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From the 9/10/2021 release of VAERS data:

Found 686,636 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 162 out of 6,867

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VAERS ID: 1623674 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-02-01
Onset:2021-08-11
   Days after vaccination:191
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Chills, Cough, Headache, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none known
Current Illness: none known
Preexisting Conditions: none known
Allergies: none known
Diagnostic Lab Data: PCR + 8/20/2021
CDC Split Type:

Write-up: Client was vaccinated with Pfizer vaccines x 2 in February, 2021. Client not sure of dates. Attended a clinic for both vaccines. Client tested positive for Covid on 8/20/2021 with symptoms starting on 8/11. chills, runny nose, cough, fever, headache. Symptoms resolved as of 8/23. Reported as breakthrough Covid case in fully vaccinated person.


VAERS ID: 1623733 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-09
Onset:2021-08-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC 3180 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ejaculation failure
SMQs:, Sexual dysfunction (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: Klonopin
Current Illness: No illnesses within 2 years
Preexisting Conditions: Back and knee pain
Allergies: No known allergies
Diagnostic Lab Data: None this is a recent event and I''m not in any pain other than the noted problem.
CDC Split Type:

Write-up: Three days after the first dose of the pfizer vaccine I noticed that I could not ejaculate or partial ejaculation during intercourse. Before the vaccine shot I had no problems ejaculating. I have been having intercourse on an almost weekly basis and it seems too much of a coincidence that I''m having trouble ejaculating after the vaccine shot. I''m deeply troubled and regret taking the vaccine shot.


VAERS ID: 1623795 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Arm started to shake uncontrolably about an hour after taking it. It quit after an hour or so later.


VAERS ID: 1623851 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3081 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: Patient complaining of redness, soreness and swelling at the injection site


VAERS ID: 1624088 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Dizziness, Feeling hot, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: Pt. c/o of being heated, woozy, and nauseated after being in observation for 41 minutes. Pt reports she feels like anxiety caused her to feel this way. She reports she did not feel the same as she has in the past when she had an anaphylactic reaction. Pt. dc'' d home with ED precautions given.


VAERS ID: 1624175 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Anxiety, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: unknown
Current Illness: unknown
Preexisting Conditions: unknown
Allergies: shell fish
Diagnostic Lab Data: Observed in the ER for an hour and given steroids in the ER. Then discharged home.
CDC Split Type:

Write-up: started to develop generalized itching about 30 minutes after receiving vaccine. Started to feel anxious. No problems swallowing. No swelling noted. Gave her 50 mg of liquid Benadryl. Two nurses talked with her for 20 minutes. Did not need to use an epi pen. We drove her to the ER for an evaluation. a 5minute drive from our office. They gave her some steroids and observed her for one hour and then discharged her with two doses of steroids to take for the next two days. She did not need an epi pen in the ER. No other complications.


VAERS ID: 1624241 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA P02F21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Blood test normal, Blood thyroid stimulating hormone normal, Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram normal, Fatigue, Headache, Heart rate increased, N-terminal prohormone brain natriuretic peptide, Oxygen saturation decreased, Rash, SARS-CoV-2 test negative, Streptococcus test negative
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Olmesartan Dextroamphetamin
Current Illness: None
Preexisting Conditions: Hypertension
Allergies: Pine nuts Levaquin Abilify
Diagnostic Lab Data: EKG normal Covid 19 test negative Bloodwork all normal findings TSH AND ProBPN NT ok Strep test negative
CDC Split Type:

Write-up: Dizziness briefly moments after shot that subsided within a couple of minutes. Later that evening approximately 5:00p.m. I rapid heart beat, elevated BP of 157/94. The following day I developed a rash on my knee. Two days later I developed mild difficulty breathing, cotton feeling in my chest, my oxygen level dropped to 88 and I felt tired and had severe headache. Difficulty breathing lasted several days but has since subsided with the help of presides medication Ciproflxacin 500 mg. Was prescribed prednisone, albuteral, and cipro from clinic on 8/19/2021.


VAERS ID: 1624263 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: The patient MAY have received a dose of Janssen vaccine that was administered after the Beyond Use Date. The provider may have given the dose outside of the 6 hour window after the vial was opened. No symptoms or signs. Pt will be contacted and offered to be re-vaccinated to offer full protection, per our Medical Group.


VAERS ID: 1624306 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Nausea, Pain, Pyrexia, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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:

Write-up: Intense nausea, headache, fever, body chills/aches. These symptoms lasted about 2 or 3 hours and in the middle of this time frame lead to vomiting. Once I got fluids to stay down, my stomach settled and and nausea/vomiting stopped. I believe I had clear soda to settle my stomach along with a crushed up Tylenol. The body aches/chills lasted until I finally passed out and proceeded to sleep for about 12 hours. The next day was feeling okay just very sore and tired like I had done an extremely intense workout the day before. Two days after the reaction I was completely better again.


VAERS ID: 1624548 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-08-02
Onset:2021-08-11
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7489 / 1 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal distension, Haemorrhage, Muscle spasms, Postmenopausal haemorrhage
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: None.
Preexisting Conditions: I have Von Willebrand''s Disease Type 1
Allergies: I have Spring allergies (pollen, etc.) and sometimes hay fever.
Diagnostic Lab Data: Since the bleeding ended completely I have not seen a doctor about it. However, if it should return I will see my medical provider.
CDC Split Type:

Write-up: After I received the vaccine I felt fine for the first week. However, I started to have post-menopausal bleeding within the second week after receiving the vaccine. I had cramping, bloating, and bleeding. I was shocked since I haven''t had a period in about 20 months. The bleeding lasted about a week and a half and has now ended. I decided not to receive the second dose as I am afraid of any further bleeding.


VAERS ID: 1624838 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-06
Onset:2021-08-11
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Fear, Musculoskeletal chest pain
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/a
Current Illness: None
Preexisting Conditions: N/a
Allergies: Pencillan
Diagnostic Lab Data: On several occasions I?ve contemplated going to urgent care or somewhere to have a EKG performed but it?s not that easy or affordable to get medical attention and I?m trying to avoid a big medical bill from the ER, but this is not normal and I?m scared to get the second dose.
CDC Split Type:

Write-up: About 6-7 days after 1st dose I started having chest pains. It?s a constant/persistent pain that I?m still having. There is a tightness, very sore chest discomfort similar to a strained muscle, but I have not done any physical activity. Similar to heartburn without the indigestion. Pain directly between my breast sore even to the touch. Sometimes the pain is worse than others but it?s been pretty constant for about 12 days now.


VAERS ID: 1625041 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Axillary pain, Chills, Feeling hot, Headache, Injection site pain, Injection site pruritus, Lymphadenopathy, Malaise, Pain in extremity, Pain of skin, Piloerection, Sleep disorder, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: COVID19 Pfizer Vaccine (1st dose). I already reported the adverse events here in VAERS
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: Benzamycin gel
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Day of vaccination: Felt good all day. Night of vaccination: Very sore arm in middle of the night. Felt a little groggy in morning. 24 hours after vaccination: I''m usually cold when sitting at my work desk in my house, but I felt a little goosebumpy with chills, my skin hurt a little (like those slight body aches when you get sick but not a terrible feeling) and I felt a very very faint headache (more like groggy) Around 30 hours after vaccine: I felt warmish. Felt a little under the weather all evening, but mostly ok On the 2nd night after vaccine: Woke up several times at night with major pain in my left armpit. It made me afraid, as I did not know if this was something to do with my heart, since in my upper left arm. In the morning (second day after vaccine), i noticed an extremely swollen armpit lymph node. The ache subsided during the day, but the lymph node remained swollen for the week. I believe the swelling has significantly reduced by now. The injection site was very itchy and painful for approx 10 days. As of today (Day 13 after 2nd vaccination), my arm is still mildly painful if I press on it, but the pain is slowly subsiding.


VAERS ID: 1625965 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site pruritus, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BABY ASPIRIN; PREVACID
Current Illness: Alcohol use (One beer in the evening relaxes him and sometimes takes two.); Hard of hearing; Non-smoker; Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker user; COVID-19; Open heart surgery (10-11 years ago and they put a ring around mitral valve); Comments: The patient is taking medications for blood pressure, cholesterol, no illicit drug use
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210843366

Write-up: ITCHING THAT GOES UP AND DOWN THE INJECTION SITE; LOOKED LIKE A LITTLE CUT AND RED AROUND INJECTION (LIKE SOMEBODY TOOK A SHARP BLADE TO IT); THE MUSCLE ON THE LEFT ARM HURT THAT SOMETIMES GOES DOWN THE ARM A LITTLE OR GOES UP NEAR SHOULDER; VERY TIRED AND FATIGUE; BURNING THAT GOES UP AND DOWN THE INJECTION SITE; This spontaneous report received from a patient concerned an 85 year old male. The patient''s height, and weight were not reported. The patient''s past medical history included: open heart surgery, pace maker, and covid-19 infection, and concurrent conditions included: non-smoker, alcohol use, penicillin allergy, and hard of hearing, and other pre-existing medical conditions included: The patient is taking medications for blood pressure, cholesterol, no illicit drug use. The patient experienced itching, shortness of breath, swelling of throat and welts when treated with sulfamethoxazole/trimethoprim, and warfarin sodium. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. Concomitant medications included lansoprazole for gastroesophageal reflux disease, and acetylsalicylic acid. On 11-AUG-2021, the patient experienced itching that goes up and down the injection site. On 11-AUG-2021, the patient experienced looked like a little cut and red around injection (like somebody took a sharp blade to it). On 11-AUG-2021, the patient experienced the muscle on the left arm hurt that sometimes goes down the arm a little or goes up near shoulder. On 11-AUG-2021, the patient experienced very tired and fatigue. On 11-AUG-2021, the patient experienced burning that goes up and down the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from looked like a little cut and red around injection (like somebody took a sharp blade to it), itching that goes up and down the injection site, the muscle on the left arm hurt that sometimes goes down the arm a little or goes up near shoulder, very tired and fatigue, and burning that goes up and down the injection site. This report was non-serious.


VAERS ID: 1627913 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1826286 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: The patient MAY have received a dose of Janssen vaccine that was administered after the Beyond Use Date. The provider may have given the dose outside of the 6 hour window after the vial was opened. No symptoms or signs. Pt will be contacted and offered to be re-vaccinated to offer full protection, per our Medical Group.


VAERS ID: 1628103 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-05-25
Onset:2021-08-11
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Malaise, 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: Patient has been fully vaccinated as of 5/25/21, she is now symptomatic and has tested positive as of 8/16.


VAERS ID: 1628222 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Headache, Hyperhidrosis, Nausea, Pain, Purging, SARS-CoV-2 test negative, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Arthritis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Nothing!
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Covid PCR taken on August 20th 2021 confirmed that I am negative
CDC Split Type:

Write-up: I was violently purging 6 hours after the shot. I had extreme vertigo and continued throwing up the next day because of the vertigo. I was sweating nauseated for 4 days after. My body started aching 2 days after. And now I?m experiencing extreme joint pain and headaches, my symptoms are still current.


VAERS ID: 1628293 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206AZ1A / 1 - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Discomfort, Induration, Musculoskeletal discomfort, Musculoskeletal stiffness, Neck pain, Nodule, Skin warm
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine B12 Vit d Ocella
Current Illness: None
Preexisting Conditions: Hypothyroid Pcos B12
Allergies: Mold mildew horse dog versed
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hard warm lump about 2 inches in diameter still. Stiff neck pain same side on 8/21. Difficult to move Neck to same side as lump in arm. Still mild Neck discomfort. Chest pain night of 8/23. Hard lump causes discomfort. Might have to get it checked soon. Not sure how long this should last or if it''s just wait a long time


VAERS ID: 1628298 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Kansas  
Vaccinated:2020-12-22
Onset:2021-08-11
   Days after vaccination:232
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK5730 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1686 / UNK LA / IM

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Fatigue, SARS-CoV-2 test positive, Upper respiratory tract congestion
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Patient was fully vaccinated. 8/11/21 fatigue, cough and congestion. Tested positive for covid on 8/12/21


VAERS ID: 1628324 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angina pectoris, Cardiac discomfort, Pain
SMQs:, Other ischaemic heart disease (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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: Pending
CDC Split Type:

Write-up: A day after I could feel all the way up to 2 weeks (current) I could feel my heart. Heart had pain every now and then but mostly I can just feel it in my chest and I never could before the shot. A numb, type of feeling. It hurts sometimes when I turn a different way.


VAERS ID: 1628378 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Kansas  
Vaccinated:2021-05-17
Onset:2021-08-11
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / 2 AR / IM

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Diarrhoea, Headache, Respiratory tract congestion, SARS-CoV-2 test positive
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Patient is fully vaccinated. 8/11/2021- congestion/diarrhea/headache. 8/12/21- Tested positive for Covid


VAERS ID: 1628520 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-02-15
Onset:2021-08-11
   Days after vaccination:177
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9262 / 1 - / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6201 / 2 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Acute respiratory failure, Asthenia, COVID-19, Chest X-ray abnormal, Condition aggravated, Device occlusion, Fatigue, Haemoptysis, Infection, Oxygen saturation decreased, Pneumonia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: apixaban, ascorbic acid, aspirin, atorvastatin, benazepril, famotidine, fluticasone-salmeterol, furosemide, isosorbide mononitrate, metformin, metoprolol, niacin, pantoprazole, potassium citrate
Current Illness:
Preexisting Conditions: Hx PE, bell''s palsy, calculus of ureter, cataract, cellulitis, CKD stage 3, Chronic respiratory failure with hypoxia, COPD,CAD, cystitis, DM, Emphysema, GERD, Hyperlipidemia, HTN, HX MDRO, multiple pulmonary nodules, nephrolithiasis, obesity hypoventilation syndrome, OSA, hx malignant neoplasm of prostate, hx SOB, urethral stricture, unstable angina, vertigo, nephrostomies.
Allergies: Nitroglycerin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received both doses of the COVID 19 Pfizer vaccine (on 1/25/2021 and 2/15/2021). Pt presented to the ED on 8/11/2021 and tested positive for COVID-19. At first, he had only generalized non specific symptoms relating to COVID (weakness, fatigue), and treatment was focused on blocked nephrostomy tubes with infection. Starting on 8/14/2021, provider was notified that patient was having O2 desaturation to 83% and transient increases in O2 requirement (up to 10 L and then weaned to 6L). Diagnosed with acute hypoxic respiratory failure, experienced episodes of hemoptysis. Chest xray on 8/17 showed right upper lobe pneumonia. Pt started on dexamethasone remdesivir on 8/14/2021. Appears that COVID extended hospitalization but unsure by how many days. Discharged from hospital on 8/23/2021.


VAERS ID: 1628621 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 2 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Amnesia, Gait disturbance, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Staff reported patient entered facility on 08/11/2021 at approximately 0700, dragging right leg. At approximately 7:15am patient passed out for approximately 1 minute, She became alert within 1 minute but could not remember what happened. EMS was call, patient transferred to ER for further evaluation.


VAERS ID: 1628784 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenopia, Bradypnoea, Cold sweat, Confusional state, Cough, Decreased appetite, Feeling cold, Flank pain, Headache, Insomnia, Lichen planus, Muscle spasms, Myalgia, Neck pain, Oropharyngeal pain, Pain in extremity, Pruritus, Pyrexia, Rhinorrhoea, Sleep apnoea syndrome, Sneezing, Tinnitus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Adverse Effects- Muscle pain, Arm Pain, LICHEN PLANUS upper thigh area and other areas, stomach pain, tinnitus, headache, insomina, fever, cough, cold sweats, chills, runny nose, sneezing, sore throat, sleep apnea, bradypnea, strained eyes, itching, confusion, loss of appetite, flank pain, neck pain, neck spasms, upper leg spasms


VAERS ID: 1629077 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Bi- estrogen 0.625 mg. Atenolol 25 mg . Vitamin D and K2 omega 370 mg Saul Palmetto vitamin C echinacea DHA turmeric L lysine.
Current Illness: Checking for my exhaustion from the doctor.
Preexisting Conditions: Checking for my exhaustion from the doctor.High blood pressure.
Allergies: Penicillin
Diagnostic Lab Data: None!!
CDC Split Type:

Write-up: Received the shot and within one to two minute I was extreme dizzy to the point I had to Touch the side of the shelving because I thought for sure I was gonna pass out on the floor. I felt like I needed more oxygen is the reason I got up out of that chair the pharmacist had advised me to sit in. This extreme dizziness lasted for a few minutes and then I regain composure and left the store. No I did not tell anybody because they were very very busy and what could they do about dizziness nothing. I got into my car I drink my drink I went to the pool I swim for about an hour and a half of course I felt better during


VAERS ID: 1631063 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1082068 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Therapy non-responder
SMQs:, Lack of efficacy/effect (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: Cancer; Rheumatoid arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Heart attack (Twice.); Comments: The patient had no known drug allergies and was suffering from multiple ailments.
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: Antibody test; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210842984

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 74 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included that the patient had two heart attacks, and concurrent conditions included: cancer, and rheumatoid arthritis, and other pre-existing medical conditions included that the patient had no known drug allergies and was suffering from multiple ailments. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1082068 expiry: Unknown) dose was not reported, 1 total administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of reporting. On 11-AUG-2021, the patient visited her Infectious Disease doctor who carried out the COVID (Corona virus) antibody test which came out to be negative (confirmed immunological vaccine failure). The patient never had COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210842984-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1631110 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
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: USJNJFOC20210847204

Write-up: VACCINATED WITH THE JANSSEN COVID-19 VACCINE FOR THE 2ND TIME IN ABOUT 3 MONTHS; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) dose was not reported, administered on 04-MAY-2021, and dose was not reported, administered on 11-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-AUG-2021, the patient experienced vaccinated with the janssen covid-19 vaccine for the 2nd time in about 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccinated with the janssen covid-19 vaccine for the 2nd time in about 3 months was not reported. This report was non-serious.


VAERS ID: 1632016 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-08
Onset:2021-08-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Blood test abnormal, Computerised tomogram, Magnetic resonance imaging, Renal haemorrhage, Renal impairment, Renal surgery, Thrombosis, Ureteral disorder, Ureteral stent insertion, Ureteral stent removal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Benazepril Vitamin D Vitamin C
Current Illness: None
Preexisting Conditions: High Blood Pressure - mild
Allergies: None
Diagnostic Lab Data: CT scan (completed 8/12/21) Surgery (completed 8/13/21) Blood tests (numerous 8/12 - 8/13- 8/14 - 8-16 - 8/27) MRI (on August 30)
CDC Split Type:

Write-up: 3 days after vaccine (8/11/21) I had pain in my upper right abdominal in kidney area. Due to the pain, I had to go to ER. I was diagnosed with a blood clot in my ureter and scheduled for surgery the next day. I spent the night in the ER on pain medication and fluids. 8/12/21 I had surgery to remove blood clot from my kidney and identify why my kidney was bleeding. I also had a CT scan. Clot was removed. Identification of why my kidney was bleeding is still a mystery. A stent was inserted into my ureter. Since my blood tests were showing a kidney function of 30% I was forced to stay another night in the hospital. 8/13/20 Kidney started to perform better and I was released. 8/24/20 Ureter stent was removed during office procedure. More tests will be run to try to determine source of the problem.


VAERS ID: 1632223 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 2 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test abnormal, Chest X-ray, Chest pain, Computerised tomogram thorax, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control and multi vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: X-ray - no visible clots of lungs at the time, blood work abnormal then CT scan it didn?t show clots at this time. Was advised to continue monitoring and if signs reappear to come back to emergency room.
CDC Split Type:

Write-up: Shot on Tuesday Wednesday woke up fever abs throwing up, felt better then Saturday woke up with shortness of breath and chest pains went to emergency room.


VAERS ID: 1632314 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Migraine, Migraine with aura, Photophobia
SMQs:, Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal 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: 2 Tylenol 500mg and next day took 2 naproxen PM
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 15 minutes after receiving the 2nd covid shot, I instantly got a migraine. It lasted about 4 hours long and no medication took it away. I had to sleep it off. The next morning at 7:30 AM, my alarm went off for work and as soon as I opened my eyes, I had an aura in my vision and I got another migraine. I took 2 naproxen PMs so that I can sleep it off. The migraine lasted until 12:30PM that same day. The rest of the day I had a light headache and was very tired and sensitive to the light. It has been 2 weeks since my second shot and I have had 2 additional migraines. This is way more than I typically get and nothing helps. I have had migraines for the last 11 years and this is the most I have ever gotten. I had COVID-19 4 months ago and did not see an increase in migraines after having covid.


VAERS ID: 1632315 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-02-24
Onset:2021-08-11
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: COVID-19, Cough, Exposure to SARS-CoV-2, Nasopharyngitis, Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Everything was going great. My wife works for a nursing home. She tested positive for COVID. Since we sleep in the same room and everything, I ended up contracting COVID from her. I did not have a fever or problems breathing. I was having coughing and sneezing. I am getting over it right now. It has been getting better. I have more of a slight cough now and a little runny nose. Mostly I am doing much better than I was a week or two ago. I tested positive for COVID on 08/11. I was also tested on 08/04 and it was negative. I was feeling like I was coming down with a serious cold so I went to my PCP on 08/09. He had me do my test through the hospital. I recommend that everybody takes the vaccine when they are ready for it.


VAERS ID: 1632360 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA O66D21A / 1 RA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
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: unknown
Current Illness: none
Preexisting Conditions: none
Allergies: none noted
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Moderna Covid 19 Vaccine was administered to an underage person. No adverse reactions.


VAERS ID: 1632540 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-03-05
Onset:2021-08-11
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuterol HFA Casirivimab / Imdevimab
Current Illness: Metastatic colon cancer in female Malignant tumor of splenic flexure Hypercholesterolemia
Preexisting Conditions: Metastatic colon cancer in female Malignant tumor of splenic flexure Hypercholesterolemia
Allergies: Codeine, Latex
Diagnostic Lab Data: COVID-19 - Swab, Nasopharynx CXRAY
CDC Split Type:

Write-up: Patient is admitted to the hospital with Covid-19


VAERS ID: 1632646 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

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

Write-up: Patient states that arm has been in pain since the next day and that her hand is numb.


VAERS ID: 1632763 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-01-28
Onset:2021-08-11
   Days after vaccination:195
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032L20A / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASPIRIN, CALCIUM, CHOLECALCIFEROL, DONEPEZIL, FEXOFENADINE, FLONASE, LEVOTHYROXINE, LISINOPRIL, MONTELUKAST, OCUVITE, OXYBUTYNIN, PLAVIX, ROSUVASTATIN, TRAZODONE
Current Illness: UNKNOWN
Preexisting Conditions: CVA, HYPERTENSION, HYPERLIPIDEMIA, DEPRESSION, ANXIETY, HYPOTHYROIDISM
Allergies: NONE
Diagnostic Lab Data: 8/11/21 Abbott ID-NOW COVID-19 Virus Molecular Test Positive
CDC Split Type:

Write-up: COVID 19 DIAGNOSIS AND HOSPITALIZATION WHILE FULLY IMMUNIZED


VAERS ID: 1632838 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-08-09
Onset:2021-08-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cough, Fatigue, Headache, Pain in extremity, Pyrexia, Sinus pain, Sinusitis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin d, magnesium, zinc, multi-vitamin, fish oil, vitamin b complex, vitamin k, turmeric
Current Illness: none
Preexisting Conditions: no chronic health conditions
Allergies: wheat and dairy sensitivity
Diagnostic Lab Data: none
CDC Split Type:

Write-up: 2 day fever of 101, headache, deep dry cough for three days, fatigue, ongoing left arm deltoid pain, sinus pain and infection


VAERS ID: 1632905 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Montana  
Vaccinated:2021-03-29
Onset:2021-08-11
   Days after vaccination:135
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003B21A / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: apalutamide (ERLEADA) 60 mg tablet Take 4 tablets by mouth Daily. 11/17/20 cholecalciferol (VITAMIN D3) 50 mcg (2,000 units) capsule Take 1 capsule by mouth Daily . ELIQUIS 5 MG tablet TAKE 1 TABLET TWICE DAILY Patient taking diff
Current Illness: ? Acute respiratory failure (HCC) 1/2017 mechanically ventilated, pneumonia, influenza, CHF, possibly undiagnosed COPD all involved ? Colon polyps Adenomatous polyps ? Diastolic CHF (HCC) 1/2017 LVEF 60% on echo 1/2017; diastolic CHF while hospitalized ? Duodenal ulcer 1/2017 with GI bleeding while in hospital, treated endoscopically, H pylori negative ? DVT (deep venous thrombosis) (HCC) 11/2016 treated with apixaban ? Elevated troponin 1/2017 to $g 4, without EKG changes, symptoms or wall motion abnormalities on echo; low risk nuclear stress test 1/30/17 ? Esophageal dysmotility 1/2017 EGD and barium swallow findings suggestive of achalasia 1/2017 ? History of ITP treated with IVIG and prednisone April-June 2016 ? Hypertension ? Prostate cancer (HCC) ? Sarcoidosis
Preexisting Conditions: See section 11
Allergies: Latex
Diagnostic Lab Data: Ordered Test: SARS-CoV-2 RNA Resp Ql NAA+probe Ordered Test Codes: 94500-6 Status: Final Accession Number: 212230060LP-198922 Specimen Source: SOFT TISSUE SAMPLE Specimen Site: ENTIRE NASOPHARYNX(181200003) Specimen Collection Date/Time: 2021-08-11 11:23:00.0 Patient Status at Specimen Collection: Specimen Details:
CDC Split Type:

Write-up: Case completed 2 dose Covid vaccine series on 3/29/21, then was hospitalized for Covid pneumonia on 8/11/2021.


VAERS ID: 1632930 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 035C21A / 1 - / -

Administered by: Senior Living       Purchased by: ?
Symptoms: DNA antibody, Menstruation irregular
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nexplanon in place, Miralax
Current Illness: Strep pharyngitis on 7/20/21
Preexisting Conditions: NA
Allergies: NKDA
Diagnostic Lab Data: Pt has gonorrhea and chlamydia testing and vaginitis DNA probe testing pending.
CDC Split Type:

Write-up: Pt notes her menstrual period has gone on for 16 days, which is unusual for pt. Her period started on 8/9/21 and continues to today (8/25/21). Pt is worried that this could be r/t her COVID Vaccine that she got on 8/11/21. Pt''s Nexplanon was placed on April of 2021. It is unclear if this is r/t her recent Nexplanon placement vs other cause.


VAERS ID: 1633111 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-17
Onset:2021-08-11
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: School       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenia, Feeling of body temperature change, Headache, Pain in extremity, Sleep disorder, Throat irritation
SMQs:, Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: I took the first dose of Phizer vaccine and I had symptoms of getting hotness and being more tired than normally. After the second dose with the recommended wait time, I have pain in the legs, stomach, and arms. The beginning phase I also had hot and cold feeling where I could not sleep. I feel very weak with a headache. Additionally, I just felt my throat to bother me. Now, my son has similar symptoms a week after I experienced mine.


VAERS ID: 1633798 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-02-23
Onset:2021-08-11
   Days after vaccination:169
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6202 / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Positive COVID result on hospital admission despite fully vaccination Feb 2021


VAERS ID: 1636561 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Fatigue, Headache, Hyperhidrosis, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily vitamin
Current Illness: No
Preexisting Conditions: No
Allergies: Penicillin
Diagnostic Lab Data: 08/26/21 getting blood work done to see whats going on.
CDC Split Type: vsafe

Write-up: Nausea comes and go, fever for a couple of days, tired, sweating, and a headache.


VAERS ID: 1636631 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: California  
Vaccinated:2021-02-11
Onset:2021-08-11
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007M20A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood test normal, Chest pain, Computerised tomogram normal, Coronary artery dissection, Dizziness, Gait disturbance, Nausea, Paraesthesia, Surgery, Ultrasound kidney normal, Vision blurred
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Other ischaemic heart disease (narrow), 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? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: no
Allergies: Tracylines; Gluten
Diagnostic Lab Data: 08/11/2021-08/13/2021-Ct images, ultrasound of the kidneys, blood work all tests normal
CDC Split Type: vsafe

Write-up: On 08/11/2021-I had lightheadedness, chest pain, nausea, tingling in hands and feet, blurred vison, difficulty walking. On 08/11/2021 EMS took me to a Medical Center, had emergency surgery due to spontaneous Coronary artery dissection . I was in the hospital for 2 days.


VAERS ID: 1636696 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Kansas  
Vaccinated:2021-08-09
Onset:2021-08-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 023C21A / 1 - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: blood pressure - statin for cholesterol - Prostate medicine
Current Illness: none
Preexisting Conditions: none
Allergies: Pain medicine makes me anxious and depressed but that is not an allergy. I do have seasonal allergies that are normal and under control with zyrtec.
Diagnostic Lab Data:
CDC Split Type:

Write-up: I broke out in hives all through my sweat areas and my eyes. I thought it was poison ivy first and my doctor gave me an allergy shot on the afternoon of 8-12-21. 24 hours later everything flamed back up much worse and the early morning 1:00 AM of 8-14-21 I had to go to the emergency room. The doctor there gave me IV fluids and something the knocked me out for 12 hours along with prednisone. This calmed everything down to a scratching situation. She also advised me talk to the doctor before I took another vaccine shot. today is the 26th of August and I still have hives but they stay manageable with Zyrtec and Binadril.


VAERS ID: 1636751 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Balance disorder, Computerised tomogram, Dizziness, Fatigue, Feeling abnormal, Headache, Muscular weakness, Neck pain, Neuralgia, Pain in extremity, Urinary incontinence, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (narrow), Arthritis (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? Yes
Hospitalized? No
Previous Vaccinations: Tested for flu vaccine in 2020.....significant skin reaction
Other Medications: Synthroid 10 mg., Fluoxetine 40 mg., Zyrtex 10 mg.
Current Illness: None
Preexisting Conditions: None ER blook work, CT scan were all normal.
Allergies: Tested by allergist to the Moderna vaccine. No visible reaction. Allergic to many things: dairy, wheat, barely, onions, red dye, etc.
Diagnostic Lab Data: Doctor exam on August 24 Blood work, CT scan at ER on August 21, 2021
CDC Split Type:

Write-up: Nerve pain in back/arm/neck, loss of bladder control (twice), headache, brain fog, vertigo, dizziness, balance problems, weakness in leg muscles, fatigue


VAERS ID: 1636785 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Pain in extremity
SMQs:, Arthritis (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:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Day after vaccine, reported arm pain. On 8/25/21, patient reported she had been in a great deal of shoulder pain following vaccine administration so she went to the doctor. They recommended physical therapy to her and suggested she may eventually need an MRI (this has not been performed or scheduled). Treated with NSAIDs.


VAERS ID: 1636810 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-31
Onset:2021-08-11
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / UNK AR / IM

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
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: Pt with PMH schizophrenia and homelessness. Pt showed up at paper only mobile mass vax site. He had reported to staff he had no prior immunization for Covid-19?. Pt received dose 1 on 7/31/21. No ADRs were described during this immunization. Following manual entry of immunization into patients chart, it was discovered patient had previously received Pfizer on 3/1/21 (lot# EN6198; right arm) and 6/3/2021 (Lot#EW0173; left arm).


VAERS ID: 1637048 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-04-14
Onset:2021-08-11
   Days after vaccination:119
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Exposure to SARS-CoV-2, Fatigue, Rhinorrhoea, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/24/21 2nd dose 04/14/21 Diagnosed covid positive:08/17/21 Symptom onset:08/11/21 Exposure:community Symptoms:cough, fatigue,loss of smell/taste, runny nose.


VAERS ID: 1637079 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

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

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

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


VAERS ID: 1637083 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1826286 / 1 LA / IM

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

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

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


VAERS ID: 1637165 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049E21A / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erythema, Headache, Pain in extremity, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: metFORMIN HCL 500 MG; Pravastatin Sodium 40 MG; Clopidogrel 75 MG, hydroCHLOROthiazide 25 MG; Zyrtec 10MG; Alendronate Sodium 70 MG; Caltrate 600 Bone/Calcium + D Supplement; Centrum Silver Vitamin Women +50; Fish Oil 1000 mg.
Current Illness: Pre-diabetes; Menniere''s Disease; Seasonal Allergies
Preexisting Conditions: No
Allergies: Penicillen; Seasonal Allergies
Diagnostic Lab Data: None to date
CDC Split Type:

Write-up: 1. Pain in arm 2. Significant itching and redness 3. headaches No medical treatment other than but benadryl jel for itching and benadryl oral


VAERS ID: 1637239 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002F21A / 1 LA / IM

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

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

Write-up: Patient came in as a walk in to receive a Covid Vaccine with her father. She spoke English, but he spoke Spanish. She was translating to her father as I was counseling them regarding the vaccine. I asked the patient if she was 18 and she said, "yes." Her paperwork stated a 01 birthday. They were talking to each other as I was preparing vaccine and I am not sure what they were discussing. She stated that she understood all of the information. She waited the required 15 minutes and left with her father. As we were entering her vaccine into Web IZ we noticed her birthday was changed to a 04.


VAERS ID: 1638425 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-02
Onset:2021-08-11
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: I ended up at the er because I had severe hives all Over my body. It was on my legs, face, neck, vaginal, etc. I was prescribed 40 mg of prednisone for 5 days.


VAERS ID: 1640737 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-04-23
Onset:2021-08-11
   Days after vaccination:110
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abortion spontaneous, Ultrasound antenatal screen abnormal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

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

Write-up: Patient found that she had a miscarriage/intrauterine fetal demise at estimated 9wks gestational age, diagnosed by ultrasound performed 8/11/2021.


VAERS ID: 1640751 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-03-11
Onset:2021-08-11
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Groin pain, Lethargy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Osteonecrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Groin pain, lethargy, fever and hospitalized.


VAERS ID: 1640945 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-03
Onset:2021-08-11
   Days after vaccination:130
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6204 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cough, Fatigue, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: calcium carbonate (TUMS) 500 mg (200 mg calcium) chewable tablet doxycycline (VIBRAMYCIN) 100 mg capsule metoprolol tartrate (LOPRESSOR) 50 mg tablet olmesartan-hydroCHLOROthiazide (BENICAR HCT) 40-12.5 mg per tablet warfarin (COUMADIN)
Current Illness:
Preexisting Conditions: Nervous Pain in joint involving pelvic region and thigh Chronic midline low back pain without sciatica Circulatory Chronic atrial fibrillation (CMS/HCC) Hypertension Digestive Gastroesophageal reflux disease Genitourinary Overactive bladder Other Cardiac pacemaker in situ Long term (current) use of anticoagulants Incarcerated hernia
Allergies: LisinoprilCoughing
Diagnostic Lab Data: COVID-19 PCR
CDC Split Type:

Write-up: Cough Fatigue and Congestion or runny nose


VAERS ID: 1640946 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-05-03
Onset:2021-08-11
   Days after vaccination:100
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204AZ1A / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Back pain, Chest X-ray normal, Cough, Dyspnoea, Fibrin D dimer increased, Flank pain, Painful respiration, Pneumonia, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
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: HCTZ 25mg daily Diovan 80mg daly Ventolin inh 2 puffs Q4hrs prn SOA/wheezing
Current Illness: none
Preexisting Conditions: HTN
Allergies: NKDA
Diagnostic Lab Data: COVID positive 1/21 and Covid vaccine 5/21
CDC Split Type:

Write-up: on August 11, 2021 pt was cleaning out a horse stall and began having pain to his back and stabbing pain in his right side with breathing. Pt unable to lay down due to difficulty breathing. Pt was seen in the clinic on 8/14/21 and prescribed Flexeril 10mg prn, Toradol 60mg IM and Depomedrol 80mg IM. Pt was instructed on risk of PNA and PE and instrcuted to go to ER with worseing symptoms. Pt presented to my office on 8/20/21 with continued symptoms as above. I ordered a CXR which was negative adn a D-Dimer which was elevated at 1.5. Pt was instructed to go to the ER for further eval for a CTA chest to r/o PE and was found to have RLL PE and PNA. Pt was started on Eliquis 5mg BID, Norco 5/325mg QID prn pain, Mucinex DM 1 BID prn cough, Decadron 4mg daily for 10 days, Levaquin 500mg daily for 10 days and to f/u with PCP. I saw the pt in the office on 8/23/21 and ordered at BLE venous doppler and hematology referral


VAERS ID: 1641062 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-02-25
Onset:2021-08-11
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, COVID-19, Cough, Headache, Nasal congestion, Nausea, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: amLODIPine (NORVASC) 10 mg tablet busPIRone (BUSPAR) 15 mg tablet cetirizine (ZyrTEC) 10 mg tablet citalopram (CeleXA) 40 mg tablet clobetasoL (TEMOVATE) 0.05 % ointment diphenhydrAMINE-acetaminophen (TYLENOL PM) 25-500 mg tablet flut
Current Illness:
Preexisting Conditions: Respiratory Obstructive sleep apnea syndrome Circulatory Essential hypertension Digestive Gastroesophageal reflux disease without esophagitis Musculoskeletal Bilateral primary osteoarthritis of knee Primary osteoarthritis of right shoulder Polyarthritis Primary osteoarthritis of left shoulder Endocrine/Metabolic Mixed hyperlipidemia Other Mixed anxiety and depressive disorder Encounter for long-term (current) use of medicatio
Allergies: NKA
Diagnostic Lab Data: Updated Procedure 08/18/21 0500 COVID-19 (SARS CoV-2 RNA, RT-PCR) Collected: 08/16/21 0000 | Final result | Specimen: Swab from Nasopharynx COVID-19 POSITIVEAbnormal
CDC Split Type:

Write-up: Nausea ? Nasal Congestion ? loss of taste ? Headache ? Cough


VAERS ID: 1641072 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Chest discomfort, Deafness, Dizziness, Dysgeusia, Ear discomfort, Ear pain, Fatigue, Headache, Intermenstrual bleeding, Nausea, Pain in extremity, Pyrexia, Respiratory tract congestion, Sleep disorder, Tinnitus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Broth control Vit D Fish oil
Current Illness: None
Preexisting Conditions: IGA Neuropathy
Allergies: Gluten Allergy Sulfur
Diagnostic Lab Data: Dr visit
CDC Split Type:

Write-up: 10 minutes after shot metallic taste in mouth, sore arm Wed 8/11 /2021 2am Woke up both ears were ringing Then immediately plugged Blocked ears Breakthrough menstrual bleeding Headache Fever Tired but couldn?t sleep Wed 8/11/21 afternoon: Ears become completely blocked, couldn?t hear at all for a few seconds, ringing, whooshing sound like air is being blown into them and then they go back to being plugged Low grade fever, headache, very sore arm, plugged ears Very tired woke up 2am Thur 8/12/21 Arm better Ears plugged Extremely Tired Headache pm Pounding left side/tightness chest Fri 8/13/2021 5am Headache If I Lay flat- get very nauseous, light headed Am: When Walking-pounding/tightness left side of chest Both thighs very sore Saw my primary dr in the afternoon because of these symptoms Saturday 8/14-Wednesday 8/18/21 Very congested, issues with left ear, dizzy at times 8/26/2021 Achey joints at night- knees, ankles, legs, still getting dizzy at times, left ear pain at times


VAERS ID: 1641073 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Nevada  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 25ug Synthroid daily
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, aches, headache, fatigue


VAERS ID: 1641077 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-02-26
Onset:2021-08-11
   Days after vaccination:166
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6201 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Diarrhoea, Nausea, Rhinorrhoea, SARS-CoV-2 test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: acetaZOLAMIDE (DIAMOX) 250 mg tablet ascorbic acid, vitamin C, (VITAMIN C) 500 mg CR tablet aspirin 81 mg tablet biotin 5,000 mcg tablet,disintegrating calcium polycarbophiL (FIBER, CALCIUM POLYCARBOPHIL,) 625 mg tablet calcium-vitamin
Current Illness:
Preexisting Conditions: Nervous Acute myringitis Genitourinary Dysplasia of cervix
Allergies: NKA
Diagnostic Lab Data: Updated Procedure 08/19/21 0711 COVID-19 (SARS CoV-2,RNA Molecular Amplification) Collected: 08/18/21 0909 | Final result | Specimen: Swab COVID-19 SARS-CoV-2 Overall Result DetectedCritical 08/19/21 0711 COVID-19 PCR Collected: 08/18/21 0909 | Final result | Specimen: Swab
CDC Split Type:

Write-up: Congestion or runny nose, Nausea or vomiting and Diarrhea


VAERS ID: 1641210 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: New York  
Vaccinated:2021-08-09
Onset:2021-08-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / -

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

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

Write-up: Rash


VAERS ID: 1644695 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoacusis, Intermenstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Noticed spotting/her cycle is due beginning of September/spotting continued until the evening; Earing a little bit cloudy; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (Noticed spotting/her cycle is due beginning of September/spotting continued until the evening) and HYPOACUSIS (Earing a little bit cloudy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced INTERMENSTRUAL BLEEDING (Noticed spotting/her cycle is due beginning of September/spotting continued until the evening) and HYPOACUSIS (Earing a little bit cloudy). At the time of the report, INTERMENSTRUAL BLEEDING (Noticed spotting/her cycle is due beginning of September/spotting continued until the evening) and HYPOACUSIS (Earing a little bit cloudy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. No treatment medication was provided.


VAERS ID: 1644723 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-01-08
Onset:2021-08-11
   Days after vaccination:215
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011J20A / 1 - / OT

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

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

Write-up: Patient accidentally received a third dose of the Moderna covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient accidentally received a third dose of the Moderna covid-19 vaccine) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Patient accidentally received a third dose of the Moderna covid-19 vaccine). On 11-Aug-2021, EXTRA DOSE ADMINISTERED (Patient accidentally received a third dose of the Moderna covid-19 vaccine) had resolved. no medical history was reported no concomitant medication were reported no treatment medication were reported Patient accidentally received a third dose on 11 Aug 2021


VAERS ID: 1644736 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Alabama  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: COVID test negative
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Rash on the injected arm after second dose and later traveled to the right arm; Fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after second dose) and RASH (Rash on the injected arm after second dose and later traveled to the right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced PYREXIA (Fever after second dose). On an unknown date, the patient experienced RASH (Rash on the injected arm after second dose and later traveled to the right arm). At the time of the report, PYREXIA (Fever after second dose) and RASH (Rash on the injected arm after second dose and later traveled to the right arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: negative (Negative) COVID test negative. No concomitant medication reported. No treatment medication reported. Expiration Date of both dose was unknown . Patient took second dose on AUG 2021 .


VAERS ID: 1644740 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-22
Onset:2021-08-11
   Days after vaccination:142
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012A21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Product dose omission issue
SMQs:, Medication errors (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.MOD20212

Write-up: Has not received the second dose $g 4 months after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received the second dose $g 4 months after the first dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose $g 4 months after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the second dose $g 4 months after the first dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Patient decided not to get the second shot. On 11 Aug 2021, she walked in to this pharmacy and presented her vaccination card and she is requesting to get the second shot. No treatment information was provided.


VAERS ID: 1644745 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Illinois  
Vaccinated:2020-12-29
Onset:2021-08-11
   Days after vaccination:225
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026L20A / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhage, Skin injury
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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: MULTIVITAMIN [VITAMINS NOS]; VITAMIN D2; VITAMIN B12 NOS; ALLEGRA; WIXELA INHUB; FLONASE [FLUTICASONE PROPIONATE]
Current Illness: Environmental allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: experienced sudden bleeding in lower leg like artery is broken; open skin 1mmx 1mm, small opening needle-stick like; This spontaneous case was reported by a physical therapist and describes the occurrence of HAEMORRHAGE (experienced sudden bleeding in lower leg like artery is broken) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Environmental allergy. Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D2, VITAMIN B12 NOS, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication. On 29-Dec-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced HAEMORRHAGE (experienced sudden bleeding in lower leg like artery is broken) (seriousness criterion medically significant) and SKIN INJURY (open skin 1mmx 1mm, small opening needle-stick like). The patient was treated with NAPROXEN SODIUM (ALEVE) on 10-Aug-2021 for Headache, at a dose of 220 mg. At the time of the report, HAEMORRHAGE (experienced sudden bleeding in lower leg like artery is broken) and SKIN INJURY (open skin 1mmx 1mm, small opening needle-stick like) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication reported, as centrum. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested


VAERS ID: 1644758 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002F21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bone pain, SARS-CoV-2 test
SMQs:, 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: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: COVID-19; Test Result: Positive ; Result Unstructured Data: had COVID-19
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Bones were aching,especially at my joints; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bones were aching,especially at my joints) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The patient''s past medical history included COVID-19 in April 2021. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced BONE PAIN (Bones were aching,especially at my joints). At the time of the report, BONE PAIN (Bones were aching,especially at my joints) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: positive (Positive) had COVID-19. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.


VAERS ID: 1644780 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Kansas  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007021A / 1 - / OT

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

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

Write-up: 16 Year old patient given 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (16 Year old patient given 1st dose) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007021A) for COVID-19 vaccination. No Medical History information was reported. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced OFF LABEL USE (16 Year old patient given 1st dose). On 11-Aug-2021, OFF LABEL USE (16 Year old patient given 1st dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment and concomitant drugs were provided. Reporter did not allow further contact.


VAERS ID: 1644786 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-15
Onset:2021-08-11
   Days after vaccination:118
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078L21A / 1 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0164 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Feeling abnormal, Headache, Interchange of vaccine products, Lymphadenopathy, Myalgia, Nausea, Pain, Pain of skin, Product administered to patient of inappropriate age, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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.MOD20212

Write-up: Received pfizer vaccine; Vaccine received by a patient under 18 years of age; Swollen lymph nodes; Pains; Skin was hurting; Fuzzy headed; Started to get tired; Headaches; Injection site pain; Fever/low-grade fever/warm to touch/ fever has ranged between 101-102 Fahrenheit; Nausea; Aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains), PAIN OF SKIN ("skin was hurting"), FEELING ABNORMAL ("fuzzy headed"), FATIGUE ("started to get tired") and HEADACHE (headaches) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078l21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PAIN (pains), PAIN OF SKIN ("skin was hurting"), FEELING ABNORMAL ("fuzzy headed"), FATIGUE ("started to get tired"), HEADACHE (headaches), VACCINATION SITE PAIN (injection site pain), PYREXIA (FEVER/low-grade fever/warm to the touch/ fever has ranged between 101-102 Fahrenheit), NAUSEA (nausea) and MYALGIA (aches). On 12-Aug-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received pfizer vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine received by a patient under 18 years of age). At the time of the report, PAIN (pains), PAIN OF SKIN ("skin was hurting"), FEELING ABNORMAL ("fuzzy headed"), FATIGUE ("started to get tired"), HEADACHE (headaches), VACCINATION SITE PAIN (injection site pain), PYREXIA (FEVER/low-grade fever/warm to the touch/ fever has ranged between 101-102 Fahrenheit), NAUSEA (nausea), MYALGIA (aches) and LYMPHADENOPATHY (swollen lymph nodes) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (received pfizer vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine received by a patient under 18 years of age) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product information was not provided. The patient was treated with Tylenol (dosed every 6 hours). On 11-Aug-2021 around 10:45 AM, the patient was supposed to be given a Hepatitis B vaccine as a school requirement, but instead, the patient was given the Moderna COVID-19 vaccine. Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Added events : started to get tired" and "fuzzy headed, headaches, "skin was hurting",having a low-grade fever (warm to the touch)/fever/ fever has ranged between 101-102 Fahrenheit, nausea, aches and pains,enausea, swollen lymph nodes. All new events having outcome unknown. treatment was added. Co-suspect drug dosage information was added.


VAERS ID: 1644814 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: 17 year old pregnant patient that was given her first dose; 17 year old pregnant patient that was given her first dose; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (17 year old pregnant patient that was given her first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old pregnant patient that was given her first dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Aug-2021, the patient experienced EXPOSURE DURING PREGNANCY (17 year old pregnant patient that was given her first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old pregnant patient that was given her first dose). At the time of the report, EXPOSURE DURING PREGNANCY (17 year old pregnant patient that was given her first dose) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old pregnant patient that was given her first dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication details were reported. No treatment medication details was reported. Company Comment: This is a case of product exposure during pregnancy and inappropriate age at vaccine administration with no associated AEs for this 17-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy; Sender''s Comments: This is a case of product exposure during pregnancy and inappropriate age at vaccine administration with no associated AEs for this 17-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.


VAERS ID: 1644826 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 002F21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Feeling hot, Myalgia, Peripheral swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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? 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.MOD20212

Write-up: her arm felt hot; arm swollen; red; very sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (her arm felt hot), PERIPHERAL SWELLING (arm swollen), ERYTHEMA (red) and MYALGIA (very sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced FEELING HOT (her arm felt hot), PERIPHERAL SWELLING (arm swollen), ERYTHEMA (red) and MYALGIA (very sore). At the time of the report, FEELING HOT (her arm felt hot), PERIPHERAL SWELLING (arm swollen) and MYALGIA (very sore) outcome was unknown and ERYTHEMA (red) had resolved. No concomitant medication was provided No treatment received by the patient


VAERS ID: 1644952 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Discomfort, Headache, Intentional dose omission, Limb discomfort, Vaccination complication
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: USMODERNATX, INC.MOD20212

Write-up: she won''t be getting the second dose of the vaccine; chills; headaches; side effects that she is not comfortable with; "Everything it''s sticking to me and I don''t like it at all" ? to her arm and forehead.; she laid down on her phone and it got stuck to her arm; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (side effects that she is not comfortable with), VACCINATION COMPLICATION ("Everything it''s sticking to me and I don''t like it at all" ? to her arm and forehead.), LIMB DISCOMFORT (she laid down on her phone and it got stuck to her arm), INTENTIONAL DOSE OMISSION (she won''t be getting the second dose of the vaccine) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced DISCOMFORT (side effects that she is not comfortable with), VACCINATION COMPLICATION ("Everything it''s sticking to me and I don''t like it at all" ? to her arm and forehead.), LIMB DISCOMFORT (she laid down on her phone and it got stuck to her arm), CHILLS (chills) and HEADACHE (headaches). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (she won''t be getting the second dose of the vaccine). At the time of the report, DISCOMFORT (side effects that she is not comfortable with), VACCINATION COMPLICATION ("Everything it''s sticking to me and I don''t like it at all" ? to her arm and forehead.), LIMB DISCOMFORT (she laid down on her phone and it got stuck to her arm), INTENTIONAL DOSE OMISSION (she won''t be getting the second dose of the vaccine), CHILLS (chills) and HEADACHE (headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not reported.


VAERS ID: 1644978 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-01-09
Onset:2021-08-11
   Days after vaccination:214
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 012L20A / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Chills, Drug ineffective, Pyrexia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Tested positive for Covid-19
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: feeling feverish fever reached 101F; Chills; Tested positive for Covid-19/tested positive after 6 months; tested positive after 6 months; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19/tested positive after 6 months), DRUG INEFFECTIVE (tested positive after 6 months), PYREXIA (feeling feverish fever reached 101F) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced COVID-19 (Tested positive for Covid-19/tested positive after 6 months) and DRUG INEFFECTIVE (tested positive after 6 months). On an unknown date, the patient experienced PYREXIA (feeling feverish fever reached 101F) and CHILLS (Chills). At the time of the report, COVID-19 (Tested positive for Covid-19/tested positive after 6 months), PYREXIA (feeling feverish fever reached 101F) and CHILLS (Chills) had resolved and DRUG INEFFECTIVE (tested positive after 6 months) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19. Treatment medication was not provided. Concomitant medication was not provided. Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Live Follow up received on 13-Aug-2021, event information updated


VAERS ID: 1645009 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-07
Onset:2021-08-11
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 009D21A / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Hyperhidrosis, Pruritus, Vaccination site erythema, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: fatigue; Redness left arm; Sore left arm; joint pain left hip; itchy in the back; sweats; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy in the back), HYPERHIDROSIS (sweats), the first episode of FATIGUE (fatigue), the second episode of FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (Redness left arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A and 009D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced PRURITUS (itchy in the back), HYPERHIDROSIS (sweats) and the first episode of FATIGUE (fatigue). On 12-Aug-2021, the patient experienced the second episode of FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Redness left arm) and VACCINATION SITE PAIN (Sore left arm). 12-Aug-2021, the patient experienced ARTHRALGIA (joint pain left hip). At the time of the report, PRURITUS (itchy in the back), HYPERHIDROSIS (sweats), the last episode of FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (Redness left arm), VACCINATION SITE PAIN (Sore left arm) and ARTHRALGIA (joint pain left hip) outcome was unknown. No Concomitant medication was reported. No treatment was reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious. Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The company physician considers the reported events as non-serious, because there is no apparent rationale to deal them as serious.


VAERS ID: 1645010 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-07-21
Onset:2021-08-11
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, COVID-19, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210813; Test Name: body temperature; Result Unstructured Data: 99.9 Fahrenheit; Test Date: 20210811; Test Name: rapid test for covid; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: rapid test that was positive for COVID-19; having temperature/temperature of 99.9?F; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (rapid test that was positive for COVID-19) and PYREXIA (having temperature/temperature of 99.9?F) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PYREXIA (having temperature/temperature of 99.9?F). On 11-Aug-2021, the patient experienced COVID-19 (rapid test that was positive for COVID-19). At the time of the report, COVID-19 (rapid test that was positive for COVID-19) and PYREXIA (having temperature/temperature of 99.9?F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. On 13-Aug-2021, Body temperature: 99.9 (High) 99.9 Fahrenheit. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. It was reported that patient had a polymer chain reaction (PCR) test and result pending at the time of this report. No treatment information was provided.


VAERS ID: 1645018 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011D2NA / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysgeusia, Fatigue, Feeling abnormal, Gait disturbance, Headache, Myalgia, Pain, Peripheral swelling, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: COVID test negative
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: little headache; I could barely lift my left arm; could barely walk; arm swollen; brain fog like I was out of it; metal taste in mouth; whole body hurt; muscle ache; so tired; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could barely walk), PERIPHERAL SWELLING (arm swollen), FEELING ABNORMAL (brain fog like I was out of it), DYSGEUSIA (metal taste in mouth) and PAIN (whole body hurt) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D2NA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PAIN (whole body hurt), MYALGIA (muscle ache) and FATIGUE (so tired). On 12-Aug-2021, the patient experienced GAIT DISTURBANCE (could barely walk), PERIPHERAL SWELLING (arm swollen), FEELING ABNORMAL (brain fog like I was out of it), DYSGEUSIA (metal taste in mouth) and VACCINATION SITE PAIN (I could barely lift my left arm). On 13-Aug-2021, the patient experienced HEADACHE (little headache). At the time of the report, GAIT DISTURBANCE (could barely walk), PERIPHERAL SWELLING (arm swollen), FEELING ABNORMAL (brain fog like I was out of it), DYSGEUSIA (metal taste in mouth), PAIN (whole body hurt), VACCINATION SITE PAIN (I could barely lift my left arm), MYALGIA (muscle ache), HEADACHE (little headache) and FATIGUE (so tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, SARS-CoV-2 test: negative (Negative) COVID test negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were provided by reporter. No treatment medication were provided by reporter. Patient felt stuck on left arm and chest. Patient felt better on 13-Aug-2021. The patient felt that whole body was hurt on 12-Aug-2021. Reporter did not allow further contact


VAERS ID: 1645070 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 035C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dysphonia, Oropharyngeal pain
SMQs:, Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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: METOPROLOL; SIMVASTATIN; CLOPIDOGREL; BABY ASPIRIN; AMLODIPINE
Current Illness: Drug allergy (Flagyl); Drug allergy (cephamycin); Penicillin allergy (Penicillin)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: started getting a bad sore throat/it was like I was getting a cold, like strep throat/still had a sore throat/where my Adam''s apple is, it feels a little sore; voice dropped about 2 degrees/voice dropped way down/voice felt different; hurt my right shoulder/shoulder is achy; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (started getting a bad sore throat/it was like I was getting a cold, like strep throat/still had a sore throat/where my Adam''s apple is, it feels a little sore), DYSPHONIA (voice dropped about 2 degrees/voice dropped way down/voice felt different) and ARTHRALGIA (hurt my right shoulder/shoulder is achy) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (cephamycin), Drug allergy (Flagyl) and Penicillin allergy (Penicillin). Concomitant products included METOPROLOL, SIMVASTATIN, CLOPIDOGREL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and AMLODIPINE for an unknown indication. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced ARTHRALGIA (hurt my right shoulder/shoulder is achy). On 12-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (started getting a bad sore throat/it was like I was getting a cold, like strep throat/still had a sore throat/where my Adam''s apple is, it feels a little sore) and DYSPHONIA (voice dropped about 2 degrees/voice dropped way down/voice felt different). At the time of the report, OROPHARYNGEAL PAIN (started getting a bad sore throat/it was like I was getting a cold, like strep throat/still had a sore throat/where my Adam''s apple is, it feels a little sore), DYSPHONIA (voice dropped about 2 degrees/voice dropped way down/voice felt different) and ARTHRALGIA (hurt my right shoulder/shoulder is achy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided by the reporter.


VAERS ID: 1645103 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood urine present, Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Also spotted medium bright red blood in his urine; Blood and several small dark clots in his stool and it happened 3 times during the day; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood and several small dark clots in his stool and it happened 3 times during the day) and BLOOD URINE PRESENT (Also spotted medium bright red blood in his urine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included CELECOXIB for an unknown indication. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced HAEMATOCHEZIA (Blood and several small dark clots in his stool and it happened 3 times during the day) (seriousness criterion medically significant). On 12-Aug-2021, the patient experienced BLOOD URINE PRESENT (Also spotted medium bright red blood in his urine) (seriousness criterion medically significant). The patient was treated with OMEGA-3 FATTY ACIDS ongoing since an unknown date for Blood in stool and Blood in urine, at a dose of 1 dosage form; CYANOCOBALAMIN (VITAMIN B-12) ongoing since an unknown date for Blood in stool and Blood in urine, at a dose of 1 dosage form and UBIDECARENONE (CO Q-10) ongoing since an unknown date for Blood in stool and Blood in urine, at a dose of 1 dosage form. At the time of the report, HAEMATOCHEZIA (Blood and several small dark clots in his stool and it happened 3 times during the day) and BLOOD URINE PRESENT (Also spotted medium bright red blood in his urine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Additional concomitant product used included a garlic tablet, supplements to treat the symptoms, unspecified medications for anxiety and pain, two inhalers, a nasal inhaler and an allergy medication. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1645122 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-12
Onset:2021-08-11
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030B21A / 1 RA / OT

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

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

Write-up: rash across his chest and under his arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash across his chest and under his arms) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced RASH (rash across his chest and under his arms). At the time of the report, RASH (rash across his chest and under his arms) had resolved. No concomitant medication were provided by the reporter. Patient used cerave cream as treatment medication for the rash and it worked. This case was linked to MOD-2021-286916 (Patient Link). Reporter did not allow further contact


VAERS ID: 1645143 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Anosmia, Bronchitis, Chest pain, Cough, Dyspnoea, Ear pain, Eye swelling, Fatigue, Hyperhidrosis, Pain, Pharyngeal swelling, Pyrexia, Sinusitis, Swelling face, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to antibiotic (Cipro); Crohn''s disease; Drug allergy (Zofran); Drug allergy (Chlorophyl); Sulfonamide allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Ileostomy (Ileostomy placed prior to receiving vaccination.); Perianal abscess (Due to Crohn''s)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Bronchitis; Occasional cough; Sweaty; Sinus infection; ear infection; Burning pain on left ear; Chest pain; Eyes swelling; Face swelling; Throat swelling; Difficulty breathing; No taste; No smell; Vomiting; Fatigue; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection) and EAR PAIN (ear infection) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Perianal abscess (Due to Crohn''s) and Ileostomy (Ileostomy placed prior to receiving vaccination.) in February 2021. Concurrent medical conditions included Sulfonamide allergy, Allergy to antibiotic (Cipro), Drug allergy (Zofran), Drug allergy (Chlorophyl) and Crohn''s disease. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection), EAR PAIN (ear infection), PAIN (Burning pain on left ear), CHEST PAIN (Chest pain), EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), PHARYNGEAL SWELLING (Throat swelling), DYSPNOEA (Difficulty breathing), AGEUSIA (No taste), ANOSMIA (No smell), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, BRONCHITIS (Bronchitis), COUGH (Occasional cough), HYPERHIDROSIS (Sweaty), SINUSITIS (Sinus infection), EAR PAIN (ear infection), PAIN (Burning pain on left ear), CHEST PAIN (Chest pain), EYE SWELLING (Eyes swelling), SWELLING FACE (Face swelling), PHARYNGEAL SWELLING (Throat swelling), DYSPNOEA (Difficulty breathing), AGEUSIA (No taste), ANOSMIA (No smell), VOMITING (Vomiting), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient reported that she had been in and out of the hospital due to perianal abscesses and was diagnosed with Crohn''s disease. She also mentioned that she currently has an ileostomy bag that was placed in February of 2021 due to her disease. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. further information has been requested.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. further information has been requested.


VAERS ID: 1646979 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101033807

Write-up: one side of face swollen; hives to one side of her face; This is a spontaneous report from a contactable consumer. This contactable consumer reported that a 16-year-old female patient (reporter''s daughter) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine) at right arm at single dose for COVID-19 immunisation on 10Aug2021 at 3:45 pm (16-year-old at the time of vaccination). Relevant history was none. Relevant concomitant drug was none. The patient woke up with one side of face swollen with hives at the next morning (11Aug2021). The mother told her to take Benadryl and she had taken that so far. The patient had gone to a clinic. The outcome of events was not resolved; the hives and swelling to one side of her face were worsened. Relevant lab test was none. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647023 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-03-29
Onset:2021-08-11
   Days after vaccination:135
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205, ER8730 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210808; Test Name: Nasal Swab; Result Unstructured Data: Test Result: Negative; Test Date: 20210811; Test Name: Nasal Swab; Result Unstructured Data: Test Result: Positive.
CDC Split Type: USPFIZER INC202101035218

Write-up: This is a spontaneous report from a contactable consumer or other non hcp. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205, ER8730, Expiry date: unknown), via an unspecified route of administration on 29Mar2021 as dose number unknown, single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered. The patient medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient not received any other vaccines within 4 weeks and 2 weeks prior to the COVID vaccine. On 08Aug2021, the patient underwent lab tests and procedures which included sars-cov-2 test was negative. On 11Aug2021, the patient got tested and received a positive diagnosis for COVID-19 (medically significant) and Drug Ineffective, due to which as a result of event patient had doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 11Aug2021. It was reported that patient was not prolonged hospitalization and no treatment received. The clinical outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1647035 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-03-01
Onset:2021-08-11
   Days after vaccination:163
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: Positive rapid antigen Covid test; Test Result: Positive; Comments: Positive rapid antigen Covid test following full vaccination.
CDC Split Type: USPFIZER INC202101035624

Write-up: This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Mar2021 as DOSE 2, SINGLE and received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported) dose 1 via an unspecified route of administration on Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was tested positive on 11Aug2021. Full vaccination (2 doses) completed in Mar2021. It was symptomatic, not hospitalized. Event took place after use of product. The patient underwent lab tests and procedures which included sars-cov-2 test, positive on 11Aug2021. Positive rapid antigen Covid test following full vaccination. The outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647040 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-03-26
Onset:2021-08-11
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: Nasal Swab; Test Result: Positive.
CDC Split Type: USPFIZER INC202101035809

Write-up: This is a spontaneous report from contactable consumer. A 29-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6199) intramuscularly, administered in Arm Right on 04Mar2021 12:00 as single dose and dose 2 intramuscularly, administered in Arm Left on 26Mar2021 12:00 (Batch/Lot Number: EP7533) as single dose (at the age of 29-years-old) for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 11Aug2021, patient experienced breakthrough Infection, patient tested positive for COVID 19. AE resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The patient underwent lab tests and procedures which included sars-cov-2 test, positive on 09Aug2021 Nasal swab. The outcome of the events was resolving. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1647073 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Overdose, Platelet factor 4, Product preparation error
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PHENTERMINE
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment: none
Allergies:
Diagnostic Lab Data: Test Name: Antibody test to Platelet factor IV; Result Unstructured Data: Test Result:Unknown
CDC Split Type: USPFIZER INC202101040654

Write-up: was administered the entire vial of the vaccine undiluted; was administered the entire vial of the vaccine undiluted; tired; This is a spontaneous report from a contactable Other HCP. A 35-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the right deltoid on 10Aug2021 (Batch/Lot Number: EW0191; Expiration Date: 30Sep2021) as single dose (at age of 35 years old) for prevention of COVID infection. There was no relevant medical history. Concomitant medication(s) included phentermine (PHENTERMINE) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received her first dose of BNT162b2 on 19Jul2021 (Batch/lot number:EW0191, Expiration: 30Sep2021) for COVID-19 immunisation. On 10Aug2021, the patient was administered the entire vial of the vaccine undiluted (overdose). The patient reported she felt really tired the next day (11Aug2021), but she did not need treatment or medical care. The outcome of the event was unknown.


VAERS ID: 1647128 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: Body temperature; Result Unstructured Data: Test Result:fever that didn''t go over 99.9F yesterday Fahrenheit; Comments: fever that didn''t go over 99.9F yesterday
CDC Split Type: USPFIZER INC202101041810

Write-up: had a sore arm; and a fever that didn''t go over 99.9F yesterday; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Aug2021 (at the age of 39-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 11Aug2021, the patient experienced had a sore arm, and a fever that didn''t go over 99.9f yesterday. The patient underwent lab tests and procedures which included body temperature: fever that didn''t go over 99.9f yesterday fahrenheit on 11Aug2021 fever that didn''t go over 99.9F yesterday. The outcome of the events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647133 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-02-16
Onset:2021-08-11
   Days after vaccination:176
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3247 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: Nasal Swab; Test Result: Positive; Comments: Positive COVID19 PCR test.
CDC Split Type: USPFIZER INC202101041906

Write-up: This is a spontaneous report from a contactable Nurse. This Nurse reported for a 24-year-old female patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Solution for injection, Batch/Lot number EL3247, Expiration date: Not reported), dose 2 intramuscular, administered in Arm Left on 16Feb2021 as DOSE 2, SINGLE and BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number EL3247, Expiration date: Not reported), dose 1 intramuscular, administered in Arm Left on 26Jan2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 11Aug2021 patient experienced positive covid19 PCR test on 11Aug2021. The patient underwent lab tests which included covid-19 positive on 11Aug2021. Positive COVID19 PCR test Nasal Swab. Since the vaccination, has the patient had been tested for COVID-19. The outcome of both events was unknown. No follow-up attempts are possible. No further information is expected. Sender''s Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.


VAERS ID: 1647175 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: tested positive for COVID; Result Unstructured Data: Test Result: Positive; Comments: Positive.
CDC Split Type: USPFIZER INC202101046860

Write-up: This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose1, single and second dose via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose2, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had both doses of the PFIZER-BIONTECH COVID-19 VACCINE and tested positive for Covid on 11Aug2021. Patient would like to know more about her antibodies given that she tested positive Covid and has been vaccinated. She would like to know if the booster dose becomes available. Also mentioned that at this time, a booster dose (an extra or third dose after receiving the two-dose series) is not recommended or authorized yet. Events considered as non-serious. Lab tests included that patient tested positive for Covid on 11Aug2021. Outcome was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647233 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-01
Onset:2021-08-11
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8737 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SOTALOL; ELIQUIS; VIT B12; VIT D3; MAGNESIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Cardiac arrhythmia (Heart arrhythmias); Perianal fistula; Seasonal asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: COVID test name post vaccination= PCR; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101049688

Write-up: breakthrough Covid positive through PCR test; breakthrough Covid positive through PCR test; This is a spontaneous report from a contactable consumer (patient).A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6202; Expiration Date: 30Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 12:00 PM as a single dose and dose 2 via an unspecified route of administration, administered in Arm Left at public health clinic/facility on 01Apr2021 at 12:00 PM (Batch/Lot Number: ER8737; Expiration Date: 31Jul2021) as a single dose for COVID-19 immunization (at the age of 67-years-old). Medical history included atrial fibrillation, Heart arrhythmias, perianal fistula, and seasonal asthma. Concomitant medications included sotalol (SOTALOL), apixaban (ELIQUIS), cyanocobalamin (VIT B12), colecalciferol (VIT D3), and magnesium (MAGNESIUM) taken for an unspecified indication. The patient previously took mobic and chlorhexidine and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 since the vaccination. The patient had not taken any treatment for reported events. On 11Aug2021, the patient experienced breakthrough covid positive through pcr test (vaccination failure) and (covid-19). On 02Apr2021 at 15:00, the patient experience flu like symptoms, fever, chills, severe headache, body aches. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): positive on 11Aug2021. The outcome of the events breakthrough covid positive through pcr test (vaccination failure) and (covid-19) was unknown. The outcome of the event fever was recovered on 03Apr2021. The outcome of the other events was recovered on an unspecified date in 2021. Conclusion of Previously Completed Investigation (Lot: EN6202): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6202 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6202, fill lot EN5334, and the formulated drug product lot EN5323. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause. Conclusion of Previously Completed Investigation (Lot: ER8737): The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8737 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8737, fill lot EW3426, and the formulated drug product lot EP8586. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.


VAERS ID: 1647235 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-05-25
Onset:2021-08-11
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210814; Test Name: Coronavirus Antigen/Nasal Swab; Test Result: Positive ; Comments: Nasal Swab; Test Date: 20210812; Test Name: Coronavirus PCR/Nasal Swab; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101050064

Write-up: Had a second test performed on 14Aug2021 and received positive result; began experiencing symptoms on 11Aug2021; This is a spontaneous report from a contactable consumer and from pfizer product quality group providing investigation results. A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via intramuscular route, administered in left arm on 27Apr2021 (at the age of 45 -years) (Lot Number: EW0170; Expiration Date: 31Aug2021) as dose 1, single and dose 2 intramuscular, administered in left arm (at the age of 45 years) on 25May2021 (Lot Number: EW0191; Expiration Date: 30Sep2021) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that he had received positive COVID19 result. He had unknowingly exposed on 10Aug2021. The patient began experiencing symptoms on 11Aug2021. Tested showed negative for COVID-19 on 12Aug2021. Had a second test performed on 14Aug2021 and received positive result on 14Aug2021. Covid is tested post vaccination. The patient underwent lab tests which included Coronavirus PCR/Nasal Swab showed negative on 12Aug2021 and coronavirus Antigen/Nasal Swab showed positive on 14Aug2021. The patient had not received any treatment for the events. The outcome of the events was unknown. Lot number: EW0170; Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0170 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0170, fill lot EP8701, and the formulated drug product lot EP8603. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Lot number: EW0191; Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0191 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EW0191, fill lot EP8738, and bulk formulation lot EP8619. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Evaluation Comment: Pfizer reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid, and an investigation will be performed. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1647268 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-08-09
Onset:2021-08-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101050909

Write-up: Lot of itchy skin and it continued; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Aug2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as dose 1, single for COVID-19 immunization. On 11Aug2021 the patient experienced lot of itchy skin and it continued. Therapeutic measures were taken as a result of lot of itchy skin and it continued. Patient stated that: I have taken a Benadryl (treatment) and I don''t know if that''s enough or do I need to go to see an Urgent Care person. The clinical outcome of the event was Not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647272 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Chest discomfort, Confusional state, Cough, Diarrhoea, Dyspnoea, Flushing, Headache, Heart rate, Heart rate increased, Loss of consciousness, Nausea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Latex allergy; Mast cell activation syndrome; Penicillin allergy; Sjogren''s syndrome.
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: BP; Result Unstructured Data: Test Result: Increased; Test Date: 20210811; Test Name: Heart rate; Result Unstructured Data: Test Result: Increased.
CDC Split Type: USPFIZER INC202101051278

Write-up: Loss of consciousness; Tightness in chest; Confusion; Flushing; Diarrhea; Increased BP; Increased Heart rate; Breathing labored and often forgot to labor; Headache; Nausea; Vomiting; Coughing; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 11Aug2021 at 14:15 (age at vaccination: 49-year-old and non-pregnant) as DOSE 1, SINGLE for covid-19 immunization at a doctor''s office/urgent care. Medical history included mast cell activation syndrome and sjogren''s: both from an unknown date and unknown if ongoing. There were no concomitant medications (list of any other medications the patient received within 2 weeks of vaccination: no). Patient had known allergies to latex and penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Aug2021 at 14:15, patient experienced loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing with 50 mg Benedryl, orally. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing was recovered on an unspecified date in Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647274 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cardiac flutter, Diarrhoea, Fatigue, Headache, Lymphadenopathy, SARS-CoV-1 test
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tachyarrhythmia terms, nonspecific (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XANAX; VITAMIN D [VITAMIN D NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (if_covid_prior_vaccination: Yes)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19; Test Result: Positive ; Comments: if_covid_prior_vaccination: Yes
CDC Split Type: USPFIZER INC202101051304

Write-up: fluttering in chest; headache; fatigue; diarrhea; swollen lymph nodes; This is a spontaneous report from a non-contactable consumer or other non hcp. A 58-years-old female patient received bnt162b2 (BNT162B2) solution for injection dose 1 (Lot Number: FA7485 expiry date was unknown) via an unspecified route of administration at arm left on 10Aug2021 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing if covid_prior_vaccination: Yes. Concomitant medication(s) included alprazolam (XANAX), vitamin d (vitamin d nos), multivitamins and HRT. No pregnancy at time of Vaccination. The patient had received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Xanax, multivitamins, vitamin D, HRT. Prior to vaccination the patient had diagnosed with COVID-19. Since the vaccination the patient has been tested for COVID-19. Patient had no known allergies. On 11Aug2021 07:00 the patient experienced fluttering in chest, headache, fatigue, diarrhoea and swollen lymph nodes. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on an unspecified date patient had covid_prior_vaccination. No treatment was given. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1647324 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Dyspnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101058411

Write-up: having a hard time breathing; Started out with the need to constantly clear my throat and then became full on wheezing and coughing; Started out with the need to constantly clear my throat and then became full on wheezing and coughing; This is a spontaneous report from a contactable consumer (patient herself). A 33-years-old non-pregnant female patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0186; Expiration Date: unknown) intramuscular, administered in Arm Left on 11Aug2021 09:00 (at age of as 33-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine; nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that, on 11Aug2021 09:30 (about 30mins after) receiving the shot patient started having a hard time breathing. Started out with the need to constantly clear throat and then became full on wheezing and coughing. The adverse event resulted in emergency room visit/department or urgent care. Therapeutic measures were taken as a result of adverse events as patient was checked multiple times within 2 hours. Was told to take inhaler before bed that night. Since the vaccination, patient has not been tested for COVID-19. The outcome of all events was recovered on an unspecified date in Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647328 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Senior Living       Purchased by: ?
Symptoms: COVID-19 pneumonia, Drug ineffective, Loss of consciousness, SARS-CoV-2 test, Urinary tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), 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: ATORVASTATIN; TAMSULOSIN; DONEPEZIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia (NOS); Bedridden; Cardiac valve disease; Dementia; Pacemaker syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:positive
CDC Split Type: USPFIZER INC202101060319

Write-up: The patient was unconscious at one point.; UTI; patient had pneumonia. They did a covid test last Wednesday, 11Aug2021, and the patient was positive; patient had pneumonia. They did a covid test last Wednesday, 11Aug2021, and the patient was positive; This is a spontaneous report from a contactable consumer (daughter) reported for father (patient). A 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number, NDC and Expiration date was unknown), via an unspecified route of administration in arm on an unspecified date in 2021 (at the age of 86-year-old) as a dose 2, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number, NDC and Expiration date was unknown), via an unspecified route of administration in arm on an unspecified date in 2021 (at the age of 86-year-old) as a dose 1, single for COVID-19 immunisation. The family medical history relevant to AE(s) was reported as none. The patient''s medical history (including any illness at time of vaccination) included dementia, pacemaker, bedridden, degenerative valve disease, rhythm problems. The patient''s concomitant medications included atorvastatin, tamsulosin taken for BPH, donepezil. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations (within 4 weeks) were reported as none. The AE(s) following prior vaccinations were reported as none. It was reported that, the caller was a Pfizer colleague and was called on behalf of her father about the Pfizer covid vaccine. The patient has dementia and lives at a nursing home. The patient had a break through infection and the caller wanted to report it. The caller called someone earlier today on 16Aug2021, at Pfizer and stated that, she would start a report but only provided the patient''s initials and date of birth. The caller''s Territory. The caller was made aware that the patient was sick last week on 07Aug2021. They thought the patient had pneumonia. They did a covid test last Wednesday on 11Aug2021 and the patient was positive. Today on 16Aug2021, the caller was made aware of the patient having the positive covid test. When the patient first became sick they did a scan of the patient and everything. Today, the patient was doing so much better. The patient only had symptoms for 2 days. The patient was started on antibiotics, the caller thinks it was Augmentin. The patient was running a fever and they thought he had a UTI. The patient was coughing a little bit and the nurse practitioner heard wheezing so they thought the patient had pneumonia or a UTI. The caller didn''t hear the patient coughing but they stated that, he was coughing on Saturday. The patient was unconscious at one point. The caller believed that, the patient got the vaccine in his arm like the rest of us. The AE(s) require a visit to emergency room was reported as no and to the physician office was reported as yes. On 11Aug2021, the patient underwent lab tests and procedures which included COVID-19 virus test (SARS-CoV-2 test), resulted as positive. The outcome of the events was unknown.


VAERS ID: 1647330 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-11
Onset:2021-08-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Heart rate, Heart rate increased, Hypertension, Inappropriate schedule of product administration
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), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Medication errors (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?:Yes)
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: blood pressure remained high; Result Unstructured Data: Test Result:145/90 mmHg; Comments: high (145/90) for ~ 6-7 hours.; Test Date: 20210811; Test Name: rapid increase in heart rate; Result Unstructured Data: Test Result:120-130; Comments: (pulse 120-130); Test Date: 20210811; Test Name: rapid increase in heart rate; Result Unstructured Data: Test Result:pulse remained about 100 bpm for over an hour
CDC Split Type: USPFIZER INC202101060826

Write-up: I began to feel faint; blood pressure remained high (145/90); rapid increase in heart rate; shortness of Breath; Dose 1 16Apr2021/ Dose 2 11Aug2021; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 11Aug2021 12:45 (Batch/Lot Number: FA7485) (at the age of 42-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included covid-19 from an unknown date, Prior to vaccination, the patient was diagnosed with COVID-19. There were no known allergies. There were no concomitant medications. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included the patient received first dose of BNT162B2 administered in Arm Left on 16Apr2021 10:00 AM (lot number: EW016) (at the age of 42-years-old) as DOSE 1, SINGLE for covid-19 immunisation. About 8 minutes after first dose (16Apr2021), the patient began to feel faint, rapid increase in heart rate and shortness of breath. Major symptoms subsided after a couple of minutes. On 11Aug2021 12:45 PM, Immediately after receiving 2nd dose (after consulting with primary physician), the patient began to feel faint (pharmacist rush to ensure he was okay and asked if she should call an ambulance), rapid increase in heart rate (pulse 120-130) and shortness of breath. Major symptoms subsided after about 15 minutes, however pulse remained about 100 bpm for over an hour and blood pressure remained high (145/90) for 6-7 hours. Since the vaccination, the patient had not been tested for COVID-19. There was no treatment received for the events. The outcome of the events was resolving. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101039594 same patient, different vaccine dose and events


VAERS ID: 1647331 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Indiana  
Vaccinated:2021-03-01
Onset:2021-08-11
   Days after vaccination:163
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: Covid; Test Result: Positive
CDC Split Type: USPFIZER INC202101061725

Write-up: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a contactable consumer. This consumer reported that a female patient in her late 50''s received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in March as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. She tested positive for Covid last Wednesday on 11Aug2021. She is in her late 50''s and a school teacher. Her son is 12 and not vaccinated. Event took place after use of product. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1647359 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: Covid test; Test Result: Positive ; Comments: covid test post vaccination resulted positive
CDC Split Type: USPFIZER INC202101065567

Write-up: A fully vaccinated individual has been diagnosed with COVID-19; A fully vaccinated individual has been diagnosed with COVID-19/mild cold; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Lot number: was not reported, Expiration date: was not reported) as dose 1, single and then dose 2, single, both via an unspecified route of administration on an unspecified date for COVID-19 immunization. Medical history and concomitant medications were not reported. On 11Aug2021, a fully vaccinated individual has been diagnosed with COVID-19. They first experienced symptoms on 11Aug2021. It was reported that the person had mild symptoms for a couple of days (like a mild cold) and has now fully recovered while they wait for the quarantine period to complete. Manufacturer of vaccine was not disclosed. Lab test included covid test post vaccination resulted positive on 11Aug2021. The outcome of both events was recovered on an unspecified date in Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1651609 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088DZIA / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Eye swelling, Joint stiffness, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoxetine - 40 MG Nexium 24 HR - 20 MG
Current Illness: Moderate psoriasis
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: The morning following my COVID 19 vaccination shot, I awoke with swelling of my fingers and hands to the point where I could not remove the rings from my fingers. Over the next few days, the swelling continued and I started feeling pain and stiffness in all of my joints including my shoulders, fingers, wrists, hip joints and knees. I have never had or been diagnosed with any kind of arthritis, but I felt like all of a sudden I was arthritic. I have also experienced swelling of my eye, only on the left side of my body. It has been 18 days since my injection and my symptoms have not improved.


VAERS ID: 1653976 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-04-16
Onset:2021-08-11
   Days after vaccination:117
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2613 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8737 / 2 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abscess, Abscess drainage, Blood glucose abnormal, COVID-19, Cardiac failure, Computerised tomogram abnormal, Diabetic ketoacidosis, Feeling abnormal, Infection, Intensive care, Limb injury, SARS-CoV-2 test positive, Somnolence
SMQs:, Cardiac failure (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: atorvastatin (LIPITOR) 40 MG Oral Tablet Take 1 tablet by mouth nightly at bedtime. Qty: 30 tablet, Refills: 2 Associated Diagnoses: Acute respiratory failure with hypoxemia; Acute on chronic diastolic heart failure; ESRD on hemodialysis;
Current Illness:
Preexisting Conditions: HLD ESRD ? Diabetes mellitus ? Diabetic neuropathy ? Elevated troponin level 8/2/2020 ? Essential hypertension 8/2/2020
Allergies: NKDA
Diagnostic Lab Data: SARS-COV-2, NAA, Detected on 08/18/21.
CDC Split Type:

Write-up: Patient required hospitalization due to breakthrough infection. Patient received Pfizer vaccine (2nd dose in series) on 04/16/21. Patient was hospitalized from 08/11/21 - 08/20/21 and then was discharged. Then, patient was readmitted on 08/24/21 until 08/28/21. Below is copied from discharge summary: 08/28/21 - comfortable, denies any SOB, remains on RA Will complete 5 days of remdisvir this afternoon, abort solumedrol as has been on RA for last several days PT/OT advised RW; Agent to arrange and DC home on 20 days of isolation 8/16-9/14 08/20/21 - 34 M, non compliant, seen in Facility, is accepted from ER to hospitalist as DKA has resolved. Has T2DM x age 25, ESRD ( biopsy at hospital - diabetic glomerulosclresos with arteriohyalinosis ) on HD x 5/2021, HFpEF 50%, HTN, Rt 5th toe amputation hx and multiple infections on Rt foot was brought to ER by EMS 8/11 for " feeling tired", sugar was "hi", missed HD, and said had a Rt foot wound x 1 wk. Was admitted to ER in Facility for bed constrints, for DKA, was drowsey. CT showed 6 cm abscess along Rt foot lateral border and fluid collection extending along xxtensor digitorim tendon sheath c/w tenosynovitis, erosive bases of 4th and 2nd MT c/w OM. Podiatry did bedside I&D and plan OR I&D today. On vanco and zosyn, has closed with insulin and pt tx''ed to hospitalist 8/12.


VAERS ID: 1654039 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-10
Onset:2021-08-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Injection site pain, Injection site reaction, Pain, Pain in extremity, Sleep disorder
SMQs:, Extravasation events (injections, infusions and implants) (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: anastrozole, Lexapro. vit d. b-complex. magnesium. calcium, ferrous gluconate.
Current Illness: none
Preexisting Conditions: breast cancer 2015. arthritis. atypical migraine( no pain)
Allergies: penicillin. erythromycin. sudafed
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Next day head ache. left arm pain. as of 8/29 my injection site is tender And i have shooting pain in my left upper arm near the shoulder. I have a nagging head ache in the frontal lobe and on the r side of my head. this pain in my arm wakes me at night. I have trouble sleeping on my left side due to the pain. I am reporting this because It has lingered on. I visited the CDC web site that gave thus site for ongoing symptoms


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