National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

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

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



Case Details (Reverse Sorted by Onset Date)

This is page 297 out of 7,116

Result pages: prev   198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396   next


VAERS ID: 1627961 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-04-01
Onset:2021-08-02
   Days after vaccination:123
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006B21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Pain, Spinal pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Atorvastatin calcium 10 mg tap one per evening Spirvia 18 mcg per capsule Acycolvir 400 mg tab, 1/2 twice daily
Current Illness: none
Preexisting Conditions: COPD Arthritis (AS)
Allergies: Crab allergies
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Chronic pain the lower spinal column every morning for the last month or so Chronic pain in the Sternum every morning; When I would have a arthritis flair up they would normally last 2 or 3 days, not it''s every morning, I wake up normally around 3 a.m. with pain my lower back and sternum .


VAERS ID: 1628214 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-07-30
Onset:2021-08-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Dizziness, Fatigue, Head discomfort, Hypoaesthesia, Injection site pruritus, Injection site swelling, Paraesthesia, Paraesthesia oral, Rhinorrhoea, Sneezing, Tinnitus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: tinnitus
Preexisting Conditions: tinnitus
Allergies: dust, mold, pet allergies
Diagnostic Lab Data: none to date
CDC Split Type:

Write-up: First symptom was swollen and itching injection site. (08/02/2021) Next symptom was severe and constant sneezing and runny nose, heavy fatigue (08/02/2021 - 08/20/2021 except for fatigue which is ongoing) Next symptom Pulsatile Tinnitus upon rising from sleep, Tinnitus symptoms much worse and louder than before, tingling on end of tongue and tingling, numbness in left arm, fingers and face, dizziness and fullness of head(08/22-2021- present)


VAERS ID: 1628387 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

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

Write-up: Covid vaccine given to under age 12


VAERS ID: 1629720 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-18
Onset:2021-08-02
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 033C21A / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Infection
SMQs:, Termination of pregnancy and risk of abortion (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: N/A
Current Illness: N/A
Preexisting Conditions: Endometriosis, infertility
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Late July 2021 I had a bartholin gland infection and also a miscarriage around 6 weeks the first/second week of August. The bartholin gland infection required antibiotic treatment and an incision to drain. I don''t think either of these are related to the vaccine, I just noted these issues because the questionnaire asked about health issues that I have experienced since my last check in, so I''m filling out the report as requested. I have fully recovered from both issues.


VAERS ID: 1631061 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Maryland  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to animals; Immunodeficiency; Iodine allergy.
Preexisting Conditions: Comments: The patient had allergy to various medications and also had 3 to 4 autoimmune diseases.
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: SARS-CoV-2 ELISA test; Result Unstructured Data: 25.3; Test Date: 20210802; Test Name: SARS-CoV-2 IgA antibody test; Result Unstructured Data: 0.13; Test Date: 20210802; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: 0.13.
CDC Split Type: USJNJFOC20210842932

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 60 year old white and non Hispanic or Latino female. The patient''s weight was 118 pounds, and height was 62 inches. The patient''s concurrent conditions included: primary immunodeficiency along with 3 to 4 other autoimmune diseases, dog allergy, cat allergy, and iodine allergy, and other pre-existing medical conditions included that he patient had allergy to various medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total administered on 08-APR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the patient tested positive for the Protein receptor binding domain (antibody) test (SARS-CoV-2 ELISA (Enzyme linked Immunoassay) test) (NR: not provided) 25.3. On 02-AUG-2021, the patient tested negative for SARS CoV-2 s1 IgA (Immunoglobulin A) IgG (Immunoglobulin G) test (SARS-CoV-2 IgA antibody test) (SARS-CoV-2 IgG antibody test) (NR: not provided) 0.13 (confirmed immunological vaccine failure). The patient visited to the physician office. The immunologist suggested for a second shot of the Janssen Covid-19 (Corona virus) Vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210842932-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1632432 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-02-17
Onset:2021-08-02
   Days after vaccination:166
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM9809 / 2 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Infusion, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lisinopril; Statin
Current Illness: No
Preexisting Conditions: No
Allergies: Shelled shrimp
Diagnostic Lab Data: COVID-positive
CDC Split Type: Vsafe

Write-up: On 8/2 after being fully vaccinated I tested positive to COVID. I experienced SOB but no other symptoms were associated. 8/4 I had the infusion.


VAERS ID: 1632967 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-05-08
Onset:2021-08-02
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 UN / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Acute respiratory failure, Asthenia, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Chills, Cough, Diarrhoea, Dyspnoea, Intensive care, Lung infiltration, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Patient is a 60 y.o.male with PMH DM2, HTN, dyslipidemia who presents to ED on 8/2/2021 for worsening SOB, weakness and dry cough at home. He reports fevers, chills and diarrhea. He initially came to the ED on 7/29/2021- he was not hypoxic so he was sent home. He then had worsening symptoms so returned. Rapid test positive int he ED 8/2/2021. CXR with progression of bilateral infiltrates. Admitted, provider consulted on 8/2/2021 for COVID PNA, acute resp failure, increasing O2 requirement. Hospital course: 8/2- admitted; Actemra. 8/3- Provider consulted, on heated high flow nasal cannula. 8/4- transfer to ICU status


VAERS ID: 1633024 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-22
Onset:2021-08-02
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038A21A / 1 UN / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037B21A / 2 UN / SYR

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

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

Write-up: On supplemental O2, Decadron, Remdesivir (8/11/2021)


VAERS ID: 1636460 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-07-30
Onset:2021-08-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Migraine
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: Pristiq 25 mg 1 PO QOD
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: PCN
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Patient has experienced recurrent/more frequent migraines than ever experienced before post vaccination.


VAERS ID: 1636692 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: No adverse event, Product storage error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AR2170

Write-up: vaccine used past the 12 hour window of use after vial punctured. Stored in fridge entire time and cleaned between each use with alcohol. Pt contacted and no adverse reaction, pt states no problems


VAERS ID: 1636724 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-22
Onset:2021-08-02
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6206 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Chest X-ray, Diarrhoea, Nausea, SARS-CoV-2 test, Sinus operation, Upper respiratory tract infection, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: HTN, kidney disease, Dialysis, goodpasture syndrome
Allergies: Hydralazine
Diagnostic Lab Data: CXR, covid test.
CDC Split Type:

Write-up: URI, nasal drainage, nausea, vomiting, abdominal pain, diarrhea.


VAERS ID: 1636977 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-03-24
Onset:2021-08-02
   Days after vaccination:131
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN9581 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Difficulty breathing, hospitalization, high flow oxygen treatment


VAERS ID: 1637024 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

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

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

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


VAERS ID: 1637037 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

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

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

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


VAERS ID: 1637063 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

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

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

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


VAERS ID: 1637123 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-17
Onset:2021-08-02
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9266 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Cough, Myalgia, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PCR + for COVID-19
CDC Split Type:

Write-up: Muscle aches, Runny nose/Congestion, Cough, positive COVID-19 test


VAERS ID: 1637273 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-05-21
Onset:2021-08-02
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Cough, Headache, Laboratory test abnormal, Paranasal sinus discomfort, Pyrexia, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), 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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Asthma
Allergies: None
Diagnostic Lab Data: Drive-through COVID-19 testing center on 8/2/21 - POSITIVE Result BinaxNOW COVID-19 Self Test on 8/3/21 - POSITIVE Result
CDC Split Type:

Write-up: Sinus pressure/headache, runny nose, fever/chills, cough, loss of taste & smell


VAERS ID: 1637294 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-11
Onset:2021-08-02
   Days after vaccination:144
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013A21A / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: PCR+ COVID-19 test
CDC Split Type:

Write-up: Positive covid-19 PCR test and hospitalization


VAERS ID: 1641242 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-07-31
Onset:2021-08-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 AR / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram, Magnetic resonance imaging abnormal, Magnetic resonance imaging heart, Myocarditis, Troponin increased
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: troponin levels Aug 3-6, 13,20 echocardiograms Aug 3, 4, 6, 27 ekgs Aug 3-6, 13, 20 cardiac MRI Aug 12
CDC Split Type:

Write-up: chest pain, shortness of breath, elevated troponin levels, myocarditis on MRI


VAERS ID: 1641299 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-22
Onset:2021-08-02
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea, Oropharyngeal pain, SARS-CoV-2 test positive, Upper respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: atorvastatin, benzonatate, lisinopril, metformin, pantoprazole
Current Illness:
Preexisting Conditions: Type 2 diabetes, chronic kidney disease
Allergies: No known drug allergies
Diagnostic Lab Data: SARS CoV2 PCR COVID-19 detected on 8/2/21
CDC Split Type:

Write-up: 8/2/21: The is a 70 year old female that came to the emergency room on 8/2/2021 complaining of coughing and shortness of breath. She has had signs of an upper respiratory infection sore throat then followed by a non productive cough for the last week. Her oxygen level was 90% u[on arrival and 3 Liters of O2 was stated. 8/7/21: completed remdesivir, on baricitinib; on heated-high flow 90% 60L supplemental O2 8/16/21: She was discharged home with 4L oxygen and home healthcare. Note: patient previously vaccinated with J&J COVID-19 vaccine on 3/22/2021 Lot Number 1805029.


VAERS ID: 1641392 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: North Dakota  
Vaccinated:2021-06-24
Onset:2021-08-02
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039C21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039C21A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Interchange of vaccine products
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: Cetirizine, Hydroxyzine, Paliperidone inj, Sertraline, Trazodone, Naltrexone inj
Current Illness: Unknown
Preexisting Conditions: Hepatitis C, Psychotic disorder, Paranoid schizophrenia, depressive disorder, alcohol dependence
Allergies: No known drug allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt presented for COVID-19 vaccine on 6/24/21 at community event. Pt filled out paperwork stating that this was his 1st COVID-19 Vaccine and he chose to get Moderna. Pt presented to the clinic on 8/2/21 for his 2nd dose of Moderna. Pharmacy staff received email from on 8/27/21 to look into pt as he may have received too many doses. Reviewed and noted that pt had also received the Pfizer COVID-19 Vaccine on 4/22/21 and 5/13/21 at another facility. Tried contacting pt to discuss if he had any side effects, however pt is currently incarcerated and I was unable to get ahold of him.


VAERS ID: 1641449 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-05
Onset:2021-08-02
   Days after vaccination:119
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6206 / 1 UN / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8732 / 2 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, COVID-19, Dehydration, Mental status changes, SARS-CoV-2 test positive, Urinary tract infection
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Eliquis, Namenda, Cardizem, Aricept, Cozaar, Pravachol
Current Illness:
Preexisting Conditions: HTN, afib, Alzheimers, COPD
Allergies: no known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Admission date 8/2/21. Had both doses Pfizer vaccine, last dose 4/5/21. Presented with generalized weakness, dehydration and AMS due to UTI. COVID test positive on 8/2 and 8/7/21. No treatment for COVID because pt had no SOB or hypoxia. Did receive IV fluids and antibiotics for UTI. Discharged 8/6/21.


VAERS ID: 1641785 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 088D21A / 1 LA / IM

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

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

Write-up: Moderna vaccine was given without regard to patient having had the Janssen covid vaccine on 3-12-21. Moderna was given as what the patient viewed as a needed "booster". There was no adverse effect or event that occurred as a result of the additional covid vaccination.


VAERS ID: 1642019 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Muscle spasms, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (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: 5mg amlodipine daily
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Next day I woke up to complete body soreness and fatigue. Day 2 had same symptoms as when I had Covid. Consisted of muscle cramping, fatigue, headache, chills, fever of 100 degree. Day 3 symptoms went away. Had positive Covid test December of 2020.


VAERS ID: 1642281 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-16
Onset:2021-08-02
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Blood test normal, Electrocardiogram normal, Heart rate irregular, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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: Lexapro (10 mg)
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Did an EKG and a series of blood tests on August 19th, and they all came out regular/negative.
CDC Split Type:

Write-up: Racing heart and irregular heartbeat for three weeks (and still ongoing).


VAERS ID: 1644343 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027D2IA / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Breast pain, Chest pain, Dizziness, Headache, Hypoaesthesia, Memory impairment, Myalgia, Pain in extremity, Pruritus, Tinnitus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Lipodystrophy (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

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

Write-up: numbness on my head/numbness in head/now the numbness has moved to the back of her head; feel dizzy; left arm pain; itching on forehead; left breast pain,; memory issue; scalp is making noises,; body aches; headache; chest pain on the left side; back pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead) and CHEST PAIN (chest pain on the left side) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D2IA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CLONAZEPAM and PERPHENAZINE for Paranoia, CHLORPHENAMINE MALEATE (CHLORAMINE S) and DIPYRIDAMOLE (PERSANTINE) for an unknown indication. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced CHEST PAIN (chest pain on the left side), BACK PAIN (back pain) and HEADACHE (headache). On an unknown date, the patient experienced HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead), BREAST PAIN (left breast pain,), MEMORY IMPAIRMENT (memory issue), TINNITUS (scalp is making noises,) and MYALGIA (body aches). On 06-Aug-2021, CHEST PAIN (chest pain on the left side) had resolved. At the time of the report, HYPOAESTHESIA (numbness on my head/numbness in head/now the numbness has moved to the back of her head), DIZZINESS (feel dizzy), PAIN IN EXTREMITY (left arm pain), PRURITUS (itching on forehead), BREAST PAIN (left breast pain,), MEMORY IMPAIRMENT (memory issue), TINNITUS (scalp is making noises,) and MYALGIA (body aches) outcome was unknown and BACK PAIN (back pain) and HEADACHE (headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Treatment was received by the patient Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up recieved ,events were updated, On 09-Aug-2021: Significant follow up- Events updated On 11-Aug-2021: significant follow up appended


VAERS ID: 1644408 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078C21A / 1 RA / OT

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

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

Write-up: lips also began to swell pretty bad; worst reaction; woke up the next morning covered in hives; full body rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (woke up the next morning covered in hives), RASH (full body rash) and LIP SWELLING (lips also began to swell pretty bad) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced URTICARIA (woke up the next morning covered in hives) (seriousness criterion medically significant), RASH (full body rash) (seriousness criterion medically significant) and VACCINATION COMPLICATION (worst reaction). On 03-Aug-2021, the patient experienced LIP SWELLING (lips also began to swell pretty bad) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and EPINEPHRINE (EPIPEN) at a dose of 1 dosage form. At the time of the report, URTICARIA (woke up the next morning covered in hives), RASH (full body rash), LIP SWELLING (lips also began to swell pretty bad) and VACCINATION COMPLICATION (worst reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter has asked is there anything she can ask for from her doctor that isn''t a steroid that can combat the rash. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: vaccine start date was updated, concomitant medicines were added : Benadryl and Wellbutrin. adverse events were added.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded


VAERS ID: 1644410 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-04-03
Onset:2021-08-02
   Days after vaccination:121
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 020B21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy, Erythema, Paralysis, Pruritus, Pyrexia, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EZETIMIBE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: negative for COVID 19.
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: small dots were mildly itchy; rash of small undefined 2 to 5 inches in diameter (didn''t have distinct edges) red patches, all over patient''s body, predominantly in torso, but also in arms, hands and legs,a small rash right above stomach on chest; fever, symptoms associated with the fever; Bell''s palsy on left side of face, a mild to moderate bell''s palsy; Partial Paralysis; rash of small undefined 2 to 5 inches in diameter (didn''t have distinct edges) red patches, all over patient''s body, predominantly in torso, but also in arms, hands and legs,small dots were not raised; This spontaneous case was reported by a consumer and describes the occurrence of BELL''S PALSY (Bell''s palsy on left side of face, a mild to moderate bell''s palsy) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included EZETIMIBE for an unknown indication. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced BELL''S PALSY (Bell''s palsy on left side of face, a mild to moderate bell''s palsy) (seriousness criterion medically significant) and PARALYSIS (Partial Paralysis). On an unknown date, the patient experienced ERYTHEMA (rash of small undefined 2 to 5 inches in diameter (didn''t have distinct edges) red patches, all over patient''s body, predominantly in torso, but also in arms, hands and legs,small dots were not raised), PRURITUS (small dots were mildly itchy), RASH (rash of small undefined 2 to 5 inches in diameter (didn''t have distinct edges) red patches, all over patient''s body, predominantly in torso, but also in arms, hands and legs,a small rash right above stomach on chest) and PYREXIA (fever, symptoms associated with the fever). At the time of the report, BELL''S PALSY (Bell''s palsy on left side of face, a mild to moderate bell''s palsy), PARALYSIS (Partial Paralysis), ERYTHEMA (rash of small undefined 2 to 5 inches in diameter (didn''t have distinct edges) red patches, all over patient''s body, predominantly in torso, but also in arms, hands and legs,small dots were not raised), PRURITUS (small dots were mildly itchy), RASH (rash of small undefined 2 to 5 inches in diameter (didn''t have distinct edges) red patches, all over patient''s body, predominantly in torso, but also in arms, hands and legs,a small rash right above stomach on chest) and PYREXIA (fever, symptoms associated with the fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jun-2021, SARS-CoV-2 test: negative (Negative) negative for COVID 19. The patient stated that the bumps did not respond to allergy medication or antihistamines. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1644434 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood urine present, Cerebrovascular accident, Hemiplegia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

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

Write-up: Stroke; Paralyzed on one side of the body; Urinating Blood; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), HEMIPLEGIA (Paralyzed on one side of the body) and BLOOD URINE PRESENT (Urinating Blood) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced BLOOD URINE PRESENT (Urinating Blood) (seriousness criterion hospitalization). On 03-Aug-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant) and HEMIPLEGIA (Paralyzed on one side of the body) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), HEMIPLEGIA (Paralyzed on one side of the body) and BLOOD URINE PRESENT (Urinating Blood) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. It was reported within 45 minutes after the first vaccine, patient was urinating blood. The next day after vaccination he had a stroke and became paralyzed on one side of his body. Patient Doctor''s say it was not related to the vaccine. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender''s Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.


VAERS ID: 1644638 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039B12A / 1 RA / 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? 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: Vaccine administered to a 14 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 14 years old) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B12A) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 14 years old). On 02-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to a 14 years old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication information was reported. The patient did not have any side effects. Treatment medications was not provided by the reporter.


VAERS ID: 1644872 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Fatigue, Musculoskeletal stiffness, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Neck was getting stiff; Extremely tired; Red, raised area about the size of a quarter; Vaccine stung really bad when injected; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red, raised area about the size of a quarter), MUSCULOSKELETAL STIFFNESS (Neck was getting stiff), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (Vaccine stung really bad when injected) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced VACCINATION SITE PAIN (Vaccine stung really bad when injected). On 11-Aug-2021, the patient experienced ERYTHEMA (Red, raised area about the size of a quarter). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Neck was getting stiff) and FATIGUE (Extremely tired). At the time of the report, ERYTHEMA (Red, raised area about the size of a quarter), MUSCULOSKELETAL STIFFNESS (Neck was getting stiff), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (Vaccine stung really bad when injected) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was reported.


VAERS ID: 1644913 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939982 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Feeling hot, Pain, Vaccination site swelling, Varicose vein
SMQs:, Guillain-Barre syndrome (broad), Arthritis (broad)

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

Write-up: Raised, hot, and painful on the right calf; Varicose Veins bulging out; Pain in the right side of body; Bulge on the injection site; Pain in the left knee; Has No Energy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Has No Energy), FEELING HOT (Raised, hot, and painful on the right calf), VARICOSE VEIN (Varicose Veins bulging out), PAIN (Pain in the right side of body) and VACCINATION SITE SWELLING (Bulge on the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939982) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced ASTHENIA (Has No Energy), PAIN (Pain in the right side of body), VACCINATION SITE SWELLING (Bulge on the injection site) and ARTHRALGIA (Pain in the left knee). On 03-Aug-2021, the patient experienced FEELING HOT (Raised, hot, and painful on the right calf) and VARICOSE VEIN (Varicose Veins bulging out). On 06-Aug-2021, FEELING HOT (Raised, hot, and painful on the right calf) and VARICOSE VEIN (Varicose Veins bulging out) had resolved. At the time of the report, ASTHENIA (Has No Energy), PAIN (Pain in the right side of body), VACCINATION SITE SWELLING (Bulge on the injection site) and ARTHRALGIA (Pain in the left knee) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.


VAERS ID: 1645375 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: California  
Vaccinated:2021-01-01
Onset:2021-08-02
   Days after vaccination:213
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Gastric cancer stage I
SMQs:, Non-haematological malignant tumours (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: METFORMIN; GLIPIZIDE; LISINOPRIL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: Diagnosed with stomach cancer 1st stage; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC CANCER STAGE I (Diagnosed with stomach cancer 1st stage) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included METFORMIN, GLIPIZIDE and LISINOPRIL for an unknown indication. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced GASTRIC CANCER STAGE I (Diagnosed with stomach cancer 1st stage) (seriousness criterion medically significant). At the time of the report, GASTRIC CANCER STAGE I (Diagnosed with stomach cancer 1st stage) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. Company Comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.


VAERS ID: 1646133 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-02-11
Onset:2021-08-02
   Days after vaccination:172
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3247 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 TEST; Test Result: Positive.
CDC Split Type: USPFIZER INC202100985659

Write-up: Tested (+) for Covid; Tested (+) for Covid; This is a spontaneous report from a contactable other hcp. A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: El3247, Expiration date: Unknown), intramuscular, administered in left arm on 11Feb2021 06:45 (at the age of 50-years-old) as dose 2, single and first dose via intramuscular, administered in left arm on Jan2021 04:45 (Batch/Lot Number: EL3247) as dose 1, single for covid-19 immunisation. It was unknown that, other vaccine was administered in four weeks. It was unknown that, other cations were given in two weeks. The patient did not have Covid prior vaccination. It was unknown that, if Covid tested post vaccination. Known allergies was reported as unknown. The patient''s medical history and concomitant medications were not reported. On 02Aug2021, the patient tested positive for covid. The patient underwent lab tests and procedures which included COVID-19 test: positive on 02Aug2021. No treatment was received for the event. The outcome of the event was recovering. Sender''s Comments: As there is limited information in the case provided, the causal association between the event Covid 19 and Vaccination failure and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the drug is evaluated as part of 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, as appropriate.


VAERS ID: 1646144 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Dyspnoea, Hyperhidrosis, Malaise, Myalgia, Nausea, Pain, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (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: CELEXA; IBUPROFEN; TYLENOL WITH CODEINE; AMOXICILLIN; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Oral infection; Slurred speech; Stroke; Vision abnormal (40% in both eyes)
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: temp; Result Unstructured Data: Test Result:99; Comments: going up; Test Date: 202108; Test Name: temp; Result Unstructured Data: Test Result:100.5; Comments: max; Test Date: 202108; Test Name: temp; Result Unstructured Data: Test Result:trending downward; Test Date: 202108; Test Name: temp; Result Unstructured Data: Test Result:101; Test Date: 202108; Test Name: temp; Result Unstructured Data: Test Result:100
CDC Split Type: USPFIZER INC202100985794

Write-up: fevers/starting off at 99 and going up to 100.5/101; chills; nausea; shortness of pain; felt unwell; short of breath; joint pain; muscle pain; mild arm soreness; sweating; This is a spontaneous report from a contactable consumer (patient''s mother). A 54-year-old male patient (son) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 01Aug2021 16:00 (batch/lot number FA7484 and expiry date 30Sep2021, NDC 59267-1000-02) at 54 years of age as dose 2, single (also reported as "unknown dosage; 1 cc 034") for covid-19 immunization. Medical history included stroke from Sep2020, slurred speech, vision damage (40% in both eyes), depression, infection in mouth. Concomitant medications included celecoxib (CELEXA) taken for depression, ibuprofen taken for an unspecified indication, codeine phosphate, paracetamol (TYLENOL WITH CODEINE) taken for an unspecified indication, amoxicillin taken for infection in mouth, atorvastatin taken for an unspecified indication; all start and stop date were not reported. The patient previously took dose 1 of BNT162B2 on 13Jul2021 (batch/lot number EW0198 and expiry date 30Sep2021, NDC: 59267-1000-02) at 54 years of age for Covid-19 immunization. The patient''s mother informed that her son received his first dose of the Pfizer COVID-19 Vaccination 13Jul2021 and then his second dose 01Aug2021 (4:00 pm) (2 days early). The patient''s mother informed that the patient was having fevers, headache, chills, nausea; all at 06:00 (02Aug2021); and joint pain, muscle pain, mild arm soreness, although no swelling noted, and sweating this morning; all on 02Aug2021. The mother informed that the patient has no rash, no swelling of his face and seemed like his heart was okay. The patient''s mother was giving him fluids as well as treating fevers with antipyretics. The patient''s mother informed that the patient fevers has been noted as starting off at 99 and going up to 100.5 temp max and trending downward during the call (unspecified date in Aug2021). The patient''s mother informed that the patient was okay when he got the shot and then this morning he has a little bit of a headache, a fever, some chills, and a little bit of nausea but he hasn''t thrown up, there was no swelling. The patient''s temperature kept going up, it was 99 and now it was 101 (unspecified date in Aug2021). The patient has been taking ibuprofen (expiration date 27Jul2022) and Tylenol. The patient''s mother asked if there was anything that the patient need to do in case it was not going down, and how high can the fever get before the patient needs to go in. The patient mother informed that the patient got side effects this morning today at 6:00 am. The patient''s mother informed the patient also has some "shortness of pain". The patient''s mother informed that she didn''t know what to do. The patient''s mother informed that the patient wanted to know about the maximum fever and what the side effects were doing to his body. The patient''s mother later clarified and confirmed that the patient did not take Tylenol but took acetaminophen and codeine tablet. The patient''s mother provided information off of the pharmacy bottle. The patient''s mother informed that the patient took Benadryl last night. The patient''s mother informed that the patient was also a stroke patient. The patient''s mother informed that the patient felt unwell (02Aug2021) and has chills and later clarified and confirmed that the patient did not have a headache. The patient''s mother informed that the fever went down to 100. The patient''s mother informed that the patient was okay last night, the fever was hovering about 101. The patient''s mother informed that the patient felt a little short of breath (02Aug2021) and sweating. The patient''s mother informed that all of these events were ongoing. The patient''s mother that the patient was to have a routine visit with his doctor tomorrow. The patient''s mother was concerned about where she would take her son if he were to worsen because the hospitals were full everywhere was full, you hate to be a part of it. The patient''s mother reiterates her desire to continue to take care of her son and monitor him closely. The reporter considered the events non-serious. The outcome of the events was not recovered.


VAERS ID: 1646204 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Burning sensation, Limb discomfort, Nausea, Pallor, Paraesthesia, Vertigo, Vitreous floaters
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Retinal disorders (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to antibiotic (Known allergies: Several antibiotics); Gluten sensitivity (Known allergies: Gluten)
Preexisting Conditions: Medical History/Concurrent Conditions: Exercise induced asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100988889

Write-up: Intense vertigo; Spots in vision; Tingling in arms and hands; Pale skin; Burning sensation throughout body and in lungs; Heavy extremities; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 02Aug2021 at 18:30 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patients'' medical history included exercise induced asthma, a known allergy to gluten and several antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 12Jul2021 at 18:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 02Aug2021 at 18:30, within minutes, the patient experienced intense vertigo, spots in vision, tingling in arms and hands, pale skin, burning sensation throughout body and in lungs, heavy extremities and nausea. The patient reported that it took her nearly 40 minutes to feel well enough to walk. She further stated that she was still waiting to see any symptoms over the next day. The events did not result in a 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event''s intense vertigo, spots in vision, tingling in arms and hands, pale skin, burning sensation throughout body and in lungs, heavy extremities and nausea were resolving at the time of this report. The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.


VAERS ID: 1646273 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: covid 19 test; Result Unstructured Data: Test Result:Negative; Test Date: 20210803; Test Name: covid 19 test; Result Unstructured Data: Test Result:Positive
CDC Split Type: USPFIZER INC202100993167

Write-up: She had another covid 19 test done that resulted this afternoon positive; she developed cold symptoms; She had another covid 19 test done that resulted this afternoon positive; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on 02Aug2021 10:20 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunization. The patient stated that she had a covid 19 test done on Saturday that was negative on 31Jul2021. Yesterday at 10:20 AM she received her 2nd dose of the Pfizer BioNtech covid 19 vaccine, overnight she developed cold symptoms on 02Aug2021. She had another covid 19 test done that resulted this afternoon positive on 03Aug2021. She wanted to know if the vaccine could give a false positive. Outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1646309 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: New York  
Vaccinated:2021-03-18
Onset:2021-08-02
   Days after vaccination:137
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6207 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19; Result Unstructured Data: Test Result: Positive.
CDC Split Type: USPFIZER INC202100994240

Write-up: Tested positive to covid 19 on 08/02/21; Tested positive to covid 19 on 08/02/21; This is a spontaneous report from a contactable consumer or other non hcp. A 20-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration on 18Mar2021 (at the age of 20-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 02Aug2021 the patient experienced tested positive to covid-19. The patient underwent lab tests and procedures which included covid-19: positive on 30Jul2021. Conclusion: The complaint for lack of effect of the PFIZER BIONTECH COVID 19 VACCINE lot EN6207 was investigated. The investigation included a review of manufacturing and packaging batch records deviation investigations and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EN6207 fill lot EN5340 and the formulated drug product lot EN5328.A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root causes were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Scope of complaint investigation: The scope of this investigation included the reported finished goods lot EN6207 fill lot EN5340 and the bulk formulated drug product EN5328. Acceptable review of related documentation including manufacturing batch records and review of release test results at the time of lot release confirmed that there were no issues which may have resulted in a complaint of this nature. Document Review Summary: DEVIATIONS: Complete (Acceptable): There was one deviation investigation initiated related to in scope lots. QAR 5637107 The purpose of this investigation was to identify the root cause for exceeding the Time Out of Refrigeration limit of 46 hours during the production of the Covid 19 vaccine. Outcome for the event covid-19 was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1646325 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / UNK LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Dizziness, Electrocardiogram, Heart rate, Loss of consciousness, Muscle tightness, Musculoskeletal stiffness, Mydriasis, Oxygen saturation, Pallor, Seizure, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (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: PROZAC; BUSPIRONE; LORAZEPAM; CLONIDINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autism spectrum disorder; Depression; Hypersomnia; Passed out (history of passing out only during bloodwork.); Premenstrual dysphoric disorder
Allergies:
Diagnostic Lab Data: Test Name: blood sugar levels; Result Unstructured Data: Test Result:Normal; Test Name: BP; Result Unstructured Data: Test Result:Normal; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Test Name: Pulse; Result Unstructured Data: Test Result:Normal; Test Name: Oxygen; Result Unstructured Data: Test Result:Normal
CDC Split Type: USPFIZER INC202100994402

Write-up: hands clenched; Upper body and arms became stiff and ridged; Arms started to tremor like a convulsion for a period of 20 seconds; experienced lightheadedness; Arms started to tremor like a convulsion for a period of 20 seconds; Eyes dilated; became pale; passed out; This is a spontaneous report from a contactable consumer (patient). This 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm, on 02Aug2021 15:30 (at the age of 15-year-old) (Lot Number: FA7484) as single dose (dose number unknown) for COVID-19 immunisation. Relevant medical history included depression, autism spectrum, premenstrual dysphoric disorder, hypersomnia and loss of consciousness (history of passing out only during bloodwork). Concomitant medications included fluoxetine hydrochloride (PROZAC), buspirone, lorazepam and clonidine; all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Aug2021 15:32, the patient passed out and experienced eyes dilated and became pale; on 02Aug2021 15:45, she experienced arms started to tremor like a convulsion for a period of 20 seconds, hands clenched, upper body and arms became stiff and ridged and lightheadedness. The events passed out and convulsion were considered serious as medically significant; the other events were non-serious. Within 2 minutes of receiving the injection, eyes dilated, became pale and passed out. Then both hands clenched. Upper body and arms became stiff and ridged. Arms started to tremor like a convulsion for a period of 20 seconds. The patient experienced lightheadedness for 25 minutes. The patient has a history of passing out only during bloodwork. She has not had a passing out during a vaccine. She was calm and not nervous about the vaccination. Never before she has had convulsions, shaking or tightening of limbs. EMS arrived within 10 minutes and examined the patient. She did not appear to bite her tongue and EKG, pulse, oxygen, BP and blood sugar levels where normal. The events involved emergency room visit. The patient did not receive treatments for the events. The patient did not have COVID-19 prior to vaccination; she was not tested for COVID-19 post vaccination. The patient was recovering from the events. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646336 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Musculoskeletal stiffness, Neck pain, Pain in extremity, Vaccination site pain
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100995184

Write-up: had pain in the back of my shoulder; had paint in the back of my neck; stiffness; arm pain; Headache; soreness/I have pain where i received the injection.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number FA7485, expiration date unspecified), via an unspecified route of administration on 02Aug2021 DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took tylenol and experienced nausea. On 02Aug2021, the patient experienced arm pain, headache along with pain/soreness at the injection site with stiffness. On 03Aug2021, the patient developed pain in the back of shoulder and neck. The patient was treated for the events with Excedrin but it did not work. The outcome of the events was reported as unknown at the time of report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1646343 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100995534

Write-up: Rash on face/entire body red bumps appeared; entire body red bumps appeared; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccinev), dose 1 via an unspecified route of administration, administered in Arm Left on 02Aug2021 12:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 02Aug2021 14:00, the patient experienced rash on face/entire body red bumps appeared. The patient was treated with Benadryl and witch hazel. The outcome of the events was recovered on unspecified date in 2021. Follow-up attempts are needed. Information on the lot/batch number is expected.


VAERS ID: 1646352 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Constipation, Headache, Heart rate, Heart rate increased, Menstruation irregular, Movement disorder, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROBIOTIC [BIFIDOBACTERIUM LACTIS]; DEBLITANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Focal epilepsy (Other Medical History: Complex partial focal epilepsy)
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Heart rate; Result Unstructured Data: Test Result:High
CDC Split Type: USPFIZER INC202100995931

Write-up: Both doses have caused irregularities in menstrual cycle(bleeding and early period); headache; unable to lift arm in which received injection; whole body soreness; nausea; constipation; fever; Heart rate remains elevated; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 29 years), dose 2 via an unspecified route of administration, administered in Arm Left on 02Aug2021 09:30 as dose 2, single for covid-19 immunisation. Medical history included partial seizures (Other Medical History: Complex partial focal epilepsy). Concomitant medication(s) included bifidobacterium lactis (PROBIOTIC) and norethisterone (DEBLITANE) and Womens multi. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 29 years), dose 1 via an unspecified route of administration, administered in Arm Right on 12Jul2021 as dose 1, single for covid-19 immunisation and experienced Both doses have caused irregularities in menstrual cycle (bleeding and early period) and headache. The patient reported, both doses have caused irregularities in menstrual cycle (bleeding and early period), first dose caused headache but the second dose has caused headache, unable to lift arm in which received injection, whole body soreness, nausea, constipation, fever. Heart rate remains elevated. Worst part is the pain and soreness with inability to lift the arm and the racing heart on 02Aug2021 19:00 PM. The patient underwent lab tests and procedures which included heart rate: high on 02Aug2021 19:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event. Outcome of events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1646356 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-14
Onset:2021-08-02
   Days after vaccination:110
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6955 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19; Test Result: Positive; Comments: report is from a nurse who has a patient that tested positive for COVID.
CDC Split Type: USPFIZER INC202100996959

Write-up: hey had symptoms and that was why they tested; they had symptoms and that was why they tested; This is a spontaneous report from a contactable other health care professional. Caller is reporting on two patients and this report is for patient 2. A 33-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021) via an unspecified route of administration on 14Apr2021 (at the age of 33-year-old) as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021) via an unspecified route of administration on 26Mar2021 (at the age of 33-year-old) as dose 1, single both for covid-19 immunisation. Caller said that the doses had the same lot numbers and expiry dates. The patient medical history and concomitant medications were not reported. On 02Aug2021, the patient experienced tested positive for covid and had received their covid vaccines. Caller said that the patients reported to her because they had to if they were sick on site or have COVID symptoms and that all had to go through her. She did not test them, but they had both tested outside and they have sent her the positive reports. They had symptoms and that was why they tested and they had family events a week prior to this. She received an email that was sent out today and it said she needed to call for the reason being for vaccine failure. The patient underwent lab tests and procedures which included SARS-CoV-2 test with result positive on 02Aug2021 (yesterday) report was from a nurse who had a patient that tested positive for COVID. The event outcome was unknown. No follow-up attempts are possible. No further information is expected. Sender''s Comments: Based on the information provided in narrative, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. Linked Report(s): US-PFIZER INC-202100994257 same reporter, drug AE, different patient.


VAERS ID: 1646360 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-04-05
Onset:2021-08-02
   Days after vaccination:119
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 2 LA / OT

Administered by: Pharmacy       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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: PCR/Nasal Swab; Test Result: Positive
CDC Split Type: USPFIZER INC202100997416

Write-up: Covid-19 Positive test results; Covid-19 Positive test results; This is a spontaneous report from a contactable consumer. A 26-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207), dose 1 via intramuscular route in Arm Left on Mar2021 (at 26-years age) as dose 1, single, dose 2 intramuscular, and patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8734) administered in Arm Left on 05Apr2021 (at 26-years age) as dose 2, single for covid-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The patient medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test nasal Swab PCR positive on 02Aug2021. Patient visited emergency room/department or urgent care. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was not resolved. Complaint Inv. Information: Date Opened: 28Apr2021 (Parent) Complaint Priority: High (Parent) Investigation Required? Yes (Root Parent) Related to Potential AE? Yes(Root Parent) Date of Contact: 13Apr2021 (Root Parent) Description of Complaint: Product quality investigation request Lot# EN6207 & EN6199, BNT162B2 Brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE - EN6207 - Lack Of Effect (Root Parent) Triage Location / Country: Responsible Site Notif. Date : 28Apr2021 Rsnbly Suggest Device Malfunc? No Severity of Harm: N/A Failure Mode: N/A IDC - Level 1: QualitIDC - Level 2: Product Complaint IDC - Level 3: Complaint - Function / Therapeutic Properties (Parent) Complaint Class: Product Use Attributes (Parent) Complaint Sub-Class: Lack Of Effect (Parent) Brand/Trade-Name: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE (Parent) Product Family-API: BNT162B2 (Parent) Product-Description: COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML (Parent) Product-Type: RX (Parent) Product-Category: INJECTABLE (Parent) Sterile-Product: Yes (Parent) Combination-Product: No (Parent) Medical-Device: No (Parent) Combination-Product-Type: N/A (Parent) Lot-#: EN6207 (Parent) UDI- (if appl): N/A(Parent) Batch-Expiry Year: 2021 (Parent) Batch-Expiry Month: Jul (Parent) Batch-Expiry Day: 31 Investigation Decision:(Parent) FPRS Evaluation Comment: Pfizer agrees with investigation decision, classification, priority, and justification. The site assignment grid was reviewed and is accurate for this product. Repeat Investigation?: No Was CAPA Previously Identif''d?: No CAPAs in Place?: N/A CAPA Reference: N/A Full Investigation Required?: Yes Manufactured Post-CAPA: N/A QA Review & Rationale: The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for Lack of Effect related to lot EN6207 of PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot EN6207 pending review of lot genealogy. The investigation will include a include a review of the returned complaint sample (if received) and reserve samples, if necessary. Reviewed On : 25Mar2021 Investigation findings: Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot EN6207, fill lot EN5340, and the formulated drug product lot EN5328. Manufacturing and packaging batch records were reviewed for the reported complaint lot.Root cause/CAPA: Pfizer withheld QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs discovered segments of the batch exceeded the 46-hour limit. Immediate actions included submitting samples for RNA Integrity analysis, which met the release limits and batch was considered acceptable for release. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications. Regulatory/Market Assessment:NTM Decision: No-NTM not required NTM Rationale: Other Date NTM Decision Made : This should reflect the most current decision date 28Apr2021 Other NTM Rationale: Not expedited or confirmed Regulatory Impact: No Other Regulatory Notification: N/A Root Cause/CAPA: Process Related? No Final Confirmation Status: Not Confirmed Vendor Related? No Root Cause Analysis/Identif: Pfizer withheld Quality Operations could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. Review of the manufacturing and packaging batch records and release test results confirmed that the batch meets potency specifications. It is unknown how the product was handled, stored, or administered after it left the Pfizer withheld site.Impact Analysis: Based on the final scope of the investigation and that there was no probable process related root cause identified the reported complaint is not representative of the overall quality of the lot. No regulatory notification is required.Root Cause Category (Tier 1): Non-assignable (Complaint Not Confirmed) Root Cause Category (Tier 2): Non-assignable (Complaint Not Confirmed) Root Cause Category (Tier 3): N/A Special or Common Cause: Common Cause Root Cause is always present to some degree in the process. Special Cause Root Cause is something different happening at a certain time or place in the process. Improve/control:Corrective / Preventive Action: There were no corrective actions as a result of this complaint investigation. The results of all tests, inspections, and in-process controls have been reviewed and all results met the established requirements prior to the release of the reported batch for distribution. Conclusion and Approvals: Additional Approval(s) Req''d?: No Product Quality Impact: NoMarket / Clinical Impact: No Market / Clinical Impact: No SQRT Review Required?: No AQRT Review Req''d?: No Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6207 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot and product type. The final scope included the reported finished goods lot EN6207, fill lot EN5340, and the formulated drug product lot EN5328. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Follow-up attempts are completed. No further Document Review Summary:DEVIATIONS: Complete - Acceptable There was one deviation investigation initiated related to in-scope lots.QAR 5637107 - The purpose of this investigation was to identify the root cause for exceeding the Time Out of Refrigeration (TOR) limit of 46 hours during the production of the Covid-19 vaccine. Based on the investigation findings detailed below, it was determined that the threshold for when Filling begins a new segment may not provide enough time for the previous segment to reliably complete in Inspection and Packaging within the TOR limit. The worst-case TOR samples for EN6207 came from Segment 1, which had a maximum TOR of 51 hours compared to the limit of 46. The RNA Integrity result for the worst-case TOR sample from EN6207 was 68%. This meets the release limit of $g=55%. Additionally, the two validation batches that included a TOR hold time of 46 hours had RNA Integrity results of 65% and 62%. The passing result of the worst-case TOR sample from EN6207 and data comparison against the validation batches show that there was no impact as a result of the TOR excursion experienced during the manufacturing process of the subject batch. Therefore, batch EN6207 is considered to be acceptable for release with regard to QAR# 5637107. MANUFACTURING BATCH RECORDS: Complete - Acceptable The bulk manufacturing batch records for the complaint batch were reviewed as part of this investigation and were found to be acceptable. All processing steps were performed within pre-established parameters. The review of the manufacturing record confirmed that all in process checks, all line startup and end of batch challenges, and all line clearance and cleaning activities were completed satisfactorily. All raw materials used in the complaint batch were of the correct weight and identity. All the manufacturing temperatures mix speeds and mixing times were within acceptable ranges. In-process appearance and specific gravity test results were all within acceptable ranges. The solution filtration documentation confirmed that all filters and Water for Injection (WFI) were used within their expiration dates, and that all the filtration times, pH results, and pressure specifications were met. The manufacturing processes of raw material usage, solution formulation and filtration were all found to be acceptable. All manufacturing parameters met established requirements except for TOR as discussed above in the deviation section. A log is maintained throughout the manufacturing process of the amount of elapsed time that the product is out of refrigeration. PACKAGING BATCH RECORDS: Complete ? Acceptable The review of the packaging record confirmed that all in process checks, all line startup and end of batch challenges, and all line clearance and cleaning activities were completed satisfactorily. Audits are performed on the finished packaged units by Packaging Operations personnel at regular intervals throughout the final packaging process. This is done in order to ensure that all required labeling and packaging is present, complete, and meets all establishments requirements. During the audits, inspectors visually check the appearance of the finished product for defects. All defective vials were discarded, and alert limits were not exceeded. A review of the audit results for the reported lot confirmed that no quality defects related to the nature of the complaint were observed. LOT HISTORY: Complete - Acceptable The results of all tests and inspections met required specifications at the time of release for distribution on 03Mar2021. Follow up (05Aug2021): This is a follow-up spontaneous report received from a product quality complaint group providing investigation results. This report included that: investigation summary and conclusion.


VAERS ID: 1646366 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO198 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Diarrhoea, Dizziness, Heart rate, Heart rate decreased, Swelling face, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Heart rate; Result Unstructured Data: Test Result:dropped
CDC Split Type: USPFIZER INC202100997947

Write-up: Hives; Face swelled; Dizzy; Heart rate dropped; Vomiting; Diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 51-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Ewo198; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 02Aug2021 16:00 (at age of 51-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not pregnant at time of vaccination. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Other medical history was none. Known allergies reported as yes (not specified). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Aug2021 17:00 patient experienced hives, face swelled, dizzy, heart rate dropped, vomiting and diarrhea. Patient did not receive any treatment for adverse event. Patient was not tested for COVID post vaccination. The patient underwent lab tests and procedures which included heart rate: dropped on 02Aug2021. The outcome of all the events was recovering.


VAERS ID: 1646375 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100998175

Write-up: Headache; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Aug2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced headache after getting the 1st dose on 02Aug2021. The patient would like to know if Tylenol would lessen the effectiveness of the Pfizer-BioNTech COVID-19 vaccine. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1646376 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-02-09
Onset:2021-08-02
   Days after vaccination:174
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ARMOUR THYROID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: SARS COV 2 RNA/Nasal Swab; Test Result: Positive.
CDC Split Type: USPFIZER INC202100998257

Write-up: This is a spontaneous report from a contactable consumer (patient). A 51-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3247; Expiration date: unknown) intramuscular, administered in Arm Left on Jan2021 (at age of 51-years-old) as DOSE 1, SINGLE and patient had received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not reported) intramuscular, administered in Arm Left on 09Feb2021 (at age of 51-years-old) as DOSE 2, SINGLE both for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included ARMOUR THYROID taken for an unspecified indication start date and stop dates were not mentioned. There was not any past drug event. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 31Jul2021 patient experienced fatigue, headache, cough, and congestion. On 02Aug2021 the patient experienced SARS COV 2 RNA/positive (drug ineffective and COVID-19). Patient did not receive any treatment for events. Since the vaccination, the patient was tested for COVID-19. The patient underwent lab tests and procedures which included COVID test post vaccination on 02Aug2021 (Nasal Swab) which was positive. The outcome of event SARS COV 2 RNA/positive was unknown while outcome of events fatigue, headache, cough and congestion was resolving.


VAERS ID: 1646467 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Balance disorder, Disorientation, Dyskinesia, Eye movement disorder, Feeling abnormal, Feeling cold, Feeling hot, Headache, Hyperhidrosis, Loss of consciousness, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101000892

Write-up: Not feeling right; No idea where I was; Struggling to stay on the chair; blacked out; had a wave of heat hit my body/heat rushed back into my body; sweat/ skin was dripping; Head felt like it was being squeezed; Eyes rolled into the back of my head; my whole body was convulsing; I was ice cold; my body jerked; This is a spontaneous report from a contactable consumer via COVAES. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intramuscularly on 02Aug2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that within 2 minutes the patient started not feeling right; he woke up with his head against the shelf and had no idea where he was. The person who gave the shot was nowhere to be found and his wife and son were talking a few feet away. The patient''s wife quickly noted he was struggling to stay on the chair and ran over to help. The patient told her he was not okay and then blacked out. Within about a minute the patient had a wave of heat hit his body; it felt like he was in an oven. The patient sweat right through his shirt and his skin was dripping in sweat; his head felt like it was being squeezed and he blacked out again. The patient''s wife told him that his eyes rolled into the back of his head, his whole body was convulsing, and he was ice cold. After 1 minute of convulsing, he woke up again; a few minutes passed until the heat rushed back into his body. He lost consciousness for another minute while his body jerked, and his eyes were in the back of his head. He woke up to the paramedics helping him onto the stretcher. The events were reported as non-serious and did not require hospitalization. It was unknown if treatment was received. The events required an emergency room visit. The clinical outcomes of the events were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1646472 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-03-13
Onset:2021-08-02
   Days after vaccination:142
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Private       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Body temperature, COVID-19, Chest X-ray, Computerised tomogram, Electrocardiogram, Fall, Head injury, Loss of consciousness, SARS-CoV-2 test, Syncope, Urine analysis, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BABY ASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery; Cholesterol (Other medications in two weeks: Cholesterol medication QD); Prostate surgery; Surgery
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Blood pressure; Result Unstructured Data: Test Result:Clean; Test Date: 202108; Test Name: Bloodwork; Result Unstructured Data: Test Result:Clean; Test Date: 2021; Test Name: Fever; Result Unstructured Data: Test Result:101 degrees; Test Date: 202108; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Clean; Test Date: 202108; Test Name: CAT scan; Result Unstructured Data: Test Result:Clean; Test Date: 202108; Test Name: EKG; Result Unstructured Data: Test Result:Clean; Test Date: 20210803; Test Name: Covid test; Test Result: Positive ; Comments: All tests were "clean" except for the COVID test, which yielded a positive result (03Aug2021, 10AM); Test Date: 202108; Test Name: Urinalysis; Result Unstructured Data: Test Result:Clean
CDC Split Type: USPFIZER INC202101000939

Write-up: COVID test, which yielded a positive result (03Aug2021 10AM); COVID test, which yielded a positive result (03Aug2021 10AM); Fainted; Unresponsive for 20 minutes; Hit his head while falling; Hit his head/ received 7 staples in head; This is a spontaneous report from a contactable consumer.A 71-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via intramuscular on 13Mar2021 (at the age of 71-year-old) as dose 2, single for covid-19 immunization.Medical history included heart bypass (5 years ago), prostate removed (2-3 years ago), lower lumbar surgery (10 years ago) and cholesterol.Concomitant medications within 2 weeks of vaccination included acetylsalicylic acid (BABY ASPIRIN) QD, blood thinner QD taken for an unspecified indication and cholesterol medication QD taken for cholesterol. There was no known allergies.The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via intramuscular on 20Feb2021 (at the age of 71-year-old) as dose 1, single for covid-19 immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, had the patient been tested for COVID-19 was mentioned as no.It was reported that the patient attended a conference from 26Jul2021 to 30Jul2021 and returned home on 30Jul2021 where he presented with fever and dizziness. Fever self-reported at 101 degrees, symptoms persisted through 02Aug2021. On the morning of 02Aug2021, while preparing coffee at home he fainted and hit his head while falling resulting in being unresponsive for 20 minutes. Ambulance called and withheld taken to hospital. Woke up on his own after 20 min. Received 7 staples in head and hospital performed EKG, BP, chest X-ray, CAT scan, bloodwork and urinalysis. All tests were clean except for the COVID test, which yielded a positive result (03Aug2021, 10AM). Sample sent to CDC for variant confirmation. The patient was placed on fluids, antibiotics, steroids and was quarantined at the hospital. Also stated between 6 and 9 other conference attendees tested positive for COVID. As of 04Aug2021 (10AM), withheld reports fever has broken, no longer dizzy, feels better. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient was hospitalized for 3 days. The patient received treatment with regard to events. On 02Aug2021, patient recovered from loss of consciousness whereas patient was recovering from events syncope, fall, head injury and covid-19. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1646526 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6199 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID test; Result Unstructured Data: Test Result:Positive
CDC Split Type: USPFIZER INC202101006504

Write-up: Covid Positive on 02Aug2021; Covid Positive on 02Aug2021; Colleague developed sore throat; runny nose; This is a spontaneous report from a contactable Nurse. A 44-year-old female patient (pregnant: unknown) received second dose bnt162b2 (PFIZER COVID19 VACCINE, Solution for injection, Lot Number: EN6199), via intramuscular on an unspecified date as DOSE 2, SINGLE and first dose bnt162b2 (PFIZER COVID19 VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular route on 24Feb2021 as DOSE 1, SINGLE for COVID-19 Immunization (at the age of 44 years). Medical history and concomitant medications were not reported. It was reported unknown if other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Patient was tested covid post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The patient on 02Aug2021 experienced Positive on 02Aug2021 and colleague developed sore throat, runny nose. The patient underwent lab tests included SARS-CoV-2 test: positive on 02Aug2021. The patient received any treatment for adverse event as unknown. The patient adverse events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events were recovering.; Sender''s Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events


VAERS ID: 1646528 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Decreased appetite, Fall, Fear of death, Insomnia, Loss of personal independence in daily activities, Muscular weakness, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Notes: had covid and was given the antibodies in Jan2021 and was in the hospital); Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101006525

Write-up: been in bed for 3 days; has no desire to eat/drink anything; has fallen twice; has not slept in 3 days; nauseated; concerned she might be dead in the next two days with sleep status/not eating; her legs wouldn''t hold her up; shoulder is very sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) Dose 1 via an unspecified route of administration on 02Aug2021 (Batch/Lot Number: FA7485) as a single dose for COVID-19 immunisation. Medical history included pneumonia from an unknown date and unknown if ongoing , COVID-19 from Jan2021 to an unknown date (Notes: had COVID and was given the antibodies in Jan2021 and was in the hospital). The patient''s concomitant medications were not reported. On 02Aug2021, the patient experienced has been in bed for 3 days (medically significant), has no desire to eat/drink anything, has fallen twice (medically significant), has not slept in 3 days (medically significant, nauseated (medically significant), concerned she might be dead in the next two days with sleep status/not eating, her legs wouldn''t hold her up, and shoulder is very sore. Consumer received 1st dose of Pfizer Covid 19 vaccine on 02Aug2021. Since then she has been in bed for 3 days, has no desire to eat/drink anything, has fallen twice because her legs wouldn''t hold her up (fall happened the first two days), has not slept in 3 days or night. The caller hasn''t slept not even 20 minutes. When the caller fell she couldn''t get up without help. The caller feels nauseous like she is going to throw up. Patient stated she does not know what to do and thinks she should go to the hospital. It was noted that she is scheduled for her second dose of Pfizer Covid 19 vaccine in two weeks and unsure of guidance. The patient was concerned she might be dead in the next two days with sleep status/not eating and explains that her HCP will not be able to see her. It takes a week to get in. The caller is getting weaker and weaker. The caller is concerned about whether to take the second dose and if she does not get any better then she is going to have to go to the hospital. The caller had to take the nausea pill and that helped. The caller has to walk with help. The patients shoulder is very sore. The patient was recovering from the events, been in bed for 3 days, nauseated, her legs wouldn''t hold her up, and shoulder is very sore. The patient had not recovered from the events, has no desire to eat/drink anything, has no desire to eat/drink, has no desire to eat/drink anything, and has not slept in 3 days. The outcome of the events, has fallen twice, and concerned she might be dead in the next two days with sleep status/not eating was unknown.


VAERS ID: 1646562 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthritis, Lymphadenopathy, Nodule, Pain, Peripheral swelling, Ultrasound scan
SMQs:, Cardiac failure (broad), Angioedema (broad), Systemic lupus erythematosus (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: ultrasound of her veins; Result Unstructured Data: Test Result:Arthritis and the knots on her arm might be a refl; Comments: Arthritis and the knots on her arm might be a reflex of swollen lymph nodes
CDC Split Type: USPFIZER INC202101007545

Write-up: on the opposite arm she had a knot on her right wrist/in between the forearm and underarm the skin was also knots; the knots on her arm might be a reflex of swollen lymph nodes; Arthritis; on the bottom of her thumb got swollen and another know developed; she had severe pain; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 59-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced had severe pain on 02Aug2021 (2 hours after vaccine administration) with outcome of unknown, on the opposite arm she had a knot on her right wrist/in between the forearm and underarm the skin was also knots on 03Aug2021 with outcome of unknown, the knots on her arm might be a reflex of swollen lymph nodes on 03Aug2021 with outcome of unknown, arthritis on 03Aug2021 with outcome of unknown, and on the bottom of her thumb got swollen and another ''know'' developed on 03Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included ultrasound of her veins, then her doctor told her she had two things going on: Arthritis and the knots on her arm might be a reflex of swollen lymph nodes on 04Aug2021. The events involved emergency room visit. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1646619 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-07-29
Onset:2021-08-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Menstruation irregular, Pain in extremity
SMQs:, Fertility disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101011364

Write-up: Arm sore.; Headache for 3 days; Two week mark start the period on birth control.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 29Jul2021 at 12:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. The patient''s medical history were reported as no. 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. The concomitant medications are not reported. On 02Aug2021 at 00:00, the patient experienced arm sore, headache for 3 days and two week mark start the patient''s period on birth control. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm sore, headache and two week mark start the period on birth control was recovering at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1646796 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-03-18
Onset:2021-08-02
   Days after vaccination:137
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3247 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Cough, Fatigue, Headache, Pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: PCR SARS COVID 2 RNA; Test Result: Positive ; Test Date: 20210804; Test Name: QLNAAT, RT, PCR/TMA (COVID 19); Test Result: Positive
CDC Split Type: USPFIZER INC202101022815

Write-up: Headache; Fever; Chills; Body Aches; Fatigue; Coughing; Tested positive for COVID; Tested positive for COVID; Runny nose; This is a spontaneous report from a non-contactable consumer or other non hcp. A 37-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: EL3247; Expiration Date: 31May2021) via an unspecified route of administration, administered on 18Mar2021 10:37 (at the age of 37-years-old) as dose 2,single for covid-19 immunisation. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: EL3247; Expiration Date: 31May2021) via an unspecified route of administration, administered on 25Feb2021 as a dose 1,single for covid-19 immunisation. The patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She has an a 11 month old baby, so she must have had a newborn. It was reported that on 02Aug2021 the patient experienced runny nose and on 04Aug2021 08:44 the patient tested positive for covid 19 who had both doses of the Pfizer COVID vaccine. Reporter further stated that on an unspecified date patient experienced headache, fever, chills, body aches, fatigue and reporter know patient was coughing because reporter heard patient was coughing. patient has no loss of taste or smell. On 04Aug2021 the patient underwent lab tests and procedures PCR SARS COVID 2 RNA which resulted positive and underwent QLNAAT, RT, PCR/TMA (COVID 19) which resulted positive. The patient was recovering from the events. For Lack of Efficacy, request the following information: Description of complaint: Received call from HCP to report a patient at the site she works at tested positive for COVID 19 virus after receiving both doses of the Pfizer COVID 19 vaccine. She did not wish to provide patient name and only gave initials as she did not tell patient that she was reporting on her behalf. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646888 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-17
Onset:2021-08-02
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Test Date: 20210728; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210802; Test Name: Nasal Swab; Test Result: Positive
CDC Split Type: USPFIZER INC202101028286

Write-up: tested positive on Aug 2.; tested positive on Aug 2.; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8727) via an unspecified route of administration on 27Mar2021 as dose 1 single and received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0162) via an unspecified route of administration on 17Apr2021 as dose 2 single for COVID-19 immunization. Medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient presented with sore throat, headache and coughing on 31Jul2021 and tested positive on 02Aug2021. The adverse event result in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. Hospitalization prolonged was no. Traveling companion was tested positive 30Jul2021. Since the vaccination, the patient had been tested for COVID-19 (sars-cov-2 test) via Nasal Swab which revealed negative on 28Jul2021 and positive 02Aug2021. The outcome of the event was recovered on an unspecified date in 2021. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646939 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-04-26
Onset:2021-08-02
   Days after vaccination:98
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6207 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 Test (Nasal Swab); Test Result: Positive
CDC Split Type: USPFIZER INC202101029838

Write-up: Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer (Other HCP) reported for a 42-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), intramuscular, administered in Arm Left on 26Apr2021 (at the age of 42-years-old) (Batch/Lot Number: EN6207) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It''s unknown whether the patient receive any other vaccine in four weeks or within 4 weeks prior to the COVID vaccine, also it was unknown the patient had covid-19 prior vaccination. The patient''s Colleague tested positive for COVID on 19Jul2021. The patient was Covid 19 positive (medically significant), The patient underwent lab tests and procedures covid test post vaccination which included sars-cov-2 test (nasal swab): positive on 02Aug2021. The patient received treatment in response to event was unknown. The clinical outcome of events was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender''s Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on available information a contributory role of BNT162B2 to the reported Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. Additional information including event onset date, concomitant medications and their indications, concurrent medical conditions, medical history, treatment done, is needed to better assess this report.


VAERS ID: 1646982 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dysphagia
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101033926

Write-up: dysphagia; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Aug2021 as single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that patient received the first dose of the vaccine on 01Aug2021. She reported dysphagia 1day post vaccination on 02Aug2021, and which still ongoing. Patient wants to know if these side effects were reported. If patients had these side effects how were they treated. The outcome for the event was reported as not resolved at the time of this report. The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.


VAERS ID: 1647061 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Burning sensation, Cerebrovascular accident, Computerised tomogram, Head discomfort, Hypoaesthesia, Magnetic resonance imaging
SMQs:, Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Blood works/blood tests; Result Unstructured Data: Test Result:came back normal and nothing out of the ordinary; Test Date: 202108; Test Name: CT scan; Result Unstructured Data: Test Result:came back normal and nothing out of the ordinary; Test Date: 202108; Test Name: MRI; Result Unstructured Data: Test Result:came back normal and nothing out of the ordinary
CDC Split Type: USPFIZER INC202101038987

Write-up: stroke-like symptoms; her arm went numb/her face went numb; fire burning through her body; her head feels like her brain was laying dead and her brain feels to her like deadweight; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm (unsure if right or left arm) on 02Aug2021 at 17:00 (Lot Number: FC3180, at the age of 45-year-old) as single dose, for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. There were no prior vaccinations (within 4 weeks). Patient took the 1st dose of the vaccine 9 days ago (on 02Aug2021 at 17:00) and 5 minutes after taking the vaccine (on 02Aug2021 at 17:05) her arm went numb and she had been going back and forth to the emergency rooms for the past couple of days; the patient had stroke-like symptoms, her face went numb along with something she described like fire burning through her body and her head felt like her brain was laying dead and her brain felt to her like deadweight. The patient had been going back and forth to different emergency rooms and had several records to show it and her other healthcare professional primary care did all a bunch of blood tests and nothing had come back so far out of the ordinary. The patient kept having the symptoms since she took the Pfizer COVID Vaccine. The patient was in excellent shape and had no health issues in the past before and took the Pfizer COVID vaccine at 5:00pm and by 5:05pm started having the symptoms and by 5:30pm was in the emergency room and it had been that way since then. When she laid down for an extended period of time sometimes it calmed down a little bit regarding her symptoms and then when she got up or started moving or any movement the symptoms kick back in so she had been laying down since then. The patient had been to the emergency room three times in a few days and had hospital visits and then clarified she had not had an overnight stay in the hospital but they pulled her blood and did computerised tomogram (CT) scans and magnetic resonance imaging (MRI) and they were there 6, 7, or 8 hours and then were back home and then went back to the same place but he did not have the additional dates of the emergency room dates to provide. The blood work, CT scans and MRI on Aug2021 that everything came back normal and nothing out of the ordinary and she was in perfect shape before this and takes no medications. The adverse events require a visit to emergency room and physician office. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1647081 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, COVID-19, Chest pain, Condition aggravated, Cough, Dizziness, Feeling abnormal, Illness, SARS-CoV-2 test, Throat irritation, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: PCR Test; Test Result: Negative ; Comments: She was negative until yesterday.; Test Date: 20210812; Test Name: PCR Test; Test Result: Positive ; Comments: She got a positive for COVID test result today. positive Covid-19 viral test result after first dose; Test Date: 20210811; Test Name: Rapid test; Test Result: Negative ; Comments: She was negative until yesterday.; Test Date: 20210812; Test Name: Rapid test; Test Result: Positive ; Comments: She got a positive for COVID test result today. positive Covid-19 viral test result after first dose
CDC Split Type: USPFIZER INC202101041132

Write-up: she was sick; It really knocked her out . She had a really bad sense; testing positive for Covid-19; Itchy throat; Light headedness; Wheezing; Coughing; Weakness; chest on fire; Itchy throat, Light headedness, Wheezing, Coughing, Weakness, chest on fire was reported as worsened.; tickle in her throat; This is a spontaneous report from a contactable consumer (patient). A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration date: unknown), via an unspecified route of administration, administered in left arm on 02Aug2021 (at the age of 49-years-old) as dose 1, single for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 02Aug2021, immediately after the receiving the covid-19 vaccine, patient felt a tickle in her throat, it became itchy, began to feel lightheaded, and was coughing and wheezing. patient stated that these symptoms became progressively worse, so was tested for Influenza and Covid-19. patient received a positive Covid-19 Viral Test Result and stated, "her lungs are killing, her right now." patient got progressively worse. On an unspecified date, it really knocked her out. patient had a really bad sense. Patient was so nervous, got tested again and got tested for the flu, and they did a rapid and PCR test for COVID. Patient was negative until yesterday. Patient got a positive for COVID test result today, was just confused and was trying to navigate what to do. Patient was coughing. Her chest was on fire., was weak and patient wasn''t at home. She flew to (city) after getting her first dose. Her weight had been evaporating since she was sick on an unspecified date. She got her positive COVID result on 12Aug2021. The patient underwent lab tests and procedures which included Rapid test and PCR test: negative, She was negative until yesterday on 11Aug2021, Rapid test and PCR test: positive, she got a positive for COVID test result today. Positive Covid-19 viral test result after first dose on 12Aug2021. Outcome of events she was sick, tickle in her throat and it really knocked her out. patient had a really bad sense and tested positive for covid-19 was unknown and outcome of other events was not recovered. Information on the Batch/Lot number has been requested.


VAERS ID: 1647280 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-23
Onset:2021-08-02
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 antibody 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: Test Date: 20210802; Test Name: Covid-19 test; Result Unstructured Data: Test Result:Positive
CDC Split Type: USPFIZER INC202101051978

Write-up: She got the first Pfizer Vaccine on 7/23 and then she got COVID; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 23Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Aug2021, patient got COVID and and she got the antibody infusion on 03Aug2021, so did not recommended to wait 90 days past antibody infusion and to get a dose of COVID vaccine and she already got her first dose and then they did not recommend doing more than 42 for your second dose. The patient underwent lab tests and procedures which included COVID-19 test: positive on 02Aug2021. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1647371 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cataplexy, Disease recurrence, Hallucination, Intermenstrual bleeding, Menstrual disorder, Narcolepsy, Sleep paralysis, Sleep terror, Somnolence
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ARMODAFINIL; ACT BUPROPION XL; ZYRTEC [CETIRIZINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to allopathic drugs (Known allergies: Macrobid, Morphine, Thiuram Mix, Gold, Gluten, Dairy, Eggs); Allergy to gold; Cataplexy (Narcolepsy (Type 1 with Cataplexy)); Dairy intolerance; Egg allergy; Endometriosis (Other medical history: Narcolepsy (Type 1 with Cataplexy), Endometriosis); Gluten sensitivity; Narcolepsy (Narcolepsy (Type 1 with Cataplexy))
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101068933

Write-up: Extreme worsening of Narcolepsy; Extreme worsening of Narcolepsy; very frequent cataplexy; very frequent cataplexy; Hallucinations; Breakthrough blood clots between menstrual cycle; Excessive daytime sleepiness; night terrors; sleep paralysis; Breakthrough blood clots between menstrual cycle; This is a spontaneous report from a contactable consumer. This 27-year-old non-pregnant female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0179, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 02Aug2021 as dose 1, single for covid-19 immunisation. Patient''s known allergies were allergic to Macrobid, Morphine, Thiuram Mix, Gold, Gluten, Dairy, Eggs. Other medical history: Narcolepsy (Type 1 with Cataplexy), Endometriosis. Other medications in two weeks: Armodafinil 250mg, Bupropion XL 150mg, Zyrtec. No other vaccine in four weeks. No Covid prior vaccination and post vaccination. On 02Aug2021 at 17:00, the patient experienced extreme worsening of Narcolepsy (Type 1, with Cataplexy), with symptoms: excessive daytime sleepiness, very frequent cataplexy, night terrors, hallucinations, sleep paralysis. She also experienced breakthrough blood clots between menstrual cycle. Adverse events resulted in doctor or other healthcare professional office/clinic visit. She did not receive any treatment. The outcome of all events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.


VAERS ID: 1647403 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:2021-02-06
Onset:2021-08-02
   Days after vaccination:177
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: PCR Covid test; Test Result: Positive ; Comments: Tested positive for Covid virus, after being fully vaccinated.
CDC Split Type: USPFIZER INC202101076363

Write-up: Testing positive for Covid virus, after both vaccines; Testing positive for Covid virus, after both vaccines; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported similar events for 37 patients. This report is for 25th of 37 reports. A 71-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number: EN5318), dose 2 via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was not provided) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on 16Jan2021 (Batch/Lot Number: EJ1685) as DOSE 1, SINGLE for covid-19 immunization at a hospital. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure and SARS-CoV-2 infection on 02Aug2021. The reporter stated they were monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The reporter at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information. Reporter stated, reclarified later in report, she had 37 patients with partial identifiers, stated she could not provide some identifying details and that she would need to check with her legal department first. Reporter stated that Covid positive was defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. Testing positive for Covid virus, after both vaccines. Description of complaint: Reporter was reporting on the Pfizer Covid 19 vaccine, reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. Some identifying details provided. Product strength and count size dispensed: not applicable. The patient underwent lab tests and procedures which included PCR Covid test (Sars-Cov-2 test): positive on 02Aug2021. The outcome of the events was unknown. Information about lot/ batch number is available. Additional information has been requested.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101075254 Master case, same reporter/drug/AE, different patients


VAERS ID: 1651496 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Chills, Cold sweat, Hyperhidrosis, Pain, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: Wellbutrin.
Current Illness: None
Preexisting Conditions: Migraines. Anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever 102. Shaking. Chills Aches pain Hot cold sweats. Weakness


VAERS ID: 1655396 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037F21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Hypoglycaemia (broad)

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

Write-up: Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Severe


VAERS ID: 1656004 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-07-30
Onset:2021-08-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 054C21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Arteriogram carotid abnormal, Back pain, Biopsy artery normal, Bruxism, C-reactive protein increased, Carotid arteriosclerosis, Chest X-ray normal, Chest pain, Computerised tomogram head normal, Dizziness, Facial pain, Gait disturbance, Haematuria, Joint stiffness, Laboratory test, Nephrocalcinosis, Pain, Pain in jaw, Pleural fibrosis, Presyncope, Pruritus, Pulmonary embolism, Pulmonary mass, Red blood cell sedimentation rate increased, Scan with contrast, Sleep disorder, Ultrasound Doppler normal, Urine cytology, Urogram abnormal, Vena cava filter insertion
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: acetaminophen (TYLENOL) 325 MG tablet 975 mg, Oral, Every 6 hours PRN amLODIPine (NORVASC) tablet 5 mg 5 mg, Oral, Daily memantine (NAMENDA) 5 MG tablet omeprazole (PriLOSEC OTC) 20 MG tablet 20 mg, Oral, Daily PARox
Current Illness: none
Preexisting Conditions: Depressive disorder Unprioritized Gastroesophageal reflux disease Unprioritized Mild cognitive disorder Unprioritized Chest pain Unprioritized
Allergies: Allergies Amoxicillin Drug Ingredient [Codeine] Statins Sulfa Antibiotics Sulfur
Diagnostic Lab Data: A CTA of Head and Neck was additionally performed in the ED 8/5/2021 noting: "Conclusion: 1. Unremarkable noncontrast head CT. 2. Mild atherosclerosis in the carotid bulbs and carotid siphons. No signs of a hemodynamically significant carotid stenosis. 3. Patent vertebrobasilar circulation. 4. Patent intracranial circulation. 5. Biapical pleural-parenchymal scarring. A 7 x 10 mm nodule is noted in the left apex. Recommend a follow-up chest CT in 3 months for surveillance." 8/12/2021: Temporal artery biopsy Final Diagnosis Artery, left temporal, biopsy:Vessel consistent with artery with atherosclerosis. No evidence of arteritis. Note: EVG stain is also performed Source: 1: Left temporal artery biopsy
CDC Split Type:

Write-up: She (reluctantly) received 1st dose moderna 7/30/21. On Aug 3rd she felt dizzy and at times, pre-syncopal. On Aug 4th, her dizziness worsened to the point that she had to walk by grabbing the furniture. That evening she developed L sided face and jaw pain, which improved with warm compresses. However she didn''t sleep that night due to pain. Then on 8/5 the pain intensified so she went to ER where the possiblity of TA was raised (CTA head and neck was done; results summarized below); ESR/CRP elevated 72/4.9 (on scale to 0.9). She was given a single dose of pain med and prednisone 60mg and pain resolved; she has been relatively asymptomatic since then. Though she still has some jaw stiffness. No eye complaints. No rash. No fatigue. She has continued pred 60mg, which for unclear reasons she has been taking at bedtime and tolerting well. She doesn''t feel systemically ill or have fever/night sweats/fatigue. Specifically no PMR symptoms, though she does have curious pruritis over the nape of her neck. She did follow up with ENT on 8/6/2021, doctor who did not believe it was temporal arteritis but rather a severe case of TMJ due to teeth grinding. Followed up with Rheumatology 8/13/2021: She underwent L TA biopsy 8/12/2021; results negative. She is currently pain free on prednisone 60mg daily x about 3 doses. My index of suspicion for temporal arteritis is high, though also on DDx is trigeminal neuralgia or impending shingles (she is s/p shingles vaccine relatively recently, though). For now, will continue prednisone 60mg once daily while we await temporal artery biopsy results. If positive, I would like to give her tocilizumab (every other week dosing, for at least 4-6 mo) as per GIACTA so as to spare her steroids and hopefully taper her off within 2-6 weeks. On 8/16/2021: patient presents to the ED via EMS related to chest pain radiating to her back. CT angiogram of the chest revealed right-sided pulmonary embolism in the right lower lobe, apical segment. Lower extremity Dopplers preliminarily showed no evidence of DVT. She was started on intravenous heparin but shortly thereafter, she had significant hematuria and the anticoagulation could not be continued any further. 8/18/2021: Lower extremity Dopplers showed no evidence of DVT. IVC filter was inserted yesterday. CT urogram showed an apparent soft tissue thickening and possible circumferential narrowing at the right UPJ. Urine cytology is pending. Urology has given clearance for the patient to resume anticoagulation. General Imaging: US Venous Duplex - Upper Extremity Bilateral No evidence for DVT in the either upper extremity CXR: No acute cardiopulmonary process. CTA Chest With and Without IV Contrast Pulmonary embolus involving apical segment right lower lobe US Venous Duplex - Lower Extremity Bilateral No deep venous thrombosis in either lower extremity. CT Urogram With and Without IV Contrast 1. Apparent soft tissue thickening and possible circumferential narrowing at the right UPJ. Please correlate with urinalysis to exclude urothelial tumor. 2. 13 mm nonobstructing calcification lower pole calyx right kidney. 3. No evidence of hydronephrosis. Upon discharge from the hospital patient was started on Eliquis BID with the knowledge that this may lead to continued hematuria. She had also made the informed decision to not pursue any additional testing or exploration of the hematuria. She and her family were in agreement with plan of care moving forward.


VAERS ID: 1656242 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SA7485 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Dizziness, Electrocardiogram abnormal, Heart rate increased, Tinnitus, Ventricular extrasystoles
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hearing impairment (narrow), Vestibular disorders (broad), Dehydration (broad), Hypokalaemia (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: IUD
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: EKG for rapid heart rate and blood pressure he found a PVC
CDC Split Type: vsafe

Write-up: 6 hours after the injection, I started having a lot of dizziness and ringing in my right ear and that continued up until 08/29/2021. I saw my Dr. on the 8/20/2021. I had an EKG for rapid heart rate and blood pressure. He a found a PVC. He does not think it is necessarily caused by the vaccine but may have been flared up by the vaccine and also induced by the stress of the media. I started a steroid, on 08/28/2021, methylprednisolone. As of 08/29/2021 the ringing in my ear has stopped.


VAERS ID: 1656365 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-06-10
Onset:2021-08-02
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 AR / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Exposure during pregnancy, Term birth
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Latex
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pfizer Covid-19 vaccine EUA Patient hospitalized for term birth of baby. No complications


VAERS ID: 1656524 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Discomfort, Electric shock sensation, Fatigue, Feeling abnormal, Gait disturbance, Hypersomnia, Loss of personal independence in daily activities, Mobility decreased, Myalgia, Pain in extremity, Vertigo, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow), 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: Levothyroxine sodium, 75mcg/daily, One-aDay women''s over 50 vitamin, Vit D 3,000/day
Current Illness: none
Preexisting Conditions: hypothyroidism, mild
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: About 8:00 pm on the day I received the vaccine, my upper arm was sore and hurt to use it so I took Naproxen Sodium 12-hour overnight for 2 nights. That relieved pain. On day 2, after the shot, my left calf muscle began to feel very sore. Sore to touch it, sore to use it, then the soreness progressed in intensity and spread to the entire calf (gastrocnemius and soleus-the outside calf muscle). On Day 3 after the shot (8-5-21), my right calf muscle also began to be sore and had same symptoms (gastrocnemius and soleus pain and soremess) the soreness was so bad, I applied ice a few times, and I withheld some of my normal walking & swimming exercises. On day 4 and 5 and 6 after the shot, I couldn''t walk normally! I had to shuffle, or shuffle backwards (!) so as not to use my calves! I sat around with my feet propped up, massaging my calves , even though that didn''t feel great. I finally took some ibuprofen and/or Tylenol and that relieved a lot of the pain and discomfort, but still couldn''t walk normally. On Day 7 I eventually regained some walking ability, only if I took Tylenol. Day 8 was much better and only took Tylenol in the night. Day 9 regular walking. I also experienced fatigue, I slept an hour or 2 longer than usual for 2 weeks. I have had low energy levels for 4 weeks. I got vertigo again (same as after 1st shot) and lasted 3 weeks. Brain zaps occasionally too. Sensations of visual interruptions.


VAERS ID: 1656578 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-03-25
Onset:2021-08-02
   Days after vaccination:130
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046A21A / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Atypical pneumonia, Chest X-ray abnormal, Dyspnoea, Hypoxia, Pneumonia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (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 (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 59 Y/O female, BMI 34.75, with PMHx of Asthma, CAD, GERD, HTN, inflammatory arthritis, tendonitis, admitted with increasing SOB on 8/5/21 and hypoxic at 86% room air. Pt received Regeneron earlier in the day. Pt was started on IV Decadron, inhaled budesonide, remdesivir, and Olumiant, while continuing home medication of Brilinta and ASA. Chest x-ray shows bilateral atypical pneumonia. Pt was discharged home with oxygen on 8/10/21. Pt was then seen in ER several times before transitioning to hospice within 3 days of discharge.


VAERS ID: 1657572 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053C21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Menometrorrhagia, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

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

Write-up: I started my period very late that night into early the next morning and bled more than I have ever in my life and then it went to clots. Normally my cycle is like clockwork and never has anything like this happened to me in my life. I should have gotten my second shot today but won?t until I can have some explanation. I started my cycle again a few days ago. It isn?t as bad as the last but it?s not the same.


VAERS ID: 1657842 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-03-11
Onset:2021-08-02
   Days after vaccination:144
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040A21A / 2 LA / OT

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

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

Write-up: Second shot $g36 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot $g36 days) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 091B21A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot $g36 days). On 02-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot $g36 days) had resolved. Treatment information was not reported


VAERS ID: 1658471 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Hyperhidrosis, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Muscle pain. Joint pain. Nausea. Dizzy. High fever. Sweat. Chills. Fatigue.


VAERS ID: 1659289 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Hypoaesthesia, Pain, Sensory loss
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness:
Preexisting Conditions:
Allergies: peanut allergy, causes stomach upset. No anaphylaxis
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt described pain and numbness at entire left side of body post vaccination. Pt was seen in ED (acquiring records still). At most recent visit (for 2nd injection), pt able to move Left side of body, but she says there is decreased sensation, etc.


VAERS ID: 1660325 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-07-30
Onset:2021-08-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059E11A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue, Myalgia, Oropharyngeal pain, Swollen tongue, Tongue disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Klonopin ,Adderall ,zolpidem, Trileptal ,levothyroxine, Atorvastatin ,Lyrica , Baclofen, Butrans transdermal 7 day patch ,vitamin D3 ,magnesium ,calcium ,one a day vitamins for women, .88 Bayer asprin
Current Illness: Osteopenia, 3 fractures in left ankle, torn AFCL Muscle left ankle, split tendon lower left leg, sprains in lower front left leg, ADHD, 13 pieces of titanium in lower back, fusion L5?S1, anxiety, depression, insomnia and pain, mood disorder.
Preexisting Conditions: All of the above EXCEPT fractured ankle, torn AFCL Muscle, split tendon and lower left leg sprains. That happened from a fall on January 15, 2021
Allergies: Sulfa antibiotics
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Bad, worst sore throat ever, swollen tongue, bumps all over tongue, fatigue, general muscle aches


VAERS ID: 1661202 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Arkansas  
Vaccinated:2021-03-28
Onset:2021-08-02
   Days after vaccination:127
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8732 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BREO ELLIPTA; VENTOLIN; SPIRIVA RESPIMAT
Current Illness: COPD (He has been diagnosed for 3 years and he is on 3 different inhalers for it)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: tested positive for the delta variant; Test Result: Positive.
CDC Split Type: USPFIZER INC202101077101

Write-up: This is a spontaneous report from a contactable consumer (patient) received from program. A 65-years-old male (reporter) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8732), via an unspecified route of administration on 28Mar2021 as dose 2, single, and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on 07Mar2021 as dose 1, single, both (at the age of 65-years-old) for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD), he had been diagnosed for 3 years and he is on 3 different inhalers for it. Concomitant medications included BREO ELLIPTA, VENTOLIN, and SPIRIVA RESPIMAT all taken for chronic obstructive pulmonary disease from an unspecified start date and ongoing. On 02Aug2021, the patient tested positive for the delta variant. It was reported that the reporter, patient, had Pfizer COVID vaccines and then tested positive for the delta variant on 02Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive for delta variant on 02Aug2021. The clinical outcome for the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Sender''s Comments: Linked Report(s): US-PFIZER INC-202101075459 Same reporter, drug, event for different patients.


VAERS ID: 1665719 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-26
Onset:2021-08-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ear discomfort, Ear pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nitrofuritoin, women?s mv, zinc, vit c, vit d
Current Illness: Sore throat
Preexisting Conditions: None
Allergies: Ciprofloxacin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pressure and aches in both ears.


VAERS ID: 1666337 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-01
Onset:2021-08-02
   Days after vaccination:123
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: Abdominal pain upper, Blood test, Chest X-ray, Electrocardiogram, Herpes zoster, Ultrasound biliary tract, Varicella
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: Flaxseed
Diagnostic Lab Data: 2 August - visual assessment - 14 August - chest xray, EKG, ultrasound of gallbladder area, extensive blood work
CDC Split Type:

Write-up: I was diagnosed with chicken pox (varicella without complication) at the Hospital Urgent care facility on 2 August 2021. within 14 days, on 14 August - I went to the emergency room with severe abdominal "Right Upper Quadrant" pain. It was diagnosed one day later as shingles - herpes sine zoster


VAERS ID: 1666481 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Unknown  
Location: Tennessee  
Vaccinated:2021-04-01
Onset:2021-08-02
   Days after vaccination:123
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Anosmia, Asthenia, Blood glucose increased, COVID-19, Chest X-ray abnormal, Chills, Cough, Dyspnoea, Fatigue, Hypoxia, Malaise, Nausea, Pneumonia, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: patient was found to be COVID + Chest xray revealed Left lung PNA patient was discharged and went home with hospice
CDC Split Type:

Write-up: presented to ED with fever, elevated glucose cough, nausea, shortness of breath, chills, weakness and fatigue, loss of taste and smell. Patient had been out of state when he got sick. He was hypoxic with a po2 of 54 and o2 sat of 85%.


VAERS ID: 1670627 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-07-28
Onset:2021-08-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Herpes simplex
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: Multi-vitamin; Glucosamine; Chondritin; MSM; D3; HCTZ; Losartan.
Current Illness: None.
Preexisting Conditions: None.
Allergies: Amoxicillin.
Diagnostic Lab Data:
CDC Split Type:

Write-up: I have rarely seen HSV outbreaks, but I had a significant one 5 days after the vaccine and then again 3 weeks later. I had no other symptoms (almost zero pain from the injection) of any kind.


VAERS ID: 1670913 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNKNOWN / 1 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Atelectasis, COVID-19, Chest X-ray abnormal, Chest discomfort, Condition aggravated, Dyspnoea, Headache, Lung infiltration, Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Pain, Rhinorrhoea, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Reported being sick with a cold in 8 days prior to vaccine. Stated it started with nasal congestion, rhinorrhea, sore throat and it worked it''s way down to her chest. Reported rapid Covid negative 7/28 or 7/29. Got her first covid vaccination 8/2.
Preexisting Conditions: hypertension, diabetes, hyperlipidemia
Allergies: Unknown
Diagnostic Lab Data: 8/3/2021 Covid detected per PCR 8/3 CXR: "Mild bibasilar airspace disease, atelectasis versus infiltrate not excluded."
CDC Split Type:

Write-up: 8/3/2021 Patient presented to Urgent Care with worsening shortness of breath, body aches and headache. She had been experiencing cold symptoms: nasal congestion, rhinorrhea, sore throat for the prior 9 days and now was also reporting chest tightness. 1st Covid vaccine 8/2/2021. Submitter does not have access to any further records of treatment or outcomes. Please contact the admitting hospital for this information. Hospital.


VAERS ID: 1671890 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-07-31
Onset:2021-08-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Stomach cramps, diarrhea, muscle pain, fatigue


VAERS ID: 1672650 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Oral disorder, Oral pain, Vaccination site pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)

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

Write-up: makes you hurt your arm; Strange sore in my mouth; Not like a blister, just a peculiar little white bump; This spontaneous case was reported by an other health care professional and describes the occurrence of ORAL PAIN (Strange sore in my mouth), ORAL DISORDER (Not like a blister, just a peculiar little white bump) and VACCINATION SITE PAIN (makes you hurt your arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced ORAL PAIN (Strange sore in my mouth) and ORAL DISORDER (Not like a blister, just a peculiar little white bump). On 03-Aug-2021, the patient experienced VACCINATION SITE PAIN (makes you hurt your arm). On 05-Aug-2021, VACCINATION SITE PAIN (makes you hurt your arm) was resolving. At the time of the report, ORAL PAIN (Strange sore in my mouth) and ORAL DISORDER (Not like a blister, just a peculiar little white bump) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter. No treatment medication was reported. Second dose scheduled for 30Aug2021.


VAERS ID: 1672995 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-07-26
Onset:2021-08-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test
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: Test Date: 20210802; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: USMODERNATX, INC.MOD20212

Write-up: the patient said he had a mild case of covid/ took the first dose on 26July2021 , and tested positive for Covid on 2August2021; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (the patient said he had a mild case of covid/ took the first dose on 26July2021 , and tested positive for Covid on 2August2021) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced COVID-19 (the patient said he had a mild case of covid/ took the first dose on 26July2021 , and tested positive for Covid on 2August2021). At the time of the report, COVID-19 (the patient said he had a mild case of covid/ took the first dose on 26July2021 , and tested positive for Covid on 2August2021) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication information was reported. No treatment medications were provided.


VAERS ID: 1673159 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-07-28
Onset:2021-08-02
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101012043

Write-up: Rash started developing all over my body, on both of my forearms and all over my neck, started moving up to my face; Rash started developing all over my body, on both of my forearms and all over my neck, started moving up to my face; Rash started developing all over my body, on both of my forearms and all over my neck, started moving up to my face; Rash started developing all over my body, on both of my forearms and all over my neck, started moving up to my face; Have rash on my chest, it look like hives; Migraine; This is a spontaneous report from a contactable consumer (Patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Jul2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 02Aug2021, the patient experienced Migraine. On 03Aug2021, the patient experienced Rash started developing all over my body, on both of my forearms and all over my neck, started moving up to my face and Have rash on my chest, it look like hives. It was reported that Consumer stated, I got my Pfizer Vaccine last week on Wednesday and on Monday I had a migraine and on Tuesday a rash all started developing all over my body now it''s Thursday I have a rash on both of my forearms and rash all over my neck, started moving up to my face and I have rash on my chest, it look like hives my little Pink sheet from the(Clarification unknown) says to call this number to report any side effects but I am hoping if you could tell me what to take to counteract, so it can go away and how long the rash was normally being reported or how long it stays. Outcome of all the events was unknown. Information about the Lot/batch number has been requested.


VAERS ID: 1674324 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939676 / 1 LA / IM

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

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

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


VAERS ID: 1677351 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue, Headache, Lymphadenopathy, Malaise, Muscular weakness, Myalgia, Nausea, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antinuclear factor abnormal (ANA Levels); Sulfonamide allergy (Known allergy: Sulfa)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101022630

Write-up: Weakness in legs; Joint pain in finger; Dizziness/weakness; Dizziness/weakness; Headache; Bad chills; Tiredness; Nausea; Feeling unwell; Injection site pain/swelling/redness; Injection site pain/swelling/redness; Injection site pain/swelling/redness; Muscle pain; Swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female 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 02Aug2021 at 11:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included antinuclear factor abnormal (ANA levels) and allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0191), via an unspecified route of administration in the left arm on 07Jul2021 at 11:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 02Aug2021 at 11:00, the patient experienced weakness in legs, joint pain in fingers, dizziness/weakness, headache, bad chills, tiredness, nausea, feeling unwell, injection site pain/ swelling/ redness, muscle pain and swollen lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events weakness in legs, joint pain in finger, dizziness/weakness, headache, bad chills, tiredness, nausea, feeling unwell, injection site pain/ swelling/ redness, muscle pain and swollen lymph nodes was not recovered at the time of this report.


VAERS ID: 1678782 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-07-26
Onset:2021-08-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Menstruation irregular, Ovarian cyst
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad)

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

Write-up: Pain to left side of abdomen. Urgent care visit for pain and rule out of kidney stone & ovarian torsion. Follow up apt to PCP and was determined to be hemorrhagic cysts to the left ovary. 2 menstrual cycles per month since 2nd dose. PCP stated this was from immune response to vaccine.


VAERS ID: 1681940 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-03-31
Onset:2021-08-02
   Days after vaccination:124
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Covid; Result Unstructured Data: Test Result:contracted Covid; Comments: contracted Covid on 02Aug2021 (COVID positive status).
CDC Split Type: USPFIZER INC202101099056

Write-up: contracted Covid; contracted Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on 31Mar2021 as dose 2, single, and received first dose of BNT162B2 (Batch/Lot number and Expiration date: Not reported), via an unspecified route of administration on 03Mar2021 as dose 1, single; both for COVID-19 immunization. Medical history and concomitant medications were not reported. for COVID-19 immunization. On 02Aug2021, Patient contracted COVID. Patient stated, that patient unblinded in order to know vaccine status (placebo) and subsequently received the Pfizer vaccine. Lab test included sars-cov-2 test reported as contracted COVID (COVID positive status). The outcome of events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1681981 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Burning sensation, Chest pain, Dyspnoea, Fatigue, Poor quality sleep
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101110346

Write-up: shortness of breath appears; I felt burning in the heart area; I have constant pain in the chest, sometimes lower, sometimes stronger; I feel constant fatigue, tiredness; I don''t have enough sleep; This is a spontaneous report from a contactable consumer, the patient. A 42-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EW0186, expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 02Aug2021 (age at vaccination: 42-years-old) as dose 2, single for covid-19 immunisation. The patient did not have any other medical history or known allergies. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EW0181, expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 23Jun2021 (age at vaccination: 42-years-old) as dose 1, single for covid-19 immunisation. On 02Aug2021, patient felt burning in the heart area which lasted for 2-3 weeks, after that he had constant pain in the chest, sometimes lower, sometimes stronger. After the second shot, he felt constant fatigue, tiredness as he did not have enough sleep. Often, when walking, shortness of breath appeared, and chest pain increased. Patient did not receive any treatment for the events. He did not have covid prior vaccination and not tested for covid post vaccination. Patient did not have other vaccine in four weeks and not received other medications in two weeks. The outcome of the event burning in the heart area was recovered and the other events was not recovered. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1682062 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-08-29
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fatigue
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101138554

Write-up: Fatigued/ tired; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) via an unspecified route of administration in the right arm on 29Aug2021 at 11:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. On 02Aug2021 at 10:00, the patient was fatigued/ tired. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event fatigued/ tired was resolved on an unknown date in Aug2021.


VAERS ID: 1682909 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-06-04
Onset:2021-08-02
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 044B21A / 1 LA / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 044B21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cardiomyopathy, Dyspnoea exertional, Echocardiogram abnormal, Ejection fraction decreased, Myocarditis
SMQs:, Cardiac failure (narrow), Pulmonary hypertension (broad), Cardiomyopathy (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Zyloprim 100 mg po daily
Current Illness: Hypertension
Preexisting Conditions: Hypertension
Allergies: NKDA
Diagnostic Lab Data: Cardia profile, echocardiogram,
CDC Split Type:

Write-up: Cardiomyopathy, dyspnea on exertion 8/10/2021 PT is a 36 YO M with PMH of HTN who presented to the ER after being seen in clinic and ECHO showed an EF of 25-30%. The patient was admitted for management. The patients cardiomyopathy was felt to be from either a viral myocarditis or a vaccination induced myocarditis. The patient was diuresed with Lasix, started on Lisinopril and spironolactone. The patient was stable with this regimen and DC home with close follow up with cardiology.


VAERS ID: 1683042 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-03-04
Onset:2021-08-02
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805022 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Cardiac monitoring, Dizziness, Electrocardiogram, Ultrasound scan
SMQs:, Anticholinergic syndrome (broad), Vestibular 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: Yes
Current Illness: No
Preexisting Conditions: Heart failure
Allergies: No
Diagnostic Lab Data: EKG; ultrasound; cardiac monitor
CDC Split Type: vsafe

Write-up: Unexpected lightheadedness. Still trying to figure out what''s causing it.


VAERS ID: 1683125 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-07-02
Onset:2021-08-02
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8732 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Alcohol withdrawal syndrome, Seizure, Wernicke's encephalopathy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient presented to the ED and was subsequently hospitalized for alcohol withdrawal syndrome with seizure, Wernicke''s encephalopathy within 6 weeks of receiving COVID vaccination.


VAERS ID: 1684926 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Aphasia, Confusional state, Feeling abnormal, Hallucination, visual, Hot flush, Loss of personal independence in daily activities
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: Lexapro, Multi Vitamin, Vitamin D, B12
Current Illness: None
Preexisting Conditions: Anemia, depression, ADHD
Allergies: Biaxin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 8/2/21 @ 5:30/6am- I had my first drug trip. I saw freaky things as I was waking up and couldn?t make it stop. They were frightening images. 1:30pm- I had a very intense hot flash that rose into my body, an anxiety attack came on and confusion took over. I couldn?t change a doctor appt in my calendar, I had a hard time making a pot of coffee. It was like there was some disconnect in my brain. I contacted my doctor because it was so frightening. 7pm- I had a very difficult time reading a bedtime story to my little guy. Again, a disconnect. 8/3/21- From this point on for the next three weeks I experienced severe anxiety attacks (not normal for me at all) and brain confusion but it was more like a disconnect. I had trouble reading and putting what I was reading into action. I have somewhat of a photographic memory and while I could pull up a picture I was unable to zero in on anything in the picture, especially if it was a word. I was unable to make an appointment at my doctor?s office for these issues. The anxiety attacks have calmed but I still have trouble reading, though not as bad as the last month.


VAERS ID: 1685542 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-02-24
Onset:2021-08-02
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: estradiol .5mg and prometrium 100mg - each 1 x daily iron tablets (1 daily) .375 Vitamin D - 1000 1 x daily
Current Illness: None
Preexisting Conditions: None
Allergies: sulfa, penicillin, flex
Diagnostic Lab Data: Covid 19 test on 8/6 - results were negative
CDC Split Type:

Write-up: I returned from a trip to help family. Arrived via plane on Sunday August 1, 2021. On August 2 I had a sore throat and by the following day I had a fever of 99.9 and requested a COVID test to be sure I did not have COVID. The test was provided by pharmacy on August 6, 2021 and I had a negative result. For 7-10 days I had slight congestion but fever disappeared by August 4. I was asked to provide this information to the CDC.


VAERS ID: 1689140 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-08-01
Onset:2021-08-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 182005 / 1 RA / JET

Administered by: Pharmacy       Purchased by: ?
Symptoms: Aphonia, Atypical pneumonia, Blood test, Chest X-ray, Computerised tomogram head, Fatigue, Headache, Hypoaesthesia, Nausea, Oropharyngeal pain, Paraesthesia, Pyrexia, SARS-CoV-2 test negative
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: GI issues
Allergies: peanuts, eggs, quinidine, ibuprofen
Diagnostic Lab Data: Head CT scan Chest x-ray Covid-19 test Blood work
CDC Split Type: vsafe

Write-up: I had tingling in my right hand, and my leg that would come and goes for a few days. I had headache, low grade fever, nausea, fatigue, and tired. My numbness in my leg from my knee down and in my right arm. I had sore throat and lost my voice. The headache was really bad. I went to the doctor, they did head CT scan, chest x-ray, blood work and Covid-19 twice, negative. I am scheduled for MRI on Sept 20th. They diagnosed me walking pneumonia.


VAERS ID: 1689194 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-02-26
Onset:2021-08-02
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6203 / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM9809 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Chills, Computerised tomogram, Cough, Diarrhoea, Dyspnoea, Full blood count, Laboratory test, Prostatic specific antigen, Pyrexia, SARS-CoV-2 test positive, Urine analysis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), 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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Xarelto, flecainide
Current Illness: Atrial flutter, Atrial Fibrillation
Preexisting Conditions: prediabetic (A1C 6.2-7.7)
Allergies: amoxacillen, doxacyclene, cipro, lisinopril, statins Omega 3 fatty acids, Vit C, D, K, Magnesium, Chromium, Co-Q10, saw palmetto milk and corn proteins may cause headaches
Diagnostic Lab Data: 7/31/2021 negative Covid test 8/4/2021 positive Covid test 8/14/2021 positive Covid test 8/29/2021 negative Covid test [CBC, chem panel, hepatic panel. lipid panel, PSA, Vit D, Omega assessment, UA, A1C,] (8/20/2021) CT Scan with contrast (8/2/2021)
CDC Split Type:

Write-up: On 8/2/2021, I developed a cough, (it lasted 3-4 weeks, the same evening I got fever / chills (which lasted for 6 days with a high on day 5 of 104.4*F), watery diarrhea for 9 days, loss of taste / smell (came about on day 3, lasting well over two weeks, some foods are still affected), shortness of breath (also presented early and was extreme at times, leading to need for rest 20-30 minutes, worse wigh flexion of torso or activities like stairs, and other ADL''s. On day 5, I received Regeneron monoclonal antibody infusion, the fever spiked that night and lasted one day longer. I applied an Erchonia EVRL violet 405nm / red 635nm cold laser to my chest, abdomen, nasal cavities, mouth and throat, and brain for 4 minutes total time to cover all areas; it was this application on two successive days, that caused the recovery of persisten dry cough and shortness of breath to abate.


VAERS ID: 1689411 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-02-06
Onset:2021-08-02
   Days after vaccination:177
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: seasonal allergies
Allergies: none
Diagnostic Lab Data: Test August 2, lab results August 3
CDC Split Type:

Write-up: I got Covid August 2, 2021. (positive test Aug 3)


VAERS ID: 1689474 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-07-25
Onset:2021-08-02
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Chest X-ray, Dyspnoea, Oxygen saturation decreased, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: NKA
Diagnostic Lab Data: Cxr, covid test.
CDC Split Type:

Write-up: Pt came to ER c/o recent dx of corona virus with worsening SOB, low sats in upper 70''s.


VAERS ID: 1689496 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-01-05
Onset:2021-08-02
   Days after vaccination:209
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011L20A / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Cough, Diarrhoea, Dyspnoea, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: CAD, COPD, Hypercholesterolemia, HTN
Allergies: NKA
Diagnostic Lab Data: Covid test, cxr.
CDC Split Type:

Write-up: Pt in ER c/o fever, diarrhea, cough, SOB.


Result pages: prev   198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=297&PERPAGE=100&ESORT=ONSET-DATE&REVERSESORT=ON&VAX=COVID19&DIED=No


Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166