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From the 7/23/2021 release of VAERS data:

Found 506,830 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 277 out of 5,069

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VAERS ID: 1483459 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-15
Onset:2021-06-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 2 LA / -

Administered by: Public       Purchased by: ?
Symptoms: Dizziness, Ear discomfort, Fatigue, Headache, Lethargy, Migraine, Musculoskeletal stiffness, Oral discomfort, Pain in jaw, Swelling, Tension headache, Toothache
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Osteonecrosis (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ACYCLOVIR [ACICLOVIR]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (known_allergies Sulfa group, Band aids); Sulfonamide allergy (known_allergies Sulfa group, Band aids)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021831618

Write-up: severe burning sensation of ceiling of mouth; severe pain on jaws/teeth; severe pain on jaws/teeth; severe migraine; severe fatigue; lethargy; temple headache; severe tightness on the back of head; severe stiff neck; right ear clogging; swelling sensation of right neck; dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient) reporting on herself. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EW0185) via an unspecified route of administration, administered in Arm Left on 15May2021 at 10:00 as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 24Apr2021 at 10:00 (Batch/Lot Number: EW0171) as both for covid-19 immunisation. Medical history included drug hypersensitivity allergies Sulfa group, Band aids, hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included acyclovir (400mg) taken for an unspecified indication, start and stop date were not reported. She was not diagnosed and tested Covid-19 prior vaccination. She was no pregnant at time of vaccination. On 01Jul2021 at 14:00 ,the patient experienced severe burning sensation of ceiling of mouth, severe pain on jaws/teeth, severe migraine, severe fatigue, temple headache, severe tightness on the back of head, severe stiff neck , right ear clogging, swelling sensation of right neck, dizziness. She went to emergency room. She was taken MethylPredisolone at two different times as a treatment for all events. Therapeutic measures were taken as a result of severe burning sensation of ceiling of mouth, severe pain on jaws/teeth, severe migraine, severe fatigue, lethargy, temple headache, severe tightness on the back of head, severe stiff neck, right ear clogging, swelling sensation of right neck, dizziness. The outcome of the events were not recovered. Follow-up attempts are possible. Further information is expected.


VAERS ID: 1483477 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-17
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Ear disorder, Ear swelling, Erythema, Feeling abnormal, Lethargy, Lymph node pain, Lymphadenopathy, Nausea, Pain, Parosmia, Skin irritation, Suspected COVID-19, Vaccination site bruising, Vertigo, Weight increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? 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 (she had COVID in Jan); Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Patient''s Medical History (including any illness at time of vaccination)? : None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021831952

Write-up: she began feeling dizzy; If she moved her head or eyes, she felt like she was spinning; She was lethargic for only 24-36 hours following the COVID-19 Vaccination; Her sweat glands, urine, bowel movements, & hair glands all smell differently. She said everything smells as if she ate garlic.; she felt completely wiped out; She had a bruise appear on her left arm at the COVID-19 Vaccine injection site almost a week later.; feel like she had COVID again; both her earlobes were swollen, red, and irritated; both her earlobes were swollen, red, and irritated; both her earlobes were swollen, red, and irritated; She felt like she gained weight since she received her first COVID-19 vaccination; She had a reaction to a pair of sterling sliver earrings that she had been wearing forever; The lymph nodes right behind both earlobes felt like they were swollen; the lymph nodes located behind both earlobes felt tender; achy; nauseous; This is a spontaneous report from a contactable consumer (patient reported for herself) from a 43-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EW0191, NDC number: 59267100001), via an unspecified route of administration, administered in arm left on 17Jun2021 14:34 (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 from on an unspecified date in Jan2021 to an unknown date (she had COVID in Jan). The patient''s concomitant medications were not reported. the patient did not receive any other vaccines within 4 weeks prior vaccinations. The patient experienced achy, nauseous on an unspecified date in 2021; she had a reaction to a pair of sterling sliver earrings that she had been wearing forever; both her earlobes were swollen, red, and irritated; she felt like she gained weight since she received her first covid-19 vaccination; the lymph nodes right behind both earlobes felt like they were swollen; the lymph nodes located behind both earlobes felt tender; she had a bruise appear on her left arm at the covid-19 vaccine injection site almost a week later; feel like she had covid again on an unspecified date in Jun2021; she was lethargic for only 24-36 hours following the covid-19 vaccination; her sweat glands, urine, bowel movements, & hair glands all smell differently. she said everything smells as if she ate garlic; she felt completely wiped out on 18Jun2021; she began feeling dizzy on 19Jun2021 13:00, if she moved her head or eyes, she felt like she was spinning on 19Jun2021. Adverse events did not result in emergency room, physician office visit. Patient was experiencing side effects, she is scheduled for her 2nd dose of the Pfizer Covid-19 vaccine on 08Jul2021 she wants to know if it would it be okay if she went out an additional week, or would it compromise the efficacy. My reaction was a little more intense then thought. Patient who was reporting an adverse event from her first COVID-19 Vaccine shot on 17Jun2021 (Thursday). The patient said she was experiencing some odd side effects since she receiving the COVID-19 Vaccine. The patient said she had a reaction to a pair of sterling sliver earrings that she had been wearing forever. The patient said her sweat glands smell differently, and every fluid, or anything her body produced smelled differently. The patient said she was also dizzy and lethargic. Patient clarified on either Tuesday (22Jun2021) or Wednesday (23Jun2021), a week after patient had her first COVID-19 Vaccine, she was driving a 2 hour trip to her mother''s house, and noticed her ears felt weird. She said when she arrived at her mother''s house she looked in a mirror and saw both her earlobes were swollen, red, and irritated. She said the lymph nodes right behind both earlobes felt like they were swollen. Swollen, Red, & Irritated Earlobe Treatment: Patient stated she used rubbing alcohol that her mother had (she stated she did not have her mother''s rubbing alcohol UPC Number, Lot Number and Expiry Date) on both earlobes. She said she again used the same rubbing alcohol on both earlobes before bedtime that evening. She said she continued to use rubbing alcohol on both earlobes the next morning, and evening. She said after she returned home, she used her own rubbing alcohol on both earlobes, providing: H-E-B generic brand 70% Rubbing Alcohol (UPC Number: 041220033737, Lot Number: 0519420, Expiry Date: Dec2023). Patient stated the (pierced) hole in both earlobes was better. She said the lymph nodes located behind both earlobes felt tender but were not swollen. She said her earlobes were no longer red and swollen. Patient clarified on Friday (18Jun2021), she noticed everything kind of smelled weird. She said it was not only her sweat glands, but her urine, bowel movements, and hair glands all smell differently. She said she thought she maybe ate some garlic, but she was zonked out on Friday (18Jun2021), so she knew she didn''t. She said everything smelled as if she ate garlic. She said her sweat, bowel movements, and urine smell weird, like a sweet, garlicky smell, but she hadn''t eaten any garlic. She said the smell had been persistent since she received the COVID-19 Vaccination. She said she asked her friends and family if they noticed the weird smell, and nobody else had noticed the weird smell, only her. Patient clarified she was lethargic for only 24-36 hours following the COVID-19 Vaccination. She said on Friday (18Jun2021) she felt completely wiped out. She said around 1:00PM on Saturday (19Jun2021) she began feeling dizzy. She said if she moved her head or eyes, she felt like she was spinning, and just very dizzy. She said she remained feeling that way through Tuesday (22Jun2021). Patient reported she felt like she gained weight since she received her first COVID-19 vaccination. She said may be her eating choices contributed to her weight gain, but her weight was normally stable. She said she ate healthy and ate fruits and vegetables. She said she was conscious of her water intake but had been eating out a bit more lately. Dizzy Treatment: Reported she drank over-the-counter electrolyte drinks, clarified as Gatorade Gatorlyte Rapid Rehydration Orange flavored drink. She said the Gatorade Gatorlyte had 5 times the electrolytes in it. She said she also drank coconut water. She said she drank a full bottle of Gatorade Gatorlyte Rapid Rehydration Orange flavored drink on Sunday (20Jun2021). She said on Monday (21Jun2021) and Tuesday (22Jun2021) she drank a half bottle of the Gatorade Gatorlyte Rapid Rehydration Orange flavored drink every morning (UPC Number: 052000047905, Lot Number: 1804YY022314, Expiry Date: Nov2021) and then had a serving of coconut water both afternoons (Full Circle Market Brand Coconut Water, UPC Number: 036800390843, Lot Number: L:035/21 02 10:292P01, Expiry Date: 04Feb2022). Lethargic Treatment: Reported on 18Jun2021 and 19Jun2021 she took 2-Ibuprofen 200mg soft gel capsules (400mg dose), (NDC Number: 0363161066, Lot Number: Z10038, Expiry Date: Jun2022). Patient reported she had a bruise appear on her left arm at the COVID-19 Vaccine injection site almost a week later. She said the bruise was now turning a green hue, and the bruise had improved. Patient reported she was concerned about the second COVID-19 Vaccine dose. She said she knew she needed both COVID-19 Vaccine doses, in order for the COVID-19 Vaccine to be effective. She asked if Pfizer would advise her waiting another week before getting her next dose on 08Jul2021. She asked if she went out another week past 08Jul2021, would the delay be helpful with the side effects she experienced after her first COVID-19 Vaccine dose, or would the delay impact the efficacy of the COVID-19 Vaccine. Patient stated she received her first dose of the Pfizer COVID-19 vaccine on 17Jun2021. and had a lot of side effects not listed that she could find and she is concerned about taking the second dose because of these reactions. Stated she had COVID in Jan and knew she was going to probably going to have some side effects, about 36 hours after the first dose she did feel like she had COVID again was just, achy and nauseous and very lethargic. Then after she recovered from those initial side effects she began getting very dizzy, where she couldn''t move her head or her eyes normally, like trying to read phone or credits on the tv she was just spinning so the second day of that she couldn''t do research herself on google so her sister started to look things up and thought she might need to try some Pedialyte or something, so she had some electrolytes, Gatorade rapid hydration and felt better within an hour but the next day felt the exact same way very, very dizzy it took three days of having to replenish with electrolytes before felt back to normal and then the day after had a sever reaction to sterling silver. Has worn these same earrings for years, never takes them out, but both had a sever reaction where it almost felt like her lymph nodes were swollen behind her ear, so she took them out and starting putting alcohol on 2-3 times a day and everything cleared up, on top of that the day after her vaccination she notices her sweat glands kinda smell different, after a week realizing that everything else still smells the same just her sweat glands smell differently. Response: A review of the Prescribing Information (LAB-1457-10.0 Revised: 25Jun2021) for Pfizer COVID-19 Vaccine did not find information regarding sweat glands smell differently or reaction to metals. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. The patient received treatment for the events. Outcome of the events her sweat glands, urine, bowel movements, & hair glands all smell differently. she said everything smells as if she ate garlic; she felt like she gained weight since she received her first covid-19 vaccination; the lymph nodes located behind both earlobes felt tender was not recovered; feel like she had covid again, achy, nauseous was unknown; she had a reaction to a pair of sterling sliver earrings that she had been wearing forever; both her earlobes were swollen, red, and irritated; the lymph nodes right behind both earlobes felt like they were swollen; she had a bruise appear on her left arm at the covid-19 vaccine injection site almost a week later was recovering; she was lethargic for only 24-36 hours following the covid-19 vaccination, she felt completely wiped out, both was recovered on 19Jun2021; she began feeling dizzy, if she moved her head or eyes, she felt like she was spinning, both was recovered on 22Jun2021.


VAERS ID: 1483488 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:2021-06-14
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling hot, Headache, Hyperhidrosis
SMQs:, Neuroleptic malignant 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: USPFIZER INC2021832093

Write-up: got hot and was sweating; got hot and was sweating; had a headache; This is a spontaneous report from a contactable other hcp (patient). This is Report 2 of 2. This report was not related to a study or programme. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: unknown; Expiration date was not reported)DOSE 1, via an unspecified route of administration on 14Jun2021 as single dose for covid-19 immunisation. Lot number was not provided as caller unwilling to complete the report. The patient''s medical history and concomitant medications were not reported. The patient got hot and was sweating, had a headache on an unspecified date. Investigation assessment was not reported. Caller stated she has not reported on this and declined to make a report as she was more worried about her son at the time of this report. No further details provided. Caller stated she can call back later if needed and report. Clinical outcome of the events was unknown. Information on lot/batch number has been requested.


VAERS ID: 1483523 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-30
Onset:2021-06-01
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Cardiac failure congestive, Chest X-ray, Electrocardiogram
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (Verbatim: Atrial fibrillation); Heart disease, unspecified (Family Medical History Relevant to AE(s): heart disease)
Allergies:
Diagnostic Lab Data: Test Name: Blood; Result Unstructured Data: Test Result:Good; Comments: More information available (Y/N): No; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Good; Comments: More information available (Y/N): No; Test Name: EKG; Result Unstructured Data: Test Result:Good; Comments: More information available (Y/N): No
CDC Split Type: USPFIZER INC2021835560

Write-up: Congestive heart failure; This is a spontaneous report received from a contactable consumer (Patient). A 60-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 30Mar2021 11:00 (at the age of 60-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, cardiac disorder from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot: unknown) on 10Mar2020 at 11:00 PM in the right arm for COVID-19 immunisation and experienced shortness of breath. The patient experienced congestive heart failure on Jun2021. The events assessed as serious (medically significant). Call was from two sisters, a 57 year old female and a 60 year old female. One received her Pfizer Covid-19 vaccine on 22Jun2021 and started experiencing shortness of breath and dyspnea. The other sister received the Pfizer Covid-19 vaccine on 10Mar2021 and starting experiencing shortness of breath as well but attributed to her history of atrial fibrillation initially. Both are wondering if anyone else was having these complaints and if there are any recommendations for the complaints. Patient mentioned while providing family history, her sister had the COVID 19 vaccination and also had shortness of breath. Adds her sister got her vaccination in Mar2021 but she does not had her card with her. She also had shortness of breath and was still having it. She did not put two and two and together until her sister had it. This was a clone report was created to document the sister''s experience. Patient adds the shortness of breath that started in Mar2021. States she had previously been off work for a year with A-Fib but she was doing really well, she had started walking around the block and everything. Reports she was unsure of exactly when she noticed the shortness of breath. She went from the car to the store and she was short of breath so she went to the emergency room to get it checked but everything was good. Mentions she was also diagnosed with congestive heart failure about a month ago. After she went to the emergency room she just went back and forth to her doctors. The lung doctor said she was okay and the heart doctor, too. She kept going to the doctor because it did not dawn on her that the shortness of breath might be related to the vaccination until her sister got her vaccination and had the shortness of breath. Now she believes she noticed the shortness of breath after the first dose. Mentions she has the emergency room records and her vaccination card at home to verify her information. Adds she was talking to a guy at the bus station and he had shortness of breath too. She does not know this person and declined to report regarding the guy at the bus station. Patient visited Emergency Room, but not admitted. Patient visited physician Office. The patient underwent lab tests and procedures which included blood test: good, chest x-ray: good, electrocardiogram: good on More information available (Y/N): No. The outcome of the events was reported as unknown. Information on the Batch/lot number has been requested.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-2021829874 same reporter/drug/event, different patient


VAERS ID: 1483545 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: D.C.  
Vaccinated:2021-06-28
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Axillary pain, Back pain, Chest pain, Feeling hot, Pain in extremity, Vaccination site erythema
SMQs:, Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), 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: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021842245

Write-up: pain in my left arm; felt weak; left armpit started to hurt; pain moved to the chest; application of the vaccine reddened an area of my arm; it got hot; back ache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 24-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: EW0180), via an unspecified route of administration, administered in arm left on 28Jun2021 16:30 (at the age of 24-year-old) at dose 2, single for covid-19 immunisation. Medical history included asthma. Patient had no known allergies. Concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: EW0182) via an unspecified route of administration, administered in arm left on 07Jun2021 10:30 (at the age of 24-year-old) at dose 1, single for covid-19 immunisation and experienced pain in the arm that was bearable. 1 dose of the vaccine that patient received on 07Jun2021, after about 2 hours, patient had pain in my arm that was bearable, that pain lasted 3 days. 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. Reported events: 1 dose of the vaccine that patient received on 07Jun2021, after about 2 hours, patient had pain in my arm that was bearable, that pain lasted 3 days. second dose that patient received on 28Jun2021 at 4:30 pm patient started a pain in patient left arm around 2 hours after the vaccine, after 12 hours after the vaccine patient felt weak, patient left arm hurt. patient left armpit started to hurt and patient took analgesic which helped patient for 8 hours. After this, patient back and both armpits began to ache, but being stronger on the right, but that pain moved to the chest subjecting pressure for about 2-3 min. This on the night of 29Jun2021 to whatever it takes patient another analgesic. Early on 30Jun2021, patient left arm and armpit continued to hurt but patient back and left armpit no longer that night (8:00 pm) patient left arm 3cm below the application of the vaccine an area of patient arm became red for 2 nights and warmed up. Patient already fine. Patient received treatment with analgesic for adverse events. Outcome of the events was resolved on an unspecified date in 2021.


VAERS ID: 1483552 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-06-25
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Illness, Nausea, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021843113

Write-up: getting very ill. and vertigo; I started getting very ill. and vertigo; I started feeling a little odd; throwing up; very dizzy and nauseous; very dizzy and nauseous; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0217 and Expiration date: Sep2021) via an unspecified route of administration on 25Jun2021 as a single dose for COVID-19 immunization. A patients medical history and concomitant medications were not provided. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) on an unspecified route of administration and an unspecified date as dose 1, single, for COVID-19 immunization and experienced arm hurts. Consumer don''t know if this was the side effect, but consumer was sick for about a week. Consumer got the second shot on 25Jun2021 on Friday morning, that Sunday on 27Jun2021, consumer started feeling a little odd but, in the morning, consumer was throwing up, consumer could not hold water down and that lasted for about day and a half and since then on an unspecified date in Jun2021, consumer had been very dizzy and nauseous, it was finally starting to go away. Consumer had not been able to go doctor yet because Consumers car broke down and it has been like about a week. Consumer stated, it was only after the 1st shot, the only thing was that my consumers hurts more than like a normal shot, Consumer did not have any fever or anything but second shot it was consumer did not feel as bad but then few days later on an unspecified date, consumer started getting very ill and vertigo. The outcome of event I started feeling a little odd and I started getting very ill and vertigo was unknown. The outcome of event throwing up was recovered on an unspecified date in Jun2021. The outcome of event very dizzy and nauseous was recovering at the time of reporting. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1483564 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-06-23
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN1699 / UNK RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Pyrexia, Sialoadenitis, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: RISPERIDONE; GUANFACINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autism spectrum disorder (Verbatim: Autism spectrum)
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Fever; Result Unstructured Data: Test Result:100 degrees Fahrenheit
CDC Split Type: USPFIZER INC2021845603

Write-up: woken up with swollen his left side of his face and his cheek near his jaw whole side was significantly swollen; Fever; Diagnosed him with salivary gland infection; This is a spontaneous report from a contactable consumer. This consumer (father) reported that a 14-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Right on 23Jun2021 16:00 (Batch/Lot Number: EN1699) as dose number unknown, single (at the age of 14-year-old) for covid-19 immunisation. Medical history included autism spectrum disorder from an unknown date and unknown if ongoing Verbatim: Autism spectrum. Concomitant medications included risperidone, guanfacine. Reporter was calling on behalf of son he was 14-years-old and so he was autism spectrum was non verbal. The patient received the vaccine at 4pm on 23Jun, the next day which in 24th in afternoon 3 pm he developed a fever which was around closed to 100 degrees Fahrenheit and then we gave him Tylenol (Further clarification was unknown) reporter thought because of the vaccine shot. On next day morning he had woken up with swollen his left side of his face and his cheek near his jaw whole side was significantly swollen. So, we immediately took him to the urgent care. Reporter stated, no laboratory test done, doctor basically put him on antibiotic Amoxicillin (Treatment) for the salivary gland infection diagnosed him with salivary gland infection they put him on Amoxicillin and swelling subsided in 3 days and fever went in 2 days and there was no further analysis needed. Therapeutic measures were taken as a result of diagnosed him with salivary gland infection, fever, woken up with swollen his left side of his face and his cheek near his jaw whole side was significantly swollen. The outcome of the event woken up with swollen his left side of his face and his cheek near his jaw whole side was significantly swollen was recovered on 28Jun2021, event fever was recovered on 26Jun2021 and diagnosed him with salivary gland infection recovered in Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1483638 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arterial catheterisation, Arterial occlusive disease, Dyspnoea, Echocardiogram, Inappropriate schedule of product administration, Sepsis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Catherization; Result Unstructured Data: Test Result:Abnormal; Comments: one of my arteries was 90 percent blocked; Test Name: Echocardiogram; Result Unstructured Data: Test Result:90% blocked; Comments: my cardiac arteries is 90% blocked
CDC Split Type: USPFIZER INC2021883307

Write-up: Caller states she and her husband received their 2nd Pfizer vaccine dose in June, 90 days after first dose; dying septic; I had an echocardiogram and one of my cardiac arteries is 90% blocked and could this be the vaccine; had trouble with breathing worse after 2nddose of vaccine; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Jun2021 as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took 1 dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6200, Expiry date: 30Jun2021), dose 1 via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation and experienced Covid and trouble breathing. The patient stated, she and her husband received their 2nd Pfizer vaccine dose in Jun, 90 days after first dose. She had trouble with breathing worse after 2nd dose of vaccine (In 2021). She had an echocardiogram and one of her cardiac arteries was 90% blocked (in 2021) and could this be the vaccine. She stated this was not blocked 1.5 yrs. ago. Her cardiologist said it was highly unusual to get blockage this soon. Could the vaccine cause blockage in her arteries. The patient wrote a letter to Pfizer asking if this could cause the blockage and no one wrote back. She wants answers. She would send another letter and if no one answers me this time, she would go to the Television (TV) and media and report Pfizer. She has been bounced between offices 2-3 times today. This was taking hours and is ridiculous. She said after her second COVID Vaccination she was dying septic (in 2021) of the (voice not clear) she doesn''t know what that was. She says that one of her arteries was 90 percent blocked now in her heart and she was wanting to know if this vaccine could''ve had anything to do with it. She wanted to speak to someone. Her question when she first roll back way back then, could the shot cause COVID. They still haven''t answered that question but now happened was she had been on wound healers (voice not clear) and have been having problems'' (not clarified further hence not captured as event) and she went in for a catheterization the other day and they found that one of her arteries was 90 percent blocked and it was not blocked at all a year and a half ago. So, the doctors wondering why (incomplete sentence). The outcome of event had trouble with breathing worse after 2nddose of vaccine was not recovered and outcome of all other events was unknown. Follow-up attempts are needed. Further information is requested.


VAERS ID: 1483763 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2021-03-31
Onset:2021-06-01
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 0331211/1808980 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Movement disorder, Muscular weakness, Neuralgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Joint paint, movement pain, nerve pain, weakness in hands and legs


VAERS ID: 1483855 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-28
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

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

Write-up: High Blood pressure


VAERS ID: 1483907 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-11
Onset:2021-06-01
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anticoagulant therapy, Blood test, Chest X-ray, Echocardiogram, Electrocardiogram, Hyperthyroidism, Inflammation, Pain in extremity, Skin discolouration, Skin ulcer, Ultrasound Doppler
SMQs:, Hyperthyroidism (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Humalog Insulin & Levothyroxine
Current Illness: Diabetes & Hypothyroidism
Preexisting Conditions:
Allergies: No
Diagnostic Lab Data: - EKG - 6/17 - Variety of Bloodwork Panels ( Through out my stay in the hospital as well as from my follow up doctor visits) - Echocardiagram 6/17 - Doppler on my hand to test Embolism from first vascular doctor on 6/10 - Chest Xray 6/17
CDC Split Type:

Write-up: June 1st: My finger tips were beginning to turn purple. It started on my left hand index and middle finger. Then it spread to my pinky, then following the same route on my other hand. I went to my GP and he had suspected Raynauds but wanted to refer me to a Vascular doctor since it seemed a little odd to see a Raynauds case in June. The next day I was able to see a Vascular doctor. He diagnosed me with a possible embolism and put me on Eliquis and recommended a cardiac workup which I scheduled right after that appointment. The doctor mentioned that if it does not get better to give him a call within the 2 week window of my recheck. A week and a half in it was not getting better, I called the office and he mentioned to go to the ER . June 17th: I went to the ER and explained my situation. Seeing my symptoms they admitted me. They started a Heparin drip IV to keep me on the thinners and ran a whole cardiac workup included an enormous amount of bloodwork. I spent less than 24 hours in the hospital because my cardiac workup was normal, bloodwork did not show any signs of emergency. In the hospital I saw the doctor on call, Vascular, Hematology/Oncology, Diabetic Educator, & Cardiologist. They discharged me with Xarelto to start and told me to see a Rhematologist. Every doctor there suspected a Rhuematoid issue. After being discharged I made an appointment with PA on July 1st. Upon arrival she ordered what had to be 10 or more vials of blood which included some Rhematoid testing as well as a special panel called Avise which narrows down the Rhematoid issues. While we waited for that bloodwork she then put me on Amlodipine 5mg once a day. In between that I went to do the check up with the Vascular doctor that I saw in the hospital and he said that it is not a vascular issue. At my recheck with PA, My bloodwork showed my thyroid number was elevated. She ordered a thyroid ultrasound in which I am still waiting to get done. All of the Rhematology bloodwork showed no diagnosis. She then raised my Amlodipine to 2.5mg in the morning and 5 mg at night as well as Nitroglycerin Cream to put on the top of my hands 3x a day if needed. I have been taking that medication and the cream as well and nothing seems to be helping. On my left hand specifically I have ulcers forming from the beginning of this ordeal. They are getting extremely worse and larger. The pain and inflammation that comes and goes in all of my fingers are unbearable. No medication that any doctor has given me from the beginning to now has helped me.


VAERS ID: 1483912 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-18
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041C21A / 1 LA / IM

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

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

Write-up: Pt had chest pain the day following her first dose of Moderna, and told me right before I gave her the second dose. I didn''t administer the second dose.


VAERS ID: 1483969 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-30
Onset:2021-06-01
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Acute myocardial infarction, Coronary artery bypass
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Other ischaemic heart disease (narrow)

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

Write-up: acute STEMI , underwent coronary artery bypass x3 vessels


VAERS ID: 1484029 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-05-01
Onset:2021-06-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

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

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

Write-up: nodule at injection site


VAERS ID: 1484041 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-05-01
Onset:2021-06-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Head discomfort, Ocular discomfort, Swelling face, Swelling of eyelid, Tinnitus, Visual impairment
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: High blood pressure, kidney stones
Allergies: Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tinnitus in right ear, which is progressively getting worse. Whooshing sound in head, especially when laying down. Pressure behind eyes, intermittent swelling on upper cheek and eyelids. Vision problems, especially when changing position from laying down to getting up, sitting to standing, where there is a gray curtain that moves slowly across the field of vision. Head constantly feels pressured and almost as though there is fluid build up.


VAERS ID: 1484469 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-05-18
Onset:2021-06-01
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / IM

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

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

Write-up: I develop an itchy raised red rash in any area that my skin is touched firmly. It could be triggered by scratching an itch or holding something tightly. I believe it is urticaria.


VAERS ID: 1484520 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-04-01
Onset:2021-06-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal operation, Endoscopy, Exploratory operation, Lumbar puncture, Magnetic resonance imaging, Paraplegia
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: HIV
Allergies:
Diagnostic Lab Data: MRI''s
CDC Split Type: vsafe

Write-up: I became paralyzed from the waist down. I had MRI''s, I had a lumbar puncture, they did exploratory surgery inside my stomach. They put a scope down my throat. I have a appointment with the neurologist. I have also seen an infectious disease doctor.


VAERS ID: 1484738 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-05-05
Onset:2021-06-01
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Sperm concentration decreased
SMQs:, Fertility disorders (narrow)

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

Write-up: Sperm count dropped to zero. As recently as 1 year ago, my wife was pregnant, but now 1 month after getting the Jansen vaccine, I am testing at zero sperm.


VAERS ID: 1485941 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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: Abstains from alcohol; Cigarette smoker (10 per day)
Preexisting Conditions: Comments: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use and no diagnostic data available.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210728889

Write-up: TINGLING IN BOTH LEGS; NUMBNESS IN BOTH LEGS; This spontaneous report received from a patient concerned a 55 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included cigarette smoker, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use and no diagnostic data available. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821286, and expiry: 06-SEP-2021) .5 ml, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced tingling in both legs. On 01-JUN-2021, the subject experienced numbness in both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in both legs, and numbness in both legs. This report was non-serious.


VAERS ID: 1485942 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ankle fracture, Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had no known allergies and no relevant medical history.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210729466

Write-up: BROKEN ANKLE; TWO DEEP VEIN THROMBOSIS IN LEFT LEG; PULMONARY EMBOLISM IN BOTH LUNGS; This spontaneous report received from a patient concerned a 44-year-old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. The patient had no known allergies and no relevant medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drug included Skyrizi (risankizumab) [form of administration unknown, subcutaneous, batch number and expiry date were not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date (reported as several months earlier), the patient broke her ankle. On unspecified date, in JUN-2021, the patient had pain and swelling in her left leg. The patient went to an urgent care to check it and discovered that she had two deep vein thrombosis in her left leg and pulmonary embolism in both lungs. She received treatment (unspecified) for it and was recovering. The patient''s physician felt that the events was not due to Skyrizi but possibly due to Janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from two deep vein thrombosis in left leg, and pulmonary embolism in both lungs, and the outcome of broken ankle was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210729466-covid-19 vaccine ad26.cov2.s ? two deep vein thrombosis in left leg, and pulmonary embolism in both lungs. This event(s) is considered unassessable. The event(s) has a unknown temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1485947 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205AZ1A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Polymerase chain reaction, SARS-CoV-2 test positive, 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: Non-smoker
Preexisting Conditions: Comments: The patient had no known allergies, no medical history.
Allergies:
Diagnostic Lab Data: Test Name: PCR; Result Unstructured Data: Positive; Test Name: COVID-19 virus test positive; Result Unstructured Data: Positive
CDC Split Type: USJNJFOC20210731093

Write-up: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 58 year old of unspecified sex. The patient''s weight was 95.5 kilograms, and height was 187.9 centimeters. The patient''s concurrent conditions included non-smoker, and other pre-existing medical conditions included the patient had no known allergies, no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205AZ1A and expiry: UNKNOWN),at a frequency of one total, dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the patient experienced clinical vaccine failure and confirmed covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Positive, and PCR (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number: 90000185952.; Sender''s Comments: V0: 20210731093-COVID-19 VACCINE AD26.COV2.S- Confirmed clinical 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: 1485986 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: New York  
Vaccinated:2021-05-01
Onset:2021-06-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8731 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0169 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid abnormal, Cerebrovascular accident, Computerised tomogram head abnormal, Electrocardiogram abnormal, Gait inability, Lacunar infarction, Pericardial effusion, Transient ischaemic attack, Vasculitis, Venogram abnormal
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vasculitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vit B12, vit D, levothyroxine,
Current Illness: No
Preexisting Conditions:
Allergies: No
Diagnostic Lab Data: CT brain wo contrast Jun30, EKG 12-lead on Jun30, Jul1, Mra Angio of neck and head Jul2.
CDC Split Type:

Write-up: Mini stroke followed a few weeks later by inability to walk. Rapid onset. Hospitalized for 2 weeks. Extensive testing showed trace pericardial effusion and acute lacunae infarction involving the right thalamus. Micro vascular ischemic changes. Critical test result of acute stroke.


VAERS ID: 1486076 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-04-01
Onset:2021-06-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKOWN / UNK RA / IM

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein increased
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: Latanoprost Ophthalmic Sol''n, Mesalamine Tab, Remicade Infusions, Simvastatin, Diclofenac, Loratadine. Calcium Citrate, Chromium Picolinate, Co-Q-10, Cranberry, Ferrous Sulfate, Folic Acid, Garlic, Magnesium, Potassium, Salmon Oil, Multiv
Current Illness: None.
Preexisting Conditions: Inflammatory bowel disease controlled via Remicade infusions every 8 weeks, Stenosis/Degenerative Disk Disease, Partial tears in biceps tendon, labrum, and impingement of right shoulder. I must have blood work done every 90 days and have been doing so since 2005 while taking Remicade for IBD. My C-Reactive protein levels have historically always been <0.8 mg/L. The first blood test results forty-six days after my 2nd dose of Pfizer vaccine shows a C-Reactive level of 3.4 mg/L. That is a sudden 425% increase above historical norms. I am not having any pericarditis or myocarditis symptoms and had a recent exam by my family physicians with no concerns indicated. I know that Covid 19 is a vascular irritant. I am theorizing the Pfizer vaccine, which mimics the actual virus, has caused this jump in C-Reactive Protein. Should I be concerned about this increased level of 3.4 mg/L and have you been aware of similar jumps in C-Reactive protein after vaccinations with Pfizer vaccines? Over time will my C-Reactive protein return to normal levels, remain elevated or is that an unknown at this time?
Allergies: NSAID''S
Diagnostic Lab Data: I have no other symptoms or heart related issues at this time.
CDC Split Type:

Write-up: Blood work done every three months showed a significant increase in C-Reactive Protein. Since 2005, C-Reactive Protein levels have been <0.8 mg/L. Forty-Six days after my second vaccination dose of Pfizer vaccine, my scheduled blood work showed a C-Reactive Protein level of 3.4 mg/L, which is a significant change from the normal <0.8. No other parameter of my normal blood work testing showed any significant changes.


VAERS ID: 1486298 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-01-22
Onset:2021-06-01
   Days after vaccination:130
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3249 / 2 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Biopsy liver, Blood test, Body temperature increased, Computerised tomogram, Electrocardiogram, Fatigue, Headache, Iliotibial band syndrome, Inappropriate schedule of product administration, Infectious disease carrier, Magnetic resonance imaging, Magnetic resonance imaging head, Overdose, Pain in extremity, Paraesthesia, Pyrexia, SARS-CoV-2 test, Ultrasound abdomen, Ultrasound pelvis
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE; ALLOPURINOL; BISOPROLOL; LATANOPROST
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Liver biopsy; Result Unstructured Data: Test Result:Unknown; Test Date: 20210601; Test Name: Numerous blood tests; Result Unstructured Data: Test Result:No diagnosis; Test Date: 20210601; Test Name: Fever; Result Unstructured Data: Test Result:104.1; Test Date: 20210601; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown; Test Date: 20210601; Test Name: ECG; Result Unstructured Data: Test Result:Unknown; Test Date: 20210601; Test Name: MRI of brain and entire spine; Result Unstructured Data: Test Result:Unknown; Test Date: 20210601; Test Name: MRI of brain; Result Unstructured Data: Test Result:Unknown; Test Date: 20210601; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210602; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210629; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210601; Test Name: Ultrasound of abdomen and pelvis; Result Unstructured Data: Test Result:Unknown; Test Date: 20210601; Test Name: Ultrasound of abdomen and pelvis; Result Unstructured Data: Test Result:Unknown
CDC Split Type: USPFIZER INC2021841388

Write-up: 6/29- facial paresthesia began admitted to hospital again; 6/9/21- released with followup scheduled with infectious disease; 6/1/21- admitted to hospital for 104.1 fever, extreme weakness, and right thigh pain thought associated with diagnosis in April for tight IT band in which he had been receiving PT; 6/15- began experiencing a headache in left front lobe when head tilted forward; Experienced sharp pain in left knee which subsided after a few days; 6/1/21- admitted to hospital for 104.1 fever; 6/1/21- admitted to hospital for 104.1 fever, extreme weakness, and right thigh pain thought associated with diagnosis in April for tight IT band in which he had been receiving PT; 6/1/21- admitted to hospital for 104.1 fever, extreme weakness, and right thigh pain thought associated with diagnosis in April for tight IT band in which he had been receiving PT; fatigue; Inappropriate schedule of vaccine administered; Overdose; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 74-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3246, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 22Jan2021 (age at vaccination was 74 years) as dose 1, single for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3249, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 22Jan2021 (age at vaccination was 74 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient did not have any known allergies. Concomitant medications the patient received within 2 weeks of vaccination included amlodipine, allopurinol, bisoprolol and latanoprost all taken for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 01Jun21, the patient was admitted to hospital for 104.1 fever, extreme weakness, and right thigh pain thought associated with diagnosis in April for tight IT band in which he had been receiving PT (physical therapy). The patient received broad spectrum intravenous antibiotics, did not respond. Physicians performed MRI of brain and entire spine, CT scan of all organs, ultrasound of abdomen and pelvis, ECG, liver biopsy, and numerous blood tests- no diagnosis. Fever, fatigue, and weakness continued- experienced sharp pain in left knee which subsided after a few days. On 09Jun2021, released with follow-up scheduled with infectious disease. On 10Jun2021, the patient continued to battle low grade fever until 6/24. On 15Jun2021, the patient began experiencing a headache in left front lobe when head tilted forward. On 16Jun2021, the patient had infectious disease follow-up and was referred to rheumatologist. On 21Jun2021, ophthalmologist. On 23Jun2021 and 24Jun2021, the patient had rheumatologist appointment. On 25Jun2021, the patient''s retina specialist revealed nothing. On 29Jun2021, the patient had begun experiencing facial paresthesia and admitted to hospital again. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for 10 days. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab test included SARS-CoV-2 test (Nasal swab): Negative on 01Jun2021, SARS-CoV-2 test (nasal swab): Negative on 02Jun2021 and SARS-CoV-2 test (Nasal swab): Negative on 29Jun2021. The treatment was not received for the events infectious disease carrier, paraesthesia, headache and arthralgia. The device date was reported as 05Jul2021. The case was reported as serious (hosp and disabling/Incapacitating). The outcome of the events was not resolved.


VAERS ID: 1486303 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-14
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypersensitivity, Malaise, Peripheral swelling, Pharyngeal swelling, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: PROPANOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high (Verbatim: Blood pressure high)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021845356

Write-up: My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; My arm had a rash on it and its swollen. It is always on my arms and my hands. It went up to my throat so, and sick right away after I have this. I mean had really awful for three days.; I had a bad reaction because of any other medication consider allergic to it.; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via intramuscular route of administration in Arm Left on 14Jun2021 as single dose for covid-19 immunization. Medical history included blood pressure from an unknown date and unknown if ongoing. Concomitant medication included propanol taken for hypertension, start and stop date were not reported. In Jun2021 patient had her 1st shot of vaccine, 3 weeks ago and just, had a, she thinks, a had a bad reaction because of any other medication consider allergic to it. Her arm had a rash on it and its swollen. It was always on her arms and hands. It went up to her throat so, and she was sick right away after she had this. She had really awful three days after she had the shot. This does not mean that she was having allergic reaction, she stated. She stated she should not get the second shot. Patient stated it started hours after the shot. The person actually right away, I don''t know it was the vaccine necessarily or the person giving me the shot but I am wondering if he or his arm, start turning black and blue. She doesn''t have the vaccination card. 13Jun, 14Jun I guess she confirmed as 14Jun2021. Consumer stated, her second shot is due. The LOT number for the first dose, this, she can tell this person had very bad handwriting. It''s look like EW0101. Treatment taken for Adverse Event with Benadryl, Diphenhydramine 50 mg, Norco 10/325 mg. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1486320 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Georgia  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021855936

Write-up: developed pneumonia 12 days ago; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unspecified route of administration, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. In Jun2021 (12 days ago, as reported), the patient developed pneumonia for which he took antibiotics. The outcome of the event was unknown. Information about Batch/Lot number has been requested.


VAERS ID: 1486362 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-06-15
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cough
SMQs:, Anaphylactic reaction (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 INC2021874622

Write-up: Cough; This is a spontaneous report from a non-contactable consumer (patient''s mother). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 15Jun2021 as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer reported that last week (Jun2021), the patient started coughing and reported that this might be a problem after taking the first dose of Pfizer COVID-19 vaccine. The consumer cancelled the appointment for the 2nd dose due to cough which the patient was supposed to get on 06Jul2021. The patient just had cough a little bit now. The consumer wanted to know if it was safe to go if he was coughing. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1486363 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New Jersey  
Vaccinated:2021-06-15
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Ear pain, Energy increased, Insomnia, Irritability, Muscular weakness, Pain in extremity, Pulmonary embolism, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (He is allergic to "all the antibiotics" but does not specify which ones.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021880499

Write-up: pulmonary embolism; injection was very painful; left arm weakness/can''t move arm; insomnia; irritability; high energy level; leg and calf pain with severe right calf pain; pain worsening from the injection area to the back of his ear and shoulder; pain worsening from the injection area to the back of his ear and shoulder; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on 15Jun2021 (at 11 AM) as single dose for covid-19 immunization. The patient medical history included allergy (he also states that he is allergic to "all the antibiotics" but does not specify which ones). The patient''s concomitant medications were not reported. He reports a history of pulmonary embolism (prior to the vaccine). He states he has had ongoing side effects after the first dose of the vaccine and he wants to know if it''s recommended that he get the second dose. He reports that his ability to swallow has improved. On an unspecified date in Jun2021, the patient experienced pulmonary embolism, injection was very painful, left arm weakness/can''t move arm, insomnia, irritability, high energy level, leg and calf pain with severe right calf pain, and pain worsening from the injection area to the back of his ear and shoulder. The outcome of all the events was unknown. Information on the lot/ batch number has been requested.


VAERS ID: 1487137 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / SC

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: oxygen, Trelegy, Aldactone, cozaar, protonix
Current Illness: none
Preexisting Conditions: Severe COPD, chronic hypoxemic respiratory failure, GERD
Allergies: Penicillin and guaifenesin
Diagnostic Lab Data: none
CDC Split Type:

Write-up: severe myalgias, relieved by ibuprofen


VAERS ID: 1487178 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-04-07
Onset:2021-06-01
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0151 / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Atrial flutter, Cardiac monitoring abnormal, Electrocardiogram
SMQs:, Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Yes, Hydrocodone, heart medications, aspirin, vitamins,
Current Illness: No
Preexisting Conditions: Heart rhythm condition
Allergies: Yes, morphine, Cipro, macrolide
Diagnostic Lab Data: Heart monitor, EKG/ECG
CDC Split Type: vsafe

Write-up: My pulse went to 123/per min and blood pressure was 193/120. Went to the doctor who sent me to the ER for monitoring. Went to see cardiologist, put a heart monitor for 24 hours. Its was diagnosis was an atrial flutter. Have to have an ablation done on 07/26/2021. Medication has increased since this happen and I have put on blood thinners.


VAERS ID: 1487232 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-06-07
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Computerised tomogram, Eye haemorrhage, Fungal infection, Headache, Lumbar puncture abnormal, Papilloedema, Vitreous floaters
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Optic nerve disorders (narrow), Retinal disorders (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? No
Previous Vaccinations:
Other Medications: Novolog, basaglar, vitamin d
Current Illness:
Preexisting Conditions: type 1 diabetes (diagnosed in April 2021
Allergies: strawberries, oranges, cod fish
Diagnostic Lab Data: June 14th was appointment to optometrist. Optometrist advised to go to emergency room. ER visit a CAT scan was performed, but they could not ascertain the reasoning for floaters, headaches, optic nerve swelling, and hemorrhaging. Advised to follow up with ophthalmologist. Followed up in ophthalmologist office on June 16th where optometrists finding were confirmed. Advised to go back to ER for a lumbar puncture. ER doctor was not able to do the lumbar puncture, so she was admitted. Lumbar puncture the next day results were 27. Guideline is up to 29 for pediatrics. Followed up with MRI that showed a fungal sinus infection. ENT advised that had nothing to do with findings from ophthalmologist or optometrist. After a few days in the hospital and multiple tests, nothing explained her symptoms. It was discussed in the hospital and doctor''s office that the vaccine was the likely culprit.
CDC Split Type:

Write-up: complained of seeing floaters and having headaches within days of 2nd dose. Optometrist visit revealed optic nerve swelling and hemorrhaging behind eyes.


VAERS ID: 1488213 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-05-10
Onset:2021-06-01
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8731 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0161 / 2 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Parosmia
SMQs:, Taste and smell disorders (narrow)

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

Write-up: parosmia. I have a weird smell everything smells the same and it all smells horrible. Thought it would go away but it has not.


VAERS ID: 1488387 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-05-01
Onset:2021-06-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (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: I got my 1st vaccine and April and noticed a really heavy period afterward but nothing to alarming. I track my cycle month and it''s always very consistent and it follows an app on my phone. After I got my next vaccine in May my following period came when it normally does but lasted 15 days straight instead of the usual 6. After 25 days it stopped for 4 days and then started up for another 4 days. It wasn''t spotting it was a full period. So the month of June I had a 19 days period. Next cycle came in July and it was normal


VAERS ID: 1489781 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2021-06-19
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 202106; Test Name: Fever; Result Unstructured Data: Test Result:99.0 Fahrenheit
CDC Split Type: USPFIZER INC2021740387

Write-up: Body hurting; Headache; Chills; Fever of 99.0 Fahrenheit; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 19Jun2021 11:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received BNT162B2 dose 1 on an unspecified date for covid-19 immunisation and had no reaction. The patient experienced body hurting, headache, chills and fever of 99.0 Fahrenheit, all in Jun2021 after second dose. He is asking if he can take Advil/Tylenol. The patient underwent lab tests and procedures which included body temperature: 99.0 fahrenheit in Jun2021. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-2021738286 same reporter/drug/AE with different patient


VAERS ID: 1489787 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-05-08
Onset:2021-06-01
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Cholelithiasis, Gastrooesophageal reflux disease, Haematemesis, Influenza like illness, Nausea, Pancreatitis, Ulcer
SMQs:, Acute pancreatitis (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021846138

Write-up: not able to take her second dose because of pancreas problems and ulcers; Caller said that she had pancreatitis and she has gull stones and they think it was related to that; She developed nausea and started throwing up blood; It started with like a cold flu type of thing; She developed nausea and started throwing up blood; The ulcer was from all of the stomach acid and was near her esophagus and stated that it developed from the strong acid; Caller said that she had pancreatitis and she has gull stones and they think it was related to that; This is a spontaneous report from a Pfizer Sponsored Program by a contactable consumer reported for self. This 37-years-old female patient received bnt162b2, via an unspecified route of administration injection in the upper left arm on 08May2021 17:30 at age of 37-year-old (Lot Number: EW0179, Expiration Date: 31Aug2021) at DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Blood pressure. Concomitant drugs included ongoing Amlodipine 1 tablet a day by mouth sometimes every other day for Blood pressure. The patient previously received Tetanus vaccine and experienced soreness. None prior vaccinations within 4 weeks. She received her first dose on 08May2021 and she was not able to take her second dose because of pancreas problems/ pancreatitis and ulcers and hospitalization from 22Jun2021 to 25Jun2021. She said that she wants to know if she can take her second dose. She had pancreatitis and she has gull stones (Jun2021) and they think it was related to that. It started with like a cold flu type of thing. She developed nausea and started throwing up blood. The ulcer was from all of the stomach acid and was near her esophagus and stated that it developed from the strong acid. She is on some acid reducers and blood pressure medication she was already on. This started on the weekend prior to her hospitalization. It started with her cold and flu symptoms and just kind of escalated. AEs require a visit to Emergency Room and no Physician Office. Outcome of the event developed nausea and started throwing up blood, ulcer was from all of the stomach acid and was near her esophagus and stated that it developed from the strong acid was recovered. Outcome of other events was recovered on Jun2021. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1489796 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-06-28
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0150 / 1 RA / -

Administered by: Public       Purchased by: ?
Symptoms: Blood test, Dizziness, Feeling abnormal, Headache, Lymphadenopathy, Malaise, Oropharyngeal pain, Pain in extremity
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (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: NORVASC; CHLORTHALIDONE; AZOPT; OFLOXACIN; KLOR-CON; ZETIA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Blood pressure high (high blood pressure medication for about 15 years); Cholesterol; Glaucoma (eye drops for over 20 something years); Surgery (Has been having this same eye surgery since 1996.)
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Blood work; Result Unstructured Data: Test Result:Cholesterol; Comments: The only thing was her cholesterol and they gave her medicine for that. Was also her potassium
CDC Split Type: USPFIZER INC2021846507

Write-up: She would say , 29Jun or 30Jun2021 were the days she was feeling the most terrible; she felt a little more sick; Under the throat was sore; lymph nodes were swollen; soreness in arm; Dizziness; Headache; This is a spontaneous report from a contactable consumer (patient). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 28Jun2021 (Batch/Lot Number: EW0150; Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. Medical history included asthma, glaucoma, eye drops for over 20 something years, hypertension, high blood pressure medication for about 15 years , blood cholesterol, surgery from 11Jun2021 to an unknown date, has been having this same eye surgery since 1996. Concomitant medication(s) included amlodipine besilate (NORVASC) taken for blood pressure; chlorthalidone, thinks it is a water pill and ongoing; brinzolamide (AZOPT) taken for glaucoma has been taking for a long time, and takes all of the time and ongoing; ofloxacin (OFLOXACIN) taken for glaucoma, start and stop date were not reported; potassium chloride (KLOR-CON) taken for blood potassium from an unspecified start date and ongoing, taking for a long time; ezetimibe (ZETIA) taken for an unspecified indication, start and stop date were not reported, Inveltvs taking after surgery only. Inveltvs spelling is documented as provided by the caller, unable to clarify correct spelling of name. The patient experienced soreness in arm on 28Jun2021 with outcome of recovered, under the throat was sore on 01Jul2021 with outcome of not recovered, lymph nodes were swollen on 01Jul2021 with outcome of recovered, dizziness on Jun2021 with outcome of not recovered, headache on Jun2021 with outcome of recovered, she felt a little more sick on 02Jul2021 with outcome of unknown, she would say , 29Jun or 30Jun2021 were the days she was feeling the most terrible on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included blood test: The only thing was her cholesterol and they gave her medicine for that. Was also her potassium in May2021. The clinical course was reported as follows: Caller states she is calling regarding the Pfizer shot that she got at the Health department. Clarified that she is referring to the Pfizer Covid vaccine. She has to go back 15Jul2021 for the second shot. She had in the arm and swollen lymph nodes that had went away. She is now experiencing dizziness. She had headaches but they went away. She had swollen lymph nodes under her throat that went away. The soreness in the arm went away but is still experiencing dizziness. She wants to know how long this will last because she has to get the second shot 15Jul2021. States that she was not going to have it but her husband told her to get it because she has asthma. Then, she had a reaction after the first shot. Soreness in arm: The first day she had the shot, she was sore and was sore until the third day. Treatment: None. Under the throat was sore and lymph nodes were swollen: Was sore probably about 2 days. It started like the third day afterward. Had received the shot, she thinks probably 27Jun2021 but later clarified that it was 28Jun2021. Soreness in the arm: States that the soreness started the next day, after the shot and lasted about 2 days. Dizziness: Started right after, or more like the 4th day it started, after having the shot. The dizziness has gotten kind of worse. At first, she could be lying in bed and feel dizzy, and like when trying to turn over in the bed. She went on an outing 04Jul2021 and felt like she was going to faint or fall over. She now does not feel as bad but it is still there. She knows that if she bends over or tries to look down on the floor, she feels light headed. That Friday, she felt a little more sick. She would say , 29Jun or 30Jun2021 were the days she was feeling the most terrible. She figured that maybe 14 or 15 days later, it would clear up but, it is still there. Headaches: Started right after the lymph node swelling. Was a couple of days afterward, like maybe the 4th or 5th day, the headaches and dizziness started. She is not having the headaches any more. They went away last week, maybe Friday, could be 02Jul2021. The dizziness is still kind of like, still there. The lady put tape on to make sure it was not bleeding. She was sitting there for the 15 minutes and the nurse came over because it looked like it was bleeding and put the tape on it. Her husband had the vaccine and had no problems. She did not want it at first and now she does not want problems with the second one. Indication: She has asthma and her husband didn''t want her to be on a ventilator, and catching Covid. A lot of her friends had have Covid and she felt like it was more safe to get it. Caller states that she would get the vaccine again, she did not expect the side effects to last this long. She had eye surgery 11Jun2021 and has glaucoma. She waited until after the eye surgery to get it. She waited a couple of weeks, little over 2 weeks. She didn''t want it to interfere with the surgery that she had. The surgery went really good and never had any side effects from that surgery. She has been going for that eye surgery since 1996. Has been taking high blood pressure medication for about 15 years, or something like that. She takes eye drops, like the same eye drops for over 20 something years. She has not had any new medications and everything has stayed pretty much the same over 15 to 20 years. The medications she takes, she has been on for such a long time. Even when she has problems, she calls her doctor to let him know. This stuff did not start until after she got the shot. She just wanted to kind of make sure there are no more problems. Takes one blood pressure pill, one water pill and the other is for cholesterol. The rest are eye drops, which she has been taking a long time. The Azopt and Brimonidine, she has been taking on a daily basis. The other two drops, the Ofloxacin and the Inveltvs, she was taking only for the surgery and will be done taking these on Thursday. Test results: She had blood work in May of this year. The only thing was her cholesterol and they gave her medicine for that. Was also her potassium. She has been on potassium pills for a long time. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1489821 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-06-07
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 F / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, COVID-19, Condition aggravated, Dehydration, Diarrhoea, Gastrointestinal inflammation, Headache, Hypotension, Insomnia, Multisystem inflammatory syndrome in children, Overdose, Pericardial effusion, Pyrexia, SARS-CoV-2 test, Vaccination failure, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Toxic-septic shock conditions (broad), Pseudomembranous colitis (broad), Drug abuse and dependence (broad), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow), Hypokalaemia (broad), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 22 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Mosquito bite
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: IgG; Result Unstructured Data: Test Result:Positive; Comments: Blood test; Test Date: 20210615; Test Name: IgM; Result Unstructured Data: Test Result:Positive; Comments: Blood test; Test Date: 20210615; Test Name: PCR; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab; Test Date: 20210617; Test Name: PCR; Result Unstructured Data: Test Result:Positive; Comments: Nasal Swab
CDC Split Type: USPFIZER INC2021857119

Write-up: covid_test_name_post_vaccination=PCR covid_test_result=Positive; Condition worsen; pericardial effusion; develop GI; Heavier Insomia; dierrea; vomiting; fever; Headache; Hypotensive; Dehydrated; Developed into MISC; Patient said he had 4 vaccines; PCR resulted as positive on 17Jun2021 Nasal Swab; This is a spontaneous report received from a contactable other-HCP (father) reported for old son (patient). A 15-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0173 F) via an unspecified route of administration in left arm on 07Jun2021 as dose 2, single for COVID-19 immunization. Medical history included ongoing known allergy in mosquito bite (sketter syndrome) an allergic reaction to mosquito bites, as his son has grown up it has become less and less relevant. Concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Dose:01 Lot number: EW0171 Anatomical Location: Arm left) on 17May2021 for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations dates of birth or immunizations are not available. It was reported that my son traveled on 16May2021. Covid test prior traveling negative. On Jun2021, 4 days after vaccination develop GI, heavier insomia, dierrea, vomiting, fever, hypotensive, dehydraeted. On 11Jun2021 experienced pericardial effusion. On an unknown date Jun2021, developed into MISC and was intubated. The patient was hospitalized from 14 Jun 2021 to 6 Jul 2021. Treatment was received. On 15Jun2021, admission at (withheld), (Hidratation IV and IVIGs). On 16Jun2021 condition worsen and Intubated in (withheld). On 17Jun2021, transfer to (withheld) (7 days at PICU, another 7 at pediatrics). On Jun2021, developed a strong insomnia and headache. Events resulted in emergency room/department or urgent care. Treatment received for the adverse event was MISC protocol IVIGsAnakinra, esteroids and others. On an unknown date, Patient said he had 4 vaccines. His son spent 7 days in the ICU and 7 days in the pediatric unit was discharged from the hospital yesterday. Reported that other researchers studying MIS-C in children have seen how the epithelium cells in the intestine become loose, then the protein goes through the blood stream and can start a cytokine storm and asked if we have studies regarding how much S protein is being produced by different age groups; can it be checked how much S protein is going into the bloodstream to see adverse effects of the vaccine and stated he needs more data to see if his son was possibly infected with Covid during his vaccination period or what he previously infected and absolutely asymptomatic. Most MIS-C occurs 4-6 weeks after having Covid. States that for his son to travel he had to have antigen testing, which was negative. His son did well until 3-4 days after the second shot. States at that time his son became ill with vomiting, diarrhea, headache, and insomnia. She took her son to the hospital and they found him to be hypotensive and dehydrated. They started intravenous fluids and their protocols; the hospital did not have all the required medications for their son and recommended he be transferred to (withheld) Hospital. He was very tired and they decided to put him on ventilation for the ambulance drive. States that when they arrived in (withheld), his son was placed in ICU where he was on the ventilator for 5 days, the recuperating for 2 more days. His son was then moved throughout the hospital system until his discharge yesterday. His son''s insomnia may have started before he left for the (withheld). States that it was worsened after the vaccine, his son mentioned after his hospitalization that he was actually given 4 shots the day he got his vaccines, assumed it to be some kind of delirium from his son being in the ICU for so long, stated he told his son that was not possible that he got 4 vaccines at once because of the paperwork you have to fill out to get the vaccine, the lady at the vaccination site told him to sit down and then gave shothim four shots. The patient underwent lab tests and procedures which included IgG and IgM resulted as positive on 15Jun2021, PCR resulted as negative on 15Jun2021 Nasal Swab, PCR resulted as positive on 17Jun2021 Nasal Swab. The clinical outcome of the event developed MIS-C and was intubated, vomiting, dierrea, headache, insomnia, hypotensive, dehydrated on an unknown date 2021 was resolved and the event pericardial effusion, develop GI, fever was resolving, the event condition worsen, Vaccination failure, patient said he had 4 vaccines and PCR resulted as positive on 17Jun2021 Nasal Swab was unknown; Sender''s Comments: Based on the limited information currently available, the causal association between the event Insomnia, Diarrhea, vomiting, fever, Drug ineffective, COVID-19, Headache, overdose and the suspect drug cannot be excluded. Also, there is limited information in the case provided, the causal association between the event Multisystem inflammatory syndrome in children, Pericardial effusion, Gastrointestinal inflammation, Condition worsened, Hypotensive, Dehydration and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.


VAERS ID: 1490394 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-01
Onset:2021-06-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Deep vein thrombosis, Fatigue, Headache, Pain, Ultrasound scan abnormal
SMQs:, Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (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: Sertraline, Tri-Sprintec
Current Illness: none
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None for typical symptoms following the vaccine. On June 1, I had an ultrasound done of my left leg, which led to the DVT diagnosis.
CDC Split Type:

Write-up: Following each vaccine, I felt fatigue, headaches, and body aches. I never had fever with either of the two vaccines. Potentially unrelated, on June 1, 2021, I was diagnosed with a deep vein thrombosis in the posterior tibial vein in my left leg. I have since seen a hematologist, and I am on anticoagulant therapy until a reassessment in September.


VAERS ID: 1490420 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Exposure during pregnancy, Fatigue, Headache, Injection site erythema, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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:

Write-up: Adverse events: fever, fatigue, headache, injection site pain and redness. Onset of adverse events: next day of second dose. Duration of adverse events: 1 day. Currently pregnant. Estimated date of delivery: 11/2021.


VAERS ID: 1490499 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-05
Onset:2021-06-01
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ill-defined disorder
SMQs:

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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Pt. states after receiving the J&J vaccine 05/05/2021, noticed 06/01/2021 that her tonsils had disappeared. Consulted with Primary 06/28/2021 with no recommendations nor explanation.


VAERS ID: 1490913 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-22
Onset:2021-06-01
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dialysis, Dry mouth, Fluid retention
SMQs:, Acute renal failure (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: patient has End Stage Renal Disease and is on dialysis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: In June the patient started experiencing dry mouth leading to increase fluid intake. This has lead to extra fluid retention and the need for extra dialysis runs.


VAERS ID: 1492841 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: Fever; Result Unstructured Data: 103 degree
CDC Split Type: USJNJFOC20210734111

Write-up: 103 DEGREE FEVER; COULD NOT SLEEP OR ANYTHING; This spontaneous report received from a consumer concerned an 18 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced could not sleep or anything. Treatment medications included: paracetamol. On 23-JUN-2021, the subject experienced 103 degree fever. Laboratory data included: Fever (NR: not provided) 103 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 103 degree fever on 24-JUN-2021, and the outcome of could not sleep or anything was not reported. This report was non-serious.


VAERS ID: 1493137 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021743562

Write-up: I felt a little light headed and I have not had any alcohol, I haven''t take any pills; I have been left with some fatigue here and there; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0187) via an unspecified route of administration on 01Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0168) via an unspecified route of administration on 11May2021 as single dose for covid-19 immunisation and had no reaction. After second dose of vaccine, the patient had been left with some fatigue here and there and this afternoon again the patient just had it. It seems very at times. The patient reported that nothing changed and had another fatigue and went to sleep but when came out of sleep it just seems very heavy like and had taken a sleeping pill and also stated that yesterday that it seems a little better than two weeks ago. Today (20Jul2021) afternoon, the patient felt a little lightheaded which was unusual that I have not had that yet. The patient did not have any alcohol. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1493193 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-23
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN0186 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Breast pain, Burning sensation, Myalgia, Pain in extremity, Taste disorder, Therapeutic response unexpected
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Lipodystrophy (broad), 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: Allergy NOS; Arthritis; Asthma; Food allergy; Heart murmur; High cholesterol; Hypoglycemia; Macular degeneration; Osteoporosis
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer; Colon anterior resection; Diverticulitis; Drug allergy; Fish allergy; Lumpectomy; SARS-CoV-2 infection; Surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021862266

Write-up: she experience a burning sensation that right side where she got the injection, the sensation went up her neck and into her throat.; She states that she had an odd taste in her mouth, but it was not metallic, just a funny taste in her mouth; Her stomach cramped up a little bit as well.; muscle pain in the back of her neck that did last for a couple of days; A little bit of pain in the left breast; Pain in arm; She states that a couple dats after taking the vaccine she got up to walk (she walks with a walker when she is able to, other wise she uses a power chair) the pain in her hip wasn''t there.; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team. A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN0186, Expiration date: unknown), dose 1, via an intramuscular route of administration, administered in Arm Right on 23Jun2021, (at the age of 83-year-old), as dose 1, single for covid-19 immunisation. Patient medical history included ongoing Arthritis (she had arthritis as a teenager but did not know it. She reported that she was diagnosed with arthritis years ago in her late 40''s), ongoing Heart condition (she has a heart murmur and she believes that she was born with it),ongoing High cholesterol (she was diagnosed with high cholesterol many years ago and she cannot remember when), ongoing Hypoglycemia (she was diagnosed years ago), ongoing Macular degeneration (the macular degeneration began years ago and that is why she is now legally blind), ongoing Asthma (she was diagnosed years ago and it goes along with the allergies), Cancer (she reported that she had cancer surgery on her left breast), Diverticulitis, lumpectomy in the late 1990s, Covid-19, ongoing Osteoporosis (she was diagnosed with osteoporosis years ago), Colon resection in the 2000''s and guesstimate around 2011. Patient reported that her last surgery was for diverticulitis in the 2000''s, she wants to guestimate around 2011. She reported that her diverticulitis has been pretty good since the surgery. She reported that once in a while she has a little discomfort. She reported that she was not sure if the diverticulitis was causing the pain in her hip area as that is where the colon resection was done. She reported that she was not sure if was arthritis or osteoporosis or the other stuff. Family Medical History Relevant to AE(s) was none. She has allergies to strong odors and stuff like that and some foods like berries, strawberries, and chocolate cause her to break out in pimples and a rash and allergy to pollock, the fish. She has allergy to unspecified medications caused her to break out with hives really bad. She had most allergies to NSAIDs medications. The patient concomitant medications were not reported. The patient historical drugs included Lescol, Zocor, Lobid, Lipitor, Celebrex, salicylate, Darvocet, clarithromycin, erythromycin, Lyrica, Crestor, Zoloft, Zyrtec, Vicodin, Limbrel, and Vioxx and experienced allergies. She reported that she carries a list with her of her medication allergies so that she is not prescribed anything she is allergic to. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. On 23Jun2021, within the first 5 minutes of receiving the Covid-19 vaccine, the patient experienced a burning sensation that right side where she got the injection, the sensation went up into her neck and throat, felt odd taste, Her stomach cramped up a little bit as well, muscle pain in the back of her neck that did last for a couple of days, A little bit of pain in the left breast and Pain in arm and Pain in left hip is not there within a day or day and a half of receiving the Covid-19 vaccine, She states that a couple days after taking the vaccine she got up to walk (she walks with a walker when she is able to, other wise she uses a power chair on an unspecified date in Jun2021. The clinical course of the events as follows: She reported that within 10 minutes while waiting, she first experienced a burning sensation on the right side where she got the Covid-19 vaccine injection. Caller reported that the burning sensation went up into her neck and throat, also felt an odd taste that she could not distinguish, not a metallic taste, but kind of a funny feeling with her throat, an odd feeling, she reported that a couple of minutes later, she felt cramping in her stomach and later on in the afternoon, a couple hours later, she had real severe muscle pain in the back of her neck, severe muscle pain in the back of her neck lasted quite a while, for a couple of days, pain in her arm developed the evening of 23Jun2021 and she felt it for a day and a half. She stated that they say that the arm pain was normal but the other things she was not quite sure about. she did feel a little bit of pain in her left breast, she had cancer surgery on her left breast and that the pain was probably in the lymph node area. Caller inquired if these are just normal side effects for people to get and not to worry about the second Covid-19 injection. She reported that the burning sensation, odd taste in her mouth, and funny feeling in her throat only stayed a little while. Muscle pain in back of neck lasted 2-3 days, little bit of pain in the left breast lasted 2-3 days, cramping in stomach lasted a couple of days. Pain in left hip is not there: she reported that she has a lot of senior problems and one of them is that she has arthritis from head to toe. Caller reported that in her left knee and hip on the inside of the hip area, she has severe pain. She reported that she has minimal walking ability and uses a wheelchair but uses a walker in the house when she has good days. She reported that within a day or day and a half of receiving the Covid-19 vaccine, she got up to walk to the kitchen and the pain in her left hip was not there and reported that it was really weird, and she was grateful of course, but her left hip is still ok. She reported that when she was on her feet and walking, she does not have the severe pain that used to put her off her feet. She reported that when she was laying down in bed and stretching, she feels severe pain, but walking around it''s better. She reported that the pain in her left hip was not there when she was walking and that used to be when it was the worst. She reported that her second dose of the Covid-19 vaccine would be due for 14Jul2021. She reported that she knows that the vaccine is still experimental and that there are side effects, but it was better to take chances on the Covid-19 vaccine than to get Covid. She reported that one of her distant family members that got Covid got really sick, and they were young. She reported that she just wanted to make sure that these side effects would not prevent her from getting the second dose of the Covid-19 vaccine. She reported that the side effects were not severe but were annoying. The events did not require a visit to Emergency Room and Physician Office. Relevant Tests were none. No Investigation Assessment was done. she said that she had not heard of those side effects and it was nothing severe and not to worry. She reported that the girl instructed her that if she did have an allergy, she had to wait 6 hours to take an allergy pill. the outcome of the events burning sensation that right side where she got the injection, the sensation went up her neck and into her throat, felt odd taste was resolved on 23Jun2021, the outcome of events Cramping in stomach, muscle pain in the back of her neck that did last for a couple of days, little bit of pain in the left breast and Pain in arm was resolved on an unspecified date in Jun2021, while outcome of other events were unknown.


VAERS ID: 1493203 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Feeling abnormal, Palpitations, Pyrexia, Rash, Vein disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021865267

Write-up: heart palpitation very bad; like a really weird sign like an electrical current went through my body; like there is a cervical urgency in my veins, in my heart and in my body and heart palpitations; Weird things happening like rash all kinds of things happening; even fever; Weird things happening like rash all kinds of things happening; even fever; This is a spontaneous report from a contactable patient (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), dose 1 via an unspecified route of administration on Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On Jun2021, the patient had heart palpitation very bad, like a really weird sign like an electrical current went through my body, like there is a cervical urgency in my veins, in my heart and in my body and heart palpitations, weird things happening like rash all kinds of things happening, even fever and even fever. Reporter stated that, "I had the first dose two weeks ago and having like since then heart palpitation very bad and like a really weird sign like an electrical current went through my body. So, I didn''t get the second one because the first one had been rough on me and my husband both but still it''s been two weeks, I feel like an electrical current going through my veins, I don''t know how to spell it, like there is a cervical urgency in my veins, in my heart and in my body and heart palpitations." Patient stated, "Yes report it because I am afraid to get the second one, I don''t have to get the second dose or any other vaccine." Patient stated, "I am not going to wait for you when I am having heart palpitations and weird things happening like rash all kinds of things happening even fever, and nobody is helping me." Reporter seriousness for the event was Unspecified. Outcome of the events were unknown. QR Comment: This case was split however the split was not made as the information was not available over the call, as patient hung up the call abruptly. Follow-up attempts are needed; information about lot/batch number has been requested.


VAERS ID: 1493208 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-06-16
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pain in extremity
SMQs:, 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 INC2021866320

Write-up: Sore right arm; Had a passing "twingy" headache; This is a spontaneous report from a contactable consumer or other non-health care professional. A 75-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 16Jun2021 12:30 (at the age of 74-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After first dose patient experienced sore right arm. She clarified she also had a passing "twingy" headache on unspecified date Jun2021, beside her right sore arm. Her right sore arm had eased up with her first vaccine dose, as well as, today with her second COVID-19 Vaccine shot. It was reported that patient received her 2nd COVID-19 Vaccine dose yesterday. Reported she had called to get her question answered, and really wanted to know if she could take a second Tylenol. Caller was transferred to Pfizer Medical Information for further assistance. The outcome of the events was reported as unknown.


VAERS ID: 1493223 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Kentucky  
Vaccinated:2021-04-27
Onset:2021-06-01
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache, Hypoaesthesia, Illness, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bacterial infection NOS (Muscle & joint pain exceeding any past viral or bacterial infection); Pneumonia (The fatigue after was similar to double pneumonia I had decades ago); Viral infection NOS (Muscle & joint pain exceeding any past viral or bacterial infection)
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: Fever; Result Unstructured Data: Test Result:102.7
CDC Split Type: USPFIZER INC2021872037

Write-up: 5 days & nights of 102.7 fever; Chills; Bursting headache; Muscle & joint pain; Muscle & joint pain; Patient lost all feeling in fingers and toes; Fatigue; Serious illness after traveling; This is a spontaneous report from a contactable consumer or non-health care professional (the patient). A patient with unspecified age and gender received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot number/Expiration date: not reported) via an unspecified route of administration on 27Apr2021 as second dose, single for COVID-19 immunisation. Patient medical history included pneumonia and unspecified viral or bacterial infection from an unknown date and unknown if ongoing. Historical vaccine included first dose of BNT162B2 on an unspecified date via unspecified route of administration as first dose, single for covid-19 immunization. After patient being fully vaccinated on 27Apr2021 as second dose, he experienced serious illness on an unspecified after traveling to attend his father-in laws memorial on 28May2021 with unmasked. 12 days later, on an unspecified date in Jun2021 patient was endured with 5 days & nights of 102.7 fever, chills, bursting headache and muscle & joint pains which exceeding any of his past viral or bacterial infection 4 days and patient had lost all feeling in his fingers and toes. The fatigue after was similar to double pneumonia that he had decades ago. Not mild symptoms. The patient underwent lab tests which included body temperature results 102.7 degrees. Outcome of the event''s serious illness, chills, bursting headache, had lost all feeling in his fingers and toes and fatigue was unknown. Fever, joint and muscle pains was recovered on an unspecified date in 2021. Information on the lot/batch number has been requested.


VAERS ID: 1493225 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Virginia  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Insomnia, Pain in extremity, Vaccination site movement impairment
SMQs:, 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 INC2021872340

Write-up: his arm pain for14 days now; he cannot move his arm / He can only move it at 40 degrees; unable to sleep properly; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 24Jun2021 as dose 2, single for Covid-19 immunization.Medical history and concomitant medications were not reported.The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) on 03Jun2021 via an unspecified route of administration on 03Jun2021 at dose 1, single for Covid-19 immunization and did not experience any reaction to vaccine.On an unspecified date in Jun2021, patient experienced arm pain for 14 days now. He said that after the 2nd dose he received, he cannot move his arm and was unable to sleep properly. He could only move it at 40 degrees.The outcome of unable to sleep properly was unknown and patient had not yet recovered from rest of the events. Information about lot/batch number is expected.


VAERS ID: 1493230 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-06-27
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Eye irritation, Hepatic enzyme, Hepatic enzyme abnormal, Hypoaesthesia, Lymphadenopathy, Magnetic resonance imaging, Oral herpes
SMQs:, Liver related investigations, signs and symptoms (narrow), Peripheral neuropathy (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Corneal disorders (broad), Hearing impairment (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemic; Iron deficiency
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown; Test Date: 2021; Test Name: Cat scan; Result Unstructured Data: Test Result:Do not have stroke; Test Date: 20210705; Test Name: Liver enzymes; Result Unstructured Data: Test Result:Liver enzymes were still elevated; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:Do not have stroke
CDC Split Type: USPFIZER INC2021873130

Write-up: Mouth was drooping; Swollen lymph nodes; Liver enzymes were abnormally elevated; Cold sores; Arms were numbing when sleeping; Eyes were burning; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 45-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0196) via an unspecified route of administration in left arm on 27Jun2021 at 13:00 (at the age of 45-years-old) as first dose, single for COVID-19 immunization. Medical history included anemic and iron deficiency. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Jun2021, the patient experienced eyes were burning at night while sleeping they started burning a few days after the vaccine. On 05Jul2021, the patient experienced liver enzymes were abnormally elevated and cold sores. On 07Jul2021, the patient experienced swollen lymph nodes. On 08Jul2021, the patient experienced mouth was drooping. On an unspecified date in Jul2021, the patient experienced arms were numbing when she was sleeping started three or four days ago and last night did not feel the numbing in her arms, she thought it has recovered completely. Patient reported that when she saw her face she thought she had a stroke and rushed to ER. She confirmed that she was not admitted. Therapeutic measures were taken as a result of mouth was drooping (bell''s palsy), treatment was received as steroid and an antiviral medication. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date in 2021, computerized tomogram: do not have stroke on an unspecified date 2021, hepatic enzyme: liver enzymes were still elevated on 05Jul2021, magnetic resonance imaging: do not have stroke on an unspecified date in 2021. Patient was told at ER that she did not have a stoke and probably had Bells Palsy. The outcome of events of eyes were burning was recovered on an unspecified date in 2021, arms were numbing when sleeping was recovered on an unspecified date in Jul2021 and the outcome of events mouth was drooping, cold sores was recovering while the outcome of events swollen lymph nodes, liver enzymes were abnormally elevated was not recovered.


VAERS ID: 1493263 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-02
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Feeling abnormal, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: bloodwork; Result Unstructured Data: Test Result:normal results
CDC Split Type: USPFIZER INC2021907939

Write-up: foggy brain; tingling in hands and feet; This is a spontaneous report from a contactable consumer (patient''s mother). A 15-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0173), via an unspecified route of administration, administered in arm left on 02Jun2021 (at the age of 15-year-old,) as dose 1, single for covid-19 immunisation from doctor''s office/urgent care. Medical history included asthma. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications were received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she has not been tested for COVID-19. The patient experienced foggy brain and tingling in hands and feet two weeks after the first dose (Jun2021). Her pediatrician examined her and took bloodwork with normal results. The tingling lasted one week and then disappeared. She started feeling tingling in her hands and feet again, it being constant starting on the evening of 15Jul2021. This was reported to patient''s pediatrician again and the patient was advised to take rest and stay cool. The events were reported as non-serious. The patient did not receive any treatment in response to the events. The outcome of event foggy brain was not recovered and tingling in hands and feet first episode was recovered in Jun2021, while second episode was not recovered.


VAERS ID: 1493700 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-05-14
Onset:2021-06-01
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 2 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Burning sensation, Chest discomfort, Headache, Hypoaesthesia, Injection site pain, Myalgia, Neck pain, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ibuprofen (MOTRIN) 800 MG tablet valacyclovir (VALTREX) 1 g tablet valACYclovir (VALTREX) 500 MG tablet
Current Illness: NA
Preexisting Conditions: NA
Allergies: Kiwi FruitNausea and Vomiting Pepto-bismol [Bismuth Subsalicylate]Nausea and Vomiting
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Patient calling for Chronic COVID-19 Vaccine, Arm Pain, and Skin Problem (burning senstion- upper extremeties ) Symptoms started x1 month. Symptoms include: Received covid-19 vaccine. Patient has had a burning sensation since in arm since vaccine. States sensation has been spreading to the rest of her body. Patient Has not attempted treatment at home.. Pertinent negatives include: Afebrile. HISTORY OF PRESENT ILLNESS Patient is a 41 y.o. female who presents regarding a potential concern for an adverse reaction to the COVID-19 vaccine. Second Dose in Series: Vaccine was obtained from the clinic/location: on the date of: May 14th and approximate time of 2:30 Vaccine was administered to patient''s: Right Deltoid Vaccine manufacture was: Pfizer No Previous Reactions to other immunizations Known COVID Exposure since receiving vaccination?: No Patient notes the following symptoms: Headache, Localized injection site pain and Myalgias Patient is a 41-year-old female presenting with multiple different symptoms post COVID-19 vaccine. Patient reports that has any burning sensation in her vaccine arm. She reports that it almost feels like it is on fire or sunburn. Patient reports that at times the sensation travels to different parts of her body. She also reports that she had neck pain, Back pain, and upper chest discomfort. That time she reports that she has some numbness and tingling bilateral to her upper extremities. She denies any weakness. She denies any level of consciousness changes. She denies any trauma. She does not a family history of stroke or neurological problems. She also reports that she has had a change in her menstrual cycle. She reports that she is had 2 menstrual periods in the month of May and also in June. She also reports mild headache. She also reports that her eyes seem a little dry and feels as though her vision may be getting worse. 1. Adverse effect of vaccine, initial encounter At this time due to multiple different neurological symptoms and unable to do a good thorough neuro exam I would like her to be seen in person for further evaluation. Patient was educated on worsening symptoms and reasons to go to the emergency room right away such as any signs of the stroke which we discussed speech changes, numbness or tingling down one arm. Patient was agreeable to plan of care and is going to reach out to her primary care doctor. Called PCP office to let them know my recommendation for appointment as soon as available This visit was completed via health visit and 11-20 mins was spent as part of care with patient.


VAERS ID: 1493729 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-24
Onset:2021-06-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 1 RA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 2 RA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Abdominal pain, Anticoagulant therapy, Anxiety, Computerised tomogram, Condition aggravated, Decreased appetite, Endoscopy upper gastrointestinal tract normal, Laboratory test, Pain, Pelvic venous thrombosis, Rheumatoid factor increased, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Celexa, Tylenol, Qnasl, Atrovent, multivitamin
Current Illness: gi pain since vaccine #1 ; suspected food poisoning in march
Preexisting Conditions: anxiety, dust mite allergy
Allergies: sulfa drugs, sensitivity to augmentin
Diagnostic Lab Data: CT scanx4; elevated rheumatoid factor, ultrasound, several lab tests
CDC Split Type:

Write-up: 1st vaccine dose given 4/20. Expected symptoms occurred. Several provider visits past 72 hours from injection for abdominal pain, vomiting, diarrhea, muscle pain. Hospitalized first time on May 13th. Colonoscopy with focal active colitis and lab tests performed. No clear cause identified. Advised to get dose#2 on May 24th. Normal vaccine side effects occurred for 72 hours along with continued abdominal pain. Hospitalized #2 06/02/2021 with left gonadal vein thrombosis. Started on blood thinners and labs drawn. No genetic markers or predisposition for clotting. Referred to Hematology. Continued abdominal pain. Upper Endoscopy performed without ulcer or significant findings. Continued abdominal pain. Admitted to outpatient psychiatry for increased anxiety. Continued abdominal pain, poor appetite, vomiting, significant weight loss, body aches. No cause identified. Referred to rheumatology with high rheumatoid factor without other significant findings.


VAERS ID: 1494192 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-06-09
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK UN / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: pollen and birch tree allergy (incl. cross-allergy/reaction to pitted fruit such as apples, peaches, pears and cherries)
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tingling in hands and feet, started estimated 2-3 weeks after receiving the vaccine. Still there, as of today 7/22. But has not gotten worse nor have I experience muscle weakness or other symptoms.


VAERS ID: 1494214 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-05-05
Onset:2021-06-01
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0172 / 2 AR / SYR

Administered by: Private       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: olmesartan medoxomil 40mg Verapamil 240mg ER
Current Illness: none
Preexisting Conditions: hearing loss, bilateral cholesteatoma operation ~2007
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tinnitus is very loud and difficult to hear over.


VAERS ID: 1494292 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-01-15
Onset:2021-06-01
   Days after vaccination:137
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3249 / 2 UN / SYR

Administered by: Private       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D, B vitamin, and a multivitamin
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type: vsafe

Write-up: A few months after receiving the second dose, I got shingles. Diagnosed by a physician.


VAERS ID: 1494354 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-05-10
Onset:2021-06-01
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tadalafil 5mg 1x dly, Venlafaxine HCL ER 75mg 1x dly, Losartan Potassium 50mg 1x dly, , Tamsulosin HCL 0.4mg 2 tabs 1x dly,
Current Illness: NA
Preexisting Conditions: High Blood Pressure
Allergies: NA
Diagnostic Lab Data: Visited doctor during annual physical
CDC Split Type:

Write-up: Have developed inflamed lymph nods (doctor thought) on Left side of rib cage.


VAERS ID: 1494372 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-05-15
Onset:2021-06-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Aneurysm ruptured, Asthenia, Blindness, Brain injury, Cerebral thrombosis, Cognitive disorder, General physical health deterioration, Haemorrhagic stroke, Headache, Intensive care, Life support
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 90 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Baby aspirin, 1/day Tamulosin, 4mg 1/day Pravastaten 40mg, 1/day Clopidogrel, 75mg 1/day
Current Illness: None. Clean bill of health. ACTIVE. Does not smoke. Social drinker-1 to 2 per week, if that. No issues.
Preexisting Conditions: None. Had a few heart stints put in 2.5 years ago. Zero issues. All fine.
Allergies: NA
Diagnostic Lab Data: ?
CDC Split Type:

Write-up: 5/15- evening of and day after 2nd shot complained of severe headache 6/1- Suffered clot and hemorrhagic stroke/burst aneurysm. Husband was Airlifted to Hospital where he was rated a level 4, catastrophic event. He spent over 32 days in the ICU ON LIFE SUPPORT and as of day 52, remains in the hospital. His brain injury from the burst clot is life-changing. He is incapacitated and has lost 80% of his vision. He cognitively is significantly compromised and needs full assist and will likely never be Independant again- if he survives.


VAERS ID: 1497180 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Cough, Decreased appetite, Diarrhoea, Dyspnoea, Foaming at mouth, Illness, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Convulsions (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Twice Negative
CDC Split Type: USJNJFOC20210744061

Write-up: DIARRHEA; SICK; FEVER; COULD NOT BREATH DEEPLY; LOSS OF TASTE; LOSS OF SMELL; SALIVA LIKE FOAM; DRY COUGH WITH NO SECRETIONS; LOSS OF APPETITE; This spontaneous report received from a patient concerned a 60 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced loss of appetite. On 27-JUN-2021, the subject experienced loss of taste. On 27-JUN-2021, the subject experienced loss of smell. On 27-JUN-2021, the subject experienced saliva like foam. On 27-JUN-2021, the subject experienced dry cough with no secretions. On 27-JUN-2021, the subject experienced could not breath deeply. On 28-JUN-2021, the subject experienced sick. On 28-JUN-2021, the subject experienced fever. On 29-JUN-2021, the subject experienced diarrhea. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Twice Negative. Treatment medications (dates unspecified) included: dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride, and guaifenesin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of taste, loss of smell, saliva like foam, dry cough with no secretions, and fever, and the outcome of sick, could not breath deeply, loss of appetite and diarrhea was not reported. This report was non-serious.


VAERS ID: 1497441 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-04-14
Onset:2021-06-01
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8731 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthritis, Condition aggravated, Lymphoma, Neuropathy peripheral, Pain, Red blood cell sedimentation rate, Supraventricular extrasystoles
SMQs:, Peripheral neuropathy (narrow), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Guillain-Barre syndrome (broad), Malignant lymphomas (narrow), Arthritis (narrow), Haematological malignant tumours (narrow), Hypokalaemia (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: HYDROXYCHLOROQUINE ACTAVIS
Current Illness: Lupus anticoagulant; Lymphoma; Premature atrial contraction; Rheumatoid arthritis; Systemic lupus erythematosus
Preexisting Conditions: Medical History/Concurrent Conditions: Immunocompromised
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: Sedimentation rate; Result Unstructured Data: Test Result:24; Test Date: 20210702; Test Name: Sedimentation rate; Result Unstructured Data: Test Result:22
CDC Split Type: USPFIZER INC2021862077

Write-up: nerve neuropathy; lymphoma getting worse; Premature atrial contraction had gotten worse; Premature atrial contraction had gotten worse/ lymphoma getting worse; his arthritis is flaring up and "acting up".; pain; This is a spontaneous report from a consumer (patient) via regulatory authority. A 56-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 15:00 (Lot Number: ER8731) as dose 2, single at the age of 56-years-old for covid-19 immunization. Medical history included ongoing rheumatoid arthritis, ongoing lupus, ongoing lupus anticoagulant, this leaves him immunocompromised, ongoing premature atrial contraction, ongoing lymphoma. Patient said that he was included on the high risk priority for the vaccine. He has lupus, rheumatoid arthritis and other things going on. Concomitant medication included hydroxychloroquine sulfate (HYDROXYCHLOROQUINE ACTAVIS) ongoing for lupus. The patient received first dose of bnt162b2 (Lot: EM9810) on 16Mar2021 around 1pm in the left arm for covid-19 immunization. Prior vaccinations (within 4 weeks): none. AEs following prior vaccinations: none. After getting the second shot of the vaccine, his arthritis was flaring up and "acting up". The pain is "very bad" and that his doctor was telling him it went back to the vaccine. He also stated that the last month was "brutal" since he can barely get up from his chair and his bed and that he was not allowed to take Ibuprofen and most of rheumatoid arthritis medications. The patient explained that for the for past 2 months he has been feeling crappy and there are days when he cannot walk related to the arthritis. He mentioned that he had a lymphoma stage 4 before and it has gotten worse as well after the second dose. The patient clarified that his lymphoma has been inflamed. He also stated that he had premature atrial contraction (PAC), this has flared up too. Premature atrial contraction had gotten worse and confirmed that he was experiencing symptoms of chest pain, shortness of breath, and a pounding heart. The patient notes that with his PAC, he noticed his heart was palpating and racing more. Since having chemo he had side effects after that but this was 3 years ago and he had nothing since then until now. The doctor did not know if this is related to getting the vaccine. Patient felt like maybe he shouldn''t have gotten the vaccines. He was taking tramadol for pain but he did not want to be on pain killers and did not want to go back on taking hydrocodone. Patient also reiterated that before getting the shot he was okay and now he was moving "backwards". He also added that nerve neuropathy is what he got out of it. Patient also said his hydroxychloroquine and tramadol are not working anymore since getting the vaccine and wants to know for potential interaction. All the events were noticed in Jun2021. For arthritis, this was noticed about a month afterward but he didn''t know until Jun2021 what was really going on. He went to his rheumatologist and they did a sedimentation rate that showed his inflammatory marks were like they were when doing chemo. They hadn''t been that level for 3 years, since he was on chemo. She also noticed the lymphoma in his right arm was swollen. This was the same time, in Jun2021. The patient reported he had rheumatoid arthritis and the doctor think it is a flare up of that. He reported joint pain, when he sits it is hard to get up. Patient confirmed this is the arthritis mentioned above, it is all the same event. The patient stated he thought he was getting sick again, that his cancer was back or something was going on. The oncologist did note that his lymph node were going down. It was confirmed this statement is related to the above mentioned events already covered in the report. AEs require a visit to: physician office (Patient also stated he saw his doctor''s regularly). Relevant test included: Sedimentation rate: 24 on Jun2021; 22 on 02Jul2021. Outcome of the event lymphoma getting worse, premature atrial contraction had gotten worse, arthritis is flaring up was not recovered, of other events was unknown.


VAERS ID: 1497485 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-06-19
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Blood test, Chills, Ear pain, Epistaxis, Feeling of body temperature change, Headache, Pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FERROUS SULPHATE [FERROUS SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia (Verbatim: Anemic)
Allergies:
Diagnostic Lab Data: Test Name: General blood test; Result Unstructured Data: Test Result:it was like a iron, lipid, comprehensive metallic,; Comments: it was like a iron, lipid, comprehensive metallic, metabolic
CDC Split Type: USPFIZER INC2021872854

Write-up: had a short pain in my armpit in the one that, in the arm that I got the vaccine; Headache/head would hurt to; my body would get really hot and really cold at the same time and then my whole body aches; my ear would hurt too; Chills; my body would get really hot and really cold at the same time and then my whole body aches; my nose would bleed from my right nostrils for about a week and then head would hurt to and my ear would hurt too; This is a spontaneous report from a contactable female consumer or other non hcp (patient). A 20-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0181), via an unspecified route of administration, administered in arm left on 19Jun2021 (at the age of 20-year-old) as dose 2, single for COVID-19 immunization. Medical history included anaemia (patient stated, I am anemic. You can probably say low iron (later confirmed as anemic). The patient concomitant medication included ferrous sulphate (FERROUS SULFATE) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administered in arm left on 29May2021 as dose 1, single for COVID-19 immunization and experienced I had short pain in my armpit in the arm, I had mild headache. The patient experienced had a short pain in my armpit in the one that, in the arm that I got the vaccine, headache/head would hurt to, my body would get really hot and really cold at the same time and then my whole body aches, my ear would hurt too, chills, my nose would bleed from my right nostrils for about a week and then head would hurt to and my ear would hurt too, all on an unspecified date in Jun2021. Adverse events: patient stated, Okay, after the 1st dose, I had short pain in my armpit in the arm that I got my shot in, this is the few days after and then I had mild headache after that too. Then after the 2nd dose I had short pain the next day in my armpit again and then I had really bad headache and I have aches and chills like all over my body, my body would get really hot and really cold at the same time and then my whole body aches. Patient stated, Yes, I felt a little bit better after that the 2nd shot but about a week later I started to get a nose bleed for a week. So, every like morning my nose would bleed from my right nostrils for about a week and then head would hurt to and my ear would hurt too. Patient stated, I still have headache and I never had headache or nose bleed before. Date of vaccination: Patient stated, On the first dose it was June on a day like 4, this is actually the 1st dose. I had a short pain in my armpit in the one that, in the arm that I got the vaccine impetrated. When confirmed the date, patient stated, No, the 1st one dose on the 5th of 29th, I mean May, 29th. 2nd dose that was on June 19th. The patient underwent lab tests and procedures which included general blood test showed it was like a iron, lipid, comprehensive metallic, metabolic. Outcome of the event headache/head would hurt to was not recovered and rest of the events was unknown. Follow up attempts are needed. Further information is expected.


VAERS ID: 1497487 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-06-11
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy, Pain in extremity
SMQs:, 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: Cancer (she has cancer in her family.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021872906

Write-up: first dose: swollen lymph node; first dose: arm hurt a little; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 25-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: EW0217, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 11Jun2021 (age at vaccination was 25 years) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient had cancer in her family. The patient''s concomitant medications were not reported. The patient previously took prevenar 13 for pneumonia (last vaccine she got 6 months ago they actually they told her that this vaccine might have a chance of lesser mitigated side effects but that was not the case. She said that last one was Prevnar 13 for pneumonia) and flu vaccine (she was surprised because she has never had reactions. She said actually she reacted badly to the flu vaccine. She has not gotten the flu vaccine in 10 years because she reacts badly and she has not gotten the flu in 10 years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines were administered on same date of the Pfizer Suspect. The patient said that the first vaccine was fine, her arm hurt a little. The swollen lymph nodes began after the first vaccine, she got the first dose on 11Jun2021 and maybe on 13Jun2021 she was in the shower and felt the lump and freaked out and began calling doctors and they said she had just got the vaccine and it could be that but she was still going to have it checked out because there was triple negative in her family and her lymph nodes were still swollen now and it has been over a month, they got even bigger with the second dose. They said a very low percentage have the swollen lymph nodes so she wanted to report. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot number: EW0196, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 02Jul2021 at 18:30 or 19:00 pm (age at vaccination was 25 years) as dose 2, single for COVID-19 immunization. No relevant tests were done. She asked whether there was going to be a third shot, like a booster. She said she just asked because she was dreading it since getting the second shot. The outcome of the event first dose: arm hurt a little was resolved on an unknown date in 2021. The outcome of the event first dose: swollen lymph node was not resolved.


VAERS ID: 1497493 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-14
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Arthritis, Arthropathy, Cheilitis, X-ray
SMQs:, Systemic lupus erythematosus (broad), Hypersensitivity (broad), Arthritis (narrow), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMIN B; VITAMIN B12 & FOLIC ACID; NORCO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Anaphylactic shock (four times); COVID-19; Neck pain; Pneumonia NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: X-ray; Result Unstructured Data: Test Result:mild arthritis
CDC Split Type: USPFIZER INC2021873172

Write-up: Second dose: She had a rash over her lips.; her joint pain was because of mild arthritis; Second dose: She has had left knee problems. She also received the covid vaccine in her left arm.; Second dose: She has had joint pain.; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: unknown; Expiration Date: unknown, NDC: unknown), via an unspecified route of administration, administered in arm left on 14Jun2021 13:00 (at the age of 51-year-old) at dose 2, single for covid-19 immunisation. Medical history included on an unspecified date in upper pneumonia, chronic allergies, anaphylactic shock (four times), neck pain, she is allergic to sulfa. She had a mild reaction, on an unspecified date in Mar2021 covid-19. Because patient is in the health care industry. She got really sick in March from covid. She was really sick with upper pneumonia, and she has chronic allergies. Nothing was working for her. She survived on Vicks. Even with the Norco that she takes for her neck, the pain does not go away. Concomitant medication included vitamin b complex (VITAMIN B); cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID); hydrocodone bitartrate, paracetamol (NORCO) (Product strength and count size dispensed: 10-325mg) at 10-325mg, (one tablet every 12 hours) taken for neck pain (She can take it four times daily as needed for pain. She takes it a minimum of one tablet every 12 hours). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: unknown; Expiration Date: unknown, NDC: unknown), via an unspecified route of administration, administered in arm left on 24May2021 13:00 (at the age of 51-year-old) at dose 1, single for covid-19 immunisation. On an unspecified date in Jun2021 the patient experienced second dose: she has had left knee problems. she also received the covid vaccine in her left arm, second dose: she has had joint pain, her joint pain was because of mild arthritis, on 14Jun2021 second dose: she had a rash over her lips. Patient is calling about the Pfizer covid vaccine. Patient has a concern about the covid vaccine that was given to her. Patient is a nurse She received the first dose of the covid vaccine on 24May2021.She received the second dose of the covid vaccine on 14Jun2021. For the last 30 days, she has had left knee problems. She also received the covid vaccine in her left arm. Patient has had joint pain, and got an X-Ray done on her knee yesterday and it showed that she had mild arthritis. Patient went back to the university in (withheld) where she received the covid vaccine and told them about her experience after the first dose of the covid vaccine. She had a rash on her legs, by her lower heals and ankles. The rash went away. Patient also had a rash on her arm. They told her that was fine. After the second dose of the covid vaccine, she had a rash over her lips. Second dose: Patient has had left knee problems. She also received the covid vaccine in her left arm: Began about four weeks ago. She went to the doctor yesterday. She has been doing self medication, hot and cold packs, and taking Ibuprofen. It has gotten so bad to where she is limping. She thought that she might have had a blood clot. A lot of her friend''s mothers and aunts around the area are ending up in the hospital with severe arthritis after receiving the Pfizer covid vaccine. She has been bracing her knee up. She does not know if this is going to last another 30 or 45 days. She is asking if anyone else is reporting knee pain, or joint pain. Second dose: Patient has had joint pain: Began about four weeks ago. All of a sudden, she had swelling of her knee. It was not hot to touch much, but she had a hard time putting weight on it. On the back of her knee, it felt like a knot. She was wrapping it with hot and cold. She was scared she had a blood clot, and got an X-Ray done yesterday. They told her that her joint pain was because of mild arthritis. Outcome of event: Sometimes it is so bad to where she is limping. First dose: Patient had a rash on her legs, by her lower heals and ankles. She also had a rash on her arm: She received the first dose of the covid vaccine on 24May2021, and she had the reaction within eight hours. She did not have a fever or anything like that. She has had covid before, in Mar2021. The rash recovered completely within 24 hours. Second dose: She had a rash over her lips: Her lips were dry and she had bubbles around her lips. It lasted for 72 hours and recovered completely. The patient underwent lab tests and procedures which included x-ray: mild arthritis on 08Jul2021. Patient received treatment of the adverse events, she went to the doctor yesterday. She has been doing self-medication, hot and cold packs, and taking Ibuprofen. Seriousness criteria: Call handler listed options out to caller. Patient stated, she has a history of chronic allergies. She has had anaphylactic shock four times. She watches what she puts in her body food wise, and medication wise. She is allergic to sulfa. She had a mild reaction. She does not think it was a serious reaction. If it was a serious reaction, she would be in the hospital. Outcome of the event second dose: she has had left knee problems. she also received the covid vaccine in her left arm was not resolved, second dose: She has had joint pain, her joint pain was because of mild arthritis was unknown and second dose: She had a rash over her lips was resolved on 17Jun2021.


VAERS ID: 1497544 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Dyspnoea, Fatigue, Heart rate increased, Hypertension, Malaise
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety (she still has anxiety off and on.)
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: blood pressure; Result Unstructured Data: Test Result:144/72; Comments: 144/72 and 71; Test Date: 202107; Test Name: blood pressure; Result Unstructured Data: Test Result:144/77; Comments: 144/77, 63; Test Date: 202107; Test Name: blood pressure; Result Unstructured Data: Test Result:143/71; Comments: 143/71, 72
CDC Split Type: USPFIZER INC2021882721

Write-up: her blood pressure, it was a little bit high; little bit shortness of breath; she felt not well; a little bit tired; a fast pulse; This is a spontaneous report from a contactable consumer reporting for herself. An 80-years-old female patient 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 Jun2021 as single dose (at age of 80-years old) for COVID-19 immunization. The patient medical history include she still did not see doctor but the last time she saw a doctor was years ago when her husband was in critical condition, for anxiety, and he passed away she still has anxiety off and on. The patient concomitant medications were not reported. The patient had the Pfizer vaccine three weeks ago (Jun2021) and tomorrow (13Jul2021) will be the second shot that she supposed to take, but today (12Jul2021) and during the first week it was fine. she states before she took the first one, and her blood pressure was perfect, she did it twice, but after that, a week later (Jun2021), she felt a little bit tired and fast pulse and it was going on for about a week and she felt not well. She states now she feels better, and she goes to have another shot tomorrow. States on 12Jul2021 (today), she took her blood pressure, and it was a little bit high. It was 144/72 and 71 and sometimes, it came down to 142 so she wondered if it was okay if she comes tomorrow for another shot. She states her doctor was not available, so she wonders if its because of the blood pressure machine, but she did it three times. it was 144/77, 63 and then it came down to 143/71, 72 so was it okay for her to come tomorrow. She did have a little bit shortness of breath for the second week (Jun2021). She wants to know that it was okay if she comes back tomorrow with a little high blood pressure like that she states but tomorrow, it will be her appointment for her second shot and the question was if she could come tomorrow for another shot with a little bit high blood pressure like that because she afraid that the side effect of the second time will be worse than the first one. Caller states she''s short and this was not that serious of a reaction because she still keeps on doing her daily tasks, she walks, and jogging around, but with a little bit shortness of breath for the 2nd week in the beginning and a couple days later, and now its coming down, and today she feels good. The outcome of events a little bit tired, a fast pulse, her blood pressure, it was a little bit high and little bit shortness of breath was unknown and the outcome of event she felt not well was resolved on unknown Jul2021. Information regarding the lot/batch number has been requested.


VAERS ID: 1497549 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-01-20
Onset:2021-06-01
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3249 / 2 RA / OT

Administered by: Work       Purchased by: ?
Symptoms: Myelitis transverse
SMQs:, Demyelination (narrow), Immune-mediated/autoimmune disorders (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: OZEMPIC; METFORMIN; HYZAAR; CRESTOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hyperlipidemia; Hypertension (Verbatim: HTN)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021883340

Write-up: Transverse Myelitis; This is a spontaneous report from a contactable pharmacist. A 40-years-old adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: El3249) via an intramuscular route of administration in Arm Right on 20Jan2021 03:15 (age at vaccination 40years old) as Dose 2,Single for COVID-19 immunization. Medical history included diabetes mellitus from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, HTN, hyperlipidaemia from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility the most recent COVID-19 vaccine was administered in Workplace clinic. Concomitant medication(s) included semaglutide (OZEMPIC); metformin (METFORMIN); hydrochlorothiazide, losartan potassium (HYZAAR); rosuvastatin calcium (CRESTOR). All taken for an unspecified indication, start and stop date were not reported. The patient was allergic to the drug Amoxil.Since the vaccination, the patient had not been tested positive for COVID-19. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: El0142) via an intramuscular route of administration in Arm Right on 30Dec2020 03:15 as Dose 1,Single for COVID-19 immunization. The patient experienced transverse myelitis in Jun2021. The patient was hospitalized for transverse myelitis for 3 days. The patient received any treatment for the adverse events. Therapeutic measures were taken as a result of transverse myelitis. The clinical outcome of the event recovering. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1497577 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-01
Onset:2021-06-01
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse event, Antibody test, COVID-19, Cough, Malaise, Polymerase chain reaction, SARS-CoV-2 test negative, Type 2 diabetes mellitus, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (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: 20210709; Test Name: antibody test; Result Unstructured Data: Test Result:either the IgG or IgM; Test Date: 20210709; Test Name: COVID-19 PCR test positive; Test Result: Positive ; Test Date: 20210709; Test Name: COVID-19 rapid POC test negative; Test Result: Negative
CDC Split Type: USPFIZER INC2021893436

Write-up: Medical Information Potential AE; she did a PCR test that resulted yesterday as positive; COVID-19 rapid POC test negative; she did a PCR test that resulted yesterday as positive; Feeling sick; Coughs often throughout the call.; Diagnosed with type 2 Diabetes; This is a spontaneous report from a contactable consumer (patient). A 70-years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration on 01Mar2021 (at the age of 70-years-old) as single dose and the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 08Feb2021 (at the age of 70-years-old) as single dose for COVID-19 immunisation. The family medical history was reported as none. The patient''s medical history (including any illness at time of vaccination) was reported as none. The patient''s concomitant medications were not reported. Historical vaccine included Pneumonia vaccine (PNEUMOCOCCAL VACCINE), via an unspecified route of administration on an unspecified date as dose number unknown, single for an unspecified indication and experienced arm went numb, like paralyzed, for a day. The history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as first dose of the Pfizer COVID 19 Vaccine given on 08Feb2021, Lot Number: EN6201 or EN6207, uncertain if the last number was a 1 or a 7, given in the caller''s left arm. The caller denied any medications, labs or treatments relevant to report. Stated that, she was diagnosed with type 2 diabetes last month, she has otherwise been healthy. Prior vaccinations (within 4 weeks) was reported as none. Additional vaccines administered on same date of the Pfizer suspect was reported as none. It was reported that, the information was verified with the caller. She was called to report that, she has tested positive for COVID 19 after having both doses of the Pfizer COVID 19 Vaccine. She has had COVID-19 for over a week. She had three tests done on 09Jul2021. The rapid test for COVID 19 came back as negative. The PCR test done on that date yesterday, resulted as positive. She also had an antibody test, IgG or IgM. On an unspecified date in Jul2021, the caller has been feeling sick for a week. Coughs often throughout the call. The caller stated that, she believed she got COVID 19 in an outdoor setting over the weekend. It was an outdoor block party on 04Ju2021. A family of 5 came down with COVID along with some others, including the caller. The caller thinks the efficacy wore off or she contracted one of the variants. Stated that, she was the only one out of the people infected who was vaccinated. The caller stated that, she had 2 telehealth appointments with her doctor after testing positive for COVID 19. One of them was yesterday or the day before and one was today. For Lack of Efficacy, the primary infection site was reported as respiratory. Stated that, she just wanted to report her test and sickness to help with data on the people who are still getting sick after the vaccine and she just wanted to help with the information for the variants of the virus, which are highly contagious. Response included no inquiry was made by the caller. The caller declined to provide healthcare professional information at this time. On an unspecified date, medical information potential AE was reported. The description of complaint included was the caller tested positive for COVID 19 after both doses of Pfizer COVID 19 vaccine. The events required a visit to the emergency room was reported as no and physician office was reported as yes. On 09Jul2021, the patient underwent lab tests and procedures which included antibody test, resulted as either the IgG or IgM, COVID-19 PCR test positive, resulted as positive and COVID-19 rapid POC test negative, resulted as negative. The outcome of the events was unknown.


VAERS ID: 1368617 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-06-01
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0193 / UNK - / SYR

Administered by: Public       Purchased by: ?
Symptoms: Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: SYMBACORT , VENTOLIN
Current Illness: NONE
Preexisting Conditions: ASTHMA, ALLERGIES
Allergies: NO
Diagnostic Lab Data:
CDC Split Type:

Write-up: HEART PALPITATIONS WITH NO EXTRANEOUS CAUSES


VAERS ID: 1374055 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD986 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Headache, Malaise, Nausea, Seizure, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLJNJFOC20210606732

Write-up: SEIZURES; VOMITING; FELT SICK (FELT UNWELL); FAINTED AFTER VACCINATION; NAUSEA; HEADACHE; SEVERE STOMACH PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD986, expiry: UNKNOWN) dose was not reported,1 total administered on 02-JUN-2021,11:00 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the patient fainted right after the vaccination. She felt sick and took two pills of paracetamol before bedtime. On 03-JUN-2021,before breakfast, the patient had vomited and had seizures. On JUN-2021, after vaccination, the patient was generally felling unwell and had nausea. The patient also was suffering from severe stomach pain and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainted after vaccination, seizures, nausea, vomiting, felt sick, severe stomach pain and headache was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210606732-covid-19 vaccine ad26.cov2.s-fainted after vaccination, seizures. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1382894 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Burning sensation, Confusional state, Depressed level of consciousness, Dizziness, Dysstasia, Fatigue, Feeling abnormal, Hypotension, Lymphadenopathy, Myalgia, Night sweats, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to chemicals
Preexisting Conditions: Comments: The patient never experienced flu in her life.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210606153

Write-up: NIGHT WOKE UP DUE TO SOAKED; INFLATED RIGHT AXILLARY LYMPH NODE (NODULE); FELT LIKE HAD A VERY LOW BLOOD PRESSURE; NOT ABLE TO STAND UP; SKIN BURNING SENSATION IN WHOLE BODY; CONFUSED; DIZZY; FEELING WORST AND MUDDY; NO ENERGY AT ALL; HORRIBLE MUSCLES ACHES IN THE WHOLE BODY; FEVER; TIREDNESS; STATE OF SEMI CONSCIOUSNESS DURING THE NIGHT; This spontaneous report received from a patient concerned a 45 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included allergy to a pesticide substance (substance not identified). The patient never experienced flu in her life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 01-JUN-2021 at 09:30 to right arm deltoid for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On 01-JUN-2021, Physician gave a paracetamol 1000 mg 30 minutes after the vaccine shot to prevent from the adverse effects. All the storage conditions were appropriate and the administration was optimal. A doctor, a nurse and a professor were present during the vaccination to make sure everything was alright. On 01-JUN-2021, at 18:00 patient started feeling the adverse events muddy, no energy at all, she felt like had a very low blood pressure. The patient experienced dizzy and confused. At 19:45 she went to the pharmacy to buy some paracetamol because she started feeling worse than before. At 20:00 she was not able to stand up she was very tired or tiredness. At 21:00 she started feeling horrible muscles aches in the whole body and felt a sensation of burning skin in the whole body. She felt some fever as well but she could not remember exact time. She described a state of semi-consciousness during the night. She suffered in an uncontrollable way. She drunk at least two liters of water in the night and she took a Paracetamol 1000 mg. On 02-JUN-2021 (day after), she woke up at 6:30 to 7:00 am and felt better but at 10:00 she started feeling again the muscles aches. During the day, she felt better and she went at work. During the night 02-JUN-2021 (same day), she started feeling muddy, confused, dizzy again but she didn''t take any paracetamol. She was on her couch when she noticed her right axillary lymph node was very inflated (nodule). She sent a picture to her physician and he told her to call company to report that because it was not normal. On 03-JUN-2021 during night at 1:00 she woke up due to soaked. But on 03-JUN-2021, she felt a lot better but she was scared about what was next. She felt like company lied to her about the possible anaphylactic shocks. Patient mentioned that she was not allergic to the active substance or any of the other ingredients of this vaccine. She did not go to the emergencies because she couldn''t stand up and she felt like they were going to tell her just to take paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from inflated right axillary lymph node (nodule), horrible muscles aches in the whole body, fever, tiredness, no energy at all, felt like had a very low blood pressure, not able to stand up, skin burning sensation in whole body, confused, dizzy, feeling worst and muddy, state of semi consciousness during the night, and night woke up due to soaked. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210606153-COVID-19 VACCINE AD26.COV2.S- state of semi consciousness during the night. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1383299 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Diarrhea; Rash; Fever; Chills; This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and RASH (Rash) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant), RASH (Rash) (seriousness criterion medically significant), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, DIARRHOEA (Diarrhea), RASH (Rash), PYREXIA (Fever) and CHILLS (Chills) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient is not pregnant, Patient is not currently breastfeeding. No concomitant medication was reported and corrective treatment was unknown. 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: 1384156 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD 986 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Headache, Malaise, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Vestibular 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210606; Test Name: Blood pressure; Result Unstructured Data: maximum level: 155/156 minimum level: 100
CDC Split Type: PTJNJFOC20210609598

Write-up: INCREASED BLOOD PRESSURE; LIGHT-HEADED; BODY PAIN; HEADACHE; MUSCLE PAIN; NOT FEELING WELL; This spontaneous report received from a patient concerned a 53 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD986, expiry: UNKNOWN) dose was not reported,1 total administered on 02-JUN-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, immediately in the moment the vaccine was administered to the patient, the blood pressure arose (maximum level: 155/156 minimum level: 100).The physician told the patient to lie down on a stretcher where she stayed during 30 minutes to be watched over. After 30 minutes the blood pressure went down and the patient went home. At home the patient felt light-headed, headache and body pain. When the patient stood up from bed she felt even more light-headed. The patient did not have fever. The patient was still not feeling well. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased blood pressure on 02-JUN-2021, and had not recovered from light-headed, headache, muscle pain, body pain, and not feeling well. This report was serious (Other Medically Important Condition).; Sender''s Comments:COVID-19 VACCINE AD26.COV2-increased blood pressure . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1387252 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Sinus node dysfunction
SMQs:, Disorders of sinus node function (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: Blood pressure; Result Unstructured Data: Test Result:80/40; Test Date: 20210601; Test Name: Heart rate; Result Unstructured Data: Test Result:40-60
CDC Split Type: JPPFIZER INC2021642078

Write-up: Sick sinus syndrome; This is a spontaneous report from a contactable other health professional. The patient was a non-pregnant 86-year-old female. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s medical history was not reported. On 31May2021 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021 intramuscularly at hospital for COVID-19 immunization. On 01Jun2021 (1 days after the vaccination), the patient experienced sick sinus syndrome. Treatment was provided for the event. The event resulted in life-threatening (risk of death due to adverse event), hospitalization, and emergency room/department visit or urgent care. The outcome of the event was not reported. Clinical course was reported as follows: On the following day of the vaccination, the patient emergently transported for chest pain. Heart rate (HR) 40-60, blood pressure (BP) 80/40. Shock vital signs were noted. The patient was admitted to cardiology department and diagnosed as sick sinus syndrome. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event sick sinus syndrome cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1387871 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210608963

Write-up: SUSPECTED ZOSTER EXANTHEM; This spontaneous report received from a physician concerned a patient of unspecified age, sex., ethnicity and race. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: UNKNOWN) dose was not reported, 1 total administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUN-2021, the patient experienced suspected zoster exanthem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected zoster exanthem was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210608963-covid-19 vaccine ad26.cov2.s- suspected zoster exanthem. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1388715 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Insomnia
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: COPFIZER INC2021665521

Write-up: excess fatigue; insomnia (difficulty to sleep); This is a spontaneous report from a contactable consumer (Patient) received from a Pfizer colleague (sister of the reporter). This consumer reported similar events for two patients. This is the first of two reports. A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot number: EW0191) via an unspecified route of administration on 01Jun2021 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient informed that they live in Country and travelled to Country to receive the Pfizer-BioNTech vaccine and received the first dose on 01Jun2021 together with her husband. The patient informed that on the first two days she experienced excess fatigue and afterwards insomnia (difficulty to sleep). Event occurred in a country different from that of the reporter. The outcome of the events was unknown. ; Sender''s Comments: Linked Report(s) : PFIZER INC-2021665524 Same reporter and product, different patient and similar AEs


VAERS ID: 1388716 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN0191 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Insomnia
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: COPFIZER INC2021665524

Write-up: insomnia; This is a spontaneous report from a contactable consumer (patient''s wife) received from a Pfizer colleague (sister of the reporter). This consumer reported similar events for two patients. This is the second of two reports. A 38-years-old male patient received bnt162b2 via an unspecified route of administration on 01Jun2021 (Lot number: EW0191) at the age of 38-years-old as 1st dose single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The reporter informed that they live in Country, and traveled to Country to receive the Pfizer-BioNTech vaccine, and received the first dose on 01Jun2021 together with her husband. The reporter informed that her husband (patient) experienced insomnia on Jun2021 for two consecutive days. The outcome of the event was unknown. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency.; Sender''s Comments: Linked Report(s) : PFIZER INC-2021665521 Same reporter and product, different patient and similar AEs


VAERS ID: 1391237 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, Periarthritis, SARS-CoV-2 test
SMQs:, Arthritis (narrow), COVID-19 (broad)

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

Write-up: pain; Adhesive capsulitis; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (pain) and PERIARTHRITIS (Adhesive capsulitis) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PERIARTHRITIS (Adhesive capsulitis) (seriousness criterion disability). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion disability). At the time of the report, PAIN (pain) outcome was unknown and PERIARTHRITIS (Adhesive capsulitis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication and treatment information were not reported. Patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. 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: 1392291 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Influenza like illness
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC2021671835

Write-up: strong diarrhea; mild flu-like reactions; This is a spontaneous report from Medical Information Team. A non-contactable consumer (patient''s sister) reported for a male patient of an unspecified age received bnt162b2 (COMIRNATY, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 01Jun2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had mild flu-like reactions on an unspecified date in Jun2021 and started to have strong diarrhea on 05Jun2021. Reporter wanted to know if there was a forecast of days for this to stop and if the patient could take the second dose. Reporter said she would go with patient to the hospital urgently. She informed that she would return contact later. The patient received treatment of saline and Floratil. The outcome of event strong diarrhea was not recovered and mild flu-like reactions was unknown. No follow-up attempts are possible (information about batch number is not available). No further information is expected.


VAERS ID: 1393088 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3302332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Fatigue, Pain in extremity, SARS-CoV-2 test, Visual impairment
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient did not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No medical history information was provided.
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Cough; Exhaustion; Visual disturbance; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN IN EXTREMITY (Painful arm), FATIGUE (Exhaustion) and VISUAL IMPAIRMENT (Visual disturbance) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3302332) for COVID-19 vaccination. Patient did not have symptoms associated with COVID-19. Patient was not enrolled in clinical trial. No medical history information was provided. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and VISUAL IMPAIRMENT (Visual disturbance) (seriousness criterion medically significant). On 02-Jun-2021, the patient experienced COUGH (Cough) (seriousness criterion medically significant) and FATIGUE (Exhaustion) (seriousness criterion medically significant). On 02-Jun-2021, PAIN IN EXTREMITY (Painful arm) had resolved. At the time of the report, COUGH (Cough), FATIGUE (Exhaustion) and VISUAL IMPAIRMENT (Visual disturbance) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, SARS-CoV-2 test: (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. No relevant concomitant medications were reported. No treatment information was provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1393543 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Head discomfort, Headache, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20211

Write-up: Head pressure; Heart racing; Chills; Headache; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head pressure), PALPITATIONS (Heart racing), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced HEAD DISCOMFORT (Head pressure) (seriousness criterion medically significant), PALPITATIONS (Heart racing) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, HEAD DISCOMFORT (Head pressure), PALPITATIONS (Heart racing), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded. These events were classified as serious by the regulatory authority (seriousness criteria: other). However, as per medical criteria none of the events were serious (as per source narrative).; Sender''s Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded. These events were classified as serious by the regulatory authority (seriousness criteria: other). However, as per medical criteria none of the events were serious (as per source narrative).


VAERS ID: 1393550 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Earache; Sore throat; This regulatory authority case was reported by a consumer and describes the occurrence of EAR PAIN (Earache) and OROPHARYNGEAL PAIN (Sore throat) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced EAR PAIN (Earache) (seriousness criterion medically significant) and OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). At the time of the report, EAR PAIN (Earache) and OROPHARYNGEAL PAIN (Sore throat) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. No treatment information was provided. No relevant concomitant medications were reported. 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: 1393553 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Hallucination, Injection site pain
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad)

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

Write-up: Hallucinations; Dizziness; Pain injection site; Chills; This regulatory authority case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations), DIZZINESS (Dizziness), INJECTION SITE PAIN (Pain injection site) and CHILLS (Chills) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 02-Jun-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant). On 02-Jun-2021, HALLUCINATION (Hallucinations), DIZZINESS (Dizziness), INJECTION SITE PAIN (Pain injection site) and CHILLS (Chills) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication were not reported Treatment medication information were not reported. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1393568 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Musculoskeletal stiffness, SARS-CoV-2 test
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), COVID-19 (broad)

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

Write-up: Stiff neck; This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiff neck) (seriousness criterion medically significant). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product use was reported No treatment information was provided Patient has not tested positive for COVID-19 since having the vaccine. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1393570 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Ear pain, Fatigue, SARS-CoV-2 test
SMQs:, 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PROGESTERONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Diarrhoea; Earache; Tiredness; This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), EAR PAIN (Earache) and FATIGUE (Tiredness) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included PROGESTERONE for Birth control. On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced EAR PAIN (Earache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced DIARRHOEA (Diarrhoea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Diarrhoea), EAR PAIN (Earache) and FATIGUE (Tiredness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-May-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication were reported. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, and not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. 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: 1393882 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Hyperpyrexia, Injection site pain, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATINE [ATORVASTATIN]; LISINOPRIL/HYDROCHLOORTHIAZIDE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Hyperpyrexia; Result Unstructured Data: Fever 40.5 through 42 degrees Celsius
CDC Split Type: NLJNJFOC20210619207

Write-up: COLD CHILLS; FEELING UNWELL; MUSCLE PAIN; REACTION AT OR AROUND THE INJECTION SITE PAIN; FEVER 40.5 THROUGH 42 DEGREES CELSIUS; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, NL-LRB-00564898] concerned a 54 year old male. The patient''s weight was 89 kilograms, and height was 178 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C11-02 expiry: UNKNOWN) 1 total (total dose: 0.5 milliliter, start period: 10 hours) administered on 01-JUN-2021 for covid-19 immunisation. Concomitant medications included atorvastatin, and hydrochlorothiazide/lisinopril. On 01-JUN-2021, the patient had fever 40.5 through 42 degrees Celsius, and reaction at or around the injection site pain. On 02-JUN-2021, the patient had cold chills, feeling unwell and muscle pain. Laboratory data included: Hyperpyrexia (NR: not provided) Fever 40.5 through 42 degrees Celsius. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever 40.5 through 42 degrees Celsius, and cold chills on 02-JUN-2021, and reaction at or around the injection site pain on 01-JUN-2021, and was recovering from muscle pain, and feeling unwell. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210619207- covid-19 vaccine ad26.cov2.s-fever 40.5 through 42 degrees Celsius. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1394157 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4832 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dementia
SMQs:, Dementia (narrow), Noninfectious encephalopathy/delirium (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: Dementia (Known to mental health service at CHC)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021669626

Write-up: Worsening dementia symptoms?; This is a spontaneous report from a contactable physician. A 78-years-old male patient received bnt162b2 via an unspecified route of administration on 31May2021 14:15 (Lot Number: EY4832; Expiration Date: Aug2021) at the age of 78-years-old at 1st dose single dose for covid-19 immunisation. Medical history included dementia known to mental health service at CHC. The patient''s concomitant medications were not reported. The patient experienced worsening dementia symptoms? delirium, grunts, more confused on 01Jun2021. The outcome of events was unknown. Date and time of reconstitution 31May2021 at 14H00.; Sender''s Comments: Event "worsening dementia symptoms" represents worsening of intercurrent medical condition and unrelated to bnt162b2 . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1394464 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FAS843 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Dizziness, Herpes zoster, Tremor, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), 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? No
Previous Vaccinations:
Other Medications: Losartan 50mg; Aspirin
Current Illness: Hypertension; Asthma; Migraine; Hypoglycemia; Osteoarthritis
Preexisting Conditions: Asthma; Migraine
Allergies: All nuts; To CLOROX
Diagnostic Lab Data: Initially the doctor thought it was urticaria, but the next day, Wednesday confirmed that it was herpes zoster. Treatment was started for the same for 7 days. I am currently in recovery and it seems the process is going well.
CDC Split Type:

Write-up: A few minutes after application I got dizzy and my blood pressure rose to 158/92. I started trembling. I developed herpes zoster on the right side of my forehead two days later (on Tuesday).


VAERS ID: 1396219 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DOLOPROCT [FLUOCORTOLONE PIVALATE;LIDOCAINE HYDROCHLORIDE]; MELATONIN; BRENTACORT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKJNJFOC20210619239

Write-up: VASOVAGAL REACTION; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, DK-DKMA-WBS-0069696] concerned a 30 year old male with unknown ethnicity and race. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD975 expiry: UNKNOWN) 1 dosage forms, administered on 01-JUN-2021 for covid-19 immunisation. Concomitant medications included fluocortolone pivalate/lidocaine hydrochloride for anal fissure, hydrocortisone/miconazole nitrate for skin disorder, and melatonin for sleeplessness. On 01-JUN-2021, the subject experienced vasovagal reaction, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vasovagal reaction on 01-JUN-2021. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0 : 20210619239 - Covid-19 vaccine ad26.cov2.s - VASOVAGAL REACTION . This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1396890 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Facial spasm, Paraesthesia, Photopsia, Visual impairment
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Hearing impairment (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: DEPFIZER INC2021669770

Write-up: facial paralysis/numbness on the entire left side when waking up the next morning/The motor function is hardly limited apart from the central part of face (to wrinkle up nose etc is still not possible; vision was accompanied by bright, blue reflections or flashes/ vision disturbed by bright blue reflections and light flashes; vision was accompanied by bright, blue reflections or flashes/ vision disturbed by bright blue reflections and light flashes; heat sensation with tingling in my face; facial cramps; This is a spontaneous report from a contactable consumer (patient). This report is based on information received by Pfizer from Biontech [manufacturer control number: 61463], license party for COMIRNATY. A male patient of unspecified age received the first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: 1D013A), via an unspecified route of administration on 01Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that few minutes after vaccination (on 01Jun2021), he experienced "heat sensation with tingling in my face", which resolved fast. The patient felt well for 8 hours. On the same date, in the evening, rapidly increasing and massive facial cramps occurred (reported by the emergency physician already). They resolved after approximately 2 hours. On 02Jun2021, the patient experienced facial paralysis/ numbness on the entire left side when waking up the next morning which persists as of 06Jun2021. The motor function was hardly limited apart from the central part of his face (to wrinkle up nose etc. was still not possible). The patient''s vision was accompanied by bright, blue reflections or flashes/ vision disturbed by bright blue reflections and light flashes on the first day after vaccination (02Jun2021). These symptoms resolved on the second day. Considering that the symptoms of paralysis still persist, the patient asked if worsening might happen after the second vaccination (due 28Jun2021). The outcome of the events of ''heat sensation with tingling in my face'' and ''facial cramps'' was recovered on 01Jun2021, the events of visual disturbance and flashing lights was recovered on 03Jun2021, while outcome of the event of facial paralysis was not recovered.


VAERS ID: 1396988 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Injected limb mobility decreased, Pain in extremity, Vaccination site rash
SMQs:, Hypersensitivity (narrow), 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: GBMODERNATX, INC.MOD20212

Write-up: Pain in arm; Shoulder pain; Limited arm mobility and rash in injected area; rash in injected area; This regulatory authority case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Limited arm mobility and rash in injected area), PAIN IN EXTREMITY (Pain in arm), VACCINATION SITE RASH (rash in injected area) and ARTHRALGIA (Shoulder pain) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Limited arm mobility and rash in injected area) (seriousness criterion medically significant) and VACCINATION SITE RASH (rash in injected area) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant) and ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant). At the time of the report, INJECTED LIMB MOBILITY DECREASED (Limited arm mobility and rash in injected area) and VACCINATION SITE RASH (rash in injected area) had not resolved and PAIN IN EXTREMITY (Pain in arm) and ARTHRALGIA (Shoulder pain) outcome was unknown. No concomitant medications reported. No treatment information reported. Vaccine was perhaps injected incorrectly and seek advice details. Patient had limited mobility to the arm, unable to lift arm, severe pain in full arm and shoulder even during resting. Developed rash in upper arm. Company Comment: This report refers to a case of product administration error for mRNA-1273, lot # unknown with associated AEs injected limb mobility decreased, pain in extremity, and arthralgia. Concerning the event vaccination site rash, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This report refers to a case of product administration error for mRNA-1273, lot # unknown with associated AEs injected limb mobility decreased, pain in extremity, and arthralgia. Concerning the event vaccination site rash, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1397764 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Muscle ache; Headache; Fever chills; This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache), HEADACHE (Headache) and PYREXIA (Fever chills) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle ache), HEADACHE (Headache) and PYREXIA (Fever chills) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.


VAERS ID: 1397767 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Test Result: Negative ; Result Unstructured Data: Patient has not tested positive for COVID-19 since having the vaccine
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Sensitive skin; Ache; Fever chills; Headache; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Sensitive skin), PAIN (Ache), PYREXIA (Fever chills), HEADACHE (Headache) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 21-Mar-2020. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced SENSITIVE SKIN (Sensitive skin) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, SENSITIVE SKIN (Sensitive skin), PAIN (Ache), PYREXIA (Fever chills), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Patient has not tested positive for COVID-19 since having the vaccine. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information not provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397783 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Cough, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROCODONE; OXYCODONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19; Patient is not enrolled in clinical trial; Patient is not pregnant, Patient is not currently breastfeeding.
Allergies:
Diagnostic Lab Data: Test Date: 20210311; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of COUGH (Persistent dry cough) and CHEST PAIN (Chest pain) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant, Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased. Concomitant products included HYDROCODONE from 01-Nov-2020 to 25-Apr-2021 and OXYCODONE from 30-May-2017 to an unknown date for Chronic back pain. On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced COUGH (Persistent dry cough) (seriousness criterion medically significant). On 02-Jun-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced RASH (Rash on leg). On an unknown date, the patient experienced RASH (Rash). At the time of the report, COUGH (Persistent dry cough), CHEST PAIN (Chest pain) and RASH (Rash on leg) had not resolved and RASH (Rash) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19, Patient is not enrolled in clinical trial, Patient is not pregnant and not currently breastfeeding. Patient developed rash on both shins from the ankle to the knee. Patient has not tested positive for COVID-19 since having the vaccine Treatment medicines were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1397836 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Dizziness postural, Fatigue, Headache, Hemiparesis, Injection site bruising, Injection site mass, Injection site rash, Muscle spasms, Muscular weakness, Myalgia, Nausea, Pyrexia, Rash, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN (E.C.); KYLEENA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201201; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Muscle weakness right-sided; muscle weakness; Dizzy on standing; Leg cramps; Injection site lump; Injection site bruising; lacked appetite; Rash all over; Vomiting; Injection site rash; Fatigue; Headache dull; Nausea; Fever; Muscle pain; Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of HEMIPARESIS (Muscle weakness right-sided) and MUSCULAR WEAKNESS (muscle weakness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 from 27-Nov-2020 to 23-Dec-2020. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and LEVONORGESTREL (KYLEENA) for an unknown indication. On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced MYALGIA (Muscle pain) and PYREXIA (Fever). On an unknown date, the patient experienced HEMIPARESIS (Muscle weakness right-sided) (seriousness criterion medically significant), MUSCULAR WEAKNESS (muscle weakness) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizzy on standing), MUSCLE SPASMS (Leg cramps), INJECTION SITE MASS (Injection site lump), INJECTION SITE BRUISING (Injection site bruising), DECREASED APPETITE (lacked appetite ), RASH (Rash all over), NAUSEA (Nausea), VOMITING (Vomiting), INJECTION SITE RASH (Injection site rash), FATIGUE (Fatigue) and HEADACHE (Headache dull). At the time of the report, HEMIPARESIS (Muscle weakness right-sided), MUSCULAR WEAKNESS (muscle weakness), DIZZINESS POSTURAL (Dizzy on standing), MYALGIA (Muscle pain), FATIGUE (Fatigue) and HEADACHE (Headache dull) was resolving, MUSCLE SPASMS (Leg cramps), RASH (Rash all over), NAUSEA (Nausea), PYREXIA (Fever) and VOMITING (Vomiting) had resolved, INJECTION SITE MASS (Injection site lump), INJECTION SITE BRUISING (Injection site bruising) and INJECTION SITE RASH (Injection site rash) had not resolved and DECREASED APPETITE (lacked appetite ) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. Patient was not enrolled in clinical trial. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397838 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-06-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cellulitis, Electrocardiogram, Malaise, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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: IVABRADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: ECG; Test Result: Inconclusive ; Result Unstructured Data: Heart rate has been higher than usual over continuously over 100 and have since been to A and E .
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Unwell; Tachycardia; Cellulitis; This regulatory authority case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Lactation decreased. Concomitant products included IVABRADINE for Tachycardia. On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Unwell) and TACHYCARDIA (Tachycardia). At the time of the report, CELLULITIS (Cellulitis), MALAISE (Unwell) and TACHYCARDIA (Tachycardia) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2021, Electrocardiogram: unknown (Inconclusive) Heart rate has been higher than usual over continuously over 100 and have since been to A and E .. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Treatment information was mentioned as patient was put on antibiotics on 3 Jun 2021 and other lot of antibiotics were also patient took.; 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: 1397842 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site erythema, Lymphadenopathy, Peripheral swelling, Pruritus, Rash, Rash pruritic
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), 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: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: itching; noticed red mark at injection sight around 1pm today; rash appeared side of both legs; Swollen arm; Swollen glands; Rash; This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (itching), INJECTION SITE ERYTHEMA (noticed red mark at injection sight around 1pm today), RASH PRURITIC (rash appeared side of both legs), RASH (Rash), LYMPHADENOPATHY (Swollen glands) and PERIPHERAL SWELLING (Swollen arm) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On 03-Jun-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On 05-Jun-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (itching) (seriousness criterion medically significant), INJECTION SITE ERYTHEMA (noticed red mark at injection sight around 1pm today) (seriousness criterion medically significant) and RASH PRURITIC (rash appeared side of both legs) (seriousness criterion medically significant). At the time of the report, PRURITUS (itching), INJECTION SITE ERYTHEMA (noticed red mark at injection sight around 1pm today), RASH PRURITIC (rash appeared side of both legs) and RASH (Rash) was resolving and LYMPHADENOPATHY (Swollen glands) and PERIPHERAL SWELLING (Swollen arm) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications was reported Treatment information was not provided Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397843 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal pain upper, Chest pain, Chills, Dry mouth, Eye pain, Fatigue, Headache, Hyperhidrosis, Hypoaesthesia, Influenza, Injection site pain, Muscle spasms, Myalgia, Nausea, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fatigue; Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: stomach ache; sweaty; flu symptoms; numbness; muscle pain; chills; Eye pain; Chest ache; Muscle cramps; Shivers; Fatigue extreme; Upset stomach; Dry mouth; Headache; Nausea; Injection site pain; Numbness of fingers; Tingling feet/hands; This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness), EYE PAIN (Eye pain) and CHEST PAIN (Chest ache) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Fatigue, Lactation decreased and Suspected COVID-19 from 13-Mar-2020 to 31-Mar-2020. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced PARAESTHESIA (Tingling feet/hands), HYPOAESTHESIA (Numbness of fingers) and INJECTION SITE PAIN (Injection site pain). On 02-Jun-2021, the patient experienced MUSCLE SPASMS (Muscle cramps), ABDOMINAL DISCOMFORT (Upset stomach), DRY MOUTH (Dry mouth), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue extreme) and CHILLS (Shivers). On 03-Jun-2021, the patient experienced EYE PAIN (Eye pain) (seriousness criterion medically significant) and CHEST PAIN (Chest ache) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOAESTHESIA (numbness) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (stomach ache), HYPERHIDROSIS (sweaty), INFLUENZA (flu symptoms), MYALGIA (muscle pain) and CHILLS (chills). On 03-Jun-2021, NAUSEA (Nausea) and CHILLS (Shivers) had resolved. On 04-Jun-2021, DRY MOUTH (Dry mouth) had resolved. At the time of the report, HYPOAESTHESIA (numbness), EYE PAIN (Eye pain), ABDOMINAL PAIN UPPER (stomach ache), HYPERHIDROSIS (sweaty), INFLUENZA (flu symptoms), FATIGUE (Fatigue extreme), MYALGIA (muscle pain) and CHILLS (chills) was resolving, CHEST PAIN (Chest ache), PARAESTHESIA (Tingling feet/hands), HYPOAESTHESIA (Numbness of fingers), ABDOMINAL DISCOMFORT (Upset stomach), HEADACHE (Headache) and INJECTION SITE PAIN (Injection site pain) had not resolved and MUSCLE SPASMS (Muscle cramps) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Patient used drops to hydrate for Pain behind eyes and dry eyes and took pain relief every 4 hours for several times are the treatment medication reported by reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1397853 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4109 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antiphospholipid syndrome, Lymphoma, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (broad), Malignant lymphomas (narrow), Haematological malignant tumours (narrow), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antiphospholipid syndrome; Miscarriage (more then 3 miscarriages, later found out I had Antiphopholipid Syndrome); Restless legs syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021663609

Write-up: Lymphoma; swelling just under left armpit; antiphospholipid syndrome; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106061148516960-5SPXY, Safety Report Unique Identifier GB-MHRA-ADR 25427114. A 56-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW4109) via an unspecified route of administration, on 04Jun2021 as a single dose for COVID-19 immunisation. Medical history included antiphospholipid syndrome, restless legs syndrome and miscarriage (more then 3 miscarriages, later found out had Antiphopholipid Syndrome). Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. Concomitant medications included acetylsalicylic acid (ASPIRIN.) taken for antiphospholipid syndrome from 01Jun2010. The patient experienced swelling just under left armpit and antiphospholipid syndrome on an unspecified date in Jun2021. The patient experienced lymphoma on 05Jun2021. The patient underwent lab tests and procedures which included COVID-19 virus test and resulted as negative for COVID-19 on 13May2021. Therapeutic measures were taken as a result of swelling with paracetamol. The outcome of swelling, antiphospholipid syndrome was recovering and for event lymphoma was not recovered. Additionally reported that Firstly to clarify my first vaccine was Astra Zeneca, and my second was Pfizer, I have Antiphospholipid Syndrome and was told i couldn''t have Astra Zeneca as a second dose. In the night of 5.6.21 approximately 24 hrs after having the vaccine i woke in the night and could feel pressure and a burning feeling In my left armpit, the same arm i had the vaccine in. The following day i could see a visible swelling just under my left armpit, also its quite tender. I have taken paracetamol which has helped a little. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1397864 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-06-01
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhage, Menstrual disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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

Write-up: bleeding; Menstruation abnormal; This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concomitant products included ESTRADIOL (SANDRENA) for HRT, LEVONORGESTREL (MIRENA) for Hormone replacement therapy, ESTRADIOL for an unknown indication. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced MENSTRUAL DISORDER (Menstruation abnormal) (seriousness criterion medically significant). On an unknown date, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (bleeding) was resolving and MENSTRUAL DISORDER (Menstruation abnormal) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was reported.; 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: 1397887 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-06-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Neck pain; This regulatory authority case was reported by an other health care professional and describes the occurrence of NECK PAIN (Neck pain) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion disability). At the time of the report, NECK PAIN (Neck pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was unknown. Patient has not had symptoms associated with COVID-19, was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. Not had a COVID-19 test. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1397954 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Asthenia, Blood test, Body temperature, Bone pain, Dizziness, Fatigue, Feeding disorder, Inflammation, Laboratory test, Movement disorder, Muscle spasms, Musculoskeletal stiffness, Pneumonia, Pyrexia, Screaming, Seizure, Vomiting, White blood cell count, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Osteonecrosis (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:normal; Comments: before the 2nd dose; Test Date: 202106; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210606; Test Name: lab test; Result Unstructured Data: Test Result:Showed inflammation and pneumonia of left lung; Comments: WBC were high and showed inflammation and pneumonia of left lung; Test Date: 20210606; Test Name: WBC; Result Unstructured Data: Test Result:High
CDC Split Type: GRPFIZER INC2021663415

Write-up: Could not move neither she was talking; Pneumonia at her left lung; Inflammation NOS; WBC high; Bone pain; Dizziness; Tendency to vomit; Whole body was stiff; Fever 38C; Fatigue/tired; Could not eat; She had convulsions; She was only screaming as she couldn''t speak/ was only yelling because she could not talk; She was only screaming as she couldn''t speak/ was only yelling because she could not talk; Spasms; Had no strength; This is a spontaneous report from a contactable consumer (patient''s daughter) via medical information team. A 61-years-old female patient received second dose of BNT162b2 (COMIRNATY, Formulation: solution for injection; Batch/Lot number was not reported) intramuscularly on 04Jun2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as comorbidities NOS under treatment NOS. The patient''s concomitant medications were not reported. The patient previously took first dose of COMIRNATY on an unspecified date for COVID-19 immunisation and experienced fatigue. On 04Jun2021, after vaccination, the patient experienced spasms, bone pain, dizziness, tendency to vomit. She also experienced fever 38 degree centigrade, was only yelling because she could not talk, had no strength and she could not eat. On Sunday, 06Jun2021, at 09:00 am the patient could not move neither she was talking. She was admitted in the hospital on 06Jun2021 in the morning with symptoms of 38 degree centigrade fever, fatigue, bone pain, tendency for vomiting, she couldn''t eat, she couldn''t talk, her whole body was stiff, she had convulsions and she was only screaming as she couldn''t speak. Her tests at the hospital found high white blood cells, inflammation and showed pneumonia at her left lung. At the time of report she was much better, she was speaking normally and she was only tired. She further reported that she had not experienced fever for the previous 20 years. The patient underwent lab tests and procedures which included blood test: normal on before the 2nd dose, body temperature: 38 centigrade on unspecified date in Jun2021, On 06Jun2021, laboratory test: showed her WBC were high and showed inflammation and pneumonia of left lung. The events pneumonia at her left lung and had convulsions were considered as serious (Hospitalization and medically significant) whereas the events inflammation NOS, could not move neither she was talking, she was only screaming as she couldn''t speak, WBC high, bone pain, dizziness, tendency to vomit, whole body was stiff, fever 38 degree centigrade, fatigue/tired, could not eat were considered as serious (Hospitalization). The outcome of events she was only screaming as she couldn''t speak/ was only yelling because she could not talk was recovered; event fatigue/tired was not recovered and unknown for other events. Information about batch number was not available and is going to be requested upon follow-up.


VAERS ID: 1398218 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD975 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LUJNJFOC20210615139

Write-up: EXTREME WEAKNESS; TIREDNESS; This spontaneous report received from a consumer (patient''s parent) concerned an 18-year-old female patient of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: XD975, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 24-MAY-2021 for vaccination. No concomitant medications were reported. On an unspecified date, in JUN-2021 (two weeks after vaccination/few days before this report), the patient felt extremely weak and tired following which she was brought to the hospital on 04-JUN-2021. The patient felt better but was still a little bit weak. Hence, she was brought back home on 07-JUN-2021. The patient was in hospital for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extreme weakness, and tiredness. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0. 20210615139-covid-19 vaccine ad26.cov2.s -extreme weakness, and tiredness. This event(s) is labeled per RSI and is therefore considered potentially related.


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