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From the 9/3/2021 release of VAERS data:

Found 661,087 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 175 out of 6,611

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VAERS ID: 1646180 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Hypersensitivity, Hypertension, Pruritus, Pyrexia, Rash, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma (Diagnosed at birth)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Temperature of 99; Result Unstructured Data: Test Result: 99.
CDC Split Type: USPFIZER INC202100986859

Write-up: This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Lot Number: EW0198), via an unspecified route of administration on 30Jul2021 (at the age of 21-years-old) at around 5-6:00pm administered in Arm Left on 30Jul2021 as a single dose for COVID-19 immunisation at pharmacy. Medical history included ongoing asthma. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient adverse event was reported as none. The patient''s family medical history reported as none. On 30Jul2021, the patient experienced Severe allergy reactions, Began itching all over her body, Red rashes, Welts, Had high blood pressure, Temperature of 99, Shortness of breath. She is calling about the Pfizer Covid19 vaccine and states she wanted to report her side effects of the severe allergic reaction she had after she got the vaccine 1st dose on Friday 30Jul2021 and had the severe reaction later on the same day. Caller states she has the 1st dose of the Pfizer COVID19 vaccine on 30Jul2021 and began itching all over her body with red rashes and welts and everything and had high blood pressure, a temperature of 99, and shortness of breath. Caller states she also has asthma which later in the call states was diagnosed at birth. States her symptoms began around 8:00pm and from the Clinic she was rushed to the emergency room. States her paperwork says she got the first shot of Benadryl at 9:16pm that day and they immediately gave her the Benadryl shot in the clinic and the Benadryl shot did not work for her so they then rushed her to the emergency room;. States she has no lot, expiry date or NDC number to provide for the Benadryl shot from her paperwork but it says the Benadryl was given intramuscularly 25mg. States she got the Pfizer COVID19 vaccine around 5-6:00pm on 30Jul2021. Caller states for her reported symptoms as of right now they are minimal and she has the itching and was put on a few medications to help with breathing and itching and everything else and everything is minimal regarding the reported events at this time and they are not severe. States she was prescribed an Epipen to take with her everywhere and was told she could relapse and have an allergic reaction because of this but she has not used the Epipen yet and is at the pharmacy to get it but has not picked it up yet. She was given Prednisone 20mg and is taking three tablets of that per day and is not sure of the Epipen dosage and also takes Banophen 25mg and is taking one per day as needed by mouth. States she is taking Famotidine 20mg and takes two of those every day by mouth one in the morning and one at night. States for the Epipen, Famotidine, Banophen, and Prednisone she has no lots, expiry dates or NDC numbers to provide as she only has her paperwork with her at this time. Caller states the reported symptoms are ongoing and improved a minimal amount and she is still itching. Caller states written on her patient card is the lot number for her 1st dose administered on 30Jul2021 in her upper left arm and she is unsure if it is the number 0 in it, but states it is EW0198 and states the expiry date and NDC are not written on the card. She does have severe allergy reactions and told the facility this and they said it was ok to get the Pfizer COVID19 vaccine and and they told her they had not seen anything like that reported and only had people fainting and that was it. No further details provided by the caller. States after the first shot of Benadryl given at the clinic which did not work, she was rushed to the emergency room and they had to give her an IV and gave her some more Benadryl by IV and Famotidine by IV and Pepcid by IV and they gave her a third one by IV which was Methylprednisolone. States she has no lots, dosages, NDC numbers or expiry dates to provide for the Benadryl, Famotidine, Pepcid, or Methylprednisolone. Caller states written on her patient card is the lot number for her 1st dose administered on 30Jul2021 in her upper left arm and she is unsure if it is the number 0 in it, but states it is EW0198 and states the expiry date and NDC are not written on the card. Vaccine Supplemental Form completed in additional context. Caller states she is calling about the Pfizer Covid19 vaccine and states she wanted to report her side effects. States her paperwork says she got the first shot of Benadryl at 9:16pm that day and they immediately gave her the Benadryl shot in the clinic and the Benadryl shot did not work for her so they then rushed her to the emergency room. States she has no lot, expiry date or NDC number to provide for the Benadryl shot from her paperwork but it says the Benadryl was given intramuscularly 25mg. Caller states she was given Prednisone 20mg and is taking three tablets of that per day and is not sure of the Epipen dosage and also takes Banophen 25mg and is taking one per day as needed by mouth; states she is taking Famotidine 20mg and takes two of those every day by mouth one in the morning and one at night. States for the Epipen, Famotidine, Banophen, and Prednisone she has no lots, expiry dates or NDC numbers to provide as she only has her paperwork with her at this time. Caller states the reported symptoms are ongoing and improved a minimal amount and she is still itching. Caller states written on her patient card is the lot number for her 1st dose administered on 30Jul2021 in her upper left arm and she is unsure if it is the number 0, but states it is EW0198 and states the expiry date and NDC are not written on the card. States after the first shot of Benadryl given at the clinic which did not work, she was rushed to the emergency room, and they had to give her an IV and gave her some more Benadryl by IV, Famotidine by IV, and Pepcid by IV and they gave her a third one by IV which was Methylprednisolone. States she has no lots, dosages, NDC numbers or expiry dates to provide for the Benadryl, Famotidine, Pepcid or Methylprednisolone. The adverse events resulted in Physician Office and Emergency Room visit. The outcome of the events was recovering.


VAERS ID: 1646229 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Eye infection, Eye pain, Eye swelling, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (broad), Ocular 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rheumatoid arthritis (diagnosed at age 14 months)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202100992535

Write-up: eyes; infection; rash around her eyes with severe pain/rash on the bottom of her eye up to the top and side of her eyes/on her face and skin and not on the inside of her eyes but on the outer area; rash around her eyes with severe pain; put an ice pack on her eyes and they started to swell; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the left arm on 27Jul2021 (about 4:40 to 4:45 pm) (batch/lot number and expiry date unknown) at 27 years of age as dose 1, single for covid-19 immunization administered in a pharmacy and not in a military facility. Medical history included ongoing rheumatoid arthritis diagnosed at age 14 months. There were no concomitant medications. The patient previously took Enbrel 50 mg once per week by injection that began taking many years ago. The patient did not receive prior vaccinations within 4 weeks. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient informed that she received the first dose of the Pfizer Biontech COVID19 vaccine on 27Jul2021 and on the following Friday morning (30Jul2021), she woke up with a rash around her eyes with severe pain. The patient informed that she put an ice pack on her eyes and they started to swell and she still has the rash on the bottom of her eye up to the top and side of her eyes and the pain went away because she had the ice pack on it. The patient informed that she already went to the doctor and gave her an antibiotic but was not working and that it was no help. It was still on her face and skin and not on the inside of her eyes but on the outer area. The patient informed that she went to the an HCP to make sure she was not getting pink eye because she has a newborn and was told it was not pink eye and it was not getting better. The patient informed that her HCP did not know what this was, and she got the Pfizer Covid vaccine and then started having this problem. The patient informed that she went to the (redacted) clinic and the HCP did not know what was wrong and gave her a medication doxycycline that did not work for the infection and it was 100 mg and she was taking one capsule by mouth every 12 hours and just started taking it yesterday and took the next dose this morning at 9:00 am but will not continue the doxycycline because it made her sick and she left work early and was vomiting and felt dizzy and lightheaded overnight and her eye was darker than when she put the ice pack on, and the redness and inflammation had gone away since then and she went to sleep. The patient informed that she had not done anything and had not itched her eyes and her eye was back to being severe red and purple like a black eye and the rash was getting worse. The patient informed that prior to receiving the vaccine, she never had issues with her eyes like no itching, no discoloration of the eyes, no swelling and no rashes around her eyes. The patient informed that she had not had something like this before and had not had prior issues with her eyes prior to the Pfizer COVID Vaccine and was feeling fine and went to sleep and woke up with her eyes like this and it was now Tuesday and her eye was still in the same position and nothing was working. The patient informed that she did go back to (pharmacy name) where she had the Pfizer Covid vaccine and the pharmacist told her to give Pfizer a call; states her reported symptoms started on the morning of 30Jul2021 and the symptoms were still that way and are the same as when they began. The patient informed that the events did not require emergency room visit, and physician office was yes. The outcome of the events was not recovered. The patient wanted to know if there is information about her side effect and its association with the vaccine. The patient was calling to ask for any information related to her symptoms and the Pfizer COVID vaccine. The lot number for bnt162b2, was not provided and will be requested during follow up.


VAERS ID: 1646265 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-05-04
Onset:2021-07-30
   Days after vaccination:87
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3247 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210730; Test Name: Covid-19; Test Result: Positive.
CDC Split Type: USPFIZER INC202100993088

Write-up: Positive for Covid-19; Positive for Covid-19; This is a spontaneous report from a contactable other healthcare professional (nurse). A 33-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247; Expiration Date: 31May2021), via intramuscular route, administered in Left arm on 04May2021 at 06:30 as dose 2, single (at the age of 32 years) and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3247; Expiration Date: 31May2021) via intramuscular, administered in Left arm on an unspecified date in Apr2021 at 06:30 as dose 1, single (at the age of 32 years), for covid-19 immunization, at clinic. Relevant medical history, concurrent conditions and relevant past drug history was unknown. It was unknown if the patient had received any other medications within 2 weeks of vaccination (concomitant medications unknown). It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was stated that, on 30Jul2021, the patient was positive for Covid-19. The event was reported as non-serious. The event resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. There was no hospitalization. No treatment was received. The outcome of the event covid-19 was recovering at the time of report. Product complaint investigation conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3247, fill lot EL3230, and the formulated drug product lot EL3223. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1646339 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Headache, Hypoaesthesia, Migraine, Movement disorder, Night sweats, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: Covid-19 test Nasal Swab; Test Result: Negative.
CDC Split Type: USPFIZER INC202100995270

Write-up: fainted as I was walking to my daughters room; I cannot move around quickly without getting dizzy.; I cannot move around quickly without getting dizzy.; woke up in the middle of the night in a terrible sweat; headache; Felt a massive migraine; I later felt numbness in both of my calves down to my toes; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 29Jul2021 (Batch/Lot number was not reported) (at the age of 31 years old) as single dose for Covid-19 immunisation. No other medical history reported. Patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Concomitant medications were reported as none. The patient received the first dose on 29Jul2021. She felt a massive migraine on 30Jul2021. She later felt numbness in both of her calves down to her toes. On 31Jul2021, she still had a migraine and then she woke up in the middle of the night in a terrible sweat worst she''d ever experienced. The patient then woke up on 01Aug2021 and fainted as she was walking to her daughter''s room. On 01Aug2021, she cannot move around quickly without getting dizzy. She still has calf numbness and a headache which started on 30Jul2021. The patient did not receive any treatment for the adverse events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent Covid-19 test nasal swab: negative on 02Aug2021. Outcome of the events was recovering at the time of the report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1646405 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-02-10
Onset:2021-07-30
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3248 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOXYL; PROGESTERONE; ESTROGEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Fever; Result Unstructured Data: Test Result: 100.3; Test Date: 20210803; Test Name: Covid test (PCR); Test Result: Positive; Comments: Nasal Swab.
CDC Split Type: USPFIZER INC202100999219

Write-up: This is a spontaneous report from a contactable consumer, the patient. A 56-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 10Feb2021 (age at vaccination 55-years, non-pregnant at the time of vaccination) (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021) as dose 2, single and dose 1 via an unspecified route of administration, administered in arm left on 20Jan2021 (age at vaccination 55-years, non-pregnant at the time of vaccination) (Batch/Lot Number: EL3248; Expiration Date: 30Apr2021) as dose 1, single for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was at a workplace clinic. The patient medical history was not reported. Concomitant medications included LEVOXYL via oral route, progesterone via oral route and ESTROGEN patch via transdermal route. All taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient stated Although I had both doses of vaccine I still contracted COVID through a primary contact. Symptoms included (fever 100.3, chills, loss of taste, fatigue) and started on 30Jul2021. Covid test (PCR) confirmed positive on 03Aug2021. The events did not result in emergency room/ physician office visit. The patient underwent lab tests and procedures which included fever (body temperature): 100.3 on 30Jul2021 and Sars-Cov-2 test (Nasal Swab/ PCR): positive on 03Aug2021. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unknown date in Aug2021. Investigation report received from product quality complaints group. This report included that: Product-Description (CR): COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULA R 2ML MULTIPLE DOSE VIAL X 1, Lot: EL3248, Conclusion of Previously Completed: Investigation Conclusion. ID of Previously Completed. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EL3248 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3248, fill lot EL3231, and the formulated drug product lot EL3224. A complaint sample was not returned, and photographs were not received. No related quality issues were identified. Consumer calling about the Pfizer COVID19 vaccine, and says that she got the injection twice, and each time she has gotten it and gotten tested after, each test is showing positive. She says the thing is, does Pfizer have information about this, because seems to be herd immunity. Caller does not clarify this last statement. She asks if anyone else has been reporting this. She clarifies that she goes to a nursing home and is tested every 14 days and all times prior to getting the vaccine doses she was negative. She says her first dose of the vaccine was on 26Dec2021, then four days after that it was time to go get tested to go see her mom and the test was positive within no time it lights up. She says as a medical worker she can wait 5 days after that for it to come up after being positive and after that if it is showing up negative she had to wait 24 hours to confirm negative test and pay again for the test within 24 hours, which was negative too. She says then the time next she got the shot on 16Jan2021 she went to go do the shot on this past Saturday, and then she went to go get tested and again it came back positive. Caller says that the information on the card is handwritten, NDC/EXP were not written on the card. She says the card says Pfizer COVID-19, and the first dose was on 26Dec2021 of LOT: EL5738 given in her right arm. She says that the second dose was 16Jan2021 of LOT EL3248 and it was given in her left arm. Caller says that the test she was given was the rapid test, a PCR test for COVID. Caller says that other than having positive tests for COVID she has had no symptoms. Product strength and count size dispensed: two doses. Additional lot numbers: EL3248. Is a sample of the product available to be returned, if requested, not provided. Packaging sealed and intact, not provided. Brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE EL3248 Lack Of Effect, Complaint Class: Product Use Attributes, Complaint Sub-Class: Lack Of Effect, (Parent) Brand/Trade-Name: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE, BNT162B2, Product-Description: COMPOUND BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1, Product-Type: RX, Product-Category: INJECTABLE, Sterile-Product: Yes. Medical-Device No. Lot#: EL3248. Batch-Expiry Year: 2021, Batch-Expiry Month: 04, Batch-Expiry Day: 30. Reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid and an investigation will be performed. The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot EL3248 of the PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot EL3248 pending review of lot genealogy. The investigation will include a review of the returned complaint sample and reserve samples, if necessary. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3248 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3248, fill lot EL3231, and the formulated drug product lot EL3224. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Follow-up attempts are completed. No further information is expected. Follow-Up (13Aug2021): Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646480 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: tested positive for COVID-19 via PCR testing; Test Result: Positive.
CDC Split Type: USPFIZER INC202101001915

Write-up: This is a spontaneous report from a contactable other hcp (nurse). A 4-decade-old (at late 30s) male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 intramuscular on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 2021 (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''s wife reported she tested positive for COVID-19 after receiving both doses of the Moderna COVID-19 vaccine. She reports she was indirectly exposed to a patient who had not been vaccinated on Friday and swabbed the same day. The PCR test results came back positive for COVID-19 yesterday, 01Aug2021. Patient who was also fully vaccinated with the Pfizer vaccine, was directly exposed to an unvaccinated patient and also tested positive for COVID-19 via PCR testing (medically significant). The reporting HCP states she tested positive after exposure, but was completely asymptomatic, while the patient experienced a dry cough and a little headache for one day, the patient underwent lab tests and procedures which included sars-cov-2 test positive on 30Jul2021. Declined to provide any identifiers other than initials, age, and gender. No additional information obtained. Safety team follow-up consent provided for reporter. The clinical outcome of event headache and dry cough was recovered on 31Jul2021 and for all other events outcome was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected. Sender''s Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded.


VAERS ID: 1646491 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure measurement, Feeling abnormal, Hypertension, Pain in extremity, Peripheral swelling, Vaccination site swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), 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: LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: Blood pressure; Result Unstructured Data: Test Result:188/122
CDC Split Type: USPFIZER INC202101003310

Write-up: blood pressure was high; at 188/122; one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny; one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny; She took the shot Friday (30Jul2021) and they had taken it in the left shoulder. It was swollen that Friday and Saturday, Sunday, Monday and Tuesday and until today and she was at work.; her left hand, the fingers were swollen; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left (left shoulder) on 30Jul2021 (about 12:15 or 12:30) (Lot Number: FA7485) as DOSE 2, SINGLE for covid-19 immunization. Medical history and family history included high blood pressure. Concomitant medication included losartan taken for high blood pressure from May2021 and from Jun2021. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jul2021 (lot number EW0198) for covid-19 immunization. The patient was calling regarding the Pfizer Covid vaccine. She took the shot Friday (30Jul2021) and they had taken it in the left shoulder. It was swollen that Friday and Saturday, Sunday, Monday and Tuesday and until today and she was at work. In her left hand, the fingers were swollen. She could not lay on her left arm. It was the fingers on the left side and it was on Monday and Tuesday. Today (04Aug2021), one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny. It kind of throbs but was kind of the same. The patient did not receive treatment for these events, she just took her blood pressure medicine. The events did not require visit to emergency room but she was going to go today (04Aug2021), this morning when she got up to take her blood pressure pill, her blood pressure was high. It was basically 188/122. Her hand was still swollen. The patient was advised to contact her primary care provider for any medical advice. Outcome of the event "blood pressure was high; at 188/122" was unknown, while not recovered for other events. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1646582 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8737 / 1 - / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Flushing, Hypersensitivity, Malaise, Off label use, Product use issue, Pruritus, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Medication errors (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101008328

Write-up: did not feel good; Welts from head to toe/was itchy like a rash/red with welts all over; Diarrhea; allergic reaction; itchy like rash/itching all over; fever; flushed; got another vaccine on the same date as the COVID-19 injection, MENACTRA; got another vaccine on the same date as the COVID-19 injection, MENACTRA; This is a spontaneous report from a contactable nurse (patient''s mother). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, administered in the arm (reported as deltoid/arm), in the afternoon of 30Jul2021 (Batch/lot number: ER8737), at age 17 years old, as dose 1, single, for COVID-19 immunisation; and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), via an unspecified route of administration, administered in the arm (reported as deltoid/arm), on 30Jul2021 (reported as same date as BNT162B2) (Batch/lot number unknown), as second dose, for meningitis immunisation. Relevant medical history was reported as none. There were no concomitant medications. Historical vaccine included meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) received on an unspecified date, as the first dose, for meningitis immunsiation and the patient did not have any problems after this. The patient had no prior vaccinations within 4 weeks. On 30Jul2021, the patient received BNT162B2. The patient got another vaccine on the same date as the COVID-19 injection, MENACTRA. On 04Aug2021, the started complaining of welts. It was from head to toe. It was itchy like a rash. At first, the reporter thought it was bug bites. He had it all over, it was even behind his ears. It was flushed. Maybe it was from the scratching he''d been doing. He was red with welts all over. The reporter thought the patient had fever, but the patient did not think he had fever and was saying he did not have fever. The patient would not allow the reporter to take his temperature. The patient also had diarrhea. On 05Aug2021, the patient did not feel good and added he was having diarrhea and itching all over. The diarrhea was pretty bad and was worse than the day before. It was reported that welts and diarrhea worsened. The patient''s breathing was fine. The reporter sounded like she stated that "maybe they gave too much" (as reported). The reporter stated that with allergic reaction, she did not think much can be done unless it affects breathing. She then stated, "is there anything that can be done?" The reporter gave the patient some BENADRYL 50 mg. The reporter wanted to know if the patient should get the second shot and if it will be safe. The events did not result to emergency room and physician office visits. The outcome of urticarial rash and diarrhea was not recovered. The outcome of the remaining events was unknown. The reporter assessed the events urticarial rash and diarrhea as serious (medically significant).; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events of "Urticarial rash" "Diarrhoea" due to temporal relationship and current known drug safety profile. 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: 1646639 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-15
Onset:2021-07-30
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 2 LA / OT

Administered by: Pharmacy       Purchased by: ?
Symptoms: Amnesia, Balance disorder, Dizziness, Feeling abnormal, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101013081

Write-up: Memory loss; Dizziness; Balance off; In a fog; Visual disturbance; This is a spontaneous report from a contactable physician. A 15-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an intramuscular route of administration in the left arm on 15Jul2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known drug allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an intramuscular route of administration in the left arm on 24Jun2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. On 30Jul2021, the patient experienced memory loss, dizziness, balance off, visual disturbance and the patient was in a fog. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events memory loss, dizziness, balance off, visual disturbance, and in a fog were not resolved at the time of this report.


VAERS ID: 1646690 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Dyspnoea, Lung disorder, Swelling face
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: TOPIRAMATE; METOPROLOL; LISINOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CML (in remission); COPD; Heart disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: BP; Result Unstructured Data: Test Result:198/120; Comments: 196/110 plus still at 110 after 2 hours rushed to hospital
CDC Split Type: USPFIZER INC202101013992

Write-up: my face began to swell; my BP went to 198/120 plus 110/196/110 plus still at 110; I was unable to breath and chocking on my own fluids in my lungs; My lungs were chocking me; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in left arm on 30Jul2021 at 14:15 (Batch/Lot Number: FA7485) as a single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD), chronic myeloid leukaemia (CML) in remission and heart condition. Concomitant medications included topiramate, metoprolol and lisinopril; all taken for an unspecified indication from an unknown date. 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 had not been tested for COVID-19. About thirty minutes after the injection at 16:00, the patient face began to swell, and her BP went to 198/120 plus 110. Then 2 hours later she was rushed to hospital and was unable to breath and chocking on her own fluids in her lungs. She arrived at hospital unable to breathe nor catch her breath. Her lungs were chocking her, and her BP was 196/110 plus still at 110. After entering emergency room (ER) they had no clue what to do and treated her as a covid patient. She needed a nebulizer and was told the ER doctor couldn''t give it to her there and no beds were available. The doctor gave her pills without explaining and then kept treating her like she came in for covid. She had the worst reaction of her life and was treated horribly. The doctor did not give her discharge paperwork, nor did hospital follow up. It was not until she went yesterday to her GP and he even said the notes were missing information, also the doctor supposedly sent me with prescriptions which she never got. She encountered, all side effects of the shot. The adverse events resulted in emergency room/department or urgent care. The outcome of the events was recovered with sequel. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on plausible dose-event temporal relationship likely hypersensitivity post-vaccination the causal role of bnt162b2 vaccine cannot be excluded for reported events. Underlying CMLL and chronic onstructive pulmonary disease are significant risk factors. 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: 1646826 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-07-26
Onset:2021-07-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Autoimmune encephalopathy, Inappropriate schedule of product administration, SARS-CoV-2 test, Status epilepticus
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Noninfectious encephalopathy/delirium (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

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: 20210807; Test Name: COVID-19 Test/Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC202101023460

Write-up: auto-immune encephalopathy; acute respiratory failure; refractory status epilepticus; dose 2: 26Jul2021, dose 1: 05Jun2021; This is a spontaneous report from a contactable nurse. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 26Jul2021 11:15 (lot number: EW0217) at the age of 40 years as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 intramuscular on 05Jun2021 (lot number: EW0191) at the age of 39 years as single dose for covid-19 immunisation. Adverse event concerned for auto-immune encephalopathy, acute respiratory failure, refractory status epilepticus. Adverse event start date was 30Jul2021. AE resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Treatment was received. AE treatment plex for autoimmune encephalitis. Covid tested post vaccination, test type post vaccination=Nasal Swab on 07Aug2021, negative. Outcome of events were not recovered.; Sender''s Comments: Based on the available information in the case, the causal association between the events autoimmune encephalitis, acute respiratory failure, status epilepticus and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the 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: 1646866 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Florida  
Vaccinated:2021-07-22
Onset:2021-07-30
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Covid test; Test Result: Positive
CDC Split Type: USPFIZER INC202101027582

Write-up: tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable female consumer (patient) reported for herself that. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. It was reported that patient received the first dose of vaccine last 22Jul2021 and tested positive for Covid last 30Jul2021. Patient asked when her schedule was to receive the second dose. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1646901 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-02-17
Onset:2021-07-30
   Days after vaccination:163
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Nasal Swab; Test Result: Positive.
CDC Split Type: USPFIZER INC202101028962

Write-up: This is a spontaneous report from a contactable other Healthcare Professional. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular route of administration on 17Feb2021 (at the age of 53-year-old), as dose 2, single in left arm, and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular route of administration on 27Jan2021 (at the age of 53-year-old), as dose 1, single in left arm for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported as unknown if the patient had received any other vaccines within 4 weeks prior to the COVID vaccine. It was reported as unknown if the patient had COVID prior vaccination and the patient was tested COVID post vaccination. On 30Jul2021, 5 months and 13 days after second dose of vaccine, the patient was tested positive for COVID and became ill. The patient visited to Doctor or other healthcare professional office/clinic in response to event. It was reported as unknown if the patient received any treatment for event. The patient underwent lab tests and procedures which included SARS-CoV-2 test nasal swab, positive, on 30Jul2021. The clinical outcome of the events was reported as resolving. Based on the available information ,a possible contributory role of suspect product BNT162B2 to the development of the event covid 19 cannot be excluded.


VAERS ID: 1647077 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ear swelling, Pharyngeal swelling, Pruritus, Rash
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE [LEVOTHYROXINE SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic fatigue syndrome (chronic fatigue immune syndrome CFIDS diagnosed in 1992); Latex allergy; Penicillin allergy (Erythromycin (Erythromycin is used for people that are allergic to penicillin))
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101041040

Write-up: itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; itched all over, throat and ears swelled up, rash around ribs; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm in a pharmacy or drug store facility on 30Jul2021 09:00 (Batch/Lot Number: FA7484) (at the age of 61-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination and has not been tested for covid-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Medical history included chronic fatigue syndrome from 1992 (chronic fatigue immune syndrome CFIDS diagnosed in 1992), latex dermabond allergy, and known allergy to penicillin. Concomitant medication included levothyroxine sodium (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]). The patient previously took erythromycin (Erythromycin is used for people that are allergic to penicillin). On 30Jul2021 09:15 AM, within minutes of 1st vaccine, the patient experienced itched all over, throat and ears swelled up, rash around ribs. The patient took Cetirizine 10 mg (for reactions) it calmed it down. Took another 3 hours later and then another six hours later. Next day itching stopped. Therapeutic measures were taken as a result of the events. On 31Jul2021, the patient recovered from itched all over while outcome of the other events was recovered on unspecified date in Jul2021. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1647099 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-06
Onset:2021-07-30
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Diarrhoea, Drug ineffective, Fatigue, Feeling abnormal, Nasal congestion, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Taste and smell disorders (narrow), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Binax covid test; Result Unstructured Data: Test Result:Positive
CDC Split Type: USPFIZER INC202101041417

Write-up: 1Aug2021 tested postive covid; 1Aug2021 tested postive covid; mild congestion; mild fatigue; moderate brain fog; intermittent loose stools/ diarrhea; severe loss of taste and smell; severe loss of taste and smell; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for himself that a 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0176), dose 1 via an unspecified route of administration on 06May2021 10:15 as dose 1, single for covid-19 immunisation. Medical history included none. There were no concomitant medications. Patient known allergies was none. On 30Jul2021, the patient experienced mild congestion; mild fatigue; moderate brain fog; intermittent loose stools/ diarrhea and severe loss of taste and smell, on1 Aug2021 tested positive covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Aug2021. Patient did not receive treatment for the events. Facility type vaccine was pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received other medications in two weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. COVID test type post vaccination nasal swab. The clinical outcome of all event was recovering. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1647100 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Blood pressure increased, COVID-19, Drug ineffective, Heart rate increased, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy (Known allergies: penicillin)
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: moderate-elevated bp; Result Unstructured Data: Test Result: moderate-elevated; Comments: moderate-elevated; Test Date: 20210730; Test Name: high resting heart rate; Result Unstructured Data: Test Result: high resting; Comments: high resting; Test Date: 20210801; Test Name: COVID; Test Result: Positive; Comments: Nasal Swab, post vaccination.
CDC Split Type: USPFIZER INC202101041456

Write-up: This is a spontaneous report from a contactable consumer (reported himself). A 49-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8735), via an unspecified route of administration on an unknown date 2021 as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8735), via an unspecified route of administration on 25Apr2021 as dose 1, single for covid-19 immunisation. Medical history included Known allergies, penicillin from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 30Jul2021, the patient experienced symptoms included mild/moderate fever, chills, body aches, fatigue, head cold-cough, moderate-elevated bp (blood pressure), high resting heart rate, anxiety, and mild loss of smell and taste. The patient was tested positive covid on 01Aug2021. The events resulted in emergency room/department or urgent care visit. On 30Jul2021, the patient lab test includes moderate-elevated blood pressure, high resting heart rate. On 01Aug2021, the patient lab test included post vaccination the patient was test for covid-19 with COVID test was positive (nasal swab). The patient did not receive any treatment for the events. The outcome of the events COVID-19, moderate-elevated bp, high resting heart rate, and anxiety was resolving. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1647228 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Cerebrovascular accident, Contusion, Deep vein thrombosis, Fibrin D dimer, Heart rate, Hypertension, Hypothyroidism, Ill-defined disorder, Imaging procedure, Paraesthesia oral, Pharyngeal swelling, Rash pruritic, SARS-CoV-2 test, Swollen tongue, Tachycardia, Thrombosis, Transient ischaemic attack
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (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), Anaphylactic/anaphylactoid shock 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), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Hypertension (narrow), Hypothyroidism (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; OMEPRAZOLE; SERTRALINE; CELEBREX; LYRICA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma; Autoimmune disorder (being monitored for autoimmune disease but not diagnosed); COVID-19; Ehlers-Danlos syndrome; Gulf war syndrome; Penicillin allergy (known allergies: Penicillins, doxycycline, clindamycin, cymbalta, higher doses of sertraline,)
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: hypertension; Result Unstructured Data: Test Result:156/100; Test Date: 20210812; Test Name: d-dimer; Result Unstructured Data: Test Result:High; Test Date: 20210812; Test Name: tachycardia; Result Unstructured Data: Test Result:156; Test Date: 20210812; Test Name: multiple imaging; Result Unstructured Data: Test Result:other clots; Test Date: 20210812; Test Name: Oral swab; Test Result: Negative ; Comments: Other Oral swab
CDC Split Type: USPFIZER INC202101048664

Write-up: hospitalized on day 13 with TIA stroke symptoms and high d dimer; sudden hypothyroid; hypertension 156/100; tachycardia 156; 3 doses of IV steroids and multiple imaging for other clots; hospitalized on day 13 with TIA stroke symptoms and high d dimer; developed a DVT 2 days after the vaccine in my left leg; Had an anaphylactic reaction within 30 minutes of the vaccine/severe autoimmune reaction to the vaccine; tongue tingling, swelling; tongue tingling, swelling; moderate throat swelling; itchy rash; Covid toes; sudden bruising; This is a spontaneous report from a contactable nurse (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: Fc3181, expiry date not reported) via an unspecified route of administration, administered in right arm on 30Jul2021 16:45 (at the age of 40 years old), as dose 1, single for covid-19 immunisation. Medical history included gulf war illness, asthma, allergies, Ehler danlos, known allergies to penicillins, and being monitored for autoimmune disease but not diagnosed. The patient had covid prior vaccination (date unspecified). Concomitant medications included cetirizine hydrochloride (ZYRTEC), omeprazole, sertraline, celecoxib (CELEBREX), and pregabalin (LYRICA), all taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient previously took anthrax vaccine as immunization and experienced neurocardiogenic syncope; and patient had known allergies to doxycycline, clindamycin, duloxetine hydrochloride (CYMBALTA), and higher doses of sertraline. The patient was covid tested post vaccination which included oral swab negative on 12Aug2021. Patient had an anaphylactic reaction within 30 minutes of the vaccine (30Jul2021 05:15 PM) with tongue tingling, swelling, moderate throat swelling. These reactions continued for 2 weeks and throat and tongue kept swelling off and on. Patient also developed an itchy rash and covid toes and sudden bruising on 30Jul2021 05:15 PM. Patient was hospitalized with TIA stroke symptoms and high d dimer, sudden hypothyroid, hypertension 156/100 and tachycardia 156, that all began on 12Aug2021 (also reported as on day 13). Patient received 3 doses of IV steroids and multiple imaging for other clots (12Aug2021). Patient believed patient developed a DVT on 01Aug2021, also reported as 2 days after the vaccine, in the left leg but it had seemed to resolve with aspirin so patient did not go to the ER until patient had stroke symptoms on 12Aug2021. Doctors contributed my symptoms to a severe autoimmune reaction to the vaccine (anaphylactic reaction). Adverse events (AEs) resulted in emergency room/department or urgent care, hospitalization for 3 days (12Aug2021 to 15Aug2021), life threatening illness (immediate risk of death from the event), and disability or permanent damage. Therapeutic measures were taken as a result of the events reported which included mag sulfate, high dose solu-medrol, aspirin, and atorvastatin. The event "developed a DVT 2 days after the vaccine in left leg" was recovered on an unspecified date in 2021. The outcome of the other events reported was not recovered.; Sender''s Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events paraesthesia oral ,swollen tongue, pharangeal swelling, ill defined disorder, contusion, transient ischaemic attack, hypothyroidism, hypertension, tachycardia, thrombosis, deep vein thrombosis,and cerebrovascular accident 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: 1647323 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-07-01
Onset:2021-07-30
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blister, Skin exfoliation, Stevens-Johnson syndrome
SMQs:, Severe cutaneous adverse reactions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYMBICORT; TYLENOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Emphysema
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC202101058346

Write-up: Steven Johnson Syndrome; Blisters on his feet; His hands started peeling; This is a spontaneous report from a contactable consumer (patient''s child). A 62-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on unknown date in Jul2021 at 12:45 (Lot number was not reported) as single dose (at age of 62-year-old) for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), emphysema. Patient had no known allergies. Concomitant medications received within two weeks of vaccination included budesonide, formoterol fumarate (SYMBICORT); paracetamol (TYLENOL). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Patient did not have COVID prior vaccination. No COVID tested post vaccination. On 30Jul2021 17:00 patient experienced steven johnson syndrome, blisters on his feet, his hands started peeling. It was reported that patient started out with blisters on his feet and then his hands started peeling. His doctor called it Steven Johnson Syndrome. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient was treated for the events, steroids were prescribed. Patient had not recovered from the events, at the time of the report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1651377 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Back pain, Hypoaesthesia, Muscle spasms, Muscle twitching, Pain in extremity, Paraesthesia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Aspirin, ibuprofen and sulfa
Diagnostic Lab Data: Multiple chiropractor visits for back pain following and neurologist appointment 8/20 with planned EMG tests 9/23
CDC Split Type:

Write-up: Whole body numbness and tingling , muscle twitches, sensation to temperature, severe back spasms and pain in hips and legs


VAERS ID: 1651413 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-24
Onset:2021-07-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Full blood count normal, Metabolic function test, Pain in extremity, Paraesthesia, Rheumatoid factor negative
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin C, Labetalol, Bupropion, Quetiapine, Probiotic, Multivitamin
Current Illness:
Preexisting Conditions:
Allergies: Shellfish
Diagnostic Lab Data: Routine labs: CBC, CMP, Lupus, and Rheumatoid Arthritis profiles were all within normal limits and Negative.
CDC Split Type:

Write-up: Received 2nd dose of the vaccine on 7/24/21. On 7/30/21, I developed constant tingling in hands, feet, and legs around 11am. The sensation became more intense by approximately 3pm. I contacted by Primary Care Physician and informed him of my symptoms. He ordered Gabapentin 1-2 capsules twice a day, which I started that evening. That night I developed sharp and intense pains in my feet, legs, and hands. On 8/2/21, I saw my PCP and informed him that the tingling had progressed to extreme pain. He then increased the Gabapentin to three times a day. Within 4-5 days, the pain and tingling started to subside. By 8/9/21, the symptoms had resolved. I discontinued the medication on 8/15/21. Since then, I have only had one episode of sharp pain to my right foot which lasted about 5 minutes and subsided.


VAERS ID: 1654148 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Computerised tomogram head, Fatigue, Headache, Laboratory test, Oropharyngeal pain, Pain, Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Bystolic, Atorvastatin, Claritin
Current Illness: None
Preexisting Conditions: None
Allergies: Medicine: Reaction 1. Carvedilol: Headache 2. Spironolactone: Headache 3. Lisinopril: Hives, Angioedema 4. Losartan: Lichen Planus, Chronic Urticaria 5. Metoprolol: not effective, weight gain 6. Amlodipine: not effective 7. Hydrochlorothiazide: Capillaritis 8. Maxzide: Capillaritis 9. Diltiazem: Lichen Planus 10. Hydralazine: Capillaritis, headache 11. Indapamide: Capillaritis, itching 12. Edecrin: GI issues, loss of appetite, nausea 13. Singular: Urticaria 14. Rosuvastatin: fatigue, itching, tingling and numbness in left arm and hand 15. Iodine: hives, itchy rash 16. Flu shot: have not taken over 12-15 years due to become extremely sick for 5-7 days
Diagnostic Lab Data: CT scan Brain: Aug 18 Lab work: Aug 18
CDC Split Type:

Write-up: 30 Jul 2021: 1st dose of Pfizer vaccine I had a minor reaction 15 minute after the administration of the vaccine which included hives, itching, and white tiny bubbly spots (on arms, legs, tummy, and others). Took Benadryl for 3 days, hives and itching were resolved, but the white spots remain. Next 3-4 days included itching, headache, fatigue, sore throat, and body ache All symptoms have subsided except for headache. I?ve had headaches daily since 30 July 2021. Some headaches are mild and some are severe. Some medicines help for 2-6 hours such as Tylenol, Excedrin, Fioricet, and others but the headaches come right back. As of today, I?ve had headaches for 31 days (29 Aug 2021).


VAERS ID: 1655019 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-14
Onset:2021-07-30
   Days after vaccination:107
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0150 / UNK LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ADDERALL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: COVID-19 Test; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210726; Test Name: COVID-19 Test; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210731; Test Name: COVID-19 Test; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC202101048591

Write-up: Stroke; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150), unknown dose via an unspecified route of administration, administered in Arm Left on 14Apr2021(at the age of 36-years-old), as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested for COVID-19 since the vaccination. Facility where the most recent COVID-19 vaccine was administered was other. Patient had taken Blood thinners and statin for reported events. Patient visited to emergency room/department or urgent care. On 30Jul2021 at 08:30 AM, the patient experienced stroke. The patient was hospitalized for stroke for 3 days. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab) was negative on 19Jul2021, sars-cov-2 test (Nasal Swab) was negative on 26Jul2021, and sars-cov-2 test (Nasal Swab) was negative on 31Jul2021. The outcome of the event was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1655071 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:2021-02-06
Onset:2021-07-30
   Days after vaccination:174
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN5318 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Parkinson''s disease; Rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: NAAT Covid test; Test Result: Positive
CDC Split Type: USPFIZER INC202101076352

Write-up: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer reporting same event(s) under the same suspect product(s) for 37 patients. This is for 14th (69-year-old-male) of the 37people. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 06Feb2021 (Lot Number: EN5318) as dose 2, single and dose 1 via an unspecified route of administration on 16Jan2021 (Lot Number: EJ1686) as dose 1, single for covid-19 immunisation. Medical history included ongoing diabetes, ongoing Parkinson''s disease, ongoing rheumatoid arthritis. The patient''s concomitant medications were not reported. Caller was an Assistant Director of Health and works at a local health department called because she had some concerns, and the health department was tracking breakthrough cases in her area. Stated 15% of breakthrough cases were from one Pfizer Covid 19 Lot number: EN5318. On 30Jul2021, patient tested positive for covid virus, longer than two weeks after both doses. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Jul2021. Product Complaint description included Caller reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. The clinical outcome of the events was unknown at the time of report.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/ drug/ AE, different patient


VAERS ID: 1655591 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-02-20
Onset:2021-07-30
   Days after vaccination:160
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 023M20A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Chest discomfort, Cough, Insomnia, Pyrexia, SARS-CoV-2 test positive, Sinus congestion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Advair; Simvastatin; trazodone; Vitamin C; Calcium, B cComplex; Potassium; Turmeric
Current Illness:
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data: COVID-19 rapid test- positive 08/01/2021.
CDC Split Type: vsafe

Write-up: I had a low grade fever, tightness in my chest, very stuffy and clogged head, and very congested. I had a dry cough, the first few nights I had sleeplessness. I was told by nurse to use my nebulizer 2 times a day. At end of virus was when my asthma acted up.


VAERS ID: 1655958 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C1A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: The adverse event, was the Moderna vaccine shot was given to a teenager ( 14 years old) , without it been approve for that age range, but they was no adverse reaction from the vaccine itself.


VAERS ID: 1656133 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-02-23
Onset:2021-07-30
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6198 / 2 - / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Tylenol, albuterol, amlodipine, aspirin, Lipitor, Vitamin D3, Plavix, CoQ10, Benadryl, ferrous sulfate, Neurontin, Norco, insulin glargine, metformin, metoprolol, multivitamin, Prilosec, prednisone, probiotic, Ranexa, Januvia, Ambien
Current Illness:
Preexisting Conditions: Aortic stenosis, arthritis, back pain, bronchitis, skin cancer (nose), cataracts, CAD, diabetes mellitus, GERD, heart murmur, high cholesterol, hypertension, history of MI (twice, ''86 and ''03), pancreatitis
Allergies: Cephalexin, ciprofloxacin, tetanus toxoid
Diagnostic Lab Data: SARS-COV-2 (COVID19), POINT OF CARE, ANTIGEN - OFFICE: Positive (7/30/2021) SARS-COV-2 (COVID-19) by NAA, Micro: Detected (8/1/2021)
CDC Split Type:

Write-up: Patient presents to the ED secondary to cough, shortness of breath, generalized malaise and fatigue. Patient was recently diagnosed with COVID - 19. Patient reports a one-week history of worsening symptoms, tested positive 2 days prior to admission. Patient denies any nausea or vomiting. No abdominal pain. No changes in urination or bowel habitus. ID and pulmonology were consulted for COVID pneumonia. Remdesivir and steroids were given. Patient also received antibiotics for bacterial pneumonia. Oxygen supplement via nasal cannula. Symptoms improved and patient felt better, no longer required oxygen supplement. Upon discharge, he had 3 more days of doxycycline for bacterial pneumonia and follow up as outpatient with PCP.


VAERS ID: 1656510 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: New Hampshire  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0181 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad)

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

Write-up: I have had new onset, severe hyperhidrosis which began within a day of the vaccine AND HAS LASTED FOR FIVE WEEKS, so far.


VAERS ID: 1657893 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-08-19
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3182 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Drug ineffective, Pain, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Taste and smell disorders (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Neurofibromatosis; Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: Nasal Swab/Binaxnow; Test Result: Negative ; Comments: Hospital test; Test Date: 20210731; Test Name: Nasal Swab/Binaxnow; Test Result: Negative ; Comments: Binaxnow; Test Date: 20210821; Test Name: Nasal Swab/Binaxnow; Test Result: Positive ; Comments: Binaxnow
CDC Split Type: USPFIZER INC202101084410

Write-up: covid test date=21Aug2021, covid test result=Positive/Body aches, lost of smell and taste; covid test date=21Aug2021, covid test result=Positive/Body aches, lost of smell and taste; Body aches; Lost of smell and taste; Lost of smell and taste; This is a spontaneous report from a contactable other health care professional (patient). A 39-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in arm left on 29Jul2021 at 12:30 PM (at the age of 39 years) as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot Number: FC3182) via an unspecified route of administration, administered in arm left on 19Aug2021 at 08:30 AM (at the age of 39 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Vaccine was administered at pharmacy or drug store. No other vaccines were received within four weeks prior to the administration of bnt162b2. Medical history included asthma, neurofibromatosis and penicillin allergy; all from an unknown date and unknown if ongoing. Concomitant medication included montelukast sodium (SINGULAIR) taken within two weeks of vaccination for an unspecified indication, start and stop date were not reported. On 30Jul2021 at 07:30 AM, the patient experienced body aches, lost of smell and taste. The report was non serious (as reported). On 21Jul2021, the patient underwent covid test post vaccination at hospital with covid test type nasal swab: negative, on 31Jul2021, covid test post vaccination as Binaxnow test with covid test type nasal swab: negative, on 21Aug2021, covid test post vaccination as Binaxnow test with covid test type nasal swab: positive. Events were considered as medically significant. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. No treatment was received for the adverse events. Outcome of the events was not recovered.; Sender''s Comments: As there is limited information in the case provided, the causal association between the reported event Covid 19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.


VAERS ID: 1658104 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003C21A / 1 LA / IM

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

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

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


VAERS ID: 1658749 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-02-16
Onset:2021-07-30
   Days after vaccination:164
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Laboratory test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Cycle threshold on 7/31/21 = 14.7
CDC Split Type:

Write-up: hospitalization with COVID-19 reported per vaccine EUA


VAERS ID: 1658936 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-05-03
Onset:2021-07-30
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: COVID-19, Fatigue, Headache, Pyrexia, Respiratory tract congestion
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Patient fully vaccinated and hospitalized due to COVID-19. Patient stated her symptoms are a fever, congestion, fatigue, and headaches.


VAERS ID: 1659149 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood pressure increased, Blood test normal, Chills, Dizziness, Dyspnoea, Hypertension, Palpitations, Presyncope, Pyrexia, SARS-CoV-2 test negative, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none that day. Usually take a 1 a day vitamin
Current Illness: none
Preexisting Conditions: Crohn''s disease
Allergies: Strawberries
Diagnostic Lab Data: Blood tests ran showing everything looked ok Covid test given to make sure I didn''t have the virus at that moment Elevated blood pressure and pulse were monitored.
CDC Split Type:

Write-up: Hospital listed it as "Adverse reaction to Covid-19 vaccine" Symptoms were: Fever of 104 Uncontrolled chills that shook the ambulance. Heart racing for at least and hour or more. Trouble breathing. Dizziness and almost passed out when I tried to walk to the bathroom High Blood Pressure


VAERS ID: 1660305 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Fall, Fatigue, Full blood count normal, Headache, Immediate post-injection reaction, Metabolic function test normal, Muscular weakness, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), 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: LOSARTAN, OMEPRAZOLE, AMLODIPINE
Current Illness: ALLERGIES, NEG COVID TEST 7/23/21
Preexisting Conditions: HTN, GERD, DIVERTICULOSIS
Allergies: PENICILLIN, LISINOPRIL
Diagnostic Lab Data: CBC and CMP normal on 8/23/21
CDC Split Type:

Write-up: "Reports that immediately after receiving the J&J vaccination on 7/30/21, he felt a fever and diarrhea 1-2 days but then this was followed by persistent lower extremity weakness for approximately one week following, so much so that fell twice with involuntary knee buckling at work the following Monday, Tuesday, Wednesday (August 2,3,4) at truck stop location. Since then these symptoms have resolved after 5+ days but now reporting continuous bilateral frontal headaches lasting one minute and then returning. Also reporting "no energy" and severe fatigue and difficulty getting up in the morning even after 8-10 hours sleep."


VAERS ID: 1666449 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-03-20
Onset:2021-07-30
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9269 / UNK - / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Chronic kidney disease, COPD, Crohns disease, hypothryoid
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was diagnosed and hospitalized with COVID-19. Hospitalized 7/30-8/10/2021


VAERS ID: 1518201 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Tinnitus
SMQs:, Hearing impairment (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: Klonopin, hormonal birth control, OTC pain killers
Current Illness: Mental health - panic attacks, GAD, OCD, clinnical depression
Preexisting Conditions: Mental health mentioned above
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: ?Covid arm? developing second day after shot. Louder tinnitus, worsen anxiety.


VAERS ID: 1518377 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7221 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Injection site pain, Oedema peripheral, Pain
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 was just feeling muscle pain in the application region the day I was vaccinated. From the next day, I began to feel discomfort in the armpit region, and noticed that there is a swelling in this region, which causes pain and discomfort, especially when closing the arm.


VAERS ID: 1519162 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE393 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Injected limb mobility decreased, Injection site pain
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: Nothing taken before vaccination, Ibuprofen after
Current Illness:
Preexisting Conditions: Asthma, also having a higher BMI (over 40)
Allergies: Allergic to: - Soj - Nuts - Fish (lethal) - Raw Apples, Pear, Carrots, Kiwi, ...
Diagnostic Lab Data:
CDC Split Type:

Write-up: Extreme pain and soreness in the left arm where I?ve gotten the vaccine. Started slowly a couple hours after getting the shot, ongoing for the past 2 days. Stronger in the morning and in the evening, unable to move the arm above ellbow. cooling the area does not help. Ibuprofen reduces the pain temporarily. No improvement seen within last 2 days.


VAERS ID: 1527249 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Fear of injection, Syncope, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: 113/85
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: blood clots; fear of needles; Syncope; This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) and THROMBOSIS (blood clots) in a 20-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant). On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant) and FEAR OF INJECTION (fear of needles). On 30-Jul-2021, SYNCOPE (Syncope) had resolved. At the time of the report, THROMBOSIS (blood clots) and FEAR OF INJECTION (fear of needles) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 113/85 (normal) 113/85. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Approximately 10 minutes after vaccination patient had felt lightheaded and had a syncope episode. Patient is not enrolled in clinical trial. 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: 1527251 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chills, Confusional state, Dyspnoea, Epilepsy, Influenza, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lupus erythematosus; Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: flu symptoms; had first vaccination and felt rubbish for several weeks; Fainting; Difficulty breathing; Abdominal pain; Confusion; Shivering; This regulatory authority case was reported by a consumer and describes the occurrence of EPILEPSY (had first vaccination and felt rubbish for several weeks) and SYNCOPE (Fainting) in a 38-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. Concurrent medical conditions included Lupus erythematosus and Suspected COVID-19 since 26-Jun-2021. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced SYNCOPE (Fainting) (seriousness criteria disability and medically significant), DYSPNOEA (Difficulty breathing), ABDOMINAL PAIN (Abdominal pain), CONFUSIONAL STATE (Confusion) and CHILLS (Shivering). On an unknown date, the patient experienced EPILEPSY (had first vaccination and felt rubbish for several weeks) (seriousness criteria disability and medically significant) and INFLUENZA (flu symptoms). At the time of the report, EPILEPSY (had first vaccination and felt rubbish for several weeks) and INFLUENZA (flu symptoms) outcome was unknown, SYNCOPE (Fainting) and CONFUSIONAL STATE (Confusion) had resolved and DYSPNOEA (Difficulty breathing), ABDOMINAL PAIN (Abdominal pain) and CHILLS (Shivering) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications was not reported. After the patient had the first vaccination and on 28-Jun-2021, it was confirmed she had COVID infection. She then was bed bound for a couple of weeks. She still had experienced getting very tired when she had the second dose of vaccine and then she had developed flu symptoms within a few hours. Twelve hours, after the second dose she had felt weak and fainted to the floor. While being helped to the toilet she had collapsed again. She had spent an hour shivering and convulsing and drifting in and out of consciousness. Difficulty breathing, unable to speak, unable to remember own address. Ambulance called but symptoms subsided before it arrived. Treatment information was not reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. 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. Epilepsy could have been preexisting prior to vaccination but we don''t have information. Very limited information has been provided at this time. No further information is expected; 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. Epilepsy could have been preexisting prior to vaccination but we don''t have information. Very limited information has been provided at this time. No further information is expected


VAERS ID: 1527254 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, SARS-CoV-2 test
SMQs:, 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: Aching joints; This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Aching joints) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Aching joints) 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. Concomitant product use was not provided by the reporter. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. 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. 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 event, a causal relationship cannot be excluded. No further information is expected at this time.


VAERS ID: 1527963 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Injection site pain, SARS-CoV-2 test
SMQs:, Extravasation events (injections, infusions and implants) (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: TAMPLUS
Current Illness: Alcohol use (Patient drinks alcoholic beverages); Cardiac disorder; Food allergy; Smoker (smokes 5-10 sticks a day)
Preexisting Conditions: Medical History/Concurrent Conditions: Quadruple vessel bypass graft
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive; Comments: Positive (+) for Covid-19 as of 30-Jul-2021
CDC Split Type: PHJNJFOC20210803313

Write-up: PAIN IN INJECTION SITE ON THE LEFT ARM; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a 57 year old male of unknown race and ethnicity. The patient''s past medical history included quadruple bypass surgery performed in 2013, and concurrent conditions included unspecified heart condition since birth, cheese and chicken allergy. The patient usually smoke 5 to 10 sticks and drank alcoholic beverages. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, frequency 1 total, administered on 22-JUL-2021 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. Concomitant medications included finasteride/tamsulosin hydrochloride. On 30-JUL-2021, the patient turned out positive for covid-19 infection upon performing swab test with the symptoms including fever, headache, chills, and difficulty of breathing. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On an unspecified date, the patient experienced pain in injection site on the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in injection site on the left arm and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210803313-covid-19 vaccine ad26.cov2.s-Confirmed COVID-19 infection. 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: 1528057 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD974 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: SARS-CoV-2 serology test; Result Unstructured Data: IgG negative (VT equal to 0,42), IgM negative (VT equal to 0,07); Comments: had no antibodies for COVID-19
CDC Split Type: PTJNJFOC20210801488

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 53 year old male of unknown race and ethnic origin. Initial information was processed with additional information received from patient on 01-AUG-2021 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: XD974, expiry: Unknown) dose was not reported, 1 total, administered at left deltoid on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. Patient reported that on 30-JUL-2021 he underwent immunity serologic test as part of a study at a hospital which had zero degree for immunity and had confirmed immunological vaccine failure. Patient further claimed that he believes most people that was vaccinated with this lot had the same issue, but then admitted having no access to their test results. He enquired whether he would be recalled for another dose of vaccine. On 30-JUL-2021, Laboratory data included: SARS-CoV-2 serology test (NR: not provided) IgG negative (Test Value (VT) equal to 0, 42), IgM negative (VT equal to 0, 07). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210801803. This report was associated with product quality complaint:90000188002; Sender''s Comments: V0: 20210801488- Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1529646 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-07-30
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Inappropriate schedule of product administration, Rash
SMQs:, Anaphylactic reaction (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Inappropriate schedule of vaccine administration; Diarrhea; Rash; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), RASH (Rash) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003608 and 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 31-Jul-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). At the time of the report, DIARRHOEA (Diarrhea), RASH (Rash) and FATIGUE (Fatigue) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided. Company Comment:This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot# 3002332/3003608 with AEs of Diarrhea, Rash and Fatigue. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender''s Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot# 3002332/3003608 with AEs of Diarrhea, Rash and Fatigue. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.


VAERS ID: 1529897 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Hallucination, Injected limb mobility decreased, Pyrexia, Seizure, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Temperature; Result Unstructured Data: 40, high temperature
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: cannot lift the arm very much; 12 hours after the vaccine i woke up convulsing with chills; fever; High temperature; 12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating; 12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating; 12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating; This regulatory authority case was reported by a consumer and describes the occurrence of SEIZURE (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating), HALLUCINATION (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating), VACCINATION SITE PAIN (12 hours after the vaccine i woke up convulsing with chills), PYREXIA (fever) and PYREXIA (High temperature) in a 35-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 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced SEIZURE (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating) (seriousness criterion medically significant), CHILLS (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating) and HALLUCINATION (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating) (seriousness criterion medically significant). 30-Jul-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced INJECTED LIMB MOBILITY DECREASED (cannot lift the arm very much), VACCINATION SITE PAIN (12 hours after the vaccine i woke up convulsing with chills) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). At the time of the report, INJECTED LIMB MOBILITY DECREASED (cannot lift the arm very much), SEIZURE (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating), CHILLS (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating) and HALLUCINATION (12 hours after the vaccine the patient woke up convulsing with chills, very high fever and hallucinating) outcome was unknown and VACCINATION SITE PAIN (12 hours after the vaccine i woke up convulsing with chills), PYREXIA (fever) and PYREXIA (High temperature) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Body temperature: 40 (High) 40, high temperature. Relevant concomitant medications were not reported. Treatment information was not provided. It was reported that batch number of the suspect product was unknown. 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: 1529918 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Heavy menstrual bleeding, Pyrexia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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:
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: shivers; Headache; Heavy periods; Fever; This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivers), PYREXIA (Fever), HEADACHE (Headache) and HEAVY MENSTRUAL BLEEDING (Heavy periods) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivers) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant). On 31-Jul-2021, PYREXIA (Fever) had resolved. At the time of the report, CHILLS (shivers) outcome was unknown, HEADACHE (Headache) had resolved and HEAVY MENSTRUAL BLEEDING (Heavy periods) 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. No concomitant medication were reported No treatment medication were reported. Patient developed body ache, Early period (1week) unusually heavy and more painful. Patient was not tested positive for COVID-19 since having the vaccine and not enrolled in clinical trial. Company comment Very limited information regarding these events have been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected.


VAERS ID: 1529923 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), 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: PARACETAMOL
Current Illness: Generalised muscle aches
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Chills; Fever; Vomited; Generalised muscle aches; Headache fullness; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), VOMITING (Vomited), MYALGIA (Generalised muscle aches), HEADACHE (Headache fullness) and PAIN IN EXTREMITY (Painful arm) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. Concurrent medical conditions included Generalised muscle aches. Concomitant products included PARACETAMOL from 31-Jul-2021 to an unknown date for Generalised muscle aches. On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 31-Jul-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), VOMITING (Vomited) (seriousness criterion medically significant), MYALGIA (Generalised muscle aches) (seriousness criterion medically significant) and HEADACHE (Headache fullness) (seriousness criterion medically significant). At the time of the report, CHILLS (Chills), PYREXIA (Fever), MYALGIA (Generalised muscle aches), HEADACHE (Headache fullness) and PAIN IN EXTREMITY (Painful arm) had not resolved and VOMITING (Vomited) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-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 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: 1529925 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-07-30
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Dizziness, Fatigue, Headache, Inappropriate schedule of product administration, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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? 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: Body temperature; Result Unstructured Data: Body temperature 39.6.; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fever; Painful arm; Headache; Fatigue; Nausea; Dizziness; The patient received the second dose on 30-Jul-2021 , 57 days from the first dose; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and DIZZINESS (Dizziness) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3003607 and 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and (The patient received the second dose on 30-Jul-2021 , 57 days from the first dose). 30-Jul-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 31-Jul-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Fever, at an unspecified dose and frequency. On 30-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received the second dose on 30-Jul-2021 , 57 days from the first dose) had resolved. At the time of the report, PYREXIA (Fever), PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved and NAUSEA (Nausea) and DIZZINESS (Dizziness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 39.6 (High) Body temperature 39.6.. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Concomitant product use was not provided by the reporter. Company comment This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (batch nos. 3003607 and 3002332) with associated adverse events reported as pain in extremity, pyrexia, headache, fatigue and nausea. 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. Seriousness of the events are based on the Regulatory Report received, as per medical judgement the events for this case are non serious.; Sender''s Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (batch nos. 3003607 and 3002332) with associated adverse events reported as pain in extremity, pyrexia, headache, fatigue and nausea. 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. Seriousness of the events are based on the Regulatory Report received, as per medical judgement the events for this case are non serious.


VAERS ID: 1529947 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-30
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chills, Dizziness, Headache, Malaise, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TESTOSTERONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210801; 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: stomach aches; dizzy; shivering; Chills; Abdominal pain; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (stomach aches), DIZZINESS (dizzy) and ABDOMINAL PAIN (Abdominal pain) in a 38-year-old male 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 Suspected COVID-19 on 30-Jul-2021. Concomitant products included TESTOSTERONE for Testosterone deficiency. On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced HEADACHE (Headache). On 31-Jul-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced CHILLS (Chills). On an unknown date, the patient experienced MALAISE (stomach aches) (seriousness criterion medically significant), DIZZINESS (dizzy) (seriousness criterion medically significant) and CHILLS (shivering). At the time of the report, MALAISE (stomach aches), DIZZINESS (dizzy) and CHILLS (shivering) outcome was unknown and ABDOMINAL PAIN (Abdominal pain), HEADACHE (Headache) and CHILLS (Chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. Patient reported that she was taking regular steroid treatment (e.g. orally or rectally). Treatment information, if any, was not provided by the reporter. 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: 1530044 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

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

Write-up: injection time 3:45pm pain on shoulders, feeling of nausea, at night slept and felt severe headache cannot sleep till the whole next day headache and body pains


VAERS ID: 1533681 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Depressed level of consciousness, Dyspnoea, Nausea, Oxygen saturation, Oxygen saturation decreased, Retching
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

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? No
Previous Vaccinations:
Other Medications: EPIPEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis; Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210730; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:99; Comments: at 14:25; Test Date: 20210730; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:83; Comments: at 14:53
CDC Split Type: JPPFIZER INC202100977661

Write-up: Oxygen saturation decreased to 83; Depressed level of consciousness; Dyspnoea; Anaphylaxis; Vomiturition; Queasy; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21119462. The patient was a 53-year and 3-month-old female. Body temperature before vaccination was 36.6 degrees Centigrade. The patient''s medical histories included asthma and anaphylaxis. Concomitant medication included epinephrine (EPIPEN) from an unspecified date and ongoing. On 30Jul2021 at 14:14 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. The patient experienced anaphylaxis on 30Jul2021 14:17 (life-threatening, medically significant) with outcome of unknown, Depressed level of consciousness (life-threatening, medically significant) on 30Jul2021 14:50 with outcome of unknown, vomiturition (non serious) on 30Jul2021 14:17 with outcome of unknown, queasy (non serious) on 30Jul2021 14:17 with outcome of unknown, dyspnoea (non serious) on 30Jul2021 14:25 with outcome of unknown, oxygen saturation decreased to 83 (non serious) on 30Jul2021 14:53 with outcome of unknown. The course of the events was as follows: On 30Jul2021 at 14:17, the patient experienced queasy and vomiturition. Rash (-) The level of consciousness was normal. On 30Jul2021 at 14:25, the patient experienced dyspnoea. SpO2 was 99. On 30Jul2021 at 14:32, as for dyspnoea and vomiturition were still lasting, the patient received adrenaline 0.3 ml intramuscularly. On 30Jul2021 at 14:41, the events got better. On 30Jul2021 at 14:50, dyspnoea became worsen. The patient experienced depressed level of consciousness and SpO2 decreased. On 30Jul2021 at 14:53, the patient received adrenaline 0.3 ml intramuscularly. SpO2 decreased to 83. O2 stared from 2L to 10L. On 30Jul2021 at 14:55, the patient requested for emergency. It met the reporting criteria of anaphylaxis. The reporting physician classified the events anaphylaxis and depressed level of consciousness as serious (life-threatening) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The events were considered as anaphylaxis shock. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1537629 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 045F21A / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Chest pain, Myocarditis
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? 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: Methadose
Current Illness:
Preexisting Conditions:
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Inflamed heart stabbing pains started 3 hours after injection 6 days later two trips to Emergency room told my heart is inflamed


VAERS ID: 1625745 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, COVID-19 immunisation, Dysstasia, Feeling cold, Headache, Influenza like illness, Interchange of vaccine products, Nausea, Neck pain, Pain in extremity, Retching
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MULTIVITAMINS [VITAMINS NOS]; MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20212

Write-up: MAJOR PAIN IN LEGS; FEELING COLD; RETCHING; FLU LIKE SYMPTOMS; BACK PAIN; DIFFICULTY IN STANDING; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; NECK PAIN; Interchange of vaccine product; HEAD PAIN; NAUSEA; This case was received via regulatory authority (Reference number: NO-NOMAADVRE-E2B_00040795) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (MAJOR PAIN IN LEGS) in a 29-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication. Previously administered products included for Vaccination: Comirnaty. Past adverse reactions to the above products included Drug use for unknown indication with Comirnaty. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]) for Contraception, MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 30-Jul-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (COMIRNATY) (unknown route) at an unspecified dose. On 30-Jul-2021, the patient experienced PAIN IN EXTREMITY (MAJOR PAIN IN LEGS) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING COLD (FEELING COLD), RETCHING (RETCHING), INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), BACK PAIN (BACK PAIN), DYSSTASIA (DIFFICULTY IN STANDING), COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE), NECK PAIN (NECK PAIN), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), HEADACHE (HEAD PAIN) and NAUSEA (NAUSEA). At the time of the report, PAIN IN EXTREMITY (MAJOR PAIN IN LEGS) was resolving and FEELING COLD (FEELING COLD), RETCHING (RETCHING), INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), BACK PAIN (BACK PAIN), DYSSTASIA (DIFFICULTY IN STANDING), COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE), NECK PAIN (NECK PAIN), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product), HEADACHE (HEAD PAIN) and NAUSEA (NAUSEA) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Treatment details not provided. Company Comment: For the event Pain in extremity, 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. Very limited information regarding the remaining events onset dates has been provided at this time and insufficient to assess the temporal association. A causal relationship cannot be excluded.; Reporter''s Comments: Contact with healthcare professionals: Physician. Patient reports about no diseases and healthy lifestyle. Patient reports about problems with keeping legs still, due to MAJOR PAIN IN LEGS. Patient reports about visiting a physician, due to the condition, and was then referred to hospital.; Sender''s Comments: For the event Pain in extremity, 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. Very limited information regarding the remaining events onset dates has been provided at this time and insufficient to assess the temporal association. A causal relationship cannot be excluded.


VAERS ID: 1667905 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-30
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

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

Write-up: Nosebleed


VAERS ID: 1511667 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2021-07-26
Onset:2021-07-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026A21A / 1 LA / IM

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

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

Write-up: urticaria, improved with Benadryl


VAERS ID: 1512377 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-07-09
Onset:2021-07-29
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 AR / SC

Administered by: Private       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Patient developed a DVT 2 weeks after second Moderna shot. He had been on a 5 hour car ride during that time as well
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: ultrasound
CDC Split Type:

Write-up: Patient developed a DVT in right leg, pain started one week after shot but also on long car ride


VAERS ID: 1512568 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 1 RA / IM

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

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

Write-up: Concentration of the vaccine was higher than anticipated; ~1mL of diluent was used instead of intended 1.8mL. Only one vaccine from this batch was administered to this patient and the rest of the vaccines were disposed upon recognition of the error, which was discovered after reviewing the remaining quantity of diluent. The patient showed no adverse reaction upon administration or the following observation time. The patient was informed of this larger concentration after recognition of the error, patient was okay with resolution, and facility plans follow up the with patient on the week of 8/1/21. Future quantities will be evaluated by a pharmacist.


VAERS ID: 1512569 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 2 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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: history of anxiety & vasovagul
Other Medications: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data:
CDC Split Type:

Write-up: She had a history of vasovagal response & let me know ahead of time. Mom was also present. I got an ice pack, crackers, hard candy & water ready for her. Had her sit in a seat with feet elevated. A few minutes post she said she could feel it coming on & lost consciousness for about 15 seconds. She came back to & we put an ice pack on her neck. Mom & I had her lay on the floor with feet elevated & ice pack on the back of her head. Her color came back & she asked for some water. She said she was much better & we let her lay there for the 15 minutes. Mom & her left 30 minutes after


VAERS ID: 1512577 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / IM

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

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

Write-up: PATIENT CAME BACK TO THE PHARMACY AROUND 1130AM THE DAY AFTER THE VACCINATION, SHE SAID SHE WOKE UP WITH A RASH ALL OVER HER ARMS AND LEGS. TOLD HER TO TAKE SOME BENADRYL AND IF THE SYMPTOMS GOT WORSE OR DID NOT IMPROVE THEN GO SEE A DR.


VAERS ID: 1512580 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA66780 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Discomfort, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: penicillin allergy
Diagnostic Lab Data: EMTS took BP and pulse ox- all normal values
CDC Split Type:

Write-up: Pt felt dizzy, "heavy body", lightheaded, slightly nauseous at times. EMTs were called, checked vitals (all were okay), she chose to not leave in ambulance, was advised not to drive home so husband came to pick her up. She was counseled on monitoring symptoms if she felt she needed to go to hospital later. Signed waiver with EMTs


VAERS ID: 1512585 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / UNK - / IM

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

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

Write-up: Patient felt dizzy and nauseated few minutes after getting her 1st Pfizer dose. Mother stated her daughter didn?t eat anything since morning. 3 ice packs were used, 2 on her neck and 1 on her head. Two crackers and bottle water was offered. Blood pressure at 10:45am 107/66 Hg/mm. Blood pressure at 10:55 am 126/75 Hg/mm. She states I feel much better and no longer feel dizzy or nauseous.


VAERS ID: 1512587 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-01-19
Onset:2021-07-29
   Days after vaccination:191
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011J20A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anger, Crying, Fatigue, Feeling abnormal, Limb discomfort, Mood altered, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (narrow), Depression (excl suicide and self injury) (broad)

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

Write-up: I feel very tired and fatigue all the time. On edge all the time. I feel empty on the inside, my head feels like I am in a fog all the time. Am very emotional all the time. I consider myself a very strong person. But every since the vaccine, am very mody, crying and angry all the time. I have no patience for people anymore. I was never like that at first. I was a out going type and now I always want to be a lone. Both of my arms feel very heavy and tingling all the time.


VAERS ID: 1512588 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Throat tightness, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: clonidine, famotidine, haloperidol, hydroxyzine pamoate, lidoderm patch, melatonin, nabumetone, prednisone, sertraline, trazodone
Current Illness:
Preexisting Conditions: anxiety, fibromyalgia, back pain, hx substance use, depression, PTSD
Allergies: Latex - hives, anaphylaxis Pineapple - anaphylaxis Shellfish - anaphylaxis Iodinated contrast - dyskinesia/dystonia promethazine - unknown
Diagnostic Lab Data:
CDC Split Type:

Write-up: Within 30 seconds of vaccine, patient began vomiting continuously and felt like her throat was closing. She was given IM epinephrine in the clinic and transported to the ED. By ED arrival, she stated her throat no longer felt tight. In the ED, was given 25mg IV benadryl, 20mg IV famotidine, 125mg IV methylprednisolone and 1L of saline. She was monitored prior to discharge.


VAERS ID: 1512593 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 LA / IM

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

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

Write-up: Upon administration of Covid 19 vaccine, needle accidentally dislodged from syringe causing zero to a miniscule amount of vaccine be administered. OK to redose vaccine, and to report to VAERS. Patient was then administered Covid vaccine and tolerated without any complications or incidents


VAERS ID: 1512596 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 RA / IM

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

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

Write-up: After giving the vaccine I realized that I gave it wrong. I did not know that the vials were not diluted already. I thought that the amount in the vial was what was left in the vial from previous doses. I didn''t see posted anywhere how to give this vaccine. Since I know most vaccines are 0.5 ml that''s what I assumed. All the other medical assistants and nurses were busy so I didn''t have anyone to ask. I normally do not work at this location and any other time I''ve given covid vaccines they were done at other locations, with instructions on drawing up and administering.


VAERS ID: 1512602 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: No adverse event
SMQs:

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

Write-up: no adverse reactions


VAERS ID: 1512621 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: no adverse reactions just moderna vaccine given to under age patient


VAERS ID: 1512623 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-01-20
Onset:2021-07-29
   Days after vaccination:190
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / SYR

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

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

Write-up: Breakthrough COVID case. Patient completed series and became positive 7/29/21


VAERS ID: 1512627 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 - / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Accidental exposure to product, Exposure to contaminated device
SMQs:, Medication errors (narrow)

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

Write-up: After giving Covid19 immunization to patient, technician attempted to recap syringe, resulting in a poke to her left hand.


VAERS ID: 1512633 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: after 30 mins pt started having stomach pain and nausea


VAERS ID: 1512634 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Epistaxis
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: None
Current Illness: None
Preexisting Conditions: None
Allergies: Lamictal
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Blood nose left nostril


VAERS ID: 1512636 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: no adverse reactions just Moderna vaccine given to 15 year old


VAERS ID: 1512643 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-07-16
Onset:2021-07-29
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004D21A / 1 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Infection
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: REFER TO DR. AS INFECTION DEVELOPED 2 WEEKS AFTER VACCINE


VAERS ID: 1512665 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-07-16
Onset:2021-07-29
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pain, Injection site rash
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin D3, generic Paxil, atenelol, IUD, amittriphline? Depressant for sleep
Current Illness:
Preexisting Conditions: Hypertension
Allergies: Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: Circular rash around injection site, soreness


VAERS ID: 1512673 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: New York  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1816022 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: UPON WAKING UP, PATIENT HAD A 100.3 FEVER. HALF HOUR LATER, PATIENT FAINTED.


VAERS ID: 1512698 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-07-01
Onset:2021-07-29
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 2 LA / IM

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

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

Write-up: n/a


VAERS ID: 1512703 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939893 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hypotonia, Pallor, Pulse abnormal, Unresponsive to stimuli
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (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: unknown
Preexisting Conditions: none stated
Allergies: unknown
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had received vaccine and was in waiting area for observance. After around 10 minutes wife came to counter and said he was feeling dizzy. RPH walked out to check on patient whom had sit back down from standing up briefly. Patient seemed responsive until his head drifted down, unresponsive to voice and touch for one minute or less. Pulse on wrist was faint, but present and no signs of struggled breathing. No swelling or redness near throat present. Patient woke up shortly with pale skin, but responded well and water was given. Ambulance arrived to further assist.


VAERS ID: 1512704 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 059E21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Confusional state, Eye movement disorder, Hyperhidrosis, Loss of consciousness, Nausea, Pallor, Seizure, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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

Write-up: During the post-vaccine monitoring period , a bout 5-10 minutes after the first dose injection of Moderna Covid Vaccine, pt felt nausea and had seizure episode for about 2-3 minutes. Pharmacist noticed rolling eye balls and body shake with brief unconsciousness. Pt was alerted 2-3 min after with sweats and slight confusion. Meanwhile, 911 was called and paramedics came and checked patient. out . Pt was pale but all vitals were normal and returned to stable condition. Pt was released and his wife accompanied back home. Pharmacist is planning to l follow up with patient .


VAERS ID: 1512717 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / N/A LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Head injury, Immediate post-injection reaction, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRINTELLIX, GABAPENTIN, WELLBUTRIN, BUSPIRONE, ABILIFY, ZIPRASIDONE
Current Illness:
Preexisting Conditions: SEIZURES, HISTORY OF OTHER MENTAL HEALTH DISORDERS AS WELL (NOT SPECIFIED)
Allergies: CEFZIL
Diagnostic Lab Data: NONE; PATIENT WAS EVALUATED BY EMTS HOWEVER AND NOTHING OF NOTE FOUND
CDC Split Type:

Write-up: PATIENT UPON RECEIVING VACCINE IMMEDIATELY PASSED OUT IN CHAIR; SHE SLID AND BUMPED HEAD SLIGHTLY AGAINST WALL. PATIENT WAS OUT FOR ABOUT 30 SECONDS. UPON COMING TO, PATIENT WAS FINE. EMTS WERE CALLED TO EVALUATE PATIENT AND PATIENT WAS DEEMED OK AND LEFT WITH HER MOTHER WHO WAS WITH HER AT THE TIME. SHE HAD NO OTHER COMPLAINTS AND MOTHER HAD STATED PRIOR THAT THIS HAD HAPPENED IN PAST WITH OTHER VACCINES. PATIENT IS OTHERWISE OK AT THIS TIME AND WENT HOME WITH HER MOTHER; SHE IS TO CONTACT US AND MD IF ANY OTHER CONCERNS ARISE.


VAERS ID: 1512723 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Dizziness
SMQs:, Anaphylactic reaction (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: blood pressure medication
Current Illness: unknown
Preexisting Conditions: high blood pressure
Allergies: erythromycin, macrobid, lorabid, rhinocort, bactrim
Diagnostic Lab Data: BP 161/107 HR 48 BPM
CDC Split Type:

Write-up: PATIENT REPORTED DIZZINESS AND CHEST TIGHTNESS 5 MINUTES AFTER RECEIVING VACCINE. GAVE PATIENT WATER AND MONITORED. TOOK PATIENTS BLOOD PRESSURE AND HEART RATE. BP 161/107 HR 48 BPM. PATIENT REPORTED DIZZINESS WAS GETTING WORSE. CALLED 911


VAERS ID: 1512728 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted as soon as the needle come out of her body and the fainting lasted for less than a minute


VAERS ID: 1512731 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026D21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anaphylactic reaction, Chest discomfort, Chest pain, Dysphagia, Dyspnoea, Flushing, Hyperhidrosis, Paraesthesia, Tachycardia, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Hypoglycaemia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe


VAERS ID: 1512734 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fall, Flushing, Head injury, Hyperhidrosis, Loss of consciousness, Nausea, Syncope, Unresponsive to stimuli, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

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

Write-up: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: After shot told patient to sit by pharmacy for monitoring, patient refused and walked around store. Patient fell and hit his head, loss consciousness for 3 seconds, woke up and threw up. Insturcted patient to sit by pharmacy for 30 minutes, patient refused and walked to car. Walked patient to car and spoke to girlfriend. Spoke to mother on phone as well, she informed me he has a history of anxiety with shots and needles and ALWAYS faints after a vaccination (usual reaction).


VAERS ID: 1512737 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

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

Write-up: Systemic: Fainting / Unresponsive-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: left arm numbness prior to becoming unresponsive


VAERS ID: 1512762 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Dyspnoea, Migraine, Muscle spasms, Pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Adderall, Daily Vitamin, Fish oil, Vit D, Vit B Complex, Viviscal
Current Illness:
Preexisting Conditions: psoriasis, eczema
Allergies: Sulfa Abx
Diagnostic Lab Data:
CDC Split Type:

Write-up: Heart Rate in 130''s, short of breath, pulse ox 92-93%, low grade fever (99.9-100.5), chills, generalized body aches & cramping, frontal migraine. Fever seemed to occur in early morning (about 01:00 am). By 04:30 am, all of the other listed symptoms were present. Treatment was related to symptom management; 1L of water, Tylenol Cold & Sinus Severe (acetaminophen, phenylephrine, guaifenesin), and sleep.


VAERS ID: 1512782 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 1 LA / IM

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

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

Write-up: Found patient slumped over wheel in car post vaccine. She was alert and oriented and said she felt dizzy. EMS checked her out and she said she felt fine and left the site


VAERS ID: 1512791 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Condition aggravated, Epistaxis
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: Multivitamin, vitamin d, vitamin c
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Nosebleed that lasted for over 25 minutes. I have not had a nose bleed since I was a child nor am I currently sick or have irritated nostrils.


VAERS ID: 1512794 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: New York  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN A420A21 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Disorientation, Muscle spasms, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: After receiving a vaccine patient became disoriented fainted and exhibit muscle spasms. Treat it with Aromatic ammonia salt and water. Upon arrival of EMS patient got some glucose as well. Last report he was felling better, EMS took patient to the bus for check up. Unknown if patient went to the emergency room.


VAERS ID: 1512796 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-27
Onset:2021-07-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Cough, Paraesthesia
SMQs:, Anaphylactic reaction (broad), 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: Tylenol
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Since receiving the vaccine, my fingertips underneath the fingernails all felt as though they had frostbite/tingling on and off. This has reduced in effect over time. I have developed strong chest discomfort and a cough exactly 48 hours after receiving my second dose.


VAERS ID: 1512801 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7485 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenopia, Chest pain, Dizziness, Hypoaesthesia, Limb discomfort, Paraesthesia, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Corneal disorders (broad), Vestibular disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: arm swelling with Hep A/B
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: sulfa
Diagnostic Lab Data: All vitals were normal per the paramedics
CDC Split Type:

Write-up: SHE HAD NUMBNESS AND TINGLING IN THROAT, HEAD, FACE, ARM. LIGHTHEADEDNESS, MILD CHEST PAIN. she had heaviness in her eyes and arm . This was all starting about 15 min after receiving the vaccine


VAERS ID: 1512806 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 LA / -

Administered by: Public       Purchased by: ?
Symptoms: Chest discomfort, Pruritus, Rash, Rash macular
SMQs:, Anaphylactic reaction (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: Trazodone 50 mg 1/2 HS birth control pills Tylenol
Current Illness: None
Preexisting Conditions: GB issues
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pressure center of chest lasted a few seconds within the hour of the injection. Onset of red, pinpoint rash over anterior chest and shoulders. Red with some itching. No SOB, no swelling


VAERS ID: 1512847 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026C21A / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (broad)

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

Write-up: PATIENT RECIEVED MODERNA FOR SECOND DOSE, FIGURED OUT AFTERWARDS THAT PATIENT GOT PFIZER FOR 1ST SHOT


VAERS ID: 1512879 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-01-30
Onset:2021-07-29
   Days after vaccination:180
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Atrial fibrillation, Blood culture negative, Blood lactate dehydrogenase normal, Brain natriuretic peptide increased, C-reactive protein normal, COVID-19, Condition aggravated, Cough, Fibrin D dimer, Pain, SARS-CoV-2 test positive, Streptococcus test negative, Troponin, White blood cell count decreased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Albuterol inhaler PRN, Spiriva inhaler, Flomax, finasteride, apixaban, metoprolol, atorvastatin, olmesartan, mirtazapine, zolpidem, cholecalciferol, vitamin B complex
Current Illness:
Preexisting Conditions: Atrial fibrillation, HTN, BPH, hyperlipidemia, OSA
Allergies: NKA
Diagnostic Lab Data: 7/28 COVID PCR+, 7/28 blood cx NGTD, Strept PNA antigen negative 7/28 WBC 3.11, d-dimer 0.22, CRP 0.59, LDH 180 7/28 BNP 1277, Troponin up to 139
CDC Split Type:

Write-up: Completed 2 dose vaccination series on 1/30/21 w/ Moderna Vaccine. Admitted 7/28/21 to Medical Center w/ complaints of weakness, body aches, dry cough. COVID PCR+ on 7/28. Also patient in atrial fibrillation. So far treated w/ dexamethasone, remdesivir x 1, vitamin D, zinc, vitamin C; O2 has improved from 3L NC to room air (sat 92-94%).


VAERS ID: 1512881 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 RA / IM

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

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

Write-up: Brought the patient back into the room for his first COVID-19 Pfizer vaccination. Verified name/birthdate. Went to inject the vaccine, inserted the tip of the needle into the right deltoid as I realized I had not pulled up the vaccine into the syringe. Quickly removed the tip of the needle and stated, "I am so sorry I got ahead of myself and did not pull up the vaccine into the syringe. I typically do that before the patient comes back, I''m so sorry." Pt stated, "It''s okay, its fine no problem." Nothing was administered, there were no air, vaccine or medication in the syringe when the needle was inserted. Pt did not appear upset. Changed needles, pulled up the vaccine into the syringe in front of patient, showed it to him, injected the vaccine into the right deltoid no issues. Pt waited 15 minutes in the lobby with no reaction. Left without questions, complaints or issues. Occurrence report submitted.


VAERS ID: 1512886 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / IM

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

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

Write-up: 2ND DOSE OF VACCINE GIVEN TOO SOON. FIRST DOSE ADMINISTERED 7/14/21 SECOND DOSE GIVEN TODAY 7/29/21


VAERS ID: 1512898 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol
Current Illness: N/A
Preexisting Conditions: Asthma, HTN, Autism
Allergies: NKA
Diagnostic Lab Data: n/A
CDC Split Type:

Write-up: Patient was given a concentrated dose of Pfizer. Diluted with 0.8ml of sodium chloride instead of the 1.8ml


VAERS ID: 1512904 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Excessive eye blinking, Hyperhidrosis, Loss of consciousness, Seizure, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Ocular motility disorders (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: none known
Preexisting Conditions: none known
Allergies: nkda
Diagnostic Lab Data: None known
CDC Split Type:

Write-up: Patient sitting for prescribed observation time. I noticed her blinking rapidly and stepped out to ask if she was ok, she stated her vision was blurred and then proceeded to have what appeared to be a very brief seizure (5-10 seconds in length) then passed out briefly (10-15 seconds) when she came to she seemed completely normal again. We had her lie down on the bench and she drank some water, she was sweating more than normal. After 30 minutes or so she sat up for 5 minutes or so then stood and walked with mom out of store. Mom called pediatrician to see if they could have her seen.


VAERS ID: 1512906 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Chest discomfort, Discomfort, Dyspnoea, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad)

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

Write-up: Within a few moments pt complained of shortness of breath and chest tightness. We immediately called 911. I grabbed the emergency kit and sat with the patient. She became nauseous and seemed very uncomfortable, sitting and attempting to lay down. Fortunately, she remained awake and alert until emergency personnel arrived. No medication was administered by me. The emergency personnel evaluated her and determined that the pt was likely having an anxiety attack. The pt did not leave with EMS.


VAERS ID: 1512914 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-07-29
Onset:2021-07-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050C21A / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Musculoskeletal stiffness, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (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: MIRTAZAPINE, IBUPROFEN
Current Illness:
Preexisting Conditions: ASTHMA, NARCOLEPSY (IDIOPATHIC HYPERSOMNIA), Tourette''s SYNDROME
Allergies: NO KNOWN ALLERGIES
Diagnostic Lab Data:
CDC Split Type:

Write-up: tingling in right hand and stiffness in all fingers


VAERS ID: 1512917 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-03-11
Onset:2021-07-29
   Days after vaccination:140
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 01M20A / 1 - / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 044A21A / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Malaise
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: pt admitted to the hospital for COVID 19 symptoms post vaccination.


VAERS ID: 1512919 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-07-26
Onset:2021-07-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Dyspnoea, Fibrin D dimer normal, Troponin normal
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily multivitamin and probiotic
Current Illness: Summer cold at beginning of July (7/5-7/7) and underwent Covid PCR test the following week and was negative.
Preexisting Conditions: Diagnosed ADHD and was on Concerta (36 mg QD) from 07/01/2018 through 06/10/2021. Has not taken any ADHD medications since 06/10/2021.
Allergies: N/A
Diagnostic Lab Data: 07/29/2021: complete blood workup for cardiac markers, tryponins, d-dimer, etc. No abnormalities detected 07/29/2021: chest X-ray administered in ED, results normal
CDC Split Type:

Write-up: Symptoms for 14 year old male were chest pains on left side, with difficulty taking deep breath?s. Symptoms worse when lying down. Symptoms began at 3:00 AM and Continued until the morning when mother took son to local emergency room. Bloodwork and diagnostic x-ray showed no abnormalities, patient was discharged at 11:49 AM with recommendation of rest, ibuprofen or Tylenol as needed for chest discomfort. Advice to return to ED for worsening pain.


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