSKELETAL STIFFNESS (muscle stiffness), PAIN IN EXTREMITY (Pain in arm), INJECTION (injection), PYREXIA (High temperature) and FATIGUE (fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative. No concomitant medications were reported. No treatment information was provided. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Update of the events Erythema, Musculoskeletal Stiffness, Pain in Extremity, Injection, Pyrexia and Fatigue to medically significant were performed solely based on the report received. Injection is an action, not an event per se, and no PV-relevant information about injection was provided.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Update of the events Erythema, Musculoskeletal Stiffness, Pain in Extremity, Injection, Pyrexia and Fatigue to medically significant were performed solely based on the report received. Injection is an action, not an event per se, and no information about injection was provided.


VAERS ID: 1576296 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

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

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

Write-up: unconscious; dizziness; shaking; nausea; Seizure; This case was received via regulatory agency (Reference number: ADR 25755958) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (unconscious), DIZZINESS (dizziness), TREMOR (shaking), NAUSEA (nausea) and SEIZURE (Seizure) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (unconscious) (seriousness criteria hospitalization and medically significant), DIZZINESS (dizziness) (seriousness criterion hospitalization), TREMOR (shaking) (seriousness criterion hospitalization) and NAUSEA (nausea) (seriousness criterion hospitalization). At the time of the report, LOSS OF CONSCIOUSNESS (unconscious), DIZZINESS (dizziness), TREMOR (shaking) and NAUSEA (nausea) outcome was unknown and SEIZURE (Seizure) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 test. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information can''t be requested.


VAERS ID: 1576299 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

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

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

Write-up: Flu-like aching; Headache; Feverish; Nausea; This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like aching), HEADACHE (Headache), PYREXIA (Feverish) and NAUSEA (Nausea) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 03-Aug-2021, PYREXIA (Feverish) and NAUSEA (Nausea) had resolved. On 04-Aug-2021, HEADACHE (Headache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like aching) 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 information was provided. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time.


VAERS ID: 1576304 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Axillary lump; Subconjunctival hemorrhage; This case was received via the Regulatory Authority(Reference number: ADR 25756681) on 05-Aug-2021 and was forwarded to the company on 05-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of CONJUNCTIVAL HAEMORRHAGE (Subconjunctival hemorrhage) in a 52-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced CONJUNCTIVAL HAEMORRHAGE (Subconjunctival hemorrhage) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced AXILLARY MASS (Axillary lump). At the time of the report, CONJUNCTIVAL HAEMORRHAGE (Subconjunctival hemorrhage) and AXILLARY MASS (Axillary lump) 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. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Relevant investigations include Normal FBC, U&Es and CRP. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1576305 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-08-02
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20201214; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101006098

Write-up: Prolonged heavy periods; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108042152422550-CPLLW, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25756855. A 48-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ff3319) via an unspecified route of administration on 24Jul2021 (at the age of 48-years-old) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing, suspected covid-19 from 16Dec2020 and ongoing. Patient is not currently breastfeeding.The patient''s concomitant medications were not reported.Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The patient experienced prolonged heavy periods on 02Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Dec2020 Yes - Positive COVID-19 test. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1576321 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, 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: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fever; Headache; This case was received via Regulatory Authority (Reference number: ADR 25757646) on 05-Aug-2021 and was forwarded to Moderna on 05-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 05-Aug-2021, PYREXIA (Fever) and HEADACHE (Headache) was resolving. 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 information was provided. No treatment medication information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded


VAERS ID: 1576382 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Gait inability, Insomnia, Lymph node pain, Lymphadenopathy, Monoplegia, Musculoskeletal stiffness, Pain, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: exhaustion; pain; swollen lymph nodes; prevented sleeping; unable to walk; unable to move arm; Stiff neck; Lymph node pain; Fatigue; This case was received via a regulatory authority (Reference number: ADR 25765317) on 08-Aug-2021 and was forwarded to Moderna on 08-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (exhaustion), PAIN (pain), LYMPHADENOPATHY (swollen lymph nodes), LYMPH NODE PAIN (Lymph node pain), FATIGUE (Fatigue), MUSCULOSKELETAL STIFFNESS (Stiff neck) and MONOPLEGIA (unable to move arm) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient has not had symptoms associated with COVID-19. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain) (seriousness criterion medically significant). On 06-Aug-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (exhaustion) (seriousness criterion medically significant), PAIN (pain) (seriousness criterion medically significant), LYMPHADENOPATHY (swollen lymph nodes) (seriousness criterion medically significant), INSOMNIA (prevented sleeping), GAIT INABILITY (unable to walk ) and MONOPLEGIA (unable to move arm) (seriousness criterion medically significant). On 03-Aug-2021, FATIGUE (Fatigue) had resolved. At the time of the report, FATIGUE (exhaustion), PAIN (pain), LYMPHADENOPATHY (swollen lymph nodes) and LYMPH NODE PAIN (Lymph node pain) was resolving, MUSCULOSKELETAL STIFFNESS (Stiff neck) had not resolved and INSOMNIA (prevented sleeping), GAIT INABILITY (unable to walk ) and MONOPLEGIA (unable to move arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-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. Concomitant information was not provided. Treatment information was not provided. Patient was not tested positive for COVID-19 since vaccinated. Patient was not enrolled in any clinical trial. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576402 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Headache, Myalgia, Oropharyngeal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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)

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

Write-up: Headache; Backache; Sore throat; Fever; Muscle ache; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), BACK PAIN (Backache), MYALGIA (Muscle ache) and OROPHARYNGEAL PAIN (Sore throat) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), BACK PAIN (Backache) (seriousness criterion medically significant) and OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). On 03-Aug-2021, PYREXIA (Fever) had resolved. On 05-Aug-2021, BACK PAIN (Backache) had resolved. On 06-Aug-2021, HEADACHE (Headache) and MYALGIA (Muscle ache) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product information was not provided by reporter. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1576430 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Malaise, Myalgia, SARS-CoV-2 test, Sinus pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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: BRICANYL; LORATADINE; PULMICORT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Feeling ill; SARS-CoV-2 infection/COVID-19; COVID-19; Sinus pain; Breathlessness; Generalised muscle aches; This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathlessness), SINUS PAIN (Sinus pain), MALAISE (Feeling ill), MYALGIA (Generalised muscle aches), COVID-19 (SARS-CoV-2 infection/COVID-19) and COVID-19 (COVID-19) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included TERBUTALINE SULFATE (BRICANYL) and BUDESONIDE (PULMICORT) for Asthma, LORATADINE for Multiple allergies. On 02-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced MYALGIA (Generalised muscle aches) (seriousness criterion disability). On 04-Aug-2021, the patient experienced DYSPNOEA (Breathlessness) (seriousness criterion disability). On 05-Aug-2021, the patient experienced SINUS PAIN (Sinus pain) (seriousness criterion disability). 05-Aug-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion disability). On 06-Aug-2021, the patient experienced COVID-19 (SARS-CoV-2 infection/COVID-19) (seriousness criterion disability). On an unknown date, the patient experienced MALAISE (Feeling ill) (seriousness criterion disability). At the time of the report, DYSPNOEA (Breathlessness), SINUS PAIN (Sinus pain), MYALGIA (Generalised muscle aches), COVID-19 (SARS-CoV-2 infection/COVID-19) and COVID-19 (COVID-19) had not resolved and MALAISE (Feeling ill) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided by the reporter. Company comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This is also a case with an associated adverse event of COVID-19. Based on the mechanism of action of mRNA-1273 the event COVID-19 is unlikely related to the vaccine. No further information is expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This is also a case with an associated adverse event of COVID-19. Based on the mechanism of action of mRNA-1273 the event COVID-19 is unlikely related to the vaccine. No further information is expected.


VAERS ID: 1576705 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-08-02
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 2 LA / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ENALAPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomyopathy; Factor V Leiden mutation; Myasthenia gravis; Pericarditis; Thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101026405

Write-up: deep vein thrombosis right lower limb; This is a spontaneous report from contactable physician downloaded from the RA. The regulatory authority report number is IT-MINISAL02-767717. A 66-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in left arm on 23Jun2021 13:00 (Batch/Lot Number: FC5089) as dose 2, single for COVID-19 immunisation. Medical history included myasthenia gravis, thrombosis, factor V leiden mutation, cardiomyopathy, and pericarditis on 01Jan2021. Concomitant medication included enalapril taken for an unspecified indication, start and stop date were not reported. The patient experienced deep vein thrombosis right lower limb on 02Aug2021 08:00 that required access to Emergency Room/ Hospitalization and was life threatening. Therapy was established. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reaction time: 08:00.


VAERS ID: 1576752 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TALION [BEPOTASTINE BESILATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fruit allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100986303

Write-up: Erythema; This is a spontaneous report from a contactable physician received via regulatory authority. A non-pregnant 57-year-old female patient received the second dose of bnt162b2 (COMIRNATY; Batch/Lot Number: FF0843; Expiration Date: 31Oct2021) intramuscularly administered in left arm on 02Aug2021 11:30 (the day of vaccination)(at the age of 57-year-old) as dose 2, single for COVID-19 immunisation. Medical history included fruit allergy. Concomitant medication included bepotastine besilate (TALION). The patient previously took LOXOPROFEN and acetylsalicylic acid (ASPIRIN) and experienced drug allergy. Historical vaccine includes first dose of bnt162b2 (COMIRNATY; Batch/Lot Number: FC5947; Expiration Date: 30Sep2021) intramuscularly administered in left arm on 12Jul2021 (at the age of 57-year-old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 02Aug2021 at 11:45 (15 minutes after the vaccination), the patient experienced Erythema. The reporter stated the events result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on an unspecified date with treatment including steroids and Injections of antiallergic agents.; Sender''s Comments: Based on temporal association and profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event erythema cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1576754 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Embolic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardioembolic stroke (had rehabilitation treatment in convalescent rehabilitation ward); Hospitalization
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100986356

Write-up: Cardioembolic stroke; Cardioembolic stroke; This is a spontaneous report from a non-contactable physician received via regulatory authority. The patient was a non-pregnant (including the at the time of vaccination) 80-year-old female (as reported). The patient received unspecified other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. On 16May2021, the patient had Cardioembolic stroke and received rehabilitation treatment in the convalescent rehabilitation ward. On 29Jun2021, the patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) at the age of 79-years-old intramuscularly in the arm left for COVID-19 immunization. On 26Jul2021 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) at the age of 80-years-old (as reported) intramuscularly in the arm left for COVID-19 immunization. On 02Aug2021, the patient experienced that Cardioembolic stroke recurred and was transferred to acute care hospital. The reporter classified the event as serious (Hospitalized in 2021) and stated the event result in Emergency room/department or urgent care. The patient received unspecified treatment for the event. Outcome of the events was unknown. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on known disease pathophysiology, the event of cardio-embolic stroke is assessed as not related to BNT162B2 and more likely due to recent history of cardio-embolic stroke


VAERS ID: 1576877 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, COVID-19, Computerised tomogram thorax, Drug ineffective, Nucleic acid test, 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 Name: Antibody test; Result Unstructured Data: Test Result:this diagnosis was basically locked to be related; Comments: to the Nanjing epidemic situation; Test Name: Chest CT; Result Unstructured Data: Test Result:a small amount of inflammation in her left lower; Comments: lung, stable condition; Test Date: 20210802; Test Name: Nucleic acid test; Test Result: Positive ; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:approximately 10; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:this diagnosis was basically locked to be related; Comments: to the Nanjing epidemic situation
CDC Split Type: MOPFIZER INC202101032516

Write-up: TESTED POSITIVE FOR NUCLEIC ACID; TESTED POSITIVE FOR NUCLEIC ACID; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority (Regulatory authority report number: not provided) based on information received by Pfizer from BioNTech SE (manufacturer control number: MO-Fosun-2021FOS002909), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via the regulatory authority. The regulatory authority report number is not applicable. A 43-year-old female patient started to receive COVID-19 vaccine (Batch/Lot number unknown) on an unspecified date via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. On 02-Aug-2021, patient experienced sore throat, ageusia and anosmia. On 02-Aug-2021 evening, after preliminary test, the patient was positive in nucleic acid test. Patient''s CT value was approximately 10. Further diagnosis and treatment have been performed in the special emergency department of hospital. After epidemiological investigation, antibody test and virus content analysis, combined with the analysis results of gene homology, this diagnosis was basically locked to be related to the epidemic situation. As of 05-Aug-2021, the patient still had symptoms of sore throat and cough, no fever, CP showed a small amount of inflammation in her left lower lung, stable condition. On 08-Aug-2021, The general condition of patient was good. The patient had no fever after treatment, her cough symptoms and hyposmia symptoms reduced, and she did not require oxygen inhalation. Adverse event ''tested positive for nucleic acid'' was considered as Important Medical Event. The action taken for vaccine regarding the event was not applicable. Treatment was received for events. At the time of the report, the outcome of the event was resolving. Initial report was received on 04-Aug-2021. This is one of two reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS002908 and 2021FOS002909. Follow-up (06-Aug-2021) New information reported from a non-contactable HCP received via the regulatory authority. The regulatory authority report number is not applicable. New information includes: clinical course, lab test and event outcome. This is one of four reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS002908, 2021FOS002909, 2021FOS002930 and 2021FOS002931. Follow-up (09-Aug-2021) New information reported from a non-contactable HCP received via the regulatory authority. The regulatory authority report number is not applicable. New information includes: clinical course and event outcome. This is one of three reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS002908, 2021FOS002909 and 2021FOS002940. Follow-up closed, no further information is possible.; Sender''s Comments: Linked Report(s) : MO-PFIZER INC-202101026904 Same reporter, drug, different patient, event.


VAERS ID: 1576884 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Fatigue, Pain, Paraesthesia, Pyrexia, Somnolence
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MTJNJFOC20210826172

Write-up: TINGLING IN LEFT ARM; FEVER; WEAKNESS; SLEEPY; PAIN AT THE SITE OF INJECTION; DIZZINESS; TIRED; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, MT-ADM-7082021] concerned a 31 year old female patient of unspecified race and ethnicity. The patient''s weight was 55 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: XE389 and expiry: unknown) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced tingling in left arm, fever, pain at the site of injection, dizziness, weakness, was tired and sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 03-AUG-2021, was recovering from pain at the site of injection, and weakness, and the outcome of tingling in left arm, tired, dizziness and sleepy was not reported. This report was serious (Other Medically Important Condition, and Disability Or Permanent Damage).; Sender''s Comments: V0:20210826172-covid-19 vaccine ad26.cov2.s -Fever,weakness,tingling in left arm. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1577028 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 190/100 mmHg, Elevated
CDC Split Type: PHJNJFOC20210823855

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095939] concerned a 55 year old female with unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 213C21A, expiry: unknown) dose was not reported, frequency time 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, at 11:03 the patient experienced elevated blood pressure (BP). Laboratory data included: Blood pressure (NR: not provided) 190/100 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure (BP). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210823855- JANSSEN COVID-19 VACCINE Ad26.COV2.S- Elevated blood pressure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1577055 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 202108021641; Test Name: Blood pressure; Result Unstructured Data: 190/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824348

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095985] concerned a 71 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 16:41, the patient experienced elevated bp. Laboratory data included: Blood pressure (NR: not provided) 190/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated bp. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210824348-COVID-19 VACCINE aD26.COV2.S-Elevated BP. This event(s) is considered un-assessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577057 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 190/120 mmHg, elevated
CDC Split Type: PHJNJFOC20210824370

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096094] concerned a 54 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 20:36, the patient experienced elevated BP (blood pressure). Laboratory data included: Blood pressure (NR: not provided) 190/120 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210824370-covid-19 vaccine ad26.cov2.s -Elevated Blood Pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577063 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210824432

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300095953] concerned a 49 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/100 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210824432-COVID-19 VACCINE AD26.COV2.S-elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577065 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824445

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096095 ] concerned a 55 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 18:06, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) Elevated 180/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824445-COVID-19 VACCINE AD26.COV2.S- Elevated blood pressure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1577066 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 190/120 mmHg, elevated
CDC Split Type: PHJNJFOC20210824460

Write-up: Elevated BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300095961] concerned a 45 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 213C21A) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, patients laboratory data included blood pressure (NR: not provided) 190/120 mmHg (at 14:00) which showed elevated blood pressure. The action taken with covid-19 vaccine was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210824460-covid-19 vaccine -Elevated Blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577074 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 190/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210824538

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096096] concerned a 50 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, at 17:59, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 190/100 mmHg (elevated). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210824538-COVID-19 VACCINE AD26.COV2.S-Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577090 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 183/75 mmHg, Elevated
CDC Split Type: PHJNJFOC20210824846

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095958] concerned a 65 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported, 1 in total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 13:00, the patient experienced elevated BP (blood pressure) 183/75 mm/Hg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP (blood pressure). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824846-COVID-19 VACCINE AD26.COV2.S-Elevated BP. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1577092 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 200/100 mmHg, ELEVATED
CDC Split Type: PHJNJFOC20210824876

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095946] concerned a 63 year old male. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total dose administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, at 13:25 the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 200/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824876-covid-19 vaccine ad26.cov2.s- Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577098 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: Elevated
CDC Split Type: PHJNJFOC20210824912

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority PHIFDA, PH-PHFDA-300096800 concerned a 46 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) 1 total dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 14:33 the patient experienced elevated blood pressure, and was hospitalized (date unspecified). Laboratory data included: Blood pressure (NR: not provided) Elevated. Number of hospitalization days were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated blood pressure. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0- 20210824912-Covid-19 vaccine ad26.cov2.S- Elevated BP. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577099 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Name: Blood pressure; Result Unstructured Data: 200/120 mmHg, Elevated blood pressure
CDC Split Type: PHJNJFOC20210824922

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300095950] concerned a 53 year old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A expiry: unknown) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 17:05, the patient experienced elevated BP (blood pressure). Laboratory data included: Blood pressure (NR: not provided) elevated BP 200/120 mmhg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210824922-covid-19 vaccine ad26.cov2.s -Elevated BP. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577103 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 210/100 mmHg
CDC Split Type: PHJNJFOC20210824970

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095923] concerned a 47 year old male patient of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported, 01 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 15:53, the patient experienced elevated BP (Blood pressure). Laboratory data included: Blood pressure (NR: not provided) 210/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824970-covid-19 vaccine ad26.cov2.s -Elevated BP. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577109 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, Elevated
CDC Split Type: PHJNJFOC20210825031

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096107] concerned a 54 year old male patient of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A,expiry: UNKNOWN) dose was not reported,1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 20:20, the patient experienced elevated BP (Blood Pressure). Laboratory data included: Blood pressure (NR: not provided) 180/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0.20210825031-covid-19 vaccine ad26.cov2.s -elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577114 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210825085

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300095918] concerned a 60 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, at 10:42, the patients laboratory data included blood pressure was (NR: not provided) 180/100 mmHg which showed elevated blood pressure (BP). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210825085-Covid-19 vaccine ad26.cov2.s-Elevated BP. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577115 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 202108021557; Test Name: Blood pressure; Result Unstructured Data: 210/100 mmHg, Elevated BP
CDC Split Type: PHJNJFOC20210825148

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095963] concerned a 53 year old male patient of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A and expiry: unknown) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, at 15:57, the patient experienced an elevated blood pressure (BP) of 210/100 mmHg (NR: not provided). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210825148-covid-19 vaccine ad26.cov2.s -Elevated BP.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577118 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/120 mmHg, Elevated
CDC Split Type: PHJNJFOC20210825246

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096098] concerned a 35 year old female of unknown race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 16:40, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/120 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210825246- COVID-19 VACCINE AD26.COV2.S - ELEVATED BLOOD PRESSURE. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1577121 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 210/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210825293

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [-PHFDA-300096101] concerned a 55 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, at 19:21, the patient''s laboratory data included; blood pressure (NR: not provided) 210/110 mmHg which showed elevated BP (Blood pressure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210825293-covid-19 vaccine ad26.cov2.s -Elevated Blood Pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577122 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 220/110 mmHg, elevated
CDC Split Type: PHJNJFOC20210825305

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096102] concerned a 49 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 19:52, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure 220/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210825305-Covid-19 vaccine ad26.cov2.s-Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577124 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 220/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210825338

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [regulatory authority, PH-PHFDA-300096103] concerned a 38 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 19:55, the patient had measured her blood pressure (BP) and it was 220/110 mmHg (Elevated BP). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210825338-COVID-19 VACCINE AD26.COV2.S-Elevated BP. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577128 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210825437

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095972] concerned a 59 year old female unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, one total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021,15:54, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 180/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210825437-Covid-19 vaccine ad26.cov2.s-Elevated blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577129 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 190/100 mmHg, Elevated
CDC Split Type: PHJNJFOC20210825454

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095974] concerned a 65 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-AUG-2021 at 14:30 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 190/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210825454- covid-19 vaccine ad26.cov2.s-ELEVATED BLOOD PRESSURE . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577131 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/120 mmHg, ELEVATED
CDC Split Type: PHJNJFOC20210825474

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA PH-PHFDA-300095977] concerned a 39 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported at the time of vaccination. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: unknown) dose was not reported with frequency time 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the patient experienced elevated blood pressure (BP) post vaccination and laboratory data included: blood pressure reported as 180/120 mmHg. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated Blood pressure (BP). This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210825474-covid-19 vaccine ad26.cov2.s-elevated BP. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577132 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 200/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210825482

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300095980] concerned a 75 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 14:25, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) 200/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210825482 -Covid-19 vaccine ad26.cov2.s -Elevated Blood Pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1577133 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 180/110 mmHg, Elevated
CDC Split Type: PHJNJFOC20210825501

Write-up: ELEVATED BLOOD PRESSURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300096085] concerned a 60 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 19:02, the patient experienced elevated blood pressure. Laboratory data included: Blood pressure 180/110 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210825501- Covid-19 vaccine ad26.cov2.s- elevated blood pressure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1577134 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20210802; Test Name: Blood pressure; Result Unstructured Data: 240/100 mmHg, elevated
CDC Split Type: PHJNJFOC20210825508

Write-up: ELEVATED BP; This spontaneous report received from a health care professional via a Regulatory Authority (PHIFDA, PH-PHFDA-300096083) concerned a 65 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 213C21A expiry: unknown) dose was not reported, 1 total administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021 at 20:25 P.M the patient experienced Elevated BP. Laboratory data included: Blood pressure (NR: not provided) 240/100 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from Elevated BP. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210825508-COVID-19 VACCINE AD26.COV2.S-Elevated BP. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


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