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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 384 out of 8,010

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VAERS ID: 1719055 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-03-23
Onset:2021-08-26
   Days after vaccination:156
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2631 / UNK - / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6202 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Cough, Fatigue, Pain, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: acetaminophen (TYLENOL) 500 MG tablet Ascorbic Acid (VITAMIN C) 500 MG CAPS aspirin 81 MG EC tablet Cholecalciferol (VITAMIN D3) 50 MCG (2000 UT) capsule hydroCHLOROthiazide (HYDRODIURIL) 12.5 MG tablet losartan (COZAAR) 50 MG tablet pravas
Current Illness: NKA
Preexisting Conditions: Cardiovascular and Mediastinum Essential hypertension Musculoskeletal and Integument Osteopenia Other Hyperlipidemia LDL goal <130
Allergies:
Diagnostic Lab Data: SARS-CoV-2 PCR - : Detected
CDC Split Type:

Write-up: 77 yo female presents with cough, fatigue, body aches, and vomiting. She reports that the cough started on Tuesday and has worsened. She denies soa or wheezing. She is vaccinated for COVID-19. She has had 2 episodes of nb emesis today. She thinks this was caused from taking mucinex for the cough. Fever tmax at home was 100.9.


VAERS ID: 1719074 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 RL / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 RL / SYR

Administered by: Private       Purchased by: ?
Symptoms: Cellulitis, Fatigue, Influenza like illness, Injection site erythema, Injection site warmth, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Had adverse reactions to flu shots
Other Medications: Robaxin, Centagrin, Esomeprazole, Somethozene, Eliquis, Norco, Hydroxychloroquine (for Auto-Immune), Norfloxacin, Vitamin D2, Pepsin, Folic Acid, Levothyroxine, amlodipine, Diazepam, Extra Strength Tylenol, Theraflu, Vitamin B12 injections,
Current Illness: Major appendix issues
Preexisting Conditions: Methyltrexate Reductive Disorder (blood clotting disorder), Hypothyroidism, Arthritis, Kidney Stones, Mixed Connective Tissue Disease, Ehlers-Danlos Hypermobility, chronic GI issues, iron deficient anemia, Raynaud''s disease, cranial lesions, obesity, dysphagia, Vitamin D deficiency, vertigo, AnA positive, MTHFR and Homocystinuria, IBS
Allergies: Shellfish, Mycin, Flomax, Trazodone, Benadryl, Adhesives, Drezoquin and Pequin (Antibiotics)
Diagnostic Lab Data:
CDC Split Type: vsafe

Write-up: After 2nd Dose: Extreme typical flu-like symptoms, swelling in leg, redness and heat, size of golf ball, around injection site. Began to develop cellulitis, went to get checked by doctor at urgent care 4 days later, was started on antibiotics (folsamist trimethoprim) and an extra Norco to deal with pain. Symptoms began to subside soon after treatment, still having lingering exhaustion. Site of shot still has a small lump there.


VAERS ID: 1719077 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: American Samoa  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO170 / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Angina pectoris, Anxiety, Blood test, Chest discomfort, Chest pain, Dizziness, Electrocardiogram, Head discomfort, Injection site warmth, Muscle spasms, Sleep disorder, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: omeprazole
Current Illness: no
Preexisting Conditions: no
Allergies: yes. food, environmental
Diagnostic Lab Data: blood tests 08/27/2021, other testing in process
CDC Split Type:

Write-up: Heating at injection site, acute body spasms in head, arm, stomache, dizziness, tightening pain in chest area, heart. Alerted Nurse and they directed me to a separate cubicle with bed to lay down. Nurse asked about symptoms, took pulse. After 10-15 minutes most symptoms discontinued except for chest discomfort. After chest/heart discomfort continued the following days, I contacted my PCP. He administered electrocardiogram 08/30/2021. He prescribed blood pressure medicine, blood tests, allergist, ultrasound and other steps. The intermittent chest discomfort mild headaches continue today, creating sleep issues and anxiety.


VAERS ID: 1719126 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-12
Onset:2021-08-26
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048C21 A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Joint range of motion decreased
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: None
Current Illness: None
Preexisting Conditions: None
Allergies: no known allergies
Diagnostic Lab Data: 9/21/21: Medical exam. Treatment with prednisone dose pk and cyclobenzaprine
CDC Split Type:

Write-up: Left shoulder pain and decreased ROM


VAERS ID: 1719229 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site pruritus, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient called on 9/21/21 regarding long term hives and itching after vaccine. Patient was advised to take a benadryl to help with hives and itching (she has not done so due to concer that it might affect the efficacy). patient cancelled appointment for second dose until resolution of symptoms


VAERS ID: 1719382 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / IM

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

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

Write-up: This patient unknowingly was given a second dose of Janssen. The patient reported he had not received a covid vaccine prior. When internet was back up and his data was entered it was discovered he had previously received a Janssen vaccine


VAERS ID: 1720334 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-08-17
Onset:2021-08-26
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Axillary pain, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (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: Swollen and painful armpit


VAERS ID: 1720532 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature increased, Chest discomfort, Feeling cold, Headache, Myalgia, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Latex
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Developed a low grade temperature starting in the early evening, and then it increased to a high of 103.5 ?F by 10:30pm. I was cold, but I did not have the normal chills associated with a flu. I did not experience any upper respiratory symptoms except for chest tightness. I had a headache (mid-range) and also muscle aches. I took ibuprofen just before midnight so that I could sleep. I woke up with a temperature the following morning, and it was consistently between 102 and 102.5 ?F for much of the day. I did not take any fever reducers until 10pm. The next morning, I was still running a temperature, but it was low grade. All other symptoms had dissipated. By Sunday I was fine. I did note shooting pains in my right leg around 2 weeks after the injection.


VAERS ID: 1721694 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-06
Onset:2021-08-26
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Acute kidney injury, Atrial fibrillation, Chest pain, Chills, Electrophoresis protein, Heart rate, Hyperlipasaemia, Hyperproteinaemia, Hypertransaminasaemia, Illness, Lactic acidosis, Lipase, Liver disorder, Nausea, Rash, Sepsis, Transaminases, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FAMOTIDINE ACID REDUCER; METOPROLOL TARTRATE ACCORD; METRONIDAZOLE [METRONIDAZOLE SODIUM]; NYSTOP; PANTOPRAZOLE 40; REFRESH [CARMELLOSE SODIUM]; DIAZEPAM; CORTISONE; VITAMINS NOS
Current Illness: Dermatitis; Fibrillation atrial; Heart enlarged; Macular degeneration; Yeast infection
Preexisting Conditions: Medical History/Concurrent Conditions: Pacemaker insertion (cardiac)
Allergies:
Diagnostic Lab Data: Test Name: Blood protein; Result Unstructured Data: Elevated; Test Name: Heart beat; Result Unstructured Data: 150 beats per minute; Test Name: Lipase; Result Unstructured Data: Elevated; Test Name: Transaminase; Result Unstructured Data: Elevated
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Arm rash/Rash came out over the stomach; Chest pain; Elevated blood protein; elevated lipase; Elevated transaminase level; Lactic acidosis; Abdominal pain; Sepsis; Chronic atrial fibrillation; Acute kidney injury/kidney problems; Nausea; Vomiting; Chills; Liver problems; Stomach feels irritated/stomach feels like scalded; Kind of sick/so sick she could not go to the bathroom/when she started eating she started to get real sick again; Her stomach is really swollen; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Sepsis), ATRIAL FIBRILLATION (Chronic atrial fibrillation), ACUTE KIDNEY INJURY (Acute kidney injury/kidney problems), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), LIVER DISORDER (Liver problems), RASH (Arm rash/Rash came out over the stomach), CHEST PAIN (Chest pain), HYPERPROTEINAEMIA (Elevated blood protein), HYPERLIPASAEMIA (elevated lipase), HYPERTRANSAMINASAEMIA (Elevated transaminase level), LACTIC ACIDOSIS (Lactic acidosis) and ABDOMINAL PAIN (Abdominal pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Pacemaker insertion (cardiac). Concurrent medical conditions included Yeast infection, Fibrillation atrial, Heart enlarged, Macular degeneration and Dermatitis. Concomitant products included METRONIDAZOLE SODIUM (METRONIDAZOLE [METRONIDAZOLE SODIUM]) for Dermatitis, METOPROLOL TARTRATE (METOPROLOL TARTRATE ACCORD) for Heart disorder, CARMELLOSE SODIUM (REFRESH [CARMELLOSE SODIUM]) for Macular degeneration, NYSTATIN (NYSTOP) for Yeast infection, FAMOTIDINE (FAMOTIDINE ACID REDUCER), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE 40), DIAZEPAM, CORTISONE and VITAMINS NOS for an unknown indication. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced ACUTE KIDNEY INJURY (Acute kidney injury/kidney problems) (seriousness criteria hospitalization and medically significant), NAUSEA (Nausea) (seriousness criterion hospitalization), VOMITING (Vomiting) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization) and LIVER DISORDER (Liver problems) (seriousness criterion hospitalization). On 13-Sep-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach feels irritated/stomach feels like scalded), ILLNESS (Kind of sick/so sick she could not go to the bathroom/when she started eating she started to get real sick again) and ABDOMINAL DISTENSION (Her stomach is really swollen). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), ATRIAL FIBRILLATION (Chronic atrial fibrillation) (seriousness criteria hospitalization and medically significant), RASH (Arm rash/Rash came out over the stomach) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization), HYPERPROTEINAEMIA (Elevated blood protein) (seriousness criterion hospitalization), HYPERLIPASAEMIA (elevated lipase) (seriousness criterion hospitalization), HYPERTRANSAMINASAEMIA (Elevated transaminase level) (seriousness criterion hospitalization), LACTIC ACIDOSIS (Lactic acidosis) (seriousness criteria hospitalization and medically significant) and ABDOMINAL PAIN (Abdominal pain) (seriousness criterion hospitalization). The patient was hospitalized from 24-Aug-2021 to 27-Aug-2021 due to ABDOMINAL PAIN, ACUTE KIDNEY INJURY, ATRIAL FIBRILLATION, CHEST PAIN, CHILLS, HYPERLIPASAEMIA, HYPERPROTEINAEMIA, HYPERTRANSAMINASAEMIA, LACTIC ACIDOSIS, LIVER DISORDER, NAUSEA, RASH, SEPSIS and VOMITING. At the time of the report, SEPSIS (Sepsis), ATRIAL FIBRILLATION (Chronic atrial fibrillation), ACUTE KIDNEY INJURY (Acute kidney injury/kidney problems), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills), LIVER DISORDER (Liver problems), RASH (Arm rash/Rash came out over the stomach), CHEST PAIN (Chest pain), HYPERPROTEINAEMIA (Elevated blood protein), HYPERLIPASAEMIA (elevated lipase), HYPERTRANSAMINASAEMIA (Elevated transaminase level), LACTIC ACIDOSIS (Lactic acidosis), ABDOMINAL PAIN (Abdominal pain), ABDOMINAL DISCOMFORT (Stomach feels irritated/stomach feels like scalded), ILLNESS (Kind of sick/so sick she could not go to the bathroom/when she started eating she started to get real sick again) and ABDOMINAL DISTENSION (Her stomach is really swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrophoresis protein: elevated (High) Elevated. On an unknown date, Heart rate: 150 (High) 150 beats per minute. On an unknown date, Lipase: elevated (High) Elevated. On an unknown date, Transaminases: elevated (High) Elevated. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. She had heart monitor. About 3 weeks after the vaccine, when the patient quit the sulfa drug, she started with symptoms: she had nausea, vomiting, chills, her heart was beating 150 beats a minute, she had kidney problems, liver problems and for all that she was admitted in hospital for 4 days since 26Aug2021. The doctor had to pick her up and put her in a chair at hospital. She is still having some problems. Her discharge papers from hospital say: abdominal pain, acute kidney injury, chest pain, chronic atrial fibrillation, elevated blood protein, elevated lipase, elevated transaminase level, lactic acidosis, nausea and vomiting, rapid atrial fibrillation, rash, sepsis (they did not know the cause). She was on sulfa drugs at time of Moderna vaccination and rash appeared after stopping of sulfa drugs. She is also taking Blood thinners and using topical cream 100,000 units along with other concomitant drugs. No treatment information was reported by reporter. Patient is on liquid diet due to swollen stomach. She is scheduled for second dose of vaccine on 16-SEP-2021 Compnay comment This case concerns a 66-year-old, female patient with relevant medical history of heart enlarged, atrial fibrillation and cardiac pacemaker, who experienced the unexpected events of sepsis, atrial fibrillation, acute kidney injury, nausea, vomiting, chills, liver disorder, abdominal pain, chest pain, rash, hyperproteinaemia, hyperlipasemia, hypertransaminasemia and lactic acidosis. The events of nausea, vomiting, chills, kidney problems/acute kidney injury and liver problems occurred approximately 20 days after the first dose of Spikeva. The patient was hospitalised and per discharge notes the patient had additional events mentioned previously.The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report. Patient''s medical history and concomitant unspecified sulfa drug use remains a confounder.; Sender''s Comments: This case concerns a 66-year-old, female patient with relevant medical history of heart enlarged, atrial fibrillation and cardiac pacemaker, who experienced the unexpected events of sepsis, atrial fibrillation, acute kidney injury, nausea, vomiting, chills, liver disorder, abdominal pain, chest pain, rash, hyperproteinaemia, hyperlipasemia, hypertransaminasemia and lactic acidosis. The events of nausea, vomiting, chills, kidney problems/acute kidney injury and liver problems occurred approximately 20 days after the first dose of Spikeva. The patient was hospitalised and per discharge notes the patient had additional events mentioned previously.The rechallenge was not applicable. The benefit-risk relationship of Spikevax in not affected by this report. Patient''s medical history and concomitant unspecified sulfa drug use remains a confounder.


VAERS ID: 1722613 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Montana  
Vaccinated:2021-02-03
Onset:2021-08-26
   Days after vaccination:204
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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 covid-19 positive 9/14/2020 with no hospitalization. Received 2 doses Moderna covid-19 vaccine January 2021 and February 2021. Patient tested positive for covid-19 on 8/26/2021 with mild symtpoms and no hospitalization or other complications.


VAERS ID: 1722677 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Osteoarthritis, X-ray limb normal
SMQs:, Arthritis (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: Trumeq ,,Xanax,Lipitor, Flexeril, Lisinopril, Ibuprofen
Current Illness: N/A
Preexisting Conditions: HIV, Degenerative Disc Disease Back
Allergies: None
Diagnostic Lab Data: Left Shoulder X Ray show no acute abnormality. Mild AC Joint DJD
CDC Split Type:

Write-up: Left Shoulder Joint Pain, Worse with overhead reaching.


VAERS ID: 1722978 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-03-11
Onset:2021-08-26
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 AR / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Hypertension, Hypoxia, Pain, Pneumonia, Positive airway pressure therapy, Pyrexia, Respiratory tract congestion
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Presented to the ED with shortness of breath, body aches, cough, congestion, fever, hypertertensive, and hypoxic 56% Chest X ray showed bilateral multifocal pneumonia Started on decadron and remdesivir, BiPAP, combivent, pulmicort, albuterol, zinc, vitamin D, melatonin, Discharged home with decadron, amoxicillin, and azithromycin


VAERS ID: 1723042 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039B21A / UNK LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Hypersomnia, Injection site reaction, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (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: Amlodipine, Olmesartan Medoxomil, Rosuvastatin, D3, One a day vitamin
Current Illness: N/A
Preexisting Conditions: Pre-diabetic
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: 48 hours after the shot, I was extremely fatigued and ended up sleeping for 1 and 1/2 days. 48 hours after that, I got a large rash that severely itched at the shot site. I needed Benadryl and Calamine lotion to stop the itching. That lasted for 2 days.


VAERS ID: 1723275 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Mississippi  
Vaccinated:2021-08-01
Onset:2021-08-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary mass, Chest discomfort, 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:
Preexisting Conditions: PTSD, high cholestorol
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tightness and light pain in left side of chest. Lump under left armpit (thought it was an ingrown hair but it will not go away)


VAERS ID: 1723327 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939906 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Dyspnoea, Extrasystoles, Palpitations, Swelling, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (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: Cyanocobalamin Vit B-12 1,000mcg IM every 2 wks, Ipratropium bromide 42mcg x2 sprays intranasal x3 daily, Toprol XL 25mg tab x1 daily
Current Illness: F/U for decreased Kidney Function
Preexisting Conditions: A-fib, B-12 deficiency, Vit D deficiency, Anxiety, Hyperlipidemia
Allergies: Codeine, Statins-HMG-COA Reductase Inhibitors, Succinylcholine Chloride
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient reactions occurred 9hrs post vaccine and she did not go to the ER for her reactions. Pt. states she could not breath good felt like lungs were closing she used her CPAP machine which helped improve her breathing, she experienced racing HR and heart felt as if skipping beats which cleared up on its own, weakness, and swelling of neck/face still feels a little swollen up R. side of face to earlobe.


VAERS ID: 1725257 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Allergy to antibiotic; Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (The patient had Covid 19 in April 2020 and ended up on a Ventilator.); Headache
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210935171

Write-up: VOMITING; BLURRY VISION; DIZZINESS; NOT FEELING WELL; FEVER; HEADACHE/MIGRAINE; This spontaneous report received from a patient concerned a 27 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included: covid 19, and headache, and concurrent conditions included: non alcoholic, non smoker, and azithromycin allergy. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, and batch number: 1808982 expiry: 21-SEP-2021) dose was not reported, administered on 26-AUG-2021 14:30 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 26-AUG-2021, the patient experienced headache/migraine. On 27-AUG-2021, the patient experienced not feeling well. On 27-AUG-2021, the patient experienced fever. On 01-SEP-2021, the patient experienced blurry vision. On 01-SEP-2021, the patient experienced dizziness. On 09-SEP-2021, treatment medications included: sumatriptan. On 12-SEP-2021, the patient experienced vomiting. Additional treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine was not applicable. The patient recovered from blurry vision, dizziness, and vomiting on SEP-2021, not feeling well, and fever, and headache/migraine on 12-SEP-2021. This report was non-serious.


VAERS ID: 1725571 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-19
Onset:2021-08-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Hypersensitivity, Polymerase chain reaction, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101226014

Write-up: Allergic reaction.; Rash; Itching all over body; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the arm left on 19Aug2021 at 09:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medication. On 26Aug2021 at 18:00, the patient experienced an allergic reaction, rash and itching all over his body. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of events included treatment with cortisone cream (MANUFACTURER UNKNOWN) from an unknown date. Since the vaccination, the patient had been tested for COVID-19. On 14Sep2021, the patient underwent polymerase chain reaction (PCR) test (nasal swab) and the result was negative. The clinical outcome of the events allergic reaction, rash and itching all over body was not resolved at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the arm left on an unspecified date in 2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation.


VAERS ID: 1725575 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 3 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, Hyperacusis, Off label use, Tinnitus
SMQs:, Hearing impairment (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: AZATHIOPRINE; VITAMIN B-12
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease; Immunosuppressant drug therapy (chronic immunosupressive therapy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101226183

Write-up: 3rd dose of the vaccine; 3rd dose of the vaccine; Ringing and hypersensitivity of left ear; Ringing and hypersensitivity of left ear; This is a spontaneous report from a contactable nurse, the patient. A 30-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 24Aug2021 at 11:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohn''s disease and chronic immunosupressive therapy. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included azathioprine (MANUFACTURER UNKNOWN) and cyanocobalamin (Vitamin b-12), and unspecified prenatal medication; all for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also second dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 26Aug2021, the patient had ringing and hypersensitivity of her left ear which was began in the same week of her injection. It occurred frequently and had faded. The patient had not noticed the problem at the time of report. It was reported that, this was her third dose of the vaccine about 7 months after her second dose series. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events ringing and hypersensitivity of left ear was resolved on an unknown date in 2021.


VAERS ID: 1725617 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Gout
SMQs:, Arthritis (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101233473

Write-up: Gout - painful gout in right toe; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 24Aug2021 at 13:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 03Aug2021 at 13:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 26Aug2021 at 07:00, the patient experienced gout - painful gout in right toe. The event resulted in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event gout-painful gout in the right toe and included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event gout - painful gout in right toe was not resolved at the time of this report.


VAERS ID: 1727094 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Pregnancy, Product administered to patient of inappropriate age
SMQs:, Normal pregnancy conditions and outcomes (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: PRENATAL VITAMINS
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: PREGNANT ESTAMATED DUE DATE 01/06/2022 PATIENT IS ALSO UNDER 18 YEARS OLD AT TIME OF VACCINATION


VAERS ID: 1727442 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-06-28
Onset:2021-08-26
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anion gap, Back pain, Blood sodium decreased, Blood thyroid stimulating hormone normal, Blood urea nitrogen/creatinine ratio, C-reactive protein normal, Chills, Differential white blood cell count, Dizziness, Drug screen negative, Dyskinesia, Full blood count, Mean cell haemoglobin increased, Mean cell volume increased, Metabolic function test, Muscle twitching, Neck pain, Posture abnormal, Red blood cell sedimentation rate normal, Serum ferritin normal, Streptococcus test negative, Thyroxine free decreased, Tic, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hyponatraemia/SIADH (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Vestibular disorders (broad), Chronic kidney disease (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concerta, Tri-Lo-Mili, Valcyclovir, Minocycline, Clonidine, Meloxicam PRN
Current Illness: None
Preexisting Conditions: ASD, ADHD, Chronic HSV/cold sores, Menstral cramping, Acne
Allergies: Hayfever
Diagnostic Lab Data: 9/9/21 all tests done as follows with the MD office appt CMP: Only abnormal was the sodium, slightly low at 133.9, Anion Gap 4.9 low, and BUN/Creatinine Ratio 23.3 high Drug Screen Medical urine in-house: Negative Sed Rate, Manual was normal at 19 CRP was 0.75 normal Anti DNASE B Antibody: 278 normal Antistrep-O Titer Serum; 233 normal TSH: 3.55 normal T4 Free: 0.75 Normal CBC with auth diff: only abnormals were MCV at 98.9, and MCH at 33.4 Ferritin 22.3 normal Strep Group A by PCR Negative (throat swab)
CDC Split Type:

Write-up: Covid Vax 1 received 6/7/21, Covid Vax 2 received 6/28/21. Night between 8/25 and 8/28 she had a shivering full body shake enough to wake the friend on the top bunk, as she was on the bottom bunk. The friend does not remember which night it was. She came home 8/29/21 from friends sleepover. 8/30/21 she woke to dizziness and it persisted for 1/2 the day. 8/31/21 she had her first "twitch" jerking movement of the head/neck. 9/2/21 she reported to me that she was having a jerking in her head/neck and asked if that was normal. It was happening 1 to 3 x/day. 9/6/21 I (parent) noticed that the jerking was in sequence of 3-4 head jerking to the side (tilting of the head). 9/9/21 she had full blown tic and was seen in the MD office. The head drops down to the right shoulder, then chin first to the mid chest line and then back up to normal position. This happens 4-10 times in sequence when mild to moderate episodes, and constant movement for 30 to 90 minutes before starting to relax up a little. This causes pain in the upper back and neck when moderate to severe movement.


VAERS ID: 1729280 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-05-08
Onset:2021-08-26
   Days after vaccination:110
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 2 UN / UN

Administered by: Public       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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient presents to ED with COVID symptoms and positive test. Fully vaccinated May 2021.


VAERS ID: 1729470 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D3 5000 IU/day
Current Illness: None
Preexisting Conditions: PCOS -polycystic ovarian syndrome
Allergies: Allergic to bananas and toradol.
Diagnostic Lab Data:
CDC Split Type:

Write-up: I was on the last day of my mensuration when I got the vaccine. However instead of ending my menstrual started again heavy. It had since alternated between spotting and heavy bleeding but there hasn''t been a day since the vaccine that I haven''t been menstruating to some degree. This makes 5.5 weeks straight (including the first week of my normal menstruation before the vaccine).


VAERS ID: 1730345 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-18
Onset:2021-08-26
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003C21A / 2 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Rash macular, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
SMQs:, 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.MOD20213

Write-up: Hot to the touch entire upper left arm after first shot; Blotchy entire upper left arm after first shot; Itching entire upper left arm after first shot; Swollen entire upper left arm after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch entire upper left arm after first shot), RASH MACULAR (Blotchy entire upper left arm after first shot), VACCINATION SITE PRURITUS (Itching entire upper left arm after first shot) and VACCINATION SITE SWELLING (Swollen entire upper left arm after first shot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch entire upper left arm after first shot), RASH MACULAR (Blotchy entire upper left arm after first shot), VACCINATION SITE PRURITUS (Itching entire upper left arm after first shot) and VACCINATION SITE SWELLING (Swollen entire upper left arm after first shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Injection site reaction, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Injection site reaction, at a dose of 1 dosage form. On 29-Aug-2021, VACCINATION SITE WARMTH (Hot to the touch entire upper left arm after first shot), RASH MACULAR (Blotchy entire upper left arm after first shot), VACCINATION SITE PRURITUS (Itching entire upper left arm after first shot) and VACCINATION SITE SWELLING (Swollen entire upper left arm after first shot) had resolved. Concomitant medication was not provided. Treatment medication was not provided .


VAERS ID: 1730404 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Cardiac disorder, Chest pain, Dizziness, Fatigue, Feeling abnormal, Feeling hot, Flatulence, Headache, Illness, Lethargy, Lymphadenopathy, Swelling face
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), 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: Medical History/Concurrent Conditions: Surgery (She had the surgery done 30Jun2021.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101127526

Write-up: sick; headache; Dizzy; face swollen; Swollen lymph nodes; joint pain like she has never known; Heart is pounding so bad she can feel it in her toes; Chest pain; lethargic; Incredibly tired; Stomach hurt; Gassy Stomach; Really hot; Dizzy Fuzzy Head; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 54 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Aug2021 14:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included surgery done on 30Jun2021. There were no concomitant medications. The patient experienced illness, headache, dizziness on 26Aug2021 14:20 with outcome of not recovered, face swollen on 26Aug2021 14:20 with outcome of not recovered, swollen lymph nodes causing lymphadenopathy on 26Aug2021 14:20 with outcome of not recovered, joint pain like she has never known causing arthralgia on 26Aug2021 14:20 with outcome of not recovered, heart is pounding so bad she can feel it in her toes causing cardiac disorder on 26Aug2021 14:20 with outcome of recovering, chest pain on 26Aug2021 14:20 with outcome of not recovered, lethargic on 26Aug2021 14:20 with outcome of not recovered, incredibly tired causing fatigue on 26Aug2021 14:20 with outcome of not recovered, stomach hurt causing abdominal pain upper on 26Aug2021 14:20 with outcome of not recovered, gassy stomach causing flatulence on 26Aug2021 14:20 with outcome of recovering, feeling hot on 26Aug2021 14:20 with outcome of recovering , dizzy or fuzzy head feeling abnormal on 26Aug2021 14:20 with outcome of not recovered. Upon Follow-up (30Aug2021): This is a follow-up spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable 54-year old female consumer (patient) reported for herself that: She had surgery 8 weeks ago. She wanted her to see her endocrine doctor before she had it. She had the surgery done 30 Jun2021. She cannot see endocrine until Feb2022, so she did not want to wait that long. She did not wish to provide a mailing address. All of her symptoms started 20 minutes after she received the vaccine. Instantly, the back of her head where neck and head meet, where C1 is, she had a headache and her head got fuzzy after the headache. Her headache has gone, but the fuzzy has not. It is persisting. With the joint pain, even her toe joints hurt. So when the heart throb went down to her toes, it felt like her toes were going to be pinched off. She has never had this before. She has a slight improvement in heart pounding. Her stomach hurt and she was gassy from it. Then it was just an incredibly bad stomach pain. She feels hot and it is not a fever, but her body is just hot. It is persisting but slightly getting better. There was only Pfizer or Moderna available and she took Pfizer one. She will be on vacation in a cabin for a while. The lady said she can go 42 days out. She will get second dose first week of Oct2021. She wants to know how far past the 42 days would she still be fine. She stated that previous agent said they do not have any data past 42 days. Advised her that if that is what she was told, there is no additional information beyond the 42 days. She also wanted to know if she will still be considered fully vaccinated after the second dose if she receives it the first of Oct2021. The lot number for the vaccine ,[BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1731143 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-08-22
Onset:2021-08-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Amnesia, Autoscopy, Feeling abnormal, Headache, Inflammation, Magnetic resonance imaging normal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalopathy/delirium (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: Multivitamin, Tumeric gummies, Vitamin D3, Women''s probiotic
Current Illness: URI a month prior
Preexisting Conditions: Crohn''s disease- mild not on treatment
Allergies: fish oil
Diagnostic Lab Data: Primary care provider sent her for MRI which she brought to (neurologist) which was normal. Neurologist thought she had "inflammation" and needed to rest.
CDC Split Type:

Write-up: Day after vaccine had fever, headache. Then 3 days after vaccine she felt dissociated- felt out of her body, didn''t know what time it was or day of the week. Then on the 4th day after the vaccine, she went for a walk and got loss and had major short memory loss for a week starting on that day. She has had "brain fog" since then although it is very slowly improving and her short term memory is better but not back to baseline.


VAERS ID: 1731342 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-02-19
Onset:2021-08-26
   Days after vaccination:188
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Fatigue, Pyrexia, Saliva alcohol test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Allergies: Codeine
Diagnostic Lab Data: Positive saliva test on 8/29/2021
CDC Split Type:

Write-up: Exhaustion, fever, hacking non productive cough, difficulty breathing. Took Tylenol, Delsym (helped a little) then Mucinex (didn''t help), then prescription benzonatate 100 mg (that helped), along with Valerian Root so I could sleep. That helped tremendously. I started feeling better the day after the benzonatate and Valerian Root. probably because I stopped coughing as much and could sleep. After 5 days of the prescription and valerian root I was almost back to normal except that I am still week and have little stamina.


VAERS ID: 1731501 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 3 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Back pain, Extra dose administered, Feeling abnormal, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

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

Write-up: Severe headache - persistent x 3 weeks - started after 3rd dose of covid19 shot, persistent back pain/myalgias, and feels her whole body is swollen x 3 weeks. Not improving. Has been taking ibuprofen, naproxen, acetaminophen for pain x 3 weeks w/o improvement.


VAERS ID: 1731935 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pustule, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: patient presented for 2nd dose. stated that following 1st dose there was a noticeable bump. this started to decrease up until about a week ago when it began to enlarge then exude a pus like substance. patient does not have a PCP but referred to Urgent care for f/u for potential infection.


VAERS ID: 1733687 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 052E21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Insomnia, 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: Allergy to antibiotic; Asthma; Food allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: report side effects; insomnia for 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (insomnia for 3 weeks) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Food allergy, Asthma and Allergy to antibiotic. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced INSOMNIA (insomnia for 3 weeks) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION COMPLICATION (report side effects). At the time of the report, INSOMNIA (insomnia for 3 weeks) had not resolved and VACCINATION COMPLICATION (report side effects) outcome was unknown. No concomitant medication were reported. MD had prescribed medication but did not worked. So she had taken self medication with over the counter medications to help him asleep. Company comment- This case concerns a 37-year-old, female patient with previous relevant medical history of Food allergy, Asthma and Allergy to antibiotic, who experienced the unexpected events of Insomnia and Vaccination complication. The event Insomnia occurred the same day as the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable since the events occurred after the first dose. The reporter assessed the events as possible. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow Up information was received on 16-Sep-2021 and contains new event added.; Sender''s Comments: This case concerns a 37-year-old, female patient with previous relevant medical history of Food allergy, Asthma and Allergy to antibiotic, who experienced the unexpected events of Insomnia and Vaccination complication. The event Insomnia occurred the same day as the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable since the events occurred after the first dose. The reporter assessed the events as possible. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1733864 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006B21A / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Interchange of vaccine products, Wrong product 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 received J&J vaccine initially and patient received Moderna vaccine 1.5 months later; The patient was injected with Moderna''s COVID-19 vaccine in error; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received J&J vaccine initially and patient received Moderna vaccine 1.5 months later) and WRONG PRODUCT ADMINISTERED (The patient was injected with Moderna''s COVID-19 vaccine in error) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received J&J vaccine initially and patient received Moderna vaccine 1.5 months later) and WRONG PRODUCT ADMINISTERED (The patient was injected with Moderna''s COVID-19 vaccine in error). On 26-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received J&J vaccine initially and patient received Moderna vaccine 1.5 months later) and WRONG PRODUCT ADMINISTERED (The patient was injected with Moderna''s COVID-19 vaccine in error) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. The patient was previously admitted for non-COVID related reasons. The patient was previously vaccinated with J&J Covid-19 vaccine on 09-Jun-2021 via Intramuscular route (batch no. 207A21A, location LD). The reporter stated that they were initially unaware that the patient had received the J&J vaccine but learned about the J&J vaccination after the Moderna dose was given. The patient was fully vaccinated and currently had no untoward effects. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received. Updated Patient Race and ethnic group, Dose 2 details.


VAERS ID: 1734135 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC 3180 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain
SMQs:, 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Meat allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101137340

Write-up: little twinges of pain in the center of my chest; This is a spontaneous report from a contactable consumer (patient). A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: fc 3180, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 24Aug2021 16:30 (age at vaccination 55 years) as dose 2, single for covid-19 immunisation. Medical history included, meat allergy, garlic allergy. There were no concomitant medications. The patient previously took bnt162b2 for covid-19 immunisation and experienced cefadroxil and duricef experienced drug allergy. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC7484, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 03Aug2021 04:30 (age at vaccination 55 years) as dose 1, single for covid-19 immunisation and experienced the first one she was itchy that night, that was it. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced couple days later getting these little twinges of pain in the center of his chest on 26Aug2021 that come and go. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1734704 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-23
Onset:2021-08-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Muscle spasms, Premenstrual syndrome
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Fertility disorders (broad)

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

Write-up: I had an extremely irregular period following my second vaccine (August). Severe PMS cramping and excessive heavy bleeding for 3 days which has never happened before. This was the first month after receiving the second vaccine. This month (September) my period is back to normal and not heavy with very little PMS symptoms. I didn?t think anything of it but after reading that this could be a side effect I wanted to report it to help with the clinical research.


VAERS ID: 1734935 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Blood test, Chest X-ray, Chest pain, Discomfort, Electrocardiogram, Gastrooesophageal reflux disease
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi-vitamin
Current Illness: N/A
Preexisting Conditions: Asthma
Allergies: Peanuts
Diagnostic Lab Data: (8/29, 9/18) Multiple CXRs, (8/29, 9/18) EKGs, (9/18) Blood work
CDC Split Type:

Write-up: Following administration of dose 1, the night of, chest pain and acid reflux occurred. (Pt has no history of acid reflux) Total doctor visits after due to discomfort: 3. Medications given: Prilosec and Pepsid. Symptoms did subside. Following administration of dose 2, the next morning, pain level 8 chest pain and acid reflux, epigastic pain. ER visit. Given GI cocktail. Symptoms subsided days after for the most part...currently comes and goes.


VAERS ID: 1735819 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-03-11
Onset:2021-08-26
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / 1 LA / IM

Administered by: Unknown       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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received J&J. Pt tested COVID + on 8/26/21 and admitted to hospital for COVID on 8/26/2021. Pt received remdesivir x3 doses and dexamethasone.


VAERS ID: 1735822 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-03-12
Onset:2021-08-26
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2021-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6204 / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / 1 LA / IM

Administered by: Unknown       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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt received Pfizer x2. Pt tested COVID + on 8/26/21 and admitted to hospital for COVID on 8/26/2021. Pt received remdesivir x4 doses and dexamethasone.


VAERS ID: 1735891 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Arthralgia, Body temperature increased, Chills, Diarrhoea, Fatigue, Myalgia, Sleep disorder, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), 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:
Other Medications: Nadolol 10mg @ 2/day Aspirin 83 @ 1/day Vitamin C 500 mg @ 2/day Vitamin D 2,000 iu @ 1/day Vitamin E 400 iu @ 1/day
Current Illness: None
Preexisting Conditions: None
Allergies: Slight problems with dairy, shellfish, & peanuts
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 8/26/21 10:00 PM - tired 10:10 - Chills, go to bed 10:30 - 98.6 11:00 - 100.5 11:25 - 101.7 11:30 Chills stopped 8/27/21 12:00 AM - 102.7 1:30 - 102.3 4:15 - 101.1 Daytime ~100.8 sleeping most of the day 6:15 PM - 102.2 8/28/21 12:15 AM - 102.8 muscle and joint aching begins 3:15 100.9 7:30 100.3 8:15 liquid diarrhea 10:30 - 99.8 11:00 - 99.5 11:30 last episode of diarrhea 3:15 PM - 98.4 10:45 normal 97.7 temperature 8/29/21 Normal BM - all symptoms subsided


VAERS ID: 1736040 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-29
Onset:2021-08-26
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 RA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Concussion, Face injury, Hyperhidrosis, Illness, Migraine, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia, Rash, Seizure, Sleep disorder, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: birth control
Current Illness:
Preexisting Conditions:
Allergies: possibly shrimp, pineapple, mushrooms and pollen
Diagnostic Lab Data:
CDC Split Type:

Write-up: The night of my first dose I got really sick and almost went to urgent care. I woke up in the middle of the night with a fever, chills, sweating and migraine. A week after my second dose (8/25/2021), I noticed my right bicep where I got the shot felt swollen and hurt while I was at work. When I got home I noticed a large swollen rash. The next morning it had spread, and urgent care prescribed a steroid and something for the itching. 6 days later (8/31/2021) I was taken by ambulance to the ER. They originally thought I had a seizure but have not performed the proper tests but a followup has determined it was possibly convulsive syncope and not a seizure. Also got a concussion from the accident and how hard I hit my face on the floor. Was advised by a nurse and a family friend with their doctorate to fill this out. I am the only person in my family that had a reaction to the vaccine.


VAERS ID: 1737022 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-18
Onset:2021-08-26
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Computerised tomogram, Sleep disorder, Vertigo
SMQs:, Vestibular disorders (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: Vitamin D3 Fish Oil Vit B12 Vit C Sertraline
Current Illness: None
Preexisting Conditions: None
Allergies: Amoxicillin Penicillins
Diagnostic Lab Data: CT Scan- Emergency room doc said results normal-everything ok--(I have the very extensive and usual technical notes they printed -too numerous to copy here)
CDC Split Type:

Write-up: Severe, sudden Vertigo- woke me up from sleeping


VAERS ID: 1737023 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-09-25
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 3 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Chills, Fatigue, Headache, Nasal congestion, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Losartan HCTZ. BABY ASA. Calcium. 2 vitamin D3
Current Illness: None
Preexisting Conditions: Hypertension
Allergies: Penicillin Norco
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Headache fever 100.5 chills. Nausea Stuffy nose aches Today tired and weak. Nearly better


VAERS ID: 1737060 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 2 LA / IM

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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unkown
Current Illness: none
Preexisting Conditions: none
Allergies: none listed
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient did fine with first moderna vaccine then received the second dose and developed hives that have been going on for about a month right now. The reaction was not anaphylactic and is present all over body. Patient saw primary care doctor but had not seen before so is referring to a specialist.


VAERS ID: 1737270 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Nevada  
Vaccinated:2021-03-27
Onset:2021-08-26
   Days after vaccination:152
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 UN / IM

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

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

Write-up: Positive Covid results


VAERS ID: 1737493 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pain in extremity, Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Adderall
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Tingling sensation in legs and arms. sometimes slightly painful sometimes itchy.


VAERS ID: 1737545 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C12A / 3 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Back pain, Fatigue, Injection site swelling, Injection site warmth, Spondylitis
SMQs:, Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril - 10 mg daily; Etodolac - 400 mg; Folic Acid - 1 mg; Methotrexate 2.5 mg - 8 tablets once a week; Zoloft - 50 mg daily; Prilosec - 20 mg twice a day; Requip - 1 mg tablet a day; Lopressor - 25 mg a day - 1 tablet a day; Levothyro
Current Illness: no
Preexisting Conditions: Rheumatoid Arthritis; Hashimoto''s thyroid; high blood pressure
Allergies: Latex sensitivity - gets very very red and itchy but not an allergy; lactose intolerant
Diagnostic Lab Data: no
CDC Split Type: vsafe

Write-up: After the injection (day after), it was swollen - a little bit and hot to the touch (at the injection site) and it lasted a day or so. The following week, I started to get back pain and I hadn''t experienced back pain before and it was mostly lower back pain and I was feeling tired day after day and then I started feeling better but then I started having back pain again. I saw Dr. (Sept 9th) for a routine appt and I told her about my lower back pain issues. She prescribed a muscle relaxer and she said I had arthritis in my back - she pulled up my old x-rays to see about it. She said we could do further tests later if it doesn''t resolved. The muscle relaxers worked and she recommended me to do ice and hot and stretching and I''m doing health care at home and it''s much improved. Seems to be resolving at this time.


VAERS ID: 1738268 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-08-22
Onset:2021-08-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Haematospermia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None at the moment. Idk where to go besides the ER and I really don''t feel like jerking off into a cup at the ER.
CDC Split Type:

Write-up: Blood in semen/ejaculate ongoing for 4 weeks.


VAERS ID: 1740020 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032B21A / UNK LA / OT

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

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

Write-up: They gave a first dose of Moderna COVID19 Vaccine to a 15 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (They gave a first dose of Moderna COVID19 Vaccine to a 15 year old) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (They gave a first dose of Moderna COVID19 Vaccine to a 15 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (They gave a first dose of Moderna COVID19 Vaccine to a 15 year old) outcome was unknown. 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 medication was reported. No Concomitant medication was reported. No lab data was provided.; Sender''s Comments: This case concerns a 15 year-old male patient with no reported medical history, who experienced the unexpected event of Product administered to patient of inappropriate age. The event occurred on the same day as the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1741149 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-20
Onset:2021-08-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 034C21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Rash, Rash pruritic
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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: morphine and morphine related products
Diagnostic Lab Data: blood work
CDC Split Type: vsafe

Write-up: I began having a itchy, painful bumps on my heel of my foot and my fingers. It spread to my whole body. I went to the doctor about this. They did blood work, which came back normal.


VAERS ID: 1743027 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Asthenia, Chest pain, Dizziness, Dyspnoea, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: Started later that evening served having chest pains shortness of breath light-headed this is continued now into September the 28th with no let-up seems to be getting worse just tightening eyesight has gotten very blurry and I don''t have any insurance and no one wants to listen absolutely no energy it was completely not what I was before this. Haven''t left the house now in 10 days cuz I don''t have the energy


VAERS ID: 1743516 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053C21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Computerised tomogram, Confusional state, Dizziness, Dyspnoea, Headache, Hyperhidrosis, Pyrexia, Sleep deficit, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: blood pressure; Result Unstructured Data: High; Test Date: 20210906; Test Name: blood pressure; Result Unstructured Data: High; Test Date: 20210830; Test Name: CT Scan; Result Unstructured Data: Cat Scan were splotches showing on the white matter of his brain they released him
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: sweating profusely from his palms and feet; dizziness; could not breathe; severe headache; Confusion; Sleep deprivation; High BP; chills; sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), CONFUSIONAL STATE (Confusion), SLEEP DEFICIT (Sleep deprivation), BLOOD PRESSURE INCREASED (High BP), HYPERHIDROSIS (sweating profusely from his palms and feet), DIZZINESS (dizziness) and DYSPNOEA (could not breathe) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced CHILLS (chills), VACCINATION SITE PAIN (sore arm) and PYREXIA (Fever). On 29-Aug-2021, the patient experienced HEADACHE (severe headache) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confusion) (seriousness criterion hospitalization), SLEEP DEFICIT (Sleep deprivation) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (High BP) (seriousness criterion hospitalization), DIZZINESS (dizziness) (seriousness criterion hospitalization) and DYSPNOEA (could not breathe) (seriousness criterion hospitalization). On 06-Sep-2021, the patient experienced HYPERHIDROSIS (sweating profusely from his palms and feet) (seriousness criterion hospitalization). The patient was hospitalized on 06-Sep-2021 due to BLOOD PRESSURE INCREASED, CONFUSIONAL STATE, DIZZINESS, DYSPNOEA, HEADACHE, HYPERHIDROSIS and SLEEP DEFICIT. At the time of the report, HEADACHE (severe headache), CONFUSIONAL STATE (Confusion), SLEEP DEFICIT (Sleep deprivation), BLOOD PRESSURE INCREASED (High BP), DIZZINESS (dizziness) and DYSPNOEA (could not breathe) outcome was unknown, HYPERHIDROSIS (sweating profusely from his palms and feet) and VACCINATION SITE PAIN (sore arm) had not resolved and CHILLS (chills) and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2021, Blood pressure measurement (97-166): 166/97 (High) High. On 30-Aug-2021, Computerised tomogram: abnormal (abnormal) Cat Scan were splotches showing on the white matter of his brain they released him. On 06-Sep-2021, Blood pressure measurement (97-166): 178/110 (High) High. Concomitant medication was not provided Treatment medication was not provided Company Comment: This case concerns a 51 year-old male patient, with no medical history reported, who experienced the unexpected adverse events of HEADACHE, DIZZINESS, DYSPNOEA, CONFUSIONAL STATE, SLEEP DEPRIVATION, BLOOD PRESSURE INCREASED and HYPERHIDROSIS. Events of headache, dizziness, dyspnoea, confusional state, sleep deprivation and blood pressure increased occurred 4 days after the second dose of Spikevax. Event of hyperhidrosis occurred approximately 12 days after the second dose of Spikevax. Negative rechallenge remains a confounder. The benefit-risk relation of Spikevax is not affected by this report. Further information is expected for assessment. This case was linked to MOD-2021-321038 (Patient Link).; Sender''s Comments: This case concerns a 51 year-old male patient, with no medical history reported, who experienced the unexpected adverse events of HEADACHE, DIZZINESS, DYSPNOEA, CONFUSIONAL STATE, SLEEP DEPRIVATION, BLOOD PRESSURE INCREASED and HYPERHIDROSIS. Events of headache, dizziness, dyspnoea, confusional state, sleep deprivation and blood pressure increased occurred 4 days after the second dose of Spikevax. Event of hyperhidrosis occurred approximately 12 days after the second dose of Spikevax. Negative rechallenge remains a confounder. The benefit-risk relation of Spikevax is not affected by this report. Further information is expected for assessment.


VAERS ID: 1745203 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-08-19
Onset:2021-08-26
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007B21A / UNK RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Muscle twitching, Pain, Skin lesion, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Dyskinesia (broad), Dystonia (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: bulls eye lesion that is still present several weeks later and comes and goes with pain and swelling, muscle twitches


VAERS ID: 1745712 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 LA / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) / SANOFI PASTEUR - / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Nausea, Pyrexia, Retching
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Glimepiride 2mg, omeprazole 40mg, estradiol 2mg, ropinerole 2 mg, montelukast 10mg, magnesium 250mg, multiple vitamin,
Current Illness: None
Preexisting Conditions: Diabetes, excema, asthma
Allergies: Levaquin, codeine
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Severe abdominal cramps, diarrhea, nausea, dry heaves, fever over 102


VAERS ID: 1745921 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-01
Onset:2021-08-26
   Days after vaccination:178
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020B21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, Back pain, COVID-19, Cough, Decreased appetite, Fatigue, Myalgia, Oropharyngeal pain, Pain in extremity, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test negative, Sinus congestion
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Taste and smell disorders (narrow), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lipitor 20mg, Doxepin Ambien PRN
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: Civid-19 Positive 08/28/2021
CDC Split Type: vsafe

Write-up: I started to get a runny nose. I then started to get a sore throat. I started to have pain in my large muscles. My lower back and quadriceps were hurting. I went to Urgent care and I tested positive for Covid-19 on 08/28/2021. I was not prescribed anything, but the doctor called me and told me I was positive. She told me to call if my congestion got worse they would recommend Regeneron. I had heavy congestion and coughing and I was tired. I had a loss of appetite because I lost my sense of smell and taste. I took some Advil which helped the muscle aches. I started to feel better after about a week. It has been four weeks and I still have some loss of taste but my sense of smell came back gradually over the last week. I am still congested in the morning and it feels like my Sinuses are a little blocked. I took a home test after 10 days and it was negative.


VAERS ID: 1747840 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Idaho  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: fever/high temperature; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever/high temperature) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced PYREXIA (fever/high temperature). At the time of the report, PYREXIA (fever/high temperature) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) Body temperature: High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment medications were not provided.


VAERS ID: 1747952 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 3 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Chest X-ray, Chills, Diarrhoea, Electrocardiogram, Fatigue, Gait disturbance, Headache, Immunisation, Lymphadenopathy, Malaise, Myalgia, Off label use, Pain in extremity, Vaccination site erythema, Vaccination site swelling, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asperger''s syndrome; Autism; Hashimoto''s disease (All the other health problems are due to her Hashimoto); Immune disorder (NOS); Thyroid disorder
Allergies:
Diagnostic Lab Data: Test Name: Chest x-ray; Result Unstructured Data: Test Result:Unknown Results; Comments: She went to the emergency room they did a chest x-ray; Test Name: ECG; Result Unstructured Data: Test Result:Fine; Comments: ECG at the emergency room and her heart was fine.
CDC Split Type: USPFIZER INC202101140940

Write-up: She had already had her vaccine and she went to get her booster last Thursday; She had already had her vaccine and she went to get her booster last Thursday; Injection site swelling; Injection site redness; Arm pain; Vomiting; Swollen lymph nodes; Diarrhea; Feeling unwell; Joint pain; Chills; Muscle pain; Tiredness; Headache; Barely walking, without throwing up or very dizzy; This is a spontaneous report from a contactable consumer (patient''s mother). A 19-year-old female patient (reporter''s daughter) received third dose as booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EW0175), via an unspecified route of administration, in right arm on 26Aug2021 (last Thursday) (at the age of 19-year-old) at 8 or 9 as dose 3 booster, single for covid-19 immunization, at hospital facility. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6202), via intramuscular route, in right arm on 24Feb2021 (at the age of 18-year-old) in morning and haven''t remember exact what time, as dose 1, single for covid-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL9261), via intramuscular route, in right arm on 17Mar2021 (at the age of 19-year-old) in the morning, as dose 2, single for covid-19 immunization, both at hospital facility. Medical history included autism, asperger''s syndrome, all the immune disorder (intent history), thyroid disorder (intent history; further clarifications unknown) and all the other health problems are due to her Hashimoto. Concomitant medications were reported as no. The patient did not receive any other vaccines within four weeks prior to the vaccination. She did not have any other medications at the time of vaccination or before vaccination. On an unspecified date in 2021, on Saturday, she took to emergency room due to arm pain, vomiting, swollen lymph nodes, diarrhea, feeling unwell, injection site redness, injection site swelling, tiredness, headache, barely walking, without throwing up or very dizzy. She has joint pain, chills, muscle pain. She has almost every side effect that all have, except for the heart. She has been sent to an endocrinologist every six month. The patient underwent lab tests and procedures which included ECG and her heart was fine, had chest X-ray at the emergency room. There was no blood work yet and she doesn''t have any laboratory work done and they said due to the side effects are from the vaccine and to go away within 10 days. Therapeutic measures were reported as no. The outcome of the events was reported as unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1747977 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Delirium, Pain, Pyrexia, Vaginal ulceration
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101190867

Write-up: delirium; Vaginal ulcers 48 hours after vaccine with high fever and body aches; Vaginal ulcers 48 hours after vaccine with high fever and body aches; Vaginal ulcers 48 hours after vaccine with high fever and body aches; This is a spontaneous report from a non-contactable consumer. This 33-year-old female consumer (patient) reported for herself that she received a 33 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Aug2021 at 14:30 at left arm for COVID-19 immunisation (age at vaccination: 33 years old). Medical history and concomitant drugs were not provided. The patient had Vaginal ulcers 48 hours after vaccine with high fever and body aches, delirium on 26Aug2021 14:00. Events resulted in Doctor or other healthcare professional office/clinic visit. Steroids were received as treatment. Outcome of the events was resolved in 2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1749336 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: New York  
Vaccinated:2021-02-11
Onset:2021-08-26
   Days after vaccination:196
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 010M20A / 2 AR / SYR

Administered by: Public       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Headache, Pain, Pyrexia, SARS-CoV-2 test positive, Sinus congestion
SMQs:, Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: B12; D3; Fish oil; Relaxine
Current Illness:
Preexisting Conditions:
Allergies: Neosporin ointment
Diagnostic Lab Data: COVID 19 positive.
CDC Split Type: vsafe

Write-up: I had body aches, severe headaches, loss of taste and smell, fever, and sinus congestion that is still persisting.


VAERS ID: 1749412 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-07-09
Onset:2021-08-26
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: International normalised ratio decreased
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: aspirin 81mg bisoprolol 5mg digoxin 125mcg simvastatin 20mg spironolactone 25mg torsemide 10 mg warfarin 5mg miralax
Current Illness: Total Hip replacement
Preexisting Conditions: Chronic congestive heart failure short term memory loss COVID Infection Aortic Aneurism osteoarthritis hyperparathyroidism Aortic dissection atherosclerotic heart disease of native coronary artery prosthetic aortic valve hypertension with chronic kidney failure onychomycosis malignant neoplasm of the prostate hematauria bicuspid aortic valve pulmonary hypertension hyperlipidemia mitral and tricuspid valve regurgitation esophageal refl
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient''s INR was decreased out of range a month and a half after first dose of vaccination after being within range for months and was low for many consecutive readings despite adjustments. Patient''s family was concerned that the decreased INR was due to the vaccine and requested it be reported to the CDC. No clotting events occurred due to out of range INR. Warfarin dose has been adjusted and INR is now back in range.


VAERS ID: 1749502 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Dyspepsia, Gastrooesophageal reflux disease, Insomnia, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific dysfunction (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: none
Current Illness: none
Preexisting Conditions: reactive airway disease
Allergies: nkda
Diagnostic Lab Data:
CDC Split Type:

Write-up: indigestion and acid reflux, tacchycardia, insomnia


VAERS ID: 1750010 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-05
Onset:2021-08-26
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Hot flush
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? No
Previous Vaccinations:
Other Medications: Gabapentin klonopin
Current Illness: None
Preexisting Conditions:
Allergies: Rocephin doxycycline levaquin
Diagnostic Lab Data:
CDC Split Type:

Write-up: I have begun having severe hot flashes after receiving the shot. I have not had them in several years and am 6 years post menopausal. The start coincided with the shot and getting Covid 5 days after the shot.


VAERS ID: 1750140 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 010M20A / 1 LA / UN
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032M20A / 2 - / UN
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 06ZE21A / 3 LA / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Computerised tomogram normal, Headache, Injection site pain, Migraine, New daily persistent headache, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: terazosin,sodium bicarbonate, furosemide,daily-vit, tacrolimu, ferosul,losartin,amlopidine,prednisone,vitamin D, pravastatin, mycophenolate, fluconazole, biotin, asprin
Current Illness:
Preexisting Conditions: diabetes, kidney failure, kidney transplant, high blood pressure, cholestrol
Allergies:
Diagnostic Lab Data: September 17 I went to the Er , they performed a catscan... did not see anything. said if it continued I should see a neurologist. gave me a migraine coctail I on August 29,2021 I had to go back to Er approx 10:oopm because of the pain. I ended up vomitting again. They ordered another ct scan, nothing showed up. gave me another migraine cocktaill. On August 9th, 2021 I saw my Nephrologist but she didn''t have any suggestions. I talked to her again on 09/28/2021 and she said I could take excederin migraine medicine but it small doses since it could cause further kidney failure. On September 10 and Septemeber 30 2021 I again went to Hospital but still no real answers. I did finally get an appnt for a neurologist but that isn''t until November 10,2021
CDC Split Type:

Write-up: The night of the vaccine I had a sore arm at injection site and a dull headache. by the next day, my arm was better but the headaches got progressively worse. I have had daily headaches/migraines every single day since August 26,2 2021 without a break. The migraines have been so severe that I ended vomitting on 9/28/2021 and 9/29/2021. please note that prior to the booster shot I did not get headaches or migraines. I went to urgent care on 9/29/2021 they presribed me butalbital. Please note... I was not given the actual time of the booster shot


VAERS ID: 1750421 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Kansas  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test normal, Cardiac flutter, Fatigue, Heart rate increased, Hypoaesthesia, Insomnia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tachyarrhythmia terms, nonspecific (narrow), Dehydration (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: Take Zyrtec occasionally when needed; Flonase daily, and a daily vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: On Sept 9, checked heart and ran blood test. Test came back normal.
CDC Split Type:

Write-up: Due to fluttering heart, I had difficulty sleeping between the hours of 1:00 a.m. and 5:00 a.m. on Aug 26 and Augt 27. On morning of Aug. 29 around 11am, I notice numbness in the 4th finger on my right hand. Today, I still have numbness and notice a bit of swelling but no discoloration. In general, my heart pace seemed high and overall fatigue for the initial 2 weeks following the vaccination. So much fatigue, I couldn''t properly mow my lawn on Sept. 5. Feeling great fatigue and concerned about my heart on Sept. 5, I schedule an appointment with a community doctor on Sept. 9.


VAERS ID: 1752009 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Extra dose administered, Fatigue, Influenza like illness, Nasopharyngitis, Off label use, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunocompromised (Patient is immunocompromised)
Allergies:
Diagnostic Lab Data: Test Name: Covid Test; Test Result: Negative ; Comments: Patient took two Covid tests on Sunday and received two negative test results back so far.; Test Name: Covid Test; Test Result: Negative ; Comments: Patient took two Covid tests on Sunday and received two negative test results back so far
CDC Split Type: USPFIZER INC202101147162

Write-up: tired; received a booster shot of the Pfizer Covid vaccine; received a booster shot of the Pfizer Covid vaccine; a deep chesty cough; cold; sore throat; flu like symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative reported for himself. A 37-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, batch/lot number: unknown), via an unknown route of administration on 26Aug2021 as dose 3, single for Covid-19 immunisation. The patient''s medical history included immunocompromised. Concomitant medication was not reported. The patient received BNT162B2 (COMIRNATY, Solution for injection, batch/lot number: unknown), on an unknown date as historical vaccine as dose 1 and 2, single for Covid-19 immunisation. The patient received a booster shot of the Pfizer Covid vaccine on Thursday, 26Aug2021. He felt somewhat tired on Friday, but then experienced many more symptoms starting on Sunday and continuing to today 01Aug. Patient reports that symptoms have increased in severity since Sunday. Symptoms include a deep chesty cough, cold, sore throat and other flu like symptoms. Event took place after use of product. Patient took two Covid tests on Sunday and received two negative test results back so far. The outcome of events was unknown. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1753294 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051E21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood test, COVID-19, Chest X-ray, Chest pain, Electrocardiogram
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Elderberry and Citracell fiber - but not the day of the vaccination.
Current Illness: No
Preexisting Conditions: No
Allergies: NO
Diagnostic Lab Data: EKG, xray of my lungs and bloodwork. And they said it was a reaction to the first shot and if I got another one it could get worse or better or stay the same.
CDC Split Type: vsafe

Write-up: Sat. Sept 18 I ended up back in the Emergency room. So I was having chest pains again - they did a EKG, xray of my lungs and bloodwork. And they said it was a reaction to the first shot and if I got another one it could get worse or better or stay the same. And then Sept 22nd I went to get the 2nd dose and the Pharmacist did not feel comfortable giving it to me because of the reaction from the first shot. To her it sounded like inflammation of the heart and advised I go see a Cardiologist. I''m still taking the naproxen that they gave me. She said I should come back in 6 months to try again- when I''m off the medications and not currently having chest pains. This past Mon Sept 27th I was diagnosed with COVID.


VAERS ID: 1753537 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: New York  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Arteriogram coronary abnormal, C-reactive protein increased, Chest discomfort, Coronary artery disease, Echocardiogram normal, Ejection fraction normal, Laboratory test, Magnetic resonance imaging heart, Myocardial oedema, Myocarditis, Pericardial effusion, Red blood cell sedimentation rate normal, Troponin, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: High sensitivity troponin, delta change 905, ESR 13, CRP 40.9, WBC 5.1 Echocardiogram 8/28/21- EF 60%, no pericardial effusion Coronary angiogram 8/30/21- mild non-obstructive CAD Cardiac MRI 9/1/21- mild mid lateral and basal inferiolateral delayed myocardial enhancement with mild lateral wall edema. Trace pericardial effusion with probable pericardial enhancement, Findings consistent with perimyocarditis, EF 65%
CDC Split Type:

Write-up: First Pfizer vaccine administered 8/25/21, Developed substernal chest pressure 8/26/21-8/27/21, presented to Hospital on 8/28/21 AM


VAERS ID: 1753639 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3184 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hypoaesthesia, Impaired work ability
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

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

Write-up: PATIENT EXPERIENCED NUMBNESS OF HR ARM THAT THEN SPREAD TO HER ENTIRE LEG ON THE RIGHT SIDE OF HER BODY. SHE HAS BEEN SEEN BY 3 PROVIDERS WITHOUT RESOLUTION OF SYMPTOMS. SHE CAN NOW WALK AGAIN AND MOVE HER ARM BUT HER THIGH IS STILL NUMB TO TOUCH. SHE HAS BEEN DENIED A MEDICAL EXEMPTION FROM HER DOCTOR AND FROM WORK.


VAERS ID: 1753905 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-02
Onset:2021-08-26
   Days after vaccination:205
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / -

Administered by: Unknown       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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of COPD
Allergies:
Diagnostic Lab Data: Cycle threshold 23.8 on admission
CDC Split Type:

Write-up: Patient admitted to the hospital for COVID 19. Reporting per Moderna COVID vaccine EUA.


VAERS ID: 1753929 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-16
Onset:2021-08-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 3 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ventricular extrasystoles
SMQs:, Ventricular tachyarrhythmias (narrow), Hypokalaemia (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: Tetanus Booster
Other Medications: Tamoxifen; gabapentin; doxepin; spironolactone; BYSTOLIC; lisinopril; RIALIN LAFAXON; multivitamin; vitamin D supplement; biotin
Current Illness: No
Preexisting Conditions: Breast cancer; chemotherapy cardiomyopathy (mild); congenital heart defect double aortic arch
Allergies: Strong reaction to tetanus booster; naproxen sodium; antifungal azithromax
Diagnostic Lab Data: No
CDC Split Type: vsafe

Write-up: I started experiencing pcp about 10 days after. It was noticeable on my smart watch on the EKG feature. I went on vacation thinking it would resolve itself. It did not. I was put on a device to track my heart rhythm but have not heard results yet. It comes and goes, it is not constant. It is still currently present and unresolved.


VAERS ID: 1754167 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Idaho  
Vaccinated:2021-08-13
Onset:2021-08-26
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (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: CELLCEPT
Current Illness: VASCULITIS, HIGH BLOOD PRESSURE
Preexisting Conditions: VASCULITIS
Allergies: BACTRIM
Diagnostic Lab Data:
CDC Split Type:

Write-up: SHINGLES.


VAERS ID: 1754272 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / UNK LA / -

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray normal, Chest pain, Differential white blood cell count normal, Dizziness, Electrocardiogram normal, Fatigue, Feeling of body temperature change, Full blood count normal, Hypoaesthesia, Laboratory test normal, Loss of personal independence in daily activities, Muscular weakness, Neuralgia, Paraesthesia, Troponin normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None.
Current Illness: None.
Preexisting Conditions: None.
Allergies: Allergic to penicillin and related antibiotics
Diagnostic Lab Data: Chest xray, chemistry panel, troponin, d-dimer, cbc, white blood cell differential, ekg. Everything turned out normal.
CDC Split Type:

Write-up: Dizziness, light-headedness, fatigue, severe nerve pain throughout body, numbing and tingling in the extremities. Alternating cold and burning sensations throughout body, like acid on the inside. Weakness in the limbs. Chest pains, now resolved. I feel like this has incapacitated me, impairing my ability to function in life.


VAERS ID: 1755881 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088D214 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident, Facial paralysis, Feeling abnormal, Gait disturbance, Guillain-Barre syndrome, Hemiparesis, Hypoaesthesia, Muscle twitching
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), 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: AMLODIPINE; BACLOFEN; PROMETHAZINE; AJOVY [FREMANEZUMAB]; TRIAMTERENE
Current Illness:
Preexisting Conditions: Comments: The medical history information was not provided by the reporter
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Doctor''s opinion was that it was gbs, Guillain barre syndrome; lost control of the left side of her body; her face was numb; Her coworkers and other people that talked to her said that her left eye was twitching a lot.; When she was walking her arm was like limping; started feeling bad on her left side; her body, and her face felt like she almost had a stroke; still has facial paralysis and still has not gained it/she has no feeling in the left side of her face; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (her body, and her face felt like she almost had a stroke), FACIAL PARALYSIS (still has facial paralysis and still has not gained it/she has no feeling in the left side of her face), GUILLAIN-BARRE SYNDROME (Doctor''s opinion was that it was gbs, Guillain barre syndrome) and HEMIPARESIS (lost control of the left side of her body) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The medical history information was not provided by the reporter. Concomitant products included FREMANEZUMAB (AJOVY [FREMANEZUMAB]) for Migraine, BACLOFEN for Muscle relaxation, PROMETHAZINE for Nausea and Migraine, AMLODIPINE and TRIAMTERENE. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced CEREBROVASCULAR ACCIDENT (her body, and her face felt like she almost had a stroke) (seriousness criterion medically significant), FACIAL PARALYSIS (still has facial paralysis and still has not gained it/she has no feeling in the left side of her face) (seriousness criterion medically significant), HEMIPARESIS (lost control of the left side of her body) (seriousness criterion medically significant), HYPOAESTHESIA (her face was numb), MUSCLE TWITCHING (Her coworkers and other people that talked to her said that her left eye was twitching a lot.), GAIT DISTURBANCE (When she was walking her arm was like limping) and FEELING ABNORMAL (started feeling bad on her left side). On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Doctor''s opinion was that it was gbs, Guillain barre syndrome) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (her body, and her face felt like she almost had a stroke), FACIAL PARALYSIS (still has facial paralysis and still has not gained it/she has no feeling in the left side of her face), HYPOAESTHESIA (her face was numb) and MUSCLE TWITCHING (Her coworkers and other people that talked to her said that her left eye was twitching a lot.) had not resolved and GUILLAIN-BARRE SYNDROME (Doctor''s opinion was that it was gbs, Guillain barre syndrome), HEMIPARESIS (lost control of the left side of her body), GAIT DISTURBANCE (When she was walking her arm was like limping) and FEELING ABNORMAL (started feeling bad on her left side) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Amlodipine and Triamterene is taking for Blood pressure. Patient did not receive any treatment. This case concerns a 43-year-old, female patient with previous relevant medical history of hypertension and use of concomitant medication amlodipine, who experienced the unexpected events of cerebrovascular accident, facial paralysis, Guillain-Barre Syndrome and hemiparesis. The events occurred 1 days after the first dose of mRNA-1273. The rechallenge was unknown since the events have not resolved. The medical history of hypertension and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 43-year-old, female patient with previous relevant medical history of hypertension and use of concomitant medication amlodipine, who experienced the unexpected events of cerebrovascular accident, facial paralysis, Guillain-Barre Syndrome and hemiparesis. The events occurred 1 days after the first dose of mRNA-1273. The rechallenge was unknown since the events have not resolved. The medical history of hypertension and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1756035 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
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 INC202101135871

Write-up: rash was all over his back, chest, arms and legs/widespread rash; This is a spontaneous report from a contactable pharmacist reported for her brother. A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported and Expiry Date of Covid 19 vaccine: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 24Aug2021 (at the age of 37-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history was none. Concomitant medication(s) included Ibuprofen and Diazepam, both taken for an unspecified indication, start and stop date were not reported. On 26Aug2021, the patient experienced rash was all over his back, chest, arms and legs/widespread rash. The clinical details of the events as follows: She stated her brother is in (City Name) and she is in (State name) and her brother wanted to come visit her in (State name) but she told her brother he could not come unless he was vaccinated. Her brother and his wife received their first Covid 19 vaccine last Tuesday and now her brother has this rash. He was the only one she knew of who had this type of reaction. She reported she had a couple of patients faint after getting the Covid 19 vaccine. She was calling on behalf of her brother who received his first dose of the Covid 19 vaccine last Tuesday, 24Aug2021 and probably around Thursday night, 26Aug2021, her brother got a rash but not on the arm where the injection was. The rash was all over his back, chest, arms and legs. She was asking if it was safe for him to get the second dose of the Covid 19 vaccine. She stated that the reaction did not happen within the first 4 hours after the injection. Her brother sent her a picture of the rash and it was not the Covid arm at the injection site and it did not look like measles but it was widespread. She clarified from the beginning of the call when she stated the rash was not on the arm where he received the injection, she meant it was not the Covid arm associated with the injection site. Her brother asked her if he should go to the urgent care but the caller told her brother the urgent care would just suggest Benadryl and he was already taking that and Zyrtec during the day. Her brother wife did say the rash was looking better. When probing medical history and concomitant medications she stated he might just take an Ibuprofen every now and then and a Diazepam every now and then for his muscles. He was a mechanic and has been for 20 years so his body is pretty beat up. There was no investigation assessment provided. The patient outcome of the event was Resolving at the time of this report. No follow-up attempts are possible; information about lot/batch number not available for [vaccine/BNT162B2. No further information is expected.


VAERS ID: 1757409 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cough, Fatigue, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Loratidine 10mg,, aspirin
Current Illness: Stage 3 kidney disease, COPD
Preexisting Conditions: COPD, asthma, allergies
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Nagging cough that went away after a week or so, waves of fatigue every few hours I cannot fight that force me to lay down and sleep


VAERS ID: 1757456 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Dizziness, Fatigue, Feeling abnormal, Feeling hot, Headache, Lymphadenopathy, Palpitations, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi vitamin and vitamin C
Current Illness:
Preexisting Conditions:
Allergies: Sulfa, Pen, food allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Starting 20 minutes after the 1st dose. Intense headache in the back of my head, dizzy/fuzzy feeling, tired, swollen face, swollen lymph glands in both the front and back of my neck and underarm areas. Pounding heart that was felt all over my body so bad that it was throbbing from head to toe. Severe joint pain all over my body/every joint, even my fingers and toes. Chest pain like my heart hurt. I did not have a fever from the vaccine, but I felt a heat in my body for several days. My worry is that if the first dose did this and I still have the heart, vascular, lymph and joint issues, then it may not be a good idea for me to get the 2nd shot for fear of making my symptoms worse or prolonged.


VAERS ID: 1757850 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053E21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Chest pain, Disturbance in attention, Dizziness, Dyspnoea, Dysuria, Fatigue, Feeling hot, Gastrointestinal inflammation, Headache, Heart rate irregular, Hypertension, Insomnia, Limb discomfort, Loss of personal independence in daily activities, Nausea, Neck pain, Oropharyngeal pain, Pain in extremity, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Arthritis (broad), Noninfectious diarrhoea (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heartbeats irregular; Iodine allergy (Allergic to the iodine contrast, they are still trying to figure out how to do it.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: Blood pressure; Result Unstructured Data: High; Test Date: 20210913; Test Name: Blood pressure; Result Unstructured Data: Blood pressure was OK
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: Chest pain; While she talks, she feels like gasping for air/felt lack of air she had to breathe through her mouth to get air in; Weakness; Felt like someone was rubbing her legs (like pressure); Throat pain; Felt pain like needles stabbing her in the neck area; Vomiting; Feeling feverish; Nausea; trouble concentrating/could not focus; Felt febrile (like burning inside but without actual temperature); Extreme tiredness; Feeling like fainting; High blood pressure; had to leave work because of her symptoms; intestines were "all swollen"; Pain in the arm of the injection; Difficulty to pee; Irregular heartbeat; Wasn''t able to sleep; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling like fainting), DYSPNOEA (While she talks, she feels like gasping for air/felt lack of air she had to breathe through her mouth to get air in), PAIN IN EXTREMITY (Pain in the arm of the injection), DYSURIA (Difficulty to pee) and HEART RATE IRREGULAR (Irregular heartbeat) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heartbeats irregular and Iodine allergy (Allergic to the iodine contrast, they are still trying to figure out how to do it). On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm of the injection), DYSURIA (Difficulty to pee), HEART RATE IRREGULAR (Irregular heartbeat), INSOMNIA (Wasn''t able to sleep) and HEADACHE (Headache). On 27-Aug-2021, the patient experienced GASTROINTESTINAL INFLAMMATION (intestines were "all swollen"). On 28-Aug-2021, the patient experienced DIZZINESS (Feeling like fainting), HYPERTENSION (High blood pressure), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to leave work because of her symptoms) and FATIGUE (Extreme tiredness). On 29-Aug-2021, the patient experienced DISTURBANCE IN ATTENTION (trouble concentrating/could not focus) and FEELING HOT (Felt febrile (like burning inside but without actual temperature)). On 30-Aug-2021, the patient experienced NECK PAIN (Felt pain like needles stabbing her in the neck area), VOMITING (Vomiting), PYREXIA (Feeling feverish) and NAUSEA (Nausea). On 31-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Throat pain). On 02-Sep-2021, the patient experienced LIMB DISCOMFORT (Felt like someone was rubbing her legs (like pressure)). On 04-Sep-2021, the patient experienced ASTHENIA (Weakness). On 06-Sep-2021, the patient experienced DYSPNOEA (While she talks, she feels like gasping for air/felt lack of air she had to breathe through her mouth to get air in). On 16-Sep-2021, the patient experienced CHEST PAIN (Chest pain). At the time of the report, DIZZINESS (Feeling like fainting), PAIN IN EXTREMITY (Pain in the arm of the injection), DYSURIA (Difficulty to pee), HEART RATE IRREGULAR (Irregular heartbeat), INSOMNIA (Wasn''t able to sleep), GASTROINTESTINAL INFLAMMATION (intestines were "all swollen"), HYPERTENSION (High blood pressure), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (had to leave work because of her symptoms), DISTURBANCE IN ATTENTION (trouble concentrating/could not focus), NECK PAIN (Felt pain like needles stabbing her in the neck area), OROPHARYNGEAL PAIN (Throat pain), LIMB DISCOMFORT (Felt like someone was rubbing her legs (like pressure)), CHEST PAIN (Chest pain), FEELING HOT (Felt febrile (like burning inside but without actual temperature)), ASTHENIA (Weakness), VOMITING (Vomiting), HEADACHE (Headache), PYREXIA (Feeling feverish) and NAUSEA (Nausea) outcome was unknown and DYSPNOEA (While she talks, she feels like gasping for air/felt lack of air she had to breathe through her mouth to get air in) and FATIGUE (Extreme tiredness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, Blood pressure measurement: high (High) High. On 13-Sep-2021, Blood pressure measurement: normal (normal) Blood pressure was OK. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. On 15-Sep-2021 patient had headache, felt a lack of air, low intensity and her heartbeat was still irregular, medium. On 16-Sep-2021, the patient felt irregular heartbeat, low intensity. On 17-Sep-2021, the patient felt chest pain, lack of air - low intensity. On 19-Sep-2021, the patient felt irregular heartbeat - low intensity. On20-Sep-2021, the patient felt lack of air - high intensity. On 21-Sep-2021, the patient felt lack of air - medium. The patient was worried that the second dose will make everything even worse, went to a cardiologist and talked with an internist by the phone. They took some blood work and a chest X-ray. Also, they ordered a CT scan of her lungs, results were not reported. Treatment information was not provided.


VAERS ID: 1758883 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Work       Purchased by: ?
Symptoms: Contusion, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), 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: None.
Current Illness: None.
Preexisting Conditions: None.
Allergies: None.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: She got her vaccine, she didn''t have any problems until about 2 days later. She has tingling, pins and needles usually in her left hand and lasts for up to 2 hours at a time. It usually subsides as the day goes on, but then sometimes it happens in her right arm and hand as well. This still continues, and has been bad since 3:00 AM on her left hand today. She has not gone to the doctor to seek medical advise. She bruises easily now since having the vaccine.


VAERS ID: 1759055 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-06-30
Onset:2021-08-26
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Adverse event
SMQs:

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

Write-up: N/A


VAERS ID: 1759061 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Burning sensation, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (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: none
Current Illness: none
Preexisting Conditions: Renal Agenesis
Allergies: none
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Extreme itching/burning on the palms of hands and soles of feet. This continued through the waiting period between dose 1 and 2 and became worse after dose 2. The itching/burning has since mostly subsided. The itching and burning became worse during the night hours.


VAERS ID: 1759426 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-01
Onset:2021-08-26
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8733 / 2 LA / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6199 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram head, Echocardiogram, Electroencephalogram, Ischaemic stroke, Magnetic resonance imaging head, Seizure
SMQs:, Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None that I was aware of at time of vaccination
Allergies: N/A
Diagnostic Lab Data: CT scan 8/26/21 MRI 8/26/21 EEG 8/27/21 TEE 8/27/21
CDC Split Type:

Write-up: I experienced 3 ischemic strokes on 8/26/21 (44 years old) followed by 4 seizures (same day) with no family history of blood clots.


VAERS ID: 1759767 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-08-23
Onset:2021-08-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Dyspepsia, Hypoaesthesia, Muscle spasms, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NP Thyroid, Vitamins B12, B6, Zinc, D, C, Krill Oil, CoQ-10
Current Illness: None
Preexisting Conditions: Arthritis,
Allergies: Morpine, Demerol, Flagyl, food sensitivities
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Extreme dizziness out of the blue on day 4. Numbness/tingling in left hand up to elbow, and the pinky and next finger. Left knee numbness, especially if sleeping on the left side. Right foot, calf pain, cramping that sometimes go up the thigh. Continued dizziness and 4 weeks of severe indigestion.


VAERS ID: 1761337 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-04-14
Onset:2021-08-26
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003A21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 008B212A / 2 RA / IM

Administered by: Public       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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tested Positive for Covid


VAERS ID: 1761509 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2020-12-23
Onset:2021-08-26
   Days after vaccination:246
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0140 / 1 AR / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1284 / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, COVID-19, Fatigue, Pain, Pyrexia, SARS-CoV-2 test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: SARS C0V Rapid- Positive 8/30/21
CDC Split Type:

Write-up: 8/28/21 developed symptoms of weakness, fatigue, body aches, and fevers. Fully vaccinated. given IV fluids, supportive cares for at home return if 02 levels drop.


VAERS ID: 1761622 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-14
Onset:2021-08-26
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray, Chest tube insertion, Computerised tomogram, Dyspnoea, Laboratory test, Pleural effusion, Pleurisy, Pneumonia, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

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? Yes, 13 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Nexium
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Lab tests, ct scans and chest X-rays dates ranging from 8/26- present.
CDC Split Type:

Write-up: Pleural effusion, pneumonia, pleurisy, shortness of breath, tachycardia, chest tube placement,.


VAERS ID: 1761687 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-21
Onset:2021-08-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA CUS 5739 / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, Fatigue, Fungal infection, Insomnia, Nausea, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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: Hyqvia Subcutaneous IGG therapy Tirosint levothyroxine Symbicort asthma inhaler Spiriva asthma inhaler QVar asthma inhaler Singulair Xyzal
Current Illness: IGG subclass deficiency fibromyalgia Hashimoto''s hypothyroidism mild asthma
Preexisting Conditions: IGG subclass deficiency fibromyalgia Hashimoto''s hypothyroidism mild asthma
Allergies: sulpha containing medications Penicillin (not true allergy, but causes puritis) Armour thyroid (porcine derived)
Diagnostic Lab Data:
CDC Split Type:

Write-up: I obtained a Moderna booster vaccine due to innate IGG subclass immune deficiency. For 5 days after the vaccine shot, I was extremely nauseated and tired. On the 5/6th day a strong, body-wide itching began under my skin, so badly I couldn''t sleep for 3 days, despite being on antihistamines. Delayed reactions to medicines are typical for me. After 3 sleepless nights, I called Dr, who advised taking 4 Xyzal per day and the maximum amount of Benadryl and Singulair each day. He also agreed that I should use Diflucan and antifungal creams to treat for a systemic yeast infection. The maximum antihistamines and antifungals controlled the itching enough to get some sleep. Still, with treatment, the itching persisted for more than 14 days. I had felt this body-wide under-skin itching sensation before when I was allergic to a medication or, more mildly, when I had a yeast infection. We believe the full dose of the Moderna booster diverted my weak immune system entirely away from the usual task of keeping yeast in check, thus letting a body-wide yeast infection take hold. Given the outcome, it may be worth halving the dose of Moderna boosters for immune compromised individuals in order to avoid overwhelming the limits of a curtailed immune systems, allowing other opportunistic infections to take hold.


VAERS ID: 1762171 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray normal, Dyspnoea, Full blood count, Hypoxia, Laboratory test normal, Metabolic function test, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Stiloto, Flovent, Prednisone, Duoneb, Norvasc, losartan, citalopram calcium/vit d
Current Illness: None
Preexisting Conditions: Lymphoma status post treatment with Rituxin , last treatment 8/29/2020. Hypertension. COPD/emphysema. Mood disorder.
Allergies: None
Diagnostic Lab Data: Chest x-ray, CBC CMP, Covid testing 8/24 and 8/27.
CDC Split Type:

Write-up: Fever, increased Sob. Labs and chest x-ray normal. Hypoxia. Treated with Z-pack and prednisone 40 mg qd x 5 days. 3 Days later, symptoms worsened, seen in ER and admitted with hypoxia. Treated with IV Prednisone, antibiotics.


VAERS ID: 1764043 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-01-04
Onset:2021-08-26
   Days after vaccination:234
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011L20A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Balance disorder, Dizziness, Gait disturbance, Loss of consciousness, Loss of personal independence in daily activities, Neck pain, Off label use, Pain in extremity, Vertigo, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Tendinopathies and ligament 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: METOPROLOL; CALCIUM; VITAMIN D3; MAGNESIUM
Current Illness: Osteoporosis
Preexisting Conditions: Medical History/Concurrent Conditions: Vertigo
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20213

Write-up: unstable enough to need help walking anywhere; needs help walking; forced her to change her lifestyle significantly; Blacked out; vomiting; Incapacitating muscle ache in left shoulder; strong arm pain in left shoulder; vertigo; dizziness; pain in the left side of her neck/couldn''t move her neck; got a 3rd dose of the Moderna Covid-19 Vaccine in her left arm despite not being immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 032L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoporosis. Concomitant products included METOPROLOL, CALCIUM, VITAMIN D3 and MAGNESIUM for an unknown indication. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 100 microgram. On 26-Aug-2021, the patient experienced OFF LABEL USE (got a 3rd dose of the Moderna Covid-19 Vaccine in her left arm despite not being immunocompromised). On 12-Sep-2021, the patient experienced PAIN IN EXTREMITY (strong arm pain in left shoulder), VERTIGO (vertigo), DIZZINESS (dizziness), NECK PAIN (pain in the left side of her neck/couldn''t move her neck) and VOMITING (vomiting). 12-Sep-2021, the patient experienced ARTHRALGIA (Incapacitating muscle ache in left shoulder). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criterion medically significant), BALANCE DISORDER (unstable enough to need help walking anywhere) and GAIT DISTURBANCE (needs help walking). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out), BALANCE DISORDER (unstable enough to need help walking anywhere), GAIT DISTURBANCE (needs help walking) and VOMITING (vomiting) outcome was unknown, OFF LABEL USE (got a 3rd dose of the Moderna Covid-19 Vaccine in her left arm despite not being immunocompromised), PAIN IN EXTREMITY (strong arm pain in left shoulder), NECK PAIN (pain in the left side of her neck/couldn''t move her neck) and ARTHRALGIA (Incapacitating muscle ache in left shoulder) had resolved and VERTIGO (vertigo) and DIZZINESS (dizziness) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. She performed an Epley Maneuver for dizziness, but it caused her to temporarily black out. It also made the dizziness worse. dizziness. Patient reported that Every night when she got up during the night and every morning when arising, she was dizzy and unstable enough to need help walking anywhere. The dizziness tends to subside somewhat by early afternoon. After that, she generally felt closer to normal and steadier on legs, able to take a 30 minute walk. On 23SEP2021, she even ran a bit, optimistic that problems were over. On the contrary, the next morning, 24SEP2021, the dizziness was even worse than before. This case was linked to MOD-2021-331002 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow up received contains Reporter details, Patient details, Medical history, Product details, Concomitant drugs, New events.; Sender''s Comments: This is a case of an Off-label use of the vaccine that concerns an 84-year-old female patient with no relevant medical history who received a third dose of the mRNA-1273 (Moderna COVID-19 Vaccine), who experienced the unexpected event of Loss of Consciousness. The event occurred on an unknown date after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1764123 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Unknown  
Location: New York  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product 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.MOD20213

Write-up: Vaccine administered 24 hrs after 1st punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 hrs after 1st punctured) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 hrs after 1st punctured). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 hrs after 1st punctured) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up document received contains No New Information


VAERS ID: 1764322 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Unknown  
Location: New York  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product 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.MOD20213

Write-up: Expired vaccine used vial punctured before 24 hours of administration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used vial punctured before 24 hours of administration) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used vial punctured before 24 hours of administration). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used vial punctured before 24 hours of administration) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information reported. No treatment medication information reported. This case was linked to MOD-2021-332841 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information was received include no new information.


VAERS ID: 1764570 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-01-21
Onset:2021-08-26
   Days after vaccination:217
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Cough, Fatigue, SARS-CoV-2 test positive
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN
Current Illness:
Preexisting Conditions: HYPERLIPIDEMIA
Allergies:
Diagnostic Lab Data: POSITIVE COVID
CDC Split Type:

Write-up: FATIGUE, COUGH


VAERS ID: 1764592 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-01-22
Onset:2021-08-26
   Days after vaccination:216
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025J20A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030L20A / 2 RA / IM

Administered by: Public       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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tested positive for Covid


VAERS ID: 1764622 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-07-08
Onset:2021-08-26
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821281 / 1 LA / IM

Administered by: Public       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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tested Positive for Covid


VAERS ID: 1764676 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-06-02
Onset:2021-08-26
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0170 / 2 RA / IM

Administered by: Public       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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tested Positive for Covid


VAERS ID: 1764835 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-04-04
Onset:2021-08-26
   Days after vaccination:144
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6199 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8730 / 2 LA / IM

Administered by: Public       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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tested Positive for Covid


VAERS ID: 1765495 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-22
Onset:2021-08-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Cognitive disorder, Extra dose administered, Fine motor skill dysfunction, Full blood count, Hypertension, Hypoaesthesia, Hyporesponsive to stimuli, Nausea, Neuropathy peripheral, Pain, Pain in extremity, Paraesthesia, Retching
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Yes
Current Illness: No
Preexisting Conditions: 8 years ago prostatectomy; Prostate cancer metastasized to all bones except forearm and arms
Allergies: Sulfa; levofloxacin
Diagnostic Lab Data: CBC; Blood Panel
CDC Split Type: vsafe

Write-up: There were no immediate adverse events such as flu like symptoms, arrhythmia, breathing issues etc. We did notice that following his 3rd dose, his blood pressure was running high for the next number of weeks until as recent as 10/5. He has been taking medication and PRN benazepril for any reading with diastolic of 85 or systolic is 150 or higher. He has had to take these multiple times. Over this time starting on 9/30, because the pain in his legs were so severe, he was put on 25mg tramadol. It did not help so it went up to 50mg. It went up again to 75mg which caused nausea. He was taken off of tramadol. He is now on Zanaflex. His gabapentin has also been increased from 1500 to 1800mg. He is also experiencing progressively bad nausea. It started lightly and then gradually got to dry heaving and retching. We work with a mental cognition program for about 33 days straight. I have noticed over the last week that Norman''s cognition has dropped a little. Also his response rate has decreased. His dexterity has also been affected in both hands. His finger in his right hand has tingling and numbness. His oncologist has stated this is some kind of neuropathy and can be unrelated to his cancer. She has even put this in writing. It leads to question if the vaccine could be linked to the pain he is experiencing.


VAERS ID: 1766126 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 058E21A / 3 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prograf; Myfortic; Lipitor; Losartan; Amlodipine; Famotidine; Multivitamin; Calcium Supplement; D3 Supplement; Magnesium Supplement; Fish Oil; Probiotic; Tylenol.
Current Illness: Fractured Shoulder.
Preexisting Conditions: Post-Renal Transplant; Hypertension.
Allergies: Fragrances.
Diagnostic Lab Data: 8/31/2021--PCR test for COVID19 via Lab Q mobile testing. Received negative result on 9/1/2021.
CDC Split Type: vsafe

Write-up: I received my third Moderna dose on 8/26/2021 at about 3:30PM. Later that night between 11:00PM and midnight, I started to feel flu-like symptoms and developed a fever. I had very intense body aches, fever, nausea, headache, and extreme fatigue. The symptoms lasted for 2 days. My fatigue was so intense that I could barely even move myself to go to the bathroom (but I managed it). I took Tylenol to treat the symptoms, though it didn''t help much. I called my physician''s assistant on 8/27/2021 to let her know that I thought I might have COVID19. Since I am a post-transplant patient, she urged me to get tested as soon as possible, because if I tested positive, time was of the essence and I would need a monoclonal antibody transfusion. Thankfully, though, I ended up testing negative. I eventually got better afterwards.


VAERS ID: 1767367 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Idaho  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Extra dose administered, Fibrin D dimer, Fibrin D dimer decreased, Immunisation, Investigation, Joint swelling, Off label use, Peripheral swelling, Scan
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage laboratory terms (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: D-Dimer; Result Unstructured Data: Test Result:872 ng/ml; Comments: my D-Dimer was 872 ng/ml, which should be less than 500 ng/ml; Test Name: battery of tests; Result Unstructured Data: Test Result:came back normal; Comments: everything came back normal; Test Name: My right leg was scanned; Result Unstructured Data: Test Result:No Clots
CDC Split Type: USPFIZER INC202101214068

Write-up: my D-Dimer was 872 ng/ml, which should be less than 500 ng/ml; my right ankle swelled and spread into my foot; my right ankle swelled and spread into my foot; On 26Aug2021 I received my booster of your vaccine for Covid; On 26Aug2021 I received my booster of your vaccine for Covid; On 26Aug2021 I received my booster of your vaccine for Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 26Aug2021 as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Aug2021, patient received my booster of your vaccine for Covid. On 30Aug2021 patient right ankle swelled and spread into my foot. On 08Sep2021, patient physician ran a battery of tests and everything came back normal except that my D-Dimer was 872 ng/ml, which should be less than 500 ng/ml. Patient right leg was scanned the following day in search of blood clots. No Clots. Have no cause for this swelling and pain. Only thing out of the norm was the 3rd shot. The outcome of the events was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1767437 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-01
Onset:2021-08-26
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

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: Multiple sclerosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: USPFIZER INC202101243947

Write-up: tested positive for COVID-19; tested positive for COVID-19; This is a solicited report from a contactable consumer (patient) and healthcare professional, based on the information received by Pfizer (manufacturer control number: 2021SA284825). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose on Mar2021 (lot number and expiration ate not reported) at dose 1, single, then second dose on Apr2021 (lot number and expiration date not reported) at dose 2, single; both via an unspecified route of administration at the age of 63-years-old for COVID-19 immunisation; and teriflunomide (AUBAGIO 14 mg coated tablet), via oral from 12Jul2021 and ongoing at 14 mg, four times a day (QD) for multiple sclerosis. Medical history included ongoing multiple sclerosis. The patient''s concomitant medications were not reported. On 26Aug2021, the patient tested positive for COVID-19 (drug ineffective). It was stated that they wanted to start the patient on an intravenous medication Regen-COV and used Lexicomp for interactions and recommended to the physician. The patient was calling from her doctor''s office as she tested positive for COVID-19 after she had her Pfizer COVID-19 vaccine. The patient was prescribed with antibiotics and some other unspecified medications as treatments for the events. The events were ongoing. The patient called to ask if it was okay to take the medications given by her doctor with teriflunomide. As of time of report, teriflunomide was continued. The patient underwent SARS-CoV-2 test on 26Aug2021 with positive result. No additional information at the time of report. The events resulted in physician office visit and therapeutic measures were given as a result of the events. The action taken in response to the events for teriflunomide was unknown. Outcome of the events was not recovered. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1767518 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 2 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Dyspnoea, Heart rate increased, Hyperhidrosis, Oral pruritus
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE; DOXICILINA [DOXYCYCLINE]; FLONASE ALLERGY RELIEF; SINGULAIR; ZYRAC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animal; Allergy to plants; Anaphylaxis (Life threatening anaphylaxis after allergy shot (3 day hospitalization)); Fruit allergy; Grass allergy; Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101258730

Write-up: asthma attack; Sweating; elevated heart rate; itchy mouth shortly after 2nd dose; trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 26Aug2021 (Batch/Lot Number: EW0181) at the age of 36-years-old as dose 2, single for covid-19 immunisation. Medical history included life threatening anaphylaxis after allergy shot (3 day hospitalization), known allergy- penicillin, stone fruit, dogs, cats, weeds, grass and trees. The patient is not pregnant at the time of vaccination. Concomitant medications included sertraline; doxycycline (DOXICILINA); fluticasone propionate (FLONASE ALLERGY RELIEF); montelukast sodium (SINGULAIR) and cetirizine hydrochloride (ZYRAC) all taken for an unspecified indication, start and stop date were not reported. The patient previously received dose 1 of bnt162b2 (lot number: EW0181) on 04Aug2021 administered n the right arm for Covid-19 immunization. On 26Aug2021, the patient experienced asthma attack, sweating, elevated heart rate, itchy mouth shortly after 2nd dose and trouble breathing. The events required emergency room/department or urgent care visit. The patient was administered IV steroids and Benadryl. The events were assessed serious, medically significant. The outcome of t events was recovered on unspecified date.


VAERS ID: 1767529 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 3 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Extra dose administered, Feeling abnormal, Hypersensitivity, Hypoacusis, Off label use
SMQs:, Angioedema (broad), Dementia (broad), Hearing impairment (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID; PLAQUENIL; PROGESTERONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101259249

Write-up: received her third dose of the Pfizer COVID-19 vaccine; received her third dose of the Pfizer COVID-19 vaccine; hypersensitivity in the right ear; a sound of squealing in her right ear, like music that''s too loud but you can''t really hear it, it sounds like a scream; felt it going up the back of her neck and into her right ear; This is a spontaneous report from a contactable other hcp. A 43years-old female patient received BNT162b2 (Pfizer BioNTech, Solution for injection, Lot No: EW0175; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in Arm Right on 26Aug2021 as 3rddose, single for covid-19 immunisation (Age at vaccination was 43 years). Historical vaccine was A 43 years-old female patient received BNT162b2 (Solution for injection, Lot No: EK5730; NDC, and expiration date unknown), via an unspecified route of administration, administered in left arm on 21Dec2020 as1st dose, single for covid-19 immunisation, COVID-19 confirmed by positive COVID-19 test, and A 43 years-old female patient received BNT162b2 (Solution for injection, lot EK9231, NDC 59267100001, and expiration date 11Jan2021), via an unspecified route of administration, administered in right arm on 11Jan2021 as 2nd dose, single for covid-19 immunisation confirm COVID-19 confirmed by positive COVID-19 test, HPV(HPV vaccine). Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported; hydroxychloroquine sulfate (PLAQUENIL) taken for an unspecified indication, start and stop date were not reported; progesterone (PROGESTERONE) taken for an unspecified indication, start and stop date were not reported. The patient experienced received her third dose of the pfizer covid-19 vaccine (off label use) , received her third dose of the pfizer covid-19 vaccine (extra dose administered), hypersensitivity in the right ear, a sound of squealing in her right ear, like music that''s too loud but you can''t really hear it, it sounds like a scream, felt it going up the back of her neck and into her right ear on 26Aug2021. Upon Follow-up on23Sep2021new information was updated. This is a follow up spontaneous report from a contactable Nurse (patient) reported for herself that Verbatim event relatedness, dose description (1,2 and 3, anatomical location of administration, Lot Number, Lot Expire Date), concomitant products, medical history details, investigation assessment no. No. of previous doses competed her dosing this year, but this was the second dose. Follow-Up (27Sep2021): Follow-up attempts are completed. No further information is expected. The clinical outcome of the events experienced received her third dose of the pfizer covid-19 vaccine (off label use) , received her third dose of the pfizer covid-19 vaccine (extra dose administered) was unknown , hypersensitivity in the right ear was not recovered , a sound of squealing in her right ear, like music that''s too loud but you can''t really hear it, it sounds like a scream, felt it going up the back of her neck and into her right ear was not recovered. Follow-up(23Sep2021): This is a follow up spontaneous report from a contactable Nurse. This 43-year-old female Nurse(patient) reported for herself that Verbatim event relatedness, dose description (1,2 and 3, anatomical location of administration, Lot Number, Lot Expire Date), concomitant products, medical history details, investigation assessment no. No. of previous doses competed her dosing this year, but this was the second dose. Follow-Up (27Sep2021): Follow-up attempts are completed. No further information is expected.


VAERS ID: 1768332 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Migraine, Pruritus, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (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: Chlorthalidone, 25 mg, 1/2 tab; Amitriptyline 10 mg; Atorvastatin 10 mg; multivitamin; magnesium citrate, calcium citrate, potassium, CO10, Colase.
Current Illness: None.
Preexisting Conditions: Osteoporosis, migraine headaches, thyroid goiter.
Allergies: None. Nausea and vomiting with codeine.
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 1st Moderna vaccine--7/22/21: had migraine headache, very sore and red arm at injection site. 2nd Moderna vaccine--8/25/21; had migraine headache over 5 days, took 4 doses of Imitrex (very unusual); 8/27-9/1 developed bright red rash over all of torso, front and back, including even brighter red rash at injection site, took Benadryl, slight itching when resolving. No shortness of breath.


VAERS ID: 1768708 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-08-26
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8848 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperhidrosis, Pallor
SMQs:, Neuroleptic malignant syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: After injection, patient became diaphoretic and pale. Patient reclined his car seat and was closing his eyes but remained fully responsive to verbal stimuli. Ice pack applied to forehead and base of neck. B/P 128/84,pulse 70 BPM and SPO2 99%. Patient was observed additional 15 minutes. Patient reported feeling much better and returned to baseline prior to his departure with driver.


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