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

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



Case Details (Reverse Sorted by Onset Date)

This is page 400 out of 8,010

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VAERS ID: 1699145 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003657 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac discomfort, Cardiomegaly, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

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

Write-up: Felt like constant pressure on my heart; Felt like constant pressure on my heart; Heart enlarged; This case was received via regulatory agency(Reference number: GB-MHRA-ADR 25895125) on 05-Sep-2021 and was forwarded to Moderna on 05-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Felt like constant pressure on my heart), CARDIOMEGALY (Heart enlarged) and CARDIAC DISCOMFORT (Felt like constant pressure on my heart) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003657) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced CARDIOMEGALY (Heart enlarged) (seriousness criterion medically significant). On an unknown date, the patient experienced PERIPHERAL SWELLING (Felt like constant pressure on my heart) (seriousness criterion medically significant) and CARDIAC DISCOMFORT (Felt like constant pressure on my heart) (seriousness criterion medically significant). On 26-Aug-2021, CARDIOMEGALY (Heart enlarged) had resolved. At the time of the report, PERIPHERAL SWELLING (Felt like constant pressure on my heart) and CARDIAC DISCOMFORT (Felt like constant pressure on my heart) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. Patient experienced Palpitation along with pressure on heart. There were no relevant investigations or tests conducted.It was reported that patient had no symptoms associated with COVID-19 and was not enrolled in any clinical trials Company Comment : Based on the current available information and temporal association between the use of the product mRNA-1273 and the serious events Cardiomegaly, Cardiac discomfort and Peripheral swelling, a causal relationship cannot be excluded.No follow up is possible.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. Based on the temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. No follow up is possible.


VAERS ID: 1699175 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Lymphadenopathy, Nausea, Pain of skin, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fatigue
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.MOD20213

Write-up: Fatigue; Swollen lymph nodes; Nausea; Headache; Skin pain; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 25897086) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN OF SKIN (Skin pain), FATIGUE (Fatigue), LYMPHADENOPATHY (Swollen lymph nodes), NAUSEA (Nausea) and HEADACHE (Headache) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Fatigue. Concomitant products included VENLAFAXINE from 01-May-2019 to an unknown date for an unknown indication. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced PAIN OF SKIN (Skin pain) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 27-Aug-2021, PAIN OF SKIN (Skin pain), LYMPHADENOPATHY (Swollen lymph nodes), NAUSEA (Nausea) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided by the reporter. Patient was unable to stand. 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: 1699217 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: MELATONIN; RIGEVIDON (28); SERTRALINE
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Heavy periods; Insomnia
Allergies:
Diagnostic Lab Data: Test Date: 20210817; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101145576

Write-up: Swelling arm; This is a solicited report received from a contactable consumer from the regulatory authority Card Vaccine Monitor program. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-YCVM-202108191225023750-FR6PD. Safety Report Unique Identifier [GB-MHRA-ADR 25864996] A 16-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: FE3380), via an unspecified route of administration on 25Aug2021 (at the age of 16-years-old) as dose number unknown, single for COVID-19 immunization. Medical history included suspected COVID-19 from 15Aug2021 and ongoing, insomnia, heavy menstrual bleeding, depression; all from an unknown date and unknown if ongoing. Concomitant medication included melatonin (MANUFACTURER UNKNOWN) taken for insomnia from 09Jul2021 to an unspecified stop date; ethinylestradiol, levonorgestrel (RIGEVIDON (28)) taken for heavy menstrual bleeding from 11Nov2018 to an unspecified stop date; sertraline (MANUFACTURER UNKNOWN) taken for depression from 09Jul2021 to an unspecified stop date. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. On 25Aug2021 (same day of vaccination), patient experienced swelling arm. The event was serious (medically significant). The patient underwent lab tests which included SARS-CoV-2 Test: Negative (No - Negative COVID-19 test) on 17Aug2021. The outcome of event swelling arm was recovering. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1699236 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101137994

Write-up: Loss of taste; Dose 1 on 27Jun2021, dose 2 on 25Aug2021; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports. The first report is a report downloaded from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108301858241330-JDUJH. A female patient in her 20''s received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 2 via an unspecified route of administration on 25Aug2021 (Batch/Lot number was Not known) as single dose for COVID-19 immunisation. Medical history included pregnancy. Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 27Jun2021 (at the age of 26 years old) for COVID-19 immunisation and experienced Menstrual disorder, Ovulation bleeding, Frequent periods, Irregular periods, Painful periods, Breathlessness and Unintentional weight gain. The patient experienced loss of taste (medically significant) on 26Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 29Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of Loss of taste was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101133069 Same patient and drug, different event and dose


VAERS ID: 1699237 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chest pain, Chills, Feeling abnormal, Hallucination, Headache, Heart rate, Heart rate abnormal, Inappropriate schedule of product administration, Lymphadenopathy, Myalgia, Pruritus, Pyrexia, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MEBEVERINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease; Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: heart rate; Result Unstructured Data: Test Result:increasing and lowering
CDC Split Type: GBPFIZER INC202101138599

Write-up: some stronger pain under my left armpit; Skin rash; muscle pain; Headache; Chest pain; hallucinations; Glands swollen; heart rate increasing and lowering; looked extremely morbid; Inappropriate schedule of vaccine administered; chills; itching; fever; This is a spontaneous report from a contactable consumer (patient). This is the second of two reports. The first report is a report downloaded from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108292231101220-CM6K8, Safety Report Unique Identifier GB-MHRA-ADR 25865998. A 22-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), dose 2 via an unspecified route of administration on 25Aug2021 at 09:11 (at the age of 22 years old) as dose 2, single for COVID-19 immunisation. Medical history included Inflammatory bowel disease/Irritable bowel (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis); crohn''s disease, ulcerative colitis. Concomitant medications included mebeverine taken for irritable bowel from 01Mar2019. Patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: solution for injection), dose 1 via an unspecified route of administration on 25Jun2021 (at the age of 22 years) as dose 1, single for COVID-19 immunisation and experienced fever, hallucinations, rash, chills, itching and muscle pain. The patient experienced, muscle pain, headache, hallucinations, chest pain, glands swollen, heart rate increasing and lowering and looked extremely morbid on 26Aug2021; skin rash on 27Aug2021, some stronger pain under my left armpit on 29Aug2021; chills, itching and fever on an unknown date in 2021 and inappropriate schedule of vaccine administered on 25Aug2021. Patient reported that he got his first vaccine 8 weeks prior to the second one with only a fever and chills but after getting the 2nd dose of the vaccine on the Wednesday morning (25Aug2021) at 9:11 am he was fine through the day, he went to bed that night and woke up at 2 am with extreme muscle pain and a headache, that was followed by heart rate increasing and lowering. The pain was quite intense and constant for about 5 hours, He couldn''t stop himself from moving because of the pain for some reason, he noted hallucinations as a side effect as during this pain he saw his chest moving and felt like my organs were moving under his skin and moving his skin, not entirely sure if this was some kind of fever dream or lucid dream but it felt very very real, and looked extremely morbid, After about 5 hours of this he must have fallen asleep and woke up at 8 am, informed his employer she wouldn''t be at work and spent the day in bed, he had 8 capsules for paracetamol though out the day taking the recommended doses through the day however they did not really help all that much, muscle pain and headaches were constant through the day even after having lots of water, paracetamol and ibuprofen, After the day of the 26Aug2021 he did not have any more hallucinations, on the 27Aug2021 the side effects were very much the same as the previous day except for a rash appearing on his lower stomach, in between the belly button and above the groin, itchy red dots was what it looks like, and also some chest pain. Today is the night of Sunday the 29Aug2021 and he in bed still with muscle pain, not as intense as the first day but still constant, and a constant headache, still getting chest pain on the left of my chest, not sever but uncomfortable, the rash on his lower stomach are still there and itching, some stronger pain under my left armpit, he had taken no more treatment for these side effects other that OTC pain medication nor seemed medical advice. Patient had not tested positive for COVID-19, since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab test which included heart rate which was increasing and lowering on 26Aug2021. Therapeutic measures were taken as a result the events with lots of water, paracetamol and ibuprofen. The outcome of the events fever, chills, itching, muscle pain, headache, chest pain, skin rash were not recovered; heart rate increasing and lowering was recovering; some stronger pain under my left armpit, looked extremely morbid was unknown; hallucinations was recovered on 26Aug2021; glands swollen was recovered on 27Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101126216 same patient/same product, different dose/events


VAERS ID: 1699296 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-08-25
   Days after vaccination:113
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: carries the L452R mutant strain but does not carry; Comments: carries the L452R mutant strain but does not carry N501Y or E484K mutant genes; Test Date: 20210825; Test Name: COVID-19 virus test; Test Result: Negative; Test Date: 20210827; Test Name: COVID-19 virus test; Test Result: Positive.
CDC Split Type: HKPFIZER INC202101161167

Write-up: CARRIES THE L452R MUTANT STRAIN; CARRIES THE L452R MUTANT STRAIN; This is a spontaneous report from a non-contactable healthcare professional via the Regulatory Authority (regulatory authority number: not applicable), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003273), license party for bnt162b2 (COMIRNATY). This case was split for 1 of 5 cases that confirmed COVID-19 after Comirnaty vaccination and the RA is investigating this case involving a patient who carries the L452R mutant strain. A 68-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), dose 2 via an unknown route of administration on 04May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient carries the l452r mutant strain and had covid-19 and had a vaccination failure on 25Aug2021. The result of patient''s specimen collected upon arrival on the same day was tested negative for COVID-19. Subsequently, his sample collected on 27-Aug-2021 at a designated quarantine hotel was tested positive for COVID-19. The test result from the RA revealed that the patient carries the L452R mutant strain but does not carry N501Y or E484K mutant genes. The patient developed symptoms like cough, sore throat, and running nose since 25-Aug-2021. Epidemiological investigation and contact tracing of the case is continuing. The adverse event carries the L452R mutant strain was considered as Important Medical Event. The patient underwent lab tests and procedures which included Covid-19 virus test carries the l452r mutant strain on Aug2021 (carries the L452R mutant strain but does not carry N501Y or E484K mutant genes), Covid-19 virus test negative on 25Aug2021, Covid-19 virus test positive on 27Aug2021. The outcome of event was unknown. Causality Assessment for the COMIRNATY and events COVID-19, Vaccination failure as Per Reporter is Possible, and as Per Company (BioNTech SE) is Possible. This is one of six reports received from the same reporter and this case has been linked with others. Link numbers are as follows 2021FOS003268 (master case), 2021FOS003273, 2021FOS003274, 2021FOS003275, 2021FOS003276, and 2021FOS003277. Follow-up closed, no further information is possible. Linked Report(s): HK-PFIZER INC-202101167616 Same reporter, similar events in different Patients.


VAERS ID: 1699605 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-08-25
   Days after vaccination:202
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Conjunctivitis, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Severe cutaneous adverse reactions (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210825; Test Name: COVID-19 molecular test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101129269

Write-up: vaccination failure; vaccination failure/COVID-19 antigen test and COVID-19 molecular test: both positive; cluster PRIVACY Positive molecular swab in vaccinated subject 14Jan and 04Feb. Symptoms: asthenia; cluster PRIVACY Positive molecular swab in vaccinated subject 14Jan and 04Feb. Symptoms: fever, chills; cluster PRIVACY Positive molecular swab in vaccinated subject 14Jan and 04Feb. Symptoms: conjunctivitis; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority, number is IT-MINISAL02-776448. A 73-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 intramuscular, administered in left arm on 04Feb2021 (Batch/Lot Number: EK9788; Expiration Date: 31May2021) as dose 2, 0.3 ml, single, dose 1 intramuscular, administered in right arm on 14Jan2021 (Batch/Lot Number: EL1484; Expiration Date: 30Apr2021) as dose 1, 0.3 ml, single for COVID-19 immunisation. Medical history included diabetes mellitus from 22May2021. The patient''s concomitant medications were not reported. The patient experienced vaccination failure and cluster privacy positive molecular swab in vaccinated subject 14Jan2021 and 04Feb2021 symptoms: asthenia (reported as medically significant), fever chills, conjunctivitis on 25Aug2021. The patient underwent lab tests and procedures which included COVID-19 antigen test and COVID-19 molecular test: both positive on 25Aug2021. The outcome of asthenia, fever chills, conjunctivitis were not recovered and other events was unknown. Summary of Investigation: Conclusion: The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lots of the reported lot EL1484 and EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1699659 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-25
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Maternal exposure during pregnancy, Pain in extremity, Pericarditis, Respiratory fatigue
SMQs:, Systemic lupus erythematosus (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Chronic kidney disease (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: ITPFIZER INC202101135904

Write-up: Respiratory fatigue/respiratory difficulty; Pain retrosternal; Diagnosis of Pericarditis; Pain in left arm; Pregnancy: Yes; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-777148. A 39-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FG4493, Expiry date was unknown), via intramuscular route of administration in left arm on 07Aug2021 14:16 as diose 2, 0.3 ml, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine included first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch Number: FE2707, Expiry date: unknown) via unspecified route of administration in the left shoulder on 03Jul2021 at 14:06 as dose 1, single for covid-19 immunisation. On 25Aug2021, the patient experienced pain in left arm, respiratory fatigue/respiratory difficulty, pain retrosternal, diagnosis of pericarditis, on an unspecified date in 2021, the patient pregnancy the mother reported she became pregnant while taking bnt162b2. The mother was 8 months pregnant at the onset of the event. Measures taken (Admission to emergency room (ER) on 25Aug2021 with the diagnosis of pericarditis under the treatment with ibuprofen and Proton pump inhibitors (PPI)). Outcome of the events was recovering. Reporter comment: appearance of pericarditis about 15 days after the second dose of Pfizer''s sars-cov-2 vaccine Regulatory Authority Comment: No drug adverse reaction. The 1st dose of the vaccine batch FE2707 administered on 03Jul2021 at 02:06 pm on the left shoulder. The doctor reports a serious reaction with yellow code ER access. The updated information will be provided with ER discharge as soon as possible No follow-up attempts are possible, no further information is expected


VAERS ID: 1699669 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-08-25
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Hyperhidrosis, Injection site pain, Myocardial necrosis marker increased, Myocarditis
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Pain injection site; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-777785) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL NECROSIS MARKER INCREASED, HYPERHIDROSIS, CHEST PAIN, and MYOCARDITIS in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005244) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced MYOCARDIAL NECROSIS MARKER INCREASED (seriousness criteria hospitalization and medically significant), HYPERHIDROSIS (seriousness criterion hospitalization), CHEST PAIN (seriousness criterion hospitalization) and MYOCARDITIS (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INJECTION SITE PAIN (Pain injection site). On 30-Aug-2021, MYOCARDIAL NECROSIS MARKER INCREASED, HYPERHIDROSIS, CHEST PAIN and MYOCARDITIS had resolved. At the time of the report, INJECTION SITE PAIN (Pain injection site) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Lab data included were on 25 Aug 2021, Troponin I and PCR was performed - No results were provided. Based on the current available information and temporal association between the use of the product and the start date of the events Myocardial necrosis marker increased, Hyperhidrosis, Chest pain and Myocarditis, a causal relationship cannot be excluded. Very limited information regarding the event Injection site pain has been provided at this time. Translation of the document has been requested.; Reporter''s Comments:. 30/08/2021: 1 dose; 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 Myocardial necrosis marker increased, Hyperhidrosis, Chest pain and Myocarditis, a causal relationship cannot be excluded. Very limited information regarding the event Injection site pain has been provided at this time. Translation of the document has been requested.


VAERS ID: 1699685 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Headache, Hyperpyrexia, Hypokinesia, Oropharyngeal pain, Pain in extremity, Pharyngeal erythema
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: $g39.5
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory Agency (Reference number: IT-MINISAL02-778144) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of HYPERPYREXIA in a 22-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Aug-2021 at 2:10 PM, the patient experienced HYPERPYREXIA (seriousness criterion medically significant), OROPHARYNGEAL PAIN, PHARYNGEAL ERYTHEMA, PAIN IN EXTREMITY, HYPOKINESIA and HEADACHE. At the time of the report, HYPERPYREXIA, OROPHARYNGEAL PAIN, PHARYNGEAL ERYTHEMA, PAIN IN EXTREMITY, HYPOKINESIA and HEADACHE was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, Body temperature: $g39.5 (High) $g39.5. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported. 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. Hyperpyrexia is reported as non-serious, and it appears non-serious as per information In the case However it captured serious as it is I IME. Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Translation received on 09-SEP-2021 contain time of reaction.; 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.Hyperpyrexia is reported as non-serious, and it appears non-serious as per information In the case However it captured serious as it is I IME.


VAERS ID: 1699871 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Haemorrhage subcutaneous
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101136368

Write-up: Haemorrhage subcutaneous with a diameter of about 3 cm appeared on the forearm/Haemorrhage subcutaneous in forearm; Erythema which diameter was 1-2 cm; This is a spontaneous report from a contactable physician communicated to Pfizer sales representative via Medical Information Team. A 62-year-old female patient received first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: unknown, Expiration date: unknown, dosage was unknown), via an unspecified route of administration on 23Aug2021 (the day of vaccination) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Aug2021 (Two days after vaccination), the patient experienced haemorrhage subcutaneous with a diameter of about 3 cm appeared on the forearm/haemorrhage subcutaneous in forearm and the patient experienced erythema which diameter was 1-2 cm on an unspecified date in 2021. The clinical course was reported as follows: On 25Aug2021 (Two days after vaccination), the patient experienced haemorrhage subcutaneous with a diameter of about 3 cm appeared on the forearm. The physician had never seen a case of haemorrhage subcutaneous. This event was found after using the product. The patient was worried about second dose vaccination since this was the first-time experience for the patient. The reporter wanted to know if it was okay for the patient to receive the second vaccination. The patient was scheduled to receive the second vaccination on 13Sep2021. The outcome of events 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 available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of haemorrhage subcutaneous . 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: 1699963 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (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: AUPFIZER INC202101139491

Write-up: This is a spontaneous report from a contactable healthcare professional, via the regulatory authority (report number: 610857). A 36-year-old female patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# and expiration date not reported), route of administration unspecified, therapy date unspecified, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications not reported. On Aug 25, 2021, patient had spontaneous abortion; with outcome of not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1699965 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: AUPFIZER INC202101139510

Write-up: Anaphylactic reaction; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 610617. A 25-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction on 25Aug2021. The outcome of the event was recovered on an unknown date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1699970 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Menstrual disorder, Postmenopausal haemorrhage
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139546

Write-up: Postmenopausal haemorrhage; Dysmenorrhoea; Menstrual disorder; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority. Regulatory authority report number is 611017. A 53-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced postmenopausal haemorrhage, dysmenorrhea and menstrual disorder. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1699975 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dry mouth, Dysgeusia, Hypertension, Muscle twitching, Paraesthesia oral, Trichoglossia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dyskinesia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypertension (narrow), Hypersensitivity (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139603

Write-up: This is a spontaneous report from a contactable other healthcare professional, via the regulatory authority (report number: 611187). A 19-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. The patient experienced anaphylactic reaction, dry mouth, dysgeusia, hypertension, muscle twitching, oral paresthesia and trichoglossia all on Aug 25, 2021; with outcome of not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1699993 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Chills, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: AUPFIZER INC202101139728

Write-up: This is a spontaneous report from a contactable healthcare professional, via the regulatory authority (report number: 611978). A 63-year-old female patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. On Aug 25, 2021, patient experienced syncope, abdominal pain and chills. The outcome of events recovered on an unspecified date. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1700002 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Feeling cold, Seizure
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased
CDC Split Type: AUPFIZER INC202101139858

Write-up: Seizure; Blood pressure decreased; Feeling cold; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 612571. A 27-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced seizure, blood pressure decreased, feeling cold, all on 25Aug2021 with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1700004 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-25
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139869

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 612728. A 45-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 06Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis on 25Aug2021 (19 days after the vaccination). The patient is recovering from the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1700037 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Hyperhidrosis, Pericarditis, Pyrexia, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101140225

Write-up: Pericarditis; Chest pain; Dyspnoea; Hyperhidrosis; Pyrexia; Tremor; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 613534. A 32-years-old female patient received dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient also received levothyroxine sodium, via an unspecified route of administration from an unspecified date at unknown dosage for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced pericarditis, chest pain, dyspnoea, hyperhidrosis, pyrexia and tremor all on 25Aug2021. The action taken in response to the events for levothyroxine sodium was unknown. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1700042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101140286

Write-up: Anaphylactic reaction; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. The regulatory authority report number is 614145. A 51-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) dose number was unknown, single for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction on 25Aug2021. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1701248 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CETIRIZINA [CETIRIZINE HYDROCHLORIDE]; PARACETAMOL ALMUS; HEMICRANEAL [ATROPA BELLADONNA EXTRACT;CAFFEINE;ERGOTAMINE TARTRATE;PARACETAMOL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Metrorrhagia; This case was received via regulatory authority (Reference number: ES-AEMPS-985894) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (Metrorrhagia) in a 30-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETIRIZINA [CETIRIZINE HYDROCHLORIDE]) for Allergy, PARACETAMOL (PARACETAMOL ALMUS) and ATROPA BELLADONNA EXTRACT, CAFFEINE, ERGOTAMINE TARTRATE, PARACETAMOL (HEMICRANEAL [ATROPA BELLADONNA EXTRACT;CAFFEINE;ERGOTAMINE TARTRATE;PARACETAMOL]) for an unknown indication. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced INTERMENSTRUAL BLEEDING (Metrorrhagia) (seriousness criterion medically significant). At the time of the report, INTERMENSTRUAL BLEEDING (Metrorrhagia) outcome was unknown. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 25-Aug-2021. No treatment medication details was reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Events seriousness captured as per Regulatory Authority assessment in Source Document. Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Translation received on 10-sep-2021. Dose details was added.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.Events seriousness captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1701368 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-11
Onset:2021-08-25
   Days after vaccination:136
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, C-reactive protein, COVID-19, Drug ineffective, Dyspnoea, Glomerular filtration rate, Pyrexia, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: STAGID; NEBIVOLOL; HYDROCHLOROTHIAZIDE; LOSARTAN ACCORD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Diabetes; Obesity
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:45 mg/l; Test Name: GFR; Result Unstructured Data: Test Result:17; Test Date: 20210825; Test Name: rapid serological tests; Test Result: Positive ; Test Date: 20210825; Test Name: PCR; Test Result: Positive ; Comments: strong
CDC Split Type: FRPFIZER INC202101142993

Write-up: Vaccination failure; COVID-19; Acute renal insufficiency; dyspnoea; fever; This is a spontaneous report from a contactable pharmacist downloaded from a regulatory authority. regulatory authority number FR-AFSSAPS-ST20213233. A 72-year-old male patient received bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot Number: Unknown), dose 2 via an intramuscular route of administration, administered in Arm Left on 11Apr2021 as Dose 2, 0.3mL, Single for COVID-19 immunization. Medical history included Arterial hypertension, Diabetes and obesity. The patient had no COVID-19 history. Concomitant medication(s) included Metformin embonate (STAGID); Nebivolol; Hydrochlorothiazide and Losartan potassium (LOSARTAN ACCORD), all taken for an unspecified indication, start and stop date were not reported. On 25Aug2021, the patient experienced covid-19 (covid-19). On an unspecified date in 2021, the patient experienced dyspnoea, fever and acute renal insufficiency. It was reported that on 25Aug2021, patient presented oxygen dependent COVID and hospitalized. The patient underwent lab tests and procedures which included, on an unspecified date in 2021c-reactive protein: 45 mg/l, glomerular filtration rate: 17, rapid serological tests: positive on 25Aug2021, PCR (polymerase chain reaction) plus strong: positive on 25Aug2021 strong. It was reported that Screening was in progress and 50 percent pulmonary involvement with fever and dyspnea. Acute renal insufficiency on chronic renal insufficiency by renal lithiasis with GRF: 17. The patient was Put on Augmentin for focus of superinfection. The patient outcome of the event COVID-19 was not resolved and the outcome of other events was Unknown at the time of this report. No follow-up attempts are possible, information about batch number cannot be obtained.


VAERS ID: 1701400 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Electrocardiogram, Inappropriate schedule of product administration, Investigation, Pain, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Unknown Results; Test Name: general tests; Result Unstructured Data: Test Result:Unknown Results; Test Date: 20210207; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101138164

Write-up: Vomiting; Chest pain; Generalised aching/full body aches; feverish; bnt162b2 on 30Jun2021 as first dose/on 25Aug2021 as second dose; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108271314082410-O9HIU, Safety Report Unique Identifier GB-MHRA-ADR 25859417. A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 25Aug2021 (Lot Number: FE3380) at the age of 21 years old, as second dose, single for covid-19 vaccination. Medical history included non-ongoing suspected covid-19 from 07Mar2021 to 11Jul2021. Patient is not pregnant and not currently breastfeeding. Concomitant medication included ethinylestradiol, levonorgestrel (RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]) as birth control pill from 01Aug2019. The patient previously took bnt162b2 on 30Jun2021 (Lot Number: Fc9001) as first dose, single for covid-19 vaccination. On 25Aug2021, the patient experienced feverish and generalised aching/full body aches. On 26Aug2021, the patient experienced vomiting and chest pain. "Felt feverish and full body aches on the evening of the 25th (when I received 2nd jab), then threw up in the night (26Aug2021), then again the next day. Also woke up with chest pains on the 26th. Went to urgent treatment centre and got codeine and GAVISCON which helped initially but not fully better." Events feverish, vomiting, chest pain, generalised aching/full body aches required physician office visit. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included electrocardiogram: unknown results on unspecified date; covid-19 virus test: Yes - Positive COVID-19 test on 07Feb2021, and general tests: unknown results on unspecified date. Therapeutic measure was taken as a result of the events feverish, vomiting, chest pain, generalised aching/full body aches. Outcome of the events feverish, vomiting, chest pain and generalised aching/full body aches was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1701402 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Bone neoplasm, Bone pain, Inappropriate schedule of product administration, Lymphadenopathy, Neck pain, SARS-CoV-2 test
SMQs:, Osteonecrosis (broad), Arthritis (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological tumours of unspecified malignancy (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: AMITRIPTYLINE; RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Irritable bowel syndrome
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101138090

Write-up: pain up the left side of my neck and across the left side of my collar bone; pain up the left side of my neck and across the left side of my collar bone; fleshy lump sitting on my collar bone; Painful lymphadenopathy/swollen lymph nodes/swollen glands in my left armpit; bnt162b2 on 30Jun2021 as first dose/on 25Aug2021 as second dose; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108271943480680-85XKD, Safety Report Unique Identifier GB-MHRA-ADR 25861630. A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, in the left arm, on 25Aug2021 (Lot Number: FE8087), at the age of 25 years old, as second dose, single for COVID-19 vaccination. Medical history included irritable bowel syndrome. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and not currently breastfeeding. Concomitant medications included amitriptyline for irritable bowel syndrome and ethinylestradiol, levonorgestrel (RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]) for contraception. The patient previously took bnt162b2 on 30Jun2021 (Lot Number: FD5613), as first dose, single for COVID-19 vaccination. On 27Aug2021, the patient experienced painful lymphadenopathy/swollen lymph nodes. On unspecified date, the patient experienced pain up the left side of my neck and across the left side of my collar bone and fleshy lump sitting on my collar bone. "Woke up this morning with swollen glands in my left armpit which is the arm I had the vaccine in. I also had pain up the left side of my neck and across the left side of my collar bone. After inspecting my collar bone I noticed I had a fleshy lump sitting on my collar bone but when touched can easily be moved to above my collar bone." Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included covid-19 virus test: No - Negative COVID-19 test on an unspecified date. Outcome of the event painful lymphadenopathy/swollen lymph nodes was not recovered. Outcome of all the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1701413 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear swelling, Rash, SARS-CoV-2 test, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101138145

Write-up: Swelling face; Ear swelling; Rash; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108310920246910-GZUQI and Safety Report Unique Identifier GB-MHRA-ADR 25872866. A 25-year-old female patient (not pregnant, not currently breastfeeding) received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot unknown), via an unspecified route of administration on 22Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included decreased lactation. The patient''s concomitant medications were not reported. The patient informed that her ears began to swell on 25Aug2021 and a rash began on the ears at the same time. The next morning (26Aug2021), she woke up to a swollen face covered in a rash. Her neck and chest area were also rash covered. The rash then started to spread down her arms and came up on inner thigh too. Both a pharmacist and her GP have agreed it was likely a reaction to the second dose of the vaccine. She had supplied with strong antihistamines and steroid creme neither of which helped, and the reaction is still ongoing. The events were serious medically significant. The patient underwent laboratory test which included Sars-cov-2 test: negative on unspecified date. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1701488 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Decreased appetite, Fatigue, 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: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101145472

Write-up: SARS-CoV-2 infection; Fatigue; Severe fatigue; No appetite; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109011321419490-9AWUB. Safety Identifier Report Unique (GB-MHRA-ADR 25879868). A 17-year-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration at DOSE 1, SINGLE on 23Aug2021 for COVID-19 immunization. Medical history included suppressed lactation, suspected COVID-19 from 26Aug2021 and ongoing. Patient is not pregnant. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. On 26Aug2021 patient experienced SARS-CoV-2 infection, on 25Aug2021 fatigue, on an unspecified date in 2021 severe fatigue and no appetite. The patient underwent lab tests which included SARS-CoV-2 test: yes - positive COVID-19 test on 26Aug2021. Patient is not enrolled in clinical trial Suspect Reactions Please provide details of any relevant investigations or tests conducted: "Called emergency services". The outcome for severe fatigue, no appetite was unknown, for fatigue and Covid-19 it was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1701492 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Myalgia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Headache; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210526; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101145408

Write-up: feeling unwell; muscle soreness; Fainting; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109011349005600-ZJLOL. Safety Report Unique Identifier GB-MHRA-ADR 25880172. A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot number and Expiry date: not reported), dose 2 via an unspecified route of administration on 24Aug2021 as DOSE 2, SINGLE for COVID-19 immunisation. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot number and Expiry date: not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included suspected COVID-19 from 25May2021 to 12Jun2021 and headache from an unknown date and unknown if ongoing. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medications included paracetamol taken for headache from 18Jul2021 to 18Jul2021. On an unspecified date, the patient experienced feeling unwell and muscle soreness. On 25Aug2021, patient experienced fainting. It was reported that the patient woke up at 3am feeling muscle soreness and general discomfort/feeling unwell. Went to toilet and fainted while urinating (standing up) - fortunately did not hit his head. Continued to feel unwell for a few hours after, felt back to normal by 6pm the same day. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26May2021 (yes - positive COVID-19 test). Outcome of the events feeling unwell and muscle soreness was recovered on an unspecified date and fainting was recovered on 25Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.


VAERS ID: 1701546 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, SARS-CoV-2 test
SMQs:, Hearing impairment (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 ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101145360

Write-up: Bell''s palsy/onset of altered sensation in tongue; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109012232048810-NJPDL. Safety Report Unique Identifier GB-MHRA-ADR 25883187. A 20-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 25Aug2021 (age at vaccination 20-year-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Normally fit and well. No PMHx, unsure if patient had symptoms associated with COVID-19. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: not reported) on an unknown date as dose 1, single for COVID-19 immunization. On 25Aug2021, the patient experienced bell''s palsy/ onset of altered sensation in tongue. It was reported that onset of altered sensation in tongue that started on the day of the vaccine (post-dose). 3 days later started getting mild unilateral lower motor neuron facial weakness. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (No- Negative COVID-19 test) on an unspecified date. Patient was not enrolled in clinical trial. The outcome of event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.


VAERS ID: 1701612 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004667 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Erythema, Maternal exposure during breast feeding, Menstruation delayed, Migraine, Pruritus, Scab, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal exposures via breast milk (narrow), Fertility disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Migraine; Redness; Scab; Itching; Itchy; Maternal exposure during breast feeding; Late period; Swelling; Back pain; This case was received via RA (Reference number: GB-MHRA-ADR 25904819) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), ERYTHEMA (Redness), SCAB (Scab), PRURITUS (Itching), PRURITUS (Itchy), BACK PAIN (Back pain), MENSTRUATION DELAYED (Late period), SWELLING (Swelling) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004667) for COVID-19 vaccination. Concurrent medical conditions included Breast feeding. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced BACK PAIN (Back pain) (seriousness criterion medically significant). On 03-Sep-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant). On 04-Sep-2021, the patient experienced MENSTRUATION DELAYED (Late period) (seriousness criterion medically significant). On an unknown date, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant), ERYTHEMA (Redness) (seriousness criterion medically significant), SCAB (Scab) (seriousness criterion medically significant), PRURITUS (Itching) (seriousness criterion medically significant), PRURITUS (Itchy) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). On 27-Aug-2021, BACK PAIN (Back pain) had resolved. At the time of the report, MIGRAINE (Migraine), ERYTHEMA (Redness), SCAB (Scab), PRURITUS (Itching) and PRURITUS (Itchy) had resolved, MENSTRUATION DELAYED (Late period) had not resolved, SWELLING (Swelling) was resolving and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. The vaccination was administered in (private). On 24-Aug-2021, at 14:45 the patient had a migraine and sudden back pain. The migraine lasted all night but became less severe when I took paracetamol and was gone by morning but the back pain became worse. Moving was difficult, I could not sit, stand or lie down without pain. The pain was located in my lower back. On 27-Aug-2021, the patient noticed that there was swelling at the base of spine. The swelling itself was not painful but it was soft to the touch, like it was filled with gel. The back pain ended by the night of the 27-Aug-2021 and the swelling was gone by 29-Aug-2021. Further, on 03-Sep-2021 the injection site became itchy, red and swollen. The injection mark began to bleed and turned into a scab which was strange to me as I would have been hard pressed to find where the needle went in. As of now, 07-Sep-2021 the swelling and redness has gone but the itching remains. Lastly, my period was late. It was very rare for me to have a late period. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This is a case of Maternal exposure during breastfeeding with associated adverse events for this 31-year old female patient. 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. The events scab, itchy and redness refer to local symptoms related to vaccination site. Coding seems erroneous, but is is retained as reported by Regulatory Authority. Events seriousness criteria was assessed as per regulatory authority report. There is insufficient evidence to support seriousness from a clinical or regulatory standpoint.; Sender''s Comments: This is a case of Maternal exposure during breastfeeding with associated adverse events for this 31-year old female patient. 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. The events scab, itchy and redness refer to local symptoms related to vaccination site. Coding seems erroneous, but is is retained as reported by Regulatory Authority. Events seriousness criteria was assessed as per regulatory authority report. There is insufficient evidence to support seriousness from a clinical or regulatory standpoint.


VAERS ID: 1701824 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-08-25
   Days after vaccination:202
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210825; Test Name: COVID-19 molecular test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101135505

Write-up: carducci cluster, positive antigen (COVID-19 antigen test) and molecular buffer (COVID-19 molecular test) in patient (vaccinated on 12Jan2021 and 04Feb2021); carducci cluster, positive antigen (COVID-19 antigen test) and molecular buffer (COVID-19 molecular test) in patient (vaccinated on 12Jan2021 and 04Feb2021); Carducci cluster. Positive antigen and molecular buffer in subject vaccinated on 12Jan and 04Feb. Symptomatic with fever and asthenia; Carducci cluster. Positive antigen and molecular buffer in subject vaccinated on 12Jan and 04Feb. Symptomatic with fever and asthenia; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-776856. A 96-year-old female patient received the second dose of bnt162b2 (COMIRNATY, solution for injection), intramuscular, administered in Arm Left on 04Feb2021 (Lot Number: EK9788; Expiration Date: 31May2021) as dose 2, 0.3 ml single, the first dose intramuscular, administered in Arm Left on 12Jan2021 (Lot Number: EJ6797; Expiration Date: 30Apr2021) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced carducci cluster, positive antigen (COVID-19 antigen test) and molecular buffer (COVID-19 molecular test) in patient (vaccinated on 12Jan2021 and 04Feb2021). Symptomatic with fever and asthenia. The outcome of the events was not recovered. Investigation summary report details for BNT162B2 lot EJ6797 and lot EK9788. Conclusion: The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6797 and lot EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. It was concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint was not confirmed.


VAERS ID: 1701825 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-08-25
   Days after vaccination:202
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Conjunctivitis, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Severe cutaneous adverse reactions (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210825; Test Name: COVID-19 molecular test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101135511

Write-up: Positive antigenic and molecular swabs in subject vaccinated 14Jan2021 and 04Feb2021; Positive antigenic and molecular swabs in subject vaccinated 14Jan2021 and 04Feb2021; Symptomatic with asthenia; Symptomatic with fever; Symptomatic with rhinoconjunctivitis; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number is IT-MINISAL02-776857. An 86-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscularly, administered in left arm on 04Feb2021 (Batch/Lot Number: EK9788; Expiration Date: 31May2021) as dose 2, 0.3 ml single; and intramuscularly, administered in left arm on 14Jan2021 (Batch/Lot Number: EL1484; Expiration Date: 30Apr2021) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25Aug2021, positive antigenic and molecular swabs in subject vaccinated on 14Jan2021 and 04Feb2021. The patient was symptomatic with asthenia, pyrexia and rhino conjunctivitis on 25Aug2021. The patient underwent lab tests and procedures which included COVID-19 antigen test: positive and COVID-19 molecular test: positive; both on 25Aug2021. Outcome of events was not recovered. Investigation result received for BNT162B2 (COMIRNATY, Lot number: EL1484 and Expiration date: 30Apr2021). The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EL1484. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. Investigation result received for BNT162B2 (COMIRNATY, Lot number: EK9788, Expiration date: 31May2021). Conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.


VAERS ID: 1701847 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (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: ITPFIZER INC202101135916

Write-up: syncopal crisis; FARMAVIGITER This is a non-interventional study report from a contactable physician downloaded from a Regulatory Authority, regulatory authority number IT-MINISAL02-777157. A 49-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left (left shoulder) on 25Aug2021 (Lot Number: fg4686), at age of 49-year-old, as Dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced syncopal crisis (medically significant) on 25Aug2021 with outcome of recovered. Sender Comment: severity changed to "serious-other clinically relevant condition" as syncope is present in the IME list The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the reported information ,a causal relationship between the event syncope and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1701855 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-25
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Thrombosis, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to allopathic drugs; Drug allergy (Pfizer vaccine, Cefrtiaxone, and Metronidazole)
Allergies:
Diagnostic Lab Data: Test Name: CAT scan; Result Unstructured Data: Test Result: Unknown results; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result: thrombosis; Comments: Vena comitens thrombosis is diagnosed.
CDC Split Type: ITPFIZER INC202101135538

Write-up: Swollen left forearm vein with strange twinges of the same. The following day, a thrombosis of vena comitens of the humerus was diagnosed following venous Doppler ultrasound in the left arm.; This is a spontaneous report from a contactable consumer from the Regulatory Authority IT-MINISAL02-777355. A 37-year-old female patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in the left shoulder on 04Aug2021 (Batch/Lot Number: unknown) single, for COVID-19 immunization. Medical history included allergies (Pfizer vaccine, cefrtiaxone, and metronidazole) and allergy to allopathic drugs. There were no concomitant medications. On 25Aug2021, the patient experienced swollen left forearm vein with strange twinges of the same. The following day, a thrombosis of vena comitens of the humerus was diagnosed following venous doppler ultrasound in the left arm. The patient was currently being treated with Arixtra. The patient underwent laboratory tests and procedures which included CAT scan unknown results on an unspecified date. Outcome of the event was unknown. The reporter does not know the lot number, Hospital clinical documentation was requested, and Waiting for a reply. No follow-up attempts are possible, information about the lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1701864 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-25
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia, Quality of life decreased
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101150134

Write-up: Localized tingling; Impact on quality of life (5/10); This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number IT-MINISAL02-777633. A 28-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via intramuscular route, administered in left arm on 02Aug2021 (Batch/Lot Number: FF2752) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY, Solution for injection), dose 1 via intramuscular route, administered in left arm on 21Jun2021 (Batch/Lot Number: FC5089) as DOSE 1, SINGLE for covid-19 immunization. On 25Aug2021, the patient experienced localized tingling (paraesthesia). On an unspecified date in 2021, impact on quality of life (5/10) was reported. The outcome of paraesthesia was recovered with sequelae on an unspecified date and impact on quality of life was unknown. No follow-up attempts are possible; information about lot/batch number already obtained.


VAERS ID: 1701879 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Blood pressure fluctuation, Dyspnoea, Gastritis, Headache, Quality of life decreased, Tachycardia, Tinnitus, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Hypersensitivity (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Impact on quality of Life; Result Unstructured Data: Test Result:8/10
CDC Split Type: ITPFIZER INC202101150052

Write-up: Wheezing; Impact on quality of life (8/10); Continuous headache not strong; Stomach pain like gastritis; Tinnitus; Tachycardia; Stomach ache; Shortness of breath/ Breathlessness; Change in blood pressure/ Fluctuating pressure; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number IT-MINISAL02-777794. A 55-year-old female patient received first dose of bnt162b2 (COMIRNATY; Solution for injection; Lot Number: FG7387), via intramuscular, administered in left arm as single dose on 24Aug2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced continuous headache not strong, stomach pain like gastritis, tinnitus, tachycardia, shortness of breath/ breathlessness, change in blood pressure/ fluctuating pressure, wheezing and impact on quality of life (8/10). At the [time of this report, outcome of all events was not recovered, except wheezing and impact on quality of life were unknown.


VAERS ID: 1701925 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Dyspnoea, Echocardiogram, Fatigue, Laboratory test, Neck pain, Pericarditis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: cardiac echocolordoppler; Result Unstructured Data: Test Result:pericarditis; Comments: ascertained with cardiac echocolordoppler and laboratory analysis; Test Name: laboratory analysis; Result Unstructured Data: Test Result:pericarditis; Comments: ascertained with cardiac echocolordoppler and laboratory analysis
CDC Split Type: ITPFIZER INC202101147779

Write-up: Diagnosed Pericarditis; Diagnosed Pericarditis, with symptoms: neck pain; Diagnosed Pericarditis, with symptoms: fatigue in breathing; Diagnosed Pericarditis, with symptoms: fatigue in breathing; Diagnosed Pericarditis, with symptoms: back pain; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority WEB, regulatory authority number IT-MINISAL02-777923. A 23-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 25Aug2021 the patient experienced diagnosed pericarditis with symptoms of sternal and back and neck pain, fatigue in breathing. The patient underwent lab tests and procedures which included echocardiogram and laboratory test: pericarditis on ascertained with cardiac echocolordoppler and laboratory analysis on an unspecified date. The outcome of the event was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1701955 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-08-25
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003655 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Tachycardia paroxysmal
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? Yes
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: ITMODERNATX, INC.MOD20213

Write-up: Episodio di tachicardia parossistica con dispnea e dolore toracico. no sincope. non possibile ecg in urgenza madre cardiologa gi? sottoposta ad ablazione x tachic. Noda; Episodio di tachicardia parossistica con dispnea e dolore toracico. no sincope. non possibile ecg in urgenza madre cardiologa gi? sottoposta ad ablazione x tachic. Noda; Episodio di tachicardia parossistica con dispnea e dolore toracico. no sincope. non possibile ecg in urgenza madre cardiologa gi? sottoposta ad ablazione x tachic. Noda; This case was received via Regulatory Authority on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of TACHYCARDIA PAROXYSMAL (Episodio di tachicardia parossistica con dispnea e dolore toracico. no sincope. non possibile ecg in urgenza madre cardiologa gi? sottoposta ad ablazione x tachic. Noda), CHEST PAIN (Episodio di tachicardia parossistica con dispnea e dolore toracico. no sincope. non possibile ecg in urgenza madre cardiologa gi? sottoposta ad ablazione x tachic. Noda) and DYSPNOEA (Episodio di tachicardia parossistica con dispnea e dolore toracico. no sincope. non possibile ecg in urgenza madre cardiologa gi? sottoposta ad ablazione x tachic. Noda) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3005244 and 3003655) for COVID-19 immunisation. No Medical History information was reported. On 19-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 25-Aug-2021, the patient experienced TACHYCARDIA PAROXYSMAL (Episodio di tachicardia parossistica con dispnea e dolore toracico. no sincope. non possibile ecg in urgenza madre cardiologa gi? sottoposta ad ablazione x tachic. Noda) (seriousness criterion life threatening), CHEST PAIN (Episodio di tachicardia parossistica con dispnea e dolore toracico. no sincope. non possibile ecg in urgenza madre cardiologa gi? sottoposta ad ablazione x tachic. Noda) (seriousness criterion life threatening) and DYSPNOEA (Episodio di tachicardia parossistica con dispnea e dolore toracico. no sincope. non possibile ecg in urgenza madre cardiologa gi? sottoposta ad ablazione x tachic. Noda) (seriousness criterion life threatening). On 25-Aug-2021, TACHYCARDIA PAROXYSMAL (Episodio di tachicardia parossistica con dispnea e dolore toracico. no sincope. non possibile ecg in urgenza madre cardiologa gi? sottoposta ad ablazione x tachic. Noda), CHEST PAIN (Episodio di tachicardia parossistica con dispnea e dolore toracico. no sincope. non possibile ecg in urgenza madre cardiologa gi? sottoposta ad ablazione x tachic. Noda) and DYSPNOEA (Episodio di tachicardia parossistica con dispnea e dolore toracico. no sincope. non possibile ecg in urgenza madre cardiologa gi? sottoposta ad ablazione x tachic. Noda) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. First dose of Moderna lot 3003655 was administered on 19 Jul 2021 at 7:09 pm in the left shoulder. On 17-Aug-2021, the patient had undergone capillary fragility test but results was not reported. Treatment information was not provided. The patient underwent cardiac ablation for Tachycardia paroxistica. Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Translation received on 09-Sep-2021 included suspect vaccine details and updated narrative.; Reporter''s Comments: No ADR the 1st dose of Moderna lot 3003655 was administered on Jul 19, 2021 at 7:09 pm in the left shoulder. Documentation requested by RLFV Llocal pharmacovigilance manager] is attached; 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. However, more information is required for further assessment.


VAERS ID: 1701984 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101134751

Write-up: Headache; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21125391. A 14-year-month-old (age at vaccination) male patient received bnt162b2 (COMIRNATY; Solution of injection; Lot Number: FF3622; Expiration Date: 30Nov2021), via an unspecified route of administration on 25Aug2021 (the day of vaccination) (at the age of 14-years-old) at dose 2, single for covid-19 immunization. The patient''s concomitant medications were not reported. The patient had a medical history: the patient received the first dose of bnt162b2 (COMIRNATY, Intramuscular injection, Lot number FF3622 Pfizer and expiration date was 30Nov2021) on 04Aug2021. After receiving the corona virus Vaccine on 25Aug2021, the headache began from dusk and continued. The adverse event onset date was reported as on 25Aug2021 in the afternoon (the day of the vaccination). The course of the event was as follows: After receiving the corona virus Vaccine on 25Aug2021, the headache began from dusk and continued. The reporter classified the event as serious (can lead to disability) and assessed that the event was related to bnt162b2. On 30Aug2021 (5 days after the vaccination), the outcome of the event was not recovered. The reporter commented as follows: This side effect should be carefully managed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: The reporter comments: This side effect should be carefully managed.


VAERS ID: 1701993 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-25
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Angiocardiogram, Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Coronary angiography; Result Unstructured Data: Test Result:stenosis of about 75%
CDC Split Type: JPPFIZER INC202101135028

Write-up: Angina pectoris; Chest pain; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21125316. An 89-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on Jun2021 (at the age of 89 years old) as dose 2, single for COVID-19 immunisation. Medical history included arteriosclerosis. The patient''s concomitant medications were not reported. Body temperature before vaccination was unknown. On 25Aug2021 at 13:16, the patient experienced Angina pectoris. The course of the event was as follows: On 25Aug2021 (13:16), Chest pain appeared. Emergency transport because does not improve with nitro. On 25Aug2021, the patient was admitted to the hospital. Coronary angiography revealed stenosis of about 75%, and the patient was diagnosed with Angina pectoris. Outcome of events was unknown. The reporting physician classified the event as serious (caused hospitalization) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was Arteriosclerosis. The lot number for BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1701996 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Cellulitis, Erythema, Incision site complication, Joint swelling, Lymph node pain, Lymphadenopathy, Pain of skin, Skin swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before the vaccination; Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: after the vaccination
CDC Split Type: JPPFIZER INC202101135143

Write-up: Cellulitis; Swollen, redness and slight pain of lymph nodes; Swollen, redness and slight pain of lymph nodes; redness, swelling and slight pain of the surrounding skin /redness, swelling and slight pain of on the outside of the right ankle/Swollen, redness and slight pain of lymph nodes; redness, swelling and slight pain of the surrounding skin; redness, swelling and slight pain of the surrounding skin; redness, swelling and slight pain of on the outside of the right ankle; redness, swelling and slight pain of on the outside of the right ankle; deterioration of the incision site accompanied with surrounding redness and swelling; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21125322. A 40-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FE8206, Expiration date 31Oct2021) via an unspecified route of administration on 24Aug2021 at 15:00 at age of 40 years old as a single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. Body temperature before vaccination was 36.5 degrees Centigrade on 24Aug2021. Patient''s family history included H.P (as reported). There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 25Aug2021 around 06:00 (1 day after the vaccination), the patient experienced Swollen, redness and slight pain of neck lymph nodes; redness, swelling and slight pain of on the outside of the right ankle; Cellulitis (as an extra). Clinical course of the events was reported as follows: On 24Aug2021(the day of the vaccination), the patient received the first dose of Comirnaty (made by Pfizer). Multiple swollen lymph nodes in the left front neck appeared from the next day of the vaccination, redness, swelling and slight pain of the surrounding skin also appeared. Redness, swelling and slight pain of on the outside of the right ankle also appeared. The level was medium to high. The body temperature was 36.4 centigrade. On 24Aug2021(the day of the vaccination) in the morning, also, the back right proximal phalanx incision was conducted. On 25Aug2021(1 day after the vaccination), deterioration of the incision site accompanied with surrounding redness and swelling. Events resulted in Physician Office Visit. Treatment: Erythromycin 200mg (6), . Povidone-iodine solution 30cc. On an unspecified date, the outcome of event was not provided. The reporting physician classified the event as serious (medically significant) 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 above symptoms did not appear before this vaccination, the symptoms were judged as the side effects of this vaccination.


VAERS ID: 1702026 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Fall, Investigation, Loss of consciousness, Seizure, Syncope, Vomiting
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), Convulsions (narrow), 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 (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment: no other medical history
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210825; Test Name: various tests; Result Unstructured Data: Test Result:diagnosed as Neurally mediated syncope
CDC Split Type: JPPFIZER INC202101136433

Write-up: sudden Loss of consciousness; Convulsion of both hands; Neurally mediated syncope; fell down; Vomiting; This is a spontaneous report from a contactable Other Health Professional received via Regulatory Authority. A 49-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF9942, Expiration date 30Nov2021), via an intramuscular route, administered in arm left, on 25Aug2021 at 14:30 (the day of vaccination, at the age of 49-year-old) as dose 1 single, for COVID-19 immunisation. The patient''s medical history was none. The patient had no allergies to medications, food, or other products. The patient had no other medical history. The patient did not receive any other medications (concomitant medications) within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown prior to vaccination, whether the patient was diagnosed with COVID-19 or not. It was unknown since the vaccination, whether the patient has been tested for COVID-19 or not. On 25Aug2021 at 14:15 (as reported) (the day of vaccination), the patient experienced events loss of consciousness, convulsion, neurally mediated syncope, fall, and vomiting. The clinical course was reported as follows: 15 minutes after the vaccination (as reported) during the observation period at 14:45, the patient suddenly lost consciousness and fell down from the chair. There were vomiting, convulsion of both hands, and pallor facial. The patient was transferred to bed and regained consciousness but had heavy sweating and decreased blood pressure. Emergency transport to hospital was performed and patient was diagnosed as neurally mediated syncope by various tests. Symptoms were recovering by intravenous drip treatment and patient returned home with family at 18:00. The reporter stated the events result in emergency room/department or urgent care. The outcome of the events was recovering with treatment including intravenous drip administration. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available and a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1702028 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspartate aminotransferase, Aspartate aminotransferase increased, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Chest pain, Electrocardiogram, Electrocardiogram ST segment elevation
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210827; Test Name: Glutamic acid oxaloacetate transaminase; Result Unstructured Data: Test Result:increased; Test Date: 20210827; Test Name: Creatine kinase; Result Unstructured Data: Test Result:increased; Test Date: 20210827; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:ST elevated
CDC Split Type: JPPFIZER INC202101136473

Write-up: ST elevated; CK increased; GOT increased; Chest pain; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unknown age and gender received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration on 23Aug2021 as single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. On 30Jul2021, the patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration. On 23Aug2021 (the day of vaccination), the patient received the second dose of BNT162B2. On 25Aug2021 (2 days after vaccination), the patient experienced chest pain from the evening. On 27Aug2021 (4 days after vaccination), the patient received a diagnosis in the hospital. ST elevated on Electrocardiogram. CK increased (Creatine kinase) and GOT increased (Glutamic acid oxaloacetate transaminase). On 31Aug2021 (8 days after vaccination), the patient was referred to another hospital. The patient had no problems in daily life. The outcome of the events was not provided. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; 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 Electrocardiogram ST segment elevation, chest pain, Blood creatine phosphokinase increased and Aspartate aminotransferase increased 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: 1702040 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Cough, Dysphonia, Heart rate, Oropharyngeal discomfort, Oxygen saturation, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction
Allergies:
Diagnostic Lab Data: Test Date: 20210831; Test Name: blood pressure; Result Unstructured Data: Test Result:132/86; Comments: at 11:43; Test Date: 20210831; Test Name: blood pressure; Result Unstructured Data: Test Result:129/75; Comments: at 12:00; Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210831; Test Name: P; Result Unstructured Data: Test Result:68; Comments: at 11:43; Test Date: 20210831; Test Name: P; Result Unstructured Data: Test Result:66; Comments: at 12:00; Test Date: 20210831; Test Name: SpO2; Test Result: 98 %; Comments: at 11:43; Test Date: 20210831; Test Name: SpO2; Test Result: 99 %; Comments: at 12:00; Test Date: 20210831; Test Name: SpO2; Result Unstructured Data: Test Result:95~98 %; Comments: at 12:30
CDC Split Type: JPPFIZER INC202101139329

Write-up: Anaphylaxis; throat feeling strange and itching; throat feeling strange and itching; frequent coughing; Hoarseness/stenosis sounds; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21125493. A 42-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FF3622; Expiration Date: 30Nov2021), via an unspecified route of administration on 25Aug2021 10:43 (the day of vaccination, at the age of 42-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Body temperature before vaccination was 36.6 degrees Centigrade on 25Aug2021. The patient had allergy reaction due to angiographic agent, xylocaine and LYRICA. There was a medication history of orally taking FEXOFENADINE, etc. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported), as dose 1 for COVID-19 immunisation on an unspecified date. On 25Aug2021 11:43 (1 hour after the vaccination), the patient experienced anaphylaxis, throat feeling strange and itching, frequent coughing, hoarseness/stenosis sounds. The course of the event was as follows: After 60 minutes of the observation after the vaccination, at 11:43, the patient complained throat feeling strange and itching. After that, the patient had frequent coughing. The patient started to experience hoarseness. The patient took orally FEXOFENADINE 1 tablet. Blood pressure (BP): 132/86, heart rate(P): 68 and oxygen saturation (SpO2): 98%. Frequent coughing continued. At 11:48, coughing continued, and the patient had throat feeling strange, itching and stenosis sounds. Adrenaline of 0.3 ml was intramuscularly injected. At 12:00, BP: 129/75, P: 66, SpO2: 99%. Throat feeling strange still remained, but the coughing generally decreased. Hoarseness continued. At 12:30, the variation range of SpO2 was wide, between 95% to 98%, so the patient was transferred by an ambulance. The outcome of events was unknown. The reporting physician classified the event as non-serious and the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was allergy.


VAERS ID: 1702087 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autonomic nervous system imbalance, Body temperature, Fall, Loss of consciousness, Presyncope, Syncope
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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101142801

Write-up: Vasovagal reflex; Loss of consciousness; Defective vagal syncope; Autonomic symptoms; suddenly fell form the chair; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21125866. The patient was a 13-year-old (age at vaccination) female. On 25Aug2021, body temperature before vaccination was 36.5 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status (as reported). On 25Aug2021 at 18:30 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY), Solution for injection, Lot number FF9942, Expiration date 30Nov2021, via an unspecified route of administration as a single dose for COVID-19 immunization at the age of 13-year-old. The course of the event was as follows: the patient was healthy after vaccination. But the patient suddenly fell from the chair while receiving observation, and she experienced Loss of consciousness. The patient was awake after 2 minutes and she was conscious. The patient had no symptoms such as malaise and walked home after the observation. On 25Aug2021 at 18:35 (5 minutes after the vaccination), the patient experienced Vasovagal reflex. It was reported that on 25Aug2021, the patient experienced autonomic symptoms, so this might be the defective vagal syncope caused by vaccination (as reported), the patient experienced loss of consciousness, fall. On 25Aug2021 (the day of the vaccination), the patient recovered from the events. The reporting physician classified the event as non-serious 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 patient had Autonomic symptoms, so this may be the Defective vagal syncope caused by vaccination. The patient recovered rapidly without sequela.; Reporter''s Comments: the patient had Autonomic symptoms, so this may be the Defective vagal syncope caused by vaccination. The patient recovered rapidly without sequela.


VAERS ID: 1702106 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspartate aminotransferase, Aspartate aminotransferase increased, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Body temperature, Chest pain, Electrocardiogram, Electrocardiogram ST segment elevation
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:ST increased; Comments: ST increased; Test Date: 20210830; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:normal; Comments: normal; Test Date: 20210825; Test Name: CK; Result Unstructured Data: Test Result:Elevated; Test Date: 20210830; Test Name: CK; Result Unstructured Data: Test Result:Normalized; Test Date: 20210825; Test Name: CKMB; Result Unstructured Data: Test Result:Elevated; Test Date: 20210825; Test Name: GOT; Result Unstructured Data: Test Result:Elevated; Test Date: 20210823; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101146163

Write-up: Electrocardiogram ST segment elevation; GOT elevation were confirmed; CK and CKMB, GOT elevation were confirmed; CK and CKMB, GOT elevation were confirmed; Chest pain; This is a spontaneous report from a contactable physician (vaccinator) received from the regulatory authority. Regulatory authority report number is v21126074. A 17-year and 0-month-old male patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY) Solution for injection, via an unspecified route of administration on 23Aug2021 10:30, at 17 years of age, (Batch/Lot Number: FE8206; Expiration Date: 31Oct2021) as single dose for COVID-19 immunization. Medical history was none. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. From the dusk of 25Aug2021 (2 days after the vaccination), the patient experienced chest pain. On 27Aug2021 (4 days after the vaccination), the patient consulted clinic. Through anterior precordial lead to electrocardiogram, ST increased was confirmed (onset date reported as 25Aug2021). From blood sampling, CK, CKMB, and GOT elevation were confirmed. There was no hinder to daily life. On 30Aug2021 (7 days after the vaccination), the patient took electrocardiogram at another clinic, and CK normalized was confirmed. Additional lab test included body temperature on 23Aug2021 before vaccination at 36.7 degrees Centigrade. The reported events resolved on 30Aug2021. The reporting physician (vaccinator) classified the event as non-serious 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(vaccinator) commented as follows: From chronological relation with the vaccination and the symptoms were known adverse events, we determined that the causality of the symptoms with the vaccination existed.


VAERS ID: 1702113 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Body temperature, Fall, Fatigue, Hyperhidrosis, Loss of consciousness, Muscle spasms, Pallor, Syncope, 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), Dystonia (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), 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101146827

Write-up: Loss of consciousness; Neurally mediated syncope; fell from the chair; Vomiting; Cramp in both hands; Pallor facial; drenching sweats; Blood pressure decreased; feeling of fatigue; This is a spontaneous report from a contactable other healthcare professional (HCP) received from a regulatory authority. Regulatory authority report number is v21125545. A 49-year and 11-month-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF9942, Expiration date 30Nov2021) via an unspecified route of administration on 25Aug2021 at 14:20 (at the age of 49-year-old) as a single dose for COVID-19 immunization. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Body temperature before vaccination was 36.4 Centigrade. On 25Aug2021 at 14:20 (the day of vaccination), the patient received the first dose of bnt162b2. The event onset date/time was reported as on 25Aug2021 at 14:28 (8 minutes after the vaccination). The course of the event was as follows: During the 15 minutes follow up after vaccination, the patient presented with sudden loss of consciousness and fell from the chair. The patient had vomiting, cramp in both hands, and pallor facial. The patient was transported to a bed and regained the consciousness but presented with drenching sweats and blood pressure decreased. The patient was emergently transported to private hospital. After various tests, diagnosis of neurally mediated syncope was diagnosed. The symptom was improving with intravenous treatment. At PM 06:00, the patient returned home with family members. On 25Aug2021 (the day of vaccination), the outcome of the event was recovering. The reporting other HCP classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. The reporting other HCP commented as follows: The patient reportedly had feeling of fatigue because he was after night shift on the day of vaccination. On 29Aug, the patient phoned to the hospital, reporting that the physical condition was well.


VAERS ID: 1702184 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004956 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deafness unilateral, Headache, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hearing impairment (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Hearing loss of the vaccination side; Swelling; Arm pain; Headache; This case was received via the regulatory authority (Reference number: 2021TJP082130) on 26-Aug-2021 and was forwarded to Moderna on 09-Sep-2021. This case was reported by a vaccine recipient via the Drug Information Center. Hearing loss of the vaccination side was assessed as serious by the MAH. On 25-Aug-2021, at 09:15, the patient received the 1st dose of the vaccine. Swelling, arm pain, headache, and hearing loss of the vaccination side developed. On 26-Aug-2021, the symptoms were still persisting at the moment. The outcome of swelling, arm pain, headache, and hearing loss of the vaccination side was reported as ongoing and unchanged. Follow-up investigation will be impossible due to the reporter''s non-cooperation. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 36-year-old, female patient with no relevant medical history, who experienced the unexpected event of unilateral hearing loss, arm pain, and swelling, and the expected event of headache. All the events occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable, as the events happened after the first dose. The events were considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1702221 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005239 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Dehydration, Loss of consciousness, Pyrexia, Urticaria
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Loss of consciousness; Inappetence; Dehydration; Urticaria; Pyrexia; This case was received via Regulatory Authority (Reference number: --2021TJP085917) on 28-Aug-2021 and was forwarded to Moderna on 10-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the (Ref, v21125061,v21125397). On an unknown date, body temperature before the vaccination: 37.4 degrees Celsius. On 25-Aug-2021, at 15:50, the patient received the 1st dose of this vaccine. At 20:00, pyrexia of 38 degrees Celsius developed. On 26-Aug-2021, in the morning, urticaria developed. On 27-Aug-2021, loss of consciousness developed. Inappetence and dehydration were observed. The patient was admitted to a hospital. On 29-Aug-2021, the patient was discharged from the hospital. The symptoms were resolving. The outcome of urticaria, pyrexia, loss of consciousness, inappetence, and dehydration was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. 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.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Not reported.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1702249 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-25
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004221 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arterial catheterisation, Chest discomfort, Magnetic resonance imaging heart, Myocarditis, Troponin
SMQs:, Anaphylactic reaction (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? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: OLOPATADINE HYDROCHLORIDE; TRANEXAMIC ACID; ASCORBIC ACID; RIBOFLAVIN BUTYRATE
Current Illness: Allergy to metals; Asthma; Dust allergy; Pollen allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: catheterization; Result Unstructured Data: no significant stenosis. The wall motion lowering was noted from the inferior wall over the apex.; Test Date: 20210826; Test Name: Cardiac MRI; Result Unstructured Data: acute myocarditis; Test Date: 20210826; Test Name: Troponin; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Acute myocarditis; chest tightness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This case, initially reported to the regulatory authority by a physician, was received via the regulatory authority(Ref, v21125606). The patient had a history of allergy (house dust. pollen, and metal). The patient was taking olopatadine hydrochloride, tranexamic acid, ascorbic acid/calcium pantothenate, and riboflavin butyrate. On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 07-Aug-2021, at 12:00, the patient received the 2nd dose of this vaccine. On 25-Aug-2021, at 16:00, chest tightness developed. On 26-Aug-2021, the patient visited a nearby hospital and was positive for troponin. The patient visited the reporting hospital. Emergency catheterization was performed, and there was no significant stenosis. The wall motion lowering was noted from the inferior wall over the apex. Cardiac MRI showed findings suggestive of acute myocarditis. The patient was hospitalized. Chest symptoms disappeared, and the patient was making satisfactory progress. The patient was followed up without medication. On 02-Sep-2021, the symptoms were resolving, and the patient was discharged from the hospital. The outcome of acute myocarditis as reported as resolving Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; 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, however as per Sender?s comment: Another possible factor is ampulla cardiomyopathy.


VAERS ID: 1702289 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTJNJFOC20210923168

Write-up: COVID-19; VACCINATION FAILURE; This spontaneous report received from a consumer via Regulatory Authority (LT-SMCA-5791N) on 13-SEP-2021 and concerned a 58 year old male. The patient''s weight was 125 kilograms, and height was 183 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 expiry: UNKNOWN) 0.5 ml,1 total administered on 20-MAY-2021 for covid-19 immunisation. No concomitant medications were reported. On 25-AUG-2021, the patient experienced covid-19 and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from covid-19. This report was serious (Other Medically Important Condition). This report was associated with product quality complain.


VAERS ID: 1702651 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Body temperature, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? 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: 20210825; Test Name: Body temperature; Result Unstructured Data: High Body temperature degree Celsius.
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Agency (Reference number: NO-NOMAADVRE-E2B_00046307) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE, ABDOMINAL PAIN and PYREXIA in a 43-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021 at 7:45 AM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced SYNCOPE (seriousness criterion medically significant), ABDOMINAL PAIN (seriousness criterion medically significant) and PYREXIA (seriousness criterion medically significant). At the time of the report, SYNCOPE had resolved, ABDOMINAL PAIN had not resolved and PYREXIA was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, Body temperature: 39 (High) High Body temperature degree Celsius. No concomitant medication reported. No Treatment Medication reported. 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. The event coding and seriousness criteria are maintained for consistency with the RA report.; 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. The event coding and seriousness criteria are maintained for consistency with the RA report.


VAERS ID: 1702865 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9309 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE; FOLIC ACID; METHOTREXATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101125761

Write-up: itchy palms and upper limbs 10 min after Comirnaty; itchy palms and upper limbs 10 min after Comirnaty; This is a spontaneous report from a contactable physician downloaded from the (Regulatory authority number PT-INFARMED-G202108-3459). A 41 years old female patient received the first dose of BNT162B2 (COMIRNATY; lot number FD9309) intramuscular, on 25Aug2021, at the age of 41 years, at 0.3 ml single, for COVID-19 immunisation. Medical history was not reported. It was unknown if the patient was pregnant. Concomitant medications included sertraline, folic acid, methotrexate. The patient experienced itchy palms and upper limbs 10 min after Comirnaty, on 25Aug2021, with outcome of recovered on an unspecified date in Aug2021. The event lasted approximately 30 minutes. Specific treatment of the reaction included 10 mg of oral ebastine and 200 mg of hydrocortisone. The case was reported serious as medically significant. The reporter assessment of the causal relationship of the event (pruritus) with the suspect product was: relatedness of drug to reaction(s)/event(s): source of assessment: reporter, method of assessment: unknown, result of assessment: probable. Reporter comment: Concomitant medication: methotexate, folic acid, sertraline. Did medication error occur: no. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Concomitant medication: methotexate, folic acid, sertraline. Did medication error occur: no.


VAERS ID: 1702915 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis
SMQs:, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101135999

Write-up: Myocarditis; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number PT-INFARMED-M202108-3851. A 17-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 21Aug2021 (Batch/Lot Number: FG4442) as dose 2, 30 ug single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced myocarditis. It was reported that after the second immunization, she began to experience chest pain 4 days after the administration of the vaccine and went to the emergency department and was discharged that same day, on 25Aug2021. Outcome of event was recovered on 25Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1703142 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation
SMQs:, Supraventricular tachyarrhythmias (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101131539

Write-up: Atrial fibrillation; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number SE-MPA-2021-077918. A 50-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 24Aug2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25Aug2021, one day after vaccination, the patient experienced atrial fibrillation. The patient began to sweat profusely and felt his heart jump in his chest. His strength waned and he decided to seek care after about 2 hours. The patient was hospitalized on an unspecified date due to the event. Outcome of event was recovered without damage on 25Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1703738 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Movement disorder, Neurological examination, Pain in extremity, Paraesthesia, Peripheral swelling, Physical examination, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No underlying diseases
Allergies:
Diagnostic Lab Data: Test Name: Neurological examination; Result Unstructured Data: ok; Test Name: Physical examination; Result Unstructured Data: ok
CDC Split Type: ATJNJFOC20210919162

Write-up: TINGLING / SHAKY FEELING FROM THE FOREHEAD TO THE BACK OF THE HEAD; HAND HURTS; WHOLE ARM HURTS; COULD NOT BEND OR MOVE THE FINGERS; SWOLLEN LYMPH NODES; NOSE SWOLLEN BETWEEN THE EYE AREA OUTSIDE; PALM SWOLLEN INSIDE AND OUTSIDE; This spontaneous report received from a consumer by a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-043540) was received on 09-SEP-2021 and concerned a 37 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: No underlying diseases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE423 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 25-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 25-AUG-2021, the patient experienced tingling / shaky feeling from the forehead to the back of the head, hand hurts, whole arm hurts, could not bend or move the fingers, swollen lymph nodes, nose swollen between the eye area outside and palm swollen inside and outside. Laboratory data (dates unspecified) included: Neurological examination (NR: not provided) ok, and Physical examination (NR: not provided) ok. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling / shaky feeling from the forehead to the back of the head on 01-SEP-2021, whole arm hurts, and could not bend or move the fingers, and nose swollen between the eye area outside on 03-SEP-2021, and had not recovered from hand hurts, swollen lymph nodes, and palm swollen inside and outside. This report was serious (Other Medically Important Condition).


VAERS ID: 1704872 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214017 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Influenza like illness
SMQs:, Retroperitoneal fibrosis (broad)

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

Write-up: Lumbago; Influenza like illness; This case was received via regulatory authority (Reference number: FR-AFSSAPS-ST20213247) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Lumbago) in a 51-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214017) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 ml. On 25-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Influenza like illness). On 27-Aug-2021, the patient experienced BACK PAIN (Lumbago) (seriousness criterion medically significant). At the time of the report, BACK PAIN (Lumbago) was resolving and INFLUENZA LIKE ILLNESS (Influenza like illness) had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. Treatment medication was not provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1704883 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Chest pain, Fatigue, Injection site swelling, Lymphadenopathy, Muscle spasms, Muscle swelling, Musculoskeletal stiffness, Nausea, Palpitations, Peripheral swelling, Saliva altered
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Disequilibrium syndrome; Postnasal drip
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic rhinitis (Enlarged turbinates caused by chronic rhinitis.); Lactation decreased; Nausea; Tachycardia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: muscle stiffness; back pain; palpitations; chest pain; swollen arm; Stiffness; Cramping; Upper back pain; Heart pounding; Lymphadenopathy; Fatigue; Shoulder pain; Nausea; Muscle cramp; Muscle swelling; Altered saliva; Injection site swelling; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 25868003) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BACK PAIN (Upper back pain), PALPITATIONS (Heart pounding), ARTHRALGIA (Shoulder pain), LYMPHADENOPATHY (Lymphadenopathy), MUSCULOSKELETAL STIFFNESS (Stiffness), NAUSEA (Nausea), MUSCLE SPASMS (Muscle cramp), MUSCULOSKELETAL STIFFNESS (muscle stiffness), BACK PAIN (back pain), PALPITATIONS (palpitations), CHEST PAIN (chest pain), PERIPHERAL SWELLING (swollen arm), MUSCLE SWELLING (Muscle swelling), SALIVA ALTERED (Altered saliva), INJECTION SITE SWELLING (Injection site swelling), MUSCLE SPASMS (Cramping) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Nausea, Lactation decreased, Tachycardia and Chronic rhinitis (Enlarged turbinates caused by chronic rhinitis.). Concurrent medical conditions included Asthma, Postnasal drip and Disequilibrium syndrome. On 25-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), MUSCLE SPASMS (Muscle cramp) (seriousness criterion medically significant), MUSCLE SWELLING (Muscle swelling) (seriousness criterion medically significant), SALIVA ALTERED (Altered saliva) (seriousness criterion medically significant), INJECTION SITE SWELLING (Injection site swelling) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 29-Aug-2021, the patient experienced PALPITATIONS (Heart pounding) (seriousness criterion medically significant) and LYMPHADENOPATHY (Lymphadenopathy) (seriousness criterion medically significant). On 30-Aug-2021, the patient experienced BACK PAIN (Upper back pain) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (muscle stiffness) (seriousness criterion medically significant), BACK PAIN (back pain) (seriousness criterion medically significant), PALPITATIONS (palpitations) (seriousness criterion medically significant), CHEST PAIN (chest pain) (seriousness criterion medically significant), PERIPHERAL SWELLING (swollen arm) (seriousness criterion medically significant) and MUSCLE SPASMS (Cramping) (seriousness criterion medically significant). On 26-Aug-2021, SALIVA ALTERED (Altered saliva) had resolved. On 27-Aug-2021, FATIGUE (Fatigue) had resolved. On 28-Aug-2021, MUSCLE SWELLING (Muscle swelling) and INJECTION SITE SWELLING (Injection site swelling) had resolved. At the time of the report, BACK PAIN (Upper back pain), PALPITATIONS (Heart pounding), ARTHRALGIA (Shoulder pain) and LYMPHADENOPATHY (Lymphadenopathy) had not resolved, MUSCULOSKELETAL STIFFNESS (Stiffness), MUSCULOSKELETAL STIFFNESS (muscle stiffness), BACK PAIN (back pain), PALPITATIONS (palpitations), CHEST PAIN (chest pain), PERIPHERAL SWELLING (swollen arm) and MUSCLE SPASMS (Cramping) had resolved and NAUSEA (Nausea) and MUSCLE SPASMS (Muscle cramp) was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Under investigation: positional tachycardia as raised by GP. Awaiting Patient has not had symptoms associated with COVID-19 Patient has Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding No Concomitant and Treatment medication were reported. 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: 1704886 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood test, Body temperature, Chest X-ray, Chest pain, Depressed level of consciousness, Dyspnoea, Gait inability, Genital rash, Hypoaesthesia, Nausea, Pharyngeal swelling, Pyrexia, SARS-CoV-2 test, Vision blurred, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), 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 (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness: Chest anxiety feeling of
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain; Difficulty breathing; Wheezing
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Comments: Various blood tests; Test Date: 20210831; Test Name: Temperature; Result Unstructured Data: Test Result:High; Test Name: Chest x-ray; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210901; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101152222

Write-up: Chest pain; Difficulty breathing; Throat swelling; Blurry vision; Unable to walk; Nausea; Wheezing; High temperature; Weakness postural; Numbness in feet; Unconscious partial; Genital rash; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109020853528660-Q2L0H, Safety Report Unique Identifier GB-MHRA-ADR 25885445. A 17-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration on 24Aug2021 (Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. Medical history included chest pain, difficulty breathing and wheezing from an unknown date and unknown if ongoing and concurrent condition included ongoing chest anxiety feeling of. Concomitant medication included sertraline taken for chest anxiety feeling of from Mar2021 to an unspecified stop date. Patient had not had symptoms associated with COVID-19. Patient was not pregnant not currently breastfeeding at the time of vaccination. The patient experienced genital rash on 25Aug2021 and also experienced chest pain, difficulty breathing, throat swelling, blurry vision, unable to walk, nausea, wheezing, unconscious partial, high temperature, weakness postural and numbness in feet on 31Aug2021. The patient was hospitalized due to the events on an unspecified date in 2021. It was reported that ambulance called due to patient collapsed and could not breathe and had chest pains and could not keep eyes open or stand. Breathing was one of gasping for air and wheezing, high temperature. Took to Hospital. Patient had not tested positive for COVID-19 since having the vaccine. The patient''s hospitalization was prolonged as a result of genital rash on 01Sep2021. And as a result of chest pain, difficulty, throat swelling, blurry vision. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test (Sars-Cov-2 test): negative (No - Negative COVID-19 test) on 01Sep2021, blood test (various blood tests): unknown result and chest x-ray: unknown result on unspecified date, temperature (body temperature): high on 31Aug2021. The case was assessed as serious- hospitalization. The outcome of the events unconscious partial, difficulty breathing, blurry vision, nausea, wheezing, high temperature, weakness postural and numbness in feet was resolved on 01Sep2021, unable to walk was resolved on an unknown date in 2021, whereas events genital rash, chest pain, throat swelling was resolving, at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1704939 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pain in extremity, Pruritus, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Itching; Aches & pains in legs; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25909044) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aches & pains in legs), PRURITUS (Itching) and HEADACHE (Headache) 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 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 26-Aug-2021, the patient experienced PAIN IN EXTREMITY (Aches & pains in legs) (seriousness criterion medically significant). On 28-Aug-2021, the patient experienced PRURITUS (Itching) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Aches & pains in legs), PRURITUS (Itching) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. Company Comment : Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Events assessed as serious by the RA; however, based on medical judgement and the lack of evidence of seriousness from clinical or regulatory standpoint the events are considered non-serious.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Events assessed as serious by the RA; however, based on medical judgement and the lack of evidence of seriousness from clinical or regulatory standpoint the events are considered non-serious.


VAERS ID: 1704944 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Scan, Sinus headache
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: CLENIL MODULITE; FOLIC ACID; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: 12 week scan, week previous to jab; Result Unstructured Data: Test Result:All as it should be
CDC Split Type: GBPFIZER INC202101145443

Write-up: Headache sinus; Patient was exposed to the vaccine second-trimester (13-28 weeks); This is a solicited report from the Card Vaccine Monitor program from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-YCVM-202108251129053530-IB0QC, Safety Report Unique Identifier GB-MHRA-ADR 25881584. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FE8087), via an unspecified route of administration on 25Aug2021 (at the age of 29 years old) as dose 2, single for COVID-19 immunisation. Medical history included asthma. Date of last menstrual period was 01Mar2020. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medications included beclometasone dipropionate (CLENIL MODULITE) taken for asthma from 01Mar2020; folic acid taken for pregnancy and vitamin supplementation from 20Jul2021 to 24Aug2021; salbutamol taken for asthma from 02May2007. The patient experienced headache sinus (medically significant) on 28Aug2021. The mother reported she became pregnant while taking bnt162b2. The mother was 13 weeks pregnant at the onset of the event. The mother was due to deliver on 01Mar2022. The patient underwent lab tests and procedures which included 12 week scan, week previous to jab showed all as it should be on Aug2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the headache sinus was not recovered. Patient does not think vaccination had an adverse effect on any aspect of the pregnancy. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event headache sinus . 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: 1705135 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-25
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy bone marrow, Cardiopulmonary exercise test, Chest scan, Computerised tomogram, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Exercise electrocardiogram, Fibrin D dimer, Fibrin D dimer increased, Laboratory test, Magnetic resonance imaging, Pulmonary embolism, Respiratory disorder, Ultrasound Doppler, Walking distance test
SMQs:, Haemorrhage laboratory terms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Childhood asthma; Dyspnoea; Hematocrit increased; Lyme disease; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: bone marrow puncture; Result Unstructured Data: Test Result:normal findings; Test Name: Ergospirometry; Result Unstructured Data: Test Result:275W, VO2max 35.1 mL/min/kg; Test Date: 20210825; Test Name: CT thorax; Result Unstructured Data: Test Result:pulmonary emboli; Comments: emboli in segmental arteries of both lower lobes and possibly in the left upper lobe. No arguments in favor of pulmonary infarction; Test Name: CT; Result Unstructured Data: Test Result:normal (superficial milking LAD); Test Name: transthoracic echocardiography; Result Unstructured Data: Test Result:nl LVEF, no significant valve disease; Test Name: ECG; Result Unstructured Data: Test Result:sinusoidal rhythm, nonspecific repol inferior, oRB; Test Name: Holter; Result Unstructured Data: Test Result:no arrhythmias; Comments: 2x rate-dependent LBBB. Annual review indicated.; Test Name: cyclo; Result Unstructured Data: Test Result:rate dependent LBBB; Comments: with emergence of dyspnea d''effort/reduced exercise capacity; Test Date: 20210825; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:$g2000; Test Name: lab; Result Unstructured Data: Test Result:no leads (including Lyme disease).; Test Name: MRI heart; Result Unstructured Data: Test Result:nl LVEF, no fibrosis; Test Date: 20210825; Test Name: duplex lower limbs; Result Unstructured Data: Test Result:negative.; Test Name: walking test; Result Unstructured Data: Test Result:normal findings, no abnormal rhythm
CDC Split Type: BEPFIZER INC202101142560

Write-up: Fibrin D dimer increased; Problem with breathing; bilateral pulmonary emboli; This is a spontaneous report from a contactable Physician downloaded from the regulatory authority BE-FAMHP-DHH-N2021-105827. A 24-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 06Aug2021 (Batch/Lot Number: Unknown) as doe 2, single for covid-19 immunisation. Medical history included childhood asthma from 2009, discretely elevated hematocrit from 2013, new onset dyspnee d''effort from Oct2020, non-smoker and Lyme disease. The patient''s concomitant medications were not reported. On 25Aug2021, the patient experienced fibrin d dimer increased, problem with breathing and bilateral pulmonary emboli. The patent has no other triggering factors such as immobilisation/travelling. Examinations on 25Aug2021 includes: D-dimers $g2000, Computed tomography thorax: pulmonary emboli in segmental arteries of both lower lobes and possibly in the left upper lobe. No arguments in favor of pulmonary infarction, Duplex lower limbs: negative. Thrombophilia bilan will still be done after having completed treatment with Eliquis. No family medical history of thrombophilia/deep vein thrombosis. Examinations on unspecified date includes: Bone marrow puncture: normal findings, Ergospirometry: 275W, VO2max 35.1 mL/min/kg, CT: normal (superficial milking LAD), transthoracic echocardiography: nl LVEF, no significant valve disease, ECG: sinusoidal rhythm, nonspecific repol inferior, oRB; Holter: no arrhythmias - 2x rate-dependent LBBB. Annual review indicated, cyclo: rate dependent LBBB with emergence of dyspnea d''effort/reduced exercise capacity, no leads (including Lyme disease), MRI heart: nl LVEF, no fibrosis and walking test: normal findings, no abnormal rhythm. The patient was hospitalized on unspecified date and received unspecified treatment due to the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1705142 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood pressure decreased, Chills, Dyspnoea, Fatigue, Headache, Malaise, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101149604

Write-up: Shivering; Blood pressure dropped; Myalgia; Fever; Arthralgia; Malaise; Shortness of breath; Fatigue; Nausea; Headache; This is a spontaneous report from a contactable consumer or other non hcp (patient) downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-105914. A 20-year-old female patient received 2nd single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 25Aug2021 for COVID-19 immunisation. The patient''s medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced shivering on 25Aug2021 with outcome of recovering, blood pressure dropped on 25Aug2021 with outcome of recovering, myalgia on 25Aug2021 with outcome of recovering, fever on 25Aug2021 with outcome of recovering, arthralgia on 25Aug2021 with outcome of recovering, malaise on 25Aug2021 with outcome of recovering, shortness of breath on 25Aug2021 with outcome of recovering, fatigue on 25Aug2021 with outcome of recovering, nausea on 25Aug2021 with outcome of recovering, headache on 25Aug2021 with outcome of recovering. Events were serious as disability. Therapeutic measures were taken as a result of the events. It was reported that patient received paracetamol and ibuprofen as treatment for the events. Reporter comment: Treatment - Yes. Paracetamol Ibuprofen. Complete rest. Outcome of the adverse drug reaction - in the process of improvement. Examinations - Seen by GP (general physician). Adverse drug reaction description - Drop in blood pressure. Shortness of breath. No follow-up attempts are possible. Information about batch number cannot be obtained.; Reporter''s Comments: Treatment - Yes. Paracetamol Ibuprofen. Complete rest. Outcome of the adverse drug reaction - in the process of improvement. Examinations - Seen by GP (general physician). Adverse drug reaction description - Drop in blood pressure. Shortness of breath.


VAERS ID: 1705143 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Insomnia, Malaise, Myalgia, Pyrexia, Vaccination site pain, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101149608

Write-up: Shivering; Headache; Injection site reaction; Myalgia; Fever; Arthralgia; Fatigue; Malaise; Insomnia; Injection site pain; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority, regulatory authority number BE-FAMHP-DHH-N2021-105919. A male patient of an unspecified age received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 25Aug2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced injection site reaction, fever, malaise shivering, fatigue, arthralgia, myalgia, headache, injection site pain and insomnia. The outcome of the events was recovering. No treatment received for the events. Reporter comment: Treatment - No. Outcome of the adverse drug reaction - in the process of improvement. Circumstances - Administration of a spoiled vaccine; breakdown of the cold chain; mistake when preparing/reconstituting the vaccine: Adverse drug reaction description - After the second dose, the patient suffered from the following for three days: Reaction and pain at the injection site; fatigue; headache; muscle pain; chills; joint pain; fever; sleeplessness. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.


VAERS ID: 1705216 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-25
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Magnetic resonance imaging head
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: cranial magnetic resonance tomography; Result Unstructured Data: Test Result:unknown result
CDC Split Type: DEPFIZER INC202101142649

Write-up: Thrombosis of venous sinuses; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority number is DE-PEI-202100179166. A 16-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 13Aug2021 (Batch/Lot Number: Unknown) (at the age of 16-years-old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced thrombosis of venous sinuses. The patient underwent lab tests and procedures which included cranial magnetic resonance tomography (CMRT) with unknown result on an unspecified date. Outcome of event was unknown. The reporter assessed the event as serious (hospitalization). Result of Assessment: Comirnaty/event(s): Thrombosis of venous sinuses/PEI: D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1705328 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-25
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E021A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Depressed level of consciousness, Dyspnoea, Full blood count, Malaise, Pulmonary embolism, Ultrasound scan
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (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? 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: Aortic coarctation; Bundle branch block right (Right leg block)
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use (Drunk alcohol on the day of the incident); Aortic stenosis; Smoker (Smoked in the last 15 weeks)
Allergies:
Diagnostic Lab Data: Test Name: Blood count; Result Unstructured Data: Test Result:unknown results; Test Name: CT; Result Unstructured Data: Test Result:a pulmonary embolism is detected; Test Name: Ultrasound examination; Result Unstructured Data: Test Result:heart, lungs and leg veins inconspicuous
CDC Split Type: DEPFIZER INC202101149620

Write-up: Pulmonary embolism; Dyspnoea; malaise; clouded consciousness; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority number DE-PEI-CADR2021171436. A 36-years-old male patient received dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Aug2021 (Batch/Lot Number: 1E021A) as 0.3ml single for covid-19 immunisation. Medical history included ongoing bundle branch block right (right leg block), ongoing Aortic coarctation, aortic isthmus stenosis, smoked in the last 15 weeks, drunk alcohol on the day of the incident. The patient''s concomitant medications were not reported. The patient experienced pulmonary embolism, dyspnoea, malaise and clouded consciousness on 25Aug2021. The patient was delivery to the emergency room. Blood count created. Subsequently, a pulmonary embolism was detected in the CT. Ultrasound examination of the heart, lungs and leg veins inconspicuous. 2 times a day administration of Clexane in inpatient hospitalization. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. This report was serious - hospitalization. Sender''s comments Are you or the affected person aware of allergies? If so, which ones? No Information on risk factors or pre-existing conditions Aortic isthmus stenosis. Right leg block. Smoked in the last 15 weeks. Drunk alcohol on the day of the incident, Dyspnea, malaise and clouded consciousness. Delivery to the emergency room. Blood count created. Subsequently, a pulmonary embolism is detected in the CT. Ultrasound examination of the heart, lungs and leg veins inconspicuous. 2 times a day administration of Clexane in inpatient hospitalization. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1705359 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-08-25
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal X-ray, Amylase, Bilirubin conjugated, Blood bilirubin, Blood electrolytes, Blood glucose, Coagulation test, Computerised tomogram, Haemoglobin, Intestinal ischaemia, Mesenteric vein thrombosis, Platelet count, SARS-CoV-2 test, Transaminases, Urine analysis, White blood cell count
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Ischaemic colitis (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: Medical History/Concurrent Conditions: Chronic kidney disease (secondary to nephroangiosclerosis); Hypertension; Hyperuricemia; Nephroangiosclerosis; Retinal vascular accident
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: X-ray abdomen; Result Unstructured Data: Test Result:air levels suggestive of obstruction; Comments: Distal intraluminal gas, air-fluid levels probably related to abundant fecal content.; Test Date: 20210829; Test Name: amylase; Result Unstructured Data: Test Result:41; Comments: normal; Test Date: 20210829; Test Name: direct bilirubin; Result Unstructured Data: Test Result:0.64; Comments: increase; Test Date: 20210829; Test Name: total bilirubin; Result Unstructured Data: Test Result:1.51; Comments: increase; Test Date: 20210829; Test Name: ions; Result Unstructured Data: Test Result:in range; Test Date: 20210829; Test Name: glucose; Result Unstructured Data: Test Result:94; Test Date: 20210829; Test Name: coagulation; Result Unstructured Data: Test Result:in range; Test Date: 20210829; Test Name: Urgent CT scan abdomen and pelvis; Result Unstructured Data: Test Result:No signs of intestinal obstruction.; Comments: Findings suggestive of venous mesenteric ischemia with involvement of the inferior mesenteric and superior mesenteric branches, the splenoportal axis and the inferior portal branch of the right hepatic lobe, with edematous changes in the root of the mesentery and in the right hemicolon without clear demonstration of intestinal perforation.; Test Date: 20210829; Test Name: Hb; Result Unstructured Data: Test Result:15.7; Test Date: 20210829; Test Name: platelets; Result Unstructured Data: Test Result:282; Test Date: 20210829; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210829; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210829; Test Name: transaminases; Result Unstructured Data: Test Result:increase; Test Date: 2021; Test Name: Urine; Result Unstructured Data: Test Result:normal color; Test Date: 20210829; Test Name: leukocytes; Result Unstructured Data: Test Result:in range
CDC Split Type: ESPFIZER INC202101165643

Write-up: Mesenteric venous ischaemia; MESENTERAL VENOUS THROMBOSIS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-989120. A 55-year-old male patient received BNT162B2 (COMIRNATY, lot number: FC3558), via an unspecified route of administration in arm on 10Jun2021 at dose 2, single for COVID-19 immunisation. Medical history included hypertension, hyperuricemia, retinal vascular accident in the left eye, and chronic kidney disease secondary to nephroangiosclerosis. It was unknown if the patient has passed COVID-19. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, lot number and expiration date were not provided), via an unspecified route of administration on 20May2021 at dose 1, single for COVID-19 immunisation. On 25Aug2021, the patient experienced mesenteric venous ischaemia which required hospitalization from an unspecified date in 2021 and was reported as life-threatening. The course of the event was as follows: It was reported that he came for mesogastralgia not irradiated to other areas, along with a feeling of abdominal distention and constipation since Wednesday, 25Aug2021. He had no fever, nausea, or vomiting; had normal colored urine on an unspecified date in 2021; and had no dysuria or frequency urination. He went to the emergency room (ER) for the same reason and presented the following analytical and radiological findings on 29Aug2021: in laboratory tests, an increase in transaminases and bilirubin at the expense of the direct one stood out. Total bilirubin was 1.51 and direct bilirubin was 0.64. Amylase was 41 (normal). Leucocytes were in range. In X-ray of abdomen, air levels were suggestive of obstruction. Distal intraluminal gas, air-fluid levels probably related to abundant fecal content. He was discharged (from the ER) with oral laxatives. He mentioned that despite laxatives, he has not achieved defacation. Other lab tests performed on 29Aug2021 included Hb (hemoglobin): 15.7, platelets: 282, coagulation: in range, glucose: 94, ions: in range, and COVID-19 antigen test and PCR: negative. Before readmission, an X-ray of the abdomen and a new laboratory test were requested and given the findings of the X-ray of the abdomen, a CT scan was requested which showed a diagnosis of mesenteric venous thrombosis. Urgent CT (computed tomogram) scan of abdomen and pelvis on 29Aug2021 showed no signs of intestinal obstruction. Findings suggestive of venous mesenteric ischemia with involvement of the inferior mesenteric and superior mesenteric branches, the splenoportal axis and the inferior portal branch of the right hepatic lobe, with edematous changes in the root of the mesentery and in the right hemicolon without clear demonstration of intestinal perforation. Clinical judgment was reported as mesenteral venous thrombosis. The evolution during the observation stay has been very favorable and he was completely asymptomatic. No fever, no abdominal pain, and in excellent general condition. He was treated with infusion of sodium heparin at 17 mL/H. Given the good evolution and clinical and analytical stability, he was admitted to the emergency surgery ward from an unspecified date in 2021 The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1705391 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Dyspnoea, Malaise, Myocarditis
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: FIPFIZER INC202101167083

Write-up: Myocarditis/myocardial inflammatory condition; severe pain in the heart; general malaise; difficulty breathing; This is a spontaneous report from a contactable consumer (patient) downloaded from the WEB, regulatory authority number is FI-FIMEA-20214417. A 32-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 24Aug2021 (Batch/Lot Number: Unknown) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced severe pain in the heart, general malaise and difficulty breathing. Myocarditis/ myocardial inflammatory condition after examination by a doctor. Patient was instructed to take Burana for myocarditis. The patient has no allergies and other vaccinations have not caused problems. Outcome of events was not recovered. The reporter assessed the event myocarditis as serious (life threatening). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1705626 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Gingival pain, Headache, Physical examination, SARS-CoV-2 test, Sinusitis
SMQs:, Gingival disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: General GP checks; Result Unstructured Data: Test Result: unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101145382

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202109012154403650-6BIUF; safety report unique identifier: GB-MHRA-ADR 25882671). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date unknown), via an unspecified route of administration, on Aug 24, 2021, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications not reported. Patient has not had symptoms associated with COVID-19. On Aug 28, 2021, patient experienced headache, sinusitis and gum pain. The patient experienced fatigue on Aug 25, 2021. The events reported serious (other medically important condition). Patient has not tested positive for COVID-19 since the vaccination. Patient not enrolled in a clinical trial. The patient underwent lab tests and procedures, which included COVID-19 virus test: No - Negative COVID-19 test; general GP checks: unknown results; both on an unspecified date. The outcome of sinusitis and gum pain: recovering. The outcome of the remaining events recovered with sequelae on an unspecified date in 2021. No follow-up attempts possible. Information about lot/batch number cannot be requested. No further information expected.


VAERS ID: 1705632 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fetal monitoring; Palpitations; Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101145525

Write-up: Dizziness; 32 weeks pregnant; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109020752513510-5XNNU and Safety Report Unique Identifier GB-MHRA-ADR 25884312 . This consumer information for both mother and fetus/. This is the maternal report. A female patient of an unspecified age received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 25Aug2021 (Lot Number: FE3380) as dose 1, single for COVID-19 immunisation. Medical history included very low risk pregnancy, foetal monitoring, and palpitations. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced, dizziness on 26Aug2021. The patient was 32 weeks pregnant at the onset of the event. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unknown date. The events were medically significant. The patient recovered from the event, dizziness on the same day of 26Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1705831 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Arthralgia, Blood test, Chest X-ray, Dyspnoea, Electrocardiogram, Extra dose administered, Lymphadenopathy, Musculoskeletal stiffness, Myalgia, Myocardial infarction, Neurological examination, Off label use
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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: 2021; Test Name: blood test; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: Chest x-ray; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: neurological examination; Result Unstructured Data: Test Result: normal.
CDC Split Type: ILPFIZER INC202101153036

Write-up: This is a spontaneous report from a contactable consumer (patient) received via Pfizer colleague. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm on 25Aug2021 (at the age of 38-year-old) as dose 3, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) on an unspecified date for COVID-19 immunisation and she also had adverse events of fever lasting one day and weakness for about a week on the first and second vaccine. The patient was usually healthy, 38 year old [female], mother of two. She was not taking regular medications, not allergic to medications. She stated after the third vaccine: Day of vaccination - no adverse events at all. Day 2 after vaccine (26Aug2021) - swelling of lymph node between the neck and left shoulder and additional swelling of lymph node in let armpit. All the muscles of the left side of the body began to become stiff, in addition mild muscle and joint pain of the rest of the body. Day 3 +4 (27Aug2021-28Aug2021) after vaccination - muscles of the left side of the body became more and more stiff. Day 5 (29Aug2021) after vaccination - the patient woke up vey stiff in the left side of body muscles with difficulty breathing, meaning muscle pain when inhaling and a stressful feeling that the heart muscle was very sore. The patient was referred to the hospital by the HMO due to suspicion of heart attack, after ECG, chest X-ray, blood tests and neurological examination, no problem was found and she was discharged home. Day 6 (30Aug2021) after vaccination - muscles relaxed and the patient felt completely healthy. The outcome of the events was recovered on 30Aug2021.The lot number for BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1706011 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-25
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Pneumonia, SARS-CoV-2 test
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: virus response of the Delta strain; Test Result: Negative ; Comments: (Not the Delta strain, nor the pneumonia of the new coronavirus series.)
CDC Split Type: JPPFIZER INC202101143385

Write-up: Pneumonia; felt very tired; This is a spontaneous report from a contactable consumer via medical information team. A male patient of unspecified age received bnt162b2 (COMIRNATY, Solution for injection, Lot number Expiration date not provided) via an unspecified route of administration on 06Aug2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number, expiration date not provided) via an unspecified route of administration on 16Jul2021, as dose 1, single for COVID-19 immunization. The detail of the reaction was reported as follow: The patient was hospitalized on 26Aug2021 with pneumonia (on unknown date), it was not side reaction. On 25Aug2021, the patient felt very tired. On 26Aug2021, patient was taken away by ambulance. The patient was hospitalized on 26Aug2021 to an unknown date. A slender tube was inserted into the nose to check the virus response of the Delta strain. After waiting for more than 5 hours, the test was negative (not the Delta strain, nor the pneumonia of the new coronavirus series). The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1706102 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005286 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Lymphadenopathy
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; Lymph node swelling; This case was received via Regulatory Authority(Reference number: JP-TAKEDA-2021TJP087246) on 01-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the Regulatory Authority(Ref, v21125425). On an unspecified date, the patient received the 1st dose of the vaccine. Lymph node swelling developed. On 25-Aug-2021, at 20:32, the patient received the 2nd dose of the vaccine. At 20:45, the patient complained of discomfort feeling in the upper airway. Wheezing was heard on physical examination (not in both lung field and upper airway). At 20:48, the patient was placed in a supine position with leg elevation in first-aid room. BT: 36.7 degrees Celsius, BP: 161/72 mmHg, HR: 88/min, and SpO2: 96% (r/a). The patient had generalized flush (flush on the face and in both upper limbs), swelling in the mouth, redness of both eyeballs and conjunctiva, cough, runny nose, and discomfort feeling in the upper airway. The patient was diagnosed as anaphylaxis based on the 2 items as skin symptoms (major) and respiratory symptom (major) in category 2. At 20:57, adrenaline 0.3 mg was intramuscularly injected into the right femoral region. At 21:00, 8 L of oxygen was administered. At 21:07, extracellular fluid was administered at a full rate. The symptoms showed an improving tendency and improved to a certain degree. At 21:15, adrenaline 0.3 mg was intramuscularly injected into the right femoral region (for the 2nd time). The patient was urgently transported to a hospital. On an unspecified date, it was under consideration whether the patient would be hospitalized. The outcome of lymph node swelling and anaphylaxis was unknown. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: 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: 1706111 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004230 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoaesthesia, Syncope, Wound haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (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? 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: JPMODERNATX, INC.MOD20213

Write-up: Syncope due to vagal reflex; Tingling sensation of the index fingers of both hands; Bleeding from wound of the right side of the nose; This case was received via regulatory authority on 03-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This case, initially reported to the regulatory authority by a person in charge of the venue, was received via the regulatory authority. Syncope due to vagal reflex was assessed as serious by the RA. On an unknown date, the patient received the 1st dose of this vaccination. On an unknown date, body temperature before the vaccination: 36.6 degrees Celsius. On 25-Aug-2021, at 09:54, the patient received the 2nd dose of this vaccine. At 10:00, syncope due to vagal reflex developed. Blood pressure was 164/99, and pulse rate was 55. A symptom of tingling sensation of the index fingers of both hands was noted. Bleeding from wound of the right side of the nose was noted. Thereafter, blood pressure became 154/91 with pulse rate of 93, and blood pressure then became 149/90 with pulse rate of 96. The symptoms disappeared within 30 minutes and resolved. The outcome of syncope due to vagal reflex, tingling sensation of the index fingers of both hands, and bleeding from wound of the right side of the nose was unknown. Follow-up investigation will be impossible due to the reporter''s non-cooperation. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship; Sender''s Comments: This case concerns a 42 year-old, male patient with no relevant medical history, who experienced the unexpected event of syncope. The event occurred on the same day after the second dose of Spikevax. The rechallenge was not applicable for event of syncope since there is no information regarding the first dose. The event was considered related to the vaccine per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1706121 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 29125BA / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Headache, Lymphadenopathy, Nausea, Neck deformity, Pain, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210901; Test Name: Antigen; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab
CDC Split Type: MXPFIZER INC202101153437

Write-up: tiredness; fever; stomach upset; diarrhea; vomit; nausea; headache; chills; body pain; 5 days past vaccination a lymph from neck got inflammed; a ball formed in my neck; This is a spontaneous report from a contactable consumer or other non hcp (Patient). Received from agency. A 25-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: 29125BA), dose 1 via an unspecified route of administration, administered in Arm Right on 21Aug2021 12:00 (ai the age of 25 years old) at dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn''t received other medications within 2 weeks of vaccination. On 25Aug2021, 14:00 the patient experienced 5 days past vaccination a lymph from neck got inflamed, a ball formed in my neck. On 28Aug2021, 14:00 the patient experienced stomach upset, diarrhea, vomit, nausea, headache, chills, body pain, tiredness, fever. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Sep2021 Nasal Swab. Therapeutic measures were taken as a result of 5 days past vaccination a lymph from neck got inflamed, a ball formed in my neck, stomach upset, diarrhea, vomit, nausea, headache, chills, body pain, tiredness and fever. The patient was received medicines for adverse event heart and stomach. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were recovering. Follow up required.


VAERS ID: 1706219 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3430 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Blood pressure; Result Unstructured Data: Test Result:180/90 mmHg
CDC Split Type: PHPFIZER INC202101146325

Write-up: Elevated BP; Vomiting; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority. The regulatory authority report number is PH-PHFDA-300102386. A 71-year-old female patient received BNT162B2 (COMIRNATY; solution for injection; lot number: FE3430), intramuscularly on 25Aug2021 (at the age of 71-years-old) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 25Aug2021 10:15, the patient experienced elevated blood pressure (BP) and vomiting. The patient''s BP was 180/90 mmHg. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1706342 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-08-25
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101150187

Write-up: Pericarditis; Chest pain; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number SE-MPA-2021-078352. A 25-year-old male patient received first dose bnt162b2 (COMIRNATY; Batch/Lot number was not reported) via an unspecified route of administration on 13Jul2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis and chest pain on 25Aug2021. The events was reported as serious and caused hospitalization on an unspecified date. Outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1706359 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heart rate increased, Hypoaesthesia, Pulmonary embolism
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Dehydration (broad), Sexual dysfunction (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:
CDC Split Type: SEPFIZER INC202101166737

Write-up: Body numbness; High pulse; BLOOD CLOTS IN THE LUNGS/diagnosed with pulmonary embolism in both lungs; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-080396. A 25-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 24Aug2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took erythromycin (ERY-MAX). After using ERY-MAX (when he was little) he could retain neither food nor fluid. On 25Aug2021, the patient experienced body numbness, high pulse, and blood clots in the lungs. The reported suspect vaccine was Comirnaty (covid-19 vaccines), first dose given on 24Aug2021, and the reported suspect adverse events were heart rate increased, body numbness and pulmonary embolism which occurred the next day (25Aug2021). The man (patient) went to emergency clinic on 29Aug2021 and after several tests he was diagnosed with pulmonary embolism in both lungs. The report was assessed as serious - life threatening, hospitalization. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1708014 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Contusion, Headache, Loss of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Headache; Pyrexia; Loss of consciousness; Bruise on the leg; This case was received via the RA (Reference number: JP-TAKEDA-2021TJP083285) on 30-Aug-2021 and was forwarded to Moderna on 10-Sep-2021. This case was reported by a family member of a vaccine recipient via the RA. Loss of consciousness was assessed as serious by the RA. Around 19-Jul-2021, the patient received the 1st dose of the vaccine. Around 16-Aug-2021, the patient received the 2nd dose of the vaccine. After the vaccination, the patient experienced pyrexia of 39.4 degrees Celsius and headache. On 25-Aug-2021, the patient lost consciousness while commuting to work and got a bruise on the leg. On 30-Aug-2021, headache was persisting. The outcome of pyrexia, loss of consciousness, and bruise on the leg was unknown. The outcome of headache was reported as ongoing and unchanged. Follow-up investigation will be impossible because of non-cooperation of the reporter. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 24- year-old, female subject with no relevant medical history reported, who experienced the unexpected serious event of loss of consciousness. The event loss of consciousness after receiving the second dose of vaccine mRNA-1273, though it is unclear how much time passed between administration and adverse event. The rechallenge is not applicable in this case. The events are considered related to the study drug per the reporter''s assessment. The benefit-risk relationship of the vaccine mRNA-1273 is not affected by this report.


VAERS ID: 1708823 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-25
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 1 - / SYR

Administered by: Public       Purchased by: ?
Symptoms: Angina pectoris, Asthenia, Blood test, Electrocardiogram, Fatigue, Pain in extremity, Ultrasound scan
SMQs:, Guillain-Barre syndrome (broad), Other ischaemic heart disease (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: EKG 09/09/2021 , USG 09/13/2021, blood test 09/20/2021
CDC Split Type:

Write-up: Heart pain, weakness and fatigue, pain in the legs


VAERS ID: 1709383 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVC6 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain stem infarction, Computerised tomogram, Diplopia, Dizziness, Echocardiogram, Electrocardiogram, Eye disorder, Facial paralysis, Facial paresis, Hypoaesthesia, Investigation, Language disorder, Magnetic resonance imaging
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Corneal disorders (broad), Retinal disorders (broad), Hearing impairment (broad), Vestibular disorders (broad), Ocular motility disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
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: 2021; Test Name: computed tomography scan; Result Unstructured Data: Test Result:possible further triggering factors; Test Date: 2021; Test Name: transthoracic echocardiography; Result Unstructured Data: Test Result:all normal; Test Date: 2021; Test Name: Long-term electrocardiogram; Result Unstructured Data: Test Result:all normal; Test Date: 2021; Test Name: other examinations; Result Unstructured Data: Test Result:all normal; Test Date: 2021; Test Name: Magnetic Resonance Imaging (MRI); Result Unstructured Data: Test Result:Brainstem infarction; Test Date: 2021; Test Name: Magnetic Resonance Imaging (MRI); Result Unstructured Data: Test Result:possible further triggering factors
CDC Split Type: DEPFIZER INC202101149834

Write-up: Language disorder/difficulty speaking; Brain stem infarction; Diplopia/double vision; incorrect eye position; light headedness/dizziness; Facial paresis; Slightly drooping half of the face; numbness; This is a spontaneous report from a non-contactable consumer downloaded from the RA. The regulatory authority number is DE-PEI-CADR2021171403. A 52-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 24Aug2021 (Batch/Lot Number: SCVC6) as dose number unknown, 0.3ml single for COVID-19 immunisation. The patient''s weight was 95 kg, and height was 193 cm. The patient has no relevant medical history, no concurrent conditions and no known allergies. No concomitant medications were reported. On 25Aug2021, the patient experienced brain stem infarction, diplopia/ double vision, incorrect eye position, light headedness/dizziness, facial paresis, slightly drooping half of the face, numbness, and language disorder/difficulty speaking. End of reaction/event was reported as 27Aug2021. Brainstem infarction was confirmed by Magnetic Resonance Imaging (MRI). This report is serious - hospitalization. The events caused prolonged hospitalization. The outcome of the events was recovering at the time of last observation. Sender comment: Do you or the person concerned have any known allergies? If so, what are they? No. Details of risk factors or previous illnesses. No risk factors or previous illnesses, possible further triggering factors were identified by computed tomography scan and magnetic resonance imaging. Long-term electrocardiogram, transthoracic echocardiography, and other examinations all normal. Onset of symptoms was approximately 7 hours after the vaccination. As a result: Patient went to emergency room and was diagnosed with a brainstem infarction. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1709401 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Chest pain, Thrombosis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210927283

Write-up: THROMBOSIS; ACUTE MYOCARDIAL INFARCTION, OF ANTERIOR WALL; THORACIC PAIN; This spontaneous report received from a consumer by a Regulatory Authority (EVHUMAN Vaccines, DE-PEI-CADR2021175545) on 13-SEP-2021 concerned a 41 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number: Unknown expiry: Unknown) dose was not reported, 1 total, administered on 09-JUL-2021 for unknown indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 25-AUG-2021, the patient experienced thrombosis, acute myocardial infarction of anterior wall and thoracic pain (acute anterior wall infarction, thoracic pain, left ventricular thrombus). On an unspecified date, the patient was hospitalized for events. Number of days hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from thrombosis, acute myocardial infarction of anterior wall and thoracic pain. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1709504 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-25
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Electroencephalogram, Generalised tonic-clonic seizure, Neurological examination
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Sleep deficit (Just started upper secondary school and has not got much sleep the recent weeks.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: EEG; Result Unstructured Data: Test Result:Nothing abnormal; Test Date: 20210825; Test Name: Neurological examination; Result Unstructured Data: Test Result:Normal
CDC Split Type: DKPFIZER INC202101155423

Write-up: Seizure grand mal. 2 times of Generalised tonic-clonic seizure with app. 30 min interval.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory authority number DK-DKMA-WBS-0086766. A 15-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FE9174; Expiration Date: 31Oct2021), dose 2 intramuscular on 14Aug2021 as DOSE 2, SINGLE for covid-19 immunisation. Concurrent conditions included Sleep deficit (Just started upper secondary school and has not got much sleep the recent weeks 2021). There is no information regarding patient medical history. Previously healthy and well. The patient was not diagnosed with epilepsy. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (COMIRNATY; Batch: FC1433, Expiration date: 31Oct2021) via an intramuscular route of administration on 07Jul2021, as dose 1, single for COVID-19 immunization. On 25Aug2021, 11 days after second vaccination was given, the patient developed Seizure grand mal 2 times of generalised tonic-clonic seizure with app. 30 min interval. The Adverse Drug Reaction was by the reporter reported as resulting in hospitalisation (25Aug2021). The patient underwent lab tests which included electroencephalogram: nothing abnormal on Aug2021, neurological examination: normal on 25Aug2021. No treatment or medical procedure due to the ADRs was reported. There is no indication for prophylactic treatment right now. The outcome for seizure grand mal was recovered on 25Aug2021. Causality: The neurologist concludes that it can be a debut of epilepsy, but the patient will first be diagnosed after a second seizure. 2021 EEG is planned with sleep incl wakening, foto No follow-up attempts possible. No further information expected.


VAERS ID: 1709689 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-08-25
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (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: Fibrillation atrial; Hip prosthesis insertion; Parathyroid hormone
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101149692

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-NT20213589. A 61-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in arm left on 17Jun2021 (Lot Number: FC5435) as DOSE 2, SINGLE for SARS-CoV-2 vaccination. Medical history included hip prosthesis insertion, fibrillation atrial from 2011 to an unknown date, and parathyroid hormone. The patient was not diagnosed with COVID-19 prior to vaccination. The patient''s concomitant medications were not reported. On 25Aug2021, the patient was diagnosed with pulmonary embolism by a cardiologist. The event resulted in emergency room visit. Therapeutic measure was taken as the result of the event which includes treatment with XARELTO 15 mg/day for 3 weeks, then 20 mg/day. Unclear if patient had thrombocytopenia (pending assessment). Outcome of the event was recovering. Since the vaccination, the patient has not been tested for COVID-19. Note: Accountability without prejudice to the elements of investigation that could be carried out as part of legal procedures. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1709690 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-08-25
   Days after vaccination:205
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Cough, Decreased appetite, Dyspnoea, Oxygen saturation, Pyrexia, SARS-CoV-2 test, Tachypnoea, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (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: Medical History/Concurrent Conditions: Adnexectomy (Total hysterectomy with uni or bilateral adnexectomy by laparotomy); Appendicectomy; Balance disorder; Cataract; Cholecystectomy; Craniolacunia; Deep vein thrombosis (Idiopathic left sural deep vein thrombosis in 2012); Fibromyalgia; Glaucoma; Hemorrhoids; Hypertension; Hysterectomy (Total hysterectomy with uni or bilateral adnexectomy by laparotomy); Ischaemic heart disease; Lacunar stroke (Right thalamic lacunar stroke in 2019, sequelae of memory impairment); Laparotomy (Total hysterectomy with uni or bilateral adnexectomy by laparotomy); Memory impairment; Piles; Retrograde urography; Ureteral stent insertion; Wrist fracture (Fracture of both wrists in 1969)
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Oxygen saturation; Test Result: 93 %; Comments: in Ambient air; Test Date: 20210825; Test Name: Covid+ Polymerase Chain Reaction; Result Unstructured Data: Test Result:Positive
CDC Split Type: FRPFIZER INC202101155119

Write-up: Covid-19; COVID-19; Cough; Fever; Asthenia; Respiratory deterioration; Polypnea; Anorexia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20213624. An 88-year-old female patient received bnt162b2 (COMIRNATY, Formulation: solution for injection), dose 2, via an intramuscular route of administration, administered in Arm Left on an unspecified date in Feb2021 (Lot Number: Unknown) as DOSE 2, SINGLE and dose 1, via an intramuscular route of administration, administered in Arm Left on an unspecified date in Jan2021 (Lot Number: Unknown), as DOSE 1, SINGLE, both for covid-19 immunization. Medical history included Glaucoma, Ischaemic heart disease, Right thalamic lacunar stroke in 2019, sequelae of memory impairment, Disorder equilibrium/Balance disorders, hypertension, Idiopathic left sural deep vein thrombosis in 2012, Fibromyalgia, Total hysterectomy with uni or bilateral adnexectomy by laparotomy, Appendicectomy/ McBurney, Placement of a ureteral probe for therapeutic purposes, via retrograde endoscopy on 19Apr2020, Cholecystectomy, Piles, craniolacunia, cataract and Fracture of both wrists in 1969. The patient no medical history of Covid-19. The patient had no known medical history of immunosuppression. The patient concomitant medications were not reported. On an unspecified date in 2021, the patient experienced cough with fever and asthenia, respiratory deterioration, Polypnea and anorexia. On 25Aug2021, the patient experienced Covid-19. The clinical details of the events as follows: Covid positive, on 25Aug2021, due to a cough with fever and asthenia, in a context of multiple Covid positive in the residential care home. Since then, respiratory deterioration with oxygen saturation at 93 percent in Ambient air, Polypnea, asthenia and anorexia. Currently on oxygen therapy. The events covid-19 and vaccination failure were reported as serious with hospitalization and other evets were reported as non-serious. The outcome of the events was Not resolved at the time of this report. NOTE: Accountability without prejudice to the elements of investigation that could be carried out as part of legal procedures. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.


VAERS ID: 1709761 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Haemorrhage, Menstruation irregular, Muscle spasms
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Fertility 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: GEDAREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control pill
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101153151

Write-up: bleeding; period like symptoms; Fatigue; Irregular periods; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109011241238040-VVZF7. Safety Report Unique Identifier GB-MHRA-ADR 25879765. A 22-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 24Aug2021 (Lot number: FE3380, Expiry date: unknown) as single dose for COVID-19 immunisation. Medical history included oral contraception from an unknown date and unknown if ongoing. Concomitant medications included desogestrel, ethinylestradiol (GEDAREL) taken for oral contraception, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunisation. The patient experienced irregular periods on 25Aug2021, period like symptoms, fatigue and bleeding on an unspecified date. The event bleeding considered as medically significant. Patient was on the Gedarel birth control pill and her period was meant to occur between September 5th-9th. However, since having her second COVID-19 vaccine, she had been experiencing period like symptoms. She had been bleeding for a week now, had cramps and had felt more tired than normal. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The clinical outcome of period like symptoms was resolved on unspecified date in 2021. The clinical outcome of events irregular periods was not recovered, while outcome of fatigue and bleeding was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1709815 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram, Fatigue, Pain, Pericarditis, SARS-CoV-2 test, X-ray
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Pericarditis
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Bloods; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210826; Test Name: ECG; Result Unstructured Data: Test Result:heart lining inflammation; Comments: Didn''t know cause, but likely to be heart lining inflammation.; Test Date: 20210827; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Comments: Still had ECG at GP on 27Aug2021- nurse advise was to follow A&E advise.; Test Date: 20210828; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Comments: Same advise as before with regards to medication; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20210826; Test Name: X-Ray; Result Unstructured Data: Test Result:heart lining inflammation; Comments: Didn''t know cause, but likely to be heart lining inflammation.
CDC Split Type: GBPFIZER INC202101153217

Write-up: Exhaustion; Labored breathing; Chest pain; Tight chest; pain; pericarditis; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109031710407950-SHERP, Safety Report Unique Identifier GB-MHRA-ADR 25893727. A 18-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: FE3380 ), dose 2 via an unspecified route of administration on 19Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included pericarditis from an unknown date and unknown if ongoing, historical vaccine. Patient has not had symptoms associated with COVID-19. The patient concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: unknown), dose 1 via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient experienced pain, pericarditis. On 25Aug2021, the patient experienced chest pain and tight chest. On 26Aug2021, the patient experienced exhaustion and labored breathing. The events pain, pericarditis, chest pain and tight chest resulted in emergency room visit. Patient has not tested positive for COVID-19 since having the vaccine.Patient was not enrolled in clinical trial. It was reported that Contacted GP 26Aug- ECG booked for 27Aug. Pain increased later on 26Aug - went to A&E. Bloods, ECG and X-Ray taken. Didn''t know cause, but likely to be heart lining inflammation. Advised to take Ibuprofen and Gaviscon. Still had ECG at GP on 27Aug - nurse advise was to follow A&E advise. Pain worsened on 28Aug - Visited A&E again. Another ECG. Same advice as before with regards to medication. Different doctor, refused to accept Pfizer was a possible cause due to the amount of days since vaccination. 30Aug - visited GP who immediately said the Pfizer was clearly the most obvious cause of probable pericarditis as it was the only different thing in my life! Advised us to report it. Pain/discomfort only now starting to resolve. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unspecified date, No - Negative COVID-19 test , blood test: unknown results on 26Aug2021, electrocardiogram: heart lining inflammation on 26Aug2021 Didn''t know cause, but likely to be heart lining inflammation , electrocardiogram: unknown results on 27Aug2021 Still had ECG at GP on 27Aug2021- nurse advise was to follow A&E advise , electrocardiogram: unknown results on 28Aug2021 Same advise as before with regards to medication , x-ray: heart lining inflammation on 26Aug2021 Didn''t know cause, but likely to be heart lining inflammation. Therapeutic measures were taken as a result of pain (pain), chest pain (chest pain) including treatment with Ibuprofen and Gaviscon.The outcome of pericarditis was resolved, while outcome of other events was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1709960 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
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.MOD20213

Write-up: Dizziness; Headache; Fatigue; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25916275) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headache) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 01-Mar-2020. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 06-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 07-Sep-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. No relevant concomitant medications were reported. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 34 year-old, female subject with a history of Suspected COVID-19, who experienced the unexpected events of Fatigue, Dizziness and Headache. The event occurred approximately after the first dose of Moderna Covid-19 Vaccine. The event was considered related to the study drug. As per the reporter''s assessment it was not known. The benefit-risk relationship of drug mRNA-1273 , is not affected by this report.; Sender''s Comments: This case concerns a 34 year-old, female subject with a history of Suspected COVID-19, who experienced the unexpected events of Fatigue, Dizziness and Headache. The event occurred approximately after the first dose of Moderna Covid-19 Vaccine. The event was considered related to the study drug. As per the reporter''s assessment it was not known. The benefit-risk relationship of drug mRNA-1273 , is not affected by this report.


VAERS ID: 1710253 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-25
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004498 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

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

Write-up: ; This case was received via Agency Regulatory Authority (Reference number: IT-MINISAL02-779144) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM in a 46-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004498) for COVID-19 immunisation. No Medical History information was reported. On 28-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 25-Aug-2021, the patient experienced PULMONARY EMBOLISM (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication use was reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.


VAERS ID: 1710266 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site pain, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (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: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Medicines Agency (Reference number: IT-MINISAL02-779912) on 11-Sep-2021 and was forwarded to Moderna on 11-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of, INJECTION SITE PAIN and NAUSEA in a 13-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 immunisation. No Medical History information was reported. On 25-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 25-Aug-2021, the patient experienced (seriousness criterion medically significant), INJECTION SITE PAIN (seriousness criterion medically significant) and NAUSEA (seriousness criterion medically significant). On 26-Aug-2021, INJECTION SITE PAIN and NAUSEA had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information were provided. No treatment information were provided. After vaccination pain at the injection site. The following day, on awakening, paleness, widespread discomfort with a pronounced sense of nausea and loss of consciousness. The patient is waiting for allergy tests for suspected allergy to flowers with cerchio drops for therapy of 45 days total with frequency from July 23 of 20 drops daily. Company Comment: This case concerns a 13 year-old female patient with no relevant medical history, who experienced the serious unexpected events of Injection site pain, Pallor and Nausea. The events occurred 1 day after the first dose of Spikevax. Causal relationship was not provided by the reporter. The re-challenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2021: Translation document received on 14-Sep-2021: Event verbatim and reporters comment updated; Sender''s Comments: This case concerns a 13 year-old female patient with no relevant medical history, who experienced the serious unexpected events of Injection site pain, Pallor and Nausea. The events occurred 1 day after the first dose of Spikevax. Causal relationship was not provided by the reporter. The re-challenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1710336 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Epilepsy, Poor quality sleep, Seizure cluster
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (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: SODIUM VALPROATE; E KEPPRA; CARBAMAZEPINE; RIVOTRIL; POLAPREZINC; MIYA-BM; MASHININGAN; MAGMITT; FERROUS CITRATE SODIUM; LIXIANA; CINAL [ASCORBIC ACID;CALCIUM PANTOTHENATE]; SENNOSIDE A+B; HANGEKOBOKUTO [MAGNOLIA SPP. BARK;PERILLA FRUTESCEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral palsy; Epilepsy
Allergies:
Diagnostic Lab Data: Test Name: Blood Test; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101154158

Write-up: wakefulness; seizure cluster; seizure cluster of epilepsy; This is a spontaneous report from a contactable physician received from the Agency (A). Regulatory authority report number is v21125803. The patient was a 53-year and 10-month-old female. Body temperature before vaccination was 36.3 degrees Centigrade. The patient had no family history. The patient had history of cerebral palsy and epilepsy. The patient had no allergy history. No history of vaccination or worsen symptoms in the last month, and no history of side effects due to vaccination. The patient received BNT162B2 (COMIRNATY; Lot Number: FF3620; Expiration Date: 30Nov2021), via an unspecified route of administration on 24Aug2021 15:36 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. Concomitant medications included sodium valproate taken orally and ongoing; levetiracetam (E KEPPRA) taken orally and ongoing; carbamazepine taken orally and ongoing; clonazepam (RIVOTRIL) taken orally and ongoing; polaprezinc taken orally and ongoing; clostridium butyricum (MIYA-BM) taken orally and ongoing; cannabis sativa fruit, citrus spp. unripe fruit, magnolia spp. bark, paeonia lactiflora root, prunus spp. seed, rheum spp. rhizome (MASHININGAN) taken orally and ongoing; magnesium oxide (MAGMITT) taken orally and ongoing; ferrous citrate sodium taken orally and ongoing; edoxaban tosilate (LIXIANA) taken orally and ongoing; ascorbic acid, calcium pantothenate (CINAL) taken orally and ongoing; sennoside a+b taken orally and ongoing; magnolia spp. bark, perilla frutescens var. crispa herb, pinellia ternata tuber, poria cocos sclerotium, zingiber officinale fresh rhizome (HANGEKOBOKUTO [MAGNOLIA SPP. BARK;PERILLA FRUTESCENS VAR. CRISPA HERB;PINELLIA TERNATA TUBER;PORIA COCOS SCLEROTIUM;ZINGIBER OFFICINALE FRESH RHIZOME]) taken orally and ongoing. On 25Aug2021 at 05:15 (1 day after the vaccination), the patient experienced seizure cluster. The course of the event was as follows: Seizure was under control by taking anticonvulsants drug orally in daily life. On 24Aug2021 in the afternoon, the patient received the vaccination. On 25Aug2021, at early dawn, seizure cluster of epilepsy started. It was difficult to control seizure with oral medications, and drip of Dormicum was performed for sedation. On 30Aug2021, wakefulness alleviated, and seizure cluster disappeared. On 30Aug2021 (6 days after the vaccination), the outcome of the event was recovering. Blood Test was performed. No electroencephalogram was scheduled currently. The reporting physician classified the event as serious (risk of disability) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was original epilepsy. The reporting physician commented as follows: The causality between the event and bnt162b2 as unassessable due to poor control of seizure in daily life.


VAERS ID: 1710343 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Electrocardiogram, Myocarditis
SMQs:, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Sjogren''s syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Blood sampling; Result Unstructured Data: Test Result:high troponin; Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Comments: pyrexia; Test Date: 20210825; Test Name: electrocardiogram; Result Unstructured Data: Test Result:ST elevated
CDC Split Type: JPPFIZER INC202101154856

Write-up: acute perimyocarditis; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21125778. A 52-year-old male patient received BNT162B2 (COMIRNATY; Solution for injection; Lot number EY0573; Expiration date 30Sep2021), via an unspecified route of administration on 25Aug2021 (the day of vaccination) as dose 2, single for COVID-19 immunisation. Medical history included Sjogren''s syndrome. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.6 degrees Centigrade on 25Aug2021. The patient had no family history. The Patient previously received BNT162B2 (COMIRNATY; Lot number: not reported; Expiration date: not reported), via an unspecified route of administration on 04Aug2021 as dose 1, single for COVID-19 immunisation. The patient experienced acute perimyocarditis on 25Aug2021. The patient was hospitalized for acute perimyocarditis from 28Aug2021 to 01Sep2021. The course of the event was as follows: On 04Aug2021, the patient received the first novel coronavirus vaccination (no side reaction). On 25Aug2021, the patient received the second novel coronavirus vaccination. In the evening, the patient had pyrexia of 38 degrees Centigrade and headache. On 27Aug2021, from the evening, the patient was aware of pharyngodynia, inspiratory chest pain. On 28Aug2021, the patient visited this hospital, electrocardiogram showed ST elevated. Blood sampling resulted in high troponin. It was suspected as acute perimyocarditis due to side reaction of vaccine, and the patient was hospitalized. On 29Aug2021, after taking Aspirin by oral, the symptoms improved. On 01Sep2021, the patient was discharged and went home. On 01Sep2021 (7 days after the vaccination), the outcome of the event was recovered. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. Other possible cause of the event such as any other diseases was Sjogren''s syndrome. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: As the result of the careful examination after hospitalization, this case was considered as acute perimyocarditis due to side reaction of novel coronavirus vaccine.


VAERS ID: 1710397 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004733 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dermatitis allergic
SMQs:, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Allergic dermatitis; This case was received via Takeda Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP085895) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DERMATITIS ALLERGIC (Allergic dermatitis) in a 51-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004733) for COVID-19 vaccination. No Medical History information was reported. On 25-Aug-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced DERMATITIS ALLERGIC (Allergic dermatitis) (seriousness criterion hospitalization). At the time of the report, DERMATITIS ALLERGIC (Allergic dermatitis) was resolving. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DERMATITIS ALLERGIC (Allergic dermatitis) to be possibly related.; Reporter''s Comments: Not reported.; Sender''s Comments: This case concerns a 51 year old female patient with unknown medical history, who experienced an unexpected serious event of allergic dermatitis. The serious event occurred same day after the first dose of mRNA-1273 vaccine. Very limited information regarding the events have been provided at this time. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1710474 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Gastric haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (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: Body mass index low
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210927726

Write-up: GASTROINTESTINAL BLEEDING; This spontaneous report received from a consumer via Regulatory Authority (Regulatory Authority, NL-LRB-00675003) on 13-SEP-2021 and concerned a 27 year old male. The patient''s weight was 62 kilograms, and height was 190 centimeters. The patient''s concurrent conditions included: body mass index low. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD974 expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 01-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 25-AUG-2021, the patient experienced stomach bleeding, and was hospitalized on unspecified date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach bleeding. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1710562 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5029 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Blood pressure fluctuation, Blood pressure measurement, Investigation, Loss of consciousness, Nasal congestion, Respiratory arrest, Syncope
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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:110/40 mmHg; Test Name: tests; Result Unstructured Data: Test Result:correct
CDC Split Type: PLPFIZER INC202101150322

Write-up: she lost consciousness; double fainting; stopped breathing for a while; pressure jumps (110/40 mmHg); she became stuffy; stomach hurt; This is a spontaneous report from a contactable consumer via Medical Information Team (patient''s parent). A 15-year-old female patient (reporter''s daughter) received bnt162b2 (Pfizer), dose 1 via an unspecified route of administration, at age 15 years, on 25Aug2021 (Batch/Lot Number: FC5029; Expiration Date: 18Sep2021) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The 15-year-old patient was given the first dose of vaccine 25Aug2021. At night after vaccination (25Aug2021), she became stuffy and her stomach hurt. The next morning (26Aug2021) she lost consciousness, had a double fainting and stopped breathing for a while, had pressure jumps (110/40 mmHg). She was hospitalized on an unspecified date in 2021. All the tests done so far came out correct. Doctors suspect a post-vaccination reaction. Reporter also wanted to verify the expiration dates of the vaccine given to her and her daughter. Series numbers: EW9127, FA7842, FC5029. The outcome of the events was unknown.


VAERS ID: 1710599 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARBAMAZEPINE; VALPROIC ACID; LEVETIRACETAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Epilepsy; Comments: Personal history of epilepsy, not taking usual medication adequately. Infection by COVID-19 on Feb-2021
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210928828

Write-up: CONVULSIVE SEIZURE; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202108-3503) on 15-SEP-2021 and concerned a 21 year old male. The patient''s height, and weight were not reported. The patient''s past medical history included: covid-19 infection on FEB-2021, and concurrent conditions included: epilepsy. Patient was not taking usual medication adequately. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C19-02) .5 ml, 1 total (single dose), administered on 25-AUG-2021 for covid-19 immunisation. The duration of drug administration was 0 days. Concomitant medications included carbamazepine for drug used for unknown indication, levetiracetam for drug used for unknown indication, and valproic acid for drug used for unknown indication. On 25-AUG-2021, the patient experienced convulsive seizure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from convulsive seizure on 25-AUG-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Concomitant Medication-Valproic acid 300mg; Valproic acid 500mg; Levetiracetam 1000mg; Carbamazepine 400mg Did Medication Error Occur -No. Other information-Personal history of epilepsy, not taking usual medication adequately COVID-19 infection in Feb-2021


VAERS ID: 1710665 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Hypoaesthesia oral
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC202101155048

Write-up: numbness in the lips, tongue and arm; numbness in the lips, tongue and arm; numbness in the lips, tongue and arm; This is a spontaneous report from a contactable consumer (patient) received from the Health Authority (AM), regulatory authority report number E-54398317-510.01.05-526745. An 18-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number not reported) via an unspecified route of administration in the arm on 25Aug2021 (at 18-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 25Aug2021 the patient experienced numbness in the lips, tongue, and arm, reported as serious. The patient was treated with two drugs and serums intravenously, the names of which the reporter did not know. The outcomes of the events were recovered on 25Aug2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1713179 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4421 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hyperhidrosis, Thirst
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic (Moderate glucose control); Hypertension (Good BP control)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202101126537

Write-up: Excessive sweating; Feeling thirsty; This is a spontaneous report from a contactable other (Nurse). A 68-years-old male patient received bnt162b2 (BNT162B2), dose 2 on 25Aug2021 14:36 (Batch/Lot Number: FG4421; Expiration Date: 30Nov2021) as DOSE 2, SINGLE for covid-19 immunization. Medical history included hypertension -Good BP control, diabetes mellitus - Moderate glucose control, on medication for both hypertension and diabetes. The patient''s concomitant medications included unspecified medications for both hypertension and diabetes. On 25Aug2021, the patient experienced excessive sweating, feeling thirsty. The patient was hospitalized from 25Aug2021 to an unknown date. Outcome of events was recovered on unknown date.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events excessive sweating, feeling thirsty and the suspect drug BNT162B2 cannot be excluded. The case will be re-assessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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, as appropriate.


VAERS ID: 1715941 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-25
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Intestinal ischaemia
SMQs:, Ischaemic colitis (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Depression; Dyslipidaemia; Ex-alcoholic; Ex-smoker; Hypertension arterial
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210934348

Write-up: MESENTERIC ISCHAEMIA; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, FR-AFSSAPS-AN20213599) on 17-SEP-2021 and concerned a 58 year old male. The patient''s weight was 113 kilograms, and height was 185 centimeters. The patient''s concurrent conditions included: depression, dyslipidaemia, ex-smoker, ex-alcoholic, and hypertension arterial. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 12-AUG-2021 for covid-19 vaccination. The duration of drug administration was 1 day. The drug start period and drug last period was 14 days. No concomitant medications were reported. On 25-AUG-2021, the patient experienced mesenteric ischaemia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from mesenteric ischaemia. This report was serious (Life Threatening).


VAERS ID: 1716277 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness transient, Fall, Loss of consciousness, Pallor, Tinnitus
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), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), 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:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101155736

Write-up: a little pale; blackout/lost consciousness; falls to the ground; blindness transient/loss of vision; ear ringing; This is a spontaneous report from a contactable consumer (parent) downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number ES-AEMPS-989975. A 19-year-old male patient received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on 24Aug2021 (batch/lot number FE8235 and expiry date unknown) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25Aug2021, the patient experienced blackout, blindness transient, ear ringing. The patient''s mother informed that the day after the administration of the vaccine, while the patient was with his friends, he began to notice ringing in the ears and loss of vision. The patient falls to the ground (indicates that because he has lost consciousness) but regains it after a few seconds. A friend wanted to call an ambulance but as the patient recovers, they didn''t. The patient''s vision was fully restored within 5 minutes. The patient did not tell anything at home but the mother saw him a little pale because of what he asked and in the end he told her what happened. The events blackout/lost consciousness, falls to the ground, blindness transient/loss of vision were considered serious (medically significant). The outcome of the event a little pale was unknown, while recovered on 25Aug2021 for the rest of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1716852 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary mass, Influenza like illness, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101161076

Write-up: Swollen glands; Axillary lump; Flu-like aching; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109051236327820-9OKFG, Safety Report Unique Identifier GB-MHRA-ADR 25897093. A 26-year-old female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 24Aug2021 (Batch/Lot Number: FE3380) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 with unknown lot number for COVID-19 immunization. The patient experienced swollen glands on 25Aug2021 with outcome of recovered on 30Aug2021, axillary lump on 25Aug2021 with outcome of recovered on 29Aug2021, flu-like aching on 25Aug2021 with outcome of recovered on 28Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on 03Sep2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19. Patient was not pregnant, patient was not currently breastfeeding. All events were reported as medically significant. No follow-up attempts are possible. No further information is expected


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