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From the 11/19/2021 release of VAERS data:

Found 894,019 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 460 out of 8,941

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VAERS ID: 1849966 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048F21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

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

Write-up: Sleepy for one day after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy for one day after receiving the vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced SOMNOLENCE (Sleepy for one day after receiving the vaccine). In September 2021, SOMNOLENCE (Sleepy for one day after receiving the vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medications on use were not provided. No treatment information was provided.


VAERS ID: 1851015 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Blood test normal, Cardiac monitoring abnormal, Dysphagia, Feeling abnormal, Illness, Laboratory test, Lymph node pain, Lymphadenopathy, Mobility decreased, Nausea, Scan, Streptococcus test negative, Tachycardia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Venalafaxine 35 MG , Losarton 25 MGs
Current Illness: none
Preexisting Conditions: high blood pressue
Allergies: Penicillin, Amoxicillin, Neosporen, Eggs, Gluten
Diagnostic Lab Data: Went to ER on 9/30 as ordered by my Cardiologist. Two blood exams lab result Oct 22nd, went to walk in clinic on 11/5 because I could not swallow, negative for strep and mono there. Another blood test on 11/5, both show nothing hugely abnormal. Dr. ordered scan of Neck and soft Tissue for 11/9 to try and figure everything out. Still nothing has been figured out and I am sick, as if this is a auto immune issue caused by that second shot.
CDC Split Type:

Write-up: I got very sick after the 2nd covid shot and never fully recovered and we are a month and a half out now. My neck and arm pit lymph nodes are very large and hurt a lot. It is hard to swallow and if I do too much activity I get really sick. Feel like I''m floating out of my body with nausea . I''m very week and my lymph system is showing no sigs of getting better. I was tychacardic for weeks and wore a heart monitor for 14 days as well.


VAERS ID: 1851834 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Back pain, Cerebrovascular accident, Fatigue, Haematuria, Headache, Pain in extremity, Peripheral swelling, Proteinuria, Taste disorder, Tenderness, Urine analysis
SMQs:, Acute renal failure (broad), Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: nonw
Preexisting Conditions: none
Allergies: nonw
Diagnostic Lab Data: UA indicating hematuria and proteinuria on 09/29/2021 Pt followed up with urology at outside facility
CDC Split Type:

Write-up: "2nd Pfizer Covid shot on the 27th. 2 hrs later felt fatigue, back pain, headache, arm pain, and arm swelling. Reports "gasoline taste" in his mouth after vaccination, says he noticed the gasoline taste after his first shot as well." On exam pt had moderate right CVA tenderness along with mild swelling and tenderness to right upper arm


VAERS ID: 1853804 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Dizziness, Dyspnoea, Electrocardiogram, Exposure during pregnancy, Fatigue, Headache, Heart rate increased, Palpitations, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Dehydration (broad)

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

Write-up: Date of delivery is December, 9pm I woke up from my sleep in 120s my heartbeat, 100 to 168 was heartbeat and couldn''t even go to the stores, exertion and shortness of breathe, palpitations and light headedness. Urgent care on 9/28/2021 they took my vital and must be a side affect of the vaccine - high heart rate. Had COVID after 1st dose in Aug2021 - I had shortness of breathe, fever, Diarrhea , congestion - recovered but have chronic headaches in the past month and went to doctors for that.


VAERS ID: 1854006 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2589 / 3 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Inflammation, Injection site pain, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: I was very sick for a week following my first two Pfizer vaccines. I also was sick for 4 days after my second shingles vaccine.
Other Medications: Venlafaxine, ability, toparamate, probiotics, low dose aspirin, Prilosec, methyfolate
Current Illness:
Preexisting Conditions: Migraines, major depression
Allergies: Sulfa drugs, clams, Brazil nuts
Diagnostic Lab Data: I had a video visit with my doctor several weeks ago. She said that it was inflammation and prescribed heat and ibuprofen. I am now being treated with acupuncture.
CDC Split Type:

Write-up: When I extend my left arm I have excruciating pain in me deltoid


VAERS ID: 1854136 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-09-01
Onset:2021-09-27
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Headache, Hypoaesthesia, Lymphadenopathy, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

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

Write-up: Itchy face , numbness in arm , headache and swollen glands for 5 weeks, chest pains


VAERS ID: 1854642 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8839 / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Blood cholesterol increased, Blood test, Extra dose administered, Fatigue, Feeling abnormal, Hangover, Headache, Influenza like illness, Nausea, Pain, Pain in extremity, Sinusitis, Tremor
SMQs:, Acute pancreatitis (broad), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lipodystrophy (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Polio vaccination 60 years ago - pain in arm terrible 2nd dose Shingrix 1/22/2020 - similar symptoms to COVID Pfizer booster sho
Other Medications: ? Flovent 20 mcg 2 puffs once a day ? Singular 10mg once daily ? Loratadine 10mg once daily 24 hr tab ? Flonase 50 mcg once spray in each nostril twice daily ? Azelastine 130mcg 2 sprays in each nostril twice daily ? Losartan Potassium 50mg
Current Illness: None
Preexisting Conditions: Asthma, Sinusitis, Periodic vertigo, Arthritis
Allergies: Doxycycline & Codeine related medications ? sick to stomach reaction, Environmental allergies
Diagnostic Lab Data: Complete panel of blood tests - 2 1/2 weeks ago
CDC Split Type: vsafe

Write-up: -Two hours after the 3rd vaccination, I felt extremely tired and achy, and I went to bed early but I slept a lot down and I was out. The best way to describe it is like being hung over. I felt like I was hit by a truck. I had no energy whatsoever. I felt like I had the flu but I didn?t have the flu. It just hit very suddenly, and I was fine after I got the shot. I was fine after a couple hours and then it hit. Headaches, nausea, but it didn?t keep me from doing anything. I wasn?t in bed or anything the next day, I just felt like I was hung over for a couple days. I had a similar reaction to the 2nd vaccine, but it wasn?t as severe and that was over in about 1 ? - 2 days. The first shot I didn?t have any reaction to. In all cases, I just had a sore arm. -The second shot was after a couple days with similar symptoms but not as severe. Delayed reaction. -Loss of energy (most unusual), Light headed, extreme fatigue, shakiness ? not sure if in relation to the vaccine, but has been lingering after vaccination. -Also had a Sinus infection which was two weeks ago. ? headaches, sinus aches, discharge etc. at yearly check in ? does cause some of those symptoms listed above. -Cholesterol skyrocketed at yearly check in ? probably not in relation to the vaccine


VAERS ID: 1855327 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-22
Onset:2021-09-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3592 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia, Magnetic resonance imaging, Pain, Paraesthesia, X-ray normal
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: X-Ray (10/21/21): Results Negative MRI (11/4/21): Results Pending
CDC Split Type:

Write-up: After receiving my 1st Pfizer dose (Lot #FE3182) on 8/31/21, which was also administered via injection/shot in my left arm, I experienced a stiff neck (unable to turn to the left without pain) a couple days after. This stiffness/pain persisted until I received my 2nd dose on 9/22/21. Within a week after receiving my 2nd dose, I started to feel tingling and numbness in my left arm and hand--whether I was standing, sitting, or laying down. The tingling and numbness is experienced 24 hours a day, 7 days a week. I also feel slight tingling/numbness in my right arm and hand, but is typically felt when laying down to sleep. In addition to the constant pain and discomfort, I experienced one extremely bad episode on 10/1/21 when I reached for an item in our kitchen cupboards and an intense, sharp, pain shot through my right hand (hand I was using to reach in the cupboard) all the way to my left hand, causing me to bend over and "collapse" in pain. The persistent pain, coupled with that intense episode, was so excruciating and scary that I ultimately decided to see my doctor on 10/22/21. I have never experienced tingling and/or numbness in any of my limbs over the course of my entire life. After that visit, I was prescribed Gabapentin and Prednisone. I took Prednisone for a week and am continuing to take Gabapentin for pain as of today, 11/9/21.


VAERS ID: 1855907 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-23
Onset:2021-09-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Dizziness, Fatigue, Feeling abnormal, Hypoaesthesia, Hypoaesthesia oral, Palpitations, Panic attack, Paraesthesia, Paraesthesia oral, Temperature intolerance, Tremor, Vibratory sense increased
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: No objective findings as of yet. Still in process of getting treatment. I don''t have good insurance.
CDC Split Type:

Write-up: Heart palpitations, chest pain, numbness and tingling in bilateral arms, bilateral hands, bilateral lower legs, bilateral feet. Insomnia. Adrenaline surge. Tremors. Internal vibrations. Panic attacks. Numbness and tingling in face and tongue. Intolerance to heat. Dizziness, fatigue, and brain fog.


VAERS ID: 1857880 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6208 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FR8732 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0167 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Muscle fatigue, Myalgia, Neuropathy peripheral
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Plavix, metoprolol, Lipitor, pantoprazole, 81mg aspirin, Claritin, daily vitamin, fish oil, B6 tablet; I did receive my annual flu shot one day prior to vaccination booster.
Current Illness: Stomach bleed from ulcers over Labor Day weekend.
Preexisting Conditions: Had a heart attack four years ago despite normal blood pressure and cholesterol. Had two stomach bleeds in past (April, 2020, and Labor Day Weekend, 2021. Kidney stones in the past but no sign of them now.
Allergies: grasses--all types, peas
Diagnostic Lab Data: None. Awaiting appointments.
CDC Split Type:

Write-up: Very sore joints and muscles beginning three days after injection. Was worse at night. Made much worse by even moderate exercise. Muscles felt extremely fatigued. Also developed significant neuropathy in feet, ankles, and calves. After three weeks the continuously sore joints and muscles went away but there is still fatigue after exercise well beyond normal. Also, the significant neuropathy remains.


VAERS ID: 1857902 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Idaho  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2588 / 3 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Eye pain, Ocular hyperaemia, Visual impairment
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

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

Write-up: Eye pain, redness, decreased vision.


VAERS ID: 1858180 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 3 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: B12, Vit D3
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received a 0.5mL dose of vaccine. SE WNL for vaccine admin- 1 day fatigue. Arm sore. Received high dose flu in right arm at same time, which had more arm soreness than left.


VAERS ID: 1858351 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.


VAERS ID: 1858409 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.


VAERS ID: 1858415 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% normal saline, preservative free. Consulted FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised. Outreach team contacted impacted patient and offered to speak with a physician to discuss.


VAERS ID: 1858758 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SE3592 / 3 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Condition aggravated, Cough, Fatigue, Headache, Malaise, Nasopharyngitis, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Tendinopathies and ligament disorders (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: 02/11/2021 Fatigue headache and some nausea and general feeling sick, 03/04/2021 I had the same symptoms than the first one not
Other Medications: buspirone 2MG twice a day, Trazadone 50MG Once a day, Coq10 once a day, Propranolol 10MG Two tablets daily, rosuvastatin 10MG Once a day, Gabapentin 300MG Once a day when is needed, Loratadine 10MG twice a day, Wellbutrin 300MG once a day,
Current Illness: N/A
Preexisting Conditions: Mild anxiety and depression
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type: vsafe

Write-up: So Fatigue the first and second day and arm sore for about 4 days and headache on the second day, just in general I was feeling sick and that stopped after the 3rd day and the cold started a week after and I''m still coughing.


VAERS ID: 1858762 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Incorrect product formulation administered
SMQs:, Medication errors (narrow)

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

Write-up: Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% normal saline, preservative free. Consulted FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised. Outreach team contacted impacted patient and offered consult with a physician to discuss.


VAERS ID: 1858764 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cough, Dyspnoea, Fatigue, Pain in extremity, Throat irritation
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: General flu vaccines cause me to get fatigued and break out in a sweat.
Other Medications: Ramipril, albuterol
Current Illness: N/A
Preexisting Conditions: High Blood pressure and asthma
Allergies: Sulfa allergy
Diagnostic Lab Data: N/A
CDC Split Type: vsafe

Write-up: I began to feel about an after the vaccine and scratchy throat and a dry cough formed. It continued to get worse for two weeks. My arm was sore for about 3 weeks and extremely fatigued, I then had a telehealth visit with my doctor, which they gave me 5 day course of 50 mg Prednisone to help with symptoms. Symptoms are beginning to subside however I do need to use the inhaler everyday. Trouble breathing is very prevalent.


VAERS ID: 1858777 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.


VAERS ID: 1858780 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.


VAERS ID: 1860301 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8839 / 3 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Immunisation, Vaccination site pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendix disorder (Pertinent details : Surgical Removal); Colon cancer (Pertinent details : Surgical Removal portion of colon); Hernia repair (Pertinent details : Surgical Repair); Prostate cancer (Pertinent details : Surgical Removing of prostate); Tonsillitis (Pertinent details : Surgical Removal); Vasectomy (Pertinent details : Surgical)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101294938

Write-up: His arm was sore, and that was it.; The Booster was given on 27Sep2021 at 2 pm.; This is a spontaneous report from a contactable consumer(patient) reported for himself that: A 80-years-old male patient received third dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF8839) via an unspecified route of administration, administered in Arm Left on 27Sep2021 13:30 (Age at Vaccination 80-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization.Medical history included , tonsillitis from 1952 to an unknown date Pertinent details : Surgical Removal , appendix disorder from 1955 to an unknown date Pertinent details : Surgical Removal , vasectomy from 1974 to an unknown date Pertinent details : Surgical , colon cancer from 19Dec1997 to an unknown date Pertinent details : Surgical Removal portion of colon , hernia repair from 20May2005 to an unknown date Pertinent details : Surgical Repair , prostate cancer from 16Nov2011 to an unknown date Pertinent details : Surgical Removing of prostate , hernia repair from 12Nov2011 to an unknown date Pertinent details : Surgical Repair. There were no concomitant medications. Previously patient was received First dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL9263) via an unspecified route of administration, administered in Arm Left on 28Jan2021 11:30 AM (Age at Vaccination 80-years-old) as DOSE 2 SINGLE for COVID-19 immunization. second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration, administered in Arm Left on 27Sep2021 10:10 AM (Age at Vaccination 80-years-old) as DOSE 2 SINGLE for COVID-19 immunization. On 27Sep2021 17:00 the patient experienced his arm was sore, and that was it, the booster was given on 27sep2021 at 2 pm. (immunisation) on 27Sep2021 14:00. The outcome of the event His arm was sore, and that was it was recovered on 29Sep2021.The outcome of the event The Booster was given on 27Sep2021 at 2 pm was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1860982 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.


VAERS ID: 1860984 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.


VAERS ID: 1861007 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.


VAERS ID: 1861153 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Product preparation error
SMQs:, Medication errors (narrow)

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

Write-up: Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.


VAERS ID: 1861155 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with FDA and CDC to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.


VAERS ID: 1861855 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Anger, Anxiety, Depression, Dyskinesia, Generalised tonic-clonic seizure, Head discomfort, Pain, Suicidal ideation, Throat tightness, Tremor
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Suicide/self-injury (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (narrow), Depression (excl suicide and self injury) (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (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: Suboxone, topimax lexipro gabapentin
Current Illness: Prolonged QT Syndrome
Preexisting Conditions: Prolonged QT Syndrome
Allergies: Gluten
Diagnostic Lab Data: I told my psychiatrist I just thought I was losing my mind. I lost my job around the same time and had forgotten I got the shot so I had no idea what was wrong with me. I didn?t want locked in a mental ward so I didn?t go to the hospital I was very suicidal. I traced it all back to starting after my booster shot when my mind began clearing up.
CDC Split Type:

Write-up: Extreme Anxiety Extreme Anxiety Attacks shaking jerking movements in my arms and legs a grandma seizure that closed my windpipe and felt like a rubber band squeezing my brain full body jerking anger outbursts deep depression suicidal thoughts wanting to die praying for death pain intense pain


VAERS ID: 1861864 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 3 LA / IM
FLUC4: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) / SEQIRUS, INC. 308437 / UNK RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Incorrect dose administered, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multiple, n/a- reporting administration error
Current Illness:
Preexisting Conditions: Psoriasis, heart disease, Type 2 Diabetes,
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Administer 0.5ml dose to the patient instead of the indicated 0.3mL dose. Patient noted typical injection site pain and swelling, perhaps more pain the previous. No residual symptoms.


VAERS ID: 1861884 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Incorrect dose administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a, multiple; submitting due to administration error, not adverse event
Current Illness:
Preexisting Conditions: Type 2 Diabetes, Polycythemia Vera, Hypertension, hyperlipidemia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Administer 0.5ml dose to the patient instead of the indicated 0.3mL dose. Patient did not not any vaccine reactions.


VAERS ID: 1862095 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Fatigue, Headache, Incorrect dose administered, Influenza like illness
SMQs:, Medication errors (narrow)

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

Write-up: Administer 0.5ml dose to the patient instead of the indicated 0.3mL dose. Patient noted feeling like he had the flu for 5 days after his Pfizer booster- bad headache and fatigue. Before had only mild symptoms after #2 dose for 1 day. No residual symptoms.


VAERS ID: 1862113 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Incorrect dose administered, Vaccination complication
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: several; n/a- reporting only vaccine admin error
Current Illness:
Preexisting Conditions: Obesity, DM2, Hypertension, Anxiety, CKD-stage 2, hypertriglyceridemia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Administered 0.5ml dose of Pfizer booster to the patient instead of the indicated 0.3mL dose. Minor and expected side effects noted. No residual symptoms.


VAERS ID: 1863888 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Immunisation, Musculoskeletal discomfort
SMQs:, Rhabdomyolysis/myopathy (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: USPFIZER INC202101301704

Write-up: Caller and his wife received the booster dose of the Comirnaty vaccine on on 27Sep.; Shoulder discomfort; This is a spontaneous report received from a contactable consumer or other non- healthcare professional (patient reported for himself). A 73-years-old male patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: Unknown, Expiry date: Unknown) via an unspecified route of administration on 27Sep2021 (at the age of 73-years-old) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: Unknown) on an unspecified date and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: Unknown) on an unspecified date (Both at the age of 73-years-old) for COVID-19 Immunsation and patient did not had any problems after the first two doses of the vaccine. On an unspecified date of 2021 the patient experienced shoulder discomfort. The outcome of events shoulder discomfort was recovered on an unspecified date of 2021. Follow-up (12Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.


VAERS ID: 1863902 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 3183 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood disorder, Immunisation
SMQs:, Haematopoietic cytopenias affecting more than one type of blood cell (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: FLU
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101333113

Write-up: Went to donate blood today (07Oct) and it was too thick; Product=COVID 19; Administration date=27Sep2021; Dose number=3; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old female (Non pregnant) patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: 3183), via an unspecified route of administration, administered in arm left on 27Sep2021, at 10:45 (Age at vaccination 68-years-old), as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient did not have covid prior to vaccination and also not have any known allergies. The patient medical history was not reported. Concomitant medications included influenza vaccine (FLU, Lot number: 70461012103), via unspecified route, administered in arm taken for an unspecified indication from 21Sep2021 to 21Sep2021. The patient previously received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 08Mar2021 as DOSE 2, SINGLE and received first dose (Lot number: EM9809), via an unspecified route of administration, administered in arm left on 15Feb2021 as DOSE 1, SINGLE for covid-19 immunization. On 07Oct2021, the patient went to donate blood today and it was too thick, she donates it every two months, never had this reaction. On 21Sep2021, patient received dose number 3 as booster dose. The patient went to physician office. No therapeutic measures were taken as a result of event. The clinical outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1864928 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Product preparation issue
SMQs:, Medication errors (broad)

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

Write-up: Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with advisory organizations to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.


VAERS ID: 1865050 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-23
Onset:2021-09-27
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026A21A / 1 - / -
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025B21A / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Altered state of consciousness, Anticoagulant therapy, Asthenia, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Cough, Dyspnoea, Endotracheal intubation, Extubation, General physical health deterioration, Hypercoagulation, Hypoxia, Intensive care, Lung consolidation, Mental status changes, Positive airway pressure therapy, SARS-CoV-2 test positive, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 30 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuterol, allopurinol, atropine eye drops, bisacodyl, proscar, lidocaine patch, milk of magnesia, senna, flomax
Current Illness:
Preexisting Conditions: Osteoarthritis Gout Mixed hyperlipidemia Chronic atrial fibrillation Aortic stenosis, severe CAD Thrombocytopenia Lupus anticoagulant positive Chronic low back pain with sciatica OSA (obstructive sleep apnea) LVH (left ventricular hypertrophy) History of embolic stroke Solitary left kidney BPH (benign prostatic hyperplasia) Normocytic normochromic anemia CKD (chronic kidney disease) stage 4, GFR 15-29 ml/min Left ventricular systolic dysfunction Peripheral neuropathy Moderate to severe pulmonary hypertension (*) Chronic combined systolic and diastolic heart failure (*)
Allergies: NKDA
Diagnostic Lab Data: COVID positive test on 09/27/21.
CDC Split Type:

Write-up: Patient fully vaccinated (2 doses) for COVID who admitted for COVID complications testing positive for COVID upon admission. Provider note below: "87 yo M PMH gout, HLD, PAF, CAD, lupus anticoagulant positive, OSA, history of embolic stroke, solitary left kidney, HFrEF 30-35%, CKD4, severe aortic stenosis, chronic narcotic use, chronic respiratory failure, presented 9/27 with weakness, cough, and worsening SOB. He was found to be COVID+ despite being fully vaccinated in March. On 10/3 he developed increasing O2 requirements with CXR demonstrating progressive multifocal lung consolidation bilaterally compared to admission. He was transferred to the CCU for intubation. He was extubated 10/5 and transferred out of the ICU on 10/9. He is currently on 2-3L O2 via nasal cannula. He is continued on Lovenox for his hypercoagulable state secondary to COVID. " Patient was discharged to skilled nursing facility on 10/26/21. Readmitted back on 10/29/21 due to change in level of conciousness. Discharged home with hospice care, see providers discharge note below for second admission on 10/29/21: "Patient is an 87 year old male with history of chronic hypoxic respiratory failure, CKD Stage IV, HFpEF, and severe aortic stenosis who presents to the Hospital from the nursing facility after being found to be unresponsive and hypoxic. Medics reports that patient''s oxygen saturation was in the low 80s at time of arrival to the nursing facility. patient''s mental status remains altered. He awakens, however, he only occasionally will answer yes/no questions by nodding or shaking his head. Appears to deny chest pain and reports feeling comfortable presently on BiPAP. Patient was recently hospitalized at Lakeland from 9/27 - 10/26 for COVID pneumonia which required intubation.Due to his poor overall functional status and serious co-morbidities, the idea of Hospice was introduce to pt and family. They are open to the idea of Hospice. Hospice team was consulted, pt and family understand and consent signed. Pt is going home with Hospice. "


VAERS ID: 1868116 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868117 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868118 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868119 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868120 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868121 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868122 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868123 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868124 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868125 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868126 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868127 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868158 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Alaska  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868163 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Unknown  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868168 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868169 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Unknown  
Location: California  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 3 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1868756 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: 20211001; Test Name: Diagnostic ultrasound; Result Unstructured Data: Normal; Test Date: 20211018; Test Name: Diagnostic ultrasound; Result Unstructured Data: Fetal demise; Comments: Ultra sound that showed that the baby passed away (fetal demise); Test Name: Diagnostic ultrasound; Result Unstructured Data: Normal
CDC Split Type: USJNJFOC20211114914

Write-up: SPONTANEOUS ABORTION; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a physician concerned a 40 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, frequency time 1 total was administered on 27-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-SEP-2021, the patient was vaccinated with Janssen Covid-19 vaccine resulting in vaccine exposure during pregnancy. The date of the patient''s last menstrual period and expected delivery date were not reported. Before receiving the vaccine the patient had ultra sound and genetic testing which was normal. On 01-OCT-2021, patient had another ultrasound test and it was normal. On 18-OCT-2021, the patient was 14 weeks and 6 days pregnant and she had an ultra sound test that showed that the baby passed away (fetal demise). On 18-OCT-2021, the pregnancy resulted in a spontaneous abortion. On 21-OCT-2021, she had genetic test again and which was normal. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spontaneous abortion and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20211114914-COVID-19 VACCINE AD26.COV2.S-spontaneous abortion. 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: MEDICAL HISTORY 20211114914-COVID-19 VACCINE AD26.COV2.S-vaccine exposure during pregnancy . 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: 1873065 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-23
Onset:2021-09-27
   Days after vaccination:188
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006M20A / 2 LA / IM

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

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

Write-up: Breakthrough COVID-19 infection. Patient tested positive on SEPTEMBER 27, 2021. Patient was fully vaccinated on APRIL 7, 2021.


VAERS ID: 1873353 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Unknown  
Location: Washington  
Vaccinated:2021-09-02
Onset:2021-09-27
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-11-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30130MBA / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Cardiac monitoring, Dizziness, Hyperhidrosis, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoxetine 20 mg, apple cider vinegar, B-12 500 mg
Current Illness:
Preexisting Conditions: Crest syndrome
Allergies: Allergic to augmentin
Diagnostic Lab Data: Word heart monitor for one week and am waiting on results
CDC Split Type:

Write-up: A few weeks after my first dose I begin to express my heart racing at random times. When this happens I become very sweaty and feel like I might faint. This has never happened to me prior to the vaccine


VAERS ID: 1875885 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: New York  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Herpes simplex reactivation, Immunisation, Off label use
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Celiac disease; Gluten sensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101454559

Write-up: Dose 3; Dose 3; Herpes Simplex reactivation; This is a spontaneous report from a contactable consumer (patient) who reported for herself. A 66-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0191 and expiration date was not reported), dose 3 via an unspecified route of administration, administered in left arm on 27Sep2021 14:30 (Age at vaccination was 66 years) as dose 3 (booster), single for covid-19 immunisation. The facility where the most recent COVID-19 vaccine was administered was drug store. The device date was 26Oct2021. Medical history included coeliac disease, gluten sensitivity from an unknown date and unknown if ongoing. The patient was not diagnosed with covid-19 prior to vaccination. There were no concomitant medications. The patient did not receive any other vaccines within four weeks and any other medications within two weeks prior to the COVID vaccine. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ENV199 and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 19Mar2021 at 12:30 hours as dose 2, single and dose 1 via an unspecified route of administration (lot number was EL9264 and expiration date were not reported), administered in left arm, on 23Feb2021at 15:00 hours as dose 1, single for COVID-19 immunization. Age at vaccination for both the doses was 66 years. On an unspecified date in 2021 the patient experienced Herpes Simplex reactivation within a week of first two doses and 3 weeks after booster shot. The patient was not tested for covid-19 since vaccination. The patient took Valtrex as therapeutic measure. The outcome of event Herpes Simplex reactivation was recovered on an unspecified date. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1876192 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-09-17
Onset:2021-09-27
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014C21A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
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: SC 202185

Write-up: Patient received Moderna on 9/17/21, called facility on 9/27/21 to report redness at injection site. Patient encouraged to contact PCP or care.


VAERS ID: 1876923 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1822811 / N/A LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Adverse reaction, Arthritis, Blindness, Blood test normal, Computerised tomogram normal, Electrocardiogram normal, Eye movement disorder, Fear, Feeling abnormal, Headache, Joint lock, Joint range of motion decreased, Joint swelling, Myalgia, Neurological symptom, Urticaria, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Systemic lupus erythematosus (broad), Dementia (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: levothyroxine sertraline
Current Illness: None.
Preexisting Conditions: Hypothyroidism Anxiety/Depression
Allergies: Cephalosporins/Penicillin
Diagnostic Lab Data: Blood work. CT scan. EKG. Vitals and physical examination.
CDC Split Type:

Write-up: 4am headache, worsening by morning hours, lasting one full week. For a few days I treated a constant headache along with hives which broke out on my legs, arms and abdomen, worsening and then subsiding. Extremely sore muscles and joints with inflammation, swelling, and joints getting stuck with movement. Specifically both biceps and left knee. Left knee is currently swollen with limited range of motion. One week after the vaccination I experienced an extreme adverse reaction which I would term a neurological event. I lost control of my vision and felt my eyes move to the left, and then repeatedly moving, as I saw the room tilt and spin before me. Notably odd was lack of nausea or dizziness, and I did not faint. The rapid eye movements and vertigo-type experience lasted less than a minute, after which I tried to carry on with my day. I felt strange and was frightened. I went to Emergency Department. I had the diagnostic tests done, as indicated below, and evidence of TIA or any stroke or irregular heart rhythms was ruled out; however, they did not determine the cause of my extremely frightening event, and at the time, I did not have the headache which the hospital personnel inaccurately referred to in my discharge papers as a current condition.


VAERS ID: 1879205 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212AZIA / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Suspected counterfeit product, Vaccination site pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20211134415

Write-up: POSSIBLE COUNTERFEIT PRODUCT; UNBEARABLE PAIN AT THE INJECTION SITE FOR THE FIRST 15 MINUTES POST-VACCINATION/ONGOING LINGERING PAIN AT THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 37 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212AZIA, expiry: UNKNOWN) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-SEP-2021, the patient experienced unbearable pain at the injection site for the first 15 minutes post-vaccination/ongoing lingering pain at the injection site. On an unspecified date, the patient experienced possible counterfeit product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from unbearable pain at the injection site for the first 15 minutes post-vaccination/ongoing lingering pain at the injection site, and the outcome of possible counterfeit product was not reported. This report was non-serious. This case, involving the same patient is linked to 20211128020. This report was associated with a product quality complaint number 90000202127.


VAERS ID: 1881204 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-25
Onset:2021-09-27
   Days after vaccination:94
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

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

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

Write-up: BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 09/27/2021. PATIENT FULLY VACCINATED ON 07/10/2021.


VAERS ID: 1881222 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-05
Onset:2021-09-27
   Days after vaccination:234
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1284 / 2 LA / IM

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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 09/27/2021. PATIENT WAS FULLY VACCINATED ON 02/20/2021.


VAERS ID: 1882602 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-08-31
Onset:2021-09-27
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Angiogram, Angiogram normal, Echocardiogram normal, Electrocardiogram normal, Transient ischaemic attack
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (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: Multivitamin
Current Illness: no
Preexisting Conditions: no
Allergies:
Diagnostic Lab Data: Labs done in sept, ekg and CT done in october, Echo done in Nov.
CDC Split Type:

Write-up: Left sided TIA, completed labs, completed ekg, completed Echo, complete CTA all negative. .


VAERS ID: 1882621 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: New York  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8020 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3527 / 2 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Condition aggravated, Fatigue, Headache, Heart rate irregular, Vaccine positive rechallenge
SMQs:, Cardiac arrhythmia terms, nonspecific (narrow)

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

Write-up: Severe headache, irregular heartbeat, tiredness and fatigue since first shot and getting worse after second shot


VAERS ID: 1884164 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia
SMQs:, Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101419710

Write-up: she had hip pain two days after she took the first shot; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself that, A 59-years-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection via an unspecified route of administration, administered in Left Arm on 25Sep2021 (Batch/Lot Number: EW0179) as Dose 1, Single (age at vaccination:59-Years-old) for Covid-19 immunisation. Relevant medical history was none. There were no concomitant medications. Historical immunisation includes administration of pneumonia vaccination and experienced swelling on her left arm in 2012-2013. Stated that she received the pneumonia shot on while hospitalized due to being sick which was all prior to the shot (with a problem for her heart). Patient has received Flu vaccination on unspecified date and experienced rash on her right arm. Stated that she had a breakout rash on her right arm from the flu shot 7-8 years ago. Stated that she was unable to take TB, flu and pneumonia shot. No further details provided. On 27Sep2021 the patient experienced she had hip pain two days after she took the first shot. Stated that she received the vaccine because she was mandated through employment. Stated that she is concerned with the hip pain and her supervisor wanted her to get X-ray and MRI, but she cannot afford it. Stated that she took her first Pfizer shot and did not have hip pain until the shot. Stated that she waited to see if would go away. Stated that she went to get the second shot and told the nurse that she was having joint and hip pain and was told that it was a side effect from the shot. Stated that she was told to follow up with her doctor to see if needed an X-ray or MRI and was told that it would go away in 24- 48 hours. Stated that she had told him that it had been a month since she had it. The patient had not received treatment for all the events. The outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1884193 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Balance disorder, Immunisation
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CAPECITABINE; TUKYSA; PRADAXA; EFFEXOR; SINGULAIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer stage IV; Sulfonamide allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101525852

Write-up: All minor joints (knees, ankles, wrists, hands and feet) were in searing pain for a week; legs were still very unstable; booster; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authority. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 27Sep2021 at 01:15 PM (Batch/Lot number was unknown) (at the age of 46 years old) as dose 3 (booster), single for COVID-19 immunisation. Medical history included breast cancer IV and known allergy to sulfa. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included capecitabine; tucatinib (TUKYSA); dabigatran etexilate mesilate (PRADAXA); venlafaxine hydrochloride (EFFEXOR); montelukast sodium (SINGULAIR), all taken for an unspecified indication, start and stop date were not reported. The patient was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 05Mar2021 at 11:30 AM (Batch/Lot number was unknown) (at the age of 45 years old) as dose 1, single; second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm, on 27Mar2021 at 11:30 AM (Batch/Lot number was unknown) (at the age of 45 years old) as dose 2, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Sep2021 at 01:15 PM, the patient was administered the third (booster) dose of BNT162B2. On 29Sep2021, the patient''s all minor joints (knees, ankles, wrists, hands and feet) were in searing pain for a week. The patient was prescribed 3 days on a fentanyl patch and dexamethasone (DECADRON). During that time, the patient was basically bedridden. The patient was 46 years old and was now on a cane because her legs were still very unstable. Though more manageable, the patient continue to have joint pain in the areas mentioned above. The events were reported as serious (disability). The events resulted to emergency room and physician office visit. The outcome of events all minor joints (knees, ankles, wrists, hands and feet) were in searing pain for a week and legs were still very unstable was not recovered. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1763654 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 083F21B / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Parkinson's disease
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (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:
Current Illness: Parkinsonism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHMODERNATX, INC.MOD20213

Write-up: Worsening of Parkinson''s Disease; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSON''S DISEASE (Worsening of Parkinson''s Disease) and FATIGUE (Tiredness) in a 61-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 083F21B) for COVID-19 vaccination. Concurrent medical conditions included Parkinsonism. On 27-Sep-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced PARKINSON''S DISEASE (Worsening of Parkinson''s Disease) (seriousness criteria disability and medically significant) and FATIGUE (Tiredness) (seriousness criterion disability). At the time of the report, PARKINSON''S DISEASE (Worsening of Parkinson''s Disease) and FATIGUE (Tiredness) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not provided. No other vaccines was received within one month prior to the date of vaccination. Company comment: This case concerns a 61-year-old, male patient with concurrent illness of Parkinson''s disease, who experienced the unexpected events Parkinson''s disease aggravated and fatigue. The events occurred at the same day after the first dose of Moderna vaccine. The event fatigue is consistent with the current understanding of the mechanism of action of the vaccine. The patient''s current illness of Parkinson''s disease may be a confounding factor to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender''s Comments: This case concerns a 61-year-old, male patient with concurrent illness of Parkinson''s disease, who experienced the unexpected events Parkinson''s disease aggravated and fatigue. The events occurred at the same day after the first dose of Moderna vaccine. The event fatigue is consistent with the current understanding of the mechanism of action of the vaccine. The patient''s current illness of Parkinson''s disease may be a confounding factor to the event. The benefit-risk relationship of Moderna vaccine is not affected by this report.


VAERS ID: 1766363 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004668 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pyrexia, Renal pain, 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? Yes
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: Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Henoch-Schonlein purpura (Had henoch schonlein purpura previously, believed to be caused by TB vacancie, but not proven.)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Kidney pain; Fever; This case was received via the Regulatory Authority RA (Reference number: GB-MHRA-ADR 26007496) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RENAL PAIN (Kidney pain) and PYREXIA (Fever) in a 31-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. The patient''s past medical history included Henoch-Schonlein purpura (Had henoch schonlein purpura previously, believed to be caused by TB vacancie, but not proven.). Previously administered products included for Product used for unknown indication: PENICILLIN. Past adverse reactions to the above products included Adverse event with PENICILLIN. Concurrent medical conditions included Penicillin allergy. On 26-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced RENAL PAIN (Kidney pain) (seriousness criteria hospitalization, disability and medically significant) and PYREXIA (Fever) (seriousness criteria hospitalization, disability and medically significant). At the time of the report, RENAL PAIN (Kidney pain) had not resolved and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. This case concerns a 31 year-old male patient with a history of penicillin allergy, and Henoch-Schonlein purpura who experienced the unexpected events of renal pain and pyrexia. The events occurred approximately 1 day after the second dose of mRNA-1273. The rechallenge not applicable as no additional dosing will be administered. The medical history of Henoch-Schonlein purpura remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 31 year-old male patient with a history of penicillin allergy, and Henoch-Schonlein purpura who experienced the unexpected events of renal pain and pyrexia. The events occurred approximately 1 day after the second dose of mRNA-1273. The rechallenge not applicable as no additional dosing will be administered. The medical history of Henoch-Schonlein purpura remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1767246 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), 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.MOD20213

Write-up: Seizures; This case was received via RA (Reference number: GB-MHRA-ADR 26005337) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SEIZURE (Seizures) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizures) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication were not provided Treatment medication were not reported. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in Clinical trial. Company Comment: This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected event of seizure. The event occurred on the same day after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the event resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected event of seizure. The event occurred on the same day after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the event resulted in a persistent or permanent incapacity


VAERS ID: 1767248 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hallucination, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Hallucination; Swelling of hands; Fever; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26007561) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucination), PERIPHERAL SWELLING (Swelling of hands) and PYREXIA (Fever) in a 20-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced HALLUCINATION (Hallucination) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swelling of hands) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 27-Sep-2021, PERIPHERAL SWELLING (Swelling of hands) had resolved. At the time of the report, HALLUCINATION (Hallucination) had resolved and PYREXIA (Fever) 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. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment: This case concerns a 20-year-old female patient with no medical history reported, who experienced the serious unexpected events of hallucination, pyrexia and peripheral swelling. The event occurred after the second dose of mRNA-1273, Moderna COVID-19 Vaccine (dose dates were not reported). The rechallenge was considered unknown since it was not reported whether the same/similar events had occurred after the first dose. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 20-year-old female patient with no medical history reported, who experienced the serious unexpected events of hallucination, pyrexia and peripheral swelling. The event occurred after the second dose of mRNA-1273, Moderna COVID-19 Vaccine (dose dates were not reported). The rechallenge was considered unknown since it was not reported whether the same/similar events had occurred after the first dose. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1767667 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004668 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Headache, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19; Comments: Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20210722; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Joint pain; Nausea; Fever; Headache; Back pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26006561) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PYREXIA (Fever), HEADACHE (Headache), ARTHRALGIA (Joint pain) and NAUSEA (Nausea) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Suspected COVID-19 from 22-Jul-2021 to 29-Jul-2021. Concomitant products included PARACETAMOL from 22-Jul-2021 to 26-Jul-2021 for COVID-19. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced BACK PAIN (Back pain) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 28-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On 28-Sep-2021, NAUSEA (Nausea) had resolved. At the time of the report, BACK PAIN (Back pain), PYREXIA (Fever) and HEADACHE (Headache) had not resolved and ARTHRALGIA (Joint pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-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. Patient had COVID on 22 Sep 2021 with strong headache, back pain and joint pain Company comment: This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Pyrexia, Back pain, Headache, Arthralgia and Nausea . The events occurred approximately on he same day after the first dose of Moderna covid -19 vaccine. The benefit-risk relationship of Moderna covid -19 vaccine, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 32-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Pyrexia, Back pain, Headache, Arthralgia and Nausea . The events occurred approximately on he same day after the first dose of Moderna covid -19 vaccine. The benefit-risk relationship of Moderna covid -19 vaccine, is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1767668 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Peripheral swelling, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

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

Write-up: Joint pain; Muscle pain; Fatigue; Tired all the time; Swollen arm; Headache; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26005306) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), FATIGUE (Fatigue), FATIGUE (Tired all the time), PERIPHERAL SWELLING (Swollen arm) and HEADACHE (Headache) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), FATIGUE (Tired all the time) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), FATIGUE (Fatigue), FATIGUE (Tired all the time) and PERIPHERAL SWELLING (Swollen arm) had not resolved and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by reporter. No treatment information was provided. Company comment: This case concerns a 29-year-old female patient with no medical history provided, who experienced the serious (medially significant) expected events of arthralgia, myalgia, fatigue, headache and unexpected event peripheral swelling. The event occurred on the same day after receiving the second dose of mRNA-1273, Moderna COVID-19. The rechallenge was considered unknown sinceit was not reported whether the same/similar events occurred after the firts dose. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 is not affected by this report.; Sender''s Comments: This case concerns a 29-year-old female patient with no medical history provided, who experienced the serious (medially significant) expected events of arthralgia, myalgia, fatigue, headache and unexpected event peripheral swelling. The event occurred on the same day after receiving the second dose of mRNA-1273, Moderna COVID-19. The rechallenge was considered unknown sinceit was not reported whether the same/similar events occurred after the firts dose. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 is not affected by this report.


VAERS ID: 1768812 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Chills, Injection site induration, Injection site mass, Injection site pain, Injection site warmth, Lymph node pain, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu vaccine - approx 2009? Anaphylactic reaction; advised not to receive again.
Other Medications: Candesarten Lipitor Tresiba Fiasp Multivitamin
Current Illness:
Preexisting Conditions: Clear cell renal cell carcinoma Glomerulonephritis Type I Diabetes hypertension hyperlipidemia
Allergies: Biaxin banana almonds kiwi ethanol alcohol shellfish
Diagnostic Lab Data:
CDC Split Type:

Write-up: Nausea, joint pain, localized site pain with a hard lump at injection site, location site painful x 11 days (currently), and hot. Fever - temperature of 102.9-103.1 for 2+ days, lymph node tenderness, body aches, chills


VAERS ID: 1769776 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-09-27
   Days after vaccination:171
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Medication errors (narrow), Infective pneumonia (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; ASPIRIN [ACETYLSALICYLIC ACID]; FUROSEMIDE; LISINOPRIL; METFORMIN; NIFEDIPRESS MR; OMEPRAZOLE; PIOGLITAZONE; SIMVASTATIN; SITAGLIPTIN
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101287291

Write-up: COVID-19 pneumonia; SARS-CoV-2 infection; Yes - Positive COVID-19 test; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109281237190070-SDGA8. Safety Report Unique Identifier is GB-MHRA-ADR 26005327. A 78-year-old male patient received bnt162b2 (Pfizer BioNTech covid-19 mrna vaccine, lot number: er1749), via an unspecified route of administration on 09Apr2021 as dose 2, single for COVID-19 immunization. The patient previously received first dose of bnt162b2 (Pfizer BioNTech covid-19 mrna vaccine, lot number: el0739) on 21jan2021. The medical history of the patient included ongoing suspected covid-19, unsure when symptoms started. The concomitant medications of the patient included allopurinol, aspirin, furosemide, lisinopril, metformin, ifedipine, omeprazole, pioglitazone, simvastatin, sitagliptin. It was unsure if patient was enrolled in clinical trial. Report does not relate to possible blood clots or low platelet counts. On 27Sep2021 patient experienced sars-cov-2 infection (covid-19), on an unspecified date covid-19 pneumonia, yes - positive covid-19 test. The patient underwent lab tests and procedures which included sars-cov-2 test yes - positive covid-19 test. The outcome of sars-cov-2 infection (covid-19), covid-19 pneumonia was reported as not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1769787 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101294512

Write-up: Swollen lymph nodes; My armpit on the same side as the injection swollen; My armpit on the same side as the injection swollen and causing pain; It''s most uncomfortable if my arm is tight to my body; pain; This is a spontaneous report from a contactable consumer (patient) received from the Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109291722241670-E7BOH. Safety Report Unique Identifier GB-MHRA-ADR 26010735. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Sep2021 (Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced pain in 2021 and swollen lymph nodes on 27Sep2021. The events were reported as serious (medically significant). The clinical course was reported as follows: My armpit on the same side as the injection swollen and causing pain in 2021. Pain was travelling down into my forearm. I would describe it as a dull pain like a trapped nerve. It''s most uncomfortable if my arm was tight to my body in 2021. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of swollen lymph nodes was not recovered while unknown for the other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1770310 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005839 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Acute myocarditis; Pyrexia; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP101357) on 02-Oct-2021 and was forwarded to Moderna on 06-Oct-2021. This case, initially reported to the regulatory authority by a physician, was received via the PMDA (Ref, v21128514). The patient had an allergic history of food (buckwheat, pear, peach, cherry, and various fish eggs) On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.3 degrees Celsius. On 26-Sep-2021, during the medical interview, the patient complained of a sort of chest discomfort. The patient received the 2nd dose of this vaccine. On 27-Sep-201, pyrexia of 39.0-39.9 degrees Celsius developed. On 28-Sep-2021, around 10:00, chest pain developed. It was exacerbated, and the patient visited a medical institution. There were findings of acute myocarditis, and the patient was raced to the reporting hospital. The patient was hospitalized. On an unknown date, after acute myocarditis, cardiomyopathy was noted as a sequela. The outcome of pyrexia was unknown. The outcome of acute myocarditis was reported as sequela. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The association with the vaccination with this vaccine is strongly suspected. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 20-year-old male patient with medical history of allergy to foods such as, buckwheat, pear, peach, cherry and various fish eggs, who experienced the serious (hospitalization) expected events of myocarditis and pyrexia. The event myocarditis occurred approximately 2 days after receiving the second dose of mRNA-1273, Moderna COVID-19. The rechallenge was considered unknown because it was not reported whether the same/similar events occurred after the first dose. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 is not affected by this report


VAERS ID: 1771021 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Influenza, Oropharyngeal pain, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: sore throat; dizzy; flu; Rash; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26008838) on 30-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash), OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizzy) and INFLUENZA (flu) in a 14-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). Concurrent medical conditions included Asthma and Suspected COVID-19 since 27-Sep-2021. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) (seriousness criterion medically significant), DIZZINESS (dizzy) (seriousness criterion medically significant) and INFLUENZA (flu) (seriousness criterion medically significant). On 29-Sep-2021, RASH (Rash) had not resolved. At the time of the report, OROPHARYNGEAL PAIN (sore throat), DIZZINESS (dizzy) and INFLUENZA (flu) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: not provided (Inconclusive) Inconclusive test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient waiting on PCR as sons has asthma and I has to multi-dose him as coughing non stop, rash spreading daily, sore throat, flu, dizzy etc was fit n well before 1st vaccine n a complete state. Company comment: This case concerns a 14 year-old male patient with history of asthma, suspected COVID-19, and immunodeficiency, who experienced the unexpected serious events of Oropharyngeal pain, Dizziness, Influenza, and Rash. The events occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The history of asthma, suspected COVID-19 and immunodeficiency may have contributed to the events. Seriousness criteria of Medically significant maintained for events for consistency with RA report, however the source document does not include information that supports seriousness criteria.; Sender''s Comments: This case concerns a 14 year-old male patient with history of asthma, suspected COVID-19, and immunodeficiency, who experienced the unexpected serious events of Oropharyngeal pain, Dizziness, Influenza, and Rash. The events occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The history of asthma, suspected COVID-19 and immunodeficiency may have contributed to the events. Seriousness criteria of Medically significant maintained for events for consistency with RA report, however the source document does not include information that supports seriousness criteria.


VAERS ID: 1771027 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-27
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Electrocardiogram QT prolonged, Malaise, Myocarditis, Palpitations, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (narrow), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Torsade de pointes, shock-associated conditions (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension (Both parents have hypertension.)
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: palpitations; Generally unwell; qtc prolonged; Myocarditis; This case was received(Reference number: GB-MHRA-ADR 26014779) on 01-Oct-2021 and was forwarded to Moderna on 01-Oct-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of PALPITATIONS (palpitations), MALAISE (Generally unwell), ELECTROCARDIOGRAM QT PROLONGED (qtc prolonged) and MYOCARDITIS (Myocarditis) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Vaccination. The patient''s past medical history included Anxiety. Family history included Hypertension (Both parents have hypertension.) since an unknown date. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PALPITATIONS (palpitations) (seriousness criteria hospitalization and medically significant), MALAISE (Generally unwell) (seriousness criteria hospitalization and medically significant) and ELECTROCARDIOGRAM QT PROLONGED (qtc prolonged) (seriousness criteria hospitalization and medically significant). At the time of the report, PALPITATIONS (palpitations), MALAISE (Generally unwell) and ELECTROCARDIOGRAM QT PROLONGED (qtc prolonged) had resolved and MYOCARDITIS (Myocarditis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-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. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product was reported. Patient previously had heavy alcohol during COVID lockdown but none recently and denied any drugs specifically cocaine. The patient received 1st dose 8 weeks ago and developed palpitations after and settled after a couple of weeks and had 2nd dose on Sunday developed palpitations and felt generally unwell after. The patient found to have BP greater than 200. The patient was advised to go to Emergency Department. On an unknown date, in morning patient took BP and was still greater than 200, went to Emergency Department. It was Shortness of Breath with palpitation but no acute SOB. The patient had muscle aches. Patient stated that he had an abnormal ECHO as a child but that resolved. Patient took paracetamol and ephedrine OTC. Looked well. Pain was then settled. HS normal, Chest clear, JVP not raised, legs not swollen. Various Investigations included CRP 22.1, WCC 13.41, neutrophil 11.27, Creatinine 122, Troponin T 19, D-dimer 3.11, LFTs and bone NAD, CK, Mg and TFTs normal, Lact 1.1, ECGs - Variable Ant T inv. Sinus tachycardia. QTc prolonged. The patient diagnosis as had Myocarditis which was possibly secondary to COVID vaccine viral. Patient was given Bisoprolol 2.5mg and Malodipine 5mg then. Cardiology review was done and telemetry EDD 2-3 days. This case concerns a 58-year-old female patient, with relevant medical history of hypertension and anxiety, who experienced the unexpected serious event of Palpitations, Malaise, Electrocardiogram QT prolonged and expected serious event myocarditis. Additionally, the unexpected serious event blood pressure increased is also reported. The events occurred on an unknown date after the second dose of Spikevax. The rechallenge was not applicable as the AEs occurred after the second dose and we are not expecting another dose. The medical history hypertension remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 58-year-old female patient, with relevant medical history of hypertension and anxiety, who experienced the unexpected serious event of Palpitations, Malaise, Electrocardiogram QT prolonged and expected serious event myocarditis. Additionally, the unexpected serious event blood pressure increased is also reported. The events occurred on an unknown date after the second dose of Spikevax. The rechallenge was not applicable as the AEs occurred after the second dose and we are not expecting another dose. The medical history hypertension remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1772898 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GEDAREL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Swollen lymph nodes; This case was received via RA (Reference number: GB-MHRA-ADR 26015631) on 01-Oct-2021 and was forwarded to Moderna on 01-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) in a 20-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 DESOGESTREL, ETHINYLESTRADIOL (GEDAREL) from 01-Jan-2019 to an unknown date for Contraception. On 26-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criteria hospitalization and medically significant). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Patient has doctors appointment on 29-Sep-2021 (antibiotics given). Blood taken on 30-Sep-2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. company comment: This report concerns a 20-year-old female patient with no relevant medical history who experienced serious unexpected event of lymphadenopathy. The event occurred 1 day after vaccination with second dose of mRNA-1273. Re-challenge is not applicable as the event happened after the second dose with no information about the first dose. The outcome of the event is reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This report concerns a 20-year-old female patient with no relevant medical history who experienced serious unexpected event of lymphadenopathy. The event occurred 1 day after vaccination with second dose of mRNA-1273. Re-challenge is not applicable as the event happened after the second dose with no information about the first dose. The outcome of the event is reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1777187 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7204 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Oxygen saturation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: BP; Result Unstructured Data: Test Result:193/93 mmHg; Comments: BP 193/93; Test Date: 20210927; Test Name: HR; Result Unstructured Data: Test Result:84; Test Date: 20210927; Test Name: O2 sat; Test Result: 98 %; Comments: O2 sat 98%.
CDC Split Type: CAPFIZER INC202101281453

Write-up: Was leaving and fainted/responsiveness waning; BP 193/93; This is a spontaneous report from a contactable pharmacist. A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: FD7204), via intramuscular route, administered in left arm on 27Sep2021 at 10:15 (at the age of 80-year-old) as dose 1, single for COVID-19 immunisation. The patient''s medical history was not reported, and the concomitant medications were not reported. It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19 and since the vaccination, it was unknown whether the patient had been tested for COVID-19. On 27Sep2021, the patient waited for 30 minutes and the patient while leaving got fainted and had BP of 193/93, had responsiveness waning. Ambulance was called and transferred to emergency room for the reported events. The patient underwent lab tests and procedures which included blood pressure measurement: 193/93 mmHg on 27Sep2021, heart rate: 84 on 27Sep2021, oxygen saturation: 98 % on 27Sep2021. The outcome was unknown for the reported event. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Blood pressure increased and Syncope, and and BNT162B2. 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: 1777519 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101314021

Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FI-FIMEA-20215116. A 14-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 27Sep2021 (Batch/Lot Number: UNKNOWN) at age of 14 years old as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced anaphylaxis on 27Sep2021 with outcome of recovering. Immediately after the vaccination symptoms as in anaphylaxia, that is flushing of the face, malaise, swelling of the throat. The patient immediately received adrenaline 0.5 mg, after which the symptoms eased. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1777865 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-27
Submitted: 0000-00-00
Entered: 2021-10-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood glucose abnormal, Blood pressure measurement, Coma, Haemorrhage, Leg amputation, Platelet count, Thrombocytopenia, Thrombosis
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Smoker (on and off. Had been stopped for long time and started again in last few years)
Preexisting Conditions: Medical History/Concurrent Conditions: Hernia (had a hernia operation some time in the past); Comments: No prior problems, medication or labs relating to hypercoagulability, no risk factors of Deep vein thrombosis (DVT)
Allergies:
Diagnostic Lab Data: Test Name: Platelet count; Result Unstructured Data: Low; Test Name: Blood sugar abnormal; Result Unstructured Data: Normal; Test Name: Blood pressure; Result Unstructured Data: Little high
CDC Split Type: GBJNJFOC20211004127

Write-up: LOST A LOT OF BLOOD; COMA; THROMBOCYTOPENIA; CATASTROPHIC BLOOD CLOT IN THE BACK OF THE KIDNEY NEXT TO ABDOMINAL CAVITY/ CATASTROPHIC BLOOD CLOT IN GROIN AREA/ BLOOD CLOT IN LEG; LOSS OF LEG ABOVE THE KNEE; BACK ACHES; This spontaneous report received from a health care professional concerned a 68 year old male of an unspecified race and ethnic origin. The patient''s height and weight were not reported. The patient''s past medical history included that had a hernia operation some time in the past and concurrent conditions included: smoker (on and off, stopped for a long time but started again in the last few years) and other pre-existing medical conditions included no prior problems, medication or labs relating to hypercoagulability, no risk factors of deep vein thrombosis (DVT). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, frequency time 1 total administered on JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported but he occasionally took a proton-pump inhibitors (PPI). On an unspecified date, the patient started having back aches for which he went for a checkup and physician found that he had thrombocytopenia which was treated with Vitamin B12 (cyanocobalamin) or Folic acid. During WellMan health check, he underwent laboratory test which included Platelet count (NR: not provided) was found to be low and Blood sugar abnormal (NR: not provided) was found to be normal. He also performed Blood pressure (NR: not provided) which was noted to be a little high. He experienced pain in the back & abdomen, the pain felt a little similar to sciatica/previous hernia. When terrible pain developed he sought medical help. On 27-SEP-2021 (within 24 hours), he had a series of blood clots. The patient had catastrophic blood clot in the back of the kidney, next to his abdominal cavity. It was completely occluded and had to do an emergency operation. He was hospitalized on same day for operation. He came out ok and recovered but then he had another catastrophic clot in his groin area. For this second clot, they had to do a 7 hour operation. He came out bound again. After that he had a third clot and he lost his leg above the knee. After the third operation (On an unspecified date), the patient was on life support, He had three levels of anesthesia and has lost a lot of blood but he was recovering. Then they administered heparin and it was an emergency and then an oral anticoagulant. He was out of coma and came off the ventilator yesterday but still on dialysis, not fully conscious / partially conscious. Discharge date was not provided. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coma and catastrophic blood clot in the back of the kidney next to abdominal cavity/ catastrophic blood clot in groin area/ blood clot in leg, was recovering from lost a lot of blood and the outcome of thrombocytopenia, back aches and loss of leg above the knee was not reported. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, Life Threatening, and Disability Or Permanent Damage). This case, from the same reporter is linked to 20211004138.; Sender''s Comments: V0: 20211004127-COVID-19 VACCINE AD26.COV2.S- Lost a lot of blood, coma, loss of leg above the knee. 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). 20211004127-COVID-19 VACCINE AD26.COV2.S-Thrombocytopenia, catastrophic blood clot in the back of the kidney next to abdominal cavity/catastrophic blood clot in groin area/blood clot in leg. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1778015 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F93712 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Disorientation, Ear pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101280747

Write-up: ear ache; disorientation; Ear pain; This is a spontaneous report from a contactable consumer. This is a report received from the United Kingdom''s Medicines Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202109271001562750-TCYOE, Safety Report Unique Identifier GB-MHRA-ADR 25999380. A 38-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: F93712, Expiration date: Unknown), via an unspecified route of administration on 25Sep2021, as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced ear ache pain/ feeling of disorientation and as if ears were underwater. The patient experienced ear pain on 27Sep2021. The case was assessed as serious (medically significant) by the health authority. The outcome of event ear pain was not resolved and outcome of all other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1778022 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menarche, Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101280522

Write-up: Sore arm; Menarche; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109271059376250-PV9U2, safety report unique identifier is GB-MHRA-ADR 25999604. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown), via an unspecified route of administration on 24Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced menarche on 27Sep2021, sore arm on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date (No-Negative COVID-19 test). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event for menarche was not recovered, and for sore arm it was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1778064 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysgeusia, Immunisation, Off label use, Pain in jaw, Paraesthesia oral, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Osteonecrosis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101280740

Write-up: Tingling lips; Taste metallic; Jaw pain; The patient took BNT162B2 dose 3; off label use; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109271827330000-PNJEM. Safety Report Unique Identifier: GB-MHRA-ADR 26001621. A 48-year-old non-pregnant female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF2153), via an unspecified route of administration on 27Sep2021 (at the age of 48-year-old) as dose 3 (booster), single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 27Sep2021, the patient experienced tingling lips, taste metallic, and jaw pain. The patient took bnt162b2 dose 3 on 27Sep2021, which was considered as an off label use. The patient felt fine in the 5 minutes, he was told to stay in the vaccination centre, After leaving whilst walking back to his car, he started getting tingling in his lips and when he went home he also got a metallic taste and pain in his jaw on right side.The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on unspecified date in 2021.The clinical outcome of all the events was not resolved. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1778078 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Confusional state, Feeling hot, Headache, Influenza like illness, Myalgia, Neck pain, Pain in extremity, SARS-CoV-2 test, Upper gastrointestinal haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101280532

Write-up: upper; dizzy head; leg ache; neck and head ache; confusion; muscle ache; neck and head ache; Flu-like symptoms; Aching joints; 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-202109272030236540-P9YBP, Safety Report Unique Identifier GB-MHRA-ADR 26002689. A 43-years-old female patient received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, solution for injection), via an unspecified route of administration on 27Sep2021 (Batch/Lot Number: Ff2153) (A 43 years old at time of Vaccination) as DOSE 1, SINGLE for covid-19 immunization. No medical history reported. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced upper (upper gastrointestinal hemorrhage), dizzy head, leg ache, neck and head ache, confusion and muscle ache on an unspecified date, aching joints on 27Sep2021. The clinical course was reported as follows: Flu-like symptoms. Aching joints. Dizzy head. Confusion. Neck and headache. Inside of leg ache. Muscle ache in legs and upper body. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test no - negative covid-19 test on. The outcome of Events for aching joints was not recovered and for other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1778086 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dry mouth, Hallucination, Hyperhidrosis, Illness, Maternal exposure during breast feeding, Off label use, Pain, Product use issue, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal exposures via breast milk (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101280639

Write-up: rash all over; Maternal exposure during breast feeding; Off label use; Drug use in unapproved population; Hallucination; Diarrhea; Sweating; Ache; Dry mouth; Sickness; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional (patient). This is the first of 2 reports. This is the maternal report. The first report is a report received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109272134466750-ZKL6J. Safety Report Unique Identifier GB-MHRA-ADR 26002717. A 34-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: unknown) via an unspecified route of administration on 27Sep2021 (at the age of 34-years-old) as dose 2, single for COVID-19 immunization. Medical history included ongoing breast feeding. The patient''s concomitant medications were not reported. The patient previously received BNT162B2, dose 1 on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date the patient experienced rash all over, maternal exposure during breast feeding. on 27Sep2021, patient experienced diarrhea, hallucination, sweating, ache, dry mouth and sickness, off label use and drug use in unapproved population. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. It was reported that, patient breastfed baby was restless and has a rash all over his face. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event diarrhea, hallucination, sweating, ache was recovering, outcome of events dry mouth and sickness was not recovered. While outcome of event rash all over was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101287518 Baby case


VAERS ID: 1778093 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Immunisation, Off label use, Pyrexia, Rash, Rash maculo-papular, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CELECOXIB; FEXOFENADINE; FOSTAIR; MELATONIN; MONTELUKAST; NORTRIPTYLINE; PARACETAMOL; PREGABALIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma; Cardiac arrhythmia; Complex regional pain syndrome; Ehlers-Danlos syndrome; Fever; Gastroparesis (requiring jejunostomy tube); Pain; Pain joint; Poor sleep
Allergies:
Diagnostic Lab Data: Test Date: 20210923; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101280787

Write-up: maculopapular rash; chest tightness; Rash; Fever; Difficulty breathing; Off label use; Booster; This is a spontaneous report from a contactable consumer (patient) received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109272247252770-HL9TM, Safety Report Unique Identifier GB-MHRA-ADR 26002753. A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Sep2021 (Lot/batch number was not reported) as dose 3 (booster), single for COVID-19 immunisation. Medical history included asthma, Ehlers-Danlos syndrome, gastroparesis (requiring jejunostomy tube), complex regional pain syndrome (CRPS) in right arm, pain joint, allergy, poor sleep, pain and fever, all from an unknown date and unknown if ongoing. The patient previously took first dose of BNT162B2 on 18Jan2021 and second dose in Apr2021, both for COVID-19 Immunisation. Concomitant medications included celecoxib taken for pain joint, start and stop date were not reported; fexofenadine taken for allergy, start and stop date were not reported; beclometasone dipropionate, formoterol fumarate (FOSTAIR) taken for asthma, start and stop date were not reported; influenza vaccine (INFLUENZA VIRUS) taken for an unspecified indication from 17Sep2021 to an unspecified stop date; melatonin taken for poor sleep, start and stop date were not reported; montelukast taken for asthma, start and stop date were not reported; nortriptyline taken for pain, start and stop date were not reported; paracetamol taken for fever, start and stop date were not reported; pregabalin taken for pain, start and stop date were not reported. On 27Sep2021, the patient experienced maculopapular rash, chest tightness, rash, fever, difficulty breathing, off label use and booster. The case was assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 23Sep2021. Therapeutic measures were taken as a result of chest tightness, fever and difficulty breathing. The outcome of the event "difficulty breathing" was recovered on an unknown date; events "maculopapular rash", "chest tightness", "rash" and "fever" was recovering. The clinical course was reported as follows: Had booster vaccine about 2pm, felt fine initially, started feeling feverish around 6pm so took some paracetamol, erythematous maculopapular rash appeared across chest and upper arms around 7:30 ish, by 8pm started to have difficulty breathing with chest tightness but felt different to asthma which is usually well controlled, took inhaler anyway did not really help, lasted about half an hour then gradually improved with no lasting effects. Fever and rash persisted longer. She did have the fever after 1st dose vaccine and then fever plus rash after second. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional information: Asthma Ehlers - danios syndrome Gastroparesis requiring jejunostomy tube, CRPS in right arm, Cardiac arrhythmia, Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1780394 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Immunisation, Impaired work ability, Off label use, Pain, Pain in extremity, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101280715

Write-up: pain in lower arm radiating to fingers with some tingling; pain in lower arm radiating to fingers with some tingling; difficulty in typing or using a mouse; pain in lower arm radiating to fingers with some tingling; booster; off label use; Pain in arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109271450150920- QEWMD and Safety Report Unique Identifier is GB-MHRA-ADR 26000402. A 51-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/ Lot number: FF8222) via an unspecified route of administration on 25Sep2021 as dose 3 (booster), single for COVID-19 immunisation. Medical history included depression. Concomitant medication included sertraline taken for depression, start and stop date were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had previously first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/ Lot number: not reported) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. On 27Sep2021 (after 2 days of vaccination), patient experienced pain in arm (medically significant). On an unspecified date, patient experienced pain in lower arm radiating to fingers with some tingling and difficulty in typing or using a mouse (medically significant). Relieved when elevated into a sling position. Lab test on 26Sep2021, included COVID-19 virus test: negative. The outcome of event pain in arm was not resolved and for other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1780401 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Headache, Immunisation, Influenza like illness, Liver function test, Malaise, Myalgia, Nausea, Off label use, Pain in extremity, Peripheral swelling, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUORESP SPIROMAX; EMPAGLIFLOZIN; FEXOFENADINE; LOSARTAN; METFORMIN; OMEPRAZOL; SALBUTAMOL; SALBUTAMOL SULPHATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (hospitalized); Asthma; Diabetes; Gastritis; Hypertension; Pneumonia; Sleep apnea; Steroid therapy (regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: LFT; Result Unstructured Data: Test Result:negative
CDC Split Type: GBPFIZER INC202101287482

Write-up: within 4 hours arm swelling; upper arm pain; fatigue; feeling unwell; feeling cold; Joint ache; Muscle ache; Chills; Nausea; Large arm swelling; Injection site pain; Flu like symptoms; Headache; off label use; Booster; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109280818481690-GPWKL. Safety Report Unique Identifier: GB-MHRA-ADR 26004000. A 45-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection,), via an unspecified route of administration on 27Sep2021 (Lot Number: FJ5782, 45-year-old at the time of vaccination) as dose 3 (booster), single for covid-19 immunization. Medical history included pneumonia, life-threatening asthma attack in June2020 (hospitalized), diabetes from Sep2020, sleep apnea, steroid therapy (regular steroid treatment (e.g., orally or rectally)), hypertension from 2010, gastritis from 2016, asthma from 2005 and again from Jun2021. Concomitant medications included budesonide, formoterol fumarate dihydrate (DUORESP SPIROMAX) taken for asthma from Jun2021 to an unspecified stop date; empagliflozin (EMPAGLIFLOZIN) taken for diabetes mellitus from Sep2020 to an unspecified stop date; fexofenadine (FEXOFENADINE) taken for an unspecified indication from 2019 to an unspecified stop date; losartan (LOSARTAN) taken for hypertension from 2010 to an unspecified stop date; metformin (METFORMIN) taken for diabetes mellitus from Jun2020 to an unspecified stop date; omeprazole (OMEPRAZOL) taken for gastritis from 2016 to an unspecified stop date; salbutamol, salbutamol base, salbutamol sulphate. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), first dose in Jan2021 and second dose in Mar2021; both via an unspecified route of administration, as single dose for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date in 2021, within 4 hours the patient experienced arm swelling, upper arm pain, fatigue, feeling unwell and feeling cold. On 27Sep2021, she experienced chills, nausea, large arm swelling, injection site pain, flu like symptoms and headache. On 28Sep2021, the patient experienced joint ache and muscle ache. It was reported that following booster vaccine, within 4 hours arm swelling, upper arm pain, headache, nausea, feeling cold. generally feeling unwell. after 24 hours, muscle aching and joint pain all over body, feeling of heavy limbs, marked swelling of upper arm, pain at injection site and fatigue. The patient underwent liver function test which resulted negative. Suspect Reactions-Please provide details of any relevant investigations or tests conducted: "LFT negative". Outcome was not resolved for joint ache, muscle ache, large arm swelling, injection site pain, flu like symptoms and headache, was resolving for chills and nausea and was unknown for rest of the events. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1780406 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-09-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101287365

Write-up: Eye pain; This is a spontaneous report from a contactable consumer or other non-health care professional. This is the report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109280957207890-QNUAN, Safety Report Unique Identifier GB-MHRA-ADR 26004611. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine, solution for injection, lot number: FF8222), via an unspecified route of administration, on 22Sep2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient was not pregnant at the time of vaccination. Patient was not currently breastfeeding. The patient experienced eye pain on 27Sep2021. Seriousness criteria was reported as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was negative (No - Negative COVID-19 test) on an unspecified date. Outcome of the event was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1780413 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Gingival pain, Immunisation, Noninfective gingivitis, Off label use, SARS-CoV-2 test
SMQs:, Gingival disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20200916; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101287381

Write-up: Sore gums; Off-label use; Booster; Sores gum; This is a spontaneous report from a contactable consumer or other non hcp (patient) received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109281032365020-OPOEH, Safety Report Unique Identifier GB-MHRA-ADR 26004626. A 48-years-old non pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: Ff8222) via an unspecified route of administration on 27Sep2021 (at the age of 48-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. Medical history included suspected covid-19 from 16Nov2020 to 21Nov2020. The patient''s concomitant medications were not reported. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 27Sep2021, the patient experienced sores gum, off-label use, booster and had sore gums on an unspecified date. Sore gums and teeth and underneath tongue. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Yes - Positive COVID-19 test) on 16Sep2020. The outcome of event sores gum was not recovered and other events was unknown. No causality was provided for gingival pain and noninfective gingivitis. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1780416 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ETHOSUXIMIDE; INFLUENZA VIRUS; LEVETIRACETAM; MEDROXYPROGESTERONE ACETATE
Current Illness: Epilepsy
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Epilepsy; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Allergies:
Diagnostic Lab Data: Test Date: 20210919; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101287435

Write-up: vaginal bleeding; Spotting vaginal; 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-202109281049396020-NSBG9. Safety Report Unique Identifier: GB-MHRA-ADR 26004716. A 31-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot Number: Ff2153), dose 3 via an unspecified route of administration on 25Sep2021 as dose 3 (booster), single for COVID-19 immunization. Medical history included epilepsy from Mar2012 to an unknown date, immunodeficiency from an unknown date and unknown if ongoing (Taking other treatments or medicines, not listed above, known to lower the immune response and i), epilepsy from 2013and ongoing, contraception from 2020 to an unknown date. The patient has not had symptoms associated with COVID-19. The patient was not pregnant. The patient was not currently breastfeeding. Concomitant medication(s) included ethosuximide (ETHOSUXIMIDE) taken for epilepsy from Mar2012 to an unspecified stop date; influenza vaccine (INFLUENZA VIRUS) taken for an unspecified indication from 18Sep2021 to an unspecified stop date; levetiracetam (LEVETIRACETAM) taken for epilepsy from 2013 to an unspecified stop date; medroxyprogesterone acetate (MEDROXYPROGESTERONE ACETATE) taken for contraception from 2020 to an unspecified stop date. The patient was on unspecified Epilepsy medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection) as dose 1 single for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection) as dose 2 single for COVID-19 immunization. On 27Sep2021 the patient experienced vaginal bleeding and Spotting vaginal. The patient does not normally have a period due to the contraceptive injection however 27th episode the patient had episodes of spotting/vaginal bleeding, nothing has changed apart from having a booster dose of covid vaccine, she had no underlying bleeding/clotting issues, no previous side effects from other two vaccines. The problem has not resolved but appears to be getting better. The events were medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 19Sep2021. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1780420 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Inappropriate schedule of product administration, Limb discomfort, Migraine, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101287402

Write-up: Migraine; Nausea; Fever; Arm discomfort; Fatigue; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109281100441730-SL7BM.Safety Report Unique Identifier GB-MHRA-ADR 26005124. A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: FG3712), via an unspecified route of administration on 27Sep2021 (at the age of 27-year-old) as dose 2 single for COVID-19 immunisation. Medical history included suspected COVID-19 from 05Jul2021 to 09Jul2021. The patient''s concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration, on 01Aug2021, as dose 1 single for COVID-19 immunization. Patient was not enrolled in clinical trial. On 27Sep2021, inappropriate schedule of vaccine administered was observed for the patient. On 28Sep2021 (1 day after the vaccination), he experienced migraine, nausea, fever, arm discomfort, and fatigue. Seriousness for the events was disability and medically significant. The patient underwent SARS-COV-2 test which resulted positive COVID-19 test on 05Jul2021. Outcome was not resolved for the events. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1780429 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Coordination abnormal, Incoherent, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101287311

Write-up: Loss of balance; loss of coordination; incoherent speech; Sleepy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109281316218130-QIVJ8.Safety Report Unique Identifier GB-MHRA-ADR 26005510. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: FF8222) via an unspecified route of administration on 27Sep2021 as DOSE 3 (BOOSTER) (at the age of 78-years-old) SINGLE for COVID-19 immunization. Medical history included pain. Concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. It was reported that, patient was taking blood thinners and pain killers. On 27Sep2021, patient experienced sleepy. On an unspecified date, patient experienced loss of balance, loss of coordination and incoherent speech. The outcome of sleepy was resolved on 28Sep2021 and outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1780433 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haematuria, IgA nephropathy, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: IgA nephropathy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101287462

Write-up: iga nephropathy; Haematuria; Swollen lymph nodes; 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-202109281337092860-TARJ8, Safety Report Unique Identifier GB-MHRA-ADR 26005614. A 26-years-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration on 26Sep2021 (Batch/Lot Number: Not known) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included iga nephropathy from an unknown date and unknown if ongoing, patient had no symptoms associated with COVID-19, patient was not pregnant, patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced iga nephropathy on an unspecified date, swollen lymph nodes 27Sep2021, patient have not had visible blood in urine for 2 years up until they day after patient received second dose of the vaccine (haematuria) on 28Sep2021. The event seriousness was assessed as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on unspecified date. The clinical outcome of event iga nephropathy was unknown and other events outcome was unknown. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained


VAERS ID: 1780436 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-20
Onset:2021-09-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (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: Bypass surgery (four years ago); Diabetic; Heart attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101287450

Write-up: Ear noises/ Tinnitus; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109281454505140-Y6M7A, Safety Report Unique Identifier is GB-MHRA-ADR 26005736. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FE3380), via an unspecified route of administration, on 20Sep2021, as dose 1, single for COVID-19 immunization. Medical history included heart attack, diabetes mellitus, heart bypass (recently diagnosed diabetic and heart bypass four years ago). 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. The patient''s concomitant medications were not reported. The patient experienced ear noises and tinnitus on 27Sep2021. Tinnitus started in left ear a week after first dose. Seriousness criteria were reported as medically significant. Outcome of the events was not recovered. Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1780437 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Off label use, Sleep disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPIN AB; EZETIMIBE; LORATADIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101287279

Write-up: headache; Affecting sleep; Off label; Booster; Ice pick headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109281502115000-PLHKV. Safety Report Unique Identifier GB-MHRA-ADR 26005796. A 79-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: FF8222), via an unspecified route of administration on 26Sep2021 as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. 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. Concomitant medication(s) included amlodipine besilate (AMLODIPIN AB) taken for an unspecified indication from 18Aug2016 to an unspecified stop date; ezetimibe taken for an unspecified indication from 18Sep2005 to an unspecified stop date; loratadine taken for an unspecified indication from 16Oct2015 to an unspecified stop date. Patient previously took bnt162b2 on an unspecified date as dose 1 and dose 2 for COVID-19 immunisation. Did not have any reaction to 1st and 2nd Pfizer jab. On an unspecified date, the patient experienced headache, affecting sleep, off label, booster and ice pick headache on 27Sep2021. This jab has had stabbing headache for 36 hours so far. Affecting sleep. The events were assessed as serious medically significant. Any relevant investigations or tests conducted was none. The outcome of the event ice pick headache was not recovered, and rest events outcome was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1780494 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210924; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101287321

Write-up: Upper back pain; Muscle pain; Shoulder pain; This is a spontaneous report from a contactable consumer or other non-health care professional received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109281621170440-SPTQU. A 20-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: FF8288), via an unspecified route of administration (at the age of 20-year-old), on 27Sep2021 as dose 2, single for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization on unspecified date. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 27Sep2021, the patient experienced muscle pain, shoulder pain. On 28Sep2021, experienced upper back pain. The patient underwent lab tests and procedures which included Covid-19 virus test: negative on 24Sep2021 no- negative COVID-19 test. The clinical outcome for the events was reported as not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1780501 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101287276

Write-up: tingling; Facial droop; Numbness facial; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). This is a report received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109281737451290-HDUA4. Safety Report Unique Identifier is GB-MHRA-ADR 26005949. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF8222), via an unspecified route of administration on 27Sep2021 (At the age of 38-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Sep2021 patient experienced tingling, facial droop, numbness facial. It was reported that numbness to the face started within 20 minutes. Within an hour the left side of his face was tingling. Within 3hrs the patient had started to show symptoms of drooping. The patient underwent lab tests which included covid-19 virus test: negative on an unspecified date, No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1780502 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Extra dose administered, Injection site scab, Lymph node pain, Lymphadenopathy, Off label use, Pain in extremity, SARS-CoV-2 test, Vaccination site pain
SMQs:, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101287235

Write-up: Swollen lymph nodes; Painful arm; Injection site pain; Injection site scab; Off label use; Extra dose administered.; Lymph node pain; This is a spontaneous report from a contactable consumer. received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109281746348750-F6UVR. Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 26005959. A 20-year-old female patient received third dose of BNT162B2 (Pfizer BioNTech covid-19 vaccine, Solution for injection, batch/lot number was not reported), via an unspecified route of administration on 26sep2021 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19; patient was not pregnant; patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Previously, the patient received first and second dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, Solution for injection, batch/lot number was not reported), via an unspecified route of administration on on an unknown date as single dose for COVID-19 immunization. On 27Sep2021, the patient experienced lymph node pain, on an unspecified date swollen lymph node, painful arm, injection site pain, injection site scab, off label use, extra dose administered. The patient underwent lab tests and procedures which included sars-cov-2 test negative no - negative COVID-19 test. The outcome of lymph node pain, swollen lymph nodes, painful arm, injection site pain, injection site scab was not recovered, off label use, extra dose administered was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1780523 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Interchange of vaccine products, Migraine, Myalgia, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...); SLE
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101287424

Write-up: fatigue; Fever; had vaccine 4pm; Migraine; Muscle pain; Fatigue extreme; Off label use; interchange of vaccine products; This is a spontaneous report from a contactable consumer received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109282053448050-ZKOWX, Safety Report Unique Identifier GB-MHRA-ADR 26007507. A 42-years-old non-pregnant female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/ lot number: not reported) via unknown route of administration on 27Sep2021 at 16:00 as single dose for COVID-19 immunisation. The patient''s medical history included rheumatoid arthritis (taking regular medicines for rheumatoid arthritis or other types of arthritis except osteoarthritis) and SLE (Systemic lupus erythematosus). The patient''s concomitant medications were not reported. Patient had previously received (COVID-19 VACCINE ASTRAZENECA, Solution for injection, Batch/ lot number: not reported) as first dose on 29Jan2021 and second dose in Apr2021. The patient previously took azathioprine, propranolol, hydroxychloroquine, ramipril and sertraline. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. On 28Sep2021 (after 1 day of vaccination), the patient experienced migraine (began at 20:00), muscle pain and fatigue extreme. On an unspecified date, patient experienced fatigue, fever and had vaccine 4pm. Events were medically significant. Patient had vaccine at 16:00, rest of the day was fine. Woke this morning with extreme muscle pain which had persisted. Fatigue all day and migraine began at 20:00 today (day after vaccine). Lab test on an unspecified date included COVID-19 virus test: negative. The outcome of migraine and fatigue extreme was not resolved and for events fatigue, fever and had vaccine 4pm was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


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